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U.S. Department of Health and Human Services

Animal & Veterinary

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DRAFT VICH GUIDANCES AVAILABLE FOR REVIEW AND COMMENT

FDA Veterinarian Newsletter 2002 Volume XVI, No V

FDA's Center for Veterinary Medicine (CVM) is announcing the availability of three draft guidances for industry entitled, "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-day) Toxicity Testing" (VICH GL #31 FDA/CVM Guidance #147); Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing" (VICH GL #32, FDA/CVM Guidance #148); and "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing" (VICH GL #33, FDA/CVM Guidance #149).

These draft guidance documents were developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

The objective of these draft guidances is to establish the minimum recommendations for an internationally harmonized testing strategy for determining toxicity of veterinary drug residues in human food. Guidance #147 outlines studies for identifying target organ toxicity after repeating doses (90 days). Guidance #148 provides guidance on the core recommendation for a developmental toxicity study. Guidance #149 outlines a harmonized testing approach to assure human food safety following the consumption of food products derived from animals treated with veterinary drugs.

Draft Guidance documents 149 are posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the guidances 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.

Written or electronic comments on these draft guidances may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted. Comments should be identified with the full title of the guidance document and Docket number. The Docket number for Draft Guidance #147 is 02D-0368, 02D-0369 for Draft Guidance #148, and 02D-0326 for Draft Guidance #149. To ensure adequate consideration for comments in preparation of the final document, comments should be submitted by October 4, 2002.