FDA Keeps Flexibility for Some Optional Data Elements in ACE Filing Final Rule

The Food and Drug Administration is adopting the flexible approach urged by industry for filing in ACE of some data elements that may not be known at time of entry, in its final rule setting ACE filing requirements (here). Data elements for active pharmaceutical ingredients will remain optional, and the agency will continue to allow for a “UNK” intended use code where the intended use code is unknown at time of entry, the final rule said. However, FDA declined to allow more time for implementation of new ACE requirements, setting an effective date of Dec. 29 despite calls to allow several months for implementation.

The National Customs Brokers & Forwarders Association of America and other industry groups had called on FDA not to make the currently optional API data elements mandatory (see 1608250036 and 1609010044). Though remaining optional, submission of API data could increase the likelihood of getting a quick “May Proceed” from FDA, the agency said in its final rule. “Although these data elements will remain optional, FDA strongly encourages ACE filers to submit the API data elements at the time of entry to facilitate FDA’s admissibility review,” FDA said. “If the API data elements are not submitted in ACE, the entry may receive a manual review and the FDA reviewer may request that the importer provide API information for the finished dosage product.”

Filers that submit code “UNK” in the intended use field will still have the obligation to submit all other data elements required for their imported article, and their entries will likely be subject to manual review, FDA said. When “UNK” is submitted for intended use, filers will not get the benefit of an automatic prompt in ACE for all FDA data elements required to be submitted for a particular article, FDA said. “If those other data elements are not submitted in ACE at the time of entry, the entry may be transmitted by ACE to OASIS for FDA’s admissibility review but FDA may decide to not perform an admissibility review until those data elements have been submitted,” FDA said. “ACE filers also need to be aware that submitting 'UNK' as the intended use code will, in most cases, subject the entry to a manual review for admissibility provided the entry filing is not rejected by FDA.”

FDA is also declining to make mandatory several new data elements that were included in its July 1 proposed rule (see 1606300020). The agency will not require submission of an “FDA Value,” though it will still allow the total value of the article in each entry line. Similarly, filers will not have to submit an “FDA Quantity” accounting for each level of packaging, the unit of measure and the volume or weight of each of the smallest of the packaging units. Nor will filers have to submit contact information for each party related to an article’s importation, including the manufacturer, shipper, importer of record and consignee. Only contact information for the importer of record will be required. Filers will still have the option of submitting FDA Quantity and the contact information, “which may expedite the entry review process,” FDA said.

The ACE filing regulations’ definition of “owner or consignee” is also being tweaked by FDA in its final rule. Previously defined as the “person eligible to make entry,” commenters had said the term was confusing because several parties to a transaction, including the customs broker, have a right to make entry. FDA agreed, and will instead define “owner or consignee” as the “person who makes entry.”

However, FDA declined to allow the trade community more time to implement the regulations. Commenters had asked FDA to allow at least two months to implement changes to data elements in the final rule. “The trade community has already transitioned to ACE and software is available in the marketplace that conforms with the requirements in FDA’s Supplemental Guide,” FDA said. “FDA acknowledges that software vendors and the trade community may need to make a small number of alterations to their current programming to be consistent with the requirements in the final rule but 30 days should be sufficient for that purpose,” it said. “FDA will shortly issue an updated FDA Supplemental Guide to assist software vendors and the trade industry with their programming needs.”