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pdfFDA eSubmitter
User Manual
Document Version 4.7
October 1, 2009
DOCUMENT HISTORY
Version Number
Date
Description
Version 1.0
Version 1.1
May 26, 2004
August 27, 2004
Version 2.0
March 15, 2005
Version 3.0
June 24, 2005
Version 4.0
October 31, 2005
Version 4.1
Version 4.2
March 2, 2006
August 7, 2007
Version 4.3
January 7, 2008
Version 4.4
Version 4.5
May 2, 2008
March 16, 2009
Version 4.6
June 2, 2009
Version 4.7
September 11,
2009
OIVD Pre-Pilot Release (Software v1.00.00)
Updated to reflect the enhancements incorporated in the
Official OIVD Pilot Release (Software v1.00.01)
Updated to reflect enhancements incorporated into the
CeSub Pilot Release (software version 1.10). Updated for
applicability to OIVD and Radiological Health.
Updated for corrections and additional descriptions.
Also updated to reflect the enhancements in Software
versions 1.02.00 and 1.03.00.
Updated to reflect the enhancements in software versions
1.04.00 through 1.07.00
Revised the proxy server settings.
Updated the instructions in the Packaging Submission Files
section to incorporate the new packaging feature.
Updated the instructions for release 1.28.01 to include link
to special instructions for Windows Vista Users.
Updated the uninstall instructions.
Updated User Manual to accommodate eSubmitter as an
FDA tool and not solely for the use of CDRH submissions.
Updated to include revised links to the new eSubmitter
website on FDA.gov > For Industry.
Updated to include changes to eSubmitter per the Center for
Tobacco Products needs.
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i
FDA eSubmitter
Table of Contents
Section 1: Introduction.......................................................................................................... 1
Contents .............................................................................................................................. 1
Subsection 1.1: System Background................................................................................... 2
Introduction..................................................................................................................... 2
Subsection 1.2: About this Manual..................................................................................... 3
Introduction..................................................................................................................... 3
Subsection 1.3: Software Installation ................................................................................. 4
System Requirements...................................................................................................... 4
Uninstall Instructions ...................................................................................................... 4
Uninstall Instructions ...................................................................................................... 5
Installation Instructions................................................................................................... 6
Installation Instructions from Web Page......................................................................... 6
Installation Instructions for Microsoft Vista Users......................................................... 7
Proxy Server Instructions................................................................................................ 8
Section 2: Getting Started..................................................................................................... 9
Contents .............................................................................................................................. 9
Subsection 2.1: Starting the Software............................................................................... 10
Introduction................................................................................................................... 10
Starting the Software..................................................................................................... 10
Subsection 2.2: Setting User Preferences ......................................................................... 17
Introduction................................................................................................................... 17
Auto Save...................................................................................................................... 18
Layout ........................................................................................................................... 19
Networking ................................................................................................................... 20
File Location ................................................................................................................. 21
File Viewer.................................................................................................................... 23
Subsection 2.3: Creating a New Submission .................................................................... 25
Introduction................................................................................................................... 25
Create a New Submission ............................................................................................. 25
Subsection 2.4: Copy an Existing Submission to Create a New Submission................... 28
Copy an Existing Submission to Create a New Submission......................................... 28
Subsection 2.5: Re-open an Existing Submission............................................................. 31
Re-open an Existing Submission .................................................................................. 31
Section 3: Interface.............................................................................................................. 32
Contents ............................................................................................................................ 32
Subsection 3.1: Application Window ............................................................................... 33
Introduction................................................................................................................... 33
Simple View.................................................................................................................. 33
Expert View .................................................................................................................. 34
Layouts.......................................................................................................................... 35
Parts of the Primary Work Area.................................................................................... 35
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Table of Contents
Header Area .................................................................................................................. 36
Outline Area/View ........................................................................................................ 36
Screen Area/View ......................................................................................................... 37
Splitter Bar .................................................................................................................... 37
Subsection 3.2: Toolbar .................................................................................................... 38
Introduction................................................................................................................... 38
Subsection 3.3: Menu Bar - Tools .................................................................................... 40
Introduction................................................................................................................... 40
Subsection 3.4: Menu Bar - Output .................................................................................. 47
Introduction................................................................................................................... 47
Output Menu Commands.............................................................................................. 47
Section 4: Preparing a Submission..................................................................................... 48
Contents ............................................................................................................................ 48
Subsection 4.1: Entering Submission Information ........................................................... 49
Introduction................................................................................................................... 49
Entering Responses into the Submission ...................................................................... 49
Question Types ............................................................................................................. 50
Subsection 4.1.1: Question Types – Address and Contact Information ........................... 51
Copy Information from Contact Book into Question ................................................... 52
Subsection 4.1.2: Question Types – Option Lists............................................................. 54
Access the List of Available Options............................................................................ 55
Select multiple options or enter text responses into a Table......................................... 56
Subsection 4.1.3: Question Types – File Attachments ..................................................... 57
How to Attach a File to an Attachment Question Type................................................ 58
Subsection 4.1.4: Question Types – Guidance Documents .............................................. 64
Select a Guidance Document ........................................................................................ 64
Subsection 4.1.5: Question Types – Text Fields and Messages ....................................... 67
Subsection 4.1.6: Question Types – Product Codes ......................................................... 69
Enter a Three-Letter Code in the Product Code Question ............................................ 69
Search for a Three-Letter Code by Keyword................................................................ 69
Add Product Codes ....................................................................................................... 71
Enter Multiple Three-Letter Codes in the Product Code Question............................... 72
Search Multiple Codes by Keyword ............................................................................. 73
Subsection 4.1.7: Question Types – Standards................................................................. 75
