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agriculture · consumer_protection · food_and_nutrition · HHS-FDA

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

Food and Drug Administration · FOR-FD-25-017

Closed

Award Range

$0$400K

Deadline

TBD

GRANTQUICK SUMMARYPlain-English Overview

Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional). Food and Drug Administration. 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... up to $400,000 per award.

Who Should Apply

Other eligible entities

Who Should NOT Apply

Individuals and organizations outside the specified eligible types

Key Requirements (Plain English)

  • Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Oth...

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Competitiveness: Moderate to high — federal grants are always competitive

What This Grant Funds

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

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.

Eligible Applicant Types

Other (see NOFO for details)

Funding Details

Maximum Award
$400K
Cost Sharing Required?
No
Funding Instrument
grant

Key Dates

Posted: July 11, 2025
Application Deadline: TBD (0 days remaining)

Agency Contact

Kimberly Pendleton 240-402-7610

Kimberly.Pendleton@fda.hhs.gov

Ready to apply?

View the full NOFO and submit your application on Grants.gov