Cellular Therapies for Treatment of Radiation Injuries (U01) | RFA AI 17 001

Opportunity Information: Apply for RFA AI 17 001

Cellular Therapies for Treatment of Radiation Injuries (U01) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (RFA AI 17 001) aimed at moving promising cell-based medical countermeasures closer to real-world use after a radiological or nuclear incident. The core focus is on radiation-induced injuries and, importantly, on treatments that can still work when given at least 24 hours after exposure. That timing requirement reflects the reality of mass-casualty scenarios, where many people may not receive immediate care. The FOA supports studies that test candidate cellular therapies in appropriate in vivo (animal) models, with the larger objective of generating evidence that could support eventual licensure under the U.S. Food and Drug Administration (FDA) Animal Rule pathway. In practice, that means the research is expected to be framed with regulatory translation in mind, using well-justified animal models and clinically meaningful endpoints that can bridge to human benefit when human efficacy trials are not ethical or feasible.

This opportunity uses the U01 mechanism, which is a cooperative agreement rather than a standard research project grant. That matters because a U01 typically involves substantial scientific or programmatic involvement from NIH staff during the project period. Applicants should expect active coordination, milestone-driven progress, and ongoing alignment with program goals related to developing medical countermeasures. The activity category is health, and the listing references CFDA numbers 93.855 and 93.856, which are commonly associated with NIH programs in infectious diseases, biodefense, and related preparedness areas. The overall intent is not just basic discovery, but targeted preclinical development work that helps a cellular therapy candidate advance toward approval for treating radiation injury.

Eligible applicants are broad and include many types of U.S.-based organizations and governments. Examples listed include state, county, and municipal governments; special district governments; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; independent school districts; public housing/Indian housing authorities; public and state-controlled universities; private institutions of higher education; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. The intent here is to encourage participation from a wide range of institutions that can contribute relevant expertise, facilities, animal model capabilities, cell manufacturing experience, or translational development capacity.

There are specific constraints around foreign participation. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as applicant organizations. However, non-domestic components of U.S. organizations are allowed, meaning a U.S. institution can include work conducted at an overseas site if it is part of the U.S. organization’s structure. In addition, foreign components are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S. applicant can include a foreign collaborator or a distinct foreign component when it is scientifically justified and properly structured within NIH policy.

From the administrative details provided, the original closing date was 2017-08-01, and the FOA was created on 2017-02-08. The award ceiling is listed as $350,000, indicating the maximum amount expected per award under the terms described in the notice (though actual budgets in NIH awards can depend on approved scope, project period, and negotiated costs). The number of expected awards is not specified in the provided text. Overall, this FOA is best understood as a translational, preparedness-oriented NIH funding opportunity designed to produce rigorous animal efficacy data for cell-based therapies that could treat radiation injuries when treatment is delayed, specifically aligned with the evidence standards needed for FDA Animal Rule consideration.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Cellular Therapies for Treatment of Radiation Injuries (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856.
• This funding opportunity was created on 2017-02-08.
• Applicants must submit their applications by 2017-08-01. (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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