NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)

Agency: National Institutes of Health

93.839 -- Blood Diseases and Resources Research
93.233 -- National Center on Sleep Disorders Research
93.837 -- Cardiovascular Diseases Research
93.838 -- Lung Diseases Research
93.840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders

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. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.

Eligibility

Eligible applicants

Business

For-profit organizations other than small businesses
Small businesses

Nonprofit

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

Education

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

Miscellaneous

Other

Government

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

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.

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-25-026-Full-Announcement.html	PAR-25-026 Full Announcement Text	Dec 5, 2024 05:15 PM UTC

Link to additional information

https://grants.nih.gov/grants/guide/pa-files/PAR-25-026.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

$--

Award Maximum

Funding opportunity number:

PAR-25-026

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