| Title: | REJECT MESSAGES ON PRIOR NOTICE ENTRIES |
|---|---|
| Date: | 2006-01-13 |
| To: | abi |
| Links: | previous, next |
TO: ABI FILERS
FROM: OFFICE OF INFORMATION AND TECHNOLOGY
SUBJECT: FDA/ABI MESSAGES ON REJECTED PRIOR NOTICE INPUT DATA
BACKGROUND:
WHEN PRIOR NOTICE REPORTING FOR SELECTED FDA-REGULATED PRODUCTS WAS
IMPLEMENTED IN LATE 2003, SEVERAL ADMINISTRATIVE MESSAGES WERE ISSUED
TO NOTIFY ABI FILERS OF THE REQUIREMENTS FOR PARTICIPATION IN PRIOR
NOTICE REPORTING. ONE OF THOSE MESSAGES, 03-2619, ALERTED FILERS
TO THE CREATION OF A NEW OUTPUT APPLICATION, CODE BN, WHICH WOULD
ADVISE THEM OF ACCEPTANCE AND/OR REJECTION OF THE SUBMITTED PRIOR
NOTICE DATA ELEMENTS.
BASED ON RECENT TELEPHONE TRAFFIC FROM ABI FILERS, IT HAS BECOME
APPARENT THAT SOME FILERS ARE NOT ABLE TO SEE THE BN REJECTION
MESSAGES. THIS IS CAUSE FOR CONCERN, AS ALL SOFTWARE VENDORS WERE
APPRISED OF THE BN REQUIREMENT IN 2003.
ACTION:
ABI FILERS WHO DO NOT RECEIVE PROVISIONAL SELECTIVITY MESSAGES (WITHIN
THE APPROPRIATE TIME LIMITS FOR THE IMPORT MODE OF TRANSPORTATION)
ON PRIOR NOTICE ENTRY TRANSMISSIONS SHOULD CONTACT THEIR ABI SOFTWARE
PROVIDER TO CONFIRM THAT THE VENDOR'S ABI SOFWARE IS CAPTURING AND
DISPLAYING THE APPROPRIATE BN REJECTION MESSAGES.
IF THE FILER FINDS THAT ITS VENDOR'S SOFTWARE IS UNABLE TO DISPLAY
EVERY BN OUTPUT MESSAGE ISSUED BY FDA/CBP, THE FILER SHOULD
IMMEDIATELY CONTACT ITS SOFTWARE VENDOR TO RESOLVE THE PROBLEM.
THE FILER SHOULD ALSO CONTACT ITS ASSIGNED CPB CLIENT REPRESENATIVE
TO INFORM THE REPRESENTATIVE OF THE CURRENT STATUS OF THE MATTER.