| Title: | FDA SYSTEM ISSUE CONTINGENCY ON MAY 31, 2016 |
|---|---|
| Date: | 2016-05-31 |
| To: | abi,air,ocean,partner,rail,truck |
| Links: | previous, original, next |
To: All Filers
From: FDA
ON MONDAY MAY 31, 2016 FDA BEGAN EXPERIENCING AN ISSUE WITH ITS FIRM MANAGEMENT SYSTEM WHICH IS IMPACTING THE PROCESSING OF ALL ACE ENTRIES AND ALL ACS ENTRIES REQUIRING PRIOR NOTICE. AS A RESULT OF THIS ISSUE ALL ACE ENTRIES AND ACS FOOD ENTRIES ARE BEING IMPACTED AND MESSAGING IS NOT BEING SENT TO TRADE. ACS food entries are in Pending ACS Registration status. ENTRIES NOT REQUIRING PRIOR NOTICE MAY BE FILED THROUGH ACS. FDA WILL BE OPERATING UNDER THE PRIOR NOTICE SCENARIO 1 CONTINGENCY. ACS, OASIS AND PNSI ARE ALL OPERATIONAL. THIS OUTAGE WILL PREVENT SUBMITTERS WHO FILE VIA ABI/ACS/ACE FROM RECEIVING PRIOR NOTICE CONFIRMATION AND WILL PREVENT CBP FROM AUTOCHECKING THE PRIOR NOTICE CONFIRMATION FOR ABI/ACS/ACE 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.
IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACS/ACE 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/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.
UPON RESTORATION OF THE INTERFACE FDA INTENDS TO PROVIDE NOTICE, VIA WEB PAGE POSTING THAT NORMAL PROCESSING HAS RESUMED.
IF YOU HAVE ANY PRIOR NOTICE RELATED QUESTIONS DURING THIS DOWNTIME, PLEASE CONTACT THE FDA'S DIVISION OF FOOD DEFENSE TARGETING AT (866) 521-2297.
CSMS #16-000444