GrantPostedDiscretionary

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

National Institutes of Health
PAR-25-450
Application Deadline
Jul 20, 2028
863 days left
Days Remaining
863
Until deadline
Award Ceiling
Total Program Funding

Grant Opportunity Analysis

The National Institutes of Health (NIH) has announced a funding opportunity titled "Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)" aimed at supporting clinical projects that enhance readiness for clinical trials in rare diseases. This initiative seeks applications that focus on developing and testing biomarkers and clinical outcome measures, as well as defining the characteristics of rare diseases to facilitate the design of future clinical trials. The program is particularly important for addressing the needs of rare diseases affecting fewer than 200,000 individuals in the U.S., with a maximum budget of $275,000 for direct costs over a project period of up to two years. Interested applicants can find more information and submit inquiries via email to grantsinfo@nih.gov, with the application deadline set for July 20, 2028.

Eligible Applicants

Others
Additional Eligibility Information

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.

Grant Documents

2 Files
PAR-25-450-Full-Announcement.html
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PAR-25-450.html
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The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have reissued a Notice of Funding Opportunity (NOFO) titled "Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)." This initiative, PAR-25-450, aims to support clinical projects that address critical needs for clinical trial readiness in rare diseases by facilitating the movement of candidate therapeutics or diagnostics toward clinical trials. The NOFO emphasizes developing and testing rigorous biomarkers and clinical outcome assessment measures, or defining the presentation and course of rare diseases to enable the design of upcoming clinical trials. The maximum project period is 2 years, with a budget of up to $275,000 direct costs. Applications must focus on rare diseases affecting fewer than 200,000 individuals in the U.S. and should not propose clinical trials. The NOFO encourages leveraging existing research resources and partnerships to optimize trial readiness.

Related Grant Opportunities

Project Timeline

postedOriginal Opportunity PostedSep 22, 2025
deadlineApplication DeadlineJul 20, 2028
expiryArchive DateAug 25, 2028

Funding Details

No cost sharing required

Agency & Classification

Agency
National Institutes of Health(HHS-NIH11)
Funding Category
Income Security and Social Services
Funding Instrument
Grant

Grantor Contact

CFDA Numbers

93.865

Official Sources