Outage Notification and Disruption Policy

System Configuration Change Notification

ESG NextGen will notify industry users through Unified Submission Portal (USP) and AS2 listservs of any upcoming User Interface, major configuration, or major system change at least 90 days prior to implementation. This notification period allows time for users to prepare, test, and provide feedback. 

• Planned Maintenance: Notifications for scheduled maintenance will be provided 1 week in advance.
• Additional Maintenance or Minor Updates: Notices for unscheduled or minor updates will be sent 1 week prior to the completion date to allow minimal disruption.

Please email ESGNGSupport@fda.hhs.gov✉️ if you would like to receive listserv notifications.

ESG NextGen Contingency Operations Planning

While it is not anticipated, the below policy outlines procedures in the event of extended ESG NextGen outages. All communications will be sent via the USP listservs for USP and API related issues and/or the AS2 listserv for AS2-related issues. 

• Outage Resolved in 15 Minutes or Less: ESG NextGen will send an email notification with the outage duration and cause, after resolution.
• Outage Expected to be Resolved Within 4 Hours: An initial email will be sent upon detection, followed by an update within 2 hours, and a closure notification upon resolution.
• Outage Expected to be Resolved Within 24 Hours: ESG NextGen will send an initial notification upon detection, followed by updates every 2-3 hours until resolution, with a closure email upon completion. 
• Outage Expected to Last Between 24-48 Hours: ESG NextGen will send an initial notification upon detection, with updates every 3-5 hours until resolution, with a closure email upon completion. 
• Outage Exceeding 48 Hours: Users will be instructed to send submissions, including the ESG NextGen notification, on approved physical electronic devices (CDs, DVDs, USB drives) to the respective FDA Center’s mailing address. ESG NextGen will continue to provide updates every 4-6 hours until resolution, with a closure email upon completion. 

FDA Center Contact Information for Physical Submissions (Extended Outage Only)

• Center for Biologics Evaluation and Research (CBER):
  • CBER Regulatory Submissions (electronic and paper) and Mailing Address
  • CBER Guidance for Industry
• Center for Drug Evaluation and Research (CDER):
  • CDER Contact Information and Mailing Address
  • CDER Guidance for Industry

Note: In the event of an FDA-wide outage, Centers will be offline and would NOT be able to process submissions sent on physical electronic media until the outage is resolved.

For ESG NextGen related questions or to receive ESG NextGen notifications, please contact, ESGNGSupport@fda.hhs.gov✉️.