International Trade Today is a Warren News publication.

FDA Extends the Comment Period for its Interim Final Rule on Prior Notice of Imported Food

The Food and Drug Administration (FDA) has issued a notice announcing that at the request of the Government of Canada it is extending until July 13, 2004 the comment period regarding all aspects of its interim final rule on prior notice of imported food shipments.

Sign up for a free preview to unlock the rest of this article

If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.

FDA notes that the Government of Canada submitted its request with the understanding that such an extension would not interfere with the issuance of the prior notice final rule, which FDA plans to publish in March 2005.

(On October 10, 2003, the FDA published an interim final rule requiring the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the U.S. See ITT's Online Archives or 11/10/03 news, 03111010, for Part XIV of BP's series of summaries on the FDA's interim final rule.

On April 14, 2004, the FDA published a notice reopening until May 14, 2004 the comment period on all aspects of its interim final rule in order to (1) explore flexible alternatives for the submission of prior notice for food or firms covered by programs of other agencies, such as U.S. Customs and Border Protection's (CBP's) Customs-Trade Partnership Against Terrorism (C-TPAT) and the Free and Secure Trade (FAST) program, or food imported by other government agencies; (2) solicit comments on the "Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes;" and (3) ensure that those who comment on the interim final rule would have had the benefit of FDA's outreach and education efforts and would have had some experience with the systems, timeframes, and data elements of the prior notice system. See ITT's Online Archives or 04/14/04 news, 04041410 and 04041405, for BP summaries of the FDA's reopening of the comment period and the joint FDA-CBP plan.)

FDA Will Address Comments and Confirm/Amend Interim Final Rule in Final Rule

FDA notes that it will address comments received in the entire reopened/extended comment period and the previous comment period that closed on December 24, 2003, and will confirm or amend the interim final rule in a final rule. However, FDA states that it will not address any comments that have been previously considered during this rulemaking.

- written or electronic comments due by July 13, 2004

FDA contact - May D. Nelson (301) 436-1722

FDA notice extending the comment period for the prior notice interim final rule (FR Pub 05/18/04, D/N 2002N-0278) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-11247.pdf.