- To : Automated Broker Interface
Subject: FDA INTERFACE REJECTS
TO: ALL ABI FILERS
FROM: TRADE SUPPORT BRANCH
SUBJECT: FDA INTERFACE REJECTS
THE FOLLOWING MESSAGE WAS ORIGINALLY ISSUED AS ADMINISTRATIVE
MESSAGE 99-1004. THE LOS ANGELES FDA OFFICE HAS NOTED AN INCREASE
IN THE NUMBER OF SYSTEM-GENERATED FDA REJECTIONS AND HAS REQUESTED
THAT FILERS RE-FAMILIARIZE THEMSELVES WITH THE CAUSES OF THESE
REJECTS. MESSAGE 99-1004 IS REPRODUCED BELOW.
TEXT OF ADMIN 99-1004:
THE FDA INTERFACE BECAME OPERATIONAL NATIONWIDE IN 1994. APPROXIMATELY
99% OF ALL FDA ELIGIBLE ENTRIES ARE NOW SENT THROUGH THE FDA INTERFACE.
THERE IS A PERSISTENT PROBLEM WITH FDA REJECTS. THE MAJORITY OF REJECTS
RESULT FROM TWO SCENARIOS. AN AUTOMATIC REJECT, KNOWN COMMONLY AS A 'DT'
REJECT, OCCURS WHEN A FILER SENDS A FOREIGN-BASED CONSIGNEE. THE RECORD
LAYOUT FOR THE 'DT' REJECT CAN BE FOUND IN THE CATAIR, PAGE OGA 9 AND
PAGES OGA 37-38. ALTHOUGH ABI ACCEPTS A FOREIGN-BASED CONSIGNEE FOR
CUSTOMS PURPOSES, FDA DOES NOT. THEY MUST RECEIVE A U.S. ADDRESSED
CONSIGNEE OR THE ENTRY AUTOMATICALLY GOES INTO FDA REJECT STATUS AND
FDA INSPECTORS CANNOT PROCESS THE ENTRY.
THE SOLUTION: DO NOT SEND A FOREIGN-BASED CONSIGNEE IN A FDA INTERFACE
ENTRY. THIS WILL SAVE YOU MANY HOURS OF FRUSTRATION IN TRYING TO CORRECT
THE ENTRY. SEND THE IMPORTER NUMBER OF THE ENTITY IN THE UNITED STATES
AS THE CONSIGNEE. IF YOU CANNOT OBTAIN THE IMPORTER NUMBER YOU CAN SEND
THE NAME AND ADDRESS OF THE UNITED STATES ENTITY IN THE
"FDA ESTABLISHMENT IDENTIFIER ADD" TRANSACTION, KNOWN AS THE 'PP'
TRANSACTION (SEE CATAIR, PAGES OGQ 15-21) TO OBTAIN A TWELVE DIGIT
IDENTIFIER NUMBER KNOWN COMMONLY AS THE "FEI NUMBER". THIS NUMBER COULD
BE SENT IN THE ORIGINAL ENTRY TRANSACTION IN THE FD03 RECORD, POSITIONS
15-26 (SEE CATAIR, PAGE OGA 34) AND THIS WILL PREVENT A FDA REJECT EVEN
IF YOU HAVE SENT A FOREIGN-BASED CONSIGNEE. IF YOU HAVE ALREADY RECEIVED
THE 'DT' REJECT YOU MUST SENT THE FEI NUMBER IN AN "OTHER GOVERNMENT
AGENCY CORRECTION" TRANSACTION, COMMONLY KNOWN AS A 'CP' TRANSACTION (SEE
CATAIR, PAGES OGA 39-41), IN ORDER FOR FDA TO PROCESS THE ENTRY. IN THE
PAST FDA HAS PROCESSED SOME OF THESE REJECTED ENTRIES MANUALLY BECAUSE OF
CLAIMS THAT THE FILER COULD NOT CORRECT THE ENTRIES. THIS WILL CEASE IN
THE NEAR FUTURE. 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. IF YOU ARE NOT FAMILIAR WITH THE 'DT', 'PP' OR 'CP'
TRANSACTIONS WE STRONGLY RECOMMEND THAT YOU CONTACT YOUR SOFTWARE SUPPORT.
THE SECOND REJECT SITUATION OCCURS WHEN CUSTOMS PERFORMS, AT THE FILER'S
REQUEST, A "PEN AND INK" CHANGE TO A SELECTIVITY LINE(S) THAT INVOLVES
A FDA REGULATED TARIFF NUMBER. THIS ACTION PUTS THE ENTRY INTO FDA
REJECT STATUS. IT MUST BE CORRECTED USING THE 'CP' TRANSACTION. YOU MUST
SEND THE NEW OR CHANGED TARIFF NUMBER(S) ALONG WITH ALL OTHER TARIFF
NUMBERS AND APPLICABLE FDA RECORDS IN THE EXACT ORDER AS IN THE CHANGED
SELECTIVITY RECORD. AGAIN, FDA HAS MANUALLY RELEASED ENTRIES THAT WERE
NOT CORRECTED BUT THIS WILL SOON STOP. WE URGE YOU TO FAMILIARIZE
YOURSELF WITH THE OGA CORRECTION PROCEDURES SO NONE OF YOUR REJECTED
FDA ENTRIES ARE DELAYED.
IF YOU HAVE ANY QUESTIONS PLEASE CONTACT YOUR ASSIGNED CLIENT
REPRESENTATIVE.