FDA Downtime 8/24/19 11 PM EDT through 8/25/19 1 AM EDT

CSMS #39438717 - FDA Downtime 8/24/19 11 PM EDT through 8/25/19 1 AM EDT U.S. Customs and Border Protection sent this bulletin at 08/20/2019 12:13 PM EDT   Cargo Systems Messaging Service CSMS #39438717 - FDA Downtime 8/24/19 11 PM EDT through 8/25/19 1 AM EDT Due to scheduled downstream system maintenance on Saturday August 24 th from 11PM EDT to Sunday August 25 th at 1 AM EDT, FDA’s Interoperability Web Service (IWS), the interface between CBP and FDA, will be down and FDA will not be processing inbound entries or outbound messages. Normal processing of inbound and outbound traffic will resume at the end of this maintenance period.  FDA’s Prior Notice System Interface (PNSI) will be operational, therefore FDA will be operating under Prior Notice contingency scenario 1. 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 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 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. 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. Please reference instructions in "CSMS 39392173 - FOR USERS OF THE FDA PRIOR NOTICE SYSTEM INTERFACE (PNSI)" regarding closing PNSI web entries prior to 10:30 PM EDT on August 24 th.     For additional details, see Prior Notice Contingency Scenario 1 https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm078888.htm . An updated message will be sent once the issue is resolved.  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 .   Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page . You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.govdelivery.com . This service is provided to you at no charge by U.S. Customs and Border Protection . Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes. Powered by Privacy Policy | Cookie Statement | Help