Development of Candidate Radiation/Nuclear Medical Countermeasures (MCMs) (U01 Clinical Trial Not Allowed) | RFA AI 23 059

Opportunity Information: Apply for RFA AI 23 059

The NIH funding opportunity titled "Development of Candidate Radiation/Nuclear Medical Countermeasures (MCMs) (U01 Clinical Trial Not Allowed)" (RFA-AI-23-059) is a discretionary, cooperative agreement program designed to push forward investigator-initiated research aimed at creating medical countermeasures for radiation or nuclear incidents. The core goal is to support projects that develop drugs, biologics, or other therapeutic approaches that could mitigate or treat injuries caused by radiation exposure during a public health emergency. A key emphasis is on advancing novel or promising strategies in radiation research to a point where they may be positioned for future review and potential licensure by the U.S. Food and Drug Administration (FDA), meaning the work should be development-oriented and geared toward eventual regulatory readiness, even though this particular announcement does not allow clinical trials.

Because the award mechanism is a U01 cooperative agreement, applicants should expect meaningful programmatic involvement from NIH staff compared with a standard research grant. In practice, this usually means NIH may collaborate on milestones, provide technical or strategic input, and help guide the project toward clearly defined development objectives. The NOFO is structured to accommodate research at all stages of development, which signals that both earlier translational efforts and more advanced preclinical development activities can be responsive, as long as the work stays tightly focused on radiation/nuclear medical countermeasure development rather than basic science without a defined product path.

Eligibility is broad and spans many common U.S.-based applicant types. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations (other than small businesses); and small businesses. The NOFO also explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. These callouts are essentially a reminder that a wide range of institution types are welcomed, including organizations that serve historically underrepresented communities.

At the same time, there are important restrictions around foreign participation. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the primary applicant organization. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant can propose certain elements of the work to be carried out abroad if they meet NIH rules for foreign components and provide a clear scientific justification, but the applicant organization itself must be eligible and domestic under the terms stated in the NOFO.

From the program logistics provided, the awarding agency is the National Institutes of Health under CFDA number 93.855, with an original application due date of January 26, 2024. The award ceiling listed is $350,000, indicating the maximum amount NIH expects to provide per award under this announcement (as stated in the opportunity data). The opportunity record shows an "ExpectedAwards" field but does not provide a number in the text you shared, so the anticipated count of awards is not clear from the supplied source data. Overall, the opportunity is best suited to teams that can articulate a concrete development plan for a radiation/nuclear countermeasure, tie the work to the needs of emergency preparedness and response, and demonstrate a pathway that could support eventual FDA licensure, while staying within the "clinical trial not allowed" boundary.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Candidate Radiation/Nuclear Medical Countermeasures (MCMs) (U01 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): 93.855.
• This funding opportunity was created on 2023-10-24.
• Applicants must submit their applications by 2024-01-26. (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 $350,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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