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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA SEEKING COMMENTS ON IMPORT TOLERANCES

FDA Veterinarian Newsletter September/October 2001 Volume XVI, No V

The Food and Drug Administration (FDA) is soliciting comments on issues related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish drug residue tolerances (import tolerances) for imported food products of animal origin for drugs that are used in other countries, but that are unapproved new animal drugs in the United States. Food products of animal origin that are in compliance with the import tolerances will not be considered adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) and may be imported into the U.S.

In the August 10, 2001, Federal Register FDA published an advance notice of proposed rulemaking (ANPRM) on the import tolerance issue. FDA's Center for Veterinary Medicine (CVM) plans to hold a public advisory committee meeting on import tolerances on September 13-14, 2001. CVM intends to consider the comments made at the meeting and in response to this ANPRM in writing the proposed regulation.

Written or electronic comments on the ANPRM should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, by December 10, 2001. Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Comments should reference Docket No. 01N-0284.

Additional information on the ANPRM is included in the August 10, Federal Register, and from Frances Pell, Center for Veterinary Medicine (HFV-235), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0188.

The Veterinary Medicine Advisory Committee (VMAC) meeting will be held on September 13-14, 2001, from 8:30 a.m. to 5:00 p.m. at the DoubleTree Hotel, Plaza Rooms I, II, and III, 1750 Rockville Pike, Rockville, MD. The VMAC will seek recommendations on the issue of import tolerances. The public comment period is planned for the afternoon of September 13 and the morning of September 14.

Information on the VMAC meeting is contained in the August 10, 2001 Federal Register, and from Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 301-827-4515. Information on the VMAC meeting is also available on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area,) code 12546.