FDA, Customs Revise Notice Documents for Imported Foods

On Thursday, August 12, 2004, the United States Food and Drug Administration (FDA) and the U.S. Customs and Border Protection (CBP) issued a revised compliance policy guide (CPG) that describes their strategy for enforcing the requirements of the prior notice interim final rule (IFR) while maintaining an uninterrupted flow of food imports.

FDA and CBP also announced a corresponding three month delay in their projected date for issuing the prior notice final rule from March 2005 to June 2005. This will allow FDA and CBP to retain the three month assessment period to determine whether the prior notice time frames can be reached further as they develop the prior notice final rule.

Lastly, the agencies announced the issuance of an updated prior notice compliance summary, and a new "Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages." The compliance summary states that since increased enforcement began in June, entries submitted to FDA and CBP with no prior notice have been almost eliminated. Although some problems still exist, only a small percent fail to submit any prior notice information. Most prior notice data are being submitted; however, completion of registration number and bill of lading is lower than completion of most other data elements.

More detailed information is available at the FDA web site on The Bioterrorism Act of 2002 under the heading "Recent Activities" located at http://www.fda.gov/oc/bioterrorism/bioact.html

This information includes:

* The FDA Talk Paper issued on Thursday, August 12, 2004 http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01304.html

* Compliance Summary Information: Prior Notice http://www.cfsan.fda.gov/~pn/pnsum.html

* Revised Compliance Policy Guide http://www.cfsan.fda.gov/~pn/cpgpn3.html

* Revised Joint Plan http://www.cfsan.fda.gov/~pn/pnplan2.html

* Prior Notice Contingency http://www.cfsan.fda.gov/~pn/pndguid.html

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