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U.S. Department of Health and Human Services

Animal & Veterinary

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EIA DRAFT GUIDANCE DOCUMENT AVAILABLE

FDA Veterinarian Newsletter November/December 1999 Volume XIV, No VI

FDA's Center for Veterinary Medicine announced the availability for comment of a draft guidance document entitled: "Guidance for Industry, Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's) - Phase I." (#89) in the September 17, 1999, Federal Register. This draft guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It is intended to assist in harmonizing the requirements for environmental assessments for VMP's in the European Union, Japan, and the United States.

Copies of this draft guidance document may be obtained from CVM's Guidelines and Guidances Page or by calling or writing the FDA Veterinarian.

Further information about this document is contained in the September 17, 1999, Federal Register notice and from: Dr. Charles E. Eirkson, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500Standish Pl., Rockville, MD 20855, 301-827-6958, e-mail: "ceirkson@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".