CSMS Message: 03-002812

TO: ALL ABI FILERS AND INTERESTED PARTIES

ABI AVAILABILITY OF FDA BIOTERRORISM ACT (BTA) PRIOR NOTICE SOFTWARE IN
ACS.

PLEASE REFER TO ADMINISTRATIVE MESSAGES 03-2540 (OCTOBER 24, 2003),
03-2619 619 (OCTOBER 27, 2003) AND 03-2625 (NOVEMBER 4, 2003).

THE BIOTERRORISM ACT OF 2002 (BTA) GOES INTO EFFECT ON FRIDAY, DECEMBER
12, 2003. CERTAIN MERCHANDISE (MOSTLY FOOD AND FOOD PRODUCTS) MARKED BY
FD3 (BTA PRIOR NOTICE/FDA CLEARANCE MAY BE REQUIRED) OR FD4 (BTA PRIOR
NOTICE/FDA CLEARANCE IS REQUIRED) IN THE HARMONIZED TARIFF RECORD WILL
REQUIRE THAT PRIOR NOTICE DATA BE SENT IN ADDITION TO THE FDA SPECIFIC
DATA ALREADY REQUIRED.

THE BTA PRIOR NOTICE SOFTWARE FOR THE CUSTOMS PORTION WILL BE LOADED
INTO ACS DURING THE REGULARLY SCHEDULED DOWNTIME SATURDAY EVENING -
SUNDAY MORNING, DECEMBER 6-7, 2003 AND WILL BE AVAILABLE WHEN THE SYSTEM
COMES UP ON SUNDAY, DECEMBER 7, 2003. THE FDA PORTION OF THE SOFTWARE
WILL BE LOADED INTO THE FDA SYSTEM ON WEDNESDAY EVENING, DECEMBER 10,
2003, OR THURSDAY EVENING DECEMBER 11, 2003. THE COMPLETE SYSTEM MAY
BE AVAILABLE ON DECEMBER 11, 2003, BUT DEFINITELY WILL BE AVAILABLE
ON OR AFTER DECEMBER 12, 2003

DURING THE FIRST PHASE OF THE OPERATIONAL SYSTEM, CBP WILL PERFORM
BASIC EDITS AND VALIDATIONS FOR PN DATA (VALID PORT CODE,
COUNTRY CODE, DATE FORMAT, ETC.) SUBMITTED THROUGH ABI USING APPLICATION
IDENTIFIERS HI, HN, EI AND WP AS SPECIFIED IN THE ABOVE LISTED
ADMINISTRATIVE MESSAGES. MISSING PN DATA WILL GENERATE WARNING MESSAGES
THAT WILL BE SENT BACK TO THE FILER. PRIOR NOTICE DATA WILL BE
SENT TO FDA WHEN IT IS RECEIVED, BUT THE ABI FILER WILL NOT RECEIVE FDA PN
PN ERROR WARNING MESSAGES, PRIOR NOTICE RECEIVED MESSAGES, OR THE PRIOR
NOTICE CONFIRMATION NUMBER UNTIL POSSIBLY DECEMBER 11, 2003 BUT WILL
DEFINITELY RECEIVE THEM ON AFTER DECEMBER 12, 2003. BTA PRIOR NOTICE
ENTRIES, IN-BOND, AND OTHER TRANSACTIONS WILL BE PROCESSED AS DIRECTED
BY THE CBP OFFICE OF FIELD OPERATIONS AND THE FDA OFFICE OF REGULATORY
AFFAIRS, DIVISION OF IMPORT OPERATIONS AND PROCEDURES (DIOP). PLEASE
NOTE THAT THE DEFAULT DATES FOR THE DETERMINATION OF DUTY/FEE VALIDATION
REMAIN THE SAME AS DESCRIBED IN THE ENTRY SUMMARY CHAPTER OF THE
CUSTOMS AND TRADE AUTOMATED INTERFACE REQUIREMENTS (CATAIR).

PLEASE NOTE THERE ARE TWO AFFIRMATION OF COMPLIANCE CODES ON THE WP
TRANSACTION THAT WERE NOT MENTIONED AS PART OF THE PREVIOUS
ADMINISTRATIVE MESSAGE. THEY ARE:

IMN IMPORTER NUMBER
CON CONSIGNEE NUMBER

THE IMPORTER NUMBER IS A REQUIRED DATA ELEMENT FOR PRIOR NOTICE
IN THE WP TRANSACTION AND MUST BE A VALID NUMBER IN THE SPECIFIED
FORMAT IN THE CATAIR. THE CONSIGNEE NUMBER, IF SUBMITTED, MUST BE A
VALID CONSIGNEE NUMBER IN THE SPECIFIED FORMAT IN THE CATAIR.

