CSMS# 17-000413 - FDA Scheduled Maintenance, Saturday, July 22, 2017, 3:30 AM-4:30 PM ET
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07/19/2017 03:41 PM EDT
Partner Government Agencies
Due to planned maintenance and infrastructure upgrades on Saturday, July 22, 2017, starting at approximately 3:30 AM EDT, and completed at approximately 4:30 PM EDT, multiple FDA systems will be down. This includes, but is not limited to, FDA’s interface with ACE, ITACS, PNSI, OASIS, and Entry Review.
During this maintenance period FDA will not receive new data from CBP, or process any outbound messaging. New entries sent by CBP during this period will be not be processed by FDA, and no response messages will be sent until after the maintenance period has completed. As a result, FDA will be operating under the prior notice contingency scenario 3 during this time.
If prior notice has already been submitted via ABI/ACE ITDS prior to the scheduled maintenance period, and a prior notice confirmation number has been received, the submitter may proceed with prior notice using the standard process. However, if prior notice is submitted via ABI/ACE ITDS and a prior notice confirmation number is not received prior to the outage, 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 ITDS.
If prior notice has been submitted via PNSI prior to the scheduled maintenance period 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 Web Entry Summary Confirmation page, including the prior notice confirmation number and time stamp, to CBP officers for cargo release.
If prior notice has not already been submitted, ABI filers may decide to wait out the scheduled maintenance period, 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 interim final rule for filing timely prior notice.
Otherwise, if prior notice has not been submitted before the scheduled maintenance period, it may be submitted by either e-mail or fax (21 CFR 1.280(c)). The e-mail and fax submission form will appear when attempting to log into the PNSI system. If not redirected, filers may use this link to go to the form directly for email or fax submission form: https://www.accessdata.fda.gov/scripts/pnsic/Contingency_Submission.cfm. The email form may be limited during this scheduled maintenance period.
For e-mail submissions, FDA intends to transmit back to the e-mail address from which the Prior Notice was transmitted an automated receipt response from FDA, including the prior notice confirmation number. A paper copy of FDA’s e-mail receipt confirmation should be presented to the CBP officer for cargo release processing. CBP intends to enforce prior notice submission timeframes based on the e-mail receipt confirmation time stamp.
In cases of fax transmissions, the Prior Notice Center intends to return a fax acknowledgement report including the prior notice confirmation number. The fax acknowledgement report should then be presented to the CBP officer for cargo release processing. CBP officers intend to enforce prior notice submission time frames based on the fax received confirmation time stamp.
FDA ACE Support can be contacted from 6:00 AM -10:00 PM Eastern, 7 days a week, at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries. Email may be limited during this scheduled maintenance period.
Due to planned maintenance and infrastructure upgrades on Saturday, July 22, 2017, starting at approximately 3:30 AM EDT, and completed at approximately 4:30 PM EDT, multiple FDA systems will be down. This includes, but is not limited to, FDA’s interface with ACE, ITACS, PNSI, OASIS, and Entry Review.
During this maintenance period FDA will not receive new data from CBP, or process any outbound messaging. New entries sent by CBP during this period will be not be processed by FDA, and no response messages will be sent until after the maintenance period has completed. As a result, FDA will be operating under the prior notice contingency scenario 3 during this time.
If prior notice has already been submitted via ABI/ACE ITDS prior to the scheduled maintenance period, and a prior notice confirmation number has been received, the submitter may proceed with prior notice using the standard process. However, if prior notice is submitted via ABI/ACE ITDS and a prior notice confirmation number is not received prior to the outage, 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 ITDS.
If prior notice has been submitted via PNSI prior to the scheduled maintenance period 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 Web Entry Summary Confirmation page, including the prior notice confirmation number and time stamp, to CBP officers for cargo release.
If prior notice has not already been submitted, ABI filers may decide to wait out the scheduled maintenance period, 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 interim final rule for filing timely prior notice.
Otherwise, if prior notice has not been submitted before the scheduled maintenance period, it may be submitted by either e-mail or fax (21 CFR 1.280(c)). The e-mail and fax submission form will appear when attempting to log into the PNSI system. If not redirected, filers may use this link to go to the form directly for email or fax submission form: https://www.accessdata.fda.gov/scripts/pnsic/Contingency_Submission.cfm. The email form may be limited during this scheduled maintenance period.
For e-mail submissions, FDA intends to transmit back to the e-mail address from which the Prior Notice was transmitted an automated receipt response from FDA, including the prior notice confirmation number. A paper copy of FDA’s e-mail receipt confirmation should be presented to the CBP officer for cargo release processing. CBP intends to enforce prior notice submission timeframes based on the e-mail receipt confirmation time stamp.
In cases of fax transmissions, the Prior Notice Center intends to return a fax acknowledgement report including the prior notice confirmation number. The fax acknowledgement report should then be presented to the CBP officer for cargo release processing. CBP officers intend to enforce prior notice submission time frames based on the fax received confirmation time stamp.
FDA ACE Support can be contacted from 6:00 AM -10:00 PM Eastern, 7 days a week, at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries. Email may be limited during this scheduled maintenance period.
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