The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA ofprior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The infonnation must be submitted and confinned electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for .food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, ifrefused, must be held. Elsewhere in this issue ofthe FEDERAL REGISTER, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002."
To view the full document, click on the following link: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2002-N-0233.pdf
FOR FURTHER INFORMATION CONTACT:
Office ofRegulatory Affairs (HFC-l 00),
Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857,