Add a Standard.............................................................................................................. 75
Subsection 4.1.8: Question Types – Sections as Tables ................................................... 77
Subsection 4.2: Saving Submission Entries or Changes................................................... 83
Introduction................................................................................................................... 83
Subsection 4.3: Completing a Submission........................................................................ 84
Introduction................................................................................................................... 84
Missing Data ................................................................................................................. 84
Subsection 4.3.1: Completing a Submission (Packaging Submission Files).................... 90
Step 1: Overview and Package File Information .......................................................... 91
Step 2: File Attachment Verification ............................................................................ 92
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Table of Contents
Step 3: Transmission Approach, Submittal Letter, and Packaging .............................. 94
Select Transition Approach (may or may not be applicable) ....................................... 95
Output Submittal Letter (may or may not be applicable) ............................................. 95
Produce Submission Package (Always available) ........................................................ 97
Step 4: Transmit Submission Package.......................................................................... 98
Printing, Locating, and Copying Files .......................................................................... 99
Locate the Submission Files on the Computer’s Hard Drive ....................................... 99
Section 5: FDA Recommended PDF File Specifications ................................................ 103
Introduction................................................................................................................. 103
Recommended PDF File Specifications ..................................................................... 103
Section 6: User Support .................................................................................................... 110
Introduction................................................................................................................. 110
Figures
Registration Dialog Box ............................................................................................................... 10
Registration Dialog Box: Contact Information............................................................................. 11
Registration Dialog Box: Address Information ............................................................................ 11
Registration Dialog Box: Generate Email .................................................................................... 12
Registration Dialog Box: Check Results ...................................................................................... 13
Application Update Message ........................................................................................................ 13
View Application History/Updates Dialog Box ........................................................................... 14
Intro Screen................................................................................................................................... 15
Select File Location Box............................................................................................................... 22
Select Viewer Application File Box ............................................................................................. 24
User Preferences Dialog Box........................................................................................................ 24
Save Submission As Dialog Box .................................................................................................. 29
Contact List Dialog Box ............................................................................................................... 53
Selection List Dialog Box............................................................................................................. 55
File Attachment Dialog Box ......................................................................................................... 58
Select a File from a List of Previously Attached Files ................................................................. 59
Select a New File from the Workstation or Network ................................................................... 60
Guidance Document Filter Dialog Box ........................................................................................ 64
Guidance Document Containing a Response................................................................................ 66
Product Code Filter Dialog Box ................................................................................................... 70
Standard Filter Dialog Box ........................................................................................................... 75
Report Output Dialog Box ............................................................................................................ 84
Select HTML Viewer Application File Dialog Box ..................................................................... 85
Report Output Dialog Box ............................................................................................................ 88
Warning......................................................................................................................................... 90
Packaging Files Dialog Box.......................................................................................................... 91
Transmit Submission Package ...................................................................................................... 98
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Section 1: Introduction
Contents
This section contains the following topics:
Topic
System Background
About this Manual
Software Installation
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See Page
2
3
4
1
Subsection 1.1: System Background
Introduction
The Food and Drug Administration (FDA) eSubmitter tool is a program that
allows participants to electronically complete and submit information for
various products to participating Centers. This tool is intended to automate the
current paper submission process, allowing for quicker completion once users
are accustomed to the software, as well as speed up the filing process with
FDA. The eSubmitter software requires completing a series of questions in
electronic forms and allows attaching documents, images and media files when
additional information is needed.
If using the eSubmitter software is not desirable, you may continue to complete
hard copies of reports and applications, though for the reasons stated above,
electronic submission is strongly encouraged.
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Subsection 1.2: About this Manual
Introduction
The instructions in this manual provide detailed information for installing the
eSubmitter software into a computer with a Microsoft Windows operating
system. In addition, this user guide assumes familiarity with terms
associated with using a computer (e.g. clicking and double-clicking).
This manual is organized into seven sections (including this one):
• Section 1 provides an introduction and explains the requirements for
running eSubmitter software, uninstall instructions, installation
instructions, installation instructions for Microsoft Vista users, and proxy
server instructions.
• Section 2 provides instructions for starting the software, setting user
preferences, and creating or reopening a submission.
• Section 3 provides descriptive information about the eSubmitter
software’s interface and toolbar.
• Section 4 provides instructions for preparing a submission for completion,
which includes entering information, saving submission entries or changes,
and packaging submission files.
• Section 5 provides information about the Output menu on the menu bar,
which includes reports and forms.
• Section 6 provides information regarding user support.
• Section 7 provides a list of frequently asked questions and the
corresponding answers.
Please note that the screens used in this document are examples of what you
might see while using the software. However, they may not appear exactly as
shown.
Note: The terms submission, report, and submission report are used
interchangeably in this guide to refer to a submission report.
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Subsection 1.3: Software Installation
•
•
•
•
•
System
Requirements
Uninstall
Instructions
Windows Operating System
Adobe Acrobat Reader v5.0 or greater.
30 MB of disk space
Access to a Compact Disk-Recordable drive (CD-R Drive)
Software capable of viewing Rich Text, such as a Web browser,
Microsoft Word, or Adobe Acrobat (full install version, not the
Reader)
Before installing eSubmitter, uninstall any other version of the software.
Note: If you do not have a previous version of eSubmitter, proceed to
installing the current version of eSubmitter software.
To uninstall a previous version of eSubmitter, follow the instructions below.
Action
1.
Graphic
Use Windows Explorer to navigate to the label for the
computer’s installed hard drive, e.g., Local Disk (C:).
For example, on a computer with Windows 2000:
•
Open Windows Explorer.
•
Double-click My Computer to display its
contents.
•
Look for the label of the computer’s
installed hard drive. For example, (C:).
2.
Double-click on the label for the hard drive to display
its contents.
3.
Navigate to and double-click to open the Program
Files file folder.
Continued on Next Page
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Subsection 1.3: Software Installation
4.
Navigate to and click to open the eSub file folder.
You will see the folder’s contents in the pane on the
right-hand side of the screen.
5.
Double-click on the Uninstall.exe file, and follow the
instructions provided.
Note: If you do not see the Uninstall.exe file:
a. Locate and double-click to open the
JExpress file folder.
b. Double-click on the uninstall.bat file,
and follow the instructions provided.
6.
Uninstall
Instructions
When the previous version has been uninstalled, you
are ready to install the current version of the
eSubmitter software. See the following procedure.
