National Institutes of Health
Office of Extramural Research
Overview of the
NIH SBIR/STTR Programs
June 26, 2014
Betty Royster
NIH SBIR/STTR Communications Specialist
Office of Extramural Research, NIH
National Institutes of Health
Office of Extramural Research
•
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•
•
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Agenda
Overview of NIH SBIR and STTR Programs
Technical Assistance/Reauthorization Updates
Electronic Submission
Peer Review Overview
Case Studies
Questions and Answers!
National Institutes of Health
Office of Extramural Research
SBIR/STTR
Programs Overview
SMALL BUSINESS INNOVATION
RESEARCH (SBIR) PROGRAM 2.8%
Set-aside program for small business concerns to
engage in Federal R&D – with potential for
commercialization
SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) PROGRAM 0.40%
Set-aside program to facilitate cooperative R&D
between small business concerns and U.S. research
institutions – with potential for commercialization
National Institutes of Health
SBIR/STTR Programs
Office of Extramural Research
The largest, most accessible source of
SEED CAPITAL
in the nation
for innovative small businesses
Over 2 Billion $$$$ in FY 14
NIH SBIR
NIH STTR
$663 M
$ 95 M
NIH FY 14 TOTAL
$758M
National Institutes of Health
And…..
Office of Extramural Research
The seed capital is in the form of
grants and contracts….
•
Not a loan - no repayment
• No debt service
• Non-dilutive funding
• Maintain IP rights
National Institutes of Health
Office 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
Small Business Innovation Development Act of 1982
P.L. 112-81 Re-Authorizes program through FY2017
National Institutes of Health
Office 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
Small Business Research and Development
Enhancement Act of 1992
P.L. 112-81 Re-Authorizes program through FY2017
SBIR/STTR Budgets
by Agency, FY 2013
National Institutes of Health
Office of Extramural Research
Agencies with SBIR and STTR Programs
DOE
NSF NASA
All
Others
NIH
Department of Defense (DOD)
$ 1.0 B
Department of Health and Human Services:
National Institutes of Health (NIH)
$697.0 M
Department of Energy (DOE), including ARPA-E
$183.9M
National Science Foundation (NSF)
$153.0 M
National Aeronautics and Space Administration
(NASA)
$ 148.8 M
Agencies with SBIR Programs
DOD
~ $2.3B in FY13
Across all agencies
U.S. Department of Agriculture (USDA)
$18.4M
Department of Homeland Security (DHS):
Science and Technology Directorate (S&T) and
Domestic Nuclear Detection Office (DNDO)
$15.7 M
Department of Education (ED)
$13.4 M
Department of Transportation (DOT)
$7.6 M
Department of Commerce: National Oceanic
and Atmospheric Administration (NOAA) and
National Institute of Standards and Technology
(NIST)
$7.4 M
Environmental Protection Agency (EPA)
$3.8 M
National Institutes of Health
Office 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.
National Institutes of Health
Office of Extramural Research
Office of Research
Infrastructure Programs
National Institutes of Health
Office of the Director
http://www.nih.gov/icd
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 Alternative
Medicine
Fogarty
International
Center
National Center
for Advancing
Translational Sciences
NIH Clinical Center
Center for
Information
Technology
National Library
of Medicine
Center for
Scientific Review
National Institute
of Biomedical
Imaging
and
Bioengineering
No funding
authority
National Institutes of Health
Office of Extramural Research
NIH SBIR/STTR
3-Phase Program
PHASE I Feasibility Study
 Budget Guide: $150K (SBIR); $150K (STTR) Total Costs
 Project Period: 6 months (SBIR); 1 year (STTR)
PHASE II Full Research/R&D
 $1M (SBIR), $1M (STTR) over two years
PHASE IIB Competing Renewal/R&D
 Clinical R&D; Complex Instrumentation/Tools to FDA
 Many, but not all, ICs participate
 Varies ~$1M/year; 3 years
PHASE III Commercialization Stage
 NIH, generally, not the “customer”
 Consider partnering and exit strategy early
National Institutes of Health
SBIR Eligibility Criteria
Office of Extramural Research
 Organized as for-profit U.S. business

