NIAID Clinical Trial Implementation Cooperative Agreement

The National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services, is forecasting a funding opportunity titled "NIAID Clinical Trial Implementation Cooperative Agreement." The forecast notice indicates that this funding opportunity will be made available as a cooperative agreement in the area of health, specifically focusing on allergy and infectious diseases research. The associated assistance listing for this program is 93.855, which pertains to Allergy and Infectious Diseases Research. The forecast was issued on June 27, 2025, with an anticipated post date of December 5, 2025. The estimated due date for applications is February 25, 2026, and award notifications are expected by December 1, 2026. Project work will commence on December 1, 2026, aligning with Fiscal Year 2027. The purpose of this program is to support the implementation of investigator-initiated clinical trials that are both milestone-driven and high-risk. These may include mechanistic studies embedded within the clinical trials. The intent is to fund not only the primary research activities but also the auxiliary components required for effective execution and compliance with clinical research protocols. The scope of the grant includes training of study personnel, participant recruitment and enrollment, data collection and quality management, clinical data handling, investigational product costs, laboratory analyses, study oversight, post-trial responsibilities, and regulatory obligations including site monitoring. This reflects a comprehensive model for supporting clinical research infrastructure and execution, aiming to enhance the capacity for impactful health discoveries in the domain of infectious and allergic diseases. This opportunity will be made available to a broad range of entities. Eligible applicants include state governments, county governments, independent school districts, federally recognized and other Native American tribal organizations, public and private institutions of higher education, nonprofits with IRS 501(c)(3) status (excluding higher education institutions), small businesses, other for-profit organizations, and public housing authorities/Indian housing authorities. The opportunity is open to eligible applicants across the United States without geographical restriction, making it a nationwide program. There are no additional stated restrictions limiting eligibility to specific counties, cities, or jurisdictions. While detailed funding amounts such as the award ceiling, award floor, and total program funding are not provided in this forecast, the notice confirms that cost sharing or matching is not required for applicants. The number of expected awards is also not specified, as is typical for forecasted notices. These figures are likely to be disclosed when the full funding announcement is posted in December 2025. Applicants should anticipate federal oversight due to the cooperative agreement structure, which indicates active NIH involvement in project execution. There is currently no information provided regarding pre-application deadlines, concept papers, or letters of intent. The opportunity is not offered on a rolling basis, but it is expected to recur annually, based on the projected submission and project start dates. Given that the application deadline is in February 2026 and the anticipated award and start date is December 1, 2026, applicants will have several months for preparation. Interested applicants should monitor grants.gov for the full Notice of Funding Opportunity (NOFO) release. In the interim, potential applicants may reach out to the grantor contact, Dr. Cynthia de la Fuente at cynthia.delafuente@nih.gov or via phone at 240-699-2740, for more information regarding program objectives or administrative guidance.