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.Apply for RFA AI 23 059
- 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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Frequently Asked Questions (FAQs)
What is the funding opportunity?
The opportunity is an NIH funding announcement titled "Development of Candidate Radiation/Nuclear Medical Countermeasures (MCMs) (U01 Clinical Trial Not Allowed)" with identifier RFA-AI-23-059. It supports investigator-initiated, development-oriented research focused on medical countermeasures for radiation or nuclear incidents.
What is the main purpose of this program?
The core goal is to advance candidate medical countermeasures (MCMs) intended to mitigate or treat injuries caused by radiation exposure during a public health emergency. Projects should be aimed at developing drugs, biologics, or other therapeutic approaches with a clear development pathway.
What kinds of products or approaches are in scope?
The announcement is focused on development of drugs, biologics, or other therapeutic approaches intended to mitigate or treat radiation-induced injuries. The emphasis is on candidate countermeasures with a defined development trajectory rather than exploratory research without a product target.
Is this opportunity intended for basic science projects?
The opportunity is designed for development-focused work. While research at various stages of development may be supported, applications should stay tightly focused on radiation/nuclear medical countermeasure development rather than basic science that lacks a defined path toward a deliverable candidate product.
Does the program support early-stage or later-stage development?
Yes. The NOFO is described as accommodating research at all stages of development, which indicates both earlier translational efforts and more advanced preclinical development activities can be responsive, as long as the work remains development-oriented and aligned with countermeasure advancement.
Are clinical trials allowed under this opportunity?
No. The funding opportunity is explicitly labeled "Clinical Trial Not Allowed," so proposed work must stay within non-clinical boundaries under this particular announcement.
What does the U01 award mechanism mean for applicants?
This is a U01 cooperative agreement, which generally involves meaningful programmatic involvement from NIH staff compared with a standard research grant. Applicants should expect NIH participation such as collaborating on milestones, providing technical or strategic input, and helping guide the project toward clearly defined development objectives.
How is NIH staff involvement different from a standard grant?
Because this is a cooperative agreement, NIH staff may play an active role in shaping or monitoring the project through milestone alignment and programmatic guidance. The intent is to help keep projects on track toward development outcomes rather than operating with minimal federal involvement.
How does FDA licensure relate to this program if clinical trials are not allowed?
Even though clinical trials are not allowed in this announcement, the program emphasizes advancing novel or promising strategies to a point where they may be positioned for future FDA review and potential licensure. That means projects should be oriented toward regulatory readiness and a credible development path, while staying preclinical or otherwise non-clinical under this award.
Who is the awarding agency?
The awarding agency is the National Institutes of Health (NIH).
What is the CFDA number for this opportunity?
The opportunity lists CFDA number 93.855.
What types of organizations are eligible to apply?
Eligibility is broad and includes many U.S.-based organization types, such as 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.
Are institutions serving underrepresented communities specifically encouraged or included?
Yes. The NOFO explicitly highlights eligibility for organizations 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). It also calls out faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Can a non-U.S. organization apply as the primary applicant?
No. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the primary applicant organization under the terms described.
Can a non-U.S. component of a U.S. organization apply?
No. The information provided states that non-domestic components of U.S. organizations are not eligible to apply.
Are foreign components allowed in a project?
Yes, foreign components are allowed as defined in the NIH Grants Policy Statement. In general, that means a U.S. applicant organization may propose certain elements of work to be carried out abroad if NIH foreign component rules are met and there is clear scientific justification, but the primary applicant must be an eligible domestic organization.
What is the application due date listed for this opportunity?
The original application due date provided is January 26, 2024.
What is the maximum award amount (award ceiling)?
The award ceiling listed is $350,000, which indicates the maximum amount NIH expects to provide per award under this announcement, as stated in the opportunity data.
How many awards does NIH expect to make?
The opportunity record includes an "ExpectedAwards" field, but the information provided does not include a number. Based on the supplied data alone, the anticipated number of awards is not specified.
What kinds of project plans are likely to be a good fit?
Based on the description provided, the opportunity is best suited to teams that can propose a concrete development plan for a radiation/nuclear medical countermeasure, connect the work to emergency preparedness and response needs, and describe a pathway that could support future FDA licensure, while staying within the "clinical trial not allowed" constraint.
Is this funding described as discretionary, and what does that imply in context?
The opportunity is described as a discretionary, cooperative agreement program. In context, that framing aligns with an NIH-led cooperative mechanism (U01) where NIH has meaningful involvement and the program is structured to drive development progress toward defined objectives.
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