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

Open Posted

Opportunity number
PAR-25-025
Agency
Applications due
Award size
Up to $1,515,000

Opportunity facts

Funding instrument
Grant
Category
  • Health
Eligible applicants
  • 501(c)(3) Nonprofits
  • For Profit Organizations
  • Public or Indian Housing Auth.
  • Small Businesses
  • Special District Governments
  • County Governments
  • State Governments
  • Tribal Organizations (Not Federally Recognized)
  • City/Township Governments
  • Higher Education Inst. (Private)
  • Higher Education Inst. (Public)
  • Other
  • Non-501(c)(3) Nonprofits
  • Independent School Districts
  • Tribal Governments (Federally Recognized)
Points of contact
Full announcement

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health National Heart, Lung, and Blood Institute is soliciting applications for investigator-initiated phase I clinical trials for diagnostic and therapeutic interventions targeting heart, lung, blood, and sleep disorders in adults and children, with applications due February 3, 2027. Applicants must be ready to initiate the clinical trial within the first quarter of the project period, with all regulatory approvals (FDA, DSMB, IRB), drug and placebo supplies, and third-party agreements established by the time of award.

Eligible applicants include 501(c)(3) nonprofits, for-profit organizations, higher education institutions (public and private), state and local governments, small businesses, tribal organizations and governments (federally and non-federally recognized), special district governments, independent school districts, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. Non-domestic organizations are not eligible; however, non-domestic components of U.S. organizations and foreign components as defined in the NIH Grants Policy Statement are permitted.

The proposed trial can be single or multisite. Applicants should consider the companion NOFO utilizing an R61/R33 phased approach if time and support for pre-clinical and trial readiness activities are desired.

The funding opportunity is assigned to four NIH grant programs: Lung Diseases Research (CFDA 93.838), Cardiovascular Diseases Research (CFDA 93.837), Blood Diseases and Resources Research (CFDA 93.839), and the National Center on Sleep Disorders Research (CFDA 93.233). Applications are evaluated by an appropriate initial review group and receive final secondary review by the National Heart, Lung, and Blood Advisory Council. Evaluation criteria include scientific merit and significance, technical adequacy of experimental design, investigator competency, facility and resource adequacy, budget necessity, and relevance to program objectives.

Synopsis

2 versions

Update #2 · Latest ·

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.

Update #1 ·

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.

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.

Files

File Type Posted
PAR-25-025-Full-Announcement.html HTML file
PKG00289458.pdf PDF

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