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

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

Agency: Food and Drug Administration

Assistance Listings: 93.103 -- Food and Drug Administration Research

Last Updated: July 11, 2025

Description

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.

Eligibility

Eligible applicants

Miscellaneous

Other

Additional information

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.

Grantor contact information

Description

Email

Business e-mail address

Kimberly.Pendleton@fda.hhs.gov

Documents

No documents are currently available.

Link to additional information

Forecasted

Estimated Post Date:

Estimated Application Due Date:

Estimated Due Date Description:

Not available

Estimated Award Date:

Estimated Project Start Date:

Fiscal Year:

2025

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

Expected awards

$--

Award Minimum

$400,000

Award Maximum

Funding opportunity number:

FOR-FD-25-017

Cost sharing or matching requirement:

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

Category of Funding Activity:

Agriculture

Consumer protection

Food and nutrition

Category Explanation:

History

Version:

Forecast posted date:

July 11, 2025

Archive date: