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National Institutes of HealthOffice of Extramural Research
Overview and Update of the
HHS SBIR/STTR Program
Non-Dilutive Funding Summit
January 10, 2018
Matthew Portnoy, Ph.D.
SBIR/STTR Program Coordinator
Office of Extramural Research, NIH
National Institutes of HealthOffice of Extramural Research
Agenda
• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Reauthorization Updates
• Solicitations and Funding Opportunities
• The NIH Peer-Review Process
• Transitioning to the Marketplace
• Question & Answer
2
National Institutes of HealthOffice of Extramural Research
NIH SBIR/STTR Website
http://sbir.nih.gov
National Institutes of HealthOffice of Extramural Research
New to SBIR/STTR?
http://sbir.nih.gov/infographic
National Institutes of HealthOffice of Extramural Research
SBIR/STTR Program Overview
SMALL BUSINESS INNOVATION
RESEARCH (SBIR) PROGRAM
Set-aside program for small business concerns to
engage in federal R&D -- with potential for
commercialization
SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) PROGRAM
Set-aside program to facilitate cooperative R&D
between small business concerns and US
research institutions -- with potential for
commercialization
5
3.2%
0.45%
National Institutes of HealthOffice of Extramural Research
SBIR Purpose and Goals
• Stimulate technological innovation
• Use small business to meet federal R&D needs
• Foster and encourage participation by minorities and
disadvantaged persons in technological innovation
• Increase private-sector commercialization innovations
derived from federal R&D
6
Small Business Innovation Development Act of 1982
P.L. 114-328 Re-Authorizes program through FY2022
National Institutes of HealthOffice of Extramural Research
STTR Purpose and Goals
• Stimulate and foster scientific and technological
innovation through cooperative research and
development carried out between small business
concerns and research institutions
• Foster technology transfer between small business
concerns and research institutions
7
Small Business Research and Development
Enhancement Act of 1992
P.L. 114-328 Re-Authorizes program through FY2022
National Institutes of HealthOffice of Extramural Research
DOD
HHS
DOENASA NSF All
Others
Agencies with SBIR and STTR Programs Budget
Department of Defense (DOD) $ 1.070 B
Department of Health and Human Services (HHS),
including the National Institutes of Health (NIH)*
$797.0 M
Department of Energy (DOE), including Advanced
Research Projects Agency – Energy (ARPA-E)
$206.1M
National Aeronautics and Space Administration
(NASA)
$ 180.1 M
National Science Foundation (NSF) $176.0 M
Agencies with SBIR Programs Budget
U.S. Department of Agriculture (USDA) $25.3M
Department of Homeland Security (DHS):
Science and Technology Directorate (S&T) and
Domestic Nuclear Detection Office (DNDO)
$17.7 M
Department of Commerce: National Oceanic and
Atmospheric Administration (NOAA) and National
Institute of Standards and Technology (NIST)*
$8.4M
Department of Transportation (DOT) $7.9 M
Department of Education (ED) $7.5 M
Environmental Protection Agency (EPA) $4.2 M
SBIR/STTR Budgets by Agency FY2015
~ $2.5B in FY15
across all agencies
Grants
Contracts
11
National Institutes of HealthOffice of Extramural Research
HHS Program Funding
2017 Budget SBIR STTR
NIH $861M $121M
CDC ~$11.0M N/A
ACL (NIDILRR)
~$3M N/A
FDA ~$1M N/A
National Institutes of HealthOffice of Extramural Research
NIH SBIR/STTR
3-Phase Program
Discovery
Phase I Feasibility StudyBudget Guide: $150K for SBIR and STTR
Project Period: 6 months (SBIR); 1 year (STTR)
Phase
I
Development
Phase II Full Research/R&D$1M for SBIR and STTR, over two years
Phase IIB Competing Renewal/R&DClinical R&D; Complex Instrumentation/Tools to FDA
Many, but not all, IC’s participate
Varies~$1M per year; up to 3 years
Phase
II
Commercial-
ization
Phase III Commercialization StageNIH, generally, not the “customer”
Consider partnering and exit strategy early
Phase
III
Phase
IIB
13
National Institutes of HealthOffice of Extramural Research
