U.S. Food and Drug Administration (FDA) to Process Port of Entry Changes Through ACE

Categories: ABI, FDA

On May 15th, 2023 the U.S. Customs and Border Protection Agency announced an update to the SE CATAIR process. Under the new regulations, importers and their authorized agents may make Port of Entry (POE) Changes using the Cargo Release Update Transaction.

Importers and their agents filing entries with the U.S. Food and Drug Administration through the Automated Commercial Environment (ACE) are now allowed to make certain changes (using the Update Action code) after their shipment arrives and the entry is released. Traders will no longer have to resubmit a new entry or request for an entry cancellation to change a port of entry.

The FDA Supplemental Guide for ACE

It is important to note that importers and agents shall continue to use the Supplemental Guide by the FDA concerning the International Trade Data System/Automated Commercial Environment otherwise known as the FDA Supplemental Guide for ACE, the appropriate Trade Automated Interface Requirements (CATAIR) and CBP in addition to supporting documents needed for entry filing.

All processes that importers and their agents have been using remain in place. The biggest change that was announced on May 15 is that the Cargo Release CATAIR now allows importers to change POE (Port of Entry) on an update.

Port of Entry Changes for Entries with FDA Message Set Data

Importers and/or their agents will use the guidelines for the ACE Cargo Release CATAIR to make changes to the Port of Entry. If filers do not change the Port of Entry, the submission will be rejected except if it is entry types 02, 06, 07, and 12.

If it is necessary to change the Port of Entry, filers need to remember that they cannot change any other data elements in the FDA message set. The reason for this is that the FDA will only process changes in the Port of Entry data set. The FDA will usually not consider any changes to the FDA message set.
If the FDA has accepted an entry and thereafter a change is needed to be made to the message set submitted to the FDA, filers need to contact the local FDA office for assistance. If importers or their agents cannot find help from the local FDA, the entry will have to be cancelled and refiled.
All previous status messages and decisions communicated remain applicable to the entry and the corresponding FDA lines.
The FDA will usually acknowledge that a filer has made a change to the Port of Entry by sending an appropriate status code for all FDA lines. This will usually include all disclaimed lines.

Reason Code 47 – Change to Port of entry accepted. The FDA has not reviewed any other data elements. If PGA data has been changed, the filer is advised to cancel and refile the entry.
Reason Code 48 – Change to Port of Entry accepted. The FDA has not reviewed any amendments to other data elements. If PGA data has been changed the filer is advised to cancel and refile the entry. The previous status is still applicable.

These enhancements are currently only available in CERT at present. However, the FDA intends to begin processing Port of Entry changes through ACE which will include the furnishing of new reason codes in Production starting on June 17, 2023.