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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Requests Comments On Anthelmintics Draft Guidance Documents

July 22, 1999

The Food and Drug Administration (FDA) is announcing the availability for comment of four draft guidance documents entitled: "Efficacy of Anthelmintics: General Recommendations (#90),'' "Efficacy of Anthelmintics: Specific Recommendations for Bovines (#95)," "Efficacy of Anthelmintics: Specific Recommendations for Ovines (#96)," and "Efficacy of Anthelmintics: Specific Recommendations for Caprines (#97)." These related draft guidance documents have been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products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.

Copies of these documents may be obtained from the Guidelines and Guidances Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.

Interested persons should submit written comments on the draft guidance documents by August 16, 1999, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the full title of the draft guidance documents and with Docket number 99D-2248.

Further information about these draft guidance documents is contained in a July 16, 1999, Federal Register notice. Information on the draft guidance documents is also available from Dr. Thomas Letonja (HFV-130), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7576, e-mail: tletonja@cvm.fda.gov. Further information on VICH is available from Dr. Sharon R. Thompson (HFV-3), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798, e-mail: sthompso@cvm.fda.gov and from Dr. Robert C. Livingston, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, 301-594-5903, e-mail: rlivings@cvm.fda.gov.

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855