SBIR Eligibility Criteria
• Organized as for-profit US business
• Small: 500 or fewer employees, including affiliates
• Work must be done in the US (with few exceptions)
• Individual Ownership:
o Greater than 50% US-owned by individuals and independently operated
OR
o Greater than 50% owned and controlled by other business concern/s
that is/are greater than 50% owned and controlled by one or more
individuals OR
o Be a concern which is more than 50% owned by multiple venture
capital operating companies, hedge funds, private equity firms, or any
combination of these (For FOAs after 1/28/2013 NIH; 7/10/14 CDC)
11
Determined at Time of Award
National Institutes of HealthOffice of Extramural Research
STTR Eligibility Criteria
• Applicant is a Small Business Concern
• Formal Cooperative R&D Effort
o Minimum 40% by small business
o Minimum 30% by US research institution
• US Research Institution
o College or university; other non-profit research
organization; Federal R&D center
• Intellectual Property Agreement
o Allocation of rights in IP and rights to carry out follow-on
R&D and commercialization
12
National Institutes of HealthOffice of Extramural Research
SBIR and STTR Critical Differences
SBIR STTR
Partnering
Requirement
Permits partnering Requires a non-profit research
institution partner
(e.g. university)
Work
Requirement
Guidelines: May outsource
33% (Phase I) 50% (Phase II)
Minimum Work Requirements:
40% small business
30% research institution
partner
Principal
Investigator
Primary employment (>50%)
must be with the small
business
PI may be employed by either
the research institution
partner or small business
Award is always made to the small business
16
National Institutes of HealthOffice of Extramural Research
Important Facts to Remember
• Eligibility is determined at time of award
• PD/PI is not required to have a Ph.D./M.D.
• PD/PI is required to have expertise to oversee project
scientifically and technically
• Applications may be submitted to different agencies
for similar work
• Awards may not be accepted from different agencies
for duplicative projects
14
National Institutes of HealthOffice of Extramural Research
Agenda
• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Reauthorization Updates
• Solicitations and Funding Opportunities
• The NIH Peer-Review Process
• Transitioning to the Marketplace
• Question & Answer
15
National Institutes of HealthOffice of Extramural Research
NIH Mission
To seek fundamental knowledge about the
nature and behavior of living systems and
the application of that knowledge to
enhance health, lengthen life, and
reduce illness and disability.
19
National Institutes of HealthOffice of Extramural Research
No funding authority
Office of Research
Infrastructure Programs
National
Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute of
Arthritis and
Musculoskeletal and
Skin Diseases
National
Cancer
Institute
National Institute
of Child Health
and Human
Development
National Institute
on Deafness and
Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National
Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National
Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National
Institute
of Mental Health
National Institute of
Neurological
Disorders and Stroke
National Institute
of Nursing
Research
National Institute
on Minority
Health and Health
Disparities
National Center for
Complementary and
Integrative Health
Fogarty
International
Center
National Center
for Advancing
Translational Sciences
National
Library
of Medicine
National Institute
of Biomedical
Imaging and
Bioengineering
Office of the Director
NIH Clinical Center Center for Information
TechnologyCenter for Scientific Review
National Institutes of Health
http://www.nih.gov/icd
20
NIH SBIR/STTR Budget Allocations FY2017
3.2% SBIR $861.4M
0.45% STTR $121.1M
Total FY17 $982.5M
FY18 pending
19
NIH 2016 SBIR/STTR Grants
Success Rate by Phase
13% 13%
31%32%
17%
22%
15%14%
31%
Fast Track Phase I Regular Phase II Phase IIB Direct Phase II CRP
SBIR STTR STTR PHIIB: 1 Application and 1 Award