Some users may be unable to uninstall eSubmitter by following the
instructions above due to the permissions and rights restrictions established
on their system during the time of the install.
To ensure the uninstall process was successful, follow the instructions below.
Action
1.
2.
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Graphic
Use Windows Explorer to navigate to the Control
Panel. For example, on a computer with Windows
2000:
•
Open Windows Explorer.
•
Double-click My Computer to display its
contents.
•
Look for the label of the Control Panel.
Double-click on the label for the Control Panel to
display its contents.
5
Subsection 1.3: Software Installation
3.
Navigate to and double-click to open the Add or
Remove Programs location.
4.
Locate and click on the eSubmitter program icon.
5.
Click Change/Remove.
6.
Click Yes when the question window appears – “Are
you sure you want to uninstall eSubmitter?”
7.
Ensure the program is entirely removed by navigating
to the program file and deleting it. Use Windows
Explorer to navigate to the label for the computer’s
installed hard drive, e.g., Local Disk (C:). For
example, on a computer with Windows 2000:
•
Open Windows Explorer.
•
Double-click My Computer to display its
contents.
•
Look for the label of the computer’s
installed hard drive. For example, (C:).
8.
Locate the eSub program file.
9.
Right click, and select Delete.
Installation
Instructions
The eSubmitter software can be loaded from the internet or from a CD-ROM.
The following two subsections will discuss instructions for each.
Installation
Instructions
from Web Page
The eSubmitter software is available for downloading from the web at FDA
eSubmitter. To install the latest version of the eSubmitter software from this
web page, follow the instructions below.
Continued on Next Page
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Subsection 1.3: Software Installation
Action
1.
Click the link for downloading the eSubmitter
Software and save the jinstall.zip file to your
computer.
2.
Unzip the jinstall.exe file and double-click on the file
to run the eSubmitter installation.
3.
Follow the instructions provided. Following the
instructions, the software will be installed locally on
your hard drive in C:\Program Files\eSub.
Graphic
Notes: 1. You can change the location where the
software is installed by changing the file
path on the Installation Directory dialog
box when it appears.
2. The software may be installed on a
network. eSubmitter has a file locking
option that you set to prevent users from
accidentally overwriting the work of
another. For details, see Networking on
page 20.
Installation
Instructions for
Microsoft Vista
Users
Compatibility issues have been identified regarding the use of eSubmitter
with the Windows Vista operating system. These issues, related to the
installation of the software under the “Program Files” directory, can prevent
accessibility to data and output files generated by the software. These issues
can be averted by relocating the eSubmitter Data and Output folders to a less
restrictive directory (e.g., C:\Users\Public\eSub_Home). These settings can be
changed by navigating to the File > Preferences option within the application.
If you have already upgraded to the Windows Vista operating system or plan
to in the future, see Instructions for Using eSubmitter on Vista on the FDA
eSubmitter website for the latest information on successfully installing the
tool within Windows Vista.
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Subsection 1.3: Software Installation
Proxy Server
Instructions
If you are using a proxy server to connect to the Internet, then you will
need to change the application's properties file (eSubmitter.properties)
to reference the server. See your System Administrator for help in
changing the properties file.
The properties file is located in the application's JExpress subdirectory
(Program Files\eSub\JExpress). Add the following switches before
the -cp switch: -DproxySet=true -DproxyHost=[proxy_host] DproxyPort=[proxy_port] (replace [proxy_host] and [proxy_port] with
the appropriate information for your configuration).
If the proxy server requires a user id and password, add the following
two properties to the update.control file that is also located in the
JExpress subdirectory:
proxyUserName=
proxyPassword=
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Section 2: Getting Started
Contents
This section contains the following topics:
Topic
Starting the Software
Setting User Preferences
Creating a New Submission
Copy an Existing Submission to Create a New Submission
Re-open an Existing Submission
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See Page
10
17
25
28
31
9
Subsection 2.1: Starting the Software
Introduction
After you have successfully installed the eSubmitter software, you are ready
to start up the application and create a new report.
Starting the
Software
To start up the eSubmitter application, follow the instructions below.
Action
1.
Start, and select Programs > FDA Submission
Software > eSubmitter.
2.
You will see a Registration Dialog box, as shown
below.
3.
Click Next to continue the registration process. Or,
click Register Later to register at another time. If
you click Next, you will see a Registration Dialog
box asking you to enter your contact information.
Graphic
Registration
Dialog Box
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10
Subsection 2.1: Starting the Software
Registration
Dialog Box:
Contact
Information
4.
On the Registration Dialog box, enter the information
requested. Required entries are indicated by blue
dots. Click Next. You see a Registration Dialog box
asking you to enter address information.
5.
On the Address Information dialog box, enter the
information requested. Click Next. You see a
Registration Dialog box to generate an email.
Registration
Dialog Box:
Address
Information
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Subsection 2.1: Starting the Software
Registration
Dialog Box:
Generate Email
6.
In the Generate Email step, you see a summary of the
information you entered. If the information is correct,
click Next. If the information is not correct, click
Previous until you return to the screen that you need
to correct.
7.
Click Generate Email in the dialog box. You will
see an email.
8.
Click Send in the email. You see a Registration
Dialog box to check results.
/
Continued on Next Page
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Subsection 2.1: Starting the Software
Registration
Dialog Box:
Check Results
9.
Select the button corresponding to either Yes the
Email was sent correctly or No there was a
problem.
10. Click Done if the email was successful and to
complete the registration process.
11. If the eSubmitter software has been updated and you
are connected to the Internet, you will see an
Application Update Message to notify you that the
software has changed (as shown below).
Application
Update Message
Continued on Next Page
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Subsection 2.1: Starting the Software
12. On the Application Update Message:
•
Click No if you do not wish to see a list of the
changes to the software. You can review the
changes at a later time if you wish.
•
Click Yes if you do want to review a list of
changes to the software. You see the View
Application History/Updates Dialog box (as
shown below).
View
Application
History/Updates
Dialog Box
13.
