PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) | PA 23 232

Opportunity Information: Apply for PA 23 232

The PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications (Parent STTR R41/R42, Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity that supports early-stage and follow-on research and development led by U.S. small businesses working in formal collaboration with a research institution. Released as a "parent" omnibus solicitation (Funding Opportunity Number PA 23-232), it is designed to fund a wide range of biomedical, behavioral, and health-related innovations that align with the missions of participating NIH components. The program uses the STTR mechanism, which is specifically intended to move promising ideas from the research environment toward commercialization by pairing small business development capability with nonprofit research expertise.

This opportunity supports projects proposed under the STTR phased structure: Phase I (R41) typically focuses on feasibility, proof of concept, and early technical validation, while Phase II (R42) generally supports expanded R and D, refinement, and further development toward a commercial product, process, or service. The solicitation encourages applicants to propose work that fits within the defined program descriptions and topic areas used across NIH, CDC, and FDA as referenced in the PHS 2022-2 SBIR/STTR Program Descriptions and Research Topics. In practice, that means applicants should map their aims to a relevant topic area and to the interests of an NIH awarding component, with a clear plan for technical progress and a credible path toward eventual market adoption or deployment.

A key constraint is that clinical trials are not allowed under this parent announcement. Projects must therefore be structured so that they do not propose a clinical trial as defined by NIH policy. For applicants working on therapeutics, diagnostics, devices, digital health tools, or behavioral interventions, this usually means focusing on non-clinical development, preclinical studies, benchtop validation, algorithm development, usability or human factors work that does not meet the NIH definition of a clinical trial, or other R and D activities that advance readiness without initiating a trial. Applicants whose goals require a clinical trial generally need to seek a different NIH funding opportunity that explicitly allows clinical trials.

Eligibility is limited to small businesses based in the United States that meet the federal definition of a small business concern for STTR programs. Foreign entities (non-U.S. institutions) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, may be allowed in certain circumstances, which typically requires strong justification that the foreign component is necessary for the project and that comparable capabilities are not readily available domestically. Even when allowed, the applicant remains a U.S. small business, and the core STTR collaboration and project leadership must satisfy NIH and STTR requirements.

The funding opportunity is categorized as discretionary and uses the grant funding instrument. It is associated with NIH and multiple CFDA (now Assistance Listing) numbers including 93.113, 93.121, 93.173, 93.361, 93.394, 93.395, 93.847, and 93.879, reflecting the breadth of NIH program areas that may make awards under this solicitation. The activity categories listed include education, environment, food and nutrition, and health, which signals that relevant projects can span traditional biomedical R and D as well as health-related technologies with broader public health, environmental health, or nutrition-related applications when aligned with NIH component missions.

The solicitation was created on July 12, 2023, and lists an original closing date of April 5, 2024. The notice does not provide an award ceiling or expected number of awards in the provided excerpt, which is common for omnibus solicitations where budgets and award volumes vary by institute, topic area, and annual set-asides. Applicants generally need to pay close attention to the specific NIH component priorities, the STTR program rules, and the standard NIH review criteria, while also demonstrating commercialization potential, a well-structured partnership with the research institution, and a feasible technical plan that fits the non-clinical-trial scope of this parent announcement.

• The National Institutes of Health in the education, environment, food and nutrition, health sector is offering a public funding opportunity titled "PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] 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, 93.173, 93.361, 93.394, 93.395, 93.847, 93.879.
• 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 23 232

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