CSMS Message: 03-002619

Title:FDA/BTA CHANGES FOR 'HI', 'HN', AND 'EI' TRANSACTIONS
Date:2003-11-04
To:abi
Links:previous, next

THE CURRENT 'HI' (CARGO RELEASE), 'HN' (BORDER CARGO RELEASE), AND 'EI'
(ENTRY SUMMARY) ABI TRANSACTIONS HAVE BEEN MODIFIED TO ACCEPT THE NEW
FDA/BTA PRIOR NOTICE DATA FOR FOODS. PLEASE NOTE THAT FOR THE 'EI',
THIS IS APPLICABLE ONLY TO ENTRY SUMMARIES CERTIFIED FOR CARGO RELEASE.

INPUT DATA REQUIREMENTS FOR FDA/BTA:

IN ORDER TO MINIMIZE THE IMPACT ON ABI FILERS, THE CURRENT OGA RECORD
FORMATS WILL BE UTILIZED. FOR FDA-SPECIFIC DATA, THE CURRENT 'OI' AND
'FD01' THROUGH 'FD05' RECORDS WILL BE USED. FDA/BTA PRIOR NOTICE DATA
WILL BE SUBMITTED AS REQUIRED UTILIZING NEW AFFIRMATIONS OF COMPLIANCE
AND ASSOCIATED AFFIRMATION OF COMPLIANCE QUALIFIERS IN THESE RECORDS.
THIS MEANS THAT THE PRIOR NOTICE DATA CAN BE SUBMITTED WITH THE CURRENT
FDA-SPECIFIC DATA IN THE SAME 'OI' AND 'FD01' THROUGH 'FD05' RECORDS.
SINCE MUCH OF THE CURRENT FDA-SPECIFIC DATA IS ALSO USED FOR PRIOR
NOTICE, ONLY THE ADDITIONAL DATA SPECIFIC TO PRIOR NOTICE WILL NEED TO
BE ADDED VIA THE AFFIRMATIONS OF COMPLIANCE.

YOUR ATTENTION IS DIRECTED TO ADMINISTRATIVE MESSAGE 03-2540, DATED
OCTOBER 24, 2003, WHICH PROVIDED INFORMATION RELATIVE TO THE NEW FD3
AND FD4 INDICATORS IN THE HARMONIZED TARIFF FILE IN ACS.THE FD3
INDICATOR APPLIES TO ITEMS WHICH MAY REQUIRE CURRENT FDA REPORTING AS
WELL AS NEW FDA/BTA PRIOR NOTICE DATA.

IF AN ITEM OF IMPORTED MERCHANDISE CLASSIFIED WITH AN FD3 TARIFF
MARKER IS DISCLAIMED (MEANING THAT FDA REPORTING IS NOT REQUIRED), NO
PRIOR NOTICE DATA FOR FDA/BTA IS REQUIRED AND THE 'OA' RECORD INDICATING
AN 'FD0' DISCLAIM IN THE 'OA' RECORD WILL BE ACCEPTED AS APPLYING TO
BOTH THE CURRENT FDA COMPLIANCE DATA AS WELL AS THE PRIOR NOTICE DATA.
IF FDA COMPLIANCE DATA IS REQUIRED, THE CURRENT PROCEDURE USING THE
'OI' AND 'FD01' THROUGH 'FD05 RECORDS WILL BE USED AND PRIOR NOTICE
DATA WILL BE PROVIDED USING ONE OR MORE (AS NEEDED) OF THE NEW
AFFIRMATION OF COMPLIANCE INDICATORS AND QUALIFIERS DESCRIBED BELOW.

FOR ITEMS WITH AN FD4 INDICATOR IN THE HARMONIZED TARIFF RECORD, BOTH
FDA COMPLIANCE AND FDA/BTA PRIOR NOTICE DATA WILL BE REQUIRED UTILIZING
THE CURRENT 'OI' AND 'FD01' THROUGH 'FD05' REPORTING RECORDS. THE NEW
PRIOR NOTICE DATA WILL LIKEWISE BE REPORTED USING ONE OR MORE (AS
NEEDED) OF THE NEW AFFIRMATION OF COMPLIANCE INDICATORS AND QUALIFIERS
DESCRIBED BELOW.

