CSMS Message: 92-000423

ATTENTION: ABI SOFTWARE VENDORS, SERVICE BUREAUS, AND SELF-
PROGRAMMED BROKERS WITH AN INTEREST IN THE U.S.
CUSTOMS/FOOD AND DRUG ADMINISTRATION (FDA) AUTOMATED
INTERFACE PILOT IN SEATTLE, WA

LISTED BELOW ARE THE BASIC CHANGES TO THE ORIGINAL SPECIFICATIONS
FOR THE FDA INTERFACE WITH U.S. CUSTOMS. THE FDA SPECIFICATIONS
WERE MAILED TO ALL ABI PARTICIPANTS APPROXIMATELY 8 MONTHS AGO.

THE PILOT TEST WILL BEGIN OCTOBER 19, 1992 IN SEATTLE PORTS
OF (3001, 3002, 3029).

AS STATED IN ADMINISTRATIVE MESSAGE # 92-0278 (DATED 8/7/92), THE
NUMBER OF FDA REQUIRED ELEMENTS HAS DECREASED FOR ABI PURPOSES.
LISTED BELOW ARE THE REQUIRED FDA DATA ELEMENTS FOR ABI TRANSMISSION:

1) "OI" RECORD (COMMERCIAL INVOICE DESCRIPTION)
* (REQUIRED FOR OTHER GOV'T AGENCY TRANSACTIONS)
2) FDA LINE NUMBER
3) FDA PRODUCT CODE
4) FDA COUNTRY OF PRODUCTION
5) FDA AFFIRMATION OF COMPLIANCE (CODE & QUALIFIER)
* (AS REQUIRED BY FDA)
6) FDA ACTUAL MANUFACTURER NUMBER
7) FDA ACTUAL SHIPPER NUMBER

A) THE DATA ELEMENTS LISTED ABOVE (2-7) ARE PRESENT IN THE FD01
INPUT RECORD. THE FD02 AND FD03 RECORDS MUST FOLLOW THE FD01
RECORD EVEN THOUGH NO DATA IS REQUIRED TO BE PRESENT IN THESE TWO
RECORDS. IF THE FD02 & FD03 RECORDS DO NOT FOLLOW THE FD01
RECORD, THE TRANSMISSION OF THE ENTRY DATA WILL REJECT.

B) THE FDA DATA MAY BE TRANSMITTED IN THE "HI" OR "EI" APPLICATION
AND CERTIFIED FOR CARGO RELEASE IN EITHER APPLICATION. THE FDA
DATA WILL BE PROCESSED THROUGH THE FDA SCREENING FILE LOCATED
IN ACS AND WILL PRODUCE ONE OF TWO POSSIBLE MESSAGES AT THE
ENTRY LEVEL:
1) FDA MAY PROCEED
2) FDA REVIEW

C) FOR THE FIRST 2 TO 4 WEEKS, A DUAL PAPER/ELECTRONIC MODE
WILL BE REQUIRED. THE ELECTRONIC FDA DATA IS REQUIRED TO BE
TRANSMITTED THROUGH ABI AND THE FDA FORM 701 (AND INVOICE)
MUST BE SUBMITTED TO THE LOCAL FDA OFFICE, FOLLOWING CURRENT
LOCAL PROCEDURES. AFTER THIS INITIAL PERIOD, YOU WILL BE
NOTIFIED VIA AN ADMINISTRATIVE MESSAGE THAT THE HARDCOPY FDA
FORM 701 WILL NO LONGER BE REQUIRED IF ELECTRONIC DATA IS SENT
AND A "MAY PROCEED" HAS BEEN INITIALLY GENERATED.

D) DURING THIS 2-4 WEEK PERIOD, THE FDA FORM 701 WILL BE
RETURNED TO THE BROKER WITH WRITTEN INSTRUCTIONS FROM FDA,
AS IS THE PRESENT PROCEDURE. THESE WRITTEN INSTRUCTIONS WILL
TAKE PRECEDENT OVER ANY ELECTRONIC RESPONSE BY ABI. THIS IS A
NECESSITY FOR THE PROPER EVALUATION OF THE PILOT TEST.
ONCE THIS INITIAL EVALUATION IS COMPLETE, NO PAPER 701 FORM
WILL BE REQUIRED AFTER THE FILER HAS RECEIVED AN ELECTRONIC
RESPONSE OF "FDA MAY PROCEED".

