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    Country
    Opportunity Status
    Funding Instrument Type
    Category
    Clear

    First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 Clinical Trial Required)

    PAR-21-133

    National Institutes of Health

    Opening date 2 Mar 2021, 12:00AM

    Closing date 15 Feb 2024, 12:00AM

    Funding Opportunity Number: PAR-21-133

    Opportunity Category: Discretionary

    CFDA Number(s): 93.242 -- Mental Health Research Grants

    Cost Sharing or Matching Requirement: No

    Posted Date: Mar 02, 2021 12:00:00 AM EST

    Closing Date: Feb 15, 2024 12:00:00 AM EST

    Award Ceiling: none

    Award Floor: none

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

    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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Agency Name: National Institutes of Health

    Description:

    The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.

    Grantor Contact Information: NIH OER Webmaster FBOWebmaster@OD.NIH.GOV

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