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U.S. Department of Health and Human Services

Animal & Veterinary

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Guidance On Feline And Poutry (gallus gallus) Anthelmintic Effectiveness Available

June 25, 2002

The Food and Drug Administration (FDA) is announcing 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 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 113 and 114 are posted 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. 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 . 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.


Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855