CSMS# 17-000777 - FDA Scheduled maintenance on Saturday morning, December 16, 2017

Automated Broker Interface

Due to scheduled maintenance on Saturday, Dec 16, 2017, starting at approximately 3:00 AM to 6:00 AM ET, multiple FDA systems will be down. This includes, but is not limited to, PNSI, OASIS, Entry Review, ITACS, and FDA ACE Interface. As a result, FDA will be operating under the prior notice contingency scenario 3 during this time. PNSI will be down starting at 1:00 AM ET. Filers will be able to file prior notice in ABI from 1:00 am - 3:00am ET and receive a PN confirmation number. Email and Fax prior notice submissions will be accepted from 3:00 AM to approximately 6:00 AM ET while ACE FDA Interface, Oasis and PNSI are down.



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. Entries submitted in ACE AE/SE/PE transmissions may be present in the ACE PGA for verification of the submission.



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.



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.



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.



During this maintenance period, FDA will queue inbound and outbound messaging including entries until maintenance is complete. Once maintenance is complete, FDA will process all inbound and outbound messaging.



Questions regarding prior notice during this downtime should be presented to the FDA's Division of Food Defense Targeting at (866) 521-2297.

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.