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  5. Outage Notification and Disruption Policy
  1. Policies/Guidance

Outage Notification and Disruption Policy

System Configuration Change Notification

The FDA ESG will notify Industry via Web Trader and AS2 list servs of any User Interface, major configuration, or major system change 90 days prior to completion. The 90 day notification will allow Industry to prepare, test, and provide feedback in a timely manner. Please note, while planned maintenance is scheduled ahead of time, ESG will send notification only 1 week prior to planned maintenance. Any additional maintenance or minor updates will also be given 1 weeks’ notice prior to the completion date.

Please email esghelpdesk@fda.hhs.gov if you would like to receive list serv notifications.

ESG Contingency Operations Planning

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

  • If an outage is resolved in 15 minutes or less, ESG will send an email and provide the outage window time and cause after the outage has been resolved.
  • If an outage cannot be resolved in 15 minutes, but it is believed the outage will be resolved in 4 hours or less, ESG will send an initial email when the outage is detected, a follow up email within 2 hours, and provide a closure email with the outage window time and cause once the outage has been resolved.
  • If an outage cannot be resolved in 4 hours, but it is believed the outage will be resolved in 24 hours or less, ESG will send an initial email when the outage is detected, follow up emails every 2 to 3 hours until resolution, and a closure email with the outage window time and cause once the outage has been resolved.
  • If an outage cannot be resolved in 24 hours, but is believed the outage will be resolved in 48 hours or less, ESG will send an initial email when the outage is detected, follow up emails every 3 to 5 hours until resolution, and a closure email with the outage window time and cause once the outage has been resolved.
  • If an outage cannot be resolved in 48 hours, ESG will let Industry know that they should send submissions (including the ESG notification) via approved physical electronic devices (CDs, DVDs, USB Drives) to the respective Center’s mailing address listed below.  ESG will continue to send follow up emails every 4 to 6 hours until resolution, and a closure email with the outage window time and cause once the outage has been resolved.

 

Center for Biologics Evaluation and Research (CBER)

Center for Drug Evaluation and Research (CDER)

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.

Please email esghelpdesk@fda.hhs.gov if you would like to receive list serv notifications.

Contact Us

For ESG Related Questions
Email: ESGHelpDesk@fda.hhs.gov