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National Center for Research Resources

NATIONAL INSTITUTES OF HEALTH

A c c e l e r a t i n g a n d e n h a n c i n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t I e n t c a r e

NCRR’s Small Business (SBIR/STTR) Grant Opportunities

Krishan K. Arora, Ph.D.

Division of Research Infrastructure National Center for Research Resources National Institutes of Health U.S. Department of Health and Human Services [email protected]

SBIR/STTR Program Mission

Supporting scientific excellence and technological innovation through the investment of federal research funds in critical American priorities to build a strong national economy…

…one small business at a time

.

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SBIR/STTR Helps NIH Meet Its Mission

Conduct innovative R/R&D that results in product, process, or service that will...

 Improve human health  Speed process of discovery  Reduce cost of medical care/cost of research  Improve research tools, technology

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Importance of SBIR/STTR Programs to Researchers in IDeA States

 These programs provide an opportunity for small businesses in IDeA states to partner with academic institutions to develop products with biomedical applications (e.g. assays, research tools, medical devices, biomarkers, therapeutics, software development)  This is also an opportunity to advance economic development in IDeA states

NCRR

Program Descriptions

Small Business Innovation Research (SBIR) 2.5%

Set-aside program for small business concerns to engage in federal R&D - with potential for commercialization.

Small Business Technology Transfer (STTR)

Set-aside program to facilitate cooperative

0.3%

R&D between small business concerns and U.S. research institutions -- with potential for commercialization.

NCRR

SBIR/STTR Funding

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NIH FY 2008 SBIR – 2.5%: $580 M STTR – 0.3%: $70 M

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NCRR FY 2008 SBIR – 2.5%: $27 M STTR – 0.3%: $3.2 M NCRR

SBIR & STTR: Three-Phase Program

PHASE I – R41, R43

• • •

Feasibility Study $100K and 6-month (SBIR) * or 12-month (STTR) Award PHASE II – R42, R44

• • •

Full Research/R&D $750K and 2-year Award (SBIR & STTR) * Commercialization plan required PHASE III

• •

Commercialization Stage Use of non-SBIR/STTR Funds * Note: These amounts are guidelines, not ceilings. Deviations permitted where scientifically appropriate for success of the project.

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SBIR/STTR Eligibility Requirements

Applicant is Small Business Concern

Organized for-profit U.S. business

500 or fewer employees, including affiliates

Must be:

At least 51% U.S.- owned by individuals and independently operated or

At least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals NCRR

SBIR

Eligibility Requirements

Principal Investigator’s primary employment must be with the Small Business Concern at the time of award and for the duration of the project period

Subawards are permitted

May outsource 33% activities in Phase I

May outsource 50% activities in Phase II NCRR

STTR Eligibility Requirements

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Applicant is a 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 IP rights and rights to carry out follow-on R&D and commercialization Principal Investigator’s primary employment may be with either the Small Business Concern or the research institution NCRR

SBIR

SBIR and STTR Programs (Critical Differences)

• •

Permits research institution partners (e.g., universities) Small business concern may outsource ~33% of Phase I activities and 50% of Phase II activities STTR

• •

Requires research institution partners (e.g., universities) 40% of the work must be conducted by the small business concern (for profit) and 30% by a U.S. research institution (non-profit) Award always made to small business NCRR

Multiple PIs on SBIR Grant

More than one Principal Investigator is allowed on SBIR research projects

This policy offers new approaches to maximize the potential of “team science” efforts

Only the contact PI need be employed primarily by the small business concern NCRR

Omnibus Solicitations for Grants

SBIR Omnibus Solicitation

PHS 2008-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) http://grants.nih.gov/grants/guide/pa-files/PA-08-050.html

Receipt Dates: April 5, August 5, December 5, 2008

STTR Omnibus Solicitation

PHS 2008-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent SBIR [R41/R42]) http://grants.nih.gov/grants/guide/pa-files/PA-08-051.html

Receipt Dates: April 5, August 5, December 5, 2008

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NCRR SBIR/STTR Initiatives

 Lab to Marketplace: Tools for Biomedical and Behavioral Research: SBIR PA-08-114  Technologies for Transient Molecular Complex Characterization: SBIR PA-08-110, STTR PA-08 111  New Technology for Proteomics and Glycomics: SBIR PA-07-451, STTR PA-07-452  Innovations in Biomedical Computational Science and Technology Initiative: SBIR PAR-07-160, STTR PAR-07-161

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Useful Web Links

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NCRR Web Site www.ncrr.nih.gov

Sample Application (NIAID Web Site) http://www.niaid.nih.gov/ncn/sbir/app/default.htm

NIH SBIR/STTR Internet Guide http://grants.nih.gov/grants/funding/sbirsttr_sites.doc

Video Presentations on Writing Successful SBIR Application (NCI web Site) http://sbir.cancer.gov/news/recent/san_diego_forum.asp

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NIH SBIR/STTR Program

Technical Assistance Programs

Technology Niche Assessment

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Commercialization Assistance Pipeline to Partnerships (P2P)

Summary: Importance of NIH SBIR/STTR Funding

Funds early-stage, high-risk projects for which private and public funds are not traditionally available

• Establish feasibility of ideas with commercial potential • Verify technology and leverage SBIR funds to attract other funding 

Plays an important role is achieving NIH mission of improving human health

• Develop tangible products and services resulting from innovative R&D approaches to improving health 

Focuses on commercialization of the outcomes of research – a unique feature.

• SBIR program supplements -- but does not supplant or diminish -- the traditional research programs of NIH.