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NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)

Description:

The mission of the NlDA is to lead the nation in bringing the power of science to bear on drug abuse and addiction, through support and conduct of research across a broad range of disciplines and by ensuring rapid and effective dissemination and use of research results to improve prevention, treatment, and policy. For additional information about areas of interest to the NIDA, please visit our home page at http://www.nida.nih.gov/. SBIR and STTR programs at NIH are primarily intended to encourage private-sector commercialization of technology and to increase smallbusiness participation in federally funded R&D.

Both the SBIR and STTR programs consist of the three phases. During Phase I, NIDA supports the projects which establish the technical merit and feasibility of proposed research or R&D efforts and determines the quality of performance of the applicant (small business concern or SBC) before providing further Federal support in Phase II. During Phase II, NIDA supports the extension of the research or R&D efforts initiated in Phase I. Only Phase I grantees are eligible to receive Phase II funding. During Phase III, the small business concern (SBC) is to pursue commercialization with non-SBIR/STTR funds (either Federal or non-Federal). Applicants are encouraged to seek commitment(s) of funds and/or resources from an investor or partner organization for commercialization of the product(s) or service(s) resulting from the SBIR/STTR grant. Phase III funding may be from any of a number of different sources including, but not limited to: SBIR/STTR firm itself; private investors or “angels”; venture capital firms; investment companies; joint ventures; R&D limited partnerships; strategic alliances; research contracts; sales of prototypes (built as part of this project); public offering; state finance programs; non SBIR-funded R&D or production commitments from a Federal agency with the intention that the results will be used by the United States government; or other industrial firms. NIDA monitors SBC efforts to pursue, with non-SBIR/STTR funds, the commercialization of the results of the research or R&D funded in Phases I and II of the SBIR/STTR Program.

While making funding decisions, NIDA will carefully examine that proposed research has both the potential for commercialization and public benefit. NIDA funding decisions will be based on combination of factors: the review scores; theresults of Phase I and the commercial potential and scientific/technical merit of the Phase II application (for Phase II applications); the quality of performance of the applicant, including the success in Phase III for the applicants with the previous history of SBIR/STTR support; programmatic priorities and portfolio balance; and availability of funds.

Special Features of NIDA SBIR Program

Fast-Track Applications

The NIH Fast-Track mechanism expedites the decision and award of SBIR and STTR Phase II funding by incorporating a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together. The Fast-Track application will receive a single rating for the entire proposed project (i.e., it will receive a numerical score or it will receive an “unscored” designation). To be eligible for the Fast-Track option, the Phase I Research Plan must include well-defined, quantifiable milestones that should be achieved prior to initiating Phase II work. In addition, as is required for all Phase II applications, the Phase II portion of a Fast-Track application must present a Commercialization Plan. NIDA encourages Fast-Track mechanism for scientifically meritorious applications that have expressly high potential for commercialization, specifically. Applicants considering a Fast-Track application are strongly encouraged to contact program staff before submitting an application. Among the issues which potential Fast-Track applicants are encouraged to discuss with the NIDA program staff are: Value of the SBIR/STTR Project, Expected Outcomes, and Impact (the proposed project and its key technology objectives; the product, process, or service to be developed in Phase III; the need addressed, specifying weaknesses in the current approaches to meet this need; the commercial applications of the research and the innovation inherent in this application; the potential societal, educational, and scientific benefits of this work; the non-commercial impacts to the overall significance of the project); Market, Customer, and Competition (the market and/or market segments targeted, a brief profile of the potential customer, significant advantages SBC’s innovation will bring to the market, e.g., better performance, lower cost, faster, more efficient or effective, new capability, the hurdles to overcome in order to gain market/customer acceptance of the proposed innovation, any strategic alliances, partnerships, or licensing agreements already in place to market and sell the product, FDA approval (if required), marketing and sales strategy, overview of the current competitive landscape and any potential competitors over the next several years, etc.

Amount of Award

For budgetary, administrative, or programmatic reasons, NIDA may decrease the length of an award and/or the budget recommended by a review committee, or not fund an application. In general, NIDA advises to keep the amount of requested funds within $150,000 - $300,000 total cost per year for up to 2 years (Phase I) and up to $1,000,000 total cost per year for up to 3 years (Phase II). Applicants considering a requested budget greater than these limits are strongly encouraged to contact program staff before submitting an application.

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