FDA Issues Technical Corrections to its Interim Final Rule on Food Facility Registration
The Food and Drug Administration (FDA) has issued a notice, effective May 24, 2004, which contains several technical corrections to its October 10, 2003 interim final rule requiring domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA by December 12, 2003.
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
(FDA issued this interim final rule, along with another interim final rule on prior notice of imported food, in order to implement certain requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).)
FDA Corrects Certain Phone Numbers and Cites Contained in Interim Final Rule
In its notice, the FDA makes the following technical corrections to 21 CFR Part 1 as it appeared in the interim final rule:
Changes to certain phone numbers. The FDA is correcting the phone numbers to which registration form requests and other technical questions should be directed. These phone numbers, which appear in 21 CFR 1.231(b)(1), have been corrected to read "1-800-216-7331 or 301-575-0156."
Editorial errors in 21 CFR 1.232 corrected. The FDA is also correcting editorial errors which appear in the interim final rule's 21 CFR 1.232 as follows:
21 CFR 1.232(d) - this paragraph has been revised to read " For a foreign facility, the name, address, phone number, and, if no emergency contact is designated under 1.233(e), the emergency contact phone number of the foreign facility's U.S. agent."
(This paragraph previously read "For a foreign facility, the name, address, phone number, and emergency contact number of its U.S. agent (if there is no other emergency contact designated under 1.233(c)).)
21 CFR 1.232(g) - in the interim final rule, this paragraph contained a cite to 21 CFR 1.233(e). The FDA is now correcting this cite to read "21 CFR 1.233(j)."
(See ITT's Online Archives or 10/15/03 news, 03101510, for installment of BP summary of this interim final rule which concerns these amended sections.)
FDA Contact - Melissa Scales (301) 436-1720
FDA notice (D/N 2002N-0276, FR 05/24/04) available athttp://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-11598.pdf