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

More documents

Recommendations

Info

The steps to send a Submission to the FDA ESG are the same as those in Section 4.3, Send aTest Submission.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 in Section 4.5, Apply for a Production System Account.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.4.7 Sending Large (> 7.5 GB) SubmissionsThe FDA ESG is able to receive and process regulatory submissions up to 100 GB in size. Themajor consideration in determining how quickly large submissions are transmitted to the FDAESG is the bandwidth available to the Transaction Partner between their company and the FDAESG. FDA has the following recommendations concerning the transmission of large regulatorysubmissions.During the testing phase, send a 7.5 GB test submission. This test will allow TransactionPartners to evaluate bandwidth availability and to adjust their network configuration asnecessary. This test submission should be sent to the "Testing" Center with “7.5 GBSubmission“ as the submission type.Send a 7.5 GB test submission that is representative of an actual submission. The web interfacearchives and compresses the submission into a single file prior to transmission. Submissions thatconsist of text files will compress to a greater extent than PDF files, will transmit faster, and thusgive an inaccurate assessment of the time it takes for submissions to be sent and processed by theFDA ESG.Send submissions greater than 7.5 GB in size overnight. Pilot testing with selected IndustryTransaction Partners has shown that it takes approximately 24 hrs for submissions 15 GB to25 GB in total size to be transmitted and processed by the FDA ESG. These companies had T3network connections 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 target Center beforethe end of the next business day.Sending large submissions may result in the FDA ESG web interface erroneously reporting thatthe transmission was not successful, even though the FDA ESG has successfully received thetransmission. This is a known bug and FDA has asked Axway to provide an update to the webinterface that fixes this error.When the FDA ESG has received a complete submission, a backup copy is made before the Javaapplet 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 activity for sucha long time, the session timeouts and the Java applet never receives the response. The FDA ESGhas received the submission successfully, but the Java applet returns an error and indicates thatthe submission needs to be resumed. Receipt of the first acknowledgement (MDN) confirms thatthe submission was successfully received by the FDA ESG and that it is okay to cancel theresume request. Since this is a large submission, it will take several hours before the firstacknowledgement 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.4.8 Tracking SubmissionsOnce a submission has been sent using the FDA ESG Web Interface, the Transaction Partner cantrack the submission to ensure that it was received by the FDA ESG and the Center.4.8.1 The Submission ProcessWhen a submission is sent using the FDA ESG Web Interface, it goes through the followingsteps:The submission is transmitted using the FDA ESG Web Interface to the Gateway. When theFDA ESG receives this submission, it sends a receipt known as a Message Delivery Notification(MDN) to the Inbox of the account from which the submission was received.The submission is delivered from the FDA ESG to a central holding area for all the Centers.The submission is then delivered from the holding area to the appropriate Center. When a Centerreceives a submission, it sends an acknowledgement to the Inbox of the account from which thesubmission was sent.4.8.2 Message Delivery Notifications (MDNs) and AcknowledgementsWhen a submission is sent using the FDA ESG web interface, the following two messages aredelivered to the Inbox of the account from which the submission was sent.A receipt from the FDA ESG, also known as an MDN. This message denotes that the submissionhas been delivered to the FDA ESG. The name of the receipt message includes the file name ofthe submission that was sent. If a directory of files was submitted, the file name of thesubmission will be the name of the directory followed by the extension ".tar.gz". The MDNmessage contains the message ID of the submission and a date stamp for when the submissionwas received by the FDA ESG. These items may be used to track a submission.
Page 1 and 2: FDA Electronic Submissions Gateway
Page 3: Appendix C. Digital Certificates...
Page 6 and 7: Figure 1: Overview of the Registrat
Page 8 and 9: 2.6 Send Submissions to the Product
Page 10 and 11: eCTD - Electronic Common Technical
Page 12 and 13: FDAPreparation of multi-filesubmiss
Page 14 and 15: 3.7 Help and InformationThere are r
Page 16 and 17: 4. Click the Next button.The Pick a
Page 18: 8. Click the Next button.The Locate
Page 21 and 22: 14. Enter a new login User ID and P
Page 23 and 24: Confirm that the correct version of
Page 25 and 26: 7. Select the Send document menu it
Page 27 and 28: - Load tests ensure that you are ab
Page 29 and 30: 20. To access the receipt, click on
Page 31: 4.4 Apply for a Production System A
Page 35 and 36: When a Center receives a submission
Page 37 and 38: The following information is requir
Page 39 and 40: Be sure to indicate on the applicat
Page 41 and 42: - Create a local environment that s
Page 43 and 44: ___________________________________
Page 45 and 46: Upon receiving the file, signature
Page 47 and 48: or by obtaining a certificate from
Page 49 and 50: 3. Click on the Export button to cr
Page 51 and 52: 9. Give a file name and select the
Page 53 and 54: 4. Create a password for your priva
Page 55 and 56: 2. Select "Windows" from the platfo
Page 57 and 58: 2. Click on the link under Required
Page 59 and 60: 4. With the box unchecked, a warnin
Page 61 and 62: . From the Add or Remove Programs d
Page 63 and 64: Appendix E. Glossary of TermsTable
Page 65 and 66: Appendix F. AcronymsA list of acron
Page 67 and 68: Table G-1: Allowable Center Attribu
Page 69 and 70: SAMPLE LETTER #1[Company Letterhead
Page 71 and 72: EDIFACT UNB Header InformationDescr
Page 73 and 74: Consult with an FDA Center represen
Page 75 and 76: Figure 3: File System Settings, Dir
Page 77 and 78: 6. Click on the Save changes button
Page 79 and 80: Figure 7: Submission Types Supporte

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?