Development of Alternative Human Models of Radiation-Induced Injuries (Extracorporeal Systems) (U01 Clinical Trial Not Allowed) | RFA AI 24 067

Opportunity Information: Apply for RFA AI 24 067

The National Institutes of Health (NIH) is soliciting applications for a cooperative agreement under Funding Opportunity Number RFA AI 24 067 titled "Development of Alternative Human Models of Radiation-Induced Injuries (Extracorporeal Systems) (U01 Clinical Trial Not Allowed)." This opportunity is designed to fund early- to mid-stage research that builds and uses alternative, human-relevant experimental systems outside the body (extracorporeal models) to better understand how radiation causes harm and to evaluate medical countermeasures that could treat or lessen both immediate (acute) and longer-term (delayed) radiation injuries. The emphasis on extracorporeal systems points to platforms such as human cell- and tissue-based constructs, organotypic or engineered tissue models, microphysiological systems, organ-on-chip approaches, perfused bioreactor tissues, and other human-derived model systems that can reproduce key features of radiation damage without relying solely on animal models.

A central goal of the NOFO is mechanistic insight: applicants are expected to use these human model systems to clarify the biological pathways and cellular events that drive radiation-induced injury. At the same time, the opportunity is explicitly oriented toward practical testing, meaning the models should be suitable for evaluating candidate medical countermeasures intended to treat or mitigate radiation injuries. In practice, that often means designing models that are reproducible, measurable, and scalable enough to compare interventions, quantify injury and recovery, and generate data that can inform subsequent development stages. The NOFO allows work spanning acute and delayed effects, which supports projects that capture not only short-term cell death and inflammation, but also later outcomes such as fibrosis, vascular dysfunction, stem cell depletion, impaired regeneration, and chronic immune or tissue remodeling responses, depending on the targeted organ system.

The award mechanism is a U01 cooperative agreement, which typically involves substantial scientific or programmatic involvement from NIH staff compared with a standard research project grant. Applicants should therefore anticipate coordination, milestone-driven progress, and active communication with NIH program leadership as part of the project structure. The funding instrument is categorized as discretionary, and the activity area is health, with CFDA number 93.855. The listing states an award ceiling of $350,000, indicating the maximum amount expected per award under the terms described in the notice (while actual budgets would depend on NIH policies, the approved application budget, and the final award negotiations). The original application closing date is February 6, 2025, and the opportunity was created on October 4, 2024.

Eligibility is broad across U.S.-based organizational types. Eligible applicants include state, county, city, township, and special district governments; federally recognized Native American tribal governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding institutions of higher education when specified in those categories); for-profit organizations other than small businesses; and small businesses. The NOFO also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, regional organizations, U.S. territories or possessions, and Indian/Native American tribal governments that are not federally recognized.

At the same time, there are clear restrictions related to foreign participation. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may be able to include certain foreign collaborations or performance sites if they meet NIH policy requirements and are justified scientifically, even though the main applicant organization must be domestic.

Finally, the title includes "Clinical Trial Not Allowed," which signals that the funded work must not involve NIH-defined clinical trials. The scope is therefore focused on preclinical or non-clinical research, centered on developing and validating extracorporeal human model systems and using them to study radiation injury mechanisms and to test potential countermeasures in those model platforms, rather than enrolling human participants into interventional studies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Alternative Human Models of Radiation-Induced Injuries (Extracorporeal Systems) (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 2024-10-04.
• Applicants must submit their applications by 2025-02-06. (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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