The Food and Drug Administration is proposing to codify its procedures for electronic filing of entries of FDA-regulated products in ACE. The agency’s proposed rule (here) would add new sections to the FDA regulations specifying the data elements that must or may be filed in ACE at the time of entry, and make “technical revisions” to existing FDA regulations, including an alignment of the FDA definition of owner or consignee with CBP’s definition. Comments on the proposed rule are due Aug. 30. In addition to general comments, FDA is also seeking specific input on a variety of ACE requirements FDA is proposing to codify in its regulations, including the following:
CBP issued the following releases on commercial trade and related matters:
CBP posted an updated Form 3461 that will allow for filing entries and requests for release during broker or ACE system outages (see 1512140020). Form 3461 (here) applies to "Entry/Immediate Delivery for ACE," and Form 3461C (here) "supports additional Line and Bill of Lading information if there is not enough room on the 3461 for use with ACE," CBP said. The agency also released instructions for Form 3461 (here).
As CBP moves quota filing into ACE on July 23, the biggest changes seen by the trade community will be a fully electronic submission process and the automation of quota allocation and messaging, CBP officials said during a webinar June 28. Gone will be the days of time-stamped paper, at least for filers who submit quota data electronically in ACE entry summaries and imaged documents. The ACE system, not entry and import specialists, will automatically set presentation dates and, with certain exceptions, allocate quota amounts and message filers accordingly, the officials said during the webinar, which expanded on transition procedures recently outlined by CBP (see 1606270028).
CBP issued the following releases on commercial trade and related matters:
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CBP issued the following releases on commercial trade and related matters:
CBP outlined transition procedures for entries and entry summaries subject to quota that will be required to be filed in ACE beginning on July 23, in a notice to trade recently posted to its website (here). Starting on that date, entries and entry summaries associated with entry types 02, 07, 12, 21, 22 31, 32, 34 and 38 must be filed in ACE, along with entries and entry summaries of types 06 and 23 that include quota merchandise (non-quota type 06 and 23 entries are already required in ACE).
CBP issued the following releases on commercial trade and related matters:
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.