CSMS Message: 98-000095

THIS ADMINISTRATIVE MESSAGE IS DIRECTED TO ALL ABI FILERS CURRENTLY
PARTICIPATING IN THE US CUSTOMS-FDA INTERFACE PROGRAM.

THE FOOD AND DRUG ADMINISTRATION HAS REQUESTED THAT A MODIFICATION BE
MADE TO ONE OF THE CARGO RELEASE PROCESSING RESULTS OUTPUT MESSAGES.
SPECIFICALLY, THE OTHER GOVERNMENT AGENCY DISPOSITION OUTPUT RECORD
(R6) WILL BE CHANGED TO PROVIDE THE FILER WITH AN ELECTRONIC
NOTIFICATION THAT PAPER DOCUMENTS ARE REQUIRED BY THE LOCAL FDA OFFICE
TO COMPLETE REVIEW OF THE INSTANT SHIPMENT. UNTIL NOW, FDA HAS NOT HAD
AN ELECTRONIC MEANS TO REQUEST THE PRESENTATION OF PAPER DOCUMENTS.

WHEN THE REQUIRED PROGRAMMING CHANGES ARE COMPLETED AND IMPLEMENTED,
THE "FDA CANCEL REFUSAL" MESSAGE WILL BE CHANGED TO READ "FDA
DOCUMENTS REQUIRED." THE "FDA CANCEL REFUSAL" MESSAGE IS LISTED ON
PAGE CRL-31 OF THE CUSTOMS AND TRADE AUTOMATED INTERFACE REQUIREMENTS
DOCUMENT (CATAIR) AS ONE OF THE LINE LEVEL PROCESSING MESSAGES

THE GENERATION OF THIS NEW LINE LEVEL OUTPUT MESSAGE WILL BE AS
DESCRIBED ON PAGES CRL-30 AND CRL-31 OF THE CATAIR. THE ONLY CHANGE
NECESSARY FOR SELF-PROGRAMMED FILERS OR FOR SOFTWARE VENDORS IS TO
CHANGE THE DEFINITION OF THE LINE LEVEL DISPOSITION CODE 14 FROM
"FDA CANCEL REFUSAL" TO "FDA DOCUMENTS REQUIRED".

ONCE THE CHANGE HAS BEEN IMPLMENTED, FDA WILL SUSPEND GENERATING THE
CURRENT "DOCUMENTS REQUIRED" PAPER NOTICE FOR ENTRIES SUBMITTED USING
THE FDA INTERFACE. THIS PAPER NOTICE WILL CONTINUE FOR OTHER ENTRIES.

ALTHOUGH THIS IS NOT A NEW REQUIREMENT, AT TIMES FDA WILL SEND
SEVERAL MESSAGES FOR THE SAME ENTRY LINE. FILERS SHOULD ASSURE THEIR
SYSTEM WILL DISPLAY, IN THE PROPER SEQUENCE, ALL THESE MESSAGES.

IF LOCAL FDA OFFICES NEED TO NOTIFY THE FILER OF A "CANCEL REFUSAL"
ACTION, A PAPER NOTIFICATION WILL BE USED UNTIL SUCH TIME AS THIS
ACTION CAN BE INCORPORATED INTO THE ELECTRONIC INTERFACE.

THE MODIFICATION DESCRIBED IN THIS MESSAGE WILL TAKE PLACE NO SOONER
THAN 90 DAYS FROM THE DATE OF ISSUANCE OF THIS MESSAGE. QUESTIONS
REGARDING THE ABI REQUIREMENTS FOR THIS CHANGE SHOULD BE DIRECTED TO
YOUR ABI CLIENT REPRESENTATIVE. QUESTIONS REGARDING THE SUSPENSION OF
THE "DOCUMENTS REQUIRED" NOTICE CURRENTLY BEING USED BY THE FOOD AND
DRUG ADMINISTRATION SHOULD BE DIRECTED TO THE FDA OASIS SYSTEMS
BRANCH AT (301) 443-6553.

Referenced By

CSMS #98-000423