Minor Use Minor Species Development of Drugs (R01)
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Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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The Food and Drug Administration’s Center for Veterinary Medicine is soliciting Research Project (R01) grant applications to support the development of new animal drugs for minor uses in major species or for use in minor species, known collectively as MUMS. Eligible applicants must be institutions or organizations developing veterinary drugs or partnering with such entities, and must have an active Investigational New Animal Drug file with FDA/CVM and a formal MUMS designation from the Office of Minor Use and Minor Species Animal Drug Development for the specific intended use, as mandated by section 573 of the Food, Drug and Cosmetic Act and implementing regulations. Grant funding is intended to defray the costs of safety and effectiveness studies necessary to meet FDA approval requirements for these drugs. Before submitting a grant application, the proposed study protocol must have been reviewed and concurred upon by the FDA/CVM Office of New Animal Drug Evaluation. The opportunity is open to qualified applicants who can demonstrate alignment with the regulatory framework governing MUMS drug development, and applications must be submitted through the designated federal grants portal.
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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.
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