CBP Reissues 1999 Notice on FDA Interface Rejects
U.S. Customs and Border Protection (CBP) has reissued a November 1999 ABI administrative message which stated that there is a persistent problem with rejects of entries of Food and Drug Administration (FDA)-regulated products sent through the FDA interface with the Automated Broker Interface (ABI). The majority of such rejects result from the two scenarios described in this notice.
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(In the reissued version of this administrative message, CBP adds a new note stating that filers who are still sending foreign-based consignee identification numbers in their transmissions to ABI are advised to follow the instructions in Scenario 1 immediately.)
Scenario 1 - Automatic Rejects for Foreign-Based Consignees
CBP states that the first scenario is an automatic reject (known commonly as a "DT" reject), which occurs when a filer sends a foreign-based consignee in an FDA interface entry. CBP notes that although ABI accepts a foreign-based consignee for Customs purposes, FDA does not, and unless a U.S.-addressed consignee is received, an entry will automatically go into FDA reject status and FDA inspectors cannot process the entry.
According to CBP, the solution is to not send a foreign-based consignee in an FDA interface entry and instead send the importer number of the entity in the U.S. as the consignee.
CBP adds that if the importer number cannot be obtained, the name and address of the U.S. entity can be sent in the "FDA Establishment Identifier Add" Transaction (the "PP" transaction) to obtain a 12-digit identifier number known commonly as the "FEI number." CBP states that the FEI number can then be sent in the original entry transaction in the FD03 record, positions 15-26, and that this will prevent an FDA reject even if a foreign-based consignee has been sent.
If a DT reject has already been received, CBP states that the FEI number must be sent in an "Other Government Agency (OGA) Correction" transaction (commonly known as a "CP" transaction) in order for FDA to process the entry.
Scenario 2 - Rejects for "Pen and Ink" Corrections by CBP
CBP states that the second reject scenario occurs when CBP performs, at the filer's request, a "pen and ink" change to a selectivity line(s) that involves an FDA-regulated tariff number.
According to CBP, this puts the entry into FDA reject status and must be corrected using the CP transaction. CBP adds that the new or changed tariff number(s), along with all other tariff numbers and applicable FDA records, must be sent in the exact order as in the changed selectivity record.
FDA to Cease Manual Release of Uncorrected Entries in the Near Future
CBP notes that although FDA has processed and released some of these rejected entries manually in the past (e.g., because of claims that the filer could not correct the entries), this will cease in the near future (see below for BP note).
In the near future, CBP states, if an entry is in FDA reject status, the filer will be required to correct the entry through ABI or the goods will not be released by FDA. CBP urges ABI filers to become familiar with the "DT", "PP", and "CP" transactions, as well as the OGA correction procedures so that none of their rejected FDA entries are delayed.
(See ITT's Online Archives or 11/19/99 news, 99111852, for BP summary of the original administrative message, Adm: 99-1004.)
CBP Adm: 04-0354 (dated 02/23/04) available via fax or email by emailing staff@brokerpower.com
BP Note
As these instructions were originally released in 1999, BP is checking with FDA sources to confirm all the information contained in this administrative message is up-to-date.