THE NEW AFFIRMATIONS OF COMPLIANCE AND ASSOCIATED QUALIFIERS APPLICABLE
TO FDA/BTA PRIOR NOTICE DATA ARE AS FOLLOWS. PLEASE NOTE THAT ALL
QUALIFIERS IN THE CURRENT RECORDS ARE A MAXIMUM OF 25X CHARACTERS. THOSE
QUALIFIERS REQUIRING SPECIFIC INPUT DATA (E.G. - VALID PORT CODE)
HAVE BEEN IDENTIFIED. LIKEWISE, ALL MANDATORY/CONDITIONAL CODES AND
QUALIFIERS HAVE BEEN IDENTIFIED:

AFFIRMATION CODE QUALIFIER

PNC PRIOR NOTICE CONFIRMATION. DATA ALREADY
SUBMITTED TO FDA. THIS QUALIFIER
WILL CONSIST OF THE FDA/BTA
CONFIRMATION NUMBER PROVIDED BY FDA.
IF USED, THIS CODE AND QUALIFIER MUST
BE LISTED IN THE 'FD01' RECORD AS THE
FIRST AFFIRMATION.

SLN SUBMITTER LAST NAME. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED. MAY BE DIFFERENT
FROM CONTACT NAME IN 'FD04' RECORD. IF
CODE 'PNC' NOT USED, THIS CODE MUST BE
LISTED IN THE 'FD01' RECORD AS THE
FIRST AFFIRMATION.

SFN SUBMITTER FIRST NAME. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED. MAY BE DIFFERENT
FROM CONTACT NAME IN 'FD04' RECORD.

SPN SUBMITTER PHONE NUMBER. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED. MAY BE DIFFERENT
FROM CONTACT PHONE NUMBER IN 'FD04' REC.

SFX SUBMITTER FAX NUMBER. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED. IF NONE, ZERO
FILL.

SEM SUBMITTER EMAIL ADDRESS. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED. IF NONE, ENTER
"NONE" (WITHOUT QUOTES).

SCN SUBMITTER FIRM NAME. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED.

SA1 LINE 1 OF SUBMITTER ADDRESS. MANDATORY IF
CODE 'PNC' HAS NOT BEEN USED.

SA2 LINE 2 OF SUBMITTER ADDRESS. OPTIONAL. USE
ONLY AS NEEDED.

SAC SUBMITTER ADDRESS CITY. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED.

SAS SUBMITTER STATE CODE OR CANADIAN PROVINCE
CODE. IF A COUNTRY OTHER THAN U.S. OR
CANADA, USE 'FN'. MANDATORY IF CODE 'PNC'
HAS NOT BEEN USED.

SCZ SUBMITTER ZIP CODE OR MAIL CODE. MANDATORY
IF CODE 'PNC' HAS NOT BEEN USED.

SCC SUBMITTER COUNTRY CODE (ISO CODE).
MANDATORY IF CODE 'PNC' HAS NOT BEEN USED.

SFT SUBMITTER FIRM TYPE. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED. MUST BE 'M' IF
MANUFACTURER/PRODUCER, 'S' IF SHIPPER,
'C' IF CARRIER, 'I' IF IMPORTER, 'U' IF
CONSIGNEE, 'F' IF FILER OR AGENT.

OFT OWNER FIRM TYPE. MANDATORY IF CODE 'PNC'
HAS NOT BEE USED. MUST BE 'M' IF
MANUFACTURER, 'C' IF CARRIER, 'I' IF
IMPORTER, 'U' IF CONSIGNEE.

APA ANTICIPATED PORT OF ARRIVAL. USE VALID
DDPP CODE. MANDATORY IF CODE 'PNC' HAS
NOT BEEN USED.

ADA ANTICIPATED DATE OF ARRIVAL. IN MMDDYYYY
FORMAT. MANDATORY IF CODE 'PNC' HAS NOT
BEEN USED.

ATA ANTICIPATED TIME OF ARRIVAL. IN HHMM
FORMAT USING 24 HOUR CLOCK. MANDATORY IF
CODE 'PNC' HAS NOT BEEN USED.

APC ANTICIPATED POINT OF CROSSING. TO BE USED
FOR PORTS WITH MULTIPLE CROSSING POINTS,
SUCH AS BUFFALO AND DETROIT. TEXTUAL
INPUT OF NAME (E.G. - PEACE BRIDGE)

CSH COUNTRY OF SHIPPING. MANDATORY IF CODE
'PNC' HAS NOT BEEN USED. USE ISO COUNTRY
CODE.

VFT VOYAGE, TRIP, FLIGHT NUMBER. CONDITIONAL
AS APPLICABLE BY MODE OF TRANSPORT.

CAN COMMON CARRIER NAME. CONDITIONAL AS
APPLICABLE, IF IMPORTED VIA COMMON
CARRIER.

CCN COMMON CARRIER COUNTRY. USE ISO COUNTRY
CODE. CONDITIONAL AS APPLICABLE.

CNO CONTAINER NUMBER. FOR CONTAINERIZED CARGO.
CONDITIONAL AS APPLICABLE.

RNO RAIL CAR NUMBER. RAIL SHIPMENTS ONLY.
CONDITIONAL AS APPLICABLE, IF SHIPPED BY
RAIL.

PFR MANUFACTURER/PROCESSOR FDA REGISRTATION
NUMBER. THIS NUMBER CONSISTS OF 11
NUMERIC CHARACTERS. CONDITIONAL AS
APPLICABLE IF REGISTERED.

PFT PRODUCER FIRM TYPE. MUST BE 'G' IF GROWER/
HARVESTER; 'C' IF CONSOLIDATOR; 'M' IF
MANUFACTURER. CONDITIONAL AS APPLICABLE.

SFR SHIPPER FDA REGISTRATION NUMBER. THIS
NUMBER CONSISTS OF 11 NUMERIC CHARACTERS.
CONDITIONAL AS APPLICABLE IF REGISTERED.

FME BTA PRIOR NOTICE MANUFACTURER REGISTRATION
EXEMPTION. 'Y' = EXEMPT FROM REGISTRATION,
'N' = NOT EXEMPT FROM REGISTRATION.
CONDITIONAL AS APPLICABLE IF PRODUCER IS
A MANUFACTURER.

PK1 THRU PK0 (CURRENT AFFIRMATIONS OF COMPLIANCE FOR
PACKAGE/CAN CODES). 'PK1' SHOULD BE USED
FOR THE FIRST CODE, 'PK2' FOR THE SECOND,
ETC. 'PK0' REPRESENTS THE 10TH CODE. THESE
CODES SHOULD BE USED AS NEEDED.

PVL PRIVATELY OWNED VEHICLE LICENSE NUMBER.
SHOULD BE USE FOR ANY ENTRY COMING IN VIA
PRIVATE VEHICLE. CONDITIONAL AS
APPLICABLE.

PVS PRIVATELY OWNED VEHICLE STATE CODE.
SHOULD BE USE FOR ANY ENTRY COMING IN VIA
PRIVATE VEHICLE. VALID U.S. STATE CODE.
CODE APPLIES TO U.S. REGISTERED VEHICLES.
CONDITIONAL AS APPLICABLE.

PVP PRIVATELY OWNED VEHICLE FOREIGN STATE/
PROVINCE. SHOULD BE USED FOR ANY ENTRY
COMING IN VIA PRIVATE VEHICLE. CODE
APPLIES TO NON-U.S. REGISTERED VEHICLES.
ENTER VALID FOREIGN STATE/PROVINCE CODE OR
NAME. CONDITIONAL AS APPLICABLE.

PVC PRIVATELY OWNED VEHICLE COUNTRY OF
REGISTRATION. VALID ISO COUNTRY CODE.
CONDITIONAL AS APPLICABLE.

BOL MASTER BILL OF LADING - SURFACE. THIS IS
OPTIONAL BASED ON MODE OF TRANSPORT.
FIRST FOUR POSITIONS MUST BE VALID SCAC
CODE.

AWB AIR WAYBILL. OPTIONAL FOR AIR MODE OF
TRANSPORT.

AWH HOUSE AIR WAYBILL. OPTIONAL FOR AIR
MODE OF TRANSPORT.

IN ADDITION TO THE ABOVE AFFIRMATIONS OF COMPLIANCE, THE FOLLOWING
DATA ELEMENTS IN THE FD01 THROUGH FD05 RECORDS WILL BE MANDATORY FOR
ITEMS SUBJECT TO PRIOR NOTICE:

FD02 RECORD UNIT 1 - QUANTITY (POSITIONS 5-14)
FD02 RECORD UNIT 1 - UNIT OF MEASURE (POSITIONS 15-18)

FD04 RECORD CONTACT NAME (POSITIONS 19-28)
FD04 RECORD CONTACT TELEPHONE NBR (POSITIONS 29-38)

IF PRIOR NOTICE DATA IS REQUIRED FOR AN FDA LINE ITEM BUT IS NOT
SUBMITTED, FILERS WILL RECEIVE A WARNING MESSAGE (ERROR CODE 'FDP') FOR
THE FDA LINE STATING "REQ'D PRIOR NOTICE NOT SUBMITTED". GUIDELINES
WILL BE PROVIDED ON COMPLIANCE.

