CSMS Message: 04-001633

TO: ALL ABI FILERS AND ABI SOFTWARE SUPPLIERS

FROM: CLIENT REPRESENTATIVE BRANCH

SUBJECT: FDA INTERFACE PROBLEM SCENARIO & RESOLUTION

A PROBLEM IN THE REGULAR (801A) FDA INTERFACE HAS BECOME MORE
SERIOUS SINCE THE IMPLEMENTATION OF FDA PRIOR NOTICE (801M) AND MAY
BECOME A SERIOUS ISSUE AFFECTING RELEASE OF FDA REGULATED MERCHANDISE
WHEN PHASE IV OF BTA/PRIOR NOTICE COMES INTO EFFECT ON AUGUST 13, 2004.

PROBLEM SCENARIO: A FILER SENDS AN ENTRY SUMMARY (EI) TRANSACTION
CONTAINING (FOR PURPOSES OF THIS SCENARIO) FULL FDA DATA INCLUDING
FDA PRIOR NOTICE DATA AND CERTIFIES THE ENTRY FOR CARGO RELEASE.
BECAUSE OF THE ARRIVAL DATE CARGO RELEASE DOES NOT RUN IMMEDIATELY.
BEFORE SELECTIVITY RUNS THE FILER RE-SENDS THE EI TRANSACTION BUT DOES
NOT INCLUDE THE FDA DATA. THIS CAUSES A PROBLEM WHEN SELECTIVITY RUNS
AND WILL CAUSE A MAJOR PROBLEM WITH PRIOR NOTICE ONCE PHASE IV IS
ENABLED.

PROBLEM RESOLUTION: 1. DO NOT RE-SEND A FDA-REGULATED ENTRY SUMMARY
IF YOU HAVE NOT RECEIVED CARGO SELECTIVITY RESULTS (INCLUDING FDA
RESULTS. WAIT UNTIL THE SELECTIVITY RESULTS HAVE BEEN GENERATED
AND THEN RESEND THE EI TRANSACTION WHICH AT THIS TIME YOU CAN SEND
WITHOUT FDA DATA. 2. IF CIRCUMSTANCES WARRANT A RE-SEND OF THE EI
TRANSACTION THEN FULL FDA DATA MUST BE INCLUDED.

ABI SOFTWARE SUPPLIERS SHOULD ENSURE THAT THEIR SYSTEMS REQUIRE FDA
DATA ON FDA-REGULATED RE-SENDS IF SELECTIVITY RESULTS HAVE NOT BEEN
RECEIVED. THIS IS VERY IMPORTANT FOR PHASE IV OF BTA/PRIOR NOTICE.

IF YOU HAVE QUESTIONS PLEASE CONTACT YOUR ASSIGNED CLIENT
REPRESENTATIVE.

CLIENT REPRESENTATIVE BRANCH