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)

The PHS 2024-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research (SBIR) Grant Applications invites United States small businesses to apply for funding to conduct early-stage research and development (R&D) activities that have strong potential for commercialization. This Notice of Funding Opportunity (NOFO) is jointly issued by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), and supports applications for SBIR Phase I, Phase II, Direct to Phase II (NIH only), Fast-Track (NIH only), and Phase IIB (NIH only). Importantly, this funding opportunity does not support clinical trials. The objective of this NOFO is to support technological innovation and commercialization within the private sector by enabling small businesses to contribute to the R&D missions of the participating federal agencies. Eligible applicants must be small business concerns (SBCs) organized for profit and located within the United States. The program emphasizes stimulating technological innovation, fostering participation of underrepresented groups in entrepreneurship, and increasing commercialization of federally supported R&D results. Applicants may apply under different phases: Phase I focuses on establishing technical merit and feasibility, Phase II continues the R&D toward commercialization, and Fast-Track allows concurrent submission of Phase I and II. NIH also allows Direct to Phase II applications for projects where feasibility is already demonstrated. Phase IIB offers additional support for select Phase II projects requiring extended development efforts. Applicants must choose application types such as new, renewal, resubmission, or revision and must comply with specific page limits, budget ceilings, and submission instructions as outlined in the NIH Application Guide. Funding is awarded based on merit, feasibility, innovation, and commercial potential, with a focus on alignment with agency missions. Awards may reach up to $306,872 for Phase I and $2,045,816 for Phase II, although specific topics may qualify for budget waivers. Projects typically run for 6 months (Phase I) or up to 2 years (Phase II), but durations should be justified. All applications must exclude clinical trials and comply with detailed guidance on the structure, submission, and review process. Proposals are reviewed for scientific and technical merit, commercialization plans, resource environment, and potential societal impact. Eligible applicants include U.S.-based small businesses that are majority-owned by U.S. citizens or permanent residents, or by eligible entities such as Indian tribes or venture capital operating companies (with limitations). Applicants must meet registration requirements including SAM.gov, SBA Company Registry, eRA Commons, and Grants.gov. All PD/PIs must have a valid eRA Commons ID. Applicants may submit multiple scientifically distinct applications. Required components include budget justifications, a commercialization plan (for Phase II and Fast-Track), and adherence to Data Management and Sharing requirements. Evaluation emphasizes significance, innovation, approach, team qualifications, and potential for commercialization. Applications are accepted on standard due dates (September 5, January 5, April 5) through September 6, 2025, following a recent extension. Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or institutional systems. Applications undergo rigorous review, and awards depend on appropriations, submission volume, and alignment with agency priorities. Important contact points for application submission, program queries, and system support are provided, and applicants are encouraged to address any questions early in the submission process.