Minor Use Minor Species Development of Drugs (R01)
FDA grants support research for new animal drugs with minor uses or for minor species, requiring an INAD file, MUMS designation, and ONADE-approved study protocol.
Funder: Food and Drug Administration
Due Dates: Forecasted for FY2025 (exact due date not yet announced)
Funding Amounts: $250,000 per award; expected 6 awards; single-year funding
Summary: Supports research and development of new animal drugs for minor uses in major species or for minor species (MUMS), requiring INAD file, MUMS designation, and FDA protocol concurrence.
Key Information: Applicants must have an INAD file, MUMS designation, and ONADE-approved protocol before applying.
Description
This opportunity, issued by the FDA Center for Veterinary Medicine (CVM), supports research projects (R01) focused on the development of new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The grant aims to defray the costs of qualified safety and effectiveness testing required for FDA approval of MUMS-designated drugs. Projects must be directly related to the development of drugs for veterinary use in these specific contexts.
Applicants must be actively developing a drug for veterinary use or be a research partner with such an entity. The drug under investigation must have an open Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" from the FDA/CVM Office of Minor Use and Minor Species Animal Drug Development (OMUMS). Additionally, the proposed study protocol must be reviewed and concurred with by the FDA/CVM Office of New Animal Drug Evaluation (ONADE) prior to application submission.
