October 01, 2001

 
TAKE NOTICE

 FDA seeking comments on import tolerances

Posted Sept. 15, 2001

The Food and Drug Administration is soliciting comments on issues related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996. The act authorizes the FDA to establish drug residue tolerances for imported food products of animal origin for drugs that are used in other countries, but that are not approved 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 and may be imported.

In the Aug. 10 Federal Register (www.fda.gov/OHRMS/DOCKETS/98fr/081001a.htm) the FDA published an advance notice of proposed rulemaking on the import tolerance issue. A public meeting scheduled in September by the FDA-CVM's Veterinary Medicine Advisory Committee to discuss the proposed rule was postponed. A notice announcing the new meeting time will appear in the Federal Register.

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

Additional information on the proposed rule is included in the Aug. 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, E-mail: fpell@cvm.fda.gov. Additional information about the VMAC meeting will be included in a future CVM UPDATE and on the FDA/Center for Veterinary Medicine Home Page at www.fda.gov/cvm/index/vmac/vmactoc.htm.