78
Role of NIH Grants Management Specialist Anneliese Galczynski, Grants Management Specialist National Human Genome Research Institute (NHGRI) H3Africa Grants Management Webinar December 7, 2017

Role of NIH Grants Management Specialist

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Role of NIH

Grants Management

Specialist

Anneliese Galczynski Grants Management Specialist

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Who is the Grant Management

Officer (GM0) hellip

Monitors administrative and fiscal aspects of grants

Obligates expenditure of funds and permits changes to the approved projects

Responsible for ensuring that all parties met all requirement of laws regulations and formally established policies

2

Who is the Grant Management

Specialist (GMS) hellip

Acts as an agent of the GMO and

oversees the day-to-day business

and non- programmatic aspects of

the award

3

GMSrsquos Responsibilities

Evaluates administrative and budgetary content of applications reviews for compliance with NIH policy

Negotiates awards

Requests all JIT (human subject ethics approvals HS education and other support)

Issues Notice of Awards (NoA) using current funding policy

Provided technical assistance with the interpretation of NIH and Institute grants policies

Responds to post-award requests (prior approval request such as carryover request no cost extensions requests etc)

4

When to Contact your GMS

MANDATORY

You must contact a grants management specialist for any of the following events

Delay in completing paperwork required to issue your award

Any action that requires NHGRIs prior approval

5

When to Contact your GMS

(continued)

Recommended

We also recommend that you contact a grants

management specialist for the following

Questions about your budget or other support on

your grant

Questions about any terms and conditions on your

Notice of Award

Clarification of NIH or NHGRI grant policies

Any issue that your business office does not handle

or cannot advise you about

6

Where to find out who is the

assigned GMS for your grant

As your GMS can change from

time to time the best place to

look for current GMS is in the

eRA commons under the

current grant award

7

Questions

8

Thank youAnneliese Galczynski Grants Management Specialist NHGRIgalczynskiamailnihgov+1 301 443-7935

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Who is the Grant Management

Officer (GM0) hellip

Monitors administrative and fiscal aspects of grants

Obligates expenditure of funds and permits changes to the approved projects

Responsible for ensuring that all parties met all requirement of laws regulations and formally established policies

2

Who is the Grant Management

Specialist (GMS) hellip

Acts as an agent of the GMO and

oversees the day-to-day business

and non- programmatic aspects of

the award

3

GMSrsquos Responsibilities

Evaluates administrative and budgetary content of applications reviews for compliance with NIH policy

Negotiates awards

Requests all JIT (human subject ethics approvals HS education and other support)

Issues Notice of Awards (NoA) using current funding policy

Provided technical assistance with the interpretation of NIH and Institute grants policies

Responds to post-award requests (prior approval request such as carryover request no cost extensions requests etc)

4

When to Contact your GMS

MANDATORY

You must contact a grants management specialist for any of the following events

Delay in completing paperwork required to issue your award

Any action that requires NHGRIs prior approval

5

When to Contact your GMS

(continued)

Recommended

We also recommend that you contact a grants

management specialist for the following

Questions about your budget or other support on

your grant

Questions about any terms and conditions on your

Notice of Award

Clarification of NIH or NHGRI grant policies

Any issue that your business office does not handle

or cannot advise you about

6

Where to find out who is the

assigned GMS for your grant

As your GMS can change from

time to time the best place to

look for current GMS is in the

eRA commons under the

current grant award

7

Questions

8

Thank youAnneliese Galczynski Grants Management Specialist NHGRIgalczynskiamailnihgov+1 301 443-7935

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Who is the Grant Management

Specialist (GMS) hellip

Acts as an agent of the GMO and

oversees the day-to-day business

and non- programmatic aspects of

the award

3

GMSrsquos Responsibilities

Evaluates administrative and budgetary content of applications reviews for compliance with NIH policy

Negotiates awards

Requests all JIT (human subject ethics approvals HS education and other support)

