FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
NOTE: The FDA ESG uses SSL over port 4080 for all AS2 inbound and outbound transactions.5.3 Send a Test Submission1. Contact the appropriate Center testing representative or appropriate programmaticrepresentative for safety reporting to schedule a specific test date and time.Reference Section 3.3, Understand Submission Guidelines, in the FDA ElectronicSubmissions Gateway User Guide for information on how to prepare an electronicsubmission and Center contact information.2. For multi-file submission, the entire submission must reside in a single directory.This directory must then be converted to a single .tar.gz file. Reference AppendixB.,Creating tar Files and Compressing Files for Submission, for instructions oncreating this compressed file. Take special note of the naming conventions for filesand directories to ensure delivery of a complete submission.3. There are two ways to set up routing controls dictating where a document is sent:a. Add the custom header attributes to the header of the message to indicatethe type of submission (e.g., an IND) and destination (e.g., CBER).Reference Appendix G., AS2 Header Attributes, for information on headerattributes content and format. ORb. Use a unique routing ID to identify the types of submissions anddestination. The selection of the routing ID can be automated in theCyclone/Axway products through the back-end integration pick-up asdescribed in Appendix K., AS2 Routing IDs.4. At the scheduled date and time, send the test submission to the FDA. The FDAESG will send a Mail Delivery Notification (MDN) indicating that the testsubmission was received successfully.The FDA ESG will then route the testsubmission to the Center Holding Area. The Center will validate the testsubmission. For all submissions, an Acknowledgement will be sent documentingthe official date and time of receipt by FDA, and in some cases theCenter/programmatic area business rules describing the establishment of that dateand time.The Centers/programmatic area has the option to send anAcknowledgement (via AS2) indicating whether the submission was valid orinvalid.5. Contact the FDA ESG System Administrator at esgreg@fda.hhs.gov if either theMDN or the Center Acknowledgement is not received.Once a test submission has been successfully received and validated, the Transaction Partner isapproved to apply for and setup a Production System Account. This account will be used to sendsubmissions to the FDA.5.4 Apply for a Production System AccountThe steps for applying for a Production System AS2 Gateway Account are the same as thosedescribed in Section 2.1, Apply for a Test Account in the FDA Electronic Submissions GatewayUser Guide.
Be sure to indicate on the application form that this application is for a Production SystemAccount.5.5 Production System Account Setup and ApprovalThe steps for setup and approval of a Production System AS2 Gateway Account are the same asthose described in Section 2.1, Apply for a Test Account in the FDA Electronic SubmissionsGateway User Guide. Upon completion of this step, the Transaction Partner is now ready to sendsubmissions to the FDA ESG.5.6 Send Submissions to the Production SystemFor each submission sent to the FDA ESG, at least two messages will be sent, and up to threemessages will be sent back to the Transaction Partner.1. The Transaction Partner will receive the MDN from the FDA ESG indicating that thesubmission was received successfully.2. For all submissions, an Acknowledgement will be sent documenting the official date andtime of receipt by FDA, and in some cases the Center/programmatic area business rulesdescribing the establishment of that date and time.3. Indication of submission validity or invalidity (at Center/programmatic area option).5.7 Sending Large (> 7.5 GB) SubmissionsNOTE: This section primarily applies to Transaction Partners sending regulatory submissions toCBER and CDER and does not apply to Transaction Partners sending Safety Reports.The 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. Transaction Partners who will be sending regulatory submissions larger than 1 GB in size,FDA has the following recommendations.- During the testing phase, send a 7.5 GB test submission. This test will allowTransaction Partners to evaluate bandwidth availability, transmission time, and toadjust their network configuration as necessary. During pilot testing of the FDAESG, industry testers found that bandwidth availability and network configurationhad a major impact on the time to transmit submissions larger than 5 GB. Thissubmission should be sent to "GW TEST" Centers with "SIZE TEST" as thesubmission type.- Send a 7.5 GB test submission that is representative of an actual submission (PDFfiles and SAS transport files). The web interface archives and compresses thesubmission into a single file prior to transmission. Submissions that consist of textfiles 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
- 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 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: The following information is requir
- 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
Be sure to indicate on the application form that this application is for a Production SystemAccount.5.5 Production System Account Setup and ApprovalThe steps for setup and approval of a Production System AS2 <strong>Gateway</strong> Account are the same asthose described in Section 2.1, Apply for a Test Account in the <strong>FDA</strong> <strong>Electronic</strong> <strong>Submissions</strong><strong>Gateway</strong> <strong>User</strong> <strong>Guide</strong>. Upon completion of this step, the Transaction Partner is now ready to sendsubmissions to the <strong>FDA</strong> <strong>ESG</strong>.5.6 Send <strong>Submissions</strong> to the Production SystemFor each submission sent to the <strong>FDA</strong> <strong>ESG</strong>, at least two messages will be sent, and up to threemessages will be sent back to the Transaction Partner.1. The Transaction Partner will receive the MDN from the <strong>FDA</strong> <strong>ESG</strong> indicating that thesubmission was received successfully.2. For all submissions, an Acknowledgement will be sent documenting the official date andtime of receipt by <strong>FDA</strong>, and in some cases the Center/programmatic area business rulesdescribing the establishment of that date and time.3. Indication of submission validity or invalidity (at Center/programmatic area option).5.7 Sending Large (> 7.5 GB) <strong>Submissions</strong>NOTE: This section primarily applies to Transaction Partners sending regulatory submissions toCBER and CDER and does not apply to Transaction Partners sending Safety Reports.The <strong>FDA</strong> <strong>ESG</strong> 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 <strong>FDA</strong><strong>ESG</strong> is the bandwidth available to the Transaction Partner between their company and the <strong>FDA</strong><strong>ESG</strong>. Transaction Partners who will be sending regulatory submissions larger than 1 GB in size,<strong>FDA</strong> has the following recommendations.- During the testing phase, send a 7.5 GB test submission. This test will allowTransaction Partners to evaluate bandwidth availability, transmission time, and toadjust their network configuration as necessary. During pilot testing of the <strong>FDA</strong><strong>ESG</strong>, industry testers found that bandwidth availability and network configurationhad a major impact on the time to transmit submissions larger than 5 GB. Thissubmission should be sent to "GW TEST" Centers with "SIZE TEST" as thesubmission type.- Send a 7.5 GB test submission that is representative of an actual submission (PDFfiles and SAS transport files). The web interface archives and compresses thesubmission into a single file prior to transmission. <strong>Submissions</strong> that consist of textfiles 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
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