Small: 500 or fewer employees, including affiliates
PD/PI’s primary employment must be with small business
 concern at time of award and for duration of project period
 Greater than 50% U.S.- owned by individuals and
independently operated or
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
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
National Institutes of Health
Office of Extramural Research
STTR Eligibility Criteria
 Applicant is Small Business Concern
 Formal Cooperative R&D Effort
• Minimum 40% by small business
• Minimum 30% by U.S. research institution
 U.S. Research Institution
• College or university; other non-profit research
organization; Federal R&D center
 Intellectual Property Agreement
• Allocation of rights in IP and rights to carry out
follow-on R&D and commercialization
National Institutes of Health
Office of Extramural Research
PD/PI Eligibility on STTR
• PD/PI is not required to be employed by SBC
• PD/PI at RI must establish contract between RI
and SBC describing PD/PI’s involvement
• PD/PI must commit a minimum of 10% effort
• PD/PI’s “signature” on application is agreement to
conforming to Solicitation requirements
National Institutes of Health
Office of Extramural Research
• Research Partner
SBIR and STTR
Critical Differences
• Principal Investigator
 SBIR: Primary (>50%)
33% Phase I and 50% Phase employment must be with
small business concern
II
 SBIR: Permits partnering
 STTR: Requires partnering  STTR: PI may be employed
with research institution.
by either research institution
Small business (40%) and
or small business concern
U.S. research institution
(30%)
Award is always made
to Small Business Concern
NIH SBIR/STTR Budget Allocations FY2013
NIAAA
NIEHS
NHGRI
NIBIB NINR NCCAM
NIDCR
ORIP
NIDCD NIMHD
NLM
NIAMS
NIDA
2.7% SBIR $617M
0.35% STTR $80M
Total FY2013 $697M
NCI
NCATS
NEI
NIAID
NIA
NICHD
NIMH
NHLBI
NINDS
NIDDK
NIGMS
NIH-wide SBIR/STTR
Success Rates
National Institutes of Health
Office of Extramural Research
Fiscal Year
SBIR/STTR
Phase
2012
2012
2012
2012
2012
2012
2012
2013
2013
2013
2013
2013
2013
2013
SBIR
SBIR
SBIR
STTR
STTR
STTR
FY TOTAL
SBIR
SBIR
SBIR
STTR
STTR
STTR
FY TOTAL
Fast Track
Phase 1
Phase 2
Fast Track
Phase 1
Phase 2
Fast Track
Phase I
Phase II
Fast Track
Phase I
Phase II
Number of
Applications
Reviewed
Number of
Applications
Awarded
Success
Rate
Total Funding
358
4,287
557
32
542
71
5,847
313
3,738
542
42
583
72
5,290
57
667
222
11
110
28
1,095
49
495
178
12
109
19
862
15.9%
15.6%
39.9%
34.4%
20.3%
39.4%
18.7%
15.7%
13.2%
32.8%
28.6%
18.7%
26.4%
16.3%
$13,985,802
$154,237,890
$153,650,162
$2,840,632
$23,857,700
$18,240,418
$366,812,604
$13,981,386
$114,040,157
$136,348,846
$2,542,128
$24,138,629
$10,985,373
$302,036,519
Success Rates Posted Online:
http://report.nih.gov/success_rates/index.aspx
National Institutes of Health
Office of Extramural Research
HHS/NIH Program Funding
2014 Budget
NIH
SBIR
$663M
CDC
FDA
ACF
Phase I
$8.97M
$1.29M
$81K
$150K*
6 months*
$1M*
2 years*
Phase II
STTR
$95M
N/A
$150K*
1 year*
$1M*
2 years*
National Institutes of Health
Office of Extramural Research
SBIR/STTR Program Descriptions
& Research Topics
Our Ideas: Suggested topic areas*
Biodefense
Biosilicon devices
Biosensors
Biocompatible materials
Nanotechnologies
Acousto-optics / optoelectronics
Bioinformatics
Diagnostic and
Therapeutic Devices
Telehealth
Health IT
Imaging devices
Genetically engineered proteins
Proteomics / Genomics …
SBIR/STTR Program
Descriptions and Research
Topics
National Institutes of Health
Office of Extramural Research
Our Ideas: Suggested
topic areas*
Your Ideas:
R&D
Biosilicon devices
Biodefense Investigator-initiated
related to the
NIH
Biocompatible
materials
Biosensors Research projects
mission
Acousto-optics / optoNanotechnologies
 “Other” areas electronics
