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U.S. Department of Health and Human Services

For Industry

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Frequently Asked Questions - Errors

 

The following are questions about errors received from the Electronic Submissions Gateway(ESG):

Q. Why did I receive a disk space error when sending a submission using the FDA ESG web interface?

A. Every time a submission is sent to the FDA ESG via the web interface, a back up copy of the packaged (encrypted, tar'd & gzipped) submission file is stored on the local PC.   This backup file is stored under:
        C:\Documents and Settings\<your identity>\.cyclone\backup.
Make sure there is ample disk space to backup the submission. It is recommended that you have disc space of at least three times the size of the transmission. 
The backup copies can be deleted by first logging in to the FDA ESG web interface.  Then go to: WebTrader >> Recent Folder >> Sent.
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.


Q. Why did I receive a signing encryption error?

A. Be sure to use the public key certificate that matches the certificate on file with FDA ESG.  Verify the correct public key certificate was uploaded during the registration process by contacting the FDA ESG administrator and comparing the md5 fingerprints within the certificate.


Q.  Why did I receive a private key error? 

A. 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.


Q. Why did I get a Federal Information Processing Standards (FIPS) error when sending a submission using the FDA ESG web interface?

A. 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 (JRE) Installation in the User Guide for more information.

Note:  FIPS are standards and guidelines that are developed by the National Institute of Standards and Technology (NIST) when there are compelling Federal government requirements such as for security and interoperability and there are no acceptable industry standards or solutions.


Q. 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."

A. 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 Certificates in the User Guide 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.


Q. 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. 

A. 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 (> 10 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. 


Q. Why did I receive an "app not inited" error?

A. This error usually occurs when the WebTrader Java applet does not intialize correctly. You can solve this by clearing your Java applet cache:

  1. Go to the Windows Control Panel.
  2. Double-click the Java icon to go to the Java control panel.
  3. Click the "Delete Files..." button in the "Temporary Internet Files" section of the control panel.
  4. Log back into the ESG and choose "Send Document".
  5. NOTE: Do not click on anything for at least two minutes to allow the applet to download and initialize. Interrupting the initialization can corrupt the Java applet cache.

Q. My error was not listed here. What should I do?

A. We may be able to assist you with your problem. However, it will help us to have a copy of your Java log. To obtain this:

  1. Open the WebTrader interface.
  2. Open the Java console using the Internet Explorer menu "Tools|Sun Java Console".
  3. Press "5" to set the trace level to the most detail.
  4. Send your submission as usual.
  5. If it fails, send all the files in the following directory to esgprep@fda.hhs.gov:

    C:\Documents and Settings\[username]\Application Data\Sun\Java\Deployment\log\

    Replace the "[username]" in that path with the username you use to log in to Windows.


Q. How do I reinstall Java?

A. Reinstalling Java can be an effective solution to some errors. However, you must reinstall cleanly:

  1. Uninstall all versions of Java on the machine.
  2. Reboot.
  3. Delete "C:\Program Files\Java"
  4. Delete "C:\Documents and Settings\*\Application Data\Sun\Java".
  5. You must do this in the profile of every user on the machine (replace the "*" with each user's profile directory).
  6. Delete "C:\Documents and Settings\*\Local Settings\Application Data\Sun\Java". Again, you should do this for all users.
  7. Reboot.
  8. To Install the most recent version of JRE/JCE, see Appendix D, Java Runtime Edition JRE) Installation in the User Guide.

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


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