Orphan Products Natural History Studies Grants Program

The Orphan Products Natural History Studies Grants Program is a sub-program of the FDA Office of Orphan Products Development's broader orphan-products portfolio. Established in 2016, it funds protocol-driven natural history studies that close knowledge gaps, support clinical trials, and advance rare-disease medical product development. The program is on a biennial rhythm. The most recent receipt date was 10 February 2026, and the next is 8 February 2028. It uses a grant instrument, and the available sources do not publish a fixed award size, so applicants should expect the funding level to be defined in the notice for the relevant cycle rather than treated as a standing cap. Eligibility tracks the FDA orphan-products model for rare-disease work and is open to public or private, foreign or domestic, for-profit or nonprofit entities, while federal agencies remain ineligible. This is the right route for teams that can produce clean, interpretable longitudinal data and use that evidence to remove barriers to later therapeutic development. FDA is looking for efficient studies that answer a real knowledge gap and improve the design of future trials, not descriptive projects without a direct development use. Applicants tend to fare best when the study question is narrow, the protocol is disciplined, and the resulting data will help a sponsor or investigator move a rare-disease program closer to an intervention trial.

Each grant below is a distinct funding opportunity with its own eligibility, scope, and deliverables.