Minor Use Minor Species Development of Drugs

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By Mary Gilbert posted 06-03-2021 14:22

  

This Notice of Funding Opportunity (NOFO) is issued by the US Food and Drug Administration Center for Veterinary Medicine (US FDA/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 US 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 US 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 US FDA/CVM and must hold a minor use or minor species “designation” granted by the US FDA/CVM 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.
  • The US FDA/CVM 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.

Key Dates

Open Date (Earliest Submission Date): May 28, 2021 (for the July 30, 2021, application due date); December 3, 2021 (for the February 4, 2022, application due date); May 27, 2022 (for the July 29, 2022, application due date); December 2, 2022 (for the February 3, 2023, application due date); May 26, 2023 (for the July 28, 2023, application due date); December 1, 2023 (for the February 2, 2024, application due date). Please note that this NOFO has multiple open periods. Each open period has a corresponding application due date.

Application Due Date(s): July 30, 2021; February 4, 2022; July 29, 2022; February 3, 2023; July 28, 2023; February 2, 2024—by 11:59 pm Eastern Time. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 pm Eastern Time on the application due date.


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