Click Close when you are finished reviewing the list
of changes. The dialog box closes.
14.
Next, you will see the Intro Screen, which is
described in the subsequent section.
Continued on Next Page
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Subsection 2.1: Starting the Software
Intro Screen
The Intro Screen provides an introduction to the software and will serve as
your home screen. The Intro Screen will be displayed as shown below and
the contents and tools available in the Intro Screen are described in the
following table.
Menu Bar
Navigation
Bar
Tool
Bar
Menu
Options
Pane
Message
Tabs
Primary
Screen
Area
Function
Create New
Submission
Open an Existing
Submission
eSubmitter Quick
Guide
Icon
Description
Allows you to create a new submission
entry. The New Submission Dialog box
will appear. See section Creating a New
Submission for more detailed information.
Allows you to open an existing
submission. The Open Existing
Submission Dialog box will appear. See
section Subsection 2.5: Re-open an
Existing Submission for more detailed
information.
Launches the eSubmitter Quick Guide. If
the Quick Guide does not contain the
information you are searching for, see the
full length eSubmitter User Manual.
Continued on Next Page
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Subsection 2.1: Starting the Software
Exit Application
Help Topics
Forward
Navigation Arrow
Backward
Navigation Arrow
Collapse/Expand
Arrows
Notification Stars
Category
Filter
Mark as Read
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Closes the eSubmitter application.
Displays the Help Menu, which provides
instructional information and support for
utilizing the eSubmitter application.
This arrow allows you to move forward
through the Message Tabs.
This arrow allows you to move backwards
through the Message Tabs.
Allows you to collapse and expand the
Menu Options portion of the Intro
Screen.
The yellow stars are intended to notify
users when new messages are available.
The star appears next to the message tab
header with new unread messages.
Allows you to filter the message
information to display only generic
information or those messages pertaining
to a particular program. eSubmitter will
remember the selected filter option upon
closing and reopening the application.
This checkbox enables you to indicate
which message tabs have been read. Mark
this checkbox to remove the yellow star
shown next to the tab header. Unmark this
checkbox to make the yellow star on the
applicable tab header reappear.
16
Subsection 2.2: Setting User Preferences
Introduction
eSubmitter allows you to set preferences for the following categories:
•
•
•
•
•
Auto Save
Layout
Networking
File Location
File Viewer
Setting preferences prior to creating a submission will make the process much
easier. To begin setting preferences, click on the File Menu > Preferences. The
User Preferences Dialog box will appear (as shown below).
The subsections below will explain how to set preferences for each category.
Continued on Next Page
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Subsection 2.2: Setting User Preferences
•
Auto Save
Auto Save – When this option is enabled, eSubmitter automatically
saves your report while you work. You can also set the interval for how
often you want to save your report. At default, auto-save is
automatically enabled and set to save files at 10-minute intervals.
Note: The Blue Dot
indicates that a response to the question is required.
To change the auto-save option:
Action
Graphic
1.
Check the box to enable the auto-save feature (i.e., to
turn auto save on) or clear the checkbox to disabled
the auto-save feature (i.e., to turn auto-save off).
2.
If you cleared the checkbox, go to step 3. If you
selected the checkbox, in the time interval box:
Enter the interval (in minutes) for how often you want
to save the file.
OR
Use the up and down arrows to select the interval.
Continued on Next Page
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Subsection 2.2: Setting User Preferences
3.
If you want to change or set the layout, click Next or
the Layout tab. See the description for Layout
below.
OR
If you are finished and satisfied with your changes,
click OK to close the User Preferences Dialog box
with your changes saved.
OR
Click Cancel to close the User Preferences Dialog
box without saving any changes.
Layout
Allows you to set whether you want eSubmitter to open reports in the simple or
expert layout when you start up the application. At default, eSubmitter opens
reports in the simple layout. For more information, see descriptions in the
Application Window section on page 33.
To change the layout when eSubmitter starts up, follow the instructions below.
Action
1.
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Graphic
In the initial layout box, select Simple or Expert
from the drop-down menu. For more information on
these layout options, see Subsection 3.1: Application
Window, beginning on page 33.
19
Subsection 2.2: Setting User Preferences
Continued on Next Page
2.
If you want to change the settings for networking,
click Next or the Networking tab. See the description
for Networking below.
OR
If you are finished and satisfied with your changes,
click OK to close the User Preferences Dialog box
with your changes saved.
OR
Click Cancel to close the User Preferences Dialog
box without saving any changes.
Networking
Allows you to set file locking when using the software on a network. The
application is primarily designed for use by one user at a time. However, in an
effort to help support those that wish to run the application from a network, and
to prevent users from accidentally over-writing the work of another, a simple file
locking strategy has been incorporated. By enabling file locking, a user will be
warned if the file that they are attempting to open is currently in use by another
user. At default, eSubmitter opens without file locking.
To enable file locking, follow the instructions below.
Continued on Next Page
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Subsection 2.2: Setting User Preferences
Action
1.
Click to select the Enable File Locking checkbox (to
turn file locking on) or clear the checkbox (to turn file
locking off).
2.
If you want to change the settings for networking,
click Next or the File Location tab. See the
description for File Location below.
Graphic
OR
If you are finished and satisfied with your changes,
click OK to close the User Preferences Dialog box
with your changes saved.
OR
Click Cancel to close the User Preferences Dialog
box without saving any changes.
File Location
Allows you to change the location where your report data files are stored when
saved and the location where files are generated when output (e.g., reports and
packaged submissions). For more information on packaging files for submission,
go to Package Files for Submission on page 90.
To change the file location for the data folder and/or the output folder:
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Subsection 2.2: Setting User Preferences
Action
1.
Click the Select Location icon right of the text box.
2.
The Select File Location dialog box will appear. Click
the Look In box, and navigate to the file folder where
you would like your files stored.
3.
Once you have navigated to the location, highlight the
specific folder and click Select in the bottom righthand corner of the dialog box. Your files will now be
stored in the new specified location.