Issues Notice of Awards (NoA) using current funding policy

Provided technical assistance with the interpretation of NIH and Institute grants policies

Responds to post-award requests (prior approval request such as carryover request no cost extensions requests etc)

4

When to Contact your GMS

MANDATORY

You must contact a grants management specialist for any of the following events

Delay in completing paperwork required to issue your award

Any action that requires NHGRIs prior approval

5

When to Contact your GMS

(continued)

Recommended

We also recommend that you contact a grants

management specialist for the following

Questions about your budget or other support on

your grant

Questions about any terms and conditions on your

Notice of Award

Clarification of NIH or NHGRI grant policies

Any issue that your business office does not handle

or cannot advise you about

6

Where to find out who is the

assigned GMS for your grant

As your GMS can change from

time to time the best place to

look for current GMS is in the

eRA commons under the

current grant award

7

Questions

8

Thank youAnneliese Galczynski Grants Management Specialist NHGRIgalczynskiamailnihgov+1 301 443-7935

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

GMSrsquos Responsibilities

Evaluates administrative and budgetary content of applications reviews for compliance with NIH policy

Negotiates awards

Requests all JIT (human subject ethics approvals HS education and other support)

Issues Notice of Awards (NoA) using current funding policy

Provided technical assistance with the interpretation of NIH and Institute grants policies

Responds to post-award requests (prior approval request such as carryover request no cost extensions requests etc)

4

When to Contact your GMS

MANDATORY

You must contact a grants management specialist for any of the following events

Delay in completing paperwork required to issue your award

Any action that requires NHGRIs prior approval

5

When to Contact your GMS

(continued)

Recommended

We also recommend that you contact a grants

management specialist for the following

Questions about your budget or other support on

your grant

Questions about any terms and conditions on your

Notice of Award

Clarification of NIH or NHGRI grant policies

Any issue that your business office does not handle

or cannot advise you about

6

Where to find out who is the

assigned GMS for your grant

As your GMS can change from

time to time the best place to

look for current GMS is in the

eRA commons under the

current grant award

7

Questions

8

Thank youAnneliese Galczynski Grants Management Specialist NHGRIgalczynskiamailnihgov+1 301 443-7935

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

When to Contact your GMS

MANDATORY

You must contact a grants management specialist for any of the following events

Delay in completing paperwork required to issue your award

Any action that requires NHGRIs prior approval

5

When to Contact your GMS

(continued)

Recommended

We also recommend that you contact a grants

management specialist for the following

Questions about your budget or other support on

your grant

Questions about any terms and conditions on your

Notice of Award

Clarification of NIH or NHGRI grant policies

Any issue that your business office does not handle

or cannot advise you about

6

Where to find out who is the

assigned GMS for your grant

As your GMS can change from

time to time the best place to

look for current GMS is in the

eRA commons under the

current grant award

7

Questions

8

Thank youAnneliese Galczynski Grants Management Specialist NHGRIgalczynskiamailnihgov+1 301 443-7935

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

When to Contact your GMS

(continued)

Recommended

We also recommend that you contact a grants

management specialist for the following

Questions about your budget or other support on

your grant

Questions about any terms and conditions on your

Notice of Award

Clarification of NIH or NHGRI grant policies

Any issue that your business office does not handle

or cannot advise you about

6

Where to find out who is the

assigned GMS for your grant

As your GMS can change from

time to time the best place to

look for current GMS is in the

eRA commons under the

current grant award

7

Questions

8

Thank youAnneliese Galczynski Grants Management Specialist NHGRIgalczynskiamailnihgov+1 301 443-7935

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Where to find out who is the

assigned GMS for your grant

As your GMS can change from

time to time the best place to

look for current GMS is in the

eRA commons under the

current grant award

7

Questions

8

Thank youAnneliese Galczynski Grants Management Specialist NHGRIgalczynskiamailnihgov+1 301 443-7935