National Institutes of HealthOffice of Extramural Research
NIH-wide SBIR/STTR
Grant Success Rates 2016
20
Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx
Fiscal Year SBIR/STTR Phase
Number of
Applications
Reviewed
Number of
Applications
Awarded
Success
RateTotal Funding
2016 SBIR Phase I 4,178 526 12.6% $121,272,849
2016 SBIR Fast Track 512 67 13.1% $17,348,139
2016 SBIR Total Phase II 1,194 299 25.0% $240,205,166
2016 SBIR Regular Phase II 628 193 30.7% $146,728,352
2016 SBIR Direct Phase II 497 84 16.9% $74,799,524
2016 SBIR Phase IIB 69 22 31.9% $18,677,290
2016 SBIR CRP 67 15 22.4% $9,135,503
2016 STTR Phase I 1,341 191 14.2% $44,316,736
2016 STTR Fast Track 109 16 14.7% $4,866,290
2016 STTR Total Phase II 121 38 31.4% $29,964,963
2016 STTR Regular Phase II 120 37 30.8% $29,089,887
2016 STTR Phase IIB 1 1 100.0% $875,076
2016 FY TOTAL 7,522 1,152 15.3% $467,109,646
National Institutes of HealthOffice of Extramural Research
First Time Applications &
Awards for SBIR/STTR
21
35%32%
31% 30%
34%
38%36%
34% 33%35% 34%
38%
32%29% 30% 29%
31%33% 34%
32% 32%35% 33% 34%
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Percentage of New Applicant Companies and New Awardee Companies
%New Applicant Companies % New Awardee Companies
National Institutes of HealthOffice of Extramural Research
Agenda
• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Reauthorization Updates
• Solicitations and Funding Opportunities
• The NIH Peer-Review Process
• Transitioning to the Marketplace
• Question & Answer
22
National Institutes of HealthOffice of Extramural Research
SBIR/STTR Reauthorization
update
• Congress passed a 5 year SBIR/STTR Reauthorization as
part of S.2943, the 2017 National Defense Authorization
Act (NDAA)
• SBIR/STTR programs reauthorized for 5 year FY18
through FY22
• Simple, one line reauthorization
• No pilot programs extended, all expire 9/30/17
o Direct Phase II
o Commercialization Readiness Pilot Program (SB1)
o 3% Agency SBIR Admin funds
o NIH Phase 0 Proof of Concept Centers
• Bills circulating in Congress as we speak on these and
other areas. –HR 2763, S1961- Stay tuned.
23
National Institutes of HealthOffice of Extramural Research
Agenda
• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Reauthorization Updates
• Solicitations and Funding Opportunities
• The NIH Peer-Review Process
• Transitioning to the Marketplace
• Question & Answer
24
National Institutes of HealthOffice of Extramural Research
NIH SBIR/STTR FOAs
https://sbir.nih.gov/funding
31
National Institutes of HealthOffice of Extramural Research
Solicitations and Due Dates
• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation
“Parent” FOAs: SBIR: PA-17-302 STTR: PA-17-303Release: June 5, 2017 – now expired- new FOAs coming.
Standard Due Dates: September 5th, January 5th
o These FOAs are being issued with limited due dates to accommodate
the transition from FORMS-D to FORMS-E application packages.
o HHS expects to re-issue these Omnibus after the January 5, 2018
due date.
• SBIR Contract Solicitation (NIH, CDC) – Program
Solicitation PHS 2018-1 (SBIR Only)
NIH Guide Notice NOT-OD-17-089Release: July 18, 2017, Closed: October 20, 2017 5PM
• NIH Guide for Grants and Contracts
Release: Weekly receipt dates specified in each FOA
National Institutes of HealthOffice of Extramural Research
Targeted SBIR/STTR
Funding Opportunity Announcements
NIH Guide for Grants and Contracts
• High priority areas for ICs
• Various IC participation
• Nuances:
o Various due dates
o Additional review criteria
o Limited funds
o Varying project periods
o Etc
27
http://sbir.nih.gov/funding#targeted
National Institutes of HealthOffice of Extramural Research
Omnibus vs Targeted FOAs
Omnibus Targeted
Due Dates Standard Due Dates Standard or
Customized Due Dates
Review SBIR/STTR panels at CSR SBIR/STTR panels at CSR
OR
SBIR/STTR panel at IC
Application
Instructions
Follow SF424 R&R
SBIR/STTR Application Guide
& Annotated Form Set
Follow SF424 R&R
SBIR/STTR Application Guide
& Annotated Form Set
AND
any additional instructions in
FOA
Read FOA very carefully!
