In the July 26 Federal Register, the Food and Drug Administration issued final regulations to implement the Minor Use and Minor Species Animal Health Act of 2004. These regulations describe the procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act (Public Law 108-282).
This final rule, which will take effect Oct. 9, 2007, can be viewed online at www.gpoaccess.gov/fr/.
The MUMS act amended the Federal Food, Drug, and Cosmetic Act to establish new regulatory procedures that provide incentives to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and for uncommon diseases in major animal species. These incentives include exclusive marketing rights associated with the conditional approval or approval of designated new animal drugs.
Designation of a new animal drug as a MUMS drug also provides eligibility for grants to support designated new animal drug development. The 2004 act authorized the grant money, and now that the final rule was published July 26, the agency can start to seek the actual funding. The agency intends to publish an update when it acquires the new funds.
The July 26 Federal Register notice details the public comments received in response to the regulations when they were first proposed and the FDA's response to them. The notice describes several changes made to the proposed rule for clarity or in response to the comments. The proposed regulations had been published in the Sept. 27, 2005, Federal Register, and an extension of the comment period was announced Dec. 28 of that year.
For further information, contact Dr. Bernadette Dunham, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855; Bernadette.Dunham@fda.hhs.gov; or phone, (240) 276-9090.