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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Proposes Rules for Liquid Medicated Feed

FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4

FDA is proposing to change the regulations for liquid medicated feed and free-choice medicated feed. By changing the regulations for liquid medicated feed, FDA intends to clarify: what data are required to demonstrate chemical and physical stability of a drug in liquid feed, how such data may be submitted for use in the new animal drug approval process, and which liquid medicated feeds may be manufactured in a feed manufacturing facility that has not obtained a medicated feed mill license from FDA. By changing the regulations for free-choice medicated feed, FDA wants to ensure that they are consistent with the requirements for liquid medicated feed, and that provisions for free-choice medicated feed and liquid medicated feed comply with the terms of the Animal Drug Availability Act (ADAA) of 1996.

This proposed rule was published in the May 28, 2003, Federal Register. Single copies of the proposed rule may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855. Please send a self-addressed adhesive label to assist in processing your request.

Submit written comments on the proposed rule to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. FDA will consider all comments received by August 26, 2003. Comments on the proposed rule must be identified with Docket Number 93P-0174.

Additional information is available in the May 28, 2003, Federal Register and from Dr. Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0169, e-mail: dmomcilo@cvm.fda.gov.