CSMS# 17-000351 - FDA System Outages for June 16 -17, 2017

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06/16/2017 04:14 PM EDT

Partner Government Agencies

From 11 PM, tonight, June 16, 2017 to 3 AM EDT June 17, 2017:



FDA’s Prior Notice System Interface (PNSI) Food Facility Registration Module (FFRM) will be unavailable due to scheduled maintenance. As a result, FDA’s Division of Food Defense Targeting will be posting contingency scenario 4 but will not accept email or fax submissions. In this situation, prior notice may continue to be submitted through ABI/ACE.



If prior notice has been submitted via PNSI, prior to the system outage, and a confirmation number has already been received, the confirmation number must accompany the article of food (21 CFR 1.279(g)). In addition, FDA and CBP recommend that the submitter also provide the PNSI confirmation page, including the prior notice confirmation number and time stamp, to CBP officers for cargo release. If the prior notice confirmation page is not provided, this may delay cargo release while the CBP officer contacts FDA for verification of the prior notice confirmation number(s) and time of submission.



Upon restoration of PNSI and FFRM, FDA intends to issue a notice, via web page posting at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm161883.htm, that normal processing has resumed.





From 3AM – 6 AM EDT June 17, 2017:



FDA Import Systems OASIS will be down for maintenance. As a result, FDA’s Division of Food Defense Targeting will be operating under the prior notice scenario 2 contingency. This scheduled maintenance will prevent submitters who filed via ABI from receiving prior notice confirmation and will prevent CBP from auto-checking the prior notice confirmation for ABI filers. If prior notice has not already been submitted, ABI filers may decide to wait-out the system downtimes 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 ABI filers during the downtime.



Alternatively, filers may submit prior notice via PNSI (http://www.access.fda.gov/). Prior notice confirmation numbers must accompany articles 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 contacts FDA for verification of the prior notice confirmation number(s) and time of submission.



If prior notice has already been submitted via 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 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 an endorsed (signed) copy of the ABI transmission or some other evidence adequate to show that prior notice has been submitted via ACE.



During this three-hour maintenance period FDA will not receive new data from CBP or process any outbound messaging. New entries sent by CBP and outbound messaging processed during this period will be sent after the maintenance period has completed.