NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
Supports investigator-initiated phase I clinical trials of therapeutic or diagnostic interventions for heart, lung, blood, and sleep disorders in adults or children, for eligible domestic and foreign organizations under NIH rules.
⚑ Phase I clinical trial required; applicants must be ready to start the trial in the first quarter of the project period. · Regulatory approvals and trial supplies/third-party agreements should be in place by award. · Foreign organizations are eligible; foreign components of U.S. organizations are allowed. · Single-project investigator-initiated R33 with clinical trial requirement; not a preclinical readiness mechanism.
Unit fits — one characterization, each unit's own rules
| IPPRA | 58 good | peripheral portfolio topic: public_health; social/behavioral work is minor; funds evaluation research; biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped) |
| Physical Sciences & Engineering (demo) | 35 weak | technical depth: minor; funds evaluation research (capped) |
| Tom Love Innovation Hub | 15 none | deep-tech content; no commercialization signal |
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. 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.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <grantsinfo@nih.gov>
Proposal brief SEE AN EXAMPLE →
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