Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

The Food and Drug Administration (FDA) is soliciting applications for funding to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. The purpose of this notice of funding opportunity (NOFO) is to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development. Key aspects of this opportunity include: • Eligible organizations: Higher Education Institutions, Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education, Nonprofits, For-Profit Organizations, Local Governments, State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments, Federal Governments, U.S. Territory or Possession, and Non-domestic (non-U.S.) Entities. • Funding instrument: Grant • Funding activity categories: Agriculture, Consumer Protection, Food and Nutrition • Award ceiling: $600,000 • Award floor: $0 • Cost sharing: Not required • Application due date: February 8, 2028