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

HHS-NIH11 PAR-25-026

Posted: Dec 05, 2024 12:00:00 AM EST

Closes: 01/07/2027

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. 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.

Synopsis

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.

Eligibility

Eligible Applicants:

County governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education For profit organizations other than small businesses State governments Others (see text field entitled "Additional Information on Eligibility" for clarification)

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.

Funding Activity Categories

Health

CFDA Numbers

93.233 - National Center on Sleep Disorders Research
93.837 - Cardiovascular Diseases Research
93.838 - Lung Diseases Research
93.839 - Blood Diseases and Resources Research
93.840 - Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders

Contact Information

Agency: National Institutes of Health

Contact: National Institutes of Health

Email: grantsinfo@nih.gov

Phone: 301-402-2541

NIH Grants Information
grantsinfo@nih.gov

Additional Information

Document Type: synopsis

Opportunity Category: Discretionary

Version: 1

Last Updated: Dec 05, 2024 12:10:38 PM EST

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