CUSTOMS AND FDA WILL NOTIFY THE ABI FILERS AS TO THE DATE AND TIME
THE WARNING WILL BE CHANGED TO FATAL ERRORS.

IF YOU HAVE ANY QUESTIONS, PLEASE CALL YOUR ASSISNED CLIENT
REPRESENTATIVE.

FOLLOWING IS A LIST OF QUESTIONS ASKED BY THE ABI FILERS AND THEIR
RESPONSES:

1. WE HAVE SOME CONFLICTING INFORMATION ON WHEN PRIOR NOTICES CAN BE
BE SUBMITTED.

THE "FDA PRIOR NOTICE REQUIREMENTS USING THE CURRENT CUSTOMS FDA
INTERFACE DOCUMENT (FOR ENTRY) SAYS THIS ON PAGE 10: "IF FDA PN ENTRIES
AGAINST AN FD0, FD1, FD2, OR NO FD MARKER IN THE TARIFF RECORD, REJECT
THE THE ENTRY AND DISPLAY THE ERROR MESSAGE "FDA PRIOR NOTICE NOT
REQUIRED". WE INTERPRETED THIS TO MEAN THAT WE SHOULD ONLY ALLOW
USERS TO SEND PRIOR NOTICE INFORMATION TO ABI ON TARIFF NUMBERS FLAGGED
WITH AN FD3 OR FD4 MARKER.

BUT, ON THE FDA WEBSITE, IN THE DOCUMENT THAT LISTS TARIFF NUMBERS
FLAGGED WITH PRIOR NOTICE INDICATORS, IT SAYS THIS: "THE ABSENCE OF AN
FD FLAG DOES NOT MEAN THAT PRIOR NOTICE FOR AN FDA REGULATED ARTICLE OF
OF FOOD IS NOT REQUIRED". THIS WOULD INDICATE THAT USERS MIGHT NEED TO
SUBMIT A PRIOR NOTICE FOR A TARIFF NUMBER NOT FLAGGED WITH FD3 OR FD4.

CAN YOU TELL US WHICH IS CORRECT?

ANSWER: IF THE BROKER HAS KNOWLEDGE OF THE USE OF A COMMODITY THAT
WOULD WARRANT PN, THEY ARE REQUIRED TO SUBMIT THE INFORMATION EVEN
IF THE TARRIF NUMBER IS NOT FLAGGED FD3 OR FD4. HOWEVER, CUSTOMS
WOULD REJECT THIS INFORMATION IF SENT ELECTRONICALLY. CUSTOMERS SHOULD
ENTER THIS INFORMATION ON THE FDA WEB SITE UNDER THIS CIRCUMSTANCE.

2. MASTER BOL (BILL OF LADING) SURFACE SHOWS AS CONDITIONAL. WHAT ARE
THE CONDITIONS? WHAT MODE(S) OF TRANSPORTATION IS THIS FIELD FOR?
20,21,30,31? (10,11,12?)

ANSWER: PROVIDE THE BILL OF LADING NUMBER IF IT EXISTS.
IT IS VALID FOR ALL SURFACE MODES OF TRANSPORTATION. IF THERE IS
MORE THAN ONE BILL OF LADING, PROVIDE THE B/L NUMBER IN MULTIPLE
AFFIRMATION OF COMPLIANCE FIELDS, ONE FOR EACH AFFIRMATION OF
COMPLIANCE. THE AFFIRMATION OF COMPLIANCE CODE FOR BILL OF LADING IS BOL
AIR HAS ITS OWN AFFIRMATION OF COMPLIANCE CODES FOR AIR WAYBILLS, AWB
AND AWH.

3. WHEN YOU CALL CUSTOMS AND CANCEL THE ENTRY BECAUSE YOU NEED TO MAKE
PN CHANGES AND WILL THIS CANCEL ALL THE PN'S FOR THAT ENTRY AT FDA?

ANSWER: IF THE FILER CALLS TO CANCEL A PN ENTRY, CBP WILL CANCEL THE
ENTRY IN ACS AND CALL FDA. THE FILER MUST PROVIDE THE CORRECTED
INFORMATION ON A NEW PRIOR NOTICE. THE PN PROCESS BEGINS AGAIN.