36
National Institutes of HealthOffice of Extramural Research
NIH SBIR/STTR
3-Phase Program
Feasibility
Discovery
Phase I
Full R/D
Phase I Phase II
Fast-Track
$3M for up to 3 years
Development
Phase IICommercialization
Phase IIICompeting Renewal Award
Phase IIB
Only Some ICs
Participate
Direct to Phase II
$3M for up to 3 years
Commercialization
Readiness Pilot (CRP)Congressional
authority expired
Congressional
authority expired
National Institutes of HealthOffice of Extramural Research
NIH SBIR/STTR
Fast-Track
Feasibility
Discovery
Phase I
Full R/D
Phase I Phase II
Fast-Track
$3M for up to 3 years
Development
Phase IICommercialization
Phase IIICompeting Renewal Award
Phase IIB
Additional R/D
Direct to Phase II
• Simultaneous submission
and review of Phase I and II
• Phase I is awarded
• Milestones/aims of Phase I
are assessed by program
staff BEFORE Phase II is
awarded
National Institutes of HealthOffice of Extramural Research
Phase IIB Competing
Renewal Award
Discovery
Phase I
$3M for up to 3 years
Development
Phase IICommercialization
Phase IIICompeting Renewal
Phase IIB
• SBIR/STTR Phase II awardee
• Technologies that require extraordinary time/effort to develop,
and often require FDA regulatory approval
• Awards up to $1M/year for up to 3 years
• IC must accept Competing Renewal applications (NIA, NIAAA,
NIAID, NICHD, NIDA, NIDCD, NIDDK, NEI, NIGMS NHLBI, NIMH,
NINDS, NCATS, ORIP, NCI, NHLBI, NINDS)
Contact NIH Program Staff to discuss!
National Institutes of HealthOffice of Extramural Research
Electronic Submission
SBIR/STTR grant applications and SBIR contract proposals
must be submitted electronically.
Registrations are required!!!
o DUNS Number (Company)
o System for Award Management (SAM)
o Grants.gov (Company)
o eRA Commons (Company and all PD/PIs)
o SBA Company Registry at SBIR.gov
• Helpful NIH Grants Registration Infographic
• For contracts, submit proposals with electronic Contract Proposal
Submission (eCPS) website
32
National Institutes of HealthOffice of Extramural Research
Submit via ASSIST
Adobe Forms going AWAY AFTER 1/5/18 deadline. Use ASSIST or Workspace.
National Institutes of HealthOffice of Extramural Research
Clinical Trials New Reforms
& Initiatives
All Research Involving Human
Participants
New forms to collect
human subjects
information
Use of a single
Institutional Review
Board (IRB) for
domestic multi-site
studies
Research that Meets the NIH Definition of a
Clinical Trial
Training in Good Clinical
Practice (GCP)
Clinical trial-specific
Funding Opportunity
Announcements (FOAs)
New review criteria
Expanded registration
and results reporting in
ClinicalTrials.gov
National Institutes of HealthOffice of Extramural Research
NIH Definition of a Clinical Trial
• Definition was clarified in
October 2014
• Encompasses a wide range of
types of trials, including:
o Mechanistic
o Exploratory
o Pilot/Feasibility
o Behavioral
• With broader definition,
many more studies are
classified as clinical trials
Notice: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
National Institutes of HealthOffice of Extramural Research
NIH Definition of a Clinical TrialA research study in which one or more human
subjects are prospectively assigned to one or
more interventions (which may include
placebo or other control) to evaluate the
effects of those interventions on health-
related biomedical or behavioral outcomes.
Learn more at https://grants.nih.gov/policy/clinical-trials/definition.htm
NIH Definition of a Clinical Trial
National Institutes of HealthOffice of Extramural Research
WOSB and SDB Definitions
What is a Women-Owned Small
Business (WOSB)?
• A firm must be at least 51%
owned and controlled by one or
more women, and primarily
managed by one or more women
(who must be US citizens)
• The firm must be “small” in its
primary industry in accordance
with SBA’s size standards for that
industry
• SBCs self certify on the SF 424
(R&R) Form
What is a Socially and
Economically Disadvantaged
Business (SDB)?
