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

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Figure 1: Overview of the Registration Process2.1 Apply for a Test AccountOrganizations that wish to submit electronically to the FDA must apply for an account toestablish themselves as Transaction Partners. The term "Transaction Partner" refers to:An external entity authorized by the FDA to submit electronic submissions. Authorizationincludes agreement to regulatory conditions, successful completion of a certification process, andFDA administrative inclusion as a Transaction Partner.Application for a test account must be initially requested for the FDA ESG. This is done toenable Transaction Partners to send a test submission to the FDA ESG.Applying for an account involves information-sharing activities between the Transaction Partnerand the FDA to set up transmission, receipt, and identification parameters. This ensures the
correct identification of the Transaction Partner to the FDA. Digital certificate information isprovided to the FDA as part of the application.2.2 Test Account Setup and ApprovalThe account application is reviewed by the FDA ESG Administrator. The Administrator verifiesthat a letter of non-repudiation agreement is on file and that the digital certificate conforms to theX.509 version 3 standard and that all data fields in the Issuer and Subject fields are completed(see Appendix C., Digital Certificates for more information). The Administrator will alsocommunicate with the Transaction Partner to confirm the application information. If theseconditions are met, a test account is set up and connections to the FDA ESG test system areestablished before the submitting organization is approved as a Transaction Partner.2.3 Send a Test SubmissionBy sending a test submission, the Transaction Partner ensures the following conditions are met:- The test submission is received by the FDA ESG. A notification is sent by the FDAESG confirming that the submission was successfully received.- The submission is routed to the correct Center Holding Area.- The submission is prepared according to regulatory guidelines. The Center sends anacknowledgement confirming that the submission was prepared correctly.During the testing process, Transaction Partners who will be sending submissions larger than1 GB in total size will be asked to send a 7.5 GB test submission. This test will allowTransaction Partners to identify and resolve network limitations that will impact the speed ofdelivery. Send 7.5 GB test submissions to the "GW TEST” Center and select "SIZE TEST” asthe submission type.When testing connectivity, do not send the submission to the actual Center. Instead send allconnectivity test submissions to the "GW TEST” Center with the submission type"CONNECTION TEST”. Only guidance compliance test submissions should be sent to the FDACenter.2.4 Apply for a Production System AccountApplying for a Production System Account in the FDA ESG follows the same process asapplying for a test account. Reference Section 2.1, Apply for a Test Account.2.5 Production System Account Setup and ApprovalThe same process is followed to setup a Production System Account as for a Test Account.Reference Section 2.2, Test Account Setup and Approval.
Page 1 and 2: FDA Electronic Submissions Gateway
Page 3: Appendix C. Digital Certificates...
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
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Page 33 and 34: submissions (> 7.5 GB), this can ta
Page 35 and 36: When a Center receives a submission
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Page 39 and 40: Be sure to indicate on the applicat
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Page 45 and 46: Upon receiving the file, signature
Page 47 and 48: or by obtaining a certificate from
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Page 51 and 52: 9. Give a file name and select the
Page 53 and 54: 4. Create a password for your priva
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2. Click on the link under Required
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4. With the box unchecked, a warnin
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. From the Add or Remove Programs d
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Appendix E. Glossary of TermsTable
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Appendix F. AcronymsA list of acron
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Table G-1: Allowable Center Attribu
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SAMPLE LETTER #1[Company Letterhead
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EDIFACT UNB Header InformationDescr
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Consult with an FDA Center represen
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Figure 3: File System Settings, Dir
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6. Click on the Save changes button
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Figure 7: Submission Types Supporte
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FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

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