Minor Use Minor Species Development of Drugs; Research Project Grant (R01)

This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the application’s “Background and Significance” section. All funded studies are subject to the requirements of the act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.