More Changes Coming to FDA's ACE Data Requirements, Say Agency Officials
More changes are on the way for the Food and Drug Administration’s supplemental guide for filing in the Automated Commercial Environment, but the changes are meant to ease, not add to the burden on industry, said Sandra Abbott, director of FDA’s Division of Compliance Systems, during a webinar hosted by the National Customs Brokers & Forwarders Association of America on Feb. 3. The basic data elements that will become mandatory Feb. 28 are set, but FDA still needs to fix bugs that are causing hiccups for filers, she said.
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The biggest upcoming change is the addition of a new data element, PG60, which will act as an overflow for business names, addresses and brands that are too long for the current data field, said Abbott. The current name and address fields allows only 32 characters, so when the name and address entered is too long it gets cut off, causing mismatches with FDA’s databases and ultimately the rejection of the entry. Any characters over the 32 character limit will now overflow into the PG60 field.
Most other upcoming changes are clarifications and other minor changes, said Abbott. There are no other new data elements – if anything, a couple of currently mandatory data elements will become conditional, she said. FDA will continue to make other changes over time – “nothing says constant,” said Abbott – but version 2.4.1 of the supplemental guide, expected mid-to-late February, “will pretty much lock most things down.”
In response to concerns that the new data elements could cause entry rejection issues for perishable shipments, Abbott said the changes will actually minimize or reduce entry rejects that are currently being caused by programming issues, including the truncated names and addresses. “It’s not to add to the burden but rather to diminish the burden,” and “help the process flow more smoothly,” she said.
FDA is still on course to meet the Feb. 28 deadline for filing of the agency’s PGA message set in ACE, said Abbott. Concerns over fast approaching deadline “have been raised at the highest level,” and “everyone is aware of the challenges that the date creates,” she said. Nonetheless, Abbott said she could “not at this moment” say that “anything has been changed” related to the Feb. 28 deadline. FDA is doing "the best we can" to train its field staff to help with any issues that may arise post-deadline, and will provide them with three days of ACE training before Feb. 28, she said.
Meanwhile, participation in FDA’s ACE pilot continues its sharp rise, with some 24,000 entries from 500 filers, representing over 50,000 entry lines, now filed since the pilot began Aug. 19. That’s approaching triple the 8,000 entries that FDA reported filed as of two weeks prior on Jan. 19 (see 1601200024). Only 1,000 had been filed as of December, prompting FDA to relax its pilot requirements by eliminating the need to prevalidate shipment data before sending it through ACE (see 1512110027). Filers not participating in the pilot are doing themselves “a big injustice,” said Cary Weinberg of the NCBFAA’s regulatory affairs committee. Weinberg and Matt Brauner, also on the NCBFAA committee, highlighted the numerous unexpected hiccups that they’ve faced since they began participating, noting the assistance that FDA has been able through the pilot to get them up to speed.