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Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
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Service Source Final Application Due Date Funding Available Match Required
Health Care Federal
HHS
09-11-2025 N/A No Match
Required
  • Service
  • Source
  • Final Application Due Date
  • Funding Available
  • Match Required
Status
  • Past
  • Current
  • Forecasted
    • Opportunity Type Discretionary
    • CFDA

      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

    Description

    This Funding Opportunity Announcement (FOA) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This FOA will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination.

    Eligibility
    • IHE
    • Local Government
    • Non-Profit
    • Other
    • State Government
    • Tribal Government
    Additional Eligibility Information

    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.

    Key Date(s)
    • May 24, 2022: Last Updated Date
    • May 24, 2022: Posted Date
    • September 11, 2025: Current Closing Date for Applications
    • September 11, 2025: Application Due Date
    • October 17, 2025: Application Archive Date

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