Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Federal funding opportunity FOR-FD-25-017 from Food and Drug Administration.
View forecast on Grants.gov →Forecasted — not yet open
- Posted
- July 11, 2025
- Closes
- See announcement
- Award ceiling
- $400,000
- Cost sharing
- No
- Instrument
- Grant
- Assistance listing
- 93.103
- Category
- Agriculture, Consumer Protection, Food and Nutrition
Program funding history
Awards made under Assistance Listing 93.103 across FY2024–FY2026, from public federal spending records.
- FY2024 obligated
- $250.8M
- FY2025 obligated
- $213M
- FY2026 (to date) obligated
- $15M
- Awards in window
- 911
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, The Medical Device Innovation Consortium, Duke University
Source: USAspending.gov · refreshed July 2026
Synopsis
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.
Who can apply
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Local Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Federal Governments U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Foreign Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
How to apply
Applications go through the official government listing. Grants Radar links you straight to the source.
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