| Title: | FDA SYSTEM DOWNTIME THURSDAY, AUGUST 12, 2004 |
|---|---|
| Date: | 2004-08-12 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: THE FOOD & DRUG ADMINISTRATION
SUBJECT: FDA SYSTEM DOWNTIME THURSDAY, AUGUST 12, 2004
THIS ADMINISTRATIVE MESSAGE IMPACTS ONLY THE RECEIPT OF ABI ENTRIES
IN FDA'S OASIS SYSTEM.
FDA'S OASIS SYSTEM WILL BE DOWN FOR MAINTENANCE THURSDAY AUGUST 12,
2004 BETWEEN 1000 PM (EDT) AND 1200 AM (2200-2400) EDT.ABI TRANSMISSIONS
RECEIVED BY FDA DURING THAT TIME WILL BE QUEUED AND PROCESSED ONCE THE
MAINTENANCE IS COMPLETED. PRIOR NOTICE (PN) CONFIRMATION NUMBERS
WILL NOT BE TRANSMITTED BACK TO FILERS DURING THE DOWNTIME. IF PRIOR
NOTICE HAS NOT ALREADY BEEN SUBMITTED, ABI FILERS MAY DECIDE TO WAIT
OUT THE DOWNTIME IF THEY DETERMINE THAT TIMELINESS OF PN WILL NOT BE
ADVERSELY AFFECTED. ALTERNATIVELY, FILERS MAY SUBMIT PN VIA PRIOR NOTICE
SYSTEM INTERFACE (PNSI) IN WHICH CASE THE PRIOR NOTICE CONFIRMATION
NUMBER MUST ACCOMPANY THE ARTICLE OF FOOD (21 CFR 1.279(G)). IF PRIOR
NOTICE IS SUBMITTED THROUGH PNSI, FDA AND CBP RECOMMEND THAT THE
SUBMITTER PRESENT THE PNSI CONFIRMATION PAGE, INCLUDING THE PRIOR
NOTICE CONFIRMATION NUMBER AND TIME STAMP, TO CBP OFFICERS FOR CARGO
RELEASE.
IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACS PRIOR TO THE
OASIS OUTAGE AND CONFIRMATION HAS ALREADY BEEN RECEIVED, NO FURTHER
ACTION IS REQUIRED. IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA
ABI/ACS AND CONFIRMATION HAS NOT BEEN RECEIVED PRIOR TO THE OASIS OUTAGE
FDA AND CBP RECOMMEND THAT, RATHER THAN RESUBMITTING VIA PNSI,
SUBMITTERS SHOULD PROVIDE TO CBP OFFICERS, AT THE TIME OF CARGO
RELEASE, AN ENDORSED (SIGNED) COPY OF THE ABI TRANSMISSION OR SOME OTHER
EVIDENCE ADEQUATE TO SHOW THAT PRIOR NOTICE HAS BEEN SUBMITTED VIA
ABI/ACS.
THE FOOD & DRUG ADMINISTRATION