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

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3.7 Help and InformationThere are resources that can be contacted if you need assistance with various aspects of thesubmission process. These are provided in the table below.Table 5: Submission Process Aspects and Help and Information ContactsSubmission Process AspectPreparation/Registration/Policy QuestionsTechnical Issues with Submissions after becoming aProduction System Transaction PartnerCenter-specific Submission GuidanceContactEmail: esgprep@fda.hhs.govEmail: esgreg@gnsi.comReference Section 3.3, UnderstandSubmission Guidelines.4. FDA ESG Web Interface Electronic SubmissionsThe steps for the electronic submission process for FDA ESG Web Interface users are providedin the following sections.4.1 Apply for a Test AccountApplying for an FDA ESG WebTrader Test account is a multi-step process. You should have thefollowing information before beginning the process:Company and contact informationDigital Certificate file locationYou can obtains the FDA ESG Web Interface address and a temporary Login ID and passwordby emailing esgprep@fda.hhs.gov and indicating your intent to register for the FDA ESG.The remainder of this section describes the FDA ESG Test Account Application process usingscreenshots from the FDA ESG Web Interface.
1. Using the address provided by the FDA, access the FDA ESG Web Interface.The Login page is displayed. Note the test environment warning on the Login page. If the Loginpage does not have this warning, do not continue. Exit the browser and contact the FDA ESGAdministrator at esgprep@fda.hhs.gov to request access to the test environment.2. Enter the User ID and Password provided by the FDA and click the Login button.The WebTrader registration wizard is displayed. This wizard will guide the you through theremainder of the application process.
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 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 and 32: 4.4 Apply for a Production System A
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
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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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