Graphic
Select File
Location Box
Recommended Location:
If installed on a Network drive (on Vista or
Windows XP or earlier): The location of your data
and output files will be contained within the eSub
directory where the application was installed.
If installed on a Workstation (on Windows Vista):
data and output files should be hosted in the following
location: C:\Users\Public\eSub_Home\.
If installed on a Workstation (on Windows XP or
earlier): data and output files should be hosted in the
following location: C:\Documents and
Settings\eSub_Home\.
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Subsection 2.2: Setting User Preferences
4.
If you want to change the settings for networking,
click Next or the File Viewer tab. See the description
for File Viewer below.
OR
If you are finished and satisfied with your changes,
click OK to close the User Preferences Dialog box
with your changes saved.
OR
Click Cancel to close the User Preferences Dialog
box without saving any changes.
File Viewer
Allows you to identify the application that you will use as your PDF viewer.
(Generally, Adobe Acrobat is used as the application for viewing PDFs.)
Follow these instructions to set up your PDF viewer:
Action
1.
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Graphic
Click the Select Location icon to the right of the text
box. The Select Viewer Application File box is
displayed (as shown below).
23
Subsection 2.2: Setting User Preferences
Select Viewer
Application File
Box
2.
Click in the Look In box, and navigate to the file folder
for Adobe Acrobat or the Acrobat Reader. The location
is usually either:
• Program Files > Adobe > Acrobat > Acrobat.exe
• Program Files > Adobe > Reader > AcroRd32.exe
3.
Highlight (select) Acrobat.exe or AcroRd.exe and click
Select. The File Viewer tab in the User Preferences
Dialog box will appear in the text box as shown below.
4.
Click OK.
User
Preferences
Dialog Box
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Subsection 2.3: Creating a New Submission
Introduction
This section provides an overview of creating a new submission report.
Note: Before proceeding, make sure you have already reviewed the
Introduction, Getting Started, and Interface sections of this user
manual. These sections provide valuable information that is necessary in
order to follow and understand the instructions in this section.
There are two methods for creating a new submission report: starting from
scratch with a completely blank report or copying an existing report and
making the required changes. The purpose for copying an existing report would
be to save time assuming many of the responses are the same. This might be the
case if you have an existing report from the same product line or you are
submitting a supplement. The steps involved for both are provided below.
Create a New
Submission
Follow the steps below to create a new blank submission from scratch:
Action
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1.
The eSubmitter application should be open on your
computer desktop. If it is open, and you see the Intro
Screen, go to step 2. (If it is not open, open the
application first by following the instructions in
Starting the Software on page 10.)
2.
Click the Create New Submission button from the
Menu Options. Or you may select File > New or,
click the New Report icon on the Tool Bar. The New
Submission Dialog box is displayed (as shown below).
Graphic
25
Subsection 2.3: Creating a New Submission
3.
Step 1. Select a Submission Type. The New
Submission Dialog wizard is comprised of two parts.
The first section (top portion of the window) requires
that you select which Submission Type to create.
When you click on the Submission Type, the bottom
portion of the window displays information related to
the corresponding submission type (as shown in the
New Submission Dialog box figure above).
Once you have selected the appropriate Submission
Type, click Next.
4.
Step 2. Provide Submission Details (as shown
below).
Complete the fields on this dialog box as follows:
•
Descriptive name – Enter any descriptive
name, as long as it is unique to the submission
list and not blank. Use a name that distinctly
identifies the report to you. (Required Entry,
as indicated by the blue dot.)
Continued on Next Page
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Subsection 2.3: Creating a New Submission
• File name – Enter a valid name for the submission
data. Use alphanumeric characters. (Required
Entry, as indicated by the blue dot.) File names
should not contain more than 250 characters.
Do not use symbols when naming the files. For
example, do not use slashes (/) (\), tildes (~),
asterisks (*), periods (.), brackets [ ], single
quotation marks (‘), double quotation marks (“) or
parentheses ( ).
• Provide additional comments… – Enter any
additional information about this report (Optional
Entry).
5.
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When you are finished entering all information in the
fields, click OK. The first screen of your new blank
submission report is displayed.
27
Subsection 2.4: Copy an Existing Submission to Create a
New Submission
Copy an
Existing
Submission to
Create a New
Submission
To copy an existing submission in order to create a new submission, follow the
instructions below.
Action
Graphic
1.
Click File > Open. (Or, click the Open Report icon
on the Tool Bar.) The Open Report Data Dialog box
is displayed (as shown below).
2.
Click to select the existing submission report to be
used as a template, and click Open. The submission
report is displayed on your computer.
3.
Click File > Save As. The Save Submission As Dialog
box is displayed (as shown below).
Open Report
Data Dialog
Box
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Subsection 2.4: Copy an Existing Submission to Create a
New Submission
Save
Submission As
Dialog Box
4.
Complete the fields on this dialog box as follows:
•
Descriptive name – Enter any descriptive
name, as long as it is unique to the
submission list. Use a name that distinctly
identifies the report to you. (Required
Entry, as indicated by the blue dot.)
•
File name – Enter a valid name for the
submission data. Use alphanumeric
characters. (Required Entry, as indicated
by the blue dot.)
•
Provide additional comments… – Enter
any additional information about this
report (Optional Entry).
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Subsection 2.4: Copy an Existing Submission to Create a
New Submission
5.
When you are finished entering all information in the
fields, click OK.
The first screen of your new submission report is
displayed.
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6.
Since you copied an existing submission, it already
has many or all questions answered. You now have
the opportunity to go through and change responses
for this new submission. (Creating a new submission
in this manner is convenient if you are creating a
supplemental report or creating a report for a product
in an existing product family.)
7.
You are now ready to change the responses in this
submission, go to Entering Submission Information on
page 49.
30
Subsection 2.5: Re-open an Existing Submission
Re-open an
Existing
Submission
To re-open an existing submission, follow the instructions below.
Action
1.
Graphic
Click File > Open on the menu bar.
OR
Click
on the tool bar.
The Open Existing Submission Dialog box is
displayed (as shown below).
