Small Business Innovation Research (SBIR) Program

Small Business Innovation Research (SBIR) Program is sponsored by Food and Drug Administration (FDA). CDRH has an SBIR grant program for medical device innovators to engage in research and development with the potential for product commercialization. CDRH's interest areas are announced annually in the SBIR Omnibus/Parent Grant Solicitation.

PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) Solicitation Number: PA-24-245 Solicitation Status: Closed NOTE: The Solicitations and topics listed on this site are copies from the various SBIR agency solicitations and are not necessarily the latest and most up-to-date.

For this reason, you should use the agency link listed below which will take you directly to the appropriate agency server where you can read the official version of this solicitation and download the appropriate forms and rules.

View Official Solicitation September 5, 2024; January 5, 2025; April 5, 2025; September 5, 2025 The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America's Seed Fund, are one of the largest sources of early-stage capital for technology commercialization in the United States.

These programs enable US-owned and operated small businesses to conduct research and development that has a strong potential for commercialization.

National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) support small businesses through the SBIR and STTR programs to develop promising technologies and products that align with their mission to improve health and save lives.

As described by the Small Business Administration (SBA), the statutory purpose of the Small Business Innovation Research (SBIR) program is to strengthen the role of innovative small business concerns (SBCs) in federally-funded research or research and development.

The purpose of the Small Business Technology Transfer (STTR) program is to stimulate a partnership of ideas and technologies between innovative SBCs and non-profit Research Institutions. Federal agencies with extramural research budgets over $100 million are required to set-aside 3.

2% of their extramural research budget to the SBIR program, and those with extramural research budgets over $1 billion are required to set aside an additional 0. 45% to the STTR program.

This Notice of Funding Opportunity (NOFO) issued by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Direct to Phase II (NIH Only), Fast-Track (NIH only), and Phase IIB (NIH only) grant applications.

Small business applicants interested in submitting an STTR grant application should submit to PA-24-247 or PAR-24-248. SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts.

An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal).

Small businesses that are eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award.

NIH Fast-Track: An NIH SBIR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases.

NIH Direct to Phase II: For small businesses that have already demonstrated scientific and technical merit and feasibility but have not received a Phase I SBIR or STTR for that project, NIH can issue a Direct to Phase II award. The NIH will accept Direct to Phase II applications regardless of the funding source for the proof of principle work on which the proposed Phase II research is based.

Direct to Phase II awards should be submitted as “New” applications and not continuations ("Renewal") of Phase I SBIR or STTR projects. Applicants are not required to identify a potential awarding component prior to submission of the application but may request one on the Assignment Request Form.

Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH, CDC, and FDA grant applications, will assign all applications to the most appropriate Agency and Institute/Center (IC) based on their mission and the science proposed. For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website.

All applications submitted to this Parent Notice of Funding Opportunity are not allowed to propose clinical trial(s). SBIR applications that propose clinical trial(s) should be submitted to PA-24-246. Further information about the SBIR and STTR programs can be found at https://seed.

nih. gov. Frequently asked questions are available to assist applicants and can answer many basic questions about the program.