Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- PAR-25-450
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
-
- Health
- Income Security and Social Services
- Eligible applicants
-
- Special District Governments
- Tribal Governments (Federally Recognized)
- Small Businesses
- County Governments
- City/Township Governments
- Other
- Higher Education Inst. (Public)
- 501(c)(3) Nonprofits
- Non-501(c)(3) Nonprofits
- Independent School Districts
- For Profit Organizations
- Tribal Organizations (Not Federally Recognized)
- State Governments
- Higher Education Inst. (Private)
- Public or Indian Housing Auth.
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health, through the National Center for Advancing Translational Sciences and other NIH Institutes and Centers, is soliciting R21 grant applications for research on clinical trial readiness in rare diseases, with applications due July 20, 2028. Clinical trials are not allowed under this activity code.
Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, small businesses, state and local governments, tribal governments (federally and non-federally recognized), tribal organizations, special district governments, independent school districts, public or Indian housing authorities, Alaska Native and Native Hawaiian serving institutions, historically Black colleges and universities, Hispanic-serving institutions, Asian American Native American Pacific Islander serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, and eligible federal agencies. Non-domestic entities and non-domestic components of U.S. organizations are ineligible; foreign components are not allowed.
The initiative funds research projects that enable efficient movement of candidate therapeutics or diagnostics toward clinical trials and increase their likelihood of success. Supported activities include development and testing of rigorous biomarkers and clinical outcome assessment measures, or defining the presentation and course of a rare disease to enable clinical trial design.
This opportunity is assigned to CFDA 93.865 (Child Health and Human Development Extramural Research) and CFDA 93.350 (National Center for Advancing Translational Sciences). Applicants must follow Research-specific instructions and FORMS-I application procedures. Peer review includes dual scientific evaluation by non-NIH scientists and secondary review by an institute advisory council. Evaluation criteria include scientific merit and significance, technical adequacy of design, investigator competency, facility adequacy, budget necessity relative to proposed work, and relevance to program objectives.
Synopsis
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.
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.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-450-Full-Announcement.html | HTML file | |
| PKG00291534.pdf |
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