ESG Appendix A: Troubleshooting the FDA ESG Web Interface

Problem: Started sending wrong submission

Solution: When the upload progress window appears, press Cancel and this will cease the uploading 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 the FDA ESG when the computer froze or crashed, log back into the FDA ESG web interface. The file you were attempting to send will be on the top left hand side. Your options are to resume sending or deleting the submission. Check to make sure there is ample disk space. It is recommended 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 that you have disk space of at least three times the size of the transmission. Note that every time a submission is sent to the FDA ESG, a back up copy of the packaged (encrypted, tarred, and gzipped) 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 go to: WebTraderèRecent FolderèSent.

Select the desired entries for deletion. This will remove entries from the Sent view and will also remove the backup files from the backup directory on the local PC.

Problem: Received a signing encryption error

Solution: Verify the correct public key certificate was uploaded during the registration process by contacting the FDA ESG Administrator at [email protected] and comparing the md5 fingerprints within the certificate.

Problem: Received a private key error

Solution: This error occurs when there is a mismatch between the public and private key for a certificate. Check to ensure the correct private key for the public certificate sent to the FDA ESG is in place. Obtain the correct private key and resend the document.

Problem: A FIPS error was received while sending a submission

Solution: Make sure the correct JRE version or security policies are properly installed. Reinstall the JRE using instructions provided with that package. Reference Appendix D., Java Runtime Edition Installation, for more information.

Problem: The following error was received when trying to import a digital certificate using the FDA ESG Web interface:

"Invalid certificate file

An error has occurred while importing the certificate file. Most likely you selected the wrong file type.”

Solution: 1) Check the file extension. The file extension must be ".p7b” or ".cer”. Files with these extensions represent the public key part of the certificate. Only the public key part of the certificate 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 very end of a submission saying there was no response from the server and that the submission failed.

Solution: When the FDA ESG has received a complete submission, a backup copy is made before the Java applet receives a reply from the server confirming the submission is complete. For large submissions (> 7.5 GB), this can take many minutes. Since there is no network activity for such a long time, the session timeouts and the Java applet never receives the response. The FDA ESG has received the submission successfully, but the Java applet returns an error and indicates that the submission needs to be resumed. Receipt of the first acknowledgement (MDN) confirms that the submission was successfully received by the FDA ESG and that it is okay to cancel the resume request. Since this is a large submission, it will take several hours before the first acknowledgement is received.

FDA has asked Cyclone Commerce to provide an update to the web interface that fixes this error.