PAR-25-026-Full-Announcement.html

This is a Notice of Funding Opportunity (NOFO) announcement from the National Institutes of Health (NIH) for early phase clinical trials focused on therapeutics and diagnostics for heart, lung, blood, and sleep (HLBS) disorders. The funding opportunity uses a bi-phasic R61/R33 mechanism to support investigator-initiated Phase I clinical trials, including both single and multisite trials, with the R61 phase dedicated to final pre-trial activities such as stability testing, shipping studies, and site training.

The opportunity is administered through the Department of Health and Human Services NIH and encompasses five CFDA programs: Lung Diseases Research (93.838), Cardiovascular Diseases Research (93.837), Translation and Implementation Science Research (93.840), Blood Diseases and Resources Research (93.839), and the National Center on Sleep Disorders Research (93.233). Eligible applicants include higher education institutions, small businesses, nonprofit organizations, state and local governments, tribal organizations, and for-profit organizations. The funding supports both clinical trial implementation and prerequisite preclinical activities necessary for trial execution.