NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)

Background
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) is issuing a funding opportunity 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 objective is to contribute to the evidence base for important health matters relevant to the research mission of NHLBI.

Grant Details
This funding opportunity will support Phase 0 and I clinical trials (including bridging studies) for diagnosis and therapeutic interventions such as drugs, devices, and biologics. The NOFO will utilize a bi-phasic, milestone-driven R61/R33 mechanism consisting of a start-up phase (R61) and a clinical trial execution phase (R33). The R61 phase can be up to two years and will support late-stage product development activities required to allow the therapeutic or diagnostic to be administered to humans.

The R33 phase may include further testing of the intervention's feasibility, safety, and acceptability; determining the optimal dose for a subsequent trial; determining the pharmacokinetics of the dose and formulation of the product; and developing functional biological signature measures and clinical outcome measures feasible for use in larger efficacy and effectiveness trials.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state or local governments, federally recognized Indian/Native American tribal governments, federal agencies, U.S. territories or possessions, public housing authorities/Indian housing authorities, Native American tribal organizations (other than federally recognized tribal governments), faith-based or community-based organizations, regional organizations. Foreign organizations are not eligible to apply.

Period of Performance
The maximum period of the combined R61 and R33 phases is 5 years, with up to 2 years for the R61 phase and up to 3 years for the R33 phase.

Grant Value
Application budgets in the R61 phase are limited to $250,000 in direct costs per year. Application budgets in the R33 phase should not exceed $1,515,000 in direct costs per year.