FDA Scheduled Maintenance on Multiple FDA Systems (Including the Prior Notice System Interface) July 13th, 11:00 PM – July14th 5:00 AM

CSMS #38770554 - FDA Scheduled Maintenance on Multiple FDA Systems (Including the Prior Notice System Interface) July 13th, 11:00 PM – July14th 5:00 AM U.S. Customs and Border Protection sent this bulletin at 07/05/2019 08:38 AM EDT   Cargo Systems Messaging Service CSMS #38770554 - FDA Scheduled Maintenance on Multiple FDA Systems (Including the Prior Notice System Interface) July 13th, 11:00 PM – July 14th 5:00 AM Due to scheduled maintenance, there will be an outage to several FDA applications on July 13th, 11:00 PM – July14th 5:00 AM. As a result, the interface between CBP and FDA, will be down and FDA will not be processing inbound entries or outbound messages until the end of the maintenance period. In addition, the Prior Notice System Interface (PNSI) will be unavailable during this window.   Filers are advised to file Prior Notice before the scheduled maintenance window via ACE or PNSI if possible , especially for perishable food items.   Do not resubmit previously transmitted entries during this maintenance window as it will add to the backlog to be processed. During the maintenance window, the following instructions will be applicable.   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 PNSI and confirmation has been received : Proceed with the Prior Notice using the PNSI confirmation number(s). The confirmation number(s) must accompany the article(s). Presenting the PNSI confirmation page(s) to CBP officers is recommended. 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: (Preferred) 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 email: A link to submit the email submission form will be published at https://www.access.fda.gov/ . FDA will send a reply email with the prior notice confirmation number. A copy of the email should be provided to CBP. Submit Prior Notice via fax: The Division of Food Defense Targeting’s fax number will be published at https://www.access.fda.gov/ . FDA will send a return fax with the confirmation number. A copy of the fax should be provided to CBP. For additional details, see Prior Notice Contingency Scenario 6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-prior-notice-imported-food-contingency-plan-system-outages .   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