NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-026
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- For Profit Organizations
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- Other
- Public or Indian Housing Auth.
- Tribal Organizations (Not Federally Recognized)
- State Governments
- Independent School Districts
- Small Businesses
- Special District Governments
- City/Township Governments
- County Governments
- 501(c)(3) Nonprofits
- Higher Education Inst. (Public)
- Tribal Governments (Federally Recognized)
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health is soliciting applications for early-phase clinical trials supporting investigator-initiated Phase I trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children, with applications due February 3, 2027. This bi-phasic R61/R33 mechanism supports both clinical trial implementation and prerequisite preclinical activities such as stability testing, shipping studies, and site training, with single or multisite trial configurations eligible.
Eligible applicants include higher education institutions (public and private), small businesses, nonprofit organizations (including 501(c)(3) entities), state and local governments, tribal organizations (federally recognized and other), for-profit organizations, faith-based or community-based organizations, HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, TCCUs, and non-domestic entities. Eligible federal agencies and U.S. territories or possessions may also apply.
All activities proposed in the R61 phase must be directly related to the therapeutic or diagnostic intervention in preparation for the clinical trial. The funding opportunity operates through five CFDA programs: Lung Diseases Research (93.838), Cardiovascular Diseases Research (93.837), Translation and Implementation Science Research (93.840), Blood Diseases and Resources Research (93.839), and the National Center on Sleep Disorders Research (93.233). Review follows standard NIH peer-review processes, with evaluation based on scientific merit, technical adequacy of experimental design, investigator competency, facility adequacy, budget necessity, and relevance to program objectives. Applications must conform to FORMS-I submission requirements and research-specific instructions provided in the application guides.
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
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.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-026-Full-Announcement.html | HTML file | |
| PKG00289459.pdf |
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