FDA Pilot on ACE Coming in July

The Food and Drug Administration will begin a pilot on July 1 to test filing in the Automated Commercial Environment, said Domenic Veneziano, FDA director of import operations, during a March 24 webinar (here). The pilot will identify any issues with the use of ACE to file and release FDA-regulated entries in advance of the Nov. 1 deadline for mandatory filing and cargo release, said Veneziano. CBP expects to issue a Federal Register notice in April or May to provide details on the pilot, such as eligible commodities and ports, and request participation from industry, said Veneziano and CBP’s Elizabeth McQueen, who leads CBP’s International Trade Data System branch.

FDA is still working out exactly what data elements it will require when ACE becomes mandatory in November, said Veneziano. A recently updated supplemental guidance listing data elements for FDA-regulated entries (here) is still only in draft form, and the agency is going through the guide to identify what data elements are necessary to determine admissibility, he said. Data elements that aren’t directly related to admissibility, such as lot numbers and production dates for medical devices, could become optional fields and will not be mandatory, said Veneziano.

The FDA component of the Document Imaging System will likely not be ready by the November ACE transition, said Veneziano. As a result, the agency’s Import Trade Auxiliary Communication System will remain in place to give filers a way to view entry status at the line level and FDA notices of action, and any documents submitted to satisfy FDA holds for documentation will still be uploaded on the Mission Accomplishments and Regulatory Compliance Servers (MARCS) system. Even once DIS is completed and the filer can use ACE to fully monitor FDA regulated entries, the agency still plans to use ITACS on its side.

One of the big changes that is coming on Nov. 1 is the ability to correct or make changes to FDA entries instead of having to delete the entry and refile, said Veneziano. Filers will have the ability to submit their entries 60 days in advance, and will be able to change them up until a still undetermined cut-off date when FDA will have to begin reviewing the entry. Although industry has requested the ability to change port codes, that represents more of a problem for FDA because port changes often come on short notice, said Veneziano. When a port change comes after FDA’s cut-off date, the agency will have to deal with it “operationally,” although ACE will ensure that FDA officials across the country know that the FDA regulated shipment is coming in and can shift any inspection plans accordingly.