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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Requests Comments On EIA Draft Guidance Document

September 30, 1999

FDA's Center for Veterinary Medicine announced the availability for comment of a draft guidance document entitled: "Guidance for Industry, Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's) - Phase I." (#89) in the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 This draft guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).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Copies of this draft guidance document may be obtained from CVM's Guidelines and Guidances Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.

Interested persons may submit written comments on the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, by October 18, 1999. Comments should be identified with the full title of the draft guidance document and docket number 99D-2975.

Further information about this document is contained in the September 17, 1999, Federal Register notice. Also included in this Federal Register notice are questions about issues in the draft document of particular interest to FDA. Information on the final guidance document is also available from: Dr. Charles E. Eirkson, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500Standish Pl., Rockville, MD 20855, 301-827-6958. 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 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.


Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855