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Questions

8

Thank youAnneliese Galczynski Grants Management Specialist NHGRIgalczynskiamailnihgov+1 301 443-7935

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Grants Compliance -

Strategies for Success

Deanna Ingersoll Chief Grants Management Officer

National Human Genome Research Institute (NHGRI)

H3Africa Grants Management Webinar

December 7 2017

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Compliance ishelliphellip

The effective management of public

funds to maximize research outcomes

The avoidance of fraud institutional

mismanagement and poor management

of Federal funds

10

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Recipientrsquos Responsibilities

Safeguarding all assets

Spending funds in accordance with the authorized purpose

Developing and implementing systems to ensure proper stewardship of funds

Financial management systems

Procurement systems

Payroll Distribution systems

Monitoring activities

Adherence to terms amp conditions of award

11

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Compliance Requirements

Institutional Policies

Organizational Structure

Purchasing

AccountingBudgetary Controls

Payroll Distribution

Travel

Consulting

Property Management

EthicsConflict of Interest12

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

HHS Regulations

45 CFR Part 75 ndash Public Welfare Uniform

Administrative Requirements Cost

Principles and Audit Requirements for HHS

Awards

Effective for all HHS awards made on or

after December 26 2014

httpwwwecfrgovcgi-bintext-

idxnode=pt45175amprgn=div5

13

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Compliance Requirements

Administrative Requirements or Standards 45 CFR Part 75 - Subpart C ndash Pre-Federal Award Requirements

and Contents of Federal Awards (sect 75200 ndash sect 75218)

45 CFR Part 75 - Subpart D ndash Post Federal Award Requirements

(sect 75300 ndash sect 75391)

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due 14

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Compliance Requirements

Cost Principles

45 CFR Part 75 Subpart E (sect 75400- sect 75477)

Institutions of Higher Education (IHE) State Local Governments and Indian Tribes and Non-profit Organizations

45 CFR Part 75 Appendix IX

Hospitals

48 CFR Subpart 312 (Federal Acquisition Regulation)

For-Profit Institutions 15

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Compliance Requirements

Audit Requirements

45 CFR 75501 Institutions of Higher Education States and Local Governments and Non-Profit Organizations including Non-Profit Hospitals

45 CFR 75501(h) through (k) For-Profit Organizations including For-Profit Hospitals

NIH Grants Policy Statement Foreign Organizations must follow the same requirements as For-Profit Organizations

16

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Audit Requirements

17

Applicable to Non-Federal Entity Fiscal

Years Beginning on or after 12262014

For-Profit and Foreign Organization

audit requirement

Expend $750000 under one or more

Department of Health and Human Services

awards (as a direct recipient andor

consortium participant)

bull Audits are due within the earlier of 30 days after receipt of the

auditorrsquos report(s) or 9 months after the end of the recipientrsquos audit

period

Recipients delinquent in submitting audits risk the imposition of sanctions

and potential loss of Federal funds

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Summary of Audit Requirements

httpsoampodnihgovdfasfaqfor-profit-auditswhere

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Summary of Federal

Requirement References

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Compliance Requirements

NIH Grants Policy Statement (GPS) 2017

Including any addenda in effect as of the beginning

date of the budget period

httpsgrantsnihgovgrantspolicynihgpsHT

ML5introductionhtm

Notice of Award (NoA)

NIH Guide to Grants and Contracts (for

new requirements)

httpgrantsnihgovgrantsguideindexhtml

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Grant Award Basics

21

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Read the Notice of Award

Terms of Award ndash Section III 45 CFR Part 75 ndash HHS rules and

requirements that govern the administration of grants

NIH Grants Policy Statement (GPS) ndash policy requirements that serve as the terms and conditions of NIH awards

