The Small Business Innovation Research (SBIR) program is a set-aside program (2.5% of an agency's extramural budget) for domestic small business concerns to engage in Research/Research and Development (R/R&D;) that has the potential for commercialization. The SBIR program was established under the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorized until September 30, 2000 by the Small Business Research and Development Enhancement Act (P.L. 102-564), and reauthorized again until September 30, 2008 by the Small Business Reauthorization Act of 2000 (P.L. 106-554).

Federal agencies with extramural research and development budgets over $100 million are required to administer SBIR programs using an annual set-aside of 2.5% for small companies to conduct innovative research or research and development (R/R&D;) that has potential for commercialization and public benefit. Currently, eleven Federal agencies participate in the SBIR program: the Departments of Health and Human Services (DHHS), Agriculture (USDA), Commerce (DOC), Defense (DOD), Education (DoED), Energy (DOE), Homeland Security, and Transportation (DOT); the Environmental Protection Agency (EPA), the National Aeronautics and Space Administration (NASA), and the National Science Foundation (NSF). To date, over $12 billion has been awarded by the SBIR program to various small businesses.

The STTR program was established by the Small Business Technology Transfer Act of 1992 (Public Law 102-564, Title II), reauthorized until the year 2001 by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorized again until September 30, 2009, by the Small Business Technology Transfer Program Reauthorization Act of 2001 (P.L. 107-50).

Federal agencies with extramural R&D; budgets over $1 billion are required to administer STTR programs using an annual set-aside of 0.30%. Currently, five Federal agencies participate in the STTR program: DOD, DOE, DHHS (NIH), NASA and NSF. In fiscal year (FY) 2003 (October 1, 2002-September 30, 2003), the NIH made SBIR grant and contract awards totaling over $525 million and STTR grant awards totaling over $31 million.

Objectives. The SBIR Program includes the following objectives: using small businesses to stimulate technological innovation, strengthening the role of small business in meeting Federal R/R&D; needs, increasing private sector commercialization of innovations developed through Federal SBIR R&D;, increasing small business participation in Federal R/R&D;, and fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program. The STTR and SBIR programs are similar in that both programs seek to increase the participation of small businesses in Federal R&D; and to increase private sector commercialization of technology developed through Federal R&D.; The unique feature of the STTR program is the requirement for the small business concern applicant organization to formally collaborate with a research institution in Phase I and Phase II.

Differences between SBIR and STTR. The SBIR and STTR programs differ in two major ways. First, under SBIR Program, the Principal Investigator must have his/her primary employment with the small business concern at the time of award and for the duration of the project period, however, under the STTR Program, primary employment is not stipulated. Second, the STTR Program requires research partners at universities and other non-profit research institutions to have a formal collaborative relationship with the small business concern. At least 40 percent of the STTR research project is to be conducted by the small business concern and at least 30 percent of the work is to be conducted by the single, "partnering" research institution.

Structure of the SBIR and STTR Programs. The SBIR/STTR Programs are structured in three phases.

Phase I. The objective of Phase I is to establish the technical merit and feasibility 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. Support under Phase I is normally provided for six months/$100,000 for SBIR and one year/$100,000 for STTR.

Phase II. The objective of Phase II is to continue the R/R&D; efforts initiated in Phase I. Only Phase I awardees are eligible for a Phase II award. SBIR and STTR Phase II awards normally may not exceed $750,000 total. However, applicants may propose longer periods of time and greater amounts of funds necessary for completion of the project.

Deviations from the indicated Phase I/Phase II statutory award amount and project period guidelines are acceptable but must be well justified and should be discussed with appropriate NIH staff listed in the Awarding Component/Agency Contact Information Table (PDF or MS Word) prior to submission of the application prior to submission of the application.

Applicants are very strongly encouraged to contact Institute/Center Program Staff before submitting an application in which the budget and/or project period deviates from the SBIR or STTR statutory guidelines. While the Phase I and Phase II award levels are guidelines that allow for applicants to propose a budget and project period appropriate for completion of the research project, deviations from the guidelines should be discussed with appropriate NIH staff listed in the Awarding Component/Agency Contact Information Table (PDF or MS Word) prior to submission of the application.

Phase III. The objective of Phase III, where appropriate, is for the small business concern to pursue with non-SBIR/STTR funds the commercialization objectives resulting from the Phase I/II R/R&D; activities. In some Federal agencies, Phase III may involve follow-on non-SBIR/STTR funded R&D; or production contracts for products, processes or services intended for use by the U.S. Government.

In what areas is NIH interested? The National Institutes of Health (NIH) welcomes SBIR and STTR applications from small businesses in any biomedical or behavioral research area that falls within our mission, which is to improve human health. Areas of interest are described in the solicitations below. Applicants are encouraged to subscribe to the NIH Guide for Grants and Contracts and to visit the websites of our Institutes and Centers to learn of emerging interests and areas of high priority.

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