Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Key facts

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

Program name

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Issuing agency

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

Opportunity number

FOR-FD-25-020

Funding type

Grant

Funding purpose

Consumer Protection, Agriculture, Food and Nutrition

Status

Forecasted

Application deadline

Forecasted · no application dates yet

Published award range

Not published by the agency

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/359987 ↗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 359987 · Funding opportunity number FOR-FD-25-020

Posted

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

Last verified

October 29, 2026 (against Grants.gov)

Data completeness

83% of key fields published by the sourceNot published: published funding range, 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.

Description (from the official listing)

The purpose of this opportunity is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

Agency contact

Kimberly Pendleton
Kimberly.Pendleton@fda.hhs.gov