FDA to Simplify ACE Pilot Process, Hints at Changes to Mandatory Data Elements

The Food and Drug Administration is making changes to processes for participation in its Automated Commercial Environment filing pilot and modifying “the data that are required at the time of entry for admissibility,” said CBP in a CSMS message dated Dec. 9 (here). Effective immediately, FDA has removed the requirement for submitting a data element “template” for pre-validation, although it will still provide the template to assist filers and will “provide guidance and support” to “answer any questions,” said the message.

The CBP Advisory Committee on Commercial Operations recently cited FDA’s pre-validation requirements as one of several “grave concerns” related to ACE (see 1511020025). Up to now, FDA required submission of a spreadsheet of shipment data for each entry, which it checked to make sure there weren’t any issues before allowing filing in CBP’s certification environment and subsequently live in ACE. The memo said FDA was “not piloting reality,” and that the process wasn't sustainable.

The changes to FDA’s pilot will make it “simpler and easier to participate,” said Douglas Stearn, director of FDA’s Office of Enforcement and Import Operations, in a video for importers and customs brokers posted to the agency’s website Dec. 8 (here). “It is imperative that you begin using ACE and participate in the pilot,” he said. “FDA intends to move towards a mandatory system for certain additional data elements. It is in the best interest of brokers and importers to begin submitting these data elements as soon as possible.” FDA did not comment. The agency will host a webinar to discuss the changes to the ACE pilot and data elements on Dec. 10 (here).