Minor Use Minor Species Development of Drugs (R01)
FDA grants support research for new animal drugs with minor uses in major species or for minor species, requiring an INAD file, MUMS designation, and protocol review.
Funder: Food and Drug Administration
Due Dates: July 25, 2025 (Application) | December 26, 2025 (Letter of Intent) | January 30, 2026 (Application) | June 19, 2026 (Letter of Intent) | July 24, 2026 (Application) | December 25, 2026 (Letter of Intent) | January 29, 2027 (Application)
Funding Amounts: Up to $250,000 total costs per year; maximum 1 year for most studies, up to 3 years for long-term toxicological studies.
Summary: Supports research to develop or advance FDA-designated new animal drugs for minor uses in major species or for minor species, requiring INAD, MUMS designation, and FDA protocol concurrence.
Key Information: Protocol must be FDA-reviewed and concurred before application; late applications are not accepted.
Description
This grant opportunity, offered by the FDA Center for Veterinary Medicine (CVM), supports research projects (R01) that develop or facilitate the development of new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The program aims to defray the costs of qualified safety and effectiveness studies required for FDA approval or conditional approval of MUMS-designated drugs.
Eligible projects must focus on generating data that will directly support FDA approval or conditional approval of a drug for a MUMS-designated use. The applicant must have an open Investigational New Animal Drug (INAD) file and a MUMS designation for the drug and intended use, and the proposed study protocol must be reviewed and concurred by FDA/CVM's Office of New Animal Drug Evaluation (ONADE) prior to application.
