National Institutes of Health · United States

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

Open

Applications close on 20 Jul 2028. Eligible applicant types include independent school districts, state governments, special district governments and 12 more.

Deadline: 20 Jul 2028 (in 613 days)
Grant amount: Not stated — see the official call
Funding rate: No mandatory cost sharing stated; funding percentage not stated
Cost sharing: Not required
Likely applicant types: Public bodies, SMEs / start-ups, Companies, Non-profits, Universities & research From source categories or programme rules; the call decides.
Funder: National Institutes of Health
Reference: PAR-25-450
Assistance listing: 93.350 National Center for Advancing Translational Sciences; 93.865 Child Health and Human Development Extramural Research
Last checked: 13 Nov 2026

Open the official call ↗ Add deadline to calendar

About this call

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.

Who can apply

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

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.

Applicant categories are a starting point. The official call decides eligibility.

Topics

Health Income Security and Social Services

How to apply

Read the full notice of funding opportunity (NOFO) linked from the official page: eligibility, cost sharing and evaluation criteria.
Make sure your organisation has an active SAM.gov registration and Unique Entity ID (UEI); registration can take several weeks.
For NIH: the organisation and the principal investigator also need eRA Commons accounts; applications are usually submitted through Grants.gov (for example with ASSIST).
Prepare the required forms, narrative, budget and attachments exactly as the NOFO specifies.
Submit before the deadline and keep the tracking number. Check for amendments before you submit.

From the call text

Who can apply: Not stated in the call text we hold — check the official page
Company stage: Not stated in the call text we hold — check the official page
Single applicant or consortium: Not stated in the call text we hold — check the official page
Where applicants must be based: Not stated in the call text we hold — check the official page
Where to apply: Not stated in the call text we hold — check the official page

Contact

National Institutes of Health · grantsinfo@nih.gov · 301-402-2541

Where these facts come from

Fact	Value	How we know	Taken from the source
Deadline	20 July 2028	official data field	15 Nov 2026
Amount per applicant	Unknown — not stated in the source we hold	unknown	—
Total budget	Unknown — not stated in the source we hold	unknown	—
Funding rate	No mandatory cost sharing stated; funding percentage not stated	read from the official text	15 Nov 2026
Who can apply	Independent school districts; State governments; Special district governments; Small businesses; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Private…	official data field	15 Nov 2026
Where to apply	Unknown — not stated in the source we hold	unknown	—

Official sources

Official call page · Funder's programme page

Facts on this page come from the funder’s official data, taken on 13 Nov 2026. The funder's own documents, including later amendments, always take precedence.