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U.S. Department of Health and Human Services
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Food Safety and Security Constituent Update
Center for Food Safety and Applied Nutrition - Food and Drug Administration April 12, 2004

Comment Period Reopens for Interim Final Rules
On Registration and Prior Notice

FDA and the Customs and Border Protection (CBP) are reopening for 30 days the comment period for FDA's prior notice of imported food shipments interim final rule (IFR) and its registration of food facilities IFR, which were published in the Federal Register of October 10, 2003. FDA is reopening the comment period consistent with its statement in each of the preambles of the IFRs that it would do this for an additional 30 days in March 2004, to ensure that those who comment on the IFRs would have had the benefit of our outreach and education efforts and would have had some experience with the systems, timeframes, and data elements of the registration system and the prior notice system.

The complete notices of availability announcing the reopened comment period for each of these IFRs, including how to submit comments, are on FDA's website at http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm as Special Filing -- Publishing on April 14, 2004. The comment periods close on May 14, 2004.

In addition, as part of the educational effort described in the prior notice compliance policy guide announced on December 11, 2003, FDA is posting on its website at http://www.cfsan.fda.gov/~pn/pnsum.html summary information about the level of compliance with the prior notice IFR, including data on the types of errors in submitted prior notices.

The agencies have also announced a plan entitled "Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes" that they intend to implement in August 2004. The joint plan, which is posted on FDA's website at http://www.cfsan.fda.gov/~pn/pnplan.html, describes the process by which FDA and CBP intend to increase integration and examine whether they could amend the timeframe requirements in FDA's prior notice IFR to have the same advanced notice timeframes for arrivals by land via road or rail, or arrival via air that currently are in CBP's Required Advance Electronic Presentation of Cargo Information Final Rule (68 FR 68140). The comment period also closed on May 14, 2004.



Food Safety and Security Staff
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Office Number: (301) 436-2277· FAX (301) 436-2605
CFSAN Web site: http://www.cfsan.fda.gov/

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