health · income_security_and_social_services · HHS-NIH11

Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

National Institutes of Health · PAR-25-450

709 days left

Deadline

July 20, 2028

GRANTQUICK SUMMARYPlain-English Overview

Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed). National Institutes of Health. This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling... Funding amounts not specified.

Who Should Apply

Special district governments, Federally Recognized Native American Tribal Governments, Small businesses, County governments, City/township governments (+10 more)

Who Should NOT Apply

Organizations not matching the eligible applicant types listed above

Key Requirements (Plain English)

•Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Is...
•Deadline: 2028-07-20

💡 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

This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials, and to increase their likelihood of success. This could be through the development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.

Attachments

PDF

PAR-25-450 Full Announcement Text

PAR-25-450-Full-Announcement.html

Who Can Apply

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Eligible Applicant Types

Special District GovernmentsFederally Recognized Tribal GovernmentsSmall BusinessesCounty GovernmentsCity/Township GovernmentsOther (see NOFO for details)Public Colleges & Universities501(c)(3) NonprofitsNonprofits without 501(c)(3)Independent School DistrictsFor-Profit OrganizationsOther Tribal OrganizationsState GovernmentsPrivate Colleges & UniversitiesPublic And Indian Housing Authorities

Funding Details

Cost Sharing Required?: No
Funding Instrument: grant

Key Dates

Posted: September 22, 2025

Application Deadline: July 20, 2028 (709 days remaining)

Agency Contact

NIH Grants Information grantsinfo@nih.gov

grantsinfo@nih.gov

Ready to apply?

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

View on Grants.gov