Key Dates
- November 18, 2020 - NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional). See NOFO PAR-21-079.
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.
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 https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), 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
TBD
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
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.
93.838, 93.837, 93.839, 93.840, 93.233
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.
Inquiries
Please direct all inquiries to:
Michelle Freemer, MD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: michelle.freemer@nih.gov
and Human Services (HHS)
