Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Notice Number:

Key Dates

Release Date:
August 31, 2023
Estimated Publication Date of Notice of Funding Opportunity :
January 01, 2024
First Estimated Application Due Date:
February 16, 2024
Earliest Estimated Award Date:
October 01, 2024
Earliest Estimated Start Date:
December 01, 2024
Related Announcements
  •  November 18, 2020 - NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional). See NOFO PAR-21-079. 
Issued by

National Heart, Lung, and Blood Institute (NHLBI)


The National Heart, Lung and Blood Institute (NHLBI) intends to publish a reissue of the notice of funding opportunity (NOFO) PAR-21-079 NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional). This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 
The NOFO is expected to be published in Winter, 2023 with an expected application due date in February 2024.

This NOFO will utilize the R34 activity code. Details of the planned NOFO are provided below.

Research Initiative Details

The planned R34 notice of funding opportunity (NOFO) intends to support studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI's mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, the planned NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at, the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.

Funding Information

Estimated Total Funding


Expected Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Estimated Award Ceiling

Application budgets may not exceed $450,000 in direct costs over a three-year period with no more than $225,000 in direct costs allowed in any single year.

Primary Assistance Listing Number(s)

93.838, 93.837, 93.839, 93.840, 93.233

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 


Please direct all inquiries to:

Michelle Freemer, MD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202