Posted opportunity — confirm at source

Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)

National Institutes of Health · RFA-TR-25-002

Award range

See source for award amount

Deadline

2027-07-02-00-00-00

Confirm exact timezone in the announcement.

Eligible applicants

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

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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 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) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning.

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: 357570
Source ↗ · id

opportunityNumber: RFA-TR-25-002
Source ↗ · opportunityNumber

opportunityTitle: Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Source ↗ · opportunityTitle

revision: 1
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":426028,"opportunityId":357570,"cfdaNumber":"93.350","programTitle":"National Center for Advancing Translational Sciences"},{"id":426029,"opportunityId":357570}]
Source ↗ · cfdas

applicantTypes: [{"id":"04","description":"Special district governments"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"01","description":"County governments"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"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":"05","description":"Independent school districts"},{"id":"07","description":"Native American tribal governments (Federally recognized)"}]
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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 allowed.
Source ↗ · applicantEligibilityDesc

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

fundingActivityCategories: [{"id":"HL","description":"Health"}]
Source ↗ · fundingActivityCategories

awardFloor: none
Source ↗ · awardFloor

awardCeiling: none
Source ↗ · awardCeiling

responseDate: Jul 02, 2027 12:00:00 AM EDT
Source ↗ · responseDate

responseDateStr: 2027-07-02-00-00-00
Source ↗ · responseDateStr

costSharing: false
Source ↗ · costSharing

lastUpdatedDate: Jun 05, 2026 12:13:21 PM EDT
Source ↗ · lastUpdatedDate

status: posted
Source ↗ · oppHits[id=357570].oppStatus

Source retrieved 10/15/2026 · Revision 1. 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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