| Title: | FDA OASIS DOWNTIME FRIDAY, DECEMBER 21, 2007 |
|---|---|
| Date: | 2007-12-21 |
| To: | abi |
| Links: | previous, next |
TO : ALL ABI FILERS
FROM : FOOD AND DRUG ADMINISTRATION
SUBJECT: FDA OASIS DOWNTIME FRIDAY, DECEMBER 21, 2007
FDA'S OASIS SYSTEM WILL BE DOWN FOR MAINTENANCE FRIDAY, DECEMBER 21,
2007 BETWEEN 11:00 PM (2300) EST AND 12:00 AM (MIDNIGHT). ABI
TRANSMISSION 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 THE 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 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 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.
NOTE - DURING THE DOWNTIME PERIOD, FDA AND CBP WILL BE OPERATING USING
CONTINGENCY PLAN-SCENARIO 2.
IF YOU HAVE ANY QUESTIONS, PLEASE CALL THE FDA PRIOR NOTICE CENTER AT
(866) 521-2297.