The Small Business Grant program www'ncrr'nih'govsbo

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The Small Business Grant program
www.ncrr.nih.gov/sbo
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Todays Presentation

• SBIR/STTR Program Overview
• Eligibility Requirements
• Funding Opportunities
• Follow-on Assistance Programs

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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 RD 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

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Why are SBIR and STTR programs important to NCRR
Researchers?

• NCRR provides clinical and translational
  researchers with the training and tools they need
  to understand, detect, treat, and prevent a wide
  range of diseases
• SBIR and STTR
• an excellent resource for enabling
  commercialization of innovative high impact
  technologies essential for clinical and
  translational research, such as
• research tools, medical devices, therapeutics
• provide incentive to academic investigators to
  translate technology (form new company or
  collaborate with existing)
• a large source of early-stage life sciences RD
  financing

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Program Descriptions

• Small Business Innovation Research (SBIR)
• Set-aside program for small business
• concerns to engage in federal RD --
• with potential for commercialization.
• Small Business Technology Transfer (STTR)
• Set-aside program to facilitate cooperative
• RD between small business concerns
• and U.S. research institutions -- with
• potential for commercialization.

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SBIR/STTR 3-Phase Program
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Eligibility Requirements
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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

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SBIR Eligibility Requirements

• Principal Investigators 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

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STTR Eligibility Requirements

• Principal Investigators primary employment may
  be with either the Small Business Concern or the
  research institution
• Formal Cooperative RD 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 RD center
• Intellectual Property Agreement
• Defines allocation of IP rights and rights to
  carry out follow-on RD and commercialization

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A New OpportunityMultiple Principal
Investigators on SBIR Grants

• 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

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SBIR/STTR Funding Opportunities
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NIH SBIR/STTR Budget

• SBIR 2.5 NIH budget (580 M. FY08)
• STTR 0.3 NIH budget (70 M, FY08)
• NCRR FY2008
• SBIR - 27 M
• STTR - 3.2 M
• Award level range 2000-2007
• R43 77 K - 1.9 M
• R44 162 K - 1.8 M

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NIH Issues Multiple SBIR STTR Solicitations

• SBIR/STTR Omnibus Grant Solicitation
• Release January
• Receipt Dates April 5, August 5, and December
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• (2008 Release PA-08-050 PA-08-051)
• SBIR Contract Solicitation (NIH, CDC)
• Release August
• Receipt Date Early November
• NIH Guide for Grants and Contracts
• Release Weekly
• Receipt Dates Various

For more information visit http//grants.nih.gov/
grants/funding/sbir.htm
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Current NCRR-sponsored SBIR/STTR Funding
Opportunity Announcements

• New Technologies for Proteomics and Glycomics
• SBIR PA-07-451, STTR PA-07-452
• Technologies for Transient Molecular Complex
  Characterization
• SBIR PA-08-110, STTR PA-08-111
• Visualizing Biomedical Research Characteristics
• Contract Topic 012

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Current SBIR/STTR Initiatives in which NCRR
Participates

• Lab to Marketplace Tools for Biomedical and
  Behavioral Research SBIR only PA-08-114
• Technological Innovations for Interdisciplinary
  Research Incorporating the Behavioral and Social
  Sciences SBIR PA-08-202, STTR PA-08-201
• Bioengineering Nanotechnology Initiative SBIR
  PA-08-009, STTR PA-08-008
• Manufacturing Processes of Medical, Dental, and
  Biological Technologies SBIR PA-06-013, STTR
  PA-06-012
• Innovations in Biomedical Computational Science
  and Technology Initiative SBIR PA-07-160, STTR
  PA-07-161

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Keys to a Strong Application

• Significant, innovative, and focused science
• Significant product and/or commercial potential
• A product-focused application is more likely to
  have support of business reviewers
• A project with sound financial projections is
  more likely to attract a partner
• Translational research/clinical applications
  projects should involve the appropriate
  collaborators
• Clinical investigator in appropriate specialty
• Statisticians

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SBIR Follow-on Opportunities
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Competing Continuation Phase II Award

• available to SBIR Phase II awardees
• require extraordinary time and effort in the RD
  phase or may require FDA approval for the
  development of such projects, including drugs,
  devices, vaccines, therapeutics, and medical
  implants Response to an NIH Announcement
• Generally, 750k-1M/year for up to 3 years

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Transitioning to Phase III

• Pipeline to Partnerships
• http//ott.od.nih.gov/p2p/index.asp
• SBIR Technical Assistance Programs
• Commercialization Assistance Program (CAP)
• Niche Assessment Program (NAP)
• Manufacturing Assistance Program (MAP)

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Technical Assistance Programshttp//grants.nih.go
v/grants/funding/tap.htm

• Commercialization Assistance Program
• for phase II awardees
• Business strategic planning
• Builds alliances and investor partnerships
• Niche Assessment Program
• for phase I awardees
• Identify other uses of the technology
• Determine competitive advantages
• Develop market entry strategy

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Technical Assistance Programs, contd.

• Manufacturing Assistance Program
• Help developing operational manufacturing
  transition strategies

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Useful Web Links

• NCRR SBIR Web Site
• www.ncrr.nih.gov/sbo
• NIH SBIR Web Site
• http//grants.nih.gov/grants/Funding/sbirsttr_prog
  rams.htm