Radiation Biodosimetry Assays and Devices (U01 Clinical Trial Not Allowed) | RFA AI 18 045

Opportunity Information: Apply for RFA AI 18 045

Radiation Biodosimetry Assays and Devices (U01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity (RFA-AI-18-045) focused on improving the nation s ability to respond to a large-scale radiological or nuclear incident by supporting the development of practical biodosimetry tools for civilians. The core aim is to advance biomarkers, bioassays, testing techniques, and or devices that can be deployed quickly and broadly in real-world emergency settings. The FOA emphasizes solutions that are rapid, reliable, inexpensive, and easy to use, reflecting the reality that mass-casualty events require tools that work at scale, under pressure, and often outside specialized laboratory environments. Awards are made as cooperative agreements (U01), meaning applicants should expect substantial NIH involvement in project oversight and coordination, and the FOA explicitly states that clinical trials are not allowed under this announcement.

The scientific and public health need driving this FOA is triage: separating people who truly need medical evaluation and treatment from those who do not, and doing so fast enough to save lives and allocate limited resources effectively. The announcement highlights three key research gaps that proposed projects are expected to address in one or more ways. First is the ability to distinguish the "worried well" (people who fear they were exposed but were not meaningfully irradiated) from individuals who were actually exposed. Second is the capability to estimate radiation dose in affected individuals or groups, since dose strongly influences medical risk and appropriate intervention. Third is the ability to predict acute and delayed radiation injuries across major organs and physiological systems by identifying biomarkers that correlate with injury severity and timing, which can directly inform clinical triage, treatment decisions, and follow-up care after an incident.

From a practical development standpoint, the FOA is oriented toward applied products that can be used in the field or in surge clinical environments, rather than purely exploratory biology. Competitive proposals would generally be expected to justify why the proposed biomarker or assay is suitable for emergency use, describe how it can be measured quickly and robustly, and explain how results would translate into actionable categories for triage and medical management. While the FOA summary does not list specific technology preferences, the repeated emphasis on speed, simplicity, and low cost signals strong interest in assays and devices that minimize specialized equipment, reduce time-to-result, and function reliably across large numbers of people.

Eligibility is broad and includes many types of U.S.-based organizations and government entities, such as state, county, and local governments; special districts; independent school districts; public housing authorities; federally recognized tribal governments; tribal organizations that are not federally recognized; public and private institutions of higher education; and nonprofit organizations with or without 501(c)(3) status. It also allows for-profit organizations (other than small businesses) and small businesses, as well as other eligible applicants listed in the FOA text, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, the FOA restricts foreign participation in important ways: non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply, and 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, which typically means an otherwise eligible U.S. applicant may include certain well-justified foreign collaborations or elements within NIH policy boundaries.

Administratively, this is a discretionary grant program in the health area (CFDA 93.855) run by NIH. The opportunity was created on 2018-10-09 and had an original closing date of 2019-02-11. The listed award ceiling is $300,000, indicating an upper bound on budget per award within the terms of the announcement. The FOA also notes an expected awards field, though the provided extract does not specify the number, so applicants would typically consult the full FOA text for details on anticipated funding levels, project period expectations, and any milestone or deliverable structure associated with the cooperative agreement mechanism.

Overall, the opportunity is best read as an applied biodefense and emergency preparedness investment: it seeks deployable biodosimetry assays and devices that can rapidly sort large populations after radiological exposure, estimate dose, and forecast organ-specific injury risk using validated biomarkers, thereby supporting evidence-based triage and treatment decisions when time and medical capacity are limited.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Radiation Biodosimetry Assays and Devices (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 2018-10-09.
• Applicants must submit their applications by 2019-02-11. (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 $300,000.00 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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