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    NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)

    PAR-22-142

    National Institutes of Health

    Opening date 18 Apr 2022, 12:00AM

    Closing date 10 Mar 2025, 12:00AM

    Funding Opportunity Number: PAR-22-142

    Opportunity Category: Discretionary

    CFDA Number(s): 93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders

    Cost Sharing or Matching Requirement: No

    Posted Date: Apr 18, 2022 12:00:00 AM EDT

    Closing Date: Mar 10, 2025 12:00:00 AM EDT

    Award Ceiling: none

    Award Floor: none

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

    Additional Information on 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.

    Agency Name: National Institutes of Health

    Description: The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones. For a drug, biologic or device that has successfully completed the Phase 1/Early Feasibility trial(s), do not use this FOA. Instead use the Companion FOA XXX. For genetic studies, do not use this FOA. Instead, use FOA XXX.

    Grantor Contact Information: NIH OER Webmaster OERWebmaster03@od.nih.gov

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