2014_04-11 National Institutes of Health (NIH)

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


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


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


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 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


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


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


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


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


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%)

or small business concern

( )Award is always made

to Small Business Concern

NIBIB ORIP NINR NCCAM

NIH SBIR/STTR Budget Allocations FY20132.7% SBIR $617M

NIEHS

NIAMSNHGRI

NIAAA

NIDCDNIDCR

NIBIB

NIMHD

ORIP NINR NCCAM

NLM

2.7% SBIR $617M0.35% STTR $80MTotal FY2013 $697M

NCI

NIDANEI

NCATS

NIAID

NICHD

NIA

NIDA

NHLBININDS

NIMH

NICHD

NIGMSNIDDK

NINDS


NIH-wide SBIR/STTR Success Rates

Fiscal Year SBIR/STTR PhaseNumber of Applications Reviewed

Number of Applications Awarded

Success Rate Total Funding

Reviewed Awarded

2012 SBIR Fast Track 358 57 15.9% $13,985,8022012 SBIR Phase 1 4,287 667 15.6% $154,237,890

$2012 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 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 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 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:Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx


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


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*


NIH Reauthorization Webpage

http://sbir.nih.gov

Standard Due Dates:Apr 5; Aug 5; Dec 5Apr. 5; Aug. 5; Dec. 5


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)


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

19


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!

20


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

…


SBIR/STTR ProgramDescriptions and Research

O Id S t d t i *

pTopics

Y IdBiodefense Biosilicon devices

Our Ideas: Suggested topic areas*Your Ideas: Investigator-initiated R&DBiodefense

Biosensors

Biosilicon devices

Biocompatible materials

g & Research projects related to the NIH

missionNanotechnologies

Bioinformatics

Acousto-optics / opto-electronics

mission

“Other” areas of research within the Bioinformatics

Diagnostic and Therapeutic Devices

Health IT

Imaging devices

mission of an awarding componentKeyword search the SolicitationTherapeutic Devices

Telehealth

Imaging devices

Genetically engineered proteinsCtrl - FProteomics / Genomics …


Electronic Submission

SBIR/STTR grant applications must be b itt d l t i ll SBIR t tsubmitted electronically. SBIR contract

proposals still in paper form.

Registrations are required!!!

System for Award Management (SAM)G t ( )Grants.gov (company) eRA Commons (company and all PD/PIs)SBA company registry at SBIR.gov

http://era.nih.gov/ElectronicReceipt/index.htm


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 govSBIR/STTR Solicitation on http://sbir.nih.gov

– Questions about who to contact? Email [email protected]


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


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


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


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

li tiapplications

• Learn more:Learn more: http://grants.nih.gov/grants/funding/nap.htm


Commercialization Assessment Program

• Trains Phase II awardees to:– Develop tailored market entry strategies; – Build strategic partnerships;Build strategic partnerships;– Develop FDA regulatory and reimbursement

paths; andpaths; and– Identify financing strategies and expertise on

i t ll t l t ttintellectual property matters

– Learn more:– Learn more: http://grants.nih.gov/grants/funding/cap/


NIH SBIR/STTR Program Summary of Key Featuresy y

SBIR and STTR Program Single SBIR/STTR grant solicitation Investigator initiated research ideas

External Peer Review Option to request review group Experts from academia/industry Investigator-initiated research ideas

Special Funding Opportunities (NIH Guide for Grants & Contracts)

Electronic Submission (grants only)

Experts from academia/industry Five Criteria: Significance,

Approach, PI(s), Innovation, Environment Electronic Submission (grants only)

Awards: Grants, Contracts, Cooperative Agreements

Environment Summary statement for all

applicants Revise & resubmit

Gap Funding Programs Phase IIB Competing Renewals

Multiple Receipt Dates (Grants) April 5, August 5, December 5 Phase IIB Competing Renewals

Phase I/Phase II Fast Track Administrative Supplements

April 5, August 5, December 5 May 7, Sept. 7, Jan. 7 (AIDS) Contracts: November

Budget and Project Period $150K/6 - 12 months (Phase I) $1M/2 years (Phase II)

Technical Assistance Programs Technology Niche Assessment Commercialization AssistanceCommercialization Assistance

Summary


For More Information

Matthew Portnoy, PhDNIH SBIR/STTR Program Coordinator

Phone: 301- 435-2688Email: [email protected]

Lenka Fedorkova, PhDSBIR/STTR Program Analyst

Robert VinsonSBIR/STTR Program Analyst

Phone: 301-435-0921Email: [email protected]

Phone: 301-435-2713Email: [email protected]

Betty RoysterSBIR/STTR Communications Specialist

Phone 301 402 1632

Julie BeaverSBIR/STTR StatisticianPhone: 301-496-8807Phone: 301-402-1632

Email: [email protected]: 301-496-8807

Email: [email protected]


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 namethe message body: subscribe SBIR-STTR your name

• NIH Guide for Grants and Contracts (weekly notification) htt // t ih / t / id /li t hthttp://grants.nih.gov/grants/guide/listserv.htm

• Follow us on Twitter: @NIHsbir

• Submit your SBIR/STTR Success Story at: http://sbir.nih.govp g

• Email: [email protected]


Save the Date

2014 NIH SBIR/STTR Annual Conference

• October 21 – 23, 2014• Albuquerque, New Mexico

H t U i it f N M i H lth• Host: University of New Mexico Health Sciences Center

• Stay tuned – details to come!


More Information

Questions and Answers!Questions and Answers!

Documents

2014_04-11 National Institutes of Health (NIH)