PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) | PA 23 231

Opportunity Information: Apply for PA 23 231

PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) is a federal grant opportunity that supports U.S. small businesses developing health-related innovations that align with the research and development missions of participating National Institutes of Health (NIH) Institutes and Centers and the Centers for Disease Control and Prevention (CDC). It is structured as a parent SBIR solicitation, meaning it functions as a broad, multi-topic gateway for small companies to propose projects across many biomedical, behavioral, clinical, and public health areas, as long as the work fits the stated scientific interests of at least one participating NIH/CDC component. A defining feature of this specific parent announcement is that applicants must propose at least one clinical trial; it is not appropriate for projects that do not involve a clinical trial component.

The award mechanism is SBIR using the R43/R44 grant activity codes, which generally map to the SBIR phased approach: Phase I (R43) supports early-stage proof of concept and feasibility work, while Phase II (R44) supports more advanced research and development activities aimed at moving a technology toward commercialization and broader deployment. In practice, companies use this pathway to de-risk clinical innovations by generating the human-subject evidence needed for regulatory, adoption, reimbursement, or implementation decisions. Because the NOFO is an omnibus solicitation, applicants are expected to anchor their proposed aims in one of the published SBIR/STTR topic areas referenced in the companion program descriptions and research topics document (PHS 2022-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA). That topic alignment is important because it signals which awarding component is likely to consider the project and what kinds of outcomes, populations, and clinical settings are most relevant.

Eligibility is limited to eligible United States small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, the opportunity notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowed in some circumstances, which typically means discrete parts of the work can be carried out abroad when there is a strong justification (for example, unique patient populations, specialized facilities, or resources not reasonably available in the U.S.), subject to NIH policy and awards management requirements. Even when foreign components are permitted, the applicant organization itself must still be a qualifying U.S. small business, and the overall project must remain consistent with SBIR program rules.

From an applicant standpoint, the core expectation is a well-justified clinical trial embedded in a coherent product-focused development plan. That usually includes a clear statement of the unmet need, the innovation, the target users or patients, and the clinical context; a rigorous trial design that matches the stage of development (such as early feasibility, pilot, pivotal, pragmatic, or implementation-oriented trials, depending on the technology and agency mission); appropriate protections for human subjects; and a credible pathway to commercialization and real-world use. Because NIH and CDC interests vary widely, strong applications typically make the fit to a specific Institute/Center or CDC mission explicit, showing how the clinical trial outcomes will advance both public health impact and product readiness.

Administratively, this is a discretionary grant opportunity issued by NIH (with CDC participation) under a health and education-related activity category, and it is tied to CFDA/assistance listing numbers 93.361, 93.394, 93.395, and 93.867. The opportunity number is PA 23 231, and the original closing date listed is 2024-04-05. The public listing does not specify an award ceiling or expected number of awards in the provided excerpt, which is common for omnibus parent announcements because budgets and award volume often depend on the quality of submissions, available appropriations, and the priorities of participating components.

Overall, this NOFO is best understood as a broad entry point for U.S. small businesses that are ready to test a health-related innovation in humans and can propose at least one clinical trial that is scientifically rigorous, mission-aligned with a participating NIH Institute/Center or CDC program area, and oriented toward eventual commercialization and public health benefit.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "PHS 2023-2 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): 93.361, 93.394, 93.395, 93.867.
• This funding opportunity was created on 2023-07-12.
• Applicants must submit their applications by 2024-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PA 23 231

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