Special Terms and Conditions ndashSection IV

22

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Who is Responsible for

Post-Award Financial Management

A The Principal Investigator

B The Departmental Administrator

C The Department Chair

D The Institution ndash Awards are made to

institutions not people The ultimate

responsibility is the institutionrsquos

23

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Compliance Pitfalls

Unallowable costs

Misallocation of costs

Excessive cost transfers

Inaccurate effort reporting

Inadequate sub-recipient monitoring

Administrative amp Clerical costs

Noncompliance with Assurances and special terms and conditions of award

Delinquent closeout reporting

24

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Accounting

Administrative Standards in 45 CFR 75 requires

Separate account is established for each project

Program Income is identified and accounted for by project

Program Income is used in accordance with the appropriate alternative ie

Additive

Deductive

Combination

Matching 25

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Accounting (cont)

Requires thatExpenses are charged in accordance

with

NoA Terms and Conditions

NIH Grants Policy Statement

Including addenda in effect as of the beginning date of the budget period

Salary Cap Rate Limitation

Cost Accounting Standards

Federal regulations

All expenses are appropriately documented

26

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Monitoring

Institutions should ensureActual expenses are periodically compared with

budget

Actual expenses are accurate ie reasonable allocable allowable and consistently charged

Mischarges are corrected in a timely manner (cost transfers)

Prior approvals are obtained when required

Subrecipient expenses are monitored ndash(Recipientrsquos responsibility to monitor expenses)

27

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Budget vs Actual

Actual expenses should be compared to the

budget to ensure

Total funds on the grant have not been

exceeded

Total funds are used appropriately

Total funds for any cost category have not

been exceeded if restricted on the NoA

28

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Accurate Charges

Actual expenses should be reviewed to ensure

they are accurate and allowable

Reasonable (including necessary)

Allocable

Consistently applied

Conforms to any limitations or exclusions

29

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Selected Items Requiring

Prior Approval NIH Grants Policy Statement defines actions

requiring NIH prior approval

Examples of prior approval actions include the following

Carryover of funds (if required-see Section III of NoA)

Incurrence of pre-award costs greater than 90 days

Deviation from award terms and conditions

Activities disapproved or restricted as a condition of award

For a complete listing of NIH prior approval

requirements see

NIH GPS 812 Prior Approval Requirements30

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Carryover of Funds

Requests for carryover of funds should be signed by

Authorized Organization Representative

Request must be sent to GMO and include

Detailed budget by direct cost category with FampA cost

information (base and rate) If personnel costs are

requested include

a detailed breakdown of personnel costs

base salary

salary requested

effort to be spent on the project

A scientific justification for the use of funds

The reason for the unobligated balance

31

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

A Rule of Thumb

Whenever you are contemplating a significant

post award change and you are uncertain

about the need for prior approval consult in

advance with

The Notice of Award (terms and

conditions)

Your Office for Sponsored

ResearchProjects

NIH awarding component Grants

Management OfficerSpecialist

32

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Financial Reporting

Federal Financial Report (FFR)(SF-425)

Expenditure Data

Timely - Must adhere to submission deadlines

Annual ndash (Non-SNAP Awards)

FFR submitted for each budget period no later than 90

days after the end of the calendar quarter (CQ) in which

the budget period ended

Budget period ends 1312016 ndash FFR due 63016

(90 days after the end of the CQ of 33116)

Final (End of Competitive Segment) ndash (SNAP and Non-SNAP

Awards)

FFR submitted within 120 days following the end of the

project period

(SNAP ndash Streamlined Non-competing Award Process)33

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Financial Reporting

bull FFRs should be submitted timely and accurately

bull Reported expenses and program income must agree with institutional accounting records

bull Routine Revisions to correct FFRs are not appropriate

34

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Financial Reporting

Financial Reporting information

FFR (SF425) Instructions for NIH Recipients available at httpgrantsnihgovgrantsformshtm

NIH Guide Notices

NOT-OD-15-136

NOT-OD-15-135

NOT-OD-15-111

35

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Final Closeout Reporting

36

Recipients must submit the following documents

when required within 120 calendar days of the end

of the period of performance

Final Federal Financial Report (FFR) SF-425

Expenditure Data (submitted through eRA Commons)