• The firm must be 51% or more
owned and control by one or more
disadvantaged persons
• The disadvantaged person or
persons must be socially
disadvantaged and economically
disadvantaged
• The firm must be small, according
to SBA’s size standards
• You must self-certify by registering
your business in the System for
Award Management
37
National Institutes of HealthOffice of Extramural Research
Agenda
• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Reauthorization Updates
• Solicitations and Funding Opportunities
• The NIH Peer-Review Process
• Transitioning to the Marketplace
• Question & Answer
38
National Institutes of HealthOffice of Extramural Research
NIH Application & Review Process
Applicant initiates
research idea
Small Business
Concern confirms
eligibility
Submits SBIR/STTR
grant application to
NIH electronically
NIH Center for
Scientific Review
assigns to IC and IRG
Scientific Review
Group evaluates
scientific merit
Advisory Council or
Board recommend
approval
IC staff prepare
funding plan for
IC Director
IC allocates
funds
Grantee conducts
research
49
National Institutes of HealthOffice of Extramural Research
Timeline: New Applications
Sept 5
Jan 5
April 5
Oct/Nov
Feb/Mar
June/July
Jan/Feb
May/June
Aug
March
July
Sept or Dec
Due DateScientific
Review
Council
Review
Award
Date(earliest)
51
National Institutes of HealthOffice of Extramural Research
Most Important Piece of Advice
• Talk to an HHS Program Officer about your application
and SUBMIT EARLY (days not hours and minutes)!
o Program Officer contact information found on the
HHS Agency Contact webpage
o Questions about who to contact? Email sbir@od.nih.gov
41
National Institutes of HealthOffice of Extramural Research
Agenda
• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Reauthorization Updates
• Solicitations and Funding Opportunities
• The NIH Peer-Review Process
• Transitioning to the Marketplace
• Question & Answer
42
National Institutes of HealthOffice of Extramural Research
NIH Technical Assistance Programs
Helping companies cross the “Valley of Death”
Phase I Phase II Phase III
Commercialization Accelerator
Program (CAP)
Niche
Assessment
Program (NAP)
Valley
of
Death
Phase IIB
Market-
Ready
Technology
Early-Stage
Technology
?
55
National Institutes of HealthOffice of Extramural Research
NIH Technical Assistance Programs
Niche Assessment
Program Foresight S&T
(Phase I awardees)
https://sbir.nih.gov/nap
Commercialization
Accelerator Program
Larta, Inc.
(Phase II awardees)
https://sbir.nih.gov/cap
• Identifies other uses of technology
• Determines competitive advantages
• Develops market entry strategy
• “Menu” of technical
assistance/training programs in:
o Strategic/business planning
o FDA requirements
o Technology valuation
o Manufacturing issues
o Patent and licensing issues
• Helps build strategic alliances
• Facilitates investor partnerships
• Individualized mentoring/consulting
44
National Institutes of HealthOffice of Extramural Research
Investor
Forum
Multi-IC Technology Development Programs (open to eligible Awardees from participating ICs)
I-CorpsTM at NIH
An intensive Entrepreneurial
Immersion course for scientists
https://sbir.cancer.gov/programse
ducation/icorps
Facilitating
Partnerships
National Institutes of HealthOffice of Extramural Research
More Information
Get Connected!
• Subscribe to the SBIR/STTR Listserv:
o Email LISTSERV@LIST.NIH.GOV with the following text in the
message body: subscribe SBIR-STTR your name
• NIH Guide for Grants and Contracts (weekly notification)
• Follow us on Twitter: @NIHsbir
• Read our NIH SBIR/STTR Notable Successes
• Connect with Us
• Email: sbir@od.nih.gov
46
National Institutes of HealthOffice of Extramural Research
For More Information
Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator
Phone: 301-435-2688
Email: mportnoy@mail.nih.gov
Robert VinsonSBIR/STTR Program Manager
Phone: 301-435-2713
Email: vinsonr@mail.nih.gov
47
Patricia SwayneSBIR/STTR Communications
Specialist
Phone: 301-402-1632
Email: patricia.swayne@nih.gov
Julie Beaver, MD, MSSBIR/STTR Statistician
Phone: 301-496-8807
Email: julie.beaver@nih.gov
JP Kim, JD, MBA, MScSBIR/STTR Program Manager
Phone: 301-435-0189
Email: jpkim@nih.gov
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