| Title: | FDA BTA PRIOR NOTICE REPORTING ALLOWED FOR FD1,FD2,BLNK |
|---|---|
| Date: | 2004-03-24 |
| To: | abi |
| Links: | previous, next |
THE EFFECTIVE DATE OF THE PROGRAMS IN THIS MESSAGE IS APRIL 14, 2004
IN ORDER TO ALLOW THE ABI FILERS TO REPORT BTA PRIOR NOTICE WHEN, IN THE
JUDGEMENT OF THE FILER,BTA PRIOR NOTICE IS REQUIRED, THE EDITS ON TARIFF
RECORDS MARKED WITH AN FD1, FD2, OR NO FD MARKER ARE BEING RELAXED. ABI
FILERS WILL NOW BE ALLOWED TO FILE BTA PRIOR NOTICE REGARDLESS OF THE FD
INDICATORS IN THE TARIFF RECORD. THE EXCEPTION IS TARIFF RECORDS MARKED
WITH FD0, FOR WHICH NO FDA DATA, PRIOR NOTICE OR OTHERWISE IS PERMITTED.
FDA WILL VALIDATE THE NEED FOR BTA PRIOR NOTICE DATA BASED ON THE FDA
PRODUCT CODE. IF FDA LOOKS FOR BTA PRIOR NOTICE DATA BASED ON THE FDA
PRODUCT CODE AND FINDS NONE, FDA WILL TRANSMIT THE LETTER 'P'(PN DATA
REQUIRED) IN POSITION 64-79 OF THE BN02 RECORD IN THE BN APPLICATION.THE
ENTRY WILL BE PLACED IN PRIOR NOTICE REJECTED STATUS IN ACS. THE FILER
THEN MUST PROVIDE THE PN DATA TO FDA USING THE CP APPLICATION.
IF THE ABI FILER PROVIDES PN DATA FOR A TRANSACTION THAT DOES NOT
REQUIRE A PN BASED ON THE FDA PRODUCT CODE, FDA WILL ISSUE A WARNING
MESSAGE WITH THE LETTER'W' BETWEEN POSITIONS 64-79 OF THE BN02 RECORD
WHICH MEANS 'PN IS NOT REQUIRED'.THE 'P' AND 'W' STATUS MESSAGES APPLY
ONLY TO ENTRIES (HN,HI,EI).
CERTAIN TARIFF NUMBERS, ESPECIALLY THOSE THAT COVER AMERICAN GOODS
RETURNED, ARE MARKED AS FD3 AND MAY COVER GOODS REGULATED BY FDA 801(A)
REGULATIONS AND NOT COVERED BY PRIOR NOTICE BTA 2002 REGULATIONS. IN
SITUATIONS WHERE THE PRIOR NOTICE MUST BE DISCLAIMED, THE FDA HAS MADE
A NEW AFFIRMATION OF COMPLIANCE CODE, 'PND' FOR PRIOR NOTICE DISCLAIMED.
IN CASES WHERE 801(A) DATA IS REQUIRED, AND PRIOR NOTICE DATA IS NOT
REQUIRED, TRANSMIT THE PND DISCLAIMER AND THE INFORMATION REQUIRED FOR
801(A). THE PND AFFIRMATION MUST BE THE FIRST AFFIRMATION OF COMPLIANCE
REPORTED (FD01 RECORD POSITIONS 20-22). THE PND AFFIRMATION OF COMPLIACE
DOES NOT REQUIRE A QUALIFIER.
PLEASE NOTE THAT MERCHANDISE ENTERED FROM A FOREIGN TRADE ZONE (FTZ)
INTO A WAREHOUSE (ENTRY TYPE 21) DOES NOT REQUIRE BTA PRIOR NOTICE. TO
REPORT THIS TRANSACTION, TRANSMIT THE CODE FTZNNNX IN THE VESSEL NAME/
FOREIGN TRADE ZONE NUMBER FIELD IN POSITIONS 60-79 OF THE H2 RECORD.
THE VALUE OF THE NNN MUST BE FROM 001 THROUGH 300. IF NOT ACS WILL
ISSUE ERROR MSG VDP: 'FTZ NUMBER INVALID'.
PLEASE NOTE THAT AFFIRMATION OF COMPLIANCE CODES PK1-PK0 APPLY TO ALL
FDA REGULATED TRANSACTIONS, NOT ONLY BTA PRIOR NOTICE TRANSACTIONS.
SOFTWARE SUPPORTING THE ABOVE WILL BE EFFECTIVE APRIL 14, 2004.
PLEASE DIRECT ANY QUESTIONS TO YOUR CLIENT REPRESENTATIVE.