Final RPPR

Final Inventions Statement amp Certification

Timely and accurate closeout reporting is a recipient

responsibility Failure to submit reports on time will result in

unilateral closeout initiation Please see recent Guide Notice

NOT-OD-18-107

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Final Research Performance

Progress Reports (F-RPPR)

The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout effective January 1 2017

The general format is the same as the interimannual RPPR

Recipients are required to report on Project Outcomes

Due dates have not changed

See NOT-OD-17-022 for additional information

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Interim-Research Performance

Progress Reports (I-RPPR)Effective February 9 2017 NIH requires that

organizations submit an ldquoInterim-RPPRrdquo while their

renewal application (Type 2) is under consideration

In the event that the Type 2 is funded NIH will

treat the Interim-RPPR as the annual

performance report for the final year of the

previous competitive segment

If the Type 2 is not funded NIH will treat the

Interim-RPPR as the institutionrsquos Final-RPPR

Like the Final-RPPR recipients are required to report on

Project outcomes in the Interim-RPPR

See NOT-OD-17-037 for additional information

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Closeout Requirements

39

NIH must initiate unilateral closeout as an action of last resort if a recipient

does not

provide timely accurate closeout reports or

respond to NIH requests within 270 days after the end date of the period of performance to reconcile discrepancies in grant records

See NOT-OD-14-084 at

httpsgrantsnihgovgrantsguidenoti

ce-filesNOT-OD-14-084html

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Unilateral Closeout Reminder

40

Failure to submit an acceptable final FFR in a timely manner may result in disallowed costs or federal debt

If the final FFR expenditure data does not match the last FFR cash disbursement amount in PMS

NIH must use the lower amount

Recipients must ensure there are no discrepancies between final FFR expenditure data (in eRA Commons) and the FFR cash transaction data (in Payment Management System [PMS])

The FFR module in eRA Commons will display a text reminder before submitting the Final FFR

Unilateral Closeout emphasizes the need for TIMELY and ACCURATE reporting

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Closeout NIH Centralized

Processing Center

41

NIH Centralized closeout office still accepts receipt of the HHS 568 Final Invention Statement and Certification via emailed PDF attachment fax or mail

NIH Centralized Processing Center

6705 Rockledge Drive Suite 5016 MSC 7986

Bethesda MD 20892-7986 (for regular or US Postal Service Express mail)

Bethesda MD 20817 (for other courierexpress mail only)

NIHCloseoutCentermailnihgov

Fax 301-480-2304

Recipients are required to submit the FinalInterim RPPR and the Final FFR electronically through the Closeout feature in the eRA Commons

Recipients are strongly encouraged to submit the HHS 568 Final Invention Statement amp Certification electronically through the eRA Commons

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Reminder Submit Timely Reports

Progress Reports financial and final reports should be submitted on

time to avoid consequences

Failure to submit timely reports may adversely affect future NIH

funding to

The Grantee Institution

The Principal Investigator

NIH may impose sanctions on institutions that do not meet these

reporting requirements including

Corrective actions

Removal of expanded authorities

Delay or withholding of future awards to the project or

program42

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Financial Conflict of Interest

(FCOI)

What is the Regulation

42 CFR Part 50 Subpart F (grants and cooperative agreements)

Revised Final Rule published on 8-25-11

httpwwwgpogovfdsyspkgFR-2011-08-25pdf2011-21633pdf

43

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

What is the Purpose of the

Regulation

This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest

44

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Financial Conflict of Interest

(FCOI)

Who is Covered

Each Institution that applies for or receives PHSNIH grants or cooperative agreements for research

Domestic foreign public private (not Federal)

Any Investigator as defined by the regulation planning to participate in or participating in the research

45

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Significant Financial Interest (SFI)