of research within the
Bioinformatics
IT component
mission of an Health
awarding
Diagnostic and
Keyword search
the devices
Solicitation
Imaging
Therapeutic Devices
Telehealth
Proteomics / Genomics
Genetically
engineered proteins
Ctrl
-F
…
National Institutes of Health
Office of Extramural Research
Solicitations and Due Dates
• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation
“Parent” FOAs: SBIR: PA-14-071 STTR: PA-14-072
Release: January
Standard Due Dates: April 5, August 5, December 5
(AIDS/AIDS-related: May 7, September 7, January 7)
• SBIR Contract Solicitation (NIH, CDC)
Release: August
November 2014 close date
• NIH Guide for Grants and Contracts
Release: Weekly Receipt dates specified in each FOA
(http://grants.nih.gov/grants/guide/index.html)
National Institutes of Health
Office of Extramural Research
NIH SBIR/STTR FOAs
Located on the NIH SBIR/STTR Homepage: http://sbir.nih.gov
SBIR/STTR Omnibus
Solicitation
NIH SBIR Direct Phase II
Targeted FOAs
NIH SBIR Contract
Solicitation
National Institutes of Health
Office of Extramural Research
Targeted FOAs
http://grants.nih.gov/grants/funding/sbir_announcements.htm
Over 60 IC Specific
Targeted FOAs
National Institutes of Health
Office of Extramural Research
NIH SBIR/STTR FOAs
Which FOA is best for you?
SBIR vs STTR?
Phase I vs Fast-track vs Direct
Phase II?
**Contact your NIH SBIR/STTR
Program Officer!**
Technical Assistance Programs
National Institutes of Health
Office of Extramural Research
Helping Companies cross the “Valley of Death”
Niche Assessment
Program
Mt. “FDA”
???
Commercialization Assistance
Program
Phase I
Phase II
Phase III
National Institutes of Health
Technical Assistance Programs
Office of Extramural Research
Niche Assessment
Identifies other uses of technology
(Active Phase I awardees)
Determines competitive advantages
Performs market research
Commercialization
Assistance
(Phase II or IIB awardees)
“Menu” of technical assistance/training
programs in:
• Strategic/business planning
• FDA requirements
• Technology valuation
• Manufacturing issues
• Patent and licensing issues
Helps build strategic alliances
Facilitates investor partnerships
Individualized mentoring/consulting
National Institutes of Health
Office of Extramural Research
Gap Funding Programs
Additional Commercialization Resources
• No-cost extension
− Extends project period by 6 months or 1 year
• Fast-track application
− One application for Phase I and Phase II that is submitted
and reviewed together
• Phase IIB awards
− $1M per year for up to 3 years; not offered by all ICs
• Administrative supplements
− Adds money to parent grant
• Commercialization Readiness Pilot Program
− Additional gap funding opportunity – stay tuned for details!
Always talk to Program Officer!
National Institutes of Health
Office of Extramural Research
Reauthorization Changes –
Budget Hard Caps
• Reauthorization required that budgets over the hard cap
($225,000 for Phase I and $1,500,000 for Phase II)
Agencies (not applicants) apply for waiver from SBA
• SBA has recently approved a topics list, which allows
budgets to exceed the hard caps as long as the project
topics are on the list
• Pre-approved topics list is Appendix A in regular topics
document: http://1.usa.gov/1iUa5Kh
• The approval is good for the 2014 SBIR/STTR Omnibus,
and any FOA that falls on the topic list, including the
Direct Phase II FOA
National Institutes of Health
Office of Extramural Research
Other Reauthorization Changes
• Majority-owned venture capital provision
• Switching between SBIR and STTR
• SBIR Direct Phase II
• SBA Company Registry
Full list of changes located here:
http://grants.nih.gov/grants/funding/sbir/reauthorization
.htm
Questions? – Talk to your NIH IC Program Officer!
National Institutes of Health
Office of Extramural Research
SBIR and STTR Program

