FDA Concentrating Efforts on Bringing Remaining Filers Into ACE, Agency Official Says
The Food and Drug Administration is going on the offensive to get filers left behind by the agency’s recent ACE deadline on board with the new system, said Doug Stearn, director of FDA’s office of enforcement and import operations, in an interview on June 24. Though the “overwhelming” amount of FDA-regulated imports are now being filed in ACE following the June 15 deadline for FDA entries and entry summaries of entry types 01, 03, 11, 23, 51 and 52, FDA has many smaller filers, some of which have still not made the transition, Stearn said.
Currently, around 90 percent of FDA filers are transmitting their entries and entry summaries in ACE, Stearn said. FDA has said it will handle filers in the legacy Automated Commercial System on a “case-by-case basis” until ACS is taken offline on July 23 (see 1606100012), which is also the ACE deadline for a lengthy list of quota-related entry types, including for entries and entry summaries regulated by FDA. After July 23, filers will no longer have the ACS alternative, FDA has said.
FDA does not want to get to the point at which July 23 is around the corner and filers have to rush to make the adjustment to ACE, Stearn said. Any filers not submitting through ACE need to work to complete the transition now, he said, adding that FDA is willing to work with anyone to do that. FDA is doing “everything we can” to make the transition “as smooth as possible,” including enhanced outreach and a 24/7 help line it launched on June 14. The agency also continues to offer “production calls” to talk filers through entry submissions as they happen, according to a webpage on the ACE transition recently added to the FDA website (here). “Problem areas and issues can be immediately addressed, which makes for a smoother transition for the entry filer,” FDA said.
Filers that switch to ACE will also see the benefit of enhanced processing times, Stearn said. According to the FDA webpage on the transition, the average processing time for manual review of ACS entries is 40 percent faster than for ACS, and document reviews are 37 percent faster. “FDA expects the review time to only improve as entry filers make the transition to ACE,” the agency said.
Recent FDA ACE messaging issues that prompted CBP to deploy a fix on June 23 (here) were caused by high volumes associated with the “massive transition of systems” in the days after FDA’s ACE deadline, Stearn said. Overall, however, the “system continues to get better with time,” and FDA is “very satisfied” with the quicker response rates seen in the ACE system, he said. Though there may be a “few little bumps along the way,” such issues are “to some extent to be expected” in such a large rollout, he said.