Posted opportunity — confirm at source

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

National Institutes of Health · PAR-25-450

Award range

See source for award amount

Deadline

2028-07-20-00-00-00

Confirm exact timezone in the announcement.

Eligible applicants

Public housing authorities/Indian housing authorities, Special district governments, Native American tribal governments (Federally recognized), Independent school districts, Public and State controlled institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, For profit organizations other than small businesses, County governments, Private institutions of higher education, Others (see text field entitled "Additional Information on Eligibility" for clarification), City or township governments, Small businesses, State governments, Native American tribal organizations (other than Federally recognized tribal governments)

Geographic eligibility and all attachment-specific conditions require review of the original announcement.

Eligibility details

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.

Matching funds & resources

Source matching-funds field: Not Required.

Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.

About this opportunity

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.

Funding geography: Not specified — review source. A funder’s address does not establish eligibility.

Review original source ↗

Funding instrument: Grant. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.

Source fields and evidence

id: 359645
Source ↗ · id

opportunityNumber: PAR-25-450
Source ↗ · opportunityNumber

opportunityTitle: Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
Source ↗ · opportunityTitle

revision: 4
Source ↗ · revision

agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
Source ↗ · agencyDetails

owningAgencyCode: HHS-NIH11
Source ↗ · owningAgencyCode

cfdas: [{"id":429508,"opportunityId":359645,"cfdaNumber":"93.350","programTitle":"National Center for Advancing Translational Sciences"},{"id":431178,"opportunityId":359645,"cfdaNumber":"93.865","programTitle":"Child Health and Human Development Extramural Research"},{"id":431179,"opportunityId":359645}]
Source ↗ · cfdas

applicantTypes: [{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"04","description":"Special district governments"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"05","description":"Independent school districts"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"01","description":"County governments"},{"id":"20","description":"Private institutions of higher education"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"02","description":"City or township governments"},{"id":"23","description":"Small businesses"},{"id":"00","description":"State governments"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"}]
Source ↗ · applicantTypes

applicantEligibilityDesc: 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.
Source ↗ · applicantEligibilityDesc

fundingInstruments: [{"id":"G","description":"Grant"}]
Source ↗ · fundingInstruments

fundingActivityCategories: [{"id":"HL","description":"Health"},{"id":"ISS","description":"Income Security and Social Services"}]
Source ↗ · fundingActivityCategories

awardFloor: none
Source ↗ · awardFloor

awardCeiling: none
Source ↗ · awardCeiling

responseDate: Jul 20, 2028 12:00:00 AM EDT
Source ↗ · responseDate

responseDateStr: 2028-07-20-00-00-00
Source ↗ · responseDateStr

costSharing: false
Source ↗ · costSharing

lastUpdatedDate: Sep 23, 2025 10:00:04 AM EDT
Source ↗ · lastUpdatedDate

status: posted
Source ↗ · oppHits[id=359645].oppStatus

Source retrieved 10/15/2026 · Revision 4. Always confirm current requirements and dates with the funder. Structured source fields are checked; this is not a determination that every applicant qualifies.

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