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U.S. Department of Health and Human Services

Animal & Veterinary

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Comment Period Extended For Import Tolerances ANPRM

FDA Veterinarian Newsletter January/February 2002 Volume XVII, No 1

The Food and Drug Administration (FDA) is extending to March 11, 2002, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the August 10, 2001, Federal Register. The ANPRM stated that FDA intends to propose a regulation for establishing import tolerances, and solicited comments on issues related to the implementation of the import tolerances provision in section 4 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 U.S. Food products of animal origin that are in compliance with the import tolerance will not be considered adulterated under the Federal Food, Drug, and Cosmetic Act and may be imported into the United States. FDA is extending the comment period to provide stakeholders sufficient opportunity to comment at the January 22-24, 2002, public advisory committee meeting and within sixty days thereafter.

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 March 11, 2002. Electronic comments should be submitted to Regulations.gov. Comments should reference Docket No. 01N-0284.

Additional information on the ANPRM is included in the August 10 and December 7, 2001, 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, E-mail: fpell@cvm.fda.gov.