Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33)

Notice Number: NOT-HL-16-475

Key Dates
Release Date:  December 5, 2016

Estimated Publication Date of Announcement:  August 2017 
First Estimated Application Due Date:  October 2017 
Earliest Estimated Award Date:  August 1, 2018 
Earliest Estimated Start Date:  August 15, 2018

Related Announcements

Issued by
National Heart, Lung, and Blood Institute (NHLBI)


The National Heart, Lung, and Blood Institute intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for investigator-initiated, phase 0 and I clinical trials (including bridging studies) for diagnosis and therapeutic interventions (e.g., drugs, devices, and biologics, including cells and cell products) for heart, lung, blood, and sleep (HLBS) disorders in adults and children. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in Summer 2017 with a corresponding application due date in Fall 2017.

This FOA will utilize the R61/R33 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into the area of early phase clinical trials to begin to consider applying for this new FOA.

In addition, collaborative investigations combining expertise in the development of therapeutic, diagnostics, and devices will be encouraged and these investigators should also begin considering applying for this application.

NHLBI now has a number of institute and division programs that support the translational continuum from target discovery and validation through phase III clinical trials.  However, a gap, that has never been specifically addressed, exists for the conduct of phase 0, I, and safety bridging studies. To address the unmet need, we are proposing a staged program, utilizing the R61/R33 mechanism that will allow late stage development and planning activities, and initiation and conduct of the clinical trial.  This program is distinct from existing programs in that it will not fund foundational production or pharmacology/toxicology studies and trials will not have an efficacy primary endpoint.



Please direct all inquiries to:

Traci Heath Mondoro, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)


Patricia Noel, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone:  301-435-0202