PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) | PA 24 246

Opportunity Information: Apply for PA 24 246

The PHS 2024-2 Omnibus Solicitation is a parent funding opportunity announcement from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) that invites U.S. small businesses to apply for Small Business Innovation Research (SBIR) grants under the R43 and R44 mechanisms. The central purpose is to support research and development led by small companies that have the technical capability to create, refine, and test innovative products or approaches that align with NIH and CDC public health and biomedical missions. Because this is an omnibus or "parent" solicitation, it is designed to cover a wide range of scientific and technological areas rather than a single narrow topic, but applicants are expected to target one or more topic areas described in the SBIR/STTR Program Descriptions and Research Topics associated with NIH, CDC, and FDA.

A defining feature of this specific parent solicitation is that it is the "Clinical Trial Required" version. That means the application must propose at least one clinical trial as part of the project. In practical terms, the project is expected to involve prospective research in human participants in which an intervention is assigned and the effects on health-related or behavioral outcomes are evaluated. This requirement shapes the kind of work that is appropriate for the announcement: applicants should be planning clinical evaluation of a drug, biologic, device, diagnostic, digital health tool, preventive intervention, behavioral strategy, or other health-related technology where a clinical trial is necessary to establish feasibility, safety, performance, or efficacy. The clinical trial element is not optional in this NOFO, so projects that are purely preclinical, purely observational, or otherwise not meeting the NIH definition of a clinical trial would not be a fit for this particular announcement.

Eligibility is focused on U.S. small businesses. Foreign organizations are explicitly not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, may be allowed in some cases, which typically means certain discrete parts of the work can occur outside the U.S. when there is a strong justification (for example, access to a unique population, resource, or expertise) and the arrangement complies with NIH policy. Even when foreign components are permitted, the applicant organization itself must still be an eligible U.S. small business and must meet SBIR program requirements.

Programmatically, the proposed project must align with the mission interests of at least one participating NIH Institute or Center (IC) or CDC awarding component. Since NIH is made up of many institutes with different scientific priorities, applicants generally need to select the most appropriate IC based on the health condition, technology area, or population focus, and ensure the specific aims clearly map to that ICs mission. The solicitation is broad across health and related domains, reflected in the multiple CFDA numbers listed (including many NIH institutes and program areas). This breadth means projects can span a wide range of biomedical and public health innovations, as long as they are responsive to participating component priorities and include the required clinical trial.

From an administrative standpoint, the opportunity is a discretionary grant funding program with the funding instrument listed as a grant, and the eligible applicant type listed as small businesses. The opportunity number is PA 24 246, and the funding opportunity title is "PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)." The posting indicates an original closing date of 2025-04-05, and a creation date of 2024-07-03. The award ceiling and expected number of awards are not specified in the provided source data, which is common for omnibus solicitations where budgets and award counts can vary widely depending on institute participation, application volume, and appropriations.

In summary, this NOFO is aimed at U.S. small businesses developing health-related innovations that are ready for evaluation in at least one clinical trial, with projects tailored to the mission needs of NIH and CDC components. The best-fit applicants are companies that not only have a strong technical concept, but also have a realistic clinical development plan, an appropriate trial design, and a clear rationale for why their proposed clinical study is necessary to move the product or intervention toward practical use in healthcare or public health settings.

• 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 and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.142, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.286, 93.307, 93.361, 93.393, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.847, 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 24 246

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