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

Key facts

Copied from the official Grants.gov record. Last verified October 29, 2026.

Program name

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

Issuing agency

Food and Drug Administration (Department of Health and Human Services)

Opportunity number

FOR-FD-25-017

Funding type

Grant

Funding purpose

Agriculture, Food and Nutrition, Consumer Protection

Status

Forecasted

Application deadline

Forecasted · no application dates yet

Published award range

Up to $400,000

Cost sharing or match required

No

Eligible applicants (official categories)

• Others (see Additional Information on Eligibility)

Relevant to

Businesses and NonprofitsHow we determined this: Listed as 'Others'; the agency's eligibility text mentions businesses (flagged for review). Listed as 'Others'; the agency's eligibility text mentions nonprofits (flagged for review).

Geographic restrictions

None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.

Assistance Listing (CFDA)

93.103

Official source

View on Grants.gov ↗

Application URL

www.grants.gov/search-results-detail/359985 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.

Source identifier

Grants.gov opportunity ID 359985 · Funding opportunity number FOR-FD-25-017

Posted

July 11, 2025 · Source last updated July 11, 2025

Last verified

October 29, 2026 (against Grants.gov)

Data completeness

92% of key fields published by the sourceNot published: application dates.

Record confidence

loweligibility described only in free text (in review); forecast — dates and amounts are agency estimates.

Eligibility details (from the agency)

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.

Description (from 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.

Agency contact

Kimberly Pendleton
Kimberly.Pendleton@fda.hhs.gov