PRIOR NOTICE DATA PRESENTED VIA AFFIRMATIONS OF COMPLIANCE WILL BE
SUBJECTED TO BASIC EDITS SUCH AS VALID DATE FORMATS, VALID COUNTRY
CODES, VALID DDPP, ETC. ANY DATA NOT PASSING THESE EDITS WILL BE
REJECTED WITH THE APPROPRIATE EXISTING ERROR CODE.

ANY REQUIRED PRIOR NOTICE DATA WILL BE TRANSMITTED BY CBP TO FDA ALONG
WITH THE CURRENT FDA COMPLIANCE DATA, NO SOONER THAN 5 DAYS IN ADVANCE
OF THE ESTIMATED ARRIVAL UTILIZING THE CBP CARGO SELECTIVITY TIME FRAMES
AND THE EXISTING CBP/FDA INTERFACE. THEREFORE, FILERS ARE ENCOURAGED TO
FILE ELECTRONICALLY AS SOON AS POSSIBLE TO AVOID ANY POTENTIAL DELAYS.

OUTPUT DATA FOR FDA/BTA:

FILERS WILL CONTINUE TO RECEIVE THE SAME FDA ACTION MESSAGES THAT THEY
CURRENTLY RECEIVE FOR AN ENTRY VIA THE 'RR' ABI APPLICATION (I.E. -
"MAY PROCEED", "FDA REVIEW", ETC.).

ADDITIONALLY, THERE WILL BE A NEW ABI APPLICATION TO PROVIDE PRIOR
NOTICE-SPECIFIC LINE ITEM PROCESSING RESULTS. THIS NEW APPLICATION
WILL BE 'BN'. THE 'BN' TRANSACTION WILL ALLOW CBP TO TRANSMIT THE
RESULTS OF FDA PRIOR NOTICE PROCESSING TO FILERS AT THE FDA LINE-ITEM
LEVEL. THE NEW APPLICATION CONSISTS OF TWO OUTPUT RECORD TYPES, 'BN01'
AND 'BN02'. THE 'BN01' RECORD WILL BE RETURNED ONCE FOR EACH ENTRY,
AND THERE WILL BE AS MANY 'BN02' RECORDS AS THERE ARE PRIOR NOTICE
FDA LINE ITEMS FOR THE ENTRY. 'BN' IS OUTPUT ONLY.

THE NEW 'BN' TRANSACTION HAS BEEN CONSTRUCTED FOR USE IN RETURNING
PRIOR NOTICE STATUSES FOR SEVERAL TYPES OF TRANSACTIONS, INCLUDING
ENTRY. FOR THE PURPOSE OF THIS MESSAGE, WE ARE LIMITING THE 'BN'
DISCUSSION TO ENTRY DATA. FOLLOWING ARE THE LAYOUT REQUIREMENTS FOR
THE 'BN' APPLICATION:

RECORD IDENTIFIER BN01 (OUTPUT) - ONE RECORD PER FDA PRIOR NOTICE ENTRY.

DATA ELEMENT LENGTH/CLASS POSITION STATUS DESCRIPTION

CONTROL ID 4AN 1-4 M MUST ALWAYS = 'BN01'

HEADER ID 1AN 5 M MUST ALWAYS =
'A' - AIR WAYBILL(+ HOUSE
AIR WAYBILL IF USED)
'E' - ENTRY NUMBER
'I' - INBOND NUMBER
'B' - BILL OF LADING NBR
'F' - FTZ ADMISSION NBR

HEADER KEY 25AN 6-30 M MUST BE THE VALUE FOR THE
HEADER IDENTIFIER, AS
APPROPRIATE.(E.G.- THE
ACTUAL ENTRY NUMBER, THE
IN-BOND NUMBER, ETC.)
USE THE ACTUAL NUMBER WITH
NO DASHES, SLASHES, OR
OTHER SPECIAL CHARACTERS.

FILLER 50X 31-80 M SPACE FILL

RECORD IDENTIFIER BN02 (OUTPUT) - REPEATABLE AS NEEDED. ONE BN02 RECORD
FOR EACH FDA PRIOR NOTICE LINE-ITEM ON
THE ENTRY.

DATA ELEMENT LENGTH/CLASS POSITION STATUS DESCRIPTION

CONTROL ID 4AN 1-4 M MUST ALWAYS = 'BN02'

CBP ENTRY LINE 3AN 5-7 C THE CBP LINE NUMBER
WHEN THE HEADER IDENTIFIER
IN THE BN01 RECORD = 'E'.
OTHERWISE, SPACE FILL.

FDA LINE 4AN 8-11 M THE FDA LINE NUMBER
APPLICABLE TO REQUIREMENT.

