NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
National Institutes of Health
Summary
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.
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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. | applicant types: Native American tribal governments (Federally recognized); City or township governments; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Public and State controlled institutions of higher education; Private institutions of higher education; For profit organizations other than small businesses; Small businesses; Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; State governments; County governments; Others (see text field entitled "Additional Information on Eligibility" for clarification); Native American tribal organizations (other than Federally recognized tribal governments); Public housing authorities/Indian housing authorities; Special district governments