NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) | PAR 21 083

Opportunity Information: Apply for PAR 21 083

The NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number PAR-21-083, is a National Institutes of Health (NIH) discretionary funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID). It uses a cooperative agreement mechanism (U01), which typically means the award is meant to support a well-defined clinical trial project while also involving substantial scientific or programmatic interaction with NIAID staff during the life of the award. The FOA is aimed at moving beyond planning and into actual trial implementation, with a particular emphasis on investigator-initiated clinical trials that are considered high-risk, along with mechanistic studies that are closely tied to those trials.

A central goal of this announcement is to support clinical trials that are ambitious or uncertain enough that they may not fit easily into more conventional funding paths, while still having the potential to generate important clinical and scientific payoffs. The FOA highlights mechanistic research as a major value-add: integrating mechanistic studies into a clinical trial can help explain why an intervention works or does not work, identify biological pathways involved in disease or treatment response, discover biomarkers, and generate insights that inform future therapeutic development. In practice, this means applicants are encouraged to embed or tightly coordinate laboratory, immunologic, genomic, microbiologic, or other translational investigations with the clinical endpoints of the trial, so the study produces not only efficacy and safety findings but also deeper understanding of human disease processes and treatment mechanisms.

The opportunity is aligned with NIAIDs mission space, and applicants are explicitly encouraged to review NIAIDs research priorities and high-priority scientific areas on the institute website. While the text provided does not list specific topic areas, the intent is that proposed trials and associated mechanistic work should clearly fit within NIAIDs overall role and portfolio, which broadly covers allergy, immunology, and infectious diseases, as well as related countermeasure development and clinical research needs within that scope.

A key structural constraint is that only one clinical trial may be proposed per U01 application under this FOA. That means an application should be built around a single, clearly defined trial, rather than a bundle of multiple trials. Mechanistic components are encouraged, but they are expected to be associated with that one clinical trial rather than representing separate standalone clinical studies. This one-trial-per-application rule shapes how applicants should frame their aims, budgets, timelines, and operational plans, focusing on a single trial with well-integrated mechanistic objectives where appropriate.

From an eligibility standpoint, the provided source data indicates eligible applicants include small businesses. The activity category is Health and the CFDA number listed is 93.855, which corresponds to NIAID-related assistance programs. The original closing date shown is 2024-01-13, and the FOA record creation date is 2021-01-14. Award ceiling and expected award counts are not specified in the supplied data, so applicants would need to rely on the full FOA and any NIH/NIAID guidance for budget expectations and likely award volume.

Overall, PAR-21-083 is designed for teams ready to run an investigator-driven clinical trial that carries meaningful scientific risk but also the potential for major impact, especially when paired with mechanistic studies that can clarify biological effects and accelerate future therapeutic strategies. The cooperative agreement format signals that NIAID expects to be actively engaged with awardees to help steer successful execution, which can be particularly important for complex or higher-risk trial implementations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)" 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 2021-01-14.
• Applicants must submit their applications by 2024-01-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 21 083

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