Development of Microbiome-Related Approaches for Diagnosis/Mitigation/Treatment of Radiation Injuries (U01 Clinical Trial Not Allowed) | RFA AI 21 068

Opportunity Information: Apply for RFA AI 21 068

The grant opportunity titled "Development of Microbiome-Related Approaches for Diagnosis/Mitigation/Treatment of Radiation Injuries (U01 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) funding announcement aimed at expanding scientific understanding of the role the human microbiome plays in radiation injury, and translating that knowledge into practical medical countermeasures (MCMs). The central theme is that radiation exposure can disrupt microbial communities (especially in the gut), and that those disruptions may influence how injury develops, how severe it becomes, and how well an individual recovers. Projects supported under this announcement are expected to generate actionable insights into these microbiome-radiation relationships and to use those insights to develop approaches that can help diagnose, prevent, lessen (mitigate), or treat radiation-induced harm. Because the mechanism is listed as "Clinical Trial Not Allowed," the supported work is intended to be preclinical, translational, mechanistic, or otherwise non-clinical-trial research, rather than interventional trials in human participants.

This opportunity uses a cooperative agreement funding mechanism (U01), which typically means the NIH expects to have substantial programmatic involvement during the life of the award compared with a standard research grant. In practical terms, applicants should anticipate an interactive relationship with NIH scientific staff, including coordination on milestones, sharing of data or resources, and alignment with program priorities related to radiation preparedness and countermeasure development. The funding activity category is Health, and the associated CFDA number is 93.855. The announcement is identified as RFA AI 21 068, indicating it is a targeted request for applications rather than a broad, investigator-initiated call, and it was created on 2021-09-20 with an original closing date of 2022-02-09.

In terms of scope, the FOA is designed to support research that can move the field toward microbiome-informed countermeasures for radiation injuries. That can include studies that clarify how radiation alters microbial composition and function, how those changes affect host responses like inflammation, immune dysfunction, barrier integrity, infection risk, or hematopoietic recovery, and how microbiome-derived signals might be used as biomarkers for exposure level or injury severity. It also explicitly emphasizes development of countermeasures that target the microbiome, which can reasonably include microbiome-modulating therapeutics or strategies intended to prevent or reduce injury after radiation exposure. While the announcement text in your excerpt does not list specific required approaches, the stated goals point toward deliverables such as candidate diagnostics, therapeutic concepts, and mitigation strategies grounded in microbiome science, ideally with a clear path toward eventual deployment as radiation medical countermeasures.

Eligibility is broad and includes a wide range of U.S.-based organizations and government entities. Eligible applicants include state, county, city, township, and 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; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as listed); for-profit organizations other than small businesses; and small businesses, along with an "Others" category that typically captures additional eligible organizational types recognized under NIH policy. The FOA further highlights categories often encouraged or explicitly welcomed by NIH, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Indian/Native American Tribal Governments (other than federally recognized), eligible federal agencies, regional organizations, and U.S. territories or possessions.

There are important foreign involvement restrictions. Non-domestic (non-U.S.) entities, whether foreign organizations or foreign institutions, are not eligible to apply as the primary applicant. In addition, non-domestic components of U.S. organizations are not eligible to apply. At the same time, the announcement allows foreign components as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant may include certain foreign activities or collaborations when they are well-justified and meet NIH policy requirements, even though a foreign institution cannot be the applicant organization itself. This distinction matters for teams that want to incorporate unique overseas expertise, samples, or methods: collaboration may be possible, but the administrative home and applicant institution must be domestic and compliant with NIH rules.

The funding details provided indicate an award ceiling of $350,000, which is best understood as the maximum amount allowed under the FOA for an award (often per year, though the excerpt does not specify the budget period structure). The number of expected awards is not specified in the text you provided, which can mean it was not listed in the extracted metadata or was left open depending on available funds and application quality. Because this is a cooperative agreement with a defined ceiling, applicants would typically be expected to propose focused, milestone-driven projects with budgets that are realistic for microbiome profiling, mechanistic studies, and countermeasure development steps short of human clinical trials.

Overall, this NIH opportunity is positioned at the intersection of radiation biology, microbiome science, and medical countermeasure development. It is meant to fund research that does more than describe microbiome changes after radiation exposure by pushing toward practical outputs, such as microbiome-based diagnostics or interventions that can reduce harm from radiation injuries, while staying within a non-clinical-trial framework and under a cooperative agreement structure that emphasizes coordination with NIH program staff.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Microbiome-Related Approaches for Diagnosis/Mitigation/Treatment of Radiation Injuries (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 2021-09-20.
• Applicants must submit their applications by 2022-02-09. (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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