FDA Scheduled Down Time: Sat, Mar 20, 11PM ET to Sun, Mar 21, 2021 1AM ET

CSMS #46669294 - FDA Scheduled Down Time: Sat, Mar 20, 11PM ET to Sun, Mar 21, 2021 1AM ET U.S. Customs and Border Protection sent this bulletin at 03/19/2021 02:37 PM EDT CSMS #46669294 - FDA Scheduled Down Time: Sat, Mar 20, 11PM ET to Sun, Mar 21, 2021 1AM ET The Food and Drug Administration (FDA) has scheduled planned maintenance this weekend during the time shown below, impacting system availability for: Interoperability Web Service (IWS), the interface between U.S. Customs and Border Protection (CBP) and FDA FDA Import Trade Auxiliary Communications Systems (ITACS) START : Saturday, March 20, 2021, 11:00PM ET END : Sunday, March 21, 2021, 1:00AM ET During this time: FDA will not process any Inbound entries or Outbound messages. If documents must be submitted via FDA ITACS, please submit to the local FDA office at the port of entry via that office’s preferred alternate communication method. Contact information for all FDA import offices can be found on FDA’s Import Offices and Ports of Entry web page: fda.gov/industry/import-program-food-and-drug-administration-fda/import-offices-and-ports-entry FDA Prior Notice System Interface (PNSI) will be operational under Contingency Scenario 1 . Please Do Not resubmit entries during this window as it will add to the backlog to be processed 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 option 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 option 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) 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 For questions regarding Prior Notice, please 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, 877-345-1101, ACE_Support@fda.hhs.gov . ACE Support Hours: Monday - Friday, 8AM-8PM ET, ACE Support is Closed on Saturdays & Sundays.