Open Existing
Submission
Dialog Box
2.
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Click to select (highlight) the submission that you
wish to open, and click Open. The selected
submission is displayed.
31
Section 3: Interface
Contents
This section contains the following topics:
Topic
Application Window
Toolbar
Menu Bar – Tools
Menu Bar – Output
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33
38
40
47
32
Subsection 3.1: Application Window
Introduction
This section describes eSubmitter’s Application Window and its different parts.
The eSubmitter Application Window has two layouts that change the
orientation of the text on the screen: simple and expert. When you first start
up the application, eSubmitter opens in the simple layout with the screen view.
Simple View
The simple view shows only the current data entry screen and “hides” the outline
tree. The simple view separates the Submission Display Screen into three
additional areas (as shown below):
•
•
•
Header Area (located at the top)
Outline Area or Screen Area (located in the middle)
Navigation Bar (located at the bottom), which allows forward and
backward movement through the screens, as well as the ability to switch
back and forth between the outline or screen view.
Header Area
Screen
Area
Navigation
Bar
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Subsection 3.1: Application Window
Expert View
The expert view allows the user to navigate through the form using an outline
tree located on the left side of the screen. The expert view separates the
Submission Display Screen into four additional areas (as shown below).
•
•
•
•
Header Area (located at the top)
Outline Area (located at the left)
Screen Area (located to the right)
Splitter Bar (located between the outline and screen areas)
Header
Area
Outline
Area
Screen
Area
Splitter
Bar
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Subsection 3.1: Application Window
Layouts
Both layouts provide the same information. It is your choice as to which layout
works best for you. You can switch between the two layouts very easily, as
well as customize eSubmitter to open in the expert layout. To learn how to
change eSubmitter so that the application opens in the expert layout, rather than
in the simple layout, see User Preference Tab – Layout.
The Application Window, whether in simple or expert layout, is divided into
three parts, as shown below.
1. Menu Bar
2. Tool Bar
3. Primary Report Screen
Menu
Bar
Tool Bar
Primary
Report
Screen
Parts of the
Primary Work
Area
The different parts of the Primary Work Area are defined as follows:
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Subsection 3.1: Application Window
Header Area
Outline
Area/View
Displays the following general information about the open submission:
•
Submission Name – the name that you created for the report.
•
Report Type – depends on the type selected when creating the
submission in the Create New Submission wizard.
•
Last Modified – represents the date and time the submission
information was last saved to the disk file. The date and time are
automatically updated after each save.
•
Packaged Date – represents the date and time the submission files were
generated for transfer to FDA. The date and time are automatically set
after the files are packaged for submission.
Displays tabs that organize the report into sections (as shown below).
Each tab within the outline has an image to the left of its descriptive text. This
image depicts which tab contains the section that is currently displayed within
the screen area (i.e., the tab with the highlighted green image).
Each section within the outline contains a folder image to the left of the section
text. This folder image depicts the status of required information that is missing
from within the question responses of the section. For example:
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Subsection 3.1: Application Window
•
•
•
Screen
Area/View
Green check mark
indicates no required information is missing.
Blue question mark indicates at least one item of required
information is missing.
No mark
indicates that the section does not contain any required
questions.
Displays the questions and responses associated with the selected section in the
outline area. There is complete flexibility in maneuvering through the screen
area. However, questions should be answered in order. Responses to some
questions will determine whether further questions are required or even
applicable, which means they may become disabled.
Some questions within the screen area may be required in order for the report to
be considered complete. These questions are designated with a blue dot to the
right of the question text. A complete list of required information that is
currently missing from the report can be accessed by selecting the Identify
Missing Data option on the Output menu.
Splitter Bar
The splitter bar is the vertical bar between the outline and screens areas in the
Expert layout, as shown below. By dragging the bar with the mouse to the left
or right you can control the proportion of the window that is allocated to each
of the areas. Adjusting this bar may be necessary on smaller monitors in order
to improve readability of the text.
Splitter Bar
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Subsection 3.2: Toolbar
Introduction
The tool bar is a row of buttons that are designed to provide quick access to specific
or commonly used commands and options. The tool bar is located below the menu
bar.
Note: The screens and information that are accessed through the icons can
also be accessed using the following menus: File, Edit, View, and Help.
However, you must access information for Tools and Output (with the
exception of Package Files for Submission) through the actual menus. For
information relating to tools and output functions, refer to pages 40 and 102
respectively.
The buttons on the tool bar are grouped by functionality and are described below:
Tool
Function
New – Displays the New Template Dialog box, which allows
a new (empty) template to be created.
Open – Displays the Open Existing Template Dialog box,
which allows an existing template to be selected and opened.
Save – Saves any changes within the open template to
permanent storage (e.g., to the disk).
Simple Layout – Selects the simple layout, which displays
the current data entry screen and contains basic options for
moving forward and backward through the report one screen
at a time.
Expert Layout – Selects the expert layout, which contains
the overall outline and current data entry screen side-by-side.
Home – Takes you to the home screen.
Continued on Next Page
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Subsection 3.2: Toolbar
Previous – Navigates to the previous screen.
Next – Navigates to the next screen.
Process Screen Changes – Processes your changes to screens
without saving the template or selecting another node. This
option allows you to see how rules impact the form based on
the changes made without having to leave the screen.
Screen Undo – Undoes most recent changes made.
Cut – Cuts text.
Copy – Copies text.
Paste – Pastes text.
Package Files for Submission – Packages your submission
to send to FDA after you have completely answered all
required questions. For complete information, see Packaging
Submission Files on page 90.
Help Topics – Displays the Help Menu.
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Subsection 3.3: Menu Bar - Tools
Introduction
Each command on the Tools Menu is described below:
Tool
Address Book
Function
Displays the
Address List
Dialog box, which
provides the
ability to maintain
the addresses of
the pertinent
manufacturing and
corporate facilities
associated with
your reports.
You only need to
enter each organization name and address once into the Address
Book, then select the appropriate entry in response to each question.
