| Title: | FDA EXPANSION DETAILS |
|---|---|
| Date: | 1994-01-27 |
| To: | abi |
| Links: | previous, next |
DETAILS FOR THE FDA EXPANSION PORTS
-------------------------------------------
THE FDA INTERFACE WILL BE EXPANDING TO 18 US PORTS BEGINNING IN
MARCH 1994. IN THESE EXPANSION PORTS THE FDA INTERFACE WILL
OPERATE IN A MODIFIED ENVIRONMENT, COMPARED TO THE PILOT PORTS OF
SEATTLE, WA, AND PORTLAND, OR. IN THESE PORTS THERE IS A FULL SCALE
FDA INTERFACE PRESENTLY OPERATING, WITH COMPLETE INTERACTION BETWEEN
THE ABI FILERS, US CUSTOMS SERVICE (ACS) AND THE FDA. THE INTERFACE
OPERATING IN SEATTLE AND PORTLAND ALSO PROVIDES FULL PROCESSING
RESULTS ON EVERY ENTRY WHICH DOES NOT RECEIVE AN INITIAL "MAY PROCEED"
MESSAGE FROM THE ACS SCREENING FILE. THE EXPANSION TO THE NEW 18
PORTS WILL NOT BE PROGRAMMED TO PROVIDE AS MUCH DETAILED INFORMATION.
THESE 18 EXPANSION PORTS WILL OPERATE IN A MODIFIED ENVIRONMENT, THAT
BEING; ONCE THE FDA DATA HAS RUN THROUGH ACS/FDA SCREENING AND
GENERATED EITHER A "MAY PROCEED" OR AN "FDA REVIEW" MESSAGE, FDA
AUTOMATED PROCESSING IS FINISHED. THERE WILL BE NO FURTHER
PROCESSING MESSAGES GENERATED TO THE ABI FILER AFTER THIS POINT.
(EXCEPT FOR POSSIBLE REJECT MESSAGES (DT) GENERATED BY FDA).
THE FDA EXPANSION PORTS AND SCHEDULED IMPLEMENTATION DATES WERE
MENTIONED IN ADMIN MESSAGE 93-1151 DATED 12/20/93. ONLY THE FIRST
TEN INITIAL PORTS WERE LISTED, THE ADDITIONAL 8 PORTS WILL BE
PROVIDED IN A FORTHCOMING ADMIN MESSAGE. THE FIRST TEN PORTS ARE:
PORTS TARGET DATE
----------------------- --------------
- SAVANNAH & ATLANTA, GA (1703/1704) MARCH 14, 1994
- MIAMI, FL (5201/5203/5204/5206) MARCH 28, 1994
- SAN FRANCISCO, CA (2801/2809) APRIL 11, 1994
- PHILADELPHIA, PA, CHESTER, PA APRIL 25, 1994
WILMINGTON, DE (1101/1102/1103/1108)
- NEW YORK, JFK AIRPORT, NEWARK, NJ MAY 23, 1994
(1001/4701/4601)
- BOSTON, MA (0401/0417) JUNE 6, 1994
- BUFFALO, NY (0901) JUNE 20, 1994
- SAN DIEGO, OTAY MESA, CALEXICO JULY 11, 1994
(2504/2503)
>> THE PORT OF SAN DIEGO ITSELF, PORT CODE 2501,
WILL NOT BE PART OF THE FDA EXPANSION
- NOGALES, AZ (2604) JULY 25, 1994
- LOS ANGELES, CA (2704/2720) AUGUST 22, 1994
PROGRAMMING SPECIFICATIONS ARE LOCATED IN THE CUSTOMS AND TRADE
AUTOMATED INTERFACE REQUIREMENTS (CATAIR) IN THE OTHER GOVERNMENT
AGENCIES SECTION, PAGE # OGA-00-07. PLEASE REFER TO THIS SECTION
FOR DETAILED INFORMATION ON CONDITIONAL, OPTIONAL AND MANDATORY
FDA REQUIREMENTS.