4. WHEN CANCELING THE ENTRY DO WE RECEIVE A MESSAGE VIA ABI?

ANSWER: YES. ACS WILL CONTINUE TO TRANSMIT THE
THE "ENTRY CANCELLED" MESSAGE. (REFER TO THE CARGO RELEASE
CHAPTER OF THE CATAIR, NOTE 1 AFTER THE R5 RECORD.)

5. DOES CBP/FDA ANTICIPATE BEING ABLE TO CANCEL/CORRECT PN'S VIA ABI IN
FUTURE?

ANSWER: CUSTOMS IS GOING TO LOOK INTO THE POSSIBILITY OF USING THE OGA
CORRECTION TRANSACTION SET TO CORRECT PN'S (DT). THERE IS NO PLAN TO ALL
ALLOW ELECTRONIC CANCELLATIONS. CANCELLATION PROBABLY MEANS DELETE THE
ENTRY. IN THIS CASE, A NEW ENTRY WITH THE PRIOR NOTICE INFORMATION WILL
NEED TO BE CANCELLED IF APPLICABLE. IT IS NOT CLEAR WHETHER NEW PN'S
WILL BE REQUIRED ON ON THE CORRECTED ENTRY.

6. CAN A PN ENTERED VIA ABI BE CANCELED/CORRECTED ON THE WEB?

ANSWER: NOT ACCORDING TO THE REGULATIONS.

7. WHEN WILL THE WEB SITE BE AVAILABLE FOR FILING THE FDA PN?

ANSWER: THE WEB SITE HAS BEEN COMPLETED AND TESTED. BUT, IT IS NOT YET
AVAILABLE FOR USERS.

8. WHAT ACTIONS WILL BE TAKEN BY CUSTOMS AND FDA, STARTING ON DEC 12, IF
A PRIOR NOTICE IS NOT FILED FOR AN ITEM THAT SHOULD HAVE A PN?

ANSWER: THERE IS A "PHASE IN PERIOD" OF UNDETERMINED DURATION. DURING
THIS TIME, CUSTOMS WILL NOT STOP SHIPMENTS FOR FAILURE TO SUBMIT PN.
THIS IS AN INITAL PERIOD OF ENFORCEMENT DISCRETION DURING WHICH
SHIPMENTS WILL NOT BE REFUSED SOLELY DUE TO INADEQUATE PRIOR NOTICE
OR HELD AT THE BORDER FOR LACK OF REGISTRATION BY A FOREIGN FOOD
FACILITY REQUIRED TO REGISTER. FDA WILL BE ISSUING A COMPLIANCE
POLICY GUIDE EXPLAINING THEIR ENFORCEMENT POLICY DURING THIS INTIAL
PERIOD.

9. WHAT ACTIONS WILL BE TAKEN BY CUSTOMS AND FDA, STARTING ON DEC 12, IF
PRIOR NOTICE HAS BEEN FILED LATE?

ANSWER: THERE IS AN INITIAL PERIOD OF ENFORCEMENT DISCRETION. THERE ARE
NO EDITS ON THE TIMING DURING THIS PERIOD.

10. WHAT IS THE EXPECTED IMPACT IN THE PROCESSING TIME OF ENTRIES AND
RELEASES BECAUSE OF THE EXTRA COMMUNICATIONS WITH FDA?

ANSWER: NO STRESS TESTING HAS BEEN DONE. SEE ABOVE UNDER "OTHER
IMPORTANT INFORMATION".

11. CAN THE STATUS OF A PN, SUBMITTED VIA ACS, BE CHECKED ON THE FDA WEB
SITE?

ANSWER: NO.

12. IF WE RECEIVE A PN CONFIRMATION ON THE WEB SITE AND THEN ENTER A
TARIFF LINE THAT HAS AN FD04 INDICATOR, WHAT HAPPENS IF THE CONFIRMATION
NUMBER IS NOT SENT? OR, WHAT IF WE FAT FINGER THE CONFIRMATION
NUMBER AND SEND THE WRONG ONE?

ANSWER: LACK OF PN WILL CAUSE A REJECT. THERE IS NO WAY TO CHECK TO SEE
IF THE CONFIRMATION NUMBER IS THE CORRECT ONE. IT MIGHT GET CAUGHT IN A
POST ENTRY AUDIT.

13. AN AIRPLANE BOUND FOR SEATTLE WASHINGTON STOPS TO REFUEL IN ANCHORAGE
ANCHORAGE, ALASKA. NO GOODS ARE REMOVED FROM THE PLANE UNTIL IT LANDS
IN SEATTLE. WHICH IS THE THE PORT OF ARRIVAL FOR FDA PN PURPOSES,
SEATTLE OR ANCHORAGE?

