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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