NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)

Agency: National Institutes of Health

93.837 -- Cardiovascular Diseases Research
93.838 -- Lung Diseases Research
93.233 -- National Center on Sleep Disorders Research
93.839 -- Blood Diseases and Resources Research

Open opportunityLast Updated: Oct 20, 2026

Description

The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.Applicants applying for funding under this NOFO should be ready to initiate the clinical trial within the first quarter of the project period. Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award. If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion NOFO which utilizes an R61/R33 phased approach.

Eligibility

Eligible applicants

Nonprofit

Nonprofits non-higher education with 501(c)(3)
Other Native American tribal organizations
Nonprofits non-higher education without 501(c)(3)

Business

For-profit organizations other than small businesses
Small businesses

Government

Public and Indian housing authorities
Special district governments
County governments
State governments
City or township governments
Federally recognized Native American tribal governments

Education

Private institutions of higher education
Public and state institutions of higher education
Independent school districts

Miscellaneous

Other

Additional information

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 eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Documents

File name	Description	Last updated
PAR-25-025-Full-Announcement.html	PAR-25-025 Full Announcement Text	Dec 5, 2024 04:05 PM UTC

Link to additional information

https://grants.nih.gov/grants/guide/pa-files/PAR-25-025.html

Closing: February 3, 2027

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

Expected awards

$--

Award Minimum

$1,515,000

Award Maximum

Funding opportunity number:

PAR-25-025

Cost sharing or matching requirement:

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

Category of Funding Activity:

Health

Category Explanation:

History

Version:

Posted date:

December 5, 2024

Archive date:

March 5, 2027