National Institutes of Health Office of Extramural Research Overview of the Overview of the NIH SBIR/STTR Programs April 11, 2014 2014 Kentucky SBIR/STTR Conference 2014 Kentucky SBIR/STTR Conference Rb t Vi Robert Vinson NIH SBIR/STTR Program Analyst Office of Extramural Research NIH 1 Office of Extramural Research, NIH
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National Institutes of HealthOffice of Extramural Research
Overview of theOverview of the NIH SBIR/STTR Programs
April 11, 20142014 Kentucky SBIR/STTR Conference2014 Kentucky SBIR/STTR Conference
R b t ViRobert VinsonNIH SBIR/STTR Program Analyst
Office of Extramural Research NIH
1
Office of Extramural Research, NIH
National Institutes of HealthOffice of Extramural Research
SBIR/STTR Programs Overview
SMALL BUSINESS INNOVATION S US SS O ORESEARCH (SBIR) PROGRAMSet-aside program for small business concerns to
2.8%Set-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
0.40%
between small business concerns and U.S. research institutions – with potential for commercialization
National Institutes of HealthOffice of Extramural Research
SBIR Purpose and Goals
• Stimulate technological innovation• Use small business to meet Federal R&D
needsneeds• Foster and encourage participation by
minorities and disadvantaged persons inminorities and disadvantaged persons in technological innovation
• Increase private sector commercialization• Increase private-sector commercialization innovations derived from Federal R&D
Small Business Innovation Development Act of 1982P.L. 112-81 Re-Authorizes program through FY2017
National Institutes of HealthOffice of Extramural Research STTR Purpose and Goals
• Stimulate and foster scientific andStimulate and foster scientific and technological innovation through cooperative research and development carried outresearch and development carried out between small business concerns and research institutionsresearch institutions
• Foster technology transfer between small business concerns and research institutionsbusiness concerns and research institutions
Small Business Research and Development Enhancement Act of 1992
P.L. 112-81 Re-Authorizes program through FY2017
National Institutes of HealthOffice of Extramural Research
SBIR/STTR Budgetsby Agency, FY 2012
NASADOE NSF All
OthAgencies with SBIR and STTR Programs
y g y,
NIH
NASA Others Department of Defense (DOD) $ 1.1 B
Department of Health and Human Services: National Institutes of Health (NIH)
$717.0 M
N i l A i d S $161 8 MNational Aeronautics and Space Administration (NASA)
$161.8 M
Department of Energy (DOE) $188.3 M
National Science Foundation (NSF) $ 150.6 M
DOD
National Science Foundation (NSF) $ 150.6 M
Agencies with SBIR Programs
U.S. Department of Agriculture (USDA) $19.3 M
Department of Homeland Security (DHS) $12 6 MDepartment of Homeland Security (DHS) $12.6 M
Department of Education (ED) $13.4 M
Department of Transportation (DOT) $8.6 M~ $2.4B in FY12Department of Commerce: National Oceanic and Atmospheric Administration (NOAA) and National Institute of Standards and Technology (NIST)
$4.7 Macross all agencies
Environmental Protection Agency (EPA) $4.8 M
National Institutes of HealthOffice of Extramural Research NIH Mission
To seek fundamental knowledge about the
t d b h i fnature and behavior of living systems and the
application of thatapplication of that knowledge to enhance
health, lengthen life, and reduce illness and
disability.
National Institutes of HealthOffice of Extramural Research
National Institutes of Health
Office of the Director http://www.nih.gov/icdOffice of Research
Infrastructure Programs
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
National Instituteof Dental andCraniofacial
R h
National Instituteon Drug Abuse
National Instituteof EnvironmentalHealth Sciences
National Institute onDeafness and Other
CommunicationNational Eye
InstituteKidney DiseasesResearch Health SciencesDisorders
National HumanGenome Research
National Heart,Lung and Blood National Institute
National Instituteof NeurologicalNational Institute
of General National Institute
N ti l I tit t
Genome ResearchInstitute
Lung, and BloodInstitute of Mental Health
gDisorders and
Stroke
of GeneralMedical Sciences of Nursing Research
National Center National InstituteNational Instituteon Minority Health
and Health Disparities
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
National Institutes of HealthOffice of Extramural Research
NIH SBIR/STTR3-Phase Program
PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs
PHASE II F ll R h/R&D
Project Period: 6 months (SBIR); 1 year (STTR)
PHASE II Full Research/R&D $1M (STTR), $1M (SBIR) over two years
PHASE IIB C ti R l/R&DPHASE IIB Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many but not all ICs participate 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 HealthOffice of Extramural Research
SBIR Eligibility Criteria
Organized as for-profit U.S. business
S f ff
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 orGreater than 50% owned and controlled by other business concern/s that is/are greater than 50% owned
business concern/s that is/are greater than 50% owned and controlled by one or more individuals ORBe a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private
it fi bi ti f th
equity firms, or any combination of these
National Institutes of HealthOffice 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 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
ocat o o g ts a d g ts to ca y out
follow-on R&D and commercialization
National Institutes of HealthOffice of Extramural Research
PD/PI Eligibility on STTR
• PD/PI is not required to be employed by SBCPD/PI is not required to be employed by SBC
• PD/PI at RI must establish contract between RIPD/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 requirementsconforming to Solicitation requirements
National Institutes of HealthOffice of Extramural Research
SBIR and STTRCritical Differences
• Research Partner
C t ca e e ces
• Principal Investigator SBIR: Permits partnering
33% Phase I and 50% Phase
SBIR: Primary (>50%) employment must be with 33% Phase I and 50% Phase
II small business concern
STTR: Requires partnering with research institution.
