Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Food and Drug Administration · Department of Health and Human Services · FOR-FD-25-017
In plain English
Food and Drug Administration (Department of Health and Human Services) has announced this as a forecast: an opportunity it expects to post. It is not open for applications yet.
Awards are up to $400,000 each.
Eligibility is described in the listing text (the "Others" category).
The listing says cost sharing or matching is not required.
Built only from the fields in the Grants.gov listing. Always confirm on the official listing.
Key facts
| Status | Forecasted: not open yet |
|---|---|
| Estimated posting date | Not stated |
| Estimated application due date | Not stated |
| Fiscal year | 2025 |
| Forecast posted | Jul 11, 2025 |
| Opportunity number | FOR-FD-25-017 |
| Agency | Food and Drug Administration (Department of Health and Human Services) |
| Funding instrument | Grant |
| Category | Agriculture, Consumer Protection, Food and Nutrition |
| Opportunity category | Discretionary |
| Award ceiling (max per award) | $400,000 |
| Award floor (min per award) | Not stated |
| Estimated total program funding | Not stated |
| Expected number of awards | Not stated |
| Cost sharing or matching required | No |
| Assistance listing (CFDA/ALN) | 93.103 – Food and Drug Administration Research |
| Last updated on Grants.gov | Jul 11, 2025 |
Who can apply
- Others (see the eligibility details in the listing)
Additional eligibility information (excerpt from the listing):
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 …
Description
Excerpt from the official forecast on Grants.gov (shortened; read the full text on the official listing):
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.
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