E) FDA WILL PROVIDE ASSISTANCE IN THE ABI FILERS CONSTRUCTION
OF THE PRODUCT CODE. THESE ACTIONS WILL BE TAKEN:
1) FDA WILL PROVIDE DISKETTES (UPON REQUEST) CONTAINING THE
INFORMATION FOR THE CONSTRUCTION OF THE PRODUCT CODE
(SEE ADMINISTRATIVE MESSAGE: # 1025 DATED 3/30/92)
2) FDA WILL PROVIDE A NUMBER OF INSTRUCTIONAL WORKSHOPS FOR THE
SEATTLE FILERS ON CONSTRUCTION OF THE PRODUCT CODE FROM FDA
PRINTED REPORTS.
3) FDA WILL PROVIDE A LOCAL (SEATTLE) TELEPHONE NUMBER FOR THE
PRODUCT CODE HELP DESK. AN FDA REPRESENTATIVE WILL ASSIST
ANY FILER WITH QUESTIONS REGARDING THE PRODUCT CODE
4) U.S. CUSTOMS, FDA AND THE SEATTLE IMPORTING TRADE HAVE
REACHED AN AGREEMENT WITH REGARDS TO PRECLASSIFICATION OF
THE PRODUCT CODE.

F) ANY ADDITIONAL FDA DATA PRESENT IN THE ELECTRONIC TRANSMISSION,
SUCH AS DATA IN THE FD02 OR FD03 RECORDS, WILL BE ACCEPTED BY ABI,
BUT WILL BE EDITED AND VALIDATED. A REJECT MESSAGE WILL BE SENT TO
THE FILER IF ANY OF THE DATA IS INCORRECT.

G) IF AN "FDA REVIEW" MESSAGE HAS BEEN GENERATED AS A RESULT OF
THE FDA SCREENING PROCESS, FDA WILL MANUALLY REVIEW THE ENTRY AND
PROVIDE A PROCESSING MESSAGE FOR EACH FDA LINE ITEM.
ONE ELECTRONIC PROCESSING MESSAGE WILL BE GENERATED FOR THE
THE ENTIRE ENTRY, BUT FILERS WILL ALSO RECEIVE INDIVIDUAL
PROCESSING MESSAGES FOR EACH FDA LINE ITEM AS DETAILED IN THE
ORIGINAL SPECIFICATIONS (TO BE RETURNED IN THE R6 RECORD).

H) FDA WILL NOT REJECT ANY FDA DATA WHICH HAS BEEN TRANSMITTED
THROUGH ABI AND PASSED ON TO FDA'S COMPUTER SYSTEM. THE ONLY
FDA REJECTS WILL BE GENERATED BY PEN & INK CHANGES TO
CUSTOMS DATA ELEMENTS WHICH CHANGE HARMONIZE CLASSIFICATIONS,
ALTERING THE FDA REGULATED MERCHANDISE. IN THESE INSTANCES,
THE BROKER WILL BE REQUIRED TO RETRANSMIT THE FDA INFORMATION
THROUGH THE "CP" TRANSACTION, ALLOWING THE FDA DATA TO RUN
THROUGH THE FDA SCREENING AND PROCESSING AGAIN, AS NECESSARY.

I) THE CRITERIA FOR "PAPERLESS" CUSTOM RELEASES ON FDA REGULATED
MERCHANDISE WILL BE EFFECTIVE AT THE START OF THE PILOT. DURING
THE INITIAL 2-4 WEEK EVALUATION PERIOD, THE FDA PACKAGE WILL STILL
BE REQUIRED TO BE SUBMITTED TO THE LOCAL FDA OFFICE AS STATED IN
SECTION (C). ONCE THIS EVALUATION PERIOD IS OVER, IT WILL BE
POSSIBLE FOR A BROKER TO RECEIVE A "PAPERLESS" CUSTOMS RELEASE
MESSAGE ALONG WITH AN FDA SCREENING MESSAGE OF "FDA MAY PROCEED",
WHERE NO PAPER DOCUMENTATION WILL BE REQUIRED TO BE SUBMITTED.

I) PARTICIPANTS IN THE FDA PILOT TEST WILL BE ALLOWED TO TEST
THEIR FDA SOFTWARE PROGRAMMING PRIOR TO OCTOBER 19TH BY
CONTACTING MIKE TOMS AT 202-927-1037, GARY ROTHSCHILD AT
202-927-0634 OR SEAN BRADY AT 202-927-1150.

QUESTIONS MAY BE DIRECTED TO MIKE TOMS AT 202-927-1037 OR
YOUR ABI CLIENT REPRESENTATIVE.

Referenced By

CSMS #94-000378