Funder: Food and Drug Administration (FDA)
Due Dates: Letter of Intent: January 9, 2026 | Application: February 10, 2026 | Letter of Intent: January 7, 2028 | Application: February 8, 2028
Funding Amounts: Prospective studies: up to $400,000/year (max 4 years); Retrospective: up to $150,000/year (max 2 years); up to $600,000/year for innovative designs.
Summary: Supports efficient and innovative natural history studies to advance medical product development for rare diseases with unmet needs.
Key Information: Clinical trials are optional; non-U.S. and foreign organizations are eligible.