Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) FOR-HL-25-029

The National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), is preparing to release a Notice of Funding Opportunity (NOFO) under opportunity number FOR-HL-25-029. This opportunity is designed to support the development and implementation of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials. These trials must be consistent with NHLBI’s research mission and meet the NIH definition of a clinical trial. The CCC will be part of a collaborative UG3/UH3 cooperative agreement structure and will work alongside a separately funded Data Coordinating Center (DCC), which is detailed in companion NOFO FOR-HL-25-018. The primary objective of this funding opportunity is to support efficacy, comparative effectiveness, pragmatic, and implementation research clinical trials. These trials are expected to address conditions and challenges relevant to heart, lung, blood, and sleep disorders. The CCC will be responsible for presenting a comprehensive scientific rationale and operational plan for the proposed trial. It will coordinate multi-site study activities and ensure regulatory compliance and participant safety. All clinical trials funded under this NOFO must be milestone-driven and phased, beginning with a UG3 planning phase and advancing to a UH3 implementation phase upon successful milestone achievement. The funding mechanism is a cooperative agreement, which indicates substantial NIH involvement in project management. While specific spending restrictions or award ceilings and floors are not listed, the NOFO outlines a commitment to multi-year funding aligned with project milestones. The total program funding and the number of anticipated awards have not yet been disclosed. However, the project is tied to several Assistance Listings including cardiovascular, lung, blood, and sleep research programs, indicating a broad scope of eligible study areas. Eligible applicants include a diverse range of entities such as state and local governments, higher education institutions (both public and private), nonprofit organizations with 501(c)(3) status, for-profit organizations including small businesses, public housing authorities, and Native American tribal organizations and governments. Applications must be submitted in conjunction with a corresponding DCC application on the same due date to be considered. Although this is currently a forecasted opportunity, applicants are encouraged to begin developing collaborations and planning responsive projects in anticipation of the open date. The estimated posting date for this NOFO is November 11, 2025, with applications due by February 10, 2026. Awards are expected to be announced by October 1, 2026, with projects beginning December 1, 2026. This timeline suggests early engagement is critical for successful submission. There are currently no pre-application deadlines, Q&A periods, or submission portals open. For further inquiries, potential applicants should contact Dr. Yves Rosenberg, MD, MPH, in the Division of Cardiovascular Sciences at NHLBI. He can be reached by phone at 301-435-0550 or via email at rosenbey@nhlbi.nih.gov. At this time, applications are not being accepted; the forecast is intended to provide sufficient lead time for thorough planning and collaboration development.