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

National Institutes of Health · HHS

CFDA Numbers

93.233, 93.837, 93.838, 93.839

Award Ceiling

$1.5M

Award Floor

—

Expected Awards

—

Close Date

Jan 7, 2027

Section I

How to Apply

Apply Online ↗

View on grants_gov ↗

Program Contact

NIH Grants Information<br/>grantsinfo@nih.gov
grantsinfo@nih.gov

Section II

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); 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.

Eligible Applicant Types

00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23, 25

Section III

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.

Section IV

Key Dates

Posted: Dec 5, 2024
Closes: Jan 7, 2027
Archive: Feb 12, 2027