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigatorrsquos spouse and dependent children) that reasonably appears to be related to the Investigatorrsquos institutional responsibilities

(i) With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure when aggregated exceeds $5000hellipincludes salary and any payment for services not otherwise identified as salary (eg consulting fees honoraria paid authorship) equity interest includes any stock stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value

46

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

SFI continued(ii) With regard to any non-publicly traded entity a

significant financial interest exists if the value of any

remuneration received from the entity in the twelve

months preceding the disclosure when aggregated

exceeds $5000 or when the Investigator (or the

Investigatorrsquos spouse or dependent children) holds any

equity interest (eg stock stock option or other

ownership interest) or

(iii) Intellectual property rights and interests (eg patents

copyrights) upon receipt of income related to such rights

and interests

47

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

More SFIhellip(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (ie that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their Institutional responsibilities provided however that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation

But waithellipthere are some exclusionshellip

48

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

SFI exclusions

Salary royalties or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution

Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights

Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization

Income from investment vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

49

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

More SFI exclusionshellip

Income from seminars lectures or teaching

engagements sponsored by a federal state or local

government agency an Institution of higher education

as defined at 20 USC 1001(a) an academic teaching

hospital a medical center or a research institute that

is affiliated with an Institution of higher education or

Income from service on advisory committees or review

panels for a federal state or local government agency

Institution of higher education as defied at 20 USC

1001(a) an academic teaching hospital a medical

center or a research institute that is affiliated with an

Institution of higher education

50

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Investigator SFI Disclosure and Institutional FCOI Reporting Requirements

Investigator Discloses known SFI(s) to the Institution

Institution Reports identified FCOI(s) to the NIH (Designated official(s) review the

disclosures to make determinations of FCOIs and report any FCOIs to NIH)

At time of Application Prior to the Expenditure of Funds

Within 30 days of acquiring or discovering SFI

Within 60 days of identification

Annually at the time period prescribed by the Institution during the award period

Annually At the same time as when the grantee is required to submit the annual progress report including multi-year progress report or at time of extension Annual FCOI report is submitted through eRA Commons FCOI Module

51

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

52

REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE

Report Content Required when

Initial FCOIReport

Grant Number PI Name of Entity with FCOI Nature of FCOI Value of financial interest (in increments) Description of how FI relates to research Key Elements of Management Plan

(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI

Annual FCOI Report

Status of FCOI and Changes to Management Plan

Annual report due at the same time as when the grantee is required to submit annual progress report multi-year progress report or at time of extension

Revised FCOI Report

If applicable update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward

After completion of retrospective review if needed

MitigationReport

Project Number Project Title Contact PIPD Name of Investigator with FCOI Name of Entity with FCOI Reason for review Detail Methodology Findings and Conclusion

When bias is found as a result of a retrospectivereview

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

FCOI resources

Mailbox for inquiries

FCOICompliancemailnihgov

OER FCOI Web Site

httpgrantsnihgovgrantspolicycoi

FAQs are periodically updated

53

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Questions

54

Thank youDeanna Ingersoll Chief Grants Management Officer NHGRIDeannaIngersollnihgov+1 301 435 7858

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

NOTICE OF AWARD

Jill A SalettaGrants Management Specialist

H3Africa Grants Management WebinarDecember 7 2017

55

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Notice of Award (NoA)What is it and why should grantees care

Is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office

Is issued for the initial budget period (up to 12 months) and each subsequent budget period in the approved project period The NoAreflects any future-year commitments

Describes all terms and conditions of the award including the reporting requirements

A new NoA will be issued for each year of the project

56

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Notice of Award Notification

NIH notifies the recipient organization via email when an award has been issued (otherwise called the Federal award date)

IMPORTANT in order for the recipient organization to receive this email notification it must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete

NIH will not distribute NoAs other than through this system-generated email notification process

Recipients that do not maintain a current NoA notification email address will be responsible for accessing the NoAs via the eRA Commons

