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U.S. Department of Health and Human Services

Animal & Veterinary

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Proposed Rules for Liquid Medicated and Free-Choice Medicated Feed Available for Comment

May 28, 2003

The Food and Drug Administration (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 wants 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.

Interested parties are invited to comment on this proposed rule. FDA will consider all comments received by August 26, 2003. Comments on the information collection provisions should be sent by July 28, 2003.

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.

To ensure that comments on the information collection provisions are received, the Office of Management and Budget (OMB) recommends that written comments be electronically sent to sshapiro@omb.eop.gov or faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk Officer for FDA, FAX: 202-395-6974.

Comments on the proposed rule or the information collection provisions 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.


Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855