agriculture · consumer_protection · food_and_nutrition · HHS-FDA

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

Food and Drug Administration · FOR-FD-25-020

Closed

Deadline

TBD

GRANTQUICK SUMMARYPlain-English Overview

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required). Food and Drug Administration. 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... Funding amounts not specified.

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...

💡 GrantQuick Tip

Focus your proposal on clear outcomes, alignment with agency priorities, and demonstrate organizational capacity.

Competitiveness: Moderate to high — federal grants are always competitive

What This Grant Funds

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.

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.

Eligible Applicant Types

Other (see NOFO for details)

Funding Details

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

View on Grants.gov