PRIOR NOTICE
CONFIRMATION NBR 12AN 12-23 C THE CONFIRMATION NUMBER
RECEIVED FROM FDA WHEN
PRIOR NOTICE RECEIVED
MESSAGE IS GENERATED BY
FDA. (SEE NOTE 1)

PRIOR NOTICE
LINE MESSAGE 26AN 24-49 M PRIOR NOTICE LINE LEVEL
MESSAGE FROM FDA, SUCH
AS "PRIOR NOTICE RECEIVED"
OR "PRIOR NOTICE
SATISFIED". FREE FORM.

PRIOR NOTICE
RECEIPT DATE 8AN 50-57 C RECEIVED FROM FDA WHEN
PRIOR NOTICE RECEIVED
MESSAGE IS GENERATED.
THIS FIELD WILL BE
BLANK WHEN PRIOR NOTICE
SATISFIED MESSAGE IS
RECEIVED. MMDDYYYY FORMAT.
(SEE NOTE 2)

PRIOR NOTICE
RECEIPT TIME 6AN 58-63 C RECEIVED FROM FDA WHEN
PRIOR NOTICE RECEIVED
MESSAGE IS GENERATED.
THIS FIELD WILL BE BLANK
WHEN PRIOR NOTICE
SATISFIED MESSAGE IS
RECEIVED. HHMMSS FORMAT.
(SEE NOTE 2)

PRIOR NOTICE
LINE REJECT
CODES 16AN 64-79 C CODES IDENTIFYING REJECT
REASONS WHEN PRIOR NOTICE
IS REJECTED. (SEE NOTE 3)

FILLER 1X 80 M SPACE FILL

NOTES:

1. THE PRIOR NOTICE CONFIRMATION NUMBER IS THE VALIDATION AND
CERTIFICATION FROM FDA THAT THE PRIOR NOTICE DATA WAS RECEIVED FOR
THE MERCHANDISE. THIS SHOULD BE RETAINED BY THE FILER. THERE WILL BE
A SEPARATE CONFIRMATION NUMBER FOR EACH FDA LINE ITEM.

2. THE PRIOR NOTICE RECEIPT DATE AND TIME ARE RETURNED WHEN FDA
GENERATES A PRIOR NOTICE RECEIVED MESSAGE TO THE FILER FOR THE
MERCHANDISE. THIS INFORMATION SHOULD BE RETAINED WITH THE
CONFIRMATION NUMBER.

3. FOLLOWING ARE THE VALID LINE REJECT REASON CODES. THESE CODES ARE
POSITIONAL ALLOWING EACH LINE TO HAVE MULTIPLE CODES UP TO 16. WHILE
SOME CODES MAY BE REPEATED, THEIR MEANING IS SPECIFIC RELATIVE TO
THE FIELD IN THE RECORD IN WHICH THEY MAY APPEAR. THUS, FOR EXAMPLE,
AN 'S' IN POSITION 5 INDICATES "INVALID MID FOR SHIPPER" WHILE AN
'S' IN POSITION 10 INDICATES "INVALID COUNTRY OF SHIPPING".

THESE CODES REPRESENT FDA REJECT REASONS. QUESTIONS REGARDING THESE
CODES SHOULD BE DIRECTED TO FDA.

POSITION VALUE REASON

1 'F' FOREIGN CONSIGNEE
2 'R' INVALID REGISTRATION
3 'Q' INVALID QUANTITY
4 'M' INVALID MID FOR MANUFACTURER
5 'S' INVALID MID FOR SHIPPER
6 'I' INVALID IMPORTER
7 'C' INVALID CONSIGNEE
8 'Z' INVALID STATE/ZIP FOR U.S. MANUFACTURER
9 'O' INVALID COUNTRY OF ORIGIN
10 'S' INVALID COUNTRY OF SHIPPING
11 'N' OTHER REJECT REASON, CALL FDA
12 FUTURE USE
13 FUTURE USE
14 FUTURE USE
15 FUTURE USE
16 FUTURE USE

THE COMPLETE CATAIR RECORD LAYOUTS FOR THE 'EI', 'HI', AND HN'
APPLICATIONS WILL BE AVAILABLE ON THE CBP WEB SITE AS SOON AS POSSIBLE.
WE WILL ADVISE YOU WHEN THEY ARE AVAILABLE.

QUESTIONS MAY BE DIRECTED TO YOUR CLIENT REPRESENTATIVE.

Related CSMS No. 03-002540

Referenced By

CSMS #06-000066, 05-000681, 05-000580, 04-001240, 04-000031, 04-000029, 03-002812, 03-002625