S ll b i (40%) d
STTR: PI may be employed by either research institution
Small business (40%) and U.S. research institution (30%)
National Institutes of HealthOffice of Extramural Research
Kentucky Success Rates
Kentucky SBIR/STTR Phases
Fiscal Year
SBIR or State # of Apps Reviewed
# of Apps Awarded
Success Rate Total FundingSTTR
Reviewed Awarded Rate
2011 SBIR KY 65 8 12.3% $2,383,334
2011 STTR KY 16 2 12.5% $2,029,977
2012 SBIR KY 54 10 18.5% $3,631,806
2012 STTR KY 21 5 23.8% $1,353,544
2013 SBIR KY 53 11 20.8% $3,364,373
2013 STTR KY 23 3 13.0% $1,249,509
National Institutes of HealthOffice of Extramural Research
HHS/NIH Program Funding
2013 Budget SBIR STTR$ $NIH $617M $80M
CDC $8 4MCDC FDA
$8.4M$1.4M N/A
ACF $233KPhase I $150K* $150K*Phase I $150K
6 months*$150K1 year*
Ph II $1M* $1M*Phase II $1M* 2 years*
$1M* 2 years*
National Institutes of HealthOffice of Extramural Research
NIH Reauthorization Webpage
http://sbir.nih.gov
Standard Due Dates:Apr 5; Aug 5; Dec 5Apr. 5; Aug. 5; Dec. 5
National Institutes of HealthOffice of Extramural Research
Solicitations and Due Dates
• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation“Parent” FOAs: SBIR: PA 14 071 STTR: PA 14 072Release: January Standard Due Dates: April 5 August 5 December 5
“Parent” FOAs: SBIR: PA-14-071 STTR: PA-14-072
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 dateg
• NIH Guide for Grants and ContractsRelease: Weekly Receipt dates specified in each FOA(http://grants.nih.gov/grants/guide/index.html)
National Institutes of HealthOffice of Extramural Research
Reauthorization Changes –Budget Hard Capsg p
• Reauthorization required that budgets over the hard cap ($225 000 for Phase I and $1 500 000 for Phase II)($225,000 for Phase I and $1,500,000 for Phase II) Agencies (not applicants) apply for waiver from SBA
SBA h tl d t i li t hi h ll• SBA has recently approved a topics list, which allows budgets to exceed the hard caps as long as the project topics are on the listtopics 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 OmnibusThe approval is good for the 2014 SBIR/STTR Omnibus, and any FOA that falls on the topic list, including the Direct Phase II FOA
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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• 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!
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National Institutes of HealthOffice of Extramural Research
SBIR/STTR Program Descriptions & Research Topics
Our Ideas: Suggested topic areas*
p
Biodefense
Biosensors
Biosilicon devices
Biocompatible materialsBiosensors
Nanotechnologies
Biocompatible materials
Acousto-optics / opto-l iBioinformatics
Diagnostic and
electronics
Health ITDiagnostic and Therapeutic Devices
Telehealth
Imaging devices
Genetically engineered proteinsTelehealth
Proteomics / Genomics
Genetically engineered proteins
…
National Institutes of HealthOffice of Extramural Research
National Institutes of HealthOffice of Extramural Research
Application & Review Process
Small Business NIH Center for ScientificSubmitsConcern
Applicant Initiates
NIH Center for Scientific ReviewAssign to IC and IRGSBIR/STTR Grant
Application to NIHElectronically
InitiatesResearch Idea Scientific Review Groups
Evaluate Scientific Merit~2-3 months
Ad i C il B d
2-3 monthsafter submission
Advisory Council or BoardRecommend approval~2-3 months
after review
Grantee ConductsIC Staff Prepare funding Plan
for IC DirectorIC
AllocatesGrantee Conducts Research
for IC DirectorAllocatesFunds
National Institutes of HealthOffice of Extramural Research
Review Criteria
Overall Impact Score
Scored Review Criteria (score 1-9) Significance (Real Problem/Commercial Potential) Investigators (PI and team) Investigators (PI and team) Innovation (New or Improved?) Approach (Research Design, Feasible) E i t (F iliti /R ) Environment (Facilities/Resources)
Additional Review Criteria (not scored individually)dd t o a e e C te a ( ot sco ed d dua y) Protection of Human Subjects Inclusion of Women, Minorities & Children Vertebrate Animals Biohazards
National Institutes of HealthOffice of Extramural Research
Timeline: New Applications
<……………….……6-9 months…………………….>2 4 5
Due Scientific Council AwardDueDate
ScientificReview
CouncilReview Date (earliest)
D bApril 5 July October December
A ilAugust 5 November January April
J lDecember 5 March May July
National Institutes of HealthOffice of Extramural Research
Niche Assessment Program
• Provides active Phase I awardees with market research, and consumer and competition analysis
H l ll b i l t th i• Helps small businesses complete their commercialization plans as part of their Phase II