PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) | PA 22 176

Opportunity Information: Apply for PA 22 176

The PHS 2022-2 Omnibus Solicitation is a "parent" Small Business Innovation Research (SBIR) funding opportunity from 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 U.S. small businesses that can help advance the research and development missions of these agencies by proposing innovative technologies, products, tools, or services that match one of the listed agency topic areas. Applications are submitted under the SBIR grant mechanisms R43 (Phase I) and R44 (Phase II), with the overall intent of moving early-stage concepts through feasibility testing and toward further development and commercialization.

This announcement is broad and topic-driven. Rather than funding one narrow program, it points applicants to the PHS 2022-2 SBIR/STTR Program Descriptions and Research Topics document, which lays out the specific research priorities across participating NIH institutes and centers, CDC programs, and FDA components. A small business applies by selecting a topic that fits its proposed work and aligning the technical approach, milestones, and expected deliverables to that topic and to the mission needs of the awarding component. Because it is a parent solicitation, it serves as a general entry point into SBIR funding when a company has a strong fit with an identified topic but is not responding to a more targeted, single-purpose FOA.

A key limitation is that clinical trials are not allowed under this opportunity. That means the proposed project cannot include a clinical trial as defined by NIH policy. Companies can still propose a wide range of preclinical R and D activities, such as discovery work, prototype development, validation studies, analytic performance testing, usability and human factors testing (when it does not meet the definition of a clinical trial), and other non-clinical evaluations that de-risk the technology and position it for later-stage development. Applicants need to design their aims carefully so the work stays clearly outside the clinical trial category, since that is an eligibility and compliance issue for this specific FOA.

Eligibility is limited to U.S. small businesses. Non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, "foreign components" may be allowed in some cases as defined under the NIH Grants Policy Statement, which generally means certain parts of the work could potentially be conducted abroad if they meet NIH rules and are well justified, even though the applicant organization itself must be an eligible U.S. small business. In practice, applicants typically keep the core project work domestic and only consider foreign components when there is a clear and necessary reason (for example, unique expertise, populations, resources, or facilities that cannot be reasonably accessed in the U.S.), while following all applicable policy requirements.

From an administrative standpoint, this is a discretionary grant opportunity with the primary administering agency listed as NIH. The funding opportunity number is PA 22-176, and it spans many CFDA (Assistance Listing) numbers across health and related domains, reflecting how many NIH institutes and other HHS components participate. The original closing date provided in the source data is 2023-04-05, and the listed award ceiling is $275,766 (as stated in the opportunity record). As with SBIR awards generally, the specific budget, project period, and allowable costs depend on the phase (R43 vs. R44), the proposed scope, and the policies of the participating component, so applicants typically build budgets around the work plan, the phase-appropriate expectations, and any SBIR budget guidance tied to the solicitation.

Overall, this opportunity is best suited for U.S. small businesses with a clearly defined innovation and a development plan that maps to an NIH, CDC, or FDA topic area, where the near-term goal is technical feasibility and product or technology maturation rather than running a clinical trial. Strong submissions usually emphasize the significance of the public health or regulatory problem being addressed, the novelty of the solution, a rigorous and measurable technical plan with milestones, and a credible path to further development and commercialization after the SBIR phases.

• 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 2022-2 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): 93.068, 93.070, 93.073, 93.083, 93.084, 93.103, 93.113, 93.121, 93.136, 93.142, 93.172, 93.173, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.286, 93.307, 93.326, 93.350, 93.351, 93.361, 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 2022-06-02.
• Applicants must submit their applications by 2023-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $275,766.00 in funding.
• Eligible applicants include: Small businesses.

Apply for PA 22 176

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