57

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Notice of Award (NoA)

Contains many important details about the granthellip

Federal award date

Applicationgrant identification number (grant number)

Federal award identification number (FAIN)

Name of recipients organization

Name(s) of the PDPI(s)

Name(s) of Seniorkey personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs

Approved period of performance start and end dates

Budget approved by the NIH awarding IC

Total amount of Federal funds obligated (federal share)

58

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Notice of Award (NoA)Contains many important details about the granthellip

Total approved cost sharing or matching where application (Non-Federal share)

Total amount of the Federal award

Amount of anticipated future-year commitments (if applicable)

Federal award project description (Project title)

Names of the cognizant IC PO GMO and GMS

CFDA Name and Program Name

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75414)

Applicable terms and conditions of award either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final RPPR when applicable)

Any restriction on the use of funds 59

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Sample Grant Number

1 R01 HG 012345 01 A1S1

60

Year of SupportInstituteCenter

Application

Type

Activity Code

Serial Number Suffixes

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Understanding Grant Numbers

A grant number provides a unique identification for the grant

Grant Number 1R01HG11854701A1

Type CodeActivity CodeInstitute Code (Admin OrgSerial NoSupport (Budget) YearSuffix Code (supplements amendments or fellowship institutional allowances)

Application Type Code - the Type code indicates whether the application is new a renewal a noncompeting applications or other type

Activity Code - the Activity code lists the type of grant that has been applied for (research projects fellowships training)

Institute Code (Administrating Organization) - the Institute code (also known as the IC or InstituteCenter code) is a two-letter code for the name of the NIH Institute or Center

Serial Number - the serial number is a unique five or six digit number that identifies the specific application and is assigned by the NIH Center for Scientific Review (CSR)

Support Year - the Support Year indicates the current year of support (for example 01 is a new grant)

Suffix Code - the Suffix Code (optional) is a code used for supplements amendments or fellowship institutional allowances 61

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Application Types (most common)

Type 1 New Competing Award (new applications that must undergo initial peer review)

Type 2 Competing Continuation (an application requesting additional funding for a period subsequent to that provided by a current award)

Type 3 Supplement (a request for additional funds either for a current operating year or for any future year recommended) Competitive (Outside the original scope) Administrative (within the original scope)

Type 4 Continuation TransitionExtension

Type 5 NonndashCompeting Continuation ApplicationAward (A financial assistance request [in the form of an application or progress report] for a subsequent budget period for which a recipient does not have to compete with other applicants)

Type 6 Successor-In-Interest (Process whereby the rights to and obligations under an NIH grants(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s) A SII may result from legislative or other legal action such as a merger or other corporate change)

Type 7 Transfer ApplicationChange of InstitutionRecipient Organization (Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment)

Type 8 Non-Competing New IC (Type 5 transfer to a new IC or vice versa)

Type 9 Competing Award New IC (Type 2 transfer to another IC or vice versa) 62

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

NoA TerminologyGrant Type - type of grant program

Federal Department ndash a department of the federal government of the United States

Federal Agency ndash special government organizations set up for a specific purpose

Institute or Center (IC) ndash the NIH organizational component responsible for a particular grant program or set of activities

Federal Award Date ndash the date when the Federal award is signed by the authorized official of the Federal awarding agency

Grant Number ndash a unique identifier for a grant composed of the application type code activity code Institute code 6-digit serial number support year andor suffix code for the support year of the grant or other information such as supplement (S1) resubmission (A1) or a fellowshiprsquos institutional allowance Sample Grant Number 1 R01 AI 123456-01 A1 S1

Principal Investigator(s) ndash the person designated by the grantee organization to direct the project or activity supported by the grant This person is responsible and accountable for the proper conduct of the research activity

Project Title ndash name of project 63

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Authorized Organization Official (Business Official) ndashthe designated representative of the recipient organization in matters related to the award and administration of its NIH grants including those that require NIH approval

