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

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The receipt for the test submission should be displayed here. This first receipt confirms that thesubmission was received by the FDA ESG. Click on the Details link to access the receiptcontents.If there are any errors in the submission, the receipt will not appear on the My FDA submissionspage but will be sent to the Documents in Inbox page. The receipt will contain information aboutwhy the submission failed.The FDA ESG will then route the test submission to the Center Holding Area. When the Centersystem successfully receives the submission, a second acknowledgement will be sent confirmingthat the Center has received the submission. The Center will then validate the test submission.Contact the FDA ESG testing representative at esgprep@fda.hhs.gov if the receipt for the testsubmission or the Center Acknowledgements is not received.The next step is to apply for an FDA ESG Production System Account. This process is describedin the following section.
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
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: 20. To access the receipt, click on
Page 33 and 34: submissions (> 7.5 GB), this can ta
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

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