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

processed by the FDA ESG. FDA strongly encourages Transaction Partners tosend test submissions comprised of PDF files and SAS transport files.- Send submissions greater than 7.5 GB in size overnight. Pilot testing with selectedIndustry Transaction Partners has shown that, depending on available bandwidth, ittakes approximately 24 hrs for submissions 15 GB to 25 GB in total size to betransmitted and processed by the FDA ESG. These companies had T3 networkconnections or better. FDA recommends that large submissions be sent overnight,starting at 4:30 PM EST, in order for the submission to be received by the targetCenter before the end of the next business day.Sending large submissions may result in the FDA ESG erroneously reporting that thetransmission was not successful, even though the FDA ESG has successfully received thetransmission. This is a known bug and FDA has asked Cyclone Commerce to provide an updateto that fixes this error.When the FDA ESG has received a complete submission, a backup copy is made before a replyfrom the FDA ESG is sent confirming the submission is complete. For large submissions (> 7.5GB), this can take many minutes. Since there is no network activity for such a long time, thesession timeouts and a response is not received. The FDA ESG has received the submissionsuccessfully, but an error is generated indicating that the submission needs to be resumed.Receipt of the first acknowledgement (MDN) confirms that the submission was successfullyreceived by the FDA ESG and that it is okay to cancel the resume request. Since this is a largesubmission, it will take several hours before the first acknowledgement is received.If you receive this error and it has clearly occurred at the end of the transmission, do not resendthe submission right away. Wait for several hours (or longer depending on the size of thesubmissions) and see if the MDN is sent before attempting to resend the submission.5.8 Common AS2 ErrorsHere are some of the most common causes of failed AS2 submissions:- Your firewall rules are not set to allow connections with the FDA over port 4080.The FDA requires that all communications with the ESG occur with HTTPS overport 4080.- You provide a private URL during registration. (A private URL is one locatedinside of your company's firewall.)- The submissions's message header does not contain custom attributes.We recommend two strategies to avoid these errors:- Work with your IT infrastructure team throughout the registration process. Makesure they are aware of specific security settings that need to be enabled forsuccessful AS2 registration and transmission.