§ Federal grant opportunity · PAR-25-450

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

    National Institutes of Health is accepting applications for Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed). The deadline is July 20, 2028 and the published award range is Award amount not published.

    Key facts

    Funder
    National Institutes of Health
    Application deadline
    July 20, 2028
    Award range
    Award amount not published
    Eligibility
    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.
    Geography
    United States
    Focus areas
    Health, Human Services
    Opportunity number
    PAR-25-450

    Program overview

    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.

    How to apply

    1. Confirm your organization meets the eligibility criteria above.
    2. Read the full funding opportunity announcement from National Institutes of Health.
    3. Draft your narrative against the funder's stated priorities and review criteria.
    4. Submit before July 20, 2028, allowing time for registration and validation.

    View the official funding announcement

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