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National Institutes of Health Office of Extramural Research
Overview of the
NIH SBIR/STTR Programs
2014 National SBIR Conference
Gaylord National Resort & Convention Center
June 16 - 18, 2014
Robert Vinson
NIH SBIR/STTR Assistant Program Manager
National Institutes of Health Office of Extramural Research
SBIR/STTR Programs 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 U.S. research
institutions – with potential for commercialization
2.8%
0.40%
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National Institutes of Health Office of Extramural Research
SBIR/STTR Budgets by Agency, FY 2013
Agencies with SBIR and STTR Programs
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
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
DOD
NIH
DOE NSF NASA All
Others
~ $2.3B in FY13
Across all agencies
National Institutes of Health Office of Extramural Research
HHS/NIH Program Funding
2014 Budget SBIR STTR
NIH $663M $95M
CDC
FDA
ACF
$8.97M
$1.29M
$81K
N/A
Phase I
$150K*
6 months*
$150K*
1 year*
Phase II $1M*
2 years*
$1M*
2 years*
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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 the Director
National Institute
on Minority Health
and Health
Disparities
National Institutes of Health
http://www.nih.gov/icd
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute
on Aging
National Institute
of Child Health
and Human
Development
National Institute
of Allergy and
Infectious Diseases
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
of Dental and
Craniofacial
Research
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Institute on
Deafness and Other
Communication
Disorders
National Eye
Institute
National Human
Genome Research
Institute
National Heart,
Lung, and Blood
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
National Institute
of General
Medical Sciences
National Institute
of Nursing Research
National Library
of Medicine
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Advancing
Translational Sciences
National Institute
of Biomedical
Imaging
and
Bioengineering
No funding
authority
Center for
Information
Technology
Center for
Scientific Review NIH Clinical Center
Office of Research
Infrastructure Programs
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National Institutes of Health Office of Extramural Research
SBIR Eligibility Criteria
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.
NCI
NIAID
NHLBI
NIGMS NIDDK
NINDS
NIMH
NICHD
NIA
NIDA NEI
NCATS
NIEHS
NIAMS
NHGRI
NIAAA
NIDCD
NIDCR NIBIB
NIMHD
ORIP NINR NCCAM
NLM
NIH SBIR/STTR Budget Allocations FY2014 2.8% SBIR $663M
0.40% STTR $95M
Total FY2014 $758M
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National Institutes of Health Office of Extramural Research
Success Rate of SBIR/STTR
2012 and 2013 by Phase
9
15.9% 15.6%
39.9%
15.7% 13.2%
32.8%
Fast Track Phase I Phase II
34.4%
20.3%
39.4%
28.6%
18.7%
26.4%
Fast Track Phase I Phase II
2012
2013
STTR
Success Rates Posted Online:
http://report.nih.gov/success_rates/index.aspx
SBIR
National Institutes of Health Office of Extramural Research
NIH-wide SBIR/STTR Success Rates
Fiscal Year SBIR/STTR Phase Number of
Applications Reviewed
Number of Applications
Awarded
Success Rate
Total Funding
2012 SBIR Fast Track 358 57 15.9% $13,985,802
2012 SBIR Phase 1 4,287 667 15.6% $154,237,890
2012 SBIR Phase 2 557 222 39.9% $153,650,162
2012 STTR Fast Track 32 11 34.4% $2,840,632
2012 STTR Phase 1 542 110 20.3% $23,857,700
2012 STTR Phase 2 71 28 39.4% $18,240,418
2012 FY TOTAL 5,847 1,095 18.7% $366,812,604
2013 SBIR Fast Track 313 49 15.7% $13,981,386
2013 SBIR Phase I 3,738 495 13.2% $114,040,157
2013 SBIR Phase II 542 178 32.8% $136,348,846
2013 STTR Fast Track 42 12 28.6% $2,542,128
2013 STTR Phase I 583 109 18.7% $24,138,629
2013 STTR Phase II 72 19 26.4% $10,985,373
2013 FY TOTAL 5,290 862 16.3% $302,036,519
Success Rates Posted Online:
http://report.nih.gov/success_rates/index.aspx
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National Institutes of Health Office of Extramural Research
Biodefense
Biosensors
Nanotechnologies
Bioinformatics
Diagnostic and
Therapeutic Devices
Telehealth
Proteomics / Genomics
Biosilicon devices
Biocompatible materials
Acousto-optics / opto-
electronics
Health IT
Imaging devices
Genetically engineered proteins
…
Our Ideas: Suggested topic areas*
SBIR/STTR Program Descriptions
& Research Topics
National Institutes of Health Office of Extramural Research
Biodefense
Biosensors
Nanotechnologies
Bioinformatics
Diagnostic and
Therapeutic Devices
Telehealth
Proteomics / Genomics
Biosilicon devices
Biocompatible materials
Acousto-optics / opto-
electronics
Health IT
Imaging devices
Genetically engineered proteins
…
Our Ideas: Suggested topic areas*
SBIR/STTR Program
Descriptions and Research
Topics
Your Ideas:
Investigator-initiated R&D
Research projects related to the NIH
mission
“Other” areas of research within the
mission of an awarding component
Keyword search the Solicitation
Ctrl - F
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National Institutes of Health Office of Extramural Research
Solicitations and Due Dates
• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation
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)
“Parent” FOAs: SBIR: PA-14-071 STTR: PA-14-072
National Institutes of Health Office of Extramural Research NIH SBIR/STTR FOAs
SBIR/STTR Omnibus
Solicitation
NIH SBIR Direct Phase II
Targeted FOAs
NIH SBIR Contract
Solicitation
Located on the NIH SBIR/STTR Homepage: http://sbir.nih.gov
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National Institutes of Health Office of Extramural Research
New NIH SBIR/STTR Homepage
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National Institutes of Health Office of Extramural Research
Technical Assistance Programs
Commercialization
Assistance
“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
(Phase II or IIB awardees)
Niche Assessment
Identifies other uses of technology
Determines competitive advantages
Performs market research
(Active Phase I awardees)
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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
Full list of changes located here:
http://grants.nih.gov/grants/funding/sbir/reauthorization
.htm
Questions? – Talk to your NIH IC Program Officer!
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National Institutes of Health Office of Extramural Research
Gap Funding Programs
Phase IIB Competing Renewals
Phase I/Phase II Fast Track
Administrative Supplements
NIH SBIR/STTR Program
Summary of Key Features
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
Budget and Project Period
$150K/6 - 12 months (Phase I)
$1M/2 years (Phase II)
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
Technical Assistance Programs
Technology Niche Assessment
Commercialization Assistance
Multiple Receipt Dates (Grants)
April 5, August 5, December 5
May 7, Sept 7, Jan 7 (AIDS)
Contracts: November
National Institutes of Health Office of Extramural Research
Small Business
Concern
Applicant
Initiates
Research Idea
Grantee Conducts
Research
IC Staff Prepare funding Plan
for IC Director
NIH Center for Scientific
Review/Assign to IC and IRG
Scientific Review Groups
Evaluate Scientific Merit
Advisory Council or Board
Recommend approval
IC
Allocates
Funds
Submits
SBIR/STTR Grant
Application to NIH
Electronically
~2-3 months
after submission
~2-3 months
after review
Application & Review Process
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National Institutes of Health Office of Extramural Research
Timeline: New Applications
Due Date
April 5
August 5
December 5
Scientific Review
July
November
March
Council Review
October
January
May
Award Date (earliest)
December
April
July
2 4 5
<……………….……6-9 months…………………….>
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
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National Institutes of Health Office of Extramural Research
For More Information
Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator
Phone: 301- 435-2688
Email: [email protected]
Lenka Fedorkova, PhD SBIR/STTR Asst. Program Manager
Phone: 301-435-0921
Email: [email protected]
Robert Vinson SBIR/STTR Asst. Program Manager
Phone: 301-435-2713
Email: [email protected]
Betty Royster SBIR/STTR Communications Specialist
Phone: 301-402-1632
Email: [email protected]
Julie Beaver SBIR/STTR Statistician
Phone: 301-496-8807
Email: [email protected]
National Institutes of Health Office of Extramural Research
More Information
Get Connected!
• Subscribe to the SBIR/STTR Listserv:
• Email [email protected] 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: [email protected]
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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
• Conference website: sbir2014.com