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U.S. Department of Health and Human Services

Animal & Veterinary

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GUIDANCES AVAILABLE ON FELINE AND POULTRY ANTHELMINTIC EFFECTIVENESS

FDA Veterinarian Newsletter 2002 Volume XVI, No IV

The Food and Drug Administration (FDA) is announc-ing the availability of two final guidances for industry entitled "Effectiveness of Anthelmintics: Specific Recommendations for Feline" (Guidance #113) and "Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus gallus" (Guidance #114).

These related guidance documents have been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). They are intended to standardize and simplify methods used in the evaluation of new anthelmintics submitted for approval to the European Union, Japan, and the United States.

Guidance documents 114 are posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the guidance may be obtained by writing to the FDA Veterinarian. Please send a self-addressed adhesive label to assist in processing your request.

Written comments on the guidance may be submitted at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.Electronic comments may be submitted to accessdata.fda.gov/scripts/oc/dockets/comment docket.cfm. Comments should be identified with the full title of the guidance document and Docket number 00D-1629.

Additional information on the guidance documents may be found in the June 25, 2002, Federal Register and from Dr. Thomas Letonja, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7576, e-mail: tletonja@cvm.fda.gov.