CSMS Message: 11-000058

TO : ALL ABI FILERS

FROM : FOOD AND DRUG ADMINISTRATION

SUBJECT: FDA OASIS DOWNTIME SATURDAY, February 26, 2011

FDA'S OASIS SYSTEM WILL BE DOWN FOR MAINTENANCE Saturday, February 26, 2011, BETWEEN 03:00 AM (0300) EST AND 08:30 AM (0830) EST. 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 – PERIODIC OASIS DOWNTIMES MAY OCCUR DURING THE MAINTENANCE 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.