| Title: | FDA TEMPORARY INSTRUCTIONS:REGISTRATION/BILL OF LADING |
|---|---|
| Date: | 2004-08-12 |
| To: | abi |
| Links: | previous, next |
ATTENTION ALL ABI FILERS: (ALSO SOFTWARE VENDORS AND SELF PROGRAMMERS
PLEASE NOTE LAST PARAGRAPH).
SEE ADMIN. MESSAGE 04-1779 WHICH OUTLINES THE EXPANDED NEW PRIOR NOTICE
EDITS AND REJECTS CBP AND FDA WILL PUT IN PLACE ON AUGUST 13.
THIS MESSAGE GIVES TEMPORARY INSTRUCTIONS ON HOW TO SUPPLY PRIOR NOTICE
IF A FILER HAS PROBLEMS OBTAINING THE FOOD FACILITY REGISTRATION NUMBER
FOR THE MANUFACTURER OR IN PROVIDING BILL OF LADING/AIR WAYBILL NUMBERS
BECAUSE OF FORMAT PROBLEMS. THIS DOES NOT CONSTITUTE A CHANGE IN
REQUIRED PRIOR NOTICE INFORMATION AND VALID INFORMATION SHOULD BE
SUPPLIED WHENEVER POSSIBLE. IF VIOLATIONS REFLECT A HISTORY OF REPEATED
CONDUCT OF A SIMILAR NATURE BY A PERSON WHO HAD BEEN NOTIFIED OF SUCH
VIOLATIONS, THEN THE ACTION FDA AND CBP STAFF TYPICALLY WILL CONSIDER
TAKING IS ASSESSMENT OF CBP CIVIL MONETARY PENALTIES.
MANUFACTURER FOOD FACILITY REGISTRATION NUMBER -
UNTIL FURTHER NOTICE, IF A FILER CAN NOT OBTAIN THE MANUFACTURER'S FOOD
FACILITY REGISTRATION NUMBER AND THERE IS NO LEGITIMATE REGISTRATION
EXEMPTION REASON AVAILABLE, FILERS CAN TRANSMIT THE PFR AFFIRMATION OF
COMPLIANCE CODE AND ZERO-FILL THE PFR QUALIFIER FIELD (11 NUMERIC
CHARACTERS).
BILL OF LADING/AIR WAYBILL NUMBERS -
IF, BECAUSE OF FORMAT PROBLEMS, FILERS ARE UNABLE TO TRANSMIT A BILL OF
LADING, OR AIR WAYBILL NUMBER VIA THE BOL AND AWB AFFIRMATION OF
COMPLIANCE CODES, THESE CODES SHOULD NOT BE TRANSMITTED.
PNSI USERS - PLEASE SEE MODIFIED PNSI 1.4 RELEASE NOTES AT
WWW.CFSAN.FDA.GOV/~PN/PNOVIEW.HTML FOR INSTRUCTIONS ON HOW TO SUBMIT PN
IF A TRANSMITTER/SUBMITTER HAS PROBLEMS OBTAINING THE FOOD FACILITY
REGISTRATION NUMBER FOR THE MANUFACTURER OR IN PROVIDING BILL
OF LADING/AIR WAYBILL NUMBERS BECAUSE OF FORMAT PROBLEMS.
IF YOU HAVE QUESTIONS, PLEASE CONTACT THE FDA PRIOR NOTICE CENTER AT
1-(866) 521-2297.
ALSO PLEASE NOTE THAT THE PROGRAM TO EDIT FOR THE EXISTENCE OF A FOOD
FACILITY REGISTRATION NUMBER (AFFIRMATION OF COMPLIANCE INDICATOR PFR)
OR A VALID EXEMPTION CODE (AFFIRMATION OF COMPLIANCE INDICATOR FME) WILL
MOVE INTO PRODUCTION ON SATURDAY AUGUST 14, 2004. IF NEITHER
AFFIRMATION OF COMPLIANCE IS PRESENT, ACS WILL GENERATE THE
MESSAGE FGN "FACILITY REGISTRATION REQUIRED"
IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT YOUR CLIENT REPRESENTATIVE.