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    Country
    Opportunity Status
    Funding Instrument Type
    Category
    Clear

    Minor Use Minor Species Development of Drugs (R01)

    PAR-24-216

    Terrin Brown Grantor

    Opening date 29 May 2024, 12:00AM

    Closing date 29 Jan 2027, 12:00AM

    Funding Opportunity Number: PAR-24-216

    Opportunity Category: Discretionary

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

    Cost Sharing or Matching Requirement: No

    Posted Date: May 29, 2024 12:00:00 AM EDT

    Closing Date: Jan 29, 2027 12:00:00 AM EST

    Closing Date Details: Application Due Dates are as follows: July 29, 2024; January 31, 2025; July 25, 2025; January 30, 2026; July 24, 2026; January 29, 2027

    Estimated Total Program Funding: 250000

    Award Ceiling: $250000

    Award Floor: none

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

    Additional Information on Eligibility: • Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations)

    Agency Name: Terrin Brown Grantor

    Description:

    This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). 


    The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs.


    Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants.


    The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516.


    FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application.

    Grantor Contact Information: Terrin Brown Grantor

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