ForecastedFood and Drug Administration

Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Opportunity number FOR-FD-25-017 · Assistance listing 93.103

Estimated deadline
No fixed deadline
Expected posting
Jul 11, 2025
Award size
Up to $400K
Total program funding
Not listed
Expected awards
Not listed
Cost sharing
Not required
Funding type
Grant
Category
Agriculture, Consumer protection, Food and nutrition

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About this opportunity

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

  • Other (see eligibility)

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.

Agency contact

Kimberly Pendleton

240-402-7610

Kimberly.Pendleton@fda.hhs.gov
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Details from Grants.gov, last updated Mar 26, 2026. Deadlines and requirements can change: always confirm them in the official notice.