CSMS# 17-000120 - FDA Currently Experiencing Multiple System Outages 3/3/17

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03/03/2017 12:45 PM EST

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FDA is currently experiencing outages across many applications, which prevents the processing of entries. The technical team is currently investigating. As a result, FDA’s Division of Food Defense Targeting will be operating under the prior notice scenario 2 contingency.



These issues will prevent submitters who filed via Automated Broker Interface (ABI) from receiving Prior Notice Confirmation (PNC)numbers and would prevent Customs and Border Protection (CBP) Officers from auto-checking the PNC for ABI filers. The intermittent downtime will also prevent the receipt of 801(a) admissibility decisions until the systems are operational again. If prior notice has not already been submitted, ABI filers may decide to wait out the intermittent 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. PNC 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/ACE prior to the interface intermittent 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 intermittent 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/ACE. Questions regarding prior notice during this downtime should be presented to the FDA's Division of Food Defense Targeting at (866) 521-2297.

As a result of these application issues, FDA also cannot process incoming 801(a) submissions. Entries will be processed and messaging sent once the issue has been resolved. Do not re-transmit entries as this will cause further delays when the issue has been resolved.



The Import Trade Auxiliary Communication System (ITACS) is also down due to the same issue.



Updates will be provided when they become available via additional CSMS messages.



Please continue to contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries.

Please contact FDA's Division of Food Defense Targeting at (866) 521-2297 for questions regarding prior notice.