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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Publishes MUMS Designation Rule

FDA Veterinarian Newsletter 2007 Volume XXII, No III

On July 26, the Food and Drug Administration issued a final regulation implementing the animal drug “designation” provisions of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act).

MUMS designation of a new animal drug will allow drug sponsors to be granted 7 years of exclusive marketing rights for these limited-demand new animal drugs to encourage the development of drugs for minor uses or in minor animal species. (Major animal species are cattle, swine, chickens, turkeys, horses, dogs, and cats. All other species are considered minor.)

The MUMS Act amended the Federal Food, Drug, and Cosmetic Act by, among other things, establishing section 573 to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. This Act parallels the Orphan Drug Act for human drugs.

FDA has evaluated all public comments received in response to the September 27, 2005, proposed rule that described the procedure for designating a new animal drug as a minor use or minor species drug. The regulation defines content and format requirements for designation requests, as well as provisions for amending requests changing designation ownership, and annual reporting requirements.

The rule, which becomes effective October 9, 2007, describes the criteria CVM will use for granting or denying these requests. Specific sections of the rule address such topics as verifying MUMS status in a request, granting MUMS designation, and revoking MUMS designation.

Additional information about the final rule is included in the July 26, 2007, Federal Register. Questions may be directed to Dr. Bernadette Dunham, CVM, FDA, 7519 Standish Pl., Rockville, MD 20855, 240-276-9090, Bernadette.Dunham@fda.hhs.gov.