Development of Candidate Medical Countermeasures (MCMs) and Technologies Against Radiological/Nuclear or Chemical Threats (U01 Clinical Trial Not Allowed)

The National Institutes of Health, within the U.S. Department of Health and Human Services, is offering the Development of Candidate Medical Countermeasures (MCMs) and Technologies Against Radiological/Nuclear or Chemical Threats cooperative agreement through funding opportunity RFA-AI-27-014. The participating NIH components include the National Institute of Allergy and Infectious Diseases, National Eye Institute, National Heart, Lung, and Blood Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Drug Abuse, and National Institute of Neurological Disorders and Stroke. The program supports research that advances understanding of radiation or chemical exposure injuries and develops models, diagnostic tools, biomarkers, triage technologies, and medical countermeasures intended to mitigate or treat acute or delayed injuries associated with radiological, nuclear, or chemical public health emergencies. Each application must address only one of four Research Areas: Radiation MCMs, models, and natural history; Biodosimetry; Nonhuman Primate Radiation Survivor Cohort; or Chemical Countermeasures. Supported activities range from early-stage discovery through advanced product development and may include animal models and new approach methodologies such as in-silico predictive models, in vitro platforms, artificial intelligence and machine learning approaches, biodosimetry devices and signatures, maintenance and study of qualifying nonhuman primate survivor cohorts, and discovery or early development of chemical countermeasures. The program emphasizes approaches that can function in mass-casualty or emergency settings. Applications proposing pretreatment or prophylactic approaches, HIV/AIDS research, epidemiological studies, or research spanning more than one Research Area are non-responsive. Additional Research Area-specific restrictions also apply. NIAID intends to commit $12 million in fiscal year 2027 for 18 to 20 awards in Research Areas 1, 2, and 4 and $3 million for one award in Research Area 3. Application budgets for Research Areas 1, 2, and 4 are not anticipated to exceed $350,000 in direct costs per year. Research Area 3 application budgets are not expected to exceed $2 million in direct costs, and applicants for that area must provide a detailed first-year budget not exceeding $2 million in direct costs. Budgets should reflect the actual needs of the proposed project. The maximum project period is five years. Cost sharing is not required. Pre-award costs are allowable only in accordance with NIH grants policy. Research Areas 1 through 3 must budget for appropriate personnel to attend a once-yearly one-day program progress meeting with NIAID in the Rockville, Maryland area. Eligible applicants include public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses and other for-profit organizations; state, county, city or township, special district, and tribal governments; eligible federal agencies; U.S. territories or possessions; independent school districts; public or Indian housing authorities; Native American tribal organizations; faith-based or community-based organizations; and regional organizations. Foreign organizations and non-U.S. components of U.S. organizations are not eligible. Foreign components are allowed, but applications involving foreign subawards or subcontracts are not permitted under this opportunity. Applicant organizations must maintain required SAM, eRA Commons, and Grants.gov registrations, and all Program Directors and Principal Investigators must have eRA Commons accounts and valid ORCID registrations. Organizations may submit more than one application when each application is scientifically distinct. Applications must follow the Research instructions in the NIH How to Apply Application Guide together with the program-specific requirements in the NOFO. Applications may be prepared and submitted through NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace and must subsequently be tracked in eRA Commons. Required materials include the applicable SF424 forms, budget materials, PHS 398 components, and a Research Plan. Specific Aims must identify the single Research Area addressed. The Research Strategy must describe significance, innovation, approach, rigorous experimental methods, the rationale for relevant models and endpoints, and a feasible development plan with timelines. Applicants must provide annual benchmarks, including quantitative benchmarks for year-one progress and defined out-year objectives. Applications lacking annual benchmarks will not be reviewed. A Data Management and Sharing Plan is required for NIH-funded or conducted research that will generate scientific data, and additional human subjects, animal, facilities, preliminary data, and Research Area-specific requirements apply when relevant. Scientific and technical merit will be assessed through NIH peer review. Reviewers will consider the importance of the research, including significance and innovation; rigor and feasibility of the approach; and investigator expertise and institutional resources. Review will consider experimental rigor, appropriate controls, sample size justification, analysis and reporting plans, relevant biological variables, and the feasibility and relevance of proposed benchmarks. Applicable additional considerations include protections for human subjects, vertebrate animals, biohazards, authentication of key resources, and the reasonableness of the proposed budget and period of support. Funding decisions will consider scientific and technical merit, availability of funds, and relevance to program priorities. This opportunity does not allow clinical trials, although activities involving human subjects that do not constitute clinical trials may be proposed. The opportunity was posted September 1, 2026, and opens for submission October 9, 2026. The next application deadline is November 9, 2026, at 5:00 PM local time of the applicant organization. Additional listed application deadlines are October 8, 2027, and October 9, 2028. The corresponding earliest anticipated start dates are July 2027, July 2028, and July 2029. The opportunity expires October 10, 2028. Applicants are encouraged to submit early so errors can be corrected before the applicable deadline. Scientific inquiries for the lead NIAID program may be directed to RADCHEM_U01@mail.nih.gov, with additional participating-institute contacts provided in the NOFO. Awards will use the cooperative agreement mechanism, under which NIH staff will have substantial programmatic involvement, including guidance concerning benchmarks, technical issues, resources, meetings, and program coordination.

Address only one Research Area. Include rigorous experimental methods, a clear mass-casualty or emergency concept of use, justified biomarkers/models/endpoints/controls/timing/routes, and a feasible development timeline. Include annual quantitative benchmarks because applications without them are non-compliant and will not be reviewed. For MCM-focused applications, include robust preliminary data and explain candidate novelty, feasibility, PK/PD, safety, and clinically relevant post-exposure efficacy. Align the proposal with the scored review factors of research importance, rigor and feasibility, and investigator expertise and resources. Submit early enough to correct electronic submission errors before the deadline.