FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN Constituent Update
Center for Food Safety and Applied Nutrition - Food and Drug Administration April 28, 2009

FDA and CBP Announce Computer System Changes Related to the Prior Notice Final Rule
and Compliance Policy Guide for Imported Food Shipments

On November 7, 2008, the U.S. Food and Drug Administration (FDA) and the U.S. Customs and Border Protection (CBP) published the "Prior Notice of Imported Food Final Rule" and a draft compliance policy guide (CPG) that outlines the agencies' enforcement policies regarding the final rule (73 Federal Register 66294 (final rule) and 73 Federal Register 66411 (CPG)). The final rule amended the existing Prior Notice Interim Final Rule (PN IFR) contained in 21 CFR Part 1, Subpart I, which has been in effect since December 12, 2003; the final rule takes effect on May 6, 2009. Also on May 6, 2009, FDA and CBP intend to announce the availability of the final CPG, which describes FDA and CBP's strategy for enforcing the requirements of the prior notice final rule while maintaining an uninterrupted flow of food imports.

The prior notice final rule implements section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (21 U.S.C. 381), which requires that FDA receive prior notice of food imported into the United States. The final rule revises the IFR in only a few key areas, which were summarized in a Constituent Update of October 31, 2008

Beginning on May 6, 2009, FDA's Prior Notice System Interface (PNSI) may be used to file prior notices that account for and reflect requirement changes in the final rule. However, all CBP Automated Commercial System (ACS) and Automated Commercial Environment (ACE) programming changes will not be in place by May 6, 2009. As a result, import filers who file through the Automated Broker Interface (ABI) should be familiar with the final rule changes since they will need to adjust or retain their prior notice submissions in ABI/ACS as noted in the bulleted items below. Please note, however, that prior notices filed through ABI/ACS will be transmitted to FDA for review against the requirements in the final rule. For example, prior notices submitted through ABI/ACS that do not identify the site-specific manufacturer may be accepted for review initially, but upon review by FDA may be refused if they are later deemed inaccurate.

Highlights of the final rule that require careful prior notice data submission by ABI filers:

Questions may be directed to the Prior Notice Center at 1-866-521-2297.

For additional information:

Prior Notice Fact Sheet March 2009

"What You Need to Know About Prior Notice of Imported Food Shipments: A Small Entity Compliance Guide" April 2009

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