FDA reopens pre-note comment period: begins integration with CBP

WASHINGTON, (April 19, 2004) — The U.S. Food and Drug Administration is re-opening the comment period for the FDA’s interim final rule for food facility registration, and has begun preliminary plans with U.S. Customs and Border Protection to increase integration of advance electronic notification processes, as well as reduce prior notice timeframes even further.

The FDA invites comment and the submission of data or other information on facility registration. The agency wants to focus on issues such as the cost to foreign facilities of hiring and retaining a U.S. agent; and the effects on domestic small businesses, if any, if some foreign facilities cease exporting to the U.S. due to the requirement for registration. Comments can be submitted by May 14, 2004 at www.fda.gov/dockets/ecomments.

FDA and CBP will also publish a plan, including an implementation schedule, to achieve a uniform, integrated system between both agencies. Currently, CBP’s Advance Electronic Information requires trucks to notify the agency of U.S.-bound cargo no later than 1 hour prior to the arrival of the truck at the border, or 30 minutes for Free and Secure Trade (FAST)-approved trucks.

FDA has maintained it wants to cut down its own time-frames to a similar schedule. Currently, the FDA rule require domestic and foreign food facilities that manufacture, process, pack or hold food to electronically notify FDA of food shipments two hours before it reaches the border. Prior notice be submitted to FDA electronically via either CBP’s Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PN System Interface).


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