If the mailing address is the same as the physical address, the
physical address can be copied into the mailing address fields. If
they are similar but not exactly the same, it can be copied, and then
edited. The Address Book will always be accessible for future
reports, and you can update it as needed. This should reduce
confusing, misspelled, and redundant entries.
The Address List Dialog box contains a list of all the available
organizations and a comments area for viewing the comments on
the selected establishment. In addition, if you scroll across the
address list, you’ll see fields containing basic identifier information
about each organization.
The options (New, Edit, Delete, Close, and, Help) in this dialog
box are described below:
Continued on Next Page
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Subsection 3.3: Menu Bar - Tools
New
Displays the New Address Dialog box, which allows a new
organization to be created. Below is an example. Enter
information in the fields to identify a particular organization.
⇒ Click the Physical Location tab to enter address
information for where the organization is physically
located. See below.
⇒ Click the Mailing Location tab to enter address
information for the mailing address of the
organization.
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Subsection 3.3: Menu Bar - Tools
⇒ Click
if the mailing location is
the same as the physical location of the
organization. The information is automatically
copied into the address fields (as shown above).
However, if the mailing location differs drastically
from the physical location, you must manually enter
the information.
⇒ When you are finished with the addresses, click
to save your edits. Click
to
ignore all edits or
to see help text. You
return to the Address List Dialog box.
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Edit
Displays the Edit Address Dialog box, which allows the
selected establishment information to be changed. (You enter
information in this dialog box in the same manner as the New
Establishment Dialog box.)
Delete
Deletes the selected address from the list.
Close
Closes the dialog box.
Help
Displays the help window with text.
42
Subsection 3.3: Menu Bar - Tools
Tool
Function
Contact Book
Displays the
Contact List Dialog
box, which allows
the names and
addresses of the
pertinent people
associated with the
report to be
maintained. You
only need to enter
each person's name
and contact
information once into the Contact Book, and then you can select the
appropriate individual in response to each question. Existing
addresses can be selected (from the Address Book) for each contact.
The Contact Book will be retained and accessible for future reports,
and you can update it as needed. This should reduce confusing,
misspelled, and redundant entries.
The Contact List Dialog box contains a list of all the available
contacts and a comments area for viewing the comments for each
selected contact. In addition, if you scroll across the contact list, you
will see fields containing basic identifier information about each
contact.
The options provided in this dialog box are described below:
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New
Displays the New Contact Dialog box, which allows a new
contact to be created.
Edit
Displays the Edit Contact Dialog box, which allows the
selected contact information to be changed.
Delete
Deletes the selected contact from the list.
Close
Closes the dialog box.
Help
Displays the help window with text.
43
Subsection 3.3: Menu Bar - Tools
Tool
Submission
File List
Function
Displays the Master File Attachment Dialog box, which allows you to
manage the file information to be attached for use across questions in
the submission.
Attaching PDF files requires software capable of viewing and/or
printing PDF files (e.g., Adobe Acrobat). If you did not set your file
viewer under User Preferences, the first time a PDF file is attached,
the software will prompt you to locate the application within the
system that will be used to view/print such files. Once identified, the
software will no longer prompt for this information. For information
on setting up your PDF Viewer, see page 23.
Note: The file list is specific to the submission that is currently
open, thus not retained nor accessible for future reports.
The Master File Attachment Dialog box manages the file attachment
information related to the open submission. The dialog box contains a
list of all the attached files that are currently available, an area for
general information on the selected file, and options for managing the
list. The file list displays the following for each:
•
•
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Descriptive title
Physical file name
44
Subsection 3.3: Menu Bar - Tools
•
•
•
•
Number of questions that currently reference the file as an
attachment
File date
File size
Path to the file location
The options provided in the dialog box are described below:
Add a
New File
Allows you to add a new file to the Master File Attachment list
for later use as a question response. For instructions on how to
attach files as a question response, see How to Attach a File to
an Attachment Question Type, beginning on page 58.
View/
Manage
File List
Allows you to manage the existing documents in the list of files
displayed in Step 2. The options available for managing the list
of existing files include View, Edit, Delete, and Close. These
options are described below.
View
Displays the selected file within the specified PDF viewer.
Edit
Displays the Edit File Dialog box, which allows the selected
file title and general description to be changed.
Delete
Deletes the selected file from the list.
Close w/
Changes
Closes the dialog box and saves the changes made to the
Master File Attachment list.
Tool
Assign
Submission
ID
Function
Allows you to enter an FDA-related identifier to a submission. After
you have sent the submission to the FDA for processing and if you
have received a unique identifier, you may store that FDA assigned
identifier in the submission for tracking purposes. For complete
information on preparing a submission, see page 48.
To enter a Report ID:
⇒ Select Assign Submission ID from Tools on the Menu bar.
You see the Assign Submission ID dialog box (see below).
⇒ Enter the unique identifier assigned by FDA.
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Subsection 3.3: Menu Bar - Tools
⇒ If you are satisfied with your entry, click OK. Or, click
Cancel to close the dialog box without making any changes.
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Subsection 3.4: Menu Bar - Output
Introduction
The Output menu includes commands
related to the output of reports for
submission information. For complete
information on getting a submission ready
to send to FDA, see Completing a
Submission on page 84.
Note: All report outputs are generated as
Rich Text and require an application capable of viewing output, such as a WEB
browser, the full version of Adobe Acrobat (not Acrobat Reader), or Microsoft
Word.
Output Menu
Commands
Each command on the Output menu is described below.
Tool
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Function
Missing
Data
Report
Provides a list of required questions that you have not yet
answered. The list is provided in Rich Text format. You can
save the report file at any time. However, you will not be able to
package a submission file to submit to FDA until there is no
missing data. For complete information, see Subsection 4.3:
Completing a Submission on page 84.
Blank
Report
Form
Views/prints a blank submission form in Rich Text.
Submission
Report
Views/prints out the submission report with your entries in Rich
Text.
Submittal
Letter
Provides a formatted cover letter in Rich Text for you to sign
that identifies your file and must be submitted along with the
CD and any hardcopy of the report (if required) to FDA.
