SBIR and STTR

Small Business Innovation Research (SBIR) Program

The Small Business Innovation Research (SBIR) program is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization.

Three-Phase Program

The SBIR Program is structured in three phases:

Phase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and to determine the quality of performance of the small business awardee organization prior to providing further Federal support in Phase II. SBIR Phase I awards normally do not exceed $150,000 total costs for 6 months.

Phase II. The objective of Phase II is to continue the R/R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II. Only Phase I awardees are eligible for a Phase II award. SBIR Phase II awards normally do not exceed $1,000,000 total costs for 2 years.

Phase III. The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&D activities. The SBIR program does not fund Phase III. Some Federal agencies, Phase III may involve follow-on non-SBIR funded R&D or production contracts for products, processes or services intended for use by the U.S. Government.

SBIR Participating Agencies

Each year, Federal agencies with extramural research and development (R&D) budgets that exceed $100 million are required to allocate 3.2 percent (FY 2017) of their R&D budget to these programs. Currently, eleven Federal agencies participate in the SBIR program:

• Department of Agriculture
• Department of Commerce – National Institute of Standards and Technology
• Department of Commerce – National Oceanic and Atmospheric Administration
• Department of Defense
• Department of Education
• Department of Energy
• Department of Health and Human Services
• Department of Homeland Security
• Department of Transportation
• Environmental Protection Agency
• National Aeronautics and Space Administration
• National Science Foundation

Each agency administers its own individual program within guidelines established by Congress. These agencies designate R&D topics in their solicitations and accept proposals from small businesses. Awards are made on a competitive basis after proposal evaluation.

Program Eligibility Criteria

• Organised as for-profit US business
• Small: 500 or fewer employees, including affiliates
• Work must be done in the US (with few exceptions)
• Individual Ownership:
  • Greater than 50% US-owned by individuals and independently operated OR
  • Greater than 50
  • 5 owned and controlled by other business concern/s that is/are greater than 50% owned and controlled by one or more indiciduals, an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), OR
  • Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these (For some agencies)

Small Business Technology Transfer (STTR) Program

The Small Business Technology Transfer (STTR) is a program that expands funding opportunities in the federal innovation research and development (R&D) arena. Central to the program is expansion of the public/private sector partnership to include the joint venture opportunities for small businesses and nonprofit research institutions. The unique feature of the STTR program is the requirement for the small business to formally collaborate with a research institution in Phase I and Phase II.

Three-Phase Program

The STTR Program is structured in three phases:

Phase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and to determine the quality of performance of the small businesses prior to providing further Federal support in Phase II. STTR Phase I awards normally do not exceed $150,000 total costs for 1 year.

Phase II. The objective of Phase II is to continue the R/R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the Phase II project proposed. Only Phase I awardees are eligible for a Phase II award. STTR Phase II awards normally do not exceed $1,000,000 total costs for 2 years.

Phase III. The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&D activities. The STTR program does not fund Phase III. In some Federal agencies, Phase III may involve follow-on non-STTR funded R&D or production contracts for products, processes or services intended for use by the U.S. Government.

STTR Participating Agencies

Each year, Federal agencies with extramural research and development (R&D) budgets that exceed $1 billion are required to reserve 0.45% of the extramural research budget for STTR awards to small businesses. These agencies designate R&D topics and accept proposals. Currently, five agencies participate in the STTR program:

• Department of Defense
• Department of Energy
• Department of Health and Human Services
• National Aeronautics and Space Administration
• National Science Foundation

Each agency administers its own individual program within guidelines established by Congress.  These agencies designate R&D topics in their solicitations and accept proposals from small businesses. Awards are made on a competitive basis after proposal evaluation.

STTR Eligibility Criteria

• Applicant is a Small Business concern
• Formal Cooperative R&D Effort
  • Minimum 40% by small business
  • Minimum 30% by US research institution
• US 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

• Model: Collaboration between Division of Preclinical Innovation (DPI) and extramural labs
• Projects
  • Enter with clinical candidate identified
  • Any disease eligible
  • Gap Analysis followed by data generation using DPI resources and expertise to generate data necessary for IND filing
  • Exit at or before IND
  • Milestone driven
  • Therapeutic modalities: small molecules, peptides, oligonucleotides, gene therapy, antibodies, recombinant proteins
• Eligible Applicants
  • Academic (U.S. an Ex-U.S.), Non-Profit, SBIR-eligible businesses

To learn more visit the NCATS BriDGs page.

• Model: Comprehensive drug development collaboration between DPI and extramural labs with disease-area/target expertise
• Projects
  • May enter at various stages of preclinical development
  • Disease must meet FDA orphan or WHO neglected tropical disease criteria
  • Taken to stage needed to attract external organization to adopt to complete clinical development/registration, max Phase 2a
  • Milestone driven
  • Therapeutic modalities: small molecules, protiens, peptides, oligonucleotides, gene therapy, antibodies, recombinant proteins
• Eligible Applicants
  • Academic, Nonprofit, Government Lab, Biotech/Pharma
  • Ex-U.S. applicants accepted

To learn more visit the NCATS TRND page.