CSMS# 17-000169 - FDA Experienced Multiple System Outages 0600 ET - 1400 Saturday, 3/25/2017
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03/25/2017 02:48 PM EDT
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FDA experienced outages across many applications since approximately 06:00 ET this morning, Saturday, March 25, 2017, which prevented the processing of entries. These applications are up and running again and message backlogs have been cleared, as of 14:15 ET. As a result, FDA’s Division of Food Defense Targeting operated under the prior notice scenario 2 contingency.
These issues would have prevented submitters who filed via Automated Broker Interface (ABI) from receiving Prior Notice Confirmation (PNC)numbers and would prevent Customs & Border Protection (CBP) Officers from auto-checking the PNC for ABI filers. The downtime also prevents the receipt of the FDA data shipment under 801(a) admissibility decisions until the systems are operational again. If prior notice had 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 were queued and processed once the maintenance was completed. PNC numbers were not transmitted back to filers during the downtime.
Alternatively, filers may have 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 could not process incoming 801(a) submissions. Entries were processed and messaging sent once the issue had 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) was also down due to the same issue.
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.
FDA experienced outages across many applications since approximately 06:00 ET this morning, Saturday, March 25, 2017, which prevented the processing of entries. These applications are up and running again and message backlogs have been cleared, as of 14:15 ET. As a result, FDA’s Division of Food Defense Targeting operated under the prior notice scenario 2 contingency.
These issues would have prevented submitters who filed via Automated Broker Interface (ABI) from receiving Prior Notice Confirmation (PNC)numbers and would prevent Customs & Border Protection (CBP) Officers from auto-checking the PNC for ABI filers. The downtime also prevents the receipt of the FDA data shipment under 801(a) admissibility decisions until the systems are operational again. If prior notice had 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 were queued and processed once the maintenance was completed. PNC numbers were not transmitted back to filers during the downtime.
Alternatively, filers may have 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 could not process incoming 801(a) submissions. Entries were processed and messaging sent once the issue had 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) was also down due to the same issue.
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.
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