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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces Establishment of MUMS Office and Requests Comment on MUMS Implementation

November 9, 2004

FDA's Center for Veterinary Medicine is announcing the establishment of a new Office of Minor Use and Minor Species (MUMS) Animal Drug Development and is requesting comment on the implementation of the newly enacted MUMS Animal Health Act.

The MUMS Animal Health Act became law on August 2, 2004. Several elements of the law became immediately effective on that date including the provisions for designation of MUMS drugs and for conditional approval of MUMS drugs. Implementing regulations for drug designation will be the first to be developed by the new Office, with proposed regulations due by August 2, 2005, as mandated by the MUMS Act. The indexing provisions of the law will only become effective upon publication of final implementing regulations.

Written or electronic comments on any aspect of implementation of 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. Comments should be submitted by January 10, 2005, and should include Docket No. 2004N-0480.

Additional information on MUMS is available on the CVM Home Page. Questions on MUMS may be directed to Dr. Andrew Beaulieu, Office of Minor Use and Minor Species Animal Drug Development, Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855, 301-827-2945, abeaulie@cvm.fda.govor Dr. Meg Oeller, Office of Minor Use and Minor Species Animal Drug Development, Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855, 301-827-3067, moeller@cvm.fda.gov.

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855