Background

As part of its commitment to facilitating the transition to the Automated Commercial Environment, the Food and Drug Administration is providing priority processing for ACE entries of FDA-regulated products, according to a message from U.S. Customs and Border Protection. Average processing time for manual review and release of ACE-submitted entries is 25 percent faster than for ACS-submitted entries, CBP states, and release times for document reviews are 33 percent faster (a time savings of 1.5 days). The FDA expects that as entry filers make the transition to ACE the system will be able to further reduce processing times by validating up front the data necessary to process the entry.

As of June 15 all electronic entries and entry summaries for goods subject to FDA import requirements and associated with select entry types must be filed in ACE. Another step the FDA is taking to aid this transition is to conduct production calls, which allow the FDA and the entry filer to discuss the entry submission in real time and immediately address questions or issues. Production calls also allow the FDA and CBP to collaborate on entries requiring attention from both agencies. Entry filers are encouraged to include their software vendors in these calls because it assists in troubleshooting errors and enhances the filer’s understanding of the software. Production calls are not mandatory and can be requested by email.

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