CSMS Message: 08-000310

TO: ALL FILERS

FROM: FOOD & DRUG ADMINISTRATION

SUBJECT: OASIS DOWNTIME ON NOVEMBER 20, 2008

IN ORDER TO PERFORM SOME PREVIOUSLY UNPLANNED MAINTENANCE ON 11/20/08, FDA'S OASIS SYSTEM WILL BE DOWN AT 4:00 AM UNTIL 6:00 AM. AS A RESULT, FDA WILL BE OPERATING UNDER THE PRIOR NOTICE SCENARIO 2 CONTINGENCY. DURING THIS DOWNTIME ACS, PNSI AND THE LINK BETWEEN ACS AND OASIS ARE OPERATIONAL. HOWEVER, THE OASIS DOWNTIME WILL PREVENT SUBMITTERS WHO FILED VIA ABI FROM RECEIVING PRIOR NOTICE CONFIRMATION AND WOULD PREVENT CBP FROM AUTO-CHECKING THE PRIOR NOTICE CONFIRMATION FOR ABI FILERS. DURING THIS PERIOD, IF PRIOR NOTICE HAS NOT ALREADY BEEN SUBMITTED, ABI FILERS MAY DECIDE TO WAIT OUT THE OASIS DOWNTIME IF THEY DETERMINE THAT THE TIMELINESS OF PRIOR NOTICE WILL NOT BE ADVERSELY AFFECTED. FILERS WHO CHOOSE THIS OPTION SHOULD UNDERSTAND THAT THEY REMAIN RESPONSIBLE UNDER SECTION 801(M) OF THE ACT AND UNDER THE PRIOR NOTICE INTERIM FINAL RULE FOR FILING TIMELY PRIOR NOTICE. ABI TRANSMISSIONS RECEIVED BY FDA DURING THE DOWNTIME 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.

ALTERNATIVELY, FILERS MAY SUBMIT PRIOR NOTICE VIA 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 PNSI CONFIRMATION PAGE, INCLUDING THE PRIOR NOTICE CONFIRMATION NUMBER AND TIME STAMP, BE PRESENTED TO CBP OFFICERS FOR CARGO RELEASE. IF THE PNSI CONFIRMATION PAGE IS NOT PRESENTED, THIS MAY DELAY CARGO RELEASE WHILE THE CBP OFFICER, WITHOUT BEING ABLE TO ACCESS OASIS, CONTACTS FDA FOR VERIFICATION OF THE PRIOR NOTICE CONFIRMATION NUMBERS) AND TIME OF SUBMISSION.

IF PRIOR NOTICE IS ALREADY SUBMITTED VIA ABI/ACS PRIOR TO THE SUBJECT INTERFACE OUTAGE, AND CONFIRMATION HAS ALREADY BEEN RECEIVED, THE SUBMITTER MAY PROCEED WITH PRIOR NOTICE USING THE STANDARD PROCESS. IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACE AND CONFIRMATION HAS NOT BEEN RECEIVED PRIOR TO THE INTERFACE 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. IF YOU HAVE ANY QUESTIONS DURING THIS DOWNTIME, PLEASE CONTACT THE FDA'S PRIOR NOTICE CENTER AT (866) 521-2297.