Organization ndash the entity that applies for andor receives an NIH grant or cooperative agreement

Grants Management Officer (GMO) ndash the NIH Official responsible for the business management aspects of grants and cooperative agreements Only GMOrsquos are authorized to obligate funds and permit changes to approved projects on NIHrsquos behalf

Grants Management Specialist (GMS) ndash the NIH staff member who oversees the business and non-programmatic aspects of grants and cooperative agreements

Program Official (PO) ndash the NIH official responsible for the programmatic scientific andor technical aspects of assigned applications and grants

64

NoA Terminology

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

NoA Terminology (2)

Program DirectorPrincipal Investigator - an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award

Key personnel ndash The PI and other individuals who contribute to the scientific development or execution of a project in a substantive measurable way

Budget Period ndash the intervals of time (Usually 12 months each) into which a project period is divided from budgetary and funding purposes

Project Period ndash the total time for which support of a project has been programmatically approved comprises the initial competitive segment any subsequent competitive segment(s) resulting from a competing continuation award(s) and non competing extensions

65

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

NoA Example

66

Investigator Name

Name of Project

University of Blank

emailuniversityedu

1R01HG01234501A1S1

R01HG01234501

Name of Business Official

Name of Department

Name of Department Office

Address

City Zip Code

Country

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Notice of Award Acceptance

A grantee organization indicates acceptance of an NIH award and its associated terms and conditions including restrictions by spending $1 USD of the awarded funds

Applicable terms and conditions of award are determined at NIHrsquos discretion and not subject to appeal

67

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

NoA Example continued (2)

68

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

NoA Example continued (3)

69

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

NoA Example continued (4)

70

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Terms of Award (Sections III amp IV)

71

Are legally binding Accompany every NoA issued by the US government Can be either informational or restrictive Are often applied to clarify any funding human

subjects or animal welfare issues

Terms of Award come from

1 Authorizing program legislation ndash legislation that sets up or continues the legal operation of a federal program or agency and the terms and conditions under which is operates

2 The NIH Grant Policy Statement See page 228 for information about Grants to Foreign

Institutions and International Organizations3 Administrative Requirements4 Programmatic Requirements (written in a Cooperative Agreement

RFA and incorporated in full or by reference in the NoA

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Administrative Terms amp Conditions of Award

72

May Include

Issues relating to funding including funding restrictions

Human subject or animal welfare issues NIH required clinical terms Special Requirement of the Institute (identified

Key Personnel or accrual requirements for future funding) Often these requirements are in the solicitation (RFA)

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Restrictive Terms

73

There are two types of restrictive terms

One which restricts the use of funds for a purpose (Example for purchasing a specific piece of equipment)

A temporary restriction of all or a specified amount of fund until issues have been resolved

NOTE Restrictions are only lifted by issuing a Revised Notice Of Award

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Programmatic Terms of Award

74

Are a part of all Cooperative Agreements awards They are specific to the grant solicitation

(RFAFOA) andor award

They are organized in the following sections Applicability Awardee Rights and Responsibilities NHGRI Staff Responsibilities Collaborative Responsibilities Arbitration

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

NoA Example continued (5)

75

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Revised Notice of Award

A revised NoA may be issued during a budget period to effect an action resulting in a change in the period or amount of support or other change in the terms and conditions of award (eg lift a restriction on funds)

The revised NoA will always indicate

The AMOUNT of the increase or decrease or if there has been no dollar change

A TERM indicating what action has been taken (eg carryover applied supplement funds given restriction lifted and funds released change in budget period etchellip)

NIH will not issue a revised NoA to reflect a granteersquos post-award rebudgeting

76

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

Important Websites

NIH Grants Policy Statement

Notice of Award Details (page 146)

Types of Grant Programs

eRA Commons User Guide

eRA Training Video Tutorials

77

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611

78

Jill A Saletta

Grants Management Specialist NHGRI

JillSalettanihgov

301-827-0611