Information On Registration For Foreign Animal Drug Establishments

May 9, 2002

A final rule that became effective on February 11, 2002, requires owners of foreign animal drug establishments to designate a United States agent for purposes of registration and drug listing. The establishment needs to identify their U.S. agent in writing. This letter should be on the firm's letterhead, signed by an official of the firm, and mailed to the following office:

FDA/CDER/Drug Reg. and Listing
5600 Fishers Lane (HFD-095)
Rockville, MD 20857

Additional information about the final rule that amended Title 21, Part 207, of the Code of Federal Regulations, may be found in the November 27, 2001, Federal Register and in a December 5, 2001, CVM UPDATE. Further information on animal drug registration and listing may be obtained from Lowell Fried, FDA/Center for Veterinary Medicine, HFV-212, 7500 Standish Place, Rockville, MD 20855, telephone number 301-827-0165, e-mail lfried@cvm.fda.gov.