At a glance
This program funds investigator-initiated Phase 0 and Phase I clinical trials, including bridging studies, for diagnostic and therapeutic interventions for heart, lung, blood, and sleep disorders in adults and children. It supports startup work in an R61 phase and trial execution in an R33 phase, with a combined project period of up to 5 years. R61 budgets are limited to $250,000 in direct costs per year, and R33 budgets should not exceed $1,515,000 in direct costs per year. Eligible applicants include many U.S. nonprofit and other organizations, but foreign organizations that are not domestic components of U.S. organizations are not eligible. Cost sharing is not required.
What it funds
Official description from grants.gov
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. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.
Who can apply
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments