CSMS Message: 12-000076

FDA'S OASIS IMPORT SYSTEM WILL BE DOWN FOR MAINTENANCE ON FRIDAY, 3/9/2012 FROM 9:30 P.M. (EST) TO 10:00 P.M. (EST), - FDA WILL BE SWITCHING THE CBP NODE TO THE SECONDARY NODE IN PREPARATIONS FOR THE REPLACEMENT OF A FAILED HARDWARE COMPONENT. THIS WILL CAUSE THE VPN CONNECTION WITH CBP TO BE SHUTDOWN FOR 30 MINUTES, NO NEW ENTRIES WILL BE TRANSMITTED TO FDA DURING THIS TIME.
AS A RESULT, FDA WILL BE OPERATING UNDER THE PRIOR NOTICE SCENARIO 1 CONTINGENCY. DURING THE INTERMITTENT HALF HOUR (1/2 HOUR) PERIODS ACS, OASIS, AND PNSI ARE ALL OPERATIONAL, BUT THE LINK BETWEEN ACS AND OASIS IS DOWN ON FDA’S OR CBP’S SIDE OF THE SYSTEM INTERFACE.
THE OUTAGE DESCRIBED IN THIS SCENARIO WOULD PREVENT SUBMITTERS WHO FILED VIA ABI/ACS FROM RECEIVING PRIOR NOTICE CONFIRMATION AND WOULD PREVENT CBP FROM AUTO-CHECKING THE PRIOR NOTICE CONFIRMATION FOR ABI/ACS FILERS.
IN THIS SITUATION, IF DEEMED APPROPRIATE, CBP WILL ISSUE AN ADMINISTRATIVE MESSAGE TO BROKERS AND FDA WILL POST A NOTICE AT HTTP://WWW.ACCESS.FDA.GOV1, HTTP://WWW.FDA.GOV, HTTP://WWW.CFSAN.FDA.GOV/~FURLS/FISSTAT.HTML AND HTTP://WWW.CFSAN.FDA.GOV/~PN/PNOVIEW.HTML, ADVISING OF ANY AVAILABLE DOWNTIME SPECIFICS. IF PRIOR NOTICE HAS NOT ALREADY BEEN SUBMITTED, ABI FILERS MAY DECIDE TO WAIT OUT THE ACS/OASIS INTERFACE 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.
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 SUBMITTER PRESENT THE PNSI CONFIRMATION PAGE, INCLUDING THE PRIOR NOTICE CONFIRMATION NUMBER AND TIME STAMP, 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 NUMBER(S) AND TIME OF SUBMISSION.
IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACS PRIOR TO THE 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/ACS 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.
UPON RESTORATION OF THE INTERFACE FDA INTENDS TO PROVIDE NOTICE, VIA WEB PAGE POSTING AT HTTP://WWW.CFSAN.FDA.GOV/~FURLS/FISSTAT.HTML, THAT NORMAL PROCESSING HAS RESUMED.