CSMS# 19-000046 - FDA Downtime 2/9/19 10 PM Eastern through 2/10/19 6 AM Eastern

You are subscribed to Air Manifest for U.S. Customs and Border Protection. This information has recently been updated, and is now available.

02/07/2019 10:25 AM EST

Air Manifest

Both CBP and FDA will be performing scheduled maintenance from 2200 EST on February 9, 2019 to 0600 EST on February 10, 2019. During this period, FDA will not be processing inbound entries or outbound messaging. Please do not resubmit entries during this window as it will create a larger backlog of entries to be processed at the end of the maintenance period.



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:

-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.



-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:

-Wait until the maintenance is complete and messaging is restored,

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.



-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 1 https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm078888.htm



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