No Changes to FDA ACE Pilot Data Elements, Says FDA Official

The Food and Drug Administration is making no changes at the present time to the data elements it requires for filing in its Automated Commercial Environment pilot, said Domenic Veneziano, director of FDA’s import division, in response to our inquiry Nov. 11. The data elements outlined in FDA’s current supplemental guide are “critical” in admissibility decisions, allowing the agency to more timely process releases, he said at a webinar hosted by Integration Point the previous day. “The only change, at this time, to the pilot is the need to complete and submission of the template,” Veneziano said, referring to FDA’s decision to end a pilot requirement that the agency prevalidate shipment data before it is filed in ACE (see 1512080075).

That decision to end pilot prevalidation is part of an agency effort “to make the ramp-on easier for brokers,” said Doug Stearn, director of FDA’s Office of Enforcement and Import Operations, in a Nov. 9 interview. Participation in the pilot is “on an upward trend,” he said. FDA has been reaching out to the 20 largest customs brokerages, which are responsible for over 50 percent of entries, and has had at least some contact with all of them, said Stearn. With participation open for all commodities at all ports, FDA has now processed over 1,000 entries under the pilot, said Jessica Aranda of FDA’s Division of Compliance Systems during the Nov. 10 webinar. That’s up from around 200 at the beginning of November (see 1511040067).

Despite the end of mandatory prevalidation, FDA still encourages pilot participants to prevalidate their shipment data via the agency’s template before filing in ACE. In “production calls” held with filers to assist them in filing their first FDA entries in ACE, the calls go more quickly and have fewer problems when FDA is able to perform prevalidation and review, said Sandy Abbott, director of FDA’s Division of Compliance Systems. If a pilot participant wants to fill out FDA’s template for prevalidation, the agency is “happy to review,” she said.