Small Business Overview

National Institutes of Health (NIH) small business program is a congressionally-mandated set-aside program to encourage research and development leading to commercialization. The program, as established by law, is intended to stimulate a partnership of ideas and technologies in the private sector and strengthen the role of small business in meeting Federal research or research and development (R/R&D) needs.

The small business program at NINDS is used to achieve the mission of the Institute by supporting innovative ideas at different stages of development, including applied bench research, translational research, and early stage clinical trials. While NINDS has specific funding opportunities, found on the NINDS Small Business Funding Opportunities page, many of our applications are investigator initiated and come in through the general omnibus solicitation. Please contact program staff if you have questions about which institute(s) would be the best fit for your project.

The NINDS small business program has two main component programs.

  • Small Business Innovation Research (SBIR) Program - A set-aside program, currently 3.0% of the NINDS budget, for small business concerns to engage in federal R/R&D with the potential for commercialization.
  • Small Business Technology Transfer (STTR) Program - A set-aside program, currently 0.45% of the NINDS budget, to facilitate cooperative R/R&D with the potential for commercialization between small business concerns and U.S. research institutions.

The applicant success rates of both the SBIR and STTR programs depend on the budget and the number of applications and can fluctuate from year to year. While the STTR budget is significantly smaller, historically the program gets far fewer applications. Applicants are encouraged to read about both programs and pick the one that best fits their project.

Both of these component programs are structured in three phases, the first two of which are supported using small business program funds.

  • Phase I: A feasibility study to establish the technical/scientific merit of the proposed innovative R/R&D efforts.
  • Phase II: A full research study that continues the research or R&D efforts initiated in Phase I. Fast-track applications combine both Phases I and II into one application.
  • Phase III: The commercialization of the product, which should be pursued with non-STTR/SBIR funds.

Note that your firm cannot apply for a Phase II award without completing a Phase I award, as the results of a Phase I are a determining factor in deciding whether there will be a Phase II award.

The NINDS small business program makes use of the following mechanisms, which correspond to the components above:

  • R41: Small Business Technology Transfer (STTR) Grant, Phase I
  • R42: Small Business Technology Transfer (STTR) Grant, Phase II, Direct to Phase II and Fast-Track
  • R43: Small Business Innovation Research (SBIR) Grant, Phase I * R44: Small Business Innovation Research (SBIR) Grant, Phase II, Direct to Phase II and Fast-Track
  • U44: Cooperative Small Business Awards in Translational Research, Phase II and Fast-Track

Fast track grants are when Phase I and Phase II applications are submitted and reviewed concurrently. The Phase I is identified as a 1 R44, Phase II a 4 R44. If awarded, the Phase I will not show future year commitments. To be eligible for fast-track funding, the applicant must submit both a Commitment Appendix (showing committed funds and/or resources for the commercialization of the product) and a Product Development Plan (concisely providing information about the company, funding history, commercialization, product value, target dates, milestones, market analysis, and patent status). Further questions? Please contact Stephanie Fertig, MBA, or John Sheridan, PhD.