FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

4.4 Apply for a Production System AccountThe steps for applying for an FDA ESG Production System Account are the same as thosedescribed in Section 4.1, Apply for a Test Account.However, there is a difference in the Login page. The Login page should not have the testenvironment warning that it has when sending a test submission; it should look like the Loginpage shown below:If the Login page does have the warning, do not send a submission. Exit the browser, contact theFDA ESG Administrator at esgprep@fda.hhs.gov and obtain the correct address for the FDAESG Login page.4.5 Production System Account Setup and ApprovalAfter successfully completing the Production System Account setup, the FDA sends an email tothe email address provided for the primary contact, indicating approval as a Transaction Partnerand authorization to send submissions to the FDA ESG. Typically, the approval notification issent on the next business day.Submissions cannot be sent to the FDA ESG until this notification has been received.4.6 Send Submissions to the Production System