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U.S. Department of Health and Human Services

For Industry

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Instructions for Using eSubmitter on Microsoft Vista

The FDA eSubmitter application has compatibility issues with the Windows Vista Operating System. The application will appear to have installed properly and will run as intended. FDA eSubmitter may even allow you to create submissions, save, and open any partially completed submissions at a later time. However, the files that FDA eSubmitter creates are not stored properly for the new Windows Vista’s configuration. Therefore, special instructions are required for VISTA Users.

Nature of the Compatibility Issue:

By default, the FDA eSubmitter application was previously installed in the following directory: C:\Program Files\eSub. The FDA eSubmitter application appears to run as intended until you attempt to generate any of the output files (e.g., view the Missing Data Report or package files for submission).

It appears that Vista does not allow data files to be created under the Program Files directory. Vista restricts this area to be solely for applications and not for file creation or modification by the user. In addition, since the submission files created are XML based, Vista may also view these as potential configuration files and may choose to hide them from the user’s view.

This page contains the scenarios that we are currently aware of. If you encounter any issues that are not covered here, or need additional assistance, please contact our support desk at esub@cdrh.fda.gov.

Please select the scenario that applies to you:


 Scenario 1: I am planning to install FDA eSubmitter on Windows Vista. How do I proceed?

Ensure that you install version 1.28.01 or later. The compatibility issues have been resolved in FDA eSubmitter v1.28.01. If you have not installed FDA eSubmitter prior to January 8, 2008, you should not encounter any compatibility issues. Download the application from the FDA eSubmitter website. The application will install the data and output folders outside of Program Files in the following location: C:\Users\Public\eSub_Home\

Note: Do not change your Preferences within FDA eSubmitter to move the location of the data and output folders into the eSub directory under Program Files.

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 Scenario 2: I have already installed FDA eSubmitter on Windows XP or earlier and I am planning to upgrade to Windows Vista. How do I proceed?

  1. Was FDA eSubmitter installed on your workstation or are you running it from a network drive? (I don’t know. How do I find out?)
    1. If running FDA eSubmitter from a network, there are no potential issues that we are aware of at this time.
    2. If running from your workstation, was FDA eSubmitter installed within your Program Files? (I don’t know. How do I find out?)
      1. If no, there are no potential issues.
      2. If yes, are your data and output files currently being stored within Program Files? (I don’t know. How do I find out?)
        1. If no, there are no potential issues.
        2. If yes, then you must do the following:
          1. Do you have existing FDA eSubmitter Report files?
            1. If no, then there are no remaining steps.
            2. If yes, then you must create and restore backup submission files that were created in Windows XP or earlier.
          2. Change your preferences to redirect your data and output files.

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 Scenario 3: I have already installed FDA eSubmitter on Windows Vista. What are my potential issues?

  1. Was FDA eSubmitter installed on your workstation or are you running it from a network drive? (I don’t know. How do I find out?)
    1. If running FDA eSubmitter from a network, there are no potential issues that we are aware of at this time.
    2. If running from your workstation, was FDA eSubmitter installed within your Program Files? (I don’t know. How do I find out?)
      1. If no, there are no potential issues.
      2. If yes, are your data and output files currently being stored within Program Files? (I don’t know. How do I find out?)
        1. If no, there are no potential issues.
        2. If yes, then you must do the following:
          1. Do you have existing FDA eSubmitter Report files?
            1. If no, then there are no remaining steps.
            2. If yes, then you must retrieve your existing submission files from Vista’s Virtual Store.
          2. Change your preferences to redirect your data and output files.

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 Scenario 4: I had FDA eSubmitter installed on an earlier version of Windows and I have upgraded to Windows Vista. What are my potential issues?

  1. Was FDA eSubmitter installed on your workstation or are you running it from a network drive? (I don’t know. How do I find out?)
    1. If running FDA eSubmitter from a network, there are no potential issues that we are aware of at this time.
    2. If running from your workstation, was FDA eSubmitter installed within your Program Files? (I don’t know. How do I find out?)
      1. If no, there are no potential issues.
      2. If yes, are your data and output files currently being stored within Program Files? (I don’t know. How do I find out?)
        1. If no, there are no potential issues.
        2. If yes, then you must do the following:
          1. Do you have existing FDA eSubmitter Report files?
            1. If no, then there are no remaining steps.
            2. If yes, then you must retrieve your existing submission files from Vista’s Virtual Store and create and restore backup submission files that were created in Windows XP or earlier.
          2. Change your preferences to redirect your data and output files.

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 How to determine if you are running FDA eSubmitter on a Workstation or a Network:

If you are unsure where FDA eSubmitter was first installed, follow the steps outlined below to determine the installation location.

  1. Check to see where FDA eSubmitter is installed. (I don’t know. How do I find out?)
  2. The drive where FDA eSubmitter is installed will indicate if you are running the application from a workstation or a network (e.g. C:\ or S:\).

Note: If you do not know if the drive shown in the Configuration screen represents a local drive or network drive, contact your system administrator.

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 How to determine if FDA eSubmitter is installed within your Program Files:

If you are unsure where eSubmitter was first installed, follow the steps outlined below to determine the installation location.

