1. Home
  2. For Industry
  3. Electronic Submissions Gateway Next Generation (ESG NextGen)
  4. Policies/Guidance
  5. Outage Notification and Disruption Policy
  1. Policies/Guidance

Outage Notification and Disruption Policy

System Configuration Change Notification

Major System Updates

ESG NextGen will provide advanced notification to industry users through the Unified Submission Portal (USP) and AS2 listservs for any upcoming user interface, major configuration, or major system change. This notification period allows for users to prepare, test, and provide feedback.

 

Minor System Updates

Outages due to ESG NextGen releases for minor new functionality or issue resolution, an email notification will be sent out through the USP and AS2 listservs at least one week in advance.

 

Planned Maintenance Updates

All planned maintenance updates will be posted here. This list of outages will be updated when changes to the schedule have been confirmed. Email notifications for planned maintenance updates will NOT be sent out. Please check back frequently to stay up to date.

Maintenance Outage DateMaintenance Outage Timeframe
Saturday, September 6, 20252 AM ET - 8 AM ET
Friday, September 19, 202510 PM ET - 12 AM ET, Saturday, September 20, 2025
Saturday, September 27, 2025Web HelpDesk will be unavailable 8 AM ET – 4 PM ET.

Emails can still be sent to ESGNGSupport@fda.hhs.gov during this time. New ticket messages from the system will be sent after the outage and response from support personnel will continue to follow the Help Desk hours of 8 AM ET – 8 PM ET M-F.
Saturday, October 4, 20252 AM ET - 8 AM ET
Tuesday, October 14, 20259 PM ET – 7 AM ET, Wednesday, October 15, 2025

Potential for brief, intermittent interruptions with submissions via the Unified Submission Portal and API. AS2 is not impacted by this update.
Friday, October 17, 202510 PM ET - 12 AM ET, Saturday, October 18, 2025
Saturday, November 1, 20252 AM ET - 8 AM ET
Friday, November 14, 202510 PM ET - 12 AM ET, Saturday, November 15, 2025
Saturday, November 29, 20252 AM ET - 8 AM ET
Friday, December 12, 202510 PM ET - 12 AM ET, Saturday, December 13, 2025
Tuesday, December 16, 202510 PM ET – 10:30 PM ET

Potential for brief, intermittent interruptions with submissions via the Unified Submission Portal and API.

AS2 is not impacted by this update.
Saturday, December 27, 20252 AM ET - 8 AM ET

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)

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✉️.   

Back to Top