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
4.8.4 Accessing MDNs and AcknowledgementsTo access an MDN after sending a submission,Log on to the ESG using the user name and password for the account from which you sent thesubmissions.From the WebTrader menu, select the "Check inbox" option. The receipts that are displayedspecify the name of the submission file as part of their name.Click the Details link next to the name of the required receipt to see its details.To access an acknowledgement after sending a submission,Log on to the ESG using the user name and password for the account from which you sent thesubmissions.From the WebTrader menu, select the "Check inbox" option. The messages with ".ack" or ".txt"extensions are the acknowledgements from Centers for submissions. The message name beforethe extension denotes the Core ID generated by the Center for the submission.Click on the name of the required acknowledgement to see its details.5. AS2 Gateway-to-Gateway Electronic SubmissionsThe steps below represent the current understanding of the AS2 Gateway-to-Gatewaysubmission process. Further refinement and clarification of these steps will be provided in futurerevisions of the user guide.5.1 Apply for a Test AccountAn online application form is provided for Transaction Partners to register for AS2 test accounts.The registration URL and a temporary Login ID and password can be obtained from the FDAESG Administrator by sending an email to esgprep@fda.hhs.gov indicating intent to register forthe FDA ESG.
The following information is required to complete the AS2 application form:- Contact information - The name and contact information of a person whom theFDA may contact for questions or additional information. Enter the followinginformation:- Company name- Primary Contact name- Primary Contact phone- Primary Contact email- Alternate contact name- Alternate phone- Alternate emailo NOTE: Partners who have either an FDA ESG Webtrader or AS2 accountalready, must enter a unique string (different from the one used when registeringfor the FDA ESG Webtrader or AS2 account) in the Company name field. This isto ensure that this account is treated as a separate identity in the database.- The URL from where test submissions will be sent and where acknowledgementsand notifications will be received from the FDA.- The digital certificate used to digitally sign and encrypt the test submission.- The organization’s ID number. This could be, but does not have to be the DataUniversal Numbering System (DUNS) number.- Firewall security information:- Secure Socket Layer (SSL) Information – user name and password (if one isneeded for SSL)- Proxy Information – if a proxy server is used.5.2 Test Account Setup and ApprovalAfter submitting the application information as described above, the FDA ESG Administratorwill communicate with the Primary Contact to validate the information provided, to setup the testaccount, and to test the AS2 Gateway-to-Gateway connection. At that time, the FDA ESGAdministrator will also obtain security and proxy information from the Transaction Partner.The FDA ESG Administrator will provide the following information so that the TransactionPartner can set up an account for the FDA ESG within their own Gateway. This FDA ESGaccount will enable the receipt of messages from the FDA ESG.- The FDA ESG Administrator’s contact information- The URL to which the Transaction Partner will send test submissions- The FDA digital certificate for test submissions- The FDA ID numberAt this point the Gateway-to-Gateway connection will be tested to ensure that secure messagesfrom the Transaction Partner to the FDA ESG and from the FDA ESG to the TransactionPartner’s AS2 Gateway are successfully received.
- 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: When a Center receives a submission
- 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
The following information is required to complete the AS2 application form:- Contact information - The name and contact information of a person whom the<strong>FDA</strong> may contact for questions or additional information. Enter the followinginformation:- Company name- Primary Contact name- Primary Contact phone- Primary Contact email- Alternate contact name- Alternate phone- Alternate emailo NOTE: Partners who have either an <strong>FDA</strong> <strong>ESG</strong> Webtrader or AS2 accountalready, must enter a unique string (different from the one used when registeringfor the <strong>FDA</strong> <strong>ESG</strong> Webtrader or AS2 account) in the Company name field. This isto ensure that this account is treated as a separate identity in the database.- The URL from where test submissions will be sent and where acknowledgementsand notifications will be received from the <strong>FDA</strong>.- The digital certificate used to digitally sign and encrypt the test submission.- The organization’s ID number. This could be, but does not have to be the DataUniversal Numbering System (DUNS) number.- Firewall security information:- Secure Socket Layer (SSL) Information – user name and password (if one isneeded for SSL)- Proxy Information – if a proxy server is used.5.2 Test Account Setup and ApprovalAfter submitting the application information as described above, the <strong>FDA</strong> <strong>ESG</strong> Administratorwill communicate with the Primary Contact to validate the information provided, to setup the testaccount, and to test the AS2 <strong>Gateway</strong>-to-<strong>Gateway</strong> connection. At that time, the <strong>FDA</strong> <strong>ESG</strong>Administrator will also obtain security and proxy information from the Transaction Partner.The <strong>FDA</strong> <strong>ESG</strong> Administrator will provide the following information so that the TransactionPartner can set up an account for the <strong>FDA</strong> <strong>ESG</strong> within their own <strong>Gateway</strong>. This <strong>FDA</strong> <strong>ESG</strong>account will enable the receipt of messages from the <strong>FDA</strong> <strong>ESG</strong>.- The <strong>FDA</strong> <strong>ESG</strong> Administrator’s contact information- The URL to which the Transaction Partner will send test submissions- The <strong>FDA</strong> digital certificate for test submissions- The <strong>FDA</strong> ID numberAt this point the <strong>Gateway</strong>-to-<strong>Gateway</strong> connection will be tested to ensure that secure messagesfrom the Transaction Partner to the <strong>FDA</strong> <strong>ESG</strong> and from the <strong>FDA</strong> <strong>ESG</strong> to the TransactionPartner’s AS2 <strong>Gateway</strong> are successfully received.
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