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U.S. Department of Health and Human Services

Animal & Veterinary

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Draft Guidance Available for Comment

January 4, 2002

The Food and Drug Administration (FDA) is announcing the availability for comment of draft guidance for industry entitled "Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora" (Guidance #52). This draft guidance is a revision of guidance document #52 entitled "Microbiological Testing of Antimicrobial Drug Residues in Food,'' which was implemented in 1996. In this draft guidance, the Agency recommends a pathway approach for assessing the microbiological safety of antimicrobial drug residues in food, rather than the approach described in the 1996 version of the guidance. FDA's decision to revise this guidance is based on new information available to the Agency.

An electronic copy of draft guidance may be found on the FDA/Center for Veterinary Medicine Home Page . Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.

Written or electronic comments on the guidance may be submitted at any time. However, comments should be submitted by March 27, 2002 to ensure their incorporation during the next meeting of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Microbial Safety Task Force.

Comments on the draft guidance should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments are also available.

All comments should be identified with the full title of the draft guidance and docket number 93D-0398. The Agency will not implement this revised guidance until it has considered comments and prepares a final guidance. FDA will announce the availability of a final guidance in the Federal Register.

Additional information about this draft guidance document may be found in the December 27, 2001, Federal Register and from Dr. Haydee Fernandez, Center for Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20850, 301-827-6981.


Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855