PAR-25-025-Full-Announcement.html

This is a Notice of Funding Opportunity (NOFO) announcement for grant PAR-25-025, issued by the National Institutes of Health (NIH) to support investigator-initiated Phase I clinical trials for diagnostic and therapeutic interventions targeting heart, lung, blood, and sleep (HLBS) disorders in both adults and children. The funding instrument is an R33 CT grant mechanism that requires applicants to be ready to initiate clinical trials within the first quarter of the project period, with all regulatory approvals (FDA, DSMB, IRB), drug supplies, and third-party agreements established by the time of award.

The opportunity is open to a wide range of applicants including higher education institutions, nonprofits, for-profit organizations, small businesses, tribal organizations, and various government entities. The grant falls under four NIH federal grant programs: Lung Diseases Research (93.838), Cardiovascular Diseases Research (93.837), Blood Diseases and Resources Research (93.839), and the National Center on Sleep Disorders Research (93.233). For organizations requiring additional time for pre-clinical and trial readiness activities, a companion NOFO utilizing an R61/R33 phased approach is available.