CBP Sets An Ambitious Deadline for FDA Entries and Entry Summaries of June 15, 2016

As of June 16, CBP will require filing in ACE of FDA entries and entry summaries under entry types 01, 03, 06, 11, 23, 51 and 52. CBP boldly stated that the Automated Commercial System (ACS) “will no longer be a CBP-authorized [electronic system] for purposes of processing these electronic filings.” While the agency concedes that this deadline is “tight,” they seem determined to stick to this timeline despite many concerns expressed by the trade.

CBP will deploy essential PGA message set changes into the live ACE system on May 31, and this gives the trade just 15 days to test their systems to ensure that all is working perfectly. Additionally, a few of the changes are not compatible with current versions of FDA programming; this could easily lead to confusion and uncertainty.

There are legitimate concerns about the challenges with the messaging for FDA entries between ACE Release and FDA’s Predict System and the Truck Manifest Module. Given the high volume of FDA regulated shipments from Canada and Mexico, the Truck Manifest Module is a particularly daunting uncertainty.
For now, the legacy ACS will remain the electronic system for FDA-regulated entries and entry summaries of entry types 02, 07, 08, 09, 12, 21, 22, 31, 32, 34, 38, 41, 42, 43, 44, 45, 46, 61, 62, 63, 69 and 70.
The June 16 deadline leaves little more than 30 days for the trade community to get fully ready for ACE, and it comes shortly after the execution of several changes to FDA’s PGA message set.

As always, Shapiro will update you as soon as we learn of any changes or clarifications.

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