* NOTE: THESE SPECIFICATIONS LISTED IN THE CATAIR DEAL SPECIFICALLY
WITH THE FULL FDA INTERFACE. SOME MINOR ALTERATIONS WILL BE
REQUIRED TO ACCOMODATE THE FDA INTERFACE IN THESE EXPANSION PORTS.
HOW THE FDA INTERFACE WILL OPERATE IN THE EXPANSION PORTS
---------------------------------------------------------
1) ABI FILER WILL TRANSMIT THE FDA DATA IN EITHER THE (EI) ENTRY
SUMMARY, (HI) CARGO RELEASE, OR (HN) BORDER CARGO RELEASE
TRANSACTIONS.
* FURTHER BORDER CARGO RELEASE INFORMATION WILL BE ADDRESSED
IN A LATER ADMINISTRATIVE MESSAGE.
2) FDA DATA IS PROCESSED THRU THE ACS/FDA SCREENING FILE, GENERATING
EITHER A "MAY PROCEED" OR "FDA REVIEW" TO THE ABI FILER. THIS
OCCURS AT THE SAME TIME OF ACS SELECTIVITY USING THE SAME TIME
PARAMETERS.
3) FILER CAN TRANSMIT THE FDA DISCLAIMER IN THE "OA" RECORD
WHEN APPROPRIATE.
4) IF THE FILER RECEIVES A "MAY PROCEED" FROM THE ACS/FDA SCREENING
PROCESS, FDA HAS DETERMINED THERE IS NO NEED FOR FURTHER
EXAMINATION OR PROCESSING. IF THE FILER WAS OFF THE DUAL MODE *
OF PAPER PROCESSING, NO FDA DOCUMENTATION WOULD BE REQUIRED.
* IN THE BEGINNING OF EACH PORT'S FDA EXPANSION, THE ABI FILER
WILL BE REQUIRED TO SUBMIT ALL FDA PAPERWORK, REGARDLESS OF THE
ACS/FDA SCREENING RESULTS, TO THE LOCAL FDA OFFICE. THIS DUAL
PROCESSING MODE WILL BE IN EFFECT UNTIL FDA IS SATISFIED WITH
THE ACCURACY OF THE ELECTRONIC DATA FROM THE FILER. THIS WILL
BE DETERMINED ON A CASE BY CASE BASIS.
5) IF THE FILER RECEIVES AN "FDA REVIEW" FROM THE ACS/FDA SCREENING
PROCESS, FOR ALL PRACTICAL PURPOSES THAT ENTRY SHOULD BE
CONSIDERED NON-FDA-AUTOMATED, ALL FURTHER FDA PROCESSING WILL
BE DONE VIA PAPER DOCUMENTATION.
PAPER REQUIREMENTS: FDA FORM 701 VS. 3461 AND INVOICE WILL BE
ADDRESSED BY FDA HEADQUARTERS AT EACH PORTS
TRAINING SESSIONS.
6) NO ADDITIONAL FDA PROCESSING MESSAGES WILL BE GENERATED TO
THE ABI FILER AFTER THE ACS/FDA SCREENING PROCESS. THIS IS
THE MAIN DIFFERENCE BETWEEN THE FDA EXPANSION PORTS AND THE
FDA INTERFACE OPERATING IN THE PORTS OF SEATTLE, PORTLAND
AND BLAINE, WA. IN EACH OF THESE PORTS, FDA RESPONDS TO THE
FILER WITH ADDITIONAL PROCESSING MESSAGES, SUCH AS, "DO NOT
DEVAN, FDA SAMPLE, FDA RELEASED, ETC.", AT THE ENTRY LEVEL
AND AT THE LINE LEVEL. THE ABI FILER IN EACH EXPANSION PORT
WILL RECEIVE "MAY PROCEED" OR "FDA REVIEW" MESSAGES AT THE
ENTRY LEVEL ONLY, NO ADDITIONAL INFORMATION WILL BE RETURNED
TO THE FILER.
NOTE: FDA WILL AUTOMATICALLY REJECT SOME ENTRIES UNDER CERTAIN
CONDITIONS. THIS IS ADDRESSED BELOW.
