December 15, 2004

 

 MUMS office established; FDA requests input - December 15, 2004

Posted on December 1, 2004
 

As mandated by the Minor Use and Minor Species Animal Health Act, the Food and Drug Administration's Center for Veterinary Medicine has established the Office of Minor Use and Minor Species Animal Drug Development. The new office is now requesting comment on the implementation of the MUMS Animal Health Act, which became law Aug. 2, 2004. The notice was published in the Nov. 9 Federal Register.

Several elements of the MUMS law became effective Aug. 2, including the provisions for designation and conditional approval of MUMS drugs. The Office of Minor Use and Minor Species Animal Drug Development is requesting comments on any aspect of implementing the MUMS legislation. Proposed regulations on drug designation are due by Aug. 2, 2005. The indexing provisions of the law will become effective only on the publication of final regulations.

Written comments on the MUMS legislation may be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted at www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. Individuals should submit comments by Jan. 10, 2005, and they should include the docket number, 2004N-0480.

Additional information on MUMS is available at www.fda.gov/cvm/default.html. Individuals who have questions about MUMS can also contact Dr. Andrew Beaulieu, Office of Minor Use and Minor Species Animal Drug Development, Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855, phone (301) 827-2945, abeaulie@cvm.fda.gov, or Dr. Meg Oeller at the same address, (301) 827-3067, or moeller@cvm.fda.gov.