ANSWER: THE PORT FOR FDA PN PURPOSES IS SEATTLE.

14. IS IT ALL OR NONE FOR ACCEPT/REJECT OF PN'S FOR A SHIPMENT?
OR CAN SOME PN'S ON A SHIPMENT BE ACCEPTED WHILE OTHERS ARE REJECTED?

ANSWER: ACCEPT/REJECT IS AT THE FDA LINE LEVEL.

15. THIS QUESTION CONCERNS THE BN PRIOR NOTICE RESULTS TRANSACTION. ON
THE BN02 RECORD, (ONE OF WHICH IS RETURNED FOR EACH PRIOR NOTICE LINE
ITEM ON THE ENTRY) YOU ARE RETURNING A 'PRIOR NOTICE LINE MESSAGE". THE
DESCRIPTIION SAYS "PRIOR NOTICE LINE LEVEL MESSAGE FROM FDA, SUCH AS
"PRIOR NOTICE RECEIVED" OR "PRIOR NOTICE SATISFIED". FREE FORM". WHAT
IS THE DIFFERENCE BETWEEN 'RECEIVED' AND 'SATISFIED'?

ANSWER: PRIOR NOTICE RECEIVED STARTS THE CLOCK AND RETURNS THE
CONFIRMATION NUMBER. THE PRIOR NOTICE "SATISFIED" MESSAGE IS NOT SENT
TO THE ABI FILER.

16. WHY IS THERE NO REQUIREMENT TO REPORT BILL OF LADING INFORMATION FOR
OCEAN SHIPMENTS? CURRENTLY WE ONLY REPORT BILL OF LADING INFORMATION
FOR SURFACE (TRUCK AND RAIL) AND AIR.

ANSWER: WE MISREAD THE REGULATIONS. IT IS REQUIRED.

17. WHAT HAPPENS IF THE MANUFACTURER/SHIPPER DOES NOT HAVE A
REGISTRATION NUMBER?

ANSWER: AFTER THE DISCRETIONARY ENFORCEMENT PERIOD, IT WILL BE
REJECTED. THE MANUFACTURER/SHIPPER NEEDS TO GET ONE
IF THEY ARE REQUIRED TO REGISTER, THEN NOTIFY THE BROKER.

18. WILL THE REGISTRATION NUMBER BE ADDED TO THE MID QUERY RESULTS?
IF SO, WHEN, IF NOT, HOW CAN THESE NUMBERS BE QUERIED?

ANSWER: NO. FDA TREATS THIS AS CONFIDENTIAL INFORMATION.

19. HOW ARE MULTIPLE PN CONFIRMATION NUMBERS ISSUED VIA WP RETURNED TO
THE? ARE MULTIPLE PN CONFIRMATION NUMBERS IN ONE BATCH TIED TO THE
ENVELOPE UMBER OR INDIVIDUALLY? HOW ARE THEY LINKED?

ANSWER: THE WP TRANSACTION IS TIED TOGETHER BY ONE OF THE FOLLOWING
NUMBERS: AIR WAYBILL, ENTRY, INBOND, BILL OF LADING, FOR FOREIGN
TRADE ZONE (FTZ) ADMISSION NUMBER. THE PN CONFIRMATION NUMBER IS
CONTAINED IN THE BN02 RECORD. THERE MAY BE AS MANY BN02 RECORDS
FOR A GIVEN TRANSACTION AT THE FDA LINE LEVEL AS NECESSARY.

20. WHAT BN MESSAGES ARE RETURNED FOR PN INFORMATION SUBMITTED THROUGH
THE WP TRANSACTION?

ANSWER: IF FDA DETECTS AN ERROR IN THE PN TRANSACTION, ONE OR MORE OF
THE FOLLOWING MESSAGES WILL APPEAR:

"F" - FOREIGN CONSIGNEE, "R" - INVALID REGISTRATION, "Q" - INVALID
QUANTITY, "M" - BAD MID FOR MANUFACTURER, "S" - BAD MID FOR SHIPPER,
"I" - BAD ESS FOR IMPORTER, "C" - BAD ESS FOR CONSIGNEE,
"Z" - INVALID STATE/ZIP FOR US MANUFACTURER, "O" - INVALID COUNTRY OF
ORIGIN, "S" - INVALID COUNTRY OF SHIPPING

STATUS MESSAGES ARE AS FOLLOWS:

PRIOR NOTICE REJECT
PRIOR NOTICE RECEIVED
PN CONFIRMATION NUMBER NNNNNNNNNNNN

MAKING CHANGES TO PRIOR NOTICE DATA FOR AN ENTRY (ENTRY SUMMARY, CARGO
RELEASE OR BORDER CARGO RELEASE, APPLICATIONS EI, HI AND HN
RESPECTIVELY).

