FDA Finalizes New Import Data Requirements

The Automated Commercial Environment system "serves to protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being offered for import that may be associated with a greater public health risk," wrote Howard Sklamberg, J.D., deputy commissioner for Global Regulatory Operations and Policy.

The U.S. Food and Drug Administration published a final rule Nov. 29 specifying data that must be submitted electronically when an FDA-regulated product is offered for import into the United States. The effective date of the rule is Dec. 29, 30 days from the date of publication. The rule clarifies that FDA may reject an import filing that fails to provide complete and accurate information as required.

Import entries of products regulated by FDA are submitted through an electronic system called the Automated Commercial Environment (ACE). Howard Sklamberg, J.D., FDA's deputy commissioner for Global Regulatory Operations and Policy, explained in an FDA blog post that the trade community helped the agency pilot ACE, which is operated by U.S. Customs and Border Protection, from August 2015 to May 2016, and ACE became in July 2016 the sole Customs-authorized system for electronic submissions of entries that contain FDA-regulated products.

The rule includes technical revisions to certain sections of FDA regulations, he explained. For example, the owner or consignee of an FDA-regulated product is now defined as the importer of record, which brings FDA regulations up to date with previous revisions to customs laws, and FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice.

FDA will continue to provide assistance to filers working to properly submit the required data, through telephone meetings, an ACE Support Center that is staffed 24/7, and assisting directly in a filer's first ACE submission or, for filers who import various commodities, with every first submission of a particular commodity.

Sklamberg wrote that the system "serves to protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being offered for import that may be associated with a greater public health risk."

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