Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Status: Open
Posted date: July 11, 2025
Opportunity ID: 359985
Opportunity number: FOR-FD-25-017
Opportunity category: Discretionary
Agency name: Food and Drug Administration
Agency code: HHS-FDA
Award floor: $0
Award ceiling: $400,000
Cost sharing required: No
Funding Instrument Types
- Grant
Category of Funding Activity
- Agriculture
- Consumer Protection
- Food and Nutrition
Eligible Applicants
- Others
Categories (use these for quoted searches)
- agency_code:hhs_fda
- category_of_funding_activity:agriculture
- category_of_funding_activity:consumer_protection
- category_of_funding_activity:food_and_nutrition
- cost_sharing_or_matching_requirement:false
- eligible_applicants:others
- funding_instrument_type:grant
- opportunity_category:discretionary
- status:open
The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects 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.