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

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Guidance for Industry: ProvidingRegulatory Submissions to Office ofFood Additive Safety in ElectronicFormat -- General ConsiderationsICH Home PagePDUFA Main Page on FDA SitePhRMA Home Pagehttp://vm.cfsan.fda.gov/~dms/opaeguid.htmlhttp://www.ich.org/http://www.fda.gov/oc/pdufa/default.htmhttp://www.phrma.org/Appendix A. Troubleshooting the FDA ESG Web InterfaceProblem: Started sending wrong submissionSolution: When the upload progress window appears, press Cancel and this will cease theuploading of that submission.Problem: Computer froze/crashed while sending the file.Solution: If the submission had begun transmitting (i.e., signing was already completed) to theFDA ESG when the computer froze or crashed, log back into the FDA ESG web interface. Thefile you were attempting to send will be on the top left hand side. Your options are to resumesending or deleting the submission. Check to make sure there is ample disk space. It isrecommended that you have disc space of at least three times the size of the transmission.Problem: Received a disk space error.Solution: Make sure there is ample disk space to backup the submission. It is recommended thatyou have disk space of at least three times the size of the transmission. Note that every time asubmission is sent to the FDA ESG, a back up copy of the packaged (encrypted, tarred, andgzipped) submission file is stored on the local PC. This backup file is stored under:C:\Documents and Settings\\.cyclone\backup.These backup copies can be deleted by first logging in to the FDA ESG web interface. Then goto: WebTraderRecent FolderSent.Select the desired entries for deletion. This will remove entries from the Sent view and will alsoremove the backup files from the backup directory on the local PC.
_____________________________________________________________________________Problem: Received a signing encryption errorSolution: Verify the correct public key certificate was uploaded during the registration processby contacting the FDA ESG Administrator at esgprep@fda.hhs.gov and comparing the md5fingerprints within the certificate._____________________________________________________________________________Problem: Received a private key errorSolution: This error occurs when there is a mismatch between the public and private key for acertificate. Check to ensure the correct private key for the public certificate sent to the FDA ESGis in place. Obtain the correct private key and resend the document._____________________________________________________________________________Problem: A FIPS error was received while sending a submissionSolution: Make sure the correct JRE version or security policies are properly installed. Reinstallthe JRE using instructions provided with that package. Reference Appendix D., Java RuntimeEdition Installation, for more information._____________________________________________________________________________Problem: The following error was received when trying to import a digital certificate using theFDA ESG Web interface:"Invalid certificate fileAn error has occurred while importing the certificate file. Most likely you selected the wrong filetype.”Solution: 1) Check the file extension. The file extension must be ".p7b” or ".cer”. Files withthese extensions represent the public key part of the certificate. Only the public key part of thecertificate can be imported. Reference Appendix C., Digital Certificate,for more information. 2)Make sure the local PC has been configured to recognize and use the digital certificate.Reference the operating system instructions on the local PC for more information._____________________________________________________________________________Problem: When using the FDA ESG Web interface, an error message was received at the veryend of a submission saying there was no response from the server and that the submission failed.
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 and 38: The following information is requir
Page 39 and 40: Be sure to indicate on the applicat
Page 41: - Create a local environment that s
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

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