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

Solution: When the FDA ESG has received a complete submission, a backup copy is madebefore the Java applet receives a reply from the server confirming the submission is complete.For large submissions (> 7.5 GB), this can take many minutes. Since there is no network activityfor such a long time, the session timeouts and the Java applet never receives the response. TheFDA ESG has received the submission successfully, but the Java applet returns an error andindicates that the submission needs to be resumed. Receipt of the first acknowledgement (MDN)confirms that the submission was successfully received by the FDA ESG and that it is okay tocancel the resume request. Since this is a large submission, it will take several hours before thefirst acknowledgement is received.FDA has asked Cyclone Commerce to provide an update to the web interface that fixes thiserror.Appendix B. Creating tar Files and Compressing Files for SubmissionCreating tar files for FDA ESG Web Interface SubmissionsDuring the file upload process, the FDA ESG Web Interface utilizes the tar functionality for filesystem consolidation when submitting files. The process occurs during the electronic "signing"of the submission. Before the file is transmitted, it is tarred and gzipped, encrypted, signed, andmime-wrapped (or packaged) before transmitting to the FDA ESG..tar.gz files should not contain files or sub-directories that have a "." (dot) at the beginning of itsname.The figure below illustrates this process.