CUSTOMS ACS WILL PERFORM CERTAIN EDITS AND VALIDATIONS ON DATA ELEMENTS
ELEMENTS FOR BOTH FDA PRIOR NOTICE AND FDA SPECIFIC DATA AS WELL AS
CUSTOMS DATA ELEMENTS WHEN THE FILER TRANSMITS THE ENTRY TO ACS THROUGH
ABI. IF ONE OR MORE DATA ELEMENTS FAIL TO PASS THE EDITS AND
VALIDATIONS, ACS REJECTS THE ENTRY AND SENDS AN ERROR MESSAGE
BACK TO THE FILER INDICATING WHICH DATA ELEMENT(S) IS/ARE IN ERROR.
THE FILER CAN SUBMIT CORRECTED DATA AT ANY TIME, THE SOONER THE BETTER.
CUSTOMS ACS ACCEPTS ONLY ERROR FREE ENTRIES. CUSTOMS TRANSMITS ONLY
ERROR FREE ENTRIES TO FDA.

DATA, INCLUDING PRIOR NOTICE DATA, CAN BE CHANGED AT ANY TIME ON
ANY ENRY NOT CERTIFIED FOR CARGO RELEASE. DATA, INCLUDING PRIOR
NOTICE DATA, CAN BE CHANGED ON AN ENTRY UP TO THE TIME ACS
PROCESSES THE ENTRY THROUGH CARGO RELEASE. CUSTOMS TRANSMITS
ERROR FREE FDA SPECIFIC ENTRIES, INCLUDING PRIOR NOTICE ENTRIES
TO FDA.

IF FDA FINDS (AN) ERROR(S) IN THE PRIOR NOTICE ENTRY, FDA WILL
REJECT THE ENTRY TO BACK TO CUSTOMS AT THE LINE LEVEL WITH THE
APPROPRIATE ERROR MESSAGE. CUSTOMS FORWARDS THE ERROR MESSAGE
TO THE ABI FILER FOR CORRECTION AT THE LINE LEVEL IN A NEW
APPLICAITON IDENTIFIED AS "BN". DURING THE FIRST PHASE, FDA
WILL NOT BE TRANSMITTING ERROR MESSAGES TO THE FILER.
FDA WILL KEEP TRACK OF THE ERRORS AND NOTIFY THE ABI
FILER OUTSIDE OF ACS OF CONTINUAL AND EGREGIOUS ERRORS.
FDA WILL BEGIN TO SEND ERROR MESSAGES TO CUSTOMS FOR TRANSMITTAL
TO THE FILER THROUGH ABI AT A LATER TIME.

AT THIS TIME THERE IS NO AUTOMATED MECHANISM TO MAKE
CHANGES TO A PRIOR NOTICE ENTRY ONCE ACS PERFORMS CARGO SELECTIVITY
PROCESSING IF A FILER NEEDS TO CHANGE DATA TO A PRIOR NOTICE ENTRY AFTER
ACS PERFORMS CARGO RELEASE PROCESSING, THE FILER MUST CONTACT CUSTOMS TO
CANCEL THE ENTRY. THE ABI FILER MUST RESUBMIT THE CORRECTED
DATA UNDER A NEW ENTRY NUMBER. IN THE FUTURE,
CUSTOMS AND FDA PLAN TO MODIFY THE ENTRY REJECT - CORRECTION
CAPABILITY (APPLICATIONS DT AND CP) TO PROCESS
ERRORS AT THE CBP AND FDA LINE LEVEL.

CUSTOMS AND FDA WILL CONTINUE TO PROCESS ERRORS FOR ROUTINE
FDA SPECIFIC ENTRIES USING THE CURRENT ENTRY REJECT -
CORRECTION CAPABILITY (APPLICATIONS DT AND CP).

CHANGES TO PRIOR NOTICE TRANSACTIONS OTHER THAN ENTRY.

THERE IS NO AUTOMATED MECHANISM TO PROCESS PRIOR NOTICE DATA CHANGES
PN TRANSACTIONS OTHER THAN ENTRIES (APPLICATION WP).
CONTACT FDA FOR DETAILS ON MAKING CHANGES TO PRIOR NOTICE
DATA SUBMITTED FOR TRANSACTION OTHER THAN ENTRY.