FDA Soon to Issue Final Regulations on ACE Filing Requirements

MIAMI -- The Food and Drug Administration hopes to publish its final rule on ACE filing requirements by the end of November, said John Verbeten of FDA’s Division of Import Operations at the Florida Customs Brokers & Freight Forwarders Conference of the Americas on Nov. 14. The final rule, which follows a controversial proposal issued in June (see 1606300020), will be followed “sooner rather than later” by changes to FDA’s ACE Supplemental Guide to implement the new regulatory provisions, he said.

FDA has addressed comments it received in response to its proposed ACE regulations, Verbeten said. Trade associations, including the Express Association of America and the National Customs Brokers & Forwarders Association of America, took issue with burdensome new data elements required by FDA in ACE and the possibility that some hard-to-get optional data elements could become mandatory (see 1609010044 and 1608250036). The final rule is currently under review by the Department of Health and Human Services, Verbeten said.

FDA continues work on a “new and improved” product code builder, Verbeten said, declining to comment on when the new version will be released. Some in the trade community have taken issue with the descriptions used by the online tool (see 14100726 and 1508240008). The agency is also close to “finalizing” its pilot of electronic FDA notices of action, and improving its Firm Establishment Identifier system. FDA is “getting to” where it can start accepting changes to entry data submissions, like changes to the port of entry, Verbeten said. Right now the system can’t support these changes, but there’s a “good number” of data elements where FDA would be “perfectly fine” with changing after they are filed.

Some four months after FDA filing in ACE became fully mandatory, around 72 percent of entry lines are now getting automated “may proceeds,” up from around 50 percent before ACE, Verbeten said. FDA is also seeing a decrease in the number of entries for which it requires submission of additional documents. That means the data elements filers are providing to FDA through ACE are allowing the agency to make decisions based on electronic data, and don’t require additional clarification in the form of more documents, he said.