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, many of our applications are investigator initiated and come in through the general NIH SBIR and STTR omnibus solicitations. 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 3.2% 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.
  • In addition to the traditional Phase I and II applications, NINDS accepts Phase IIB SBIR/STTR Competing Renewal applications through specific opportunities that focus on the commercialization of SBIR and STTR developed technologies.
• Fast-track grants are when Phase I and Phase II applications are submitted and reviewed concurrently. Such applications should include clear, appropriate, measurable goals (milestones) that should be achieved in Phase I prior to initiating Phase II.
• 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: supports cooperative R&D projects between small business concerns and research institutions, limited in time and amount, to establish the technical merit and feasibility of ideas that have potential for commercialization.
• R42: Small Business Technology Transfer (STTR) Grant, Phase II and Fast-Track: supports in-depth development of cooperative R&D projects between small business concerns and research institutions, limited in time and amount, for which feasibility has been established in an STTR Phase I project and which have the potential for commercialization.
• R43: Small Business Innovation Research (SBIR) Grant, Phase I : supports projects to establish the technical merit and feasibility of R&D ideas which may lead to a commercial product or service and to determine the quality of performance of the small business awardee organization.
• R44: Small Business Innovation Research (SBIR) Grant, Phase II and Fast-Track: supports in-depth development of R&D ideas for which feasibility was established in Phase I projects and which may ultimately lead to a commercial product or service.
• U44: Cooperative Small Business Awards. These are milestone-driven and involve NIH program staff’s participation in developing the project plan, monitoring research progress, and appropriate go/no-go decision-making. See more information on translational research programs which utilize this mechanism.

Further questions? Please contact NINDS SBIR/STTR program staff.