CSMS Message: 18-000704

As an impact of CBP's Gateway Migration, CBP will not be sending entries to FDA on December 1, 2018 from 2200 ET to 0200 ET December 2, 2018. I.E. FDA will not be receiving inbound entries and CBP will not be sending messages from FDA to trade until the end of the outage. Prior Notice System Interface (PNSI) will be operational.

If Prior Notice has been submitted via ACE and confirmation has been received:
• No further action is required.

If Prior Notice has been submitted via ACE and confirmation has not been received:
• Please do not resubmit entries as this will cause additional delays.
• Filers have the options to:
o Wait until the issue is resolved, unless this will cause the prior notice submission to be untimely. Filers who choose this option should understand that they remain responsible under section 801(m) of the Federal Food, Drug, and Cosmetic Act and under the prior notice final rule for filing timely prior notice.
o Provide CBP officers with evidence to show prior notice was submitted via ACE (e.g. signed copy of the ABI/ACE transmission).
If Prior Notice has not been submitted:
• Filers have the options to:
o Wait until the issue is resolved, unless this will cause the prior notice submission to be untimely. Filers who choose this option should understand that they remain responsible under section 801(m) of the Federal Food, Drug, and Cosmetic Act and under the prior notice final rule for filing timely prior notice.
o Submit Prior Notice via the Prior Notice System Interface (PNSI) https://www.access.fda.gov/. The prior notice confirmation number must accompany the article(s). Presenting the PNSI confirmation page(s) to CBP officers is recommended.

For additional details, see Prior Notice Contingency Scenario 2 https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm078888.htm#s1.

An updated message will be sent once the maintenance has concluded.

For questions regarding Prior Notice, contact the FDA's Division of Food Defense Targeting (DFDT). The DFDT can be reached 24/7/365 at (866) 521-2297 or prior.notice@fda.hhs.gov.

For ACE inquiries, contact FDA ACE Support. ACE Support can be reached from 6:00 AM -10:00 PM Eastern, 7 days a week, at 877-345-1101 or ACE_Support@fda.hhs.gov.