NIH SBIR/STTR Program

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1 NIH SBIR/STTR Program Andrea Sawczuk, DDS, PhD Health Scientist Administrator Division of Clinical Innovation National Center for Advancing Translational Sciences 6701 Democracy Boulevard MSC 4874 Bethesda, MD Phone:

2 SBIR: Small Business Innovation Research Grants STTR: Small Business Technology Transfer Research Grants

3 SBIR Purpose and Goals 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 Small Business Innovation Development Act of 1982 P.L Re-Authorizes program through FY2017

4 STTR Purpose and Goals 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 Small Business Research and Development Enhancement Act of 1992 P.L Re-Authorizes program through FY2017

5 SBIR / STTR Participating Agencies $717M FY2012 $2.5B DOD SBIR/STTR (1.4B) HHS(NIH) SBIR/STTR (717M) SBIR = 2.6% of NIH budget STTR = 0.35% of NIH budget NSF SBIR/STTR (161M) DOE SBIR/STTR (157M) NASA SBIR/STTR (120M) DHS SBIR (22M) USDA SBIR (20M) DOC SBIR (12M) ED SBIR (7.6M) EPA SBIR (4.2M) DOT SBIR (4M)

6 NIH SBIR/STTR: 3-Phase Program PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR) Solicitations (i.e., RFAs) may have different guidelines PHASE II Full Research/R&D $1M (STTR), $1M (SBIR) over two years PHASE II 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

7 NIH Unique Features Program flexibility at NIH and extended to ICs o Budget/time guidelines, Fast-Track o 95% grants, 5% contracts (6 ICs, CDC) o IC Management of programs o Centralized NCI SBIR Development Center o Distributed (most ICs) SBIR lead and PO/s o One person (a few ICs) SBIR lead does it all

8 SBIR Eligibility Criteria Subject to change per new SBA Policy Directive pending 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 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

9 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 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

10 SBIR and STTR: Critical Differences Research Partner SBIR: Permits partnering 33% Phase I and 50% Phase II Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Requires partnering with Research Institution Small business (40%) and U.S. research institution (30%) STTR: PI may be employed by either research institution or small business concern Award is always made to Small Business Concern

11 To learn more: NCATS participation in the small business program: Questions: NIH SBIR/STTR solicitations: NIH CSR study sections: nologytransfer/pages/default.aspx How to apply:

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