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    Country
    Opportunity Status
    Funding Instrument Type
    Category
    Clear

    Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required

    RFA-FD-23-001

    Shashi Malhotra Grants Management Specialist

    Opening date 5 Jul 2022, 12:00AM

    Closing date 25 Oct 2022, 12:00AM

    Funding Opportunity Number: RFA-FD-23-001

    Opportunity Category: Discretionary

    Expected Number of Awards: 20

    CFDA Number(s): 93.103 -- Food and Drug Administration Research

    Cost Sharing or Matching Requirement: No

    Posted Date: Jul 05, 2022 12:00:00 AM EDT

    Closing Date: Oct 25, 2022 12:00:00 AM EDT

    Award Ceiling: $650000

    Award Floor: $200000

    Eligible Applicants: Public housing authorities/Indian housing authorities,Independent school districts,Others (see text field entitled "Additional Information on Eligibility" for clarification),Public and State controlled institutions of higher education,For profit organizations other than small businesses,State governments,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,City or township governments,Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education,Special district governments,County governments,Native American tribal organizations (other than Federally recognized tribal governments),Private institutions of higher education,Small businesses

    Additional Information on Eligibility: Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

    Agency Name: Shashi Malhotra Grants Management Specialist

    Description:

    The purpose of this funding opportunity announcement (FOA) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

    Grantor Contact Information: Shashi Malhotra Grants Management Specialist Phone 2404027592

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