  1. Run the FDA eSubmitter application.
  2. Select About from the Help menu as shown in Figure 1.

Figure 1: Help Menu
Picture of the help menu. The third item, "About..." is highlighted.

  1. Click on the Display Configuration button as shown in Figure 2.

Figure 2: About Dialog
Picture of the "About" dialog box. Shows eSubmitter logo, reads CeSub eSubmitter, Version 1.27.01 Build 6, FDA, CDRH. The button marked "Display Configuration" button below that text is highlighted.

  1. The Configuration dialog box will appear. In the Name column, look for user.dir. The value associated with user.dir will be the location where eSubmitter is installed. In the example shown in Figure 3, FDA eSubmitter is running from within the Program Files directory (C:\Program Files\eSub).

Figure 3: Configuration Dialog
Picture of the configuration dialog box. The setting "user.dir" is highlighted, with a value of c:\program files\esub.

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 How to determine if your data and output files are being stored in Program Files:

If you are unsure where your data and output files are being stored, follow the steps outlined below.

  1. Run the FDA eSubmitter application.
  2. Select Preferences from the File menu.
  3. Select the File Location tab in the User Preferences Dialog box.
  4. View the location of the Data Location and Output Location folders.

Note: If you see the words “Program Files” in the name of the specified location OR if there is no drive letter or starting back slash (e.g., C:\), then your data and/or output files are being stored within Program Files.

Figure 4 is an example of data and output files being stored within the Program Files directory.

Figure 4: User Preferences Dialog – File Location Tab (Old)

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 How to Change your Preferences in FDA eSubmitter:

To change your preferences in FDA eSubmitter, follow the steps outlined below.

  1. Run the FDA eSubmitter application.
  2. Select Preferences from the File Menu.
  3. Select the File Location tab in the User Preferences Dialog box.
  4. Verify that a data and output folder exists in the eSub_Home folder
    • Note: You may have to create an eSub_Home folder and data and output subfolders before setting your preferences.
  5. In the Data Location field, select the open folder button () and navigate to the new data location, C:\Users\Public\eSub_Home\data\ (see Figure 5).
  6. In the Output Location field, select the open folder button () and navigate to the new output location, C:\Users\Public\eSub_Home\output\ (see Figure 5).
  7. You have successfully changed you preferences in FDA eSubmitter.

Figure 5: User Preferences Dialog – File Location Tab (New)
Picture of user preferences dialog box. Data Location is highlighted with a value of c:\users\public\eSub_Home\data. Output Location is also highlighted, with a value of c:\Users\Public\eSub_Home\output.

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 How to Retrieve Existing Submission Files started in Vista:

If you have existing submission files that were created or updated in Windows Vista prior to January 8, 2008, you will need to retrieve your existing submission files and save them to an alternate directory location. To back up your data and output files, follow the steps below:

  1. Navigate to the default location where FDA eSubmitter was previously installed (C:\Program Files\eSub).
  2. In the eSub directory, you will see a Data and Output folder. (Note: You may not have an Output folder if you have not yet packaged files for submission).
  3. Open the Data folder.
  4. Click on the Compatibility Files button in the toolbar as shown in Figure 6.

Figure 6: Vista Folders and Files
Highlight of screenshot reads: Click the menu named "Compatibility Files", located next to Organize and Views, to view data file(s).

  1. The missing data files will appear. Copy the data files (these files will have an .xml extension) Note: Do not copy the prop_user.xml file. See Figure 7 .

Figure 7: Vista Compatibility Files
One row in the file list named Test1, an XML document, is highlighted with a label reading "copy data file(s)".

  1. Paste these files into an alternate location on your hard drive (outside of the eSub folder). You will need to retrieve these files and replace them into the new location, C:\Users\Public\eSub_Home\data.
  2. Repeat Steps 3 – 6 with the submission files in the Output folder. (Note: You may not have files in your Output folder if you have not packaged files for submission).
  3. Now you have successfully completed the backup of your data and output files.

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 How to Create and Restore Backup Submission Files (started in Windows XP or earlier):

If you have existing submission files that were created prior to January 8, 2008 in Windows XP or earlier, you will need to create and restore backup submission files. To backup your data and output files, follow the steps below:

  1. Navigate to the default location where FDA eSubmitter was installed (C:\Program Files\eSub).
  2. In the eSub directory, you will see a data and output folder. (Note: You may not have an Output folder if you have not yet packaged files for submission).
  3. Open the data folder.
  4. Copy all the data folders/files except the following:
    1. The support folder
    2. clist.xml
    3. elist.xml
    4. prop_user.xml
  5. Create a folder labeled eSub_Home outside of Program Files to host your data and output submission files, if one does not already exist.
    • Note: A recommended location for hosting the data and output files is: C:\Users\Public\eSub_Home
  6. Create a folder labeled data in the new eSub_Home folder, if one does not already exist.
  7. Paste the data files into the new location C:\Users\Public\eSub_Home\data.
  8. Navigate back to the default location where eSubmitter was installed (C:\Program Files\eSub).
  9. Copy the entire output folder.
  10. Paste the output folder in the new location C:\Users\Public\eSub_Home\.
  11. You have successfully created and restored your backup submission files that were created in Windows XP or earlier.

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