Title: | FDA Downtime 2/9/19 10 PM Eastern through 2/10/19 6 AM Eastern |
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Date: | 2019-02-07 |
To: | abi,air,ocean,partner,rail,truck |
Links: | previous, original, next |
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