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

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As an alternative to using the AS2 Header Attributes (Appendix G) process for sendingsubmissions to the FDA ESG, you can use unique routing IDs for your submissions to indicatethe type of submission and the intended Center. This Appendix describes how to automate theselection of the routing ID in Cyclone/Axway products through the incoming back-endintegration pickup. If you are not using a Cyclone/Axway product, refer to your gatewaysoftware's documentation for help configuring routing IDs.The routing IDs for each submission type are listed at the end of the appendix.Before routing IDs can be selected, they must be added to your partner profile.1. In your FDA partner profile, click on the "Routing IDs" link.Figure 1: Partner Profile2. Use the "Add" button at the bottom of the page to add extra routing IDs to the FDApartner.Note: "ZZFDA" (production) or "ZZFDATST" (test) must be the first routing IDlisted. Otherwise, the submission will not be processed correctly by the FDA.Figure 2: Change Routing IDs PagesOnly file system integration pickups have the ability to automatically select a routing ID.If you are not currently using file system integration pickups to interface with the backendserver, you must create a file system integration pickup must be created. Refer toyour gateway software's documentation for more information on this procedure.3. After you create a file system integration pickup, create a directory structure on the diskthat matches the routing ID's path and configure the integration pickup to automaticallyselect a routing ID based on directory names.4. In this example, the path to the integration pickup is C:\bin\cyclone\common\data\out,as shown in Figure 3: File System Settings, Directory Name. This path should match thedirectory structure you created in step 3.
Figure 3: File System Settings, Directory NameClick on the Message attributes tab. This will access the following screen:Figure 4: Message Attributes, Adding
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FDA Electronic Submissions Gateway
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Appendix C. Digital Certificates...
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Figure 1: Overview of the Registrat
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2.6 Send Submissions to the Product
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eCTD - Electronic Common Technical
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FDAPreparation of multi-filesubmiss
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3.7 Help and InformationThere are r
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4. Click the Next button.The Pick a
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8. Click the Next button.The Locate
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14. Enter a new login User ID and P
Page 23 and 24: Confirm that the correct version of
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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
Page 41 and 42: - Create a local environment that s
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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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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
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Page 71 and 72: EDIFACT UNB Header InformationDescr
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FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

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