Single SBIR/STTR grant solicitation

Investigator-initiated research ideas

Special Funding Opportunities
(NIH Guide for Grants & Contracts)

Electronic Submission (grants only)

Awards: Grants, Contracts,
Cooperative Agreements
NIH SBIR/STTR Program
Summary of Key Features
External Peer Review

Option to request review group

Experts from academia/industry

Five Criteria: Significance,
Approach, PI(s), Innovation,
Environment

Summary statement for all
applicants

Revise & resubmit
Multiple Receipt Dates (Grants)

April 5, August 5, December 5

May 7, Sept 7, Jan 7 (AIDS)

Contracts: November
Gap Funding Programs

Phase IIB Competing Renewals

Phase I/Phase II Fast Track

Administrative Supplements
Budget and Project Period

$150K/6 - 12 months (Phase I)

$1M/2 years (Phase II)
Technical Assistance Programs

Technology Niche Assessment

Commercialization Assistance
National Institutes of Health
Office of Extramural Research
Next Steps
You’ve convinced me to apply……
NOW WHAT?!?!
National Institutes of Health
Office of Extramural Research
Small Business
Concern
Applicant
Initiates
Research Idea
Application & Review Process
Submits
SBIR/STTR Grant
Application to NIH
Electronically
NIH Center for Scientific
ReviewAssign to IC and IRG
Scientific Review Groups
Evaluate Scientific Merit
~2-3 months
after submission
~2-3 months
after review
Grantee Conducts
Research
IC
Allocates
Funds
Advisory Council or Board
Recommend approval
IC Staff Prepare funding Plan
for IC Director
Timeline: New Applications
National Institutes of Health
Office of Extramural Research
<……………….……6-9 months…………………….>
2
4
5
Due
Date
Scientific
Review
Council
Review
Award
Date (earliest)
April 5
July
October
December
August 5
November
January
April
May
July
December 5 March
National Institutes of Health
Office of Extramural Research
Electronic Submission
SBIR/STTR grant applications must be
submitted electronically. SBIR contract
proposals still in paper form.
Registrations are required!!!
DUNS Number (Company)
System for Award Management (SAM)
Grants.gov (Company)
eRA Commons (Company and all PD/PIs)
SBA Company Registry at SBIR.gov
http://era.nih.gov/ElectronicReceipt/index.htm
National Institutes of Health
Office of Extramural Research
WOSB
What is a Women-Owned Small Business?
• 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.
• http://1.usa.gov/1d10b5q
National Institutes of Health
Office of Extramural Research
SDB
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.
• http://1.usa.gov/1mKnU0a
National Institutes of Health
Most Important Piece of Advice
Office of Extramural Research
• Talk to an NIH Program Officer about your
application and SUBMIT EARLY (days not hours
and minutes)!
– Program Officer contact information found in the NIH
SBIR/STTR Solicitation on http://sbir.nih.gov
– Questions about who to contact? Email
sbir@od.nih.gov
National Institutes of Health
Other Presentations to Check Out
Office of Extramural Research
• NIH Peer Review Process
– By:
• How Well Do You Know the eRA Commons?
– By:
National Institutes of Health
Case Study
Office of Extramural Research
• Case Study – SBIR or STTR?
• An SBC is developing a novel therapeutic for
hepatitis B.
• The PI has primary employment at the SBC, and
the SBC wants to partner with a university to
complete the animal studies?
• Would SBIR or STTR be most appropriate?
National Institutes of Health
Case Study
Office of Extramural Research
• Case Study – SBIR or STTR?
• It depends! For both SBIR and STTR, the SBC
can partner with a research institution, but an
STTR requires that a research partner complete
at least 30% of the overall work
• No research partner is required for SBIR
Which one is right for you? Talk to your
Program Officer!
National Institutes of Health
Case Study
Office of Extramural Research
• Case Study – PI Eligibility for SBIR?
• A researcher has primary employment at a
university, but wants to lead the research project
for an SBIR award.
• Would the SBC be eligible to apply for an
SBIR?
National Institutes of Health
Case Study
Office of Extramural Research
• Case Study – PI Eligibility for SBIC?
• No, not under current circumstances. The PI
must have primary employment at the SBC at the
time of award to be eligible for an SBIR.
• Before Notice of Award is sent out, SBC will be
asked to submit Just-in-Time information, which
will access the PI’s employment status.
• What about an STTR?
National Institutes of Health
Case Study
Office of Extramural Research
• Case Study – PI Eligibility for STTR?
• Yes, as long as the SBC completes at least 40%
of the overall work for a Phase I and Phase II,
and the partnering non-profit research institution
completes at least 30% of the work.
• The remaining 30% can go to the SBC, the RI or
another third party organization.
National Institutes of Health
Case Study
Office of Extramural Research
• Case Study – Budget Hard Caps?
• An SBC wants to submit a Phase I budget for
$300,000 to develop the proof-of-concept for a
tool to improve diabetes care.
• Is this permitted?
National Institutes of Health
Case Study
Office of Extramural Research
• Case Study – Budget Hard Caps?
• Perhaps! Look on Appendix A of the 2014
SBIR/STTR Topics Document to see if this topic
has been granted a waiver by the Small
Business Administration (SBA).
• Either way – Seek the advice of your Program
Officer!
National Institutes of Health
For More Information
Office of Extramural Research
Matthew Portnoy, PhD
NIH SBIR/STTR Program Coordinator
Phone: 301- 435-2688
Email: mportnoy@mail.nih.gov
Lenka Fedorkova, PhD
Robert Vinson
SBIR/STTR Program Analyst
Phone: 301-435-0921
Email: lenka@nih.gov
SBIR/STTR Program Analyst
Phone: 301-435-2713
Email: vinsonr@mail.nih.gov
Betty Royster
SBIR/STTR Communications Specialist
Phone: 301-402-1632
Email: roysterbr@mail.nih.gov
Julie Beaver
SBIR/STTR Statistician
Phone: 301-496-8807
Email: julie.beaver@nih.gov
National Institutes of Health
Office of Extramural Research
More Information
Get Connected!
• Subscribe to the SBIR/STTR Listserv:
• 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)
http://grants.nih.gov/grants/guide/listserv.htm
•
Follow us on Twitter: @NIHsbir
• Submit your SBIR/STTR Success Story at:
http://sbir.nih.gov
• Email: sbir@od.nih.gov
National Institutes of Health
Office of Extramural Research
Save the Date
16th Annual NIH SBIR/STTR Conference
• October 21 – 23, 2014
• Albuquerque, New Mexico
• Host: University of New Mexico
Health Sciences Center
• Stay tuned – details to come!
National Institutes of Health
More Information
Office of Extramural Research
Questions and Answers!