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) | PA 24 245

Opportunity Information: Apply for PA 24 245

The PHS 2024-2 Omnibus Solicitation is a parent Small Business Innovation Research (SBIR) grant opportunity issued jointly by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). It is designed to fund early-stage research and development (R and D) projects proposed by eligible United States small businesses that can advance the missions of participating NIH Institutes and Centers, CDC programs, and FDA components. The emphasis is on innovative, technically sound R and D with clear potential for public health impact and commercialization, aligned to the specific topic areas described in the SBIR/STTR Program Descriptions and Research Topics published for NIH, CDC, and FDA.

This solicitation uses the SBIR grant mechanisms R43 (Phase I) and R44 (Phase II). In practical terms, Phase I is intended to support feasibility work, proof-of-concept development, and early technical validation, while Phase II generally supports a more advanced stage of R and D such as iterative prototype refinement, expanded testing, and other activities that move an innovation closer to a product or service that can be deployed in the real world. Because it is a parent omnibus announcement, it acts as a broad entry point across many biomedical, behavioral, public health, regulatory science, and related technology areas rather than being limited to a single narrowly defined project theme. Applicants are expected to choose and align with the appropriate participating component and topic area when preparing the application.

A central limitation of this particular parent announcement is that clinical trials are not allowed. That means proposals must be structured so they do not include clinical trial activities as defined by NIH policy (for example, prospective assignment of human participants to an intervention to evaluate effects on health-related outcomes). Projects may still be able to involve human data or specimens in certain ways, depending on the specifics and on agency policy, but applicants need to be careful to keep the work outside the clinical trial definition and compliant with human subjects rules where applicable. If a company intends to run a clinical trial, it would generally need to pursue a different funding opportunity that explicitly allows or solicits clinical trials.

Eligibility is limited to small businesses based in the United States that meet SBIR program requirements. Foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, the announcement notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed in some circumstances. In plain terms, the applicant organization must be a U.S. small business, but there may be limited, well-justified cases where a discrete part of the work can be performed outside the U.S. if it meets the agency definition of a foreign component and is permitted under policy. Any such arrangement typically requires strong justification (for example, unique resources or expertise not available domestically) and must be disclosed and handled according to the applicable federal requirements.

From an administrative standpoint, this is a discretionary grant program with NIH listed as the agency name for the posting, reflecting NIH’s role in managing many SBIR grant processes even though CDC and FDA also participate. The opportunity number is PA 24 245, and it covers a wide range of CFDA (Assistance Listing) numbers spanning NIH, CDC, and FDA program areas, which signals the breadth of potential research domains and awarding components that can support projects under this omnibus solicitation. The posting lists an original closing date of 2025-04-05, which applicants should treat as a key deadline marker, though SBIR parent announcements often have multiple standard receipt dates or cycles; applicants should confirm the applicable due date schedule and any component-specific submission instructions in the full NOFO and associated topic listings.

Overall, this grant opportunity is best understood as a broad SBIR entry point for U.S. small businesses developing innovative health-related technologies, tools, platforms, or methods that fit the missions and topic priorities of NIH, CDC, or FDA, with the important constraint that the proposed work must not include a clinical trial. Companies with strong R and D capability, a credible technical plan for Phase I and/or Phase II, and a clear path toward commercialization and public health benefit are the intended audience for this solicitation.

• The National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "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)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.142, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.350, 93.351, 93.361, 93.393, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.859, 93.865, 93.866, 93.867, 93.879.
• This funding opportunity was created on 2024-07-03.
• Applicants must submit their applications by 2025-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PA 24 245

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