At a glance
This funding opportunity supports Phase I investigator-initiated single-site or multi-site clinical trials for diagnostic and/or therapeutic interventions for heart, lung, blood, and sleep disorders in adults and children. It is limited to clinical trials, including bridging studies, and does not accept Phase II or III trials, observational studies that are not clinical trials, mechanistic human studies, or animal studies. Applicants may be nonprofits, universities, governments, small businesses, for-profit organizations, faith-based or community-based organizations, and some other U.S. or foreign-related organizations, but non-domestic foreign organizations are not eligible to apply. Application budgets should not exceed $1,515,000 in direct costs per year, the project period can be up to 3 years, and no cost sharing is required. The number of awards depends on NIH appropriations and the number of meritorious applications.
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. 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.
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