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Overview of the NIH SBIR/STTR Programs. June 26, 2014 Betty Royster NIH SBIR/STTR Communications Specialist Office of Extramural Research, NIH. Agenda. Overview of NIH SBIR and STTR Programs Technical Assistance/Reauthorization Updates Electronic Submission Peer Review Overview - PowerPoint PPT Presentation
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National Institutes of HealthOffice of Extramural Research
Overview of the NIH SBIR/STTR Programs
June 26, 2014
Betty RoysterNIH SBIR/STTR Communications Specialist
Office of Extramural Research, NIH
National Institutes of HealthOffice of Extramural Research
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 HealthOffice of Extramural Research
SBIR/STTR Programs Overview
SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMSet-aside program for small business concerns to engage in Federal R&D – with potential for commercialization
SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMSet-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization
2.8%
0.40%
National Institutes of HealthOffice of Extramural Research
SBIR/STTR Programs
The largest, most accessible source of
SEED CAPITAL in the nation
for innovative small businesses
Over 2 Billion $$$$ in FY 14
NIH SBIR $663 MNIH STTR $ 95 M
NIH FY 14 TOTAL $758M
National Institutes of HealthOffice of Extramural Research
And…..
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 HealthOffice of Extramural Research
SBIR Purpose and Goals
Small Business Innovation Development Act of 1982P.L. 112-81 Re-Authorizes program through FY2017
• 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
National Institutes of HealthOffice of Extramural Research STTR Purpose and Goals
Small Business Research and Development Enhancement Act of 1992
P.L. 112-81 Re-Authorizes program through FY2017
• 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
National Institutes of HealthOffice of Extramural Research
SBIR/STTR Budgets by Agency, FY 2013
Agencies with SBIR and STTR ProgramsDepartment 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
DOENSF NASA All
Others
~ $2.3B in FY13Across all agencies
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.
National Institutes of HealthOffice 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 Instituteon Alcohol Abuseand Alcoholism
National Instituteof Arthritis and
Musculoskeletaland Skin Diseases
National CancerInstitute
National Instituteon Aging
National Instituteof Child Health
and HumanDevelopment
National Instituteof Allergy and
Infectious Diseases
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Dental andCraniofacial
Research
National Instituteon Drug Abuse
National Instituteof Environmental Health Sciences
National Institute onDeafness and Other
CommunicationDisorders
National EyeInstitute
National HumanGenome Research
Institute
National Heart,Lung, and Blood
Institute
National Instituteof Mental Health
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof General
Medical Sciences
National Instituteof Nursing Research
National Libraryof Medicine
National Centerfor Complementary
and AlternativeMedicine
FogartyInternational
Center
National Centerfor Advancing
Translational Sciences
National Instituteof Biomedical
Imaging and
Bioengineering
No funding authority
Center for Information Technology
Center for Scientific Review
NIH Clinical Center
Office of Research Infrastructure Programs
National Institutes of HealthOffice of Extramural Research
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
PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR)
NIH SBIR/STTR3-Phase Program
National Institutes of HealthOffice 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
National Institutes of HealthOffice of Extramural Research
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
STTR Eligibility Criteria
National Institutes of HealthOffice 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 HealthOffice of Extramural Research
• Research Partner SBIR: Permits partnering 33% Phase I and 50% Phase
II
STTR: Requires partnering with research institution.
Small business (40%) and U.S. research institution (30%)
Award is always made to Small Business Concern
SBIR and STTR Critical Differences
• Principal Investigator SBIR: Primary (>50%)
employment must be with small business concern
STTR: PI may be employed by either research institution or small business concern
NCI
NIAID
NHLBINIGMSNIDDKNINDS
NIMH
NICHD
NIA
NIDA
NEI
NCATSNIEHS
NIAMS
NHGRINIAAA
NIDCDNIDCR NIBIB NIMHD ORIP NINR NCCAMNLM
NIH SBIR/STTR Budget Allocations FY20132.7% SBIR $617M0.35% STTR $80MTotal FY2013 $697M
National Institutes of HealthOffice of Extramural Research
NIH-wide SBIR/STTR Success Rates
Fiscal Year SBIR/STTR PhaseNumber of
Applications Reviewed
Number of Applications
AwardedSuccess
Rate Total Funding
2012 SBIR Fast Track 358 57 15.9% $13,985,8022012 SBIR Phase 1 4,287 667 15.6% $154,237,8902012 SBIR Phase 2 557 222 39.9% $153,650,1622012 STTR Fast Track 32 11 34.4% $2,840,6322012 STTR Phase 1 542 110 20.3% $23,857,7002012 STTR Phase 2 71 28 39.4% $18,240,4182012 FY TOTAL 5,847 1,095 18.7% $366,812,6042013 SBIR Fast Track 313 49 15.7% $13,981,3862013 SBIR Phase I 3,738 495 13.2% $114,040,1572013 SBIR Phase II 542 178 32.8% $136,348,8462013 STTR Fast Track 42 12 28.6% $2,542,1282013 STTR Phase I 583 109 18.7% $24,138,6292013 STTR Phase II 72 19 26.4% $10,985,3732013 FY TOTAL 5,290 862 16.3% $302,036,519
Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx
National Institutes of HealthOffice of Extramural Research
HHS/NIH Program Funding
2014 Budget SBIR STTRNIH $663M $95M
CDC FDAACF
$8.97M$1.29M$81K
N/A
Phase I $150K*6 months*
$150K*1 year*
Phase II $1M* 2 years*
$1M* 2 years*
National Institutes of HealthOffice of Extramural Research
BiodefenseBiosensorsNanotechnologiesBioinformaticsDiagnostic and Therapeutic DevicesTelehealthProteomics / Genomics
Biosilicon devicesBiocompatible materialsAcousto-optics / opto-electronicsHealth ITImaging devicesGenetically engineered proteins…
Our Ideas: Suggested topic areas*
SBIR/STTR Program Descriptions & Research Topics
National Institutes of HealthOffice of Extramural Research
BiodefenseBiosensorsNanotechnologiesBioinformaticsDiagnostic and Therapeutic DevicesTelehealthProteomics / Genomics
Biosilicon devicesBiocompatible materialsAcousto-optics / opto-electronicsHealth ITImaging devicesGenetically engineered proteins…
Our Ideas: Suggested topic areas*
SBIR/STTR ProgramDescriptions 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
National Institutes of HealthOffice 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 ContractsRelease: 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 HealthOffice 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
National Institutes of HealthOffice of Extramural Research
Targeted FOAs
http://grants.nih.gov/grants/funding/sbir_announcements.htm
Over 60 IC Specific Targeted FOAs
National Institutes of HealthOffice 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!**
National Institutes of HealthOffice of Extramural Research
Technical Assistance Programs
Phase I Phase II Phase III
Mt. “FDA”???
Commercialization Assistance Program
Niche Assessment Program
Helping Companies cross the “Valley of Death”
National Institutes of HealthOffice 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)
National Institutes of HealthOffice 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 HealthOffice 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 HealthOffice 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 HealthOffice 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 HealthOffice of Extramural Research
Next Steps
You’ve convinced me to apply……
NOW WHAT?!?!
National Institutes of HealthOffice of Extramural Research
Small Business Concern
Applicant Initiates
Research Idea
Grantee Conducts Research
IC Staff Prepare funding Planfor IC Director
NIH Center for Scientific ReviewAssign to IC and IRG
Scientific Review GroupsEvaluate Scientific Merit
Advisory Council or BoardRecommend approval
IC Allocates
Funds
SubmitsSBIR/STTR Grant Application to NIH
Electronically
~2-3 monthsafter submission
~2-3 months after review
Application & Review Process
National Institutes of HealthOffice of Extramural Research
Timeline: New Applications
DueDate
April 5
August 5
December 5
ScientificReview
July
November
March
CouncilReview
October
January
May
AwardDate (earliest)
December
April
July
2 4 5
<……………….……6-9 months…………………….>
National Institutes of HealthOffice 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 HealthOffice 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 HealthOffice 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 HealthOffice of Extramural Research
Most Important Piece of Advice
• 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 [email protected]
National Institutes of HealthOffice of Extramural Research
Other Presentations to Check Out
• NIH Peer Review Process– By:
• How Well Do You Know the eRA Commons? – By:
National Institutes of HealthOffice of Extramural Research
Case Study
• 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 HealthOffice of Extramural Research
Case Study
• 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 HealthOffice of Extramural Research
Case Study
• 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 HealthOffice of Extramural Research
Case Study
• 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 HealthOffice of Extramural Research
Case Study
• 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 HealthOffice of Extramural Research
Case Study
• 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 HealthOffice of Extramural Research
Case Study
• 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 HealthOffice of Extramural Research
For More Information
Matthew Portnoy, PhDNIH SBIR/STTR Program Coordinator
Phone: 301- 435-2688Email: [email protected]
Lenka Fedorkova, PhDSBIR/STTR Program Analyst
Phone: 301-435-0921Email: [email protected]
Robert VinsonSBIR/STTR Program Analyst
Phone: 301-435-2713Email: [email protected]
Betty RoysterSBIR/STTR Communications Specialist
Phone: 301-402-1632Email: [email protected]
Julie BeaverSBIR/STTR StatisticianPhone: 301-496-8807
Email: [email protected]
National Institutes of HealthOffice 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]
National Institutes of HealthOffice 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 HealthOffice of Extramural Research
More Information
Questions and Answers!