7) THE AUTOMATIC REJECTION POLICY WHICH FDA HAS PROGRAMMED
IN THEIR SYSTEM FOR THESE EXPANSION PORTS IS THE SAME
POLICY THAT PRESENTLY OPERATES IN SEATTLE, PORTLAND AND
BLAINE, WA. THERE IS NO CHANGE.
LISTED BELOW ARE THE SCENARIOS WHICH CAUSE FDA TO GENERATE AN
AUTOMATIC REJECT (DT) TO THE ABI FILER:
A) A CUSTOMS PEN & INK CHANGE INITIATED BY THE FILER
TO CERTAIN CUSTOMS DATA, SPECIFICALLY A HARMONIZED
NUMBER FLAGGED FOR FDA REGULATION, REGARDLESS OF THE
ACS/FDA SCREENING RESULTS.
B) AN ENTRY THAT HAS RECEIVED AN "FDA REVIEW" MESSAGE FROM
ACS/FDA SCREENING AND INCLUDES DATA ELEMENTS WHICH FDA
HAS PREDETERMINED AS UNACCEPTABLE. (IE. FOREIGN BASED
CONSIGNEE, FOREIGN BASED IMPORTER OF RECORD)
NOTE: FDA CANNOT REJECT AN ENTRY WHICH HAS RECEIVED A
"MAY PROCEED" AND NO PEN AND INK CHANGE HAS OCCCURED.
8) IN EVERY REJECT SCENARIO, THE ABI FILER IS RESPONSIBLE FOR
CORRECTION OF THE INVALID FDA DATA OR THE ADDITION OF NEW FDA
DATA AND RETRANSMISSION OF THIS DATA THROUGH THE "CP"
APPLICATION. THE FDA REJECT MESSAGE (DT) GENERATED TO THE
FILER SIMPLY READS "FDA REJECT". IT IS THE FILERS RESPONSIBILITY
TO FOLLOW EVERY "DT" REJECT MESSAGE THEY RECEIVE WITH A "CP"
CORRECTION TRANSMISSION.
9) EVERY "CP" TRANSMISSION IS RUN THROUGH THE ACS/FDA SCREENING
PROCESS AND SIMILIAR TO THE ORIGINAL TRANSMISSION OF THE
FDA DATA; A "MAY PROCEED" OR AN "FDA REVIEW" MESSAGE WILL BE
GENERATED TO THE FILER AND TO FDA. AT THIS POINT, THE FILER
FOLLOWS THE SAME INSTRUCTIONS AS ORIGINALLY STATED.
10) THE FILER IS REQUIRED TO GENERATE THE CORRECT FDA PRODUCT CODE.
THIS PRODUCT CODE IS A MANDATORY DATA ELEMENT IN THE FDA RECORDS.
FDA WILL PROVIDE ASSISTANCE IN TRAINING AND THE CONSTRUCTION OF
OF THE PRODUCT CODE. IN EACH EXPANSION PORT, FDA WILL SCHEDULE
TRAINING SESSIONS DEVOTED ENTIRELY TO THE CONSTRUCTION OF THE
PRODUCT CODE.
11) THE FILERS PARTICIPATING IN THESE EXPANSION PORTS MUST HAVE
THE PROGRAMMING CAPABILITIES LISTED IN THE CATAIR, INCLUDING
ALL QUERY CAPABILITIES SUCH AS, BUT NOT LIMITED TO; AFFRIMATION
OF COMPLIANCE, FEI NUMBER, PRODUCT CODE, AND EXTRA EMPHASIS
ON THE OGA CORRECTION CAPABILITY "CP" APPLICATION.
12) PARTICIPATION IN ALL THE EXPANSION PORTS IS VOLUNTARY, BUT
THE US CUSTOMS SERVICE AND FDA STRONGLY ENCOURAGE YOUR
PARTICIPATION. AT SOME LATER DATE WE EXPECT TO CHANGE THESE
EXPANSION PORTS TO FULL FDA PROCESSING PORTS, SIMILIAR TO THE
INTERFACE WHICH PRESENTLY OPERATES IN SEATTLE, WA. PROPER
TIME NOTIFICATION WILL BE PROVIDED TO ALL CONCERNED PARTIES.