CSMS Message: 11-000108

TITLE: OGA-FDA

TO: ALL FILERS

FROM: FOOD & DRUG ADMINISTRATION

SUBJECT: SCHEDULED OASIS-ACS LINK MAINTENANCE ON MAY 21, 2011

THE LINK BETWEEN FDA'S OASIS IMPORT SYSTEM AND ACS WILL BE DOWN FOR MAINTENANCE ON SATURDAY MAY 21, 2011 STARTING AT APPROXIMATELY 03:00 AM EST (0300), AND IS NOT ANTICIPATED TO BE BACK UP UNTIL 05:00 AM EST (0500). DURING THIS MAINTENANCE WINDOW FILERS CAN EXPECT TO EXPERIENCE INTERMITTENT PERIODS OF DOWNTIME. AS A RESULT, FDA WILL BE OPERATING UNDER THE PRIOR NOTICE SCENARIO 1 CONTINGENCY. ACS, OASIS AND PNSI ARE ALL OPERATIONAL, BUT THE LINK BETWEEN ACS AND OASIS IS DOWN ON FDA'S SIDE OF THE SYSTEM INTERFACE. THIS OUTAGE WILL PREVENT SUBMITTERS WHO FILE VIA ABI/ACS FROM RECEIVING PRIOR NOTICE CONFIRMATION AND WILL PREVENT CBP FROM AUTOCHECKING THE PRIOR NOTICE CONFIRMATION FOR ABI/ACS FILERS. 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 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 NUMBER(S) AND TIME OF SUBMISSION. FILERS SHOULD NOTE THAT PNSI WILL ALSO BE UNDERGOING SCHEDULED MAINTENANCE FROM 03:00 AM EST (0300) UNTIL 1:00 PM EST (1300) ON MAY 21, 2011. AS SUCH, FILERS MAY ALSO EXPERIENCE INTERMITTENT TIME OUTS IN PNSI. PLEASE SEE: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/OnlineRegistration/ucm161883.htm FOR STATUS UPDATES.

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, THAT NORMAL PROCESSING HAS RESUMED.

IF YOU HAVE ANY QUESTIONS DURING THIS DOWNTIME, PLEASE CONTACT THE FDA'S PRIOR NOTICE CENTER AT (866) 521-2297.