Package
Files for
Submission
Allows you to package files for submission after completing the
submission and verifying that there is no information missing.
For more information on packaging files for submission, see
Subsection 4.3: Completing a Submission on page 84.
47
Section 4: Preparing a Submission
Contents
This section contains the following topics:
Topic
Entering Submission Information
Question Types
Address and Contact Information
Option Lists
File Attachments
Guidance Documents
Text Fields and Messages
Product Codes
Standards
Sections as Tables
Relationships Across Screens
Saving Submission Entries or Changes
Completing a Submission
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49
50
51
54
57
64
67
69
75
77
83
84
48
Subsection 4.1: Entering Submission Information
Introduction
Entering information for a submission requires stepping through the form and
answering questions. If you use the simple layout, you progress through the
form screen by screen, ensuring that you have filled in all appropriate
responses. If you use the expert layout, you progress through the outline
sections of the form, activate each section to load the section questions and
responses, and ensure that you have filled in all appropriate responses. You
may also use the green navigation arrows located in the tool bar to move
through the submission in expert view.
Note: For the purpose of this guide, all graphics are in the expert view. Also,
information marked with a blue dot is required.
For additional information on the simple and expert layouts, see Interface on
page 32. It is strongly recommended that you follow the order of the sections as
they are listed in the outline. The order has been set up to represent the most
logical progression through the submission form. This is especially important
for first-time users who are less familiar with the application to ensure you have
filled in all appropriate responses.
Entering
Responses into
the Submission
To enter responses into the submission, follow the instructions below.
Action
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1.
The eSubmitter application must be open on your
computer desktop, and a submission must be open. If
the application and a submission are not open, see the
instructions beginning on page 10.
2.
Navigate through the submission as follows:
•
If you are in the simple layout, use the buttons
on the navigation bar to advance to next/return to
previous screen.
•
If you are in the expert layout, use the outline
pane, and activate each section to load the screen
or the navigation arrows located on the tool bar.
Graphic
49
Subsection 4.1: Entering Submission Information
3.
Question Types
Provide a response to the question(s) on the screen.
The response required depends on the type of
question.
The eSubmitter tool uses several different types of questions to capture all the
information that is required for a specific report. The response that you enter
depends on the type of question used in your particular report. For example, to
answer a specific question, you may be required to select a response from a
drop-down box, type in text, attach a separate PDF file, select a check box, or
provide contact information.
The following subsections describe each of the different question types and
include examples of their respective responses.
Note: You may not see all of these types of questions in one particular
report. The purpose of this section is to provide a brief overview of all
of the different question types that are used in the eSubmitter software.
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Subsection 4.1.1: Question Types – Address and Contact
Information
Address
This question type requires that you enter the address and phone
numbers of your organization. You enter the information in text
fields and make selections using drop-down menus and clicking
option buttons. An example is shown below. Other types of address
questions are Contact and Multi-Part Address, which will be
discussed below.
Contact
(Simple)
This question type requires that you type contact information (first
name, last name, etc.) in text fields. Entries may or may not be
required. The figure below shows an example of a simple contact
question with the first name, last name, and email address as
required fields (as indicated by the blue dots).
Contact
(MultiPart)
This question type contains multiple sections that you need to
complete (indicated by the tabs: Contact Information,
Establishment Identification, Physical Location, and Mailing
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Subsection 4.1: Entering Submission Information
Location). For this question type, you may enter contact
information (first name, last name, etc.) directly into text fields, or
you may copy this information from the Contact Book. When you
enter the information directly (without using the Contact Book), the
contact information is only saved for the submission. Copying the
information from the Contact Book saves time for data entry
because the information is automatically copied into the question.
Information in the Contact and Address Books requires that you
only enter the data once and reuse it across multiple submissions.
You can also copy information from the question into the Contact
or Address Books if you have already begun filling in the question
fields directly.
The figure below shows an example of a multi-part contact
question.
Tabs
Copy
Information
from Contact
Book into
Question
To copy information from the Contact Book into the Contact question type,
follow the instructions below.
Action
1.
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Graphic
Click the Copy from Contact Book icon in the
question. The Contact List Dialog box is displayed, as
shown below.
52
Subsection 4.1.1: Question Types – Address and Contact
Information
Contact List
Dialog Box
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2.
Click to highlight and select the desired contact.
3.
Click Select. The contact information is
automatically populated in the different entry areas
(within each applicable tab).
4.
If the information is not exactly the same, you can
edit the information in the question fields after you
have copied it.
5.
To see the other information, click on the desired tab.
If you copied the contact information from the Contact
Book, the information for these tabs will be completed
as well.
6.
For more information about Contact Books, see page
43.
53
Subsection 4.1.2: Question Types – Option Lists
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DropDown
Menu
This question type requires that you select a response from a
list of entries that appear after you click the box with the down
arrow ( ). Below is an example of a question with a dropdown menu.
Radio
Button
This question type requires that you click on the radio button to
select a question response. Only one response can be selected.
See the example below.
Check
Box
This question type requires that you click on the box to select
or clear the check mark to answer a question. See the example
below.
Check
Box
Group
This question type requires that you click on the box(es) to
select or clear the check mark(s) to answer a question. Multiple
responses can be selected. See the example below.
List Item
This question type allows you to select an item from a list of
options. Below is an example of a list item question.
54
Subsection 4.1.2: Question Types – Option Lists
Access the List
of Available
Options
To access the list of available options, follow the instructions below.
Action
1.
Click the Select Item icon. A Selection List Dialog
box is displayed (as shown below).
2.
Click to select (highlight) the desired option.
3.
Click the Select button. The Selection List Dialog box
closes, and you return to the open submission with the
list item question showing your selection (as shown
below).
4.
If you wish to change your response, click the delete
icon. Your response selection is deleted from the
question.
Graphic
Selection List
Dialog Box
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Subsection 4.1.2: Question Types – Option Lists
5.
Repeat steps 1 through 3 to make another selection.
Table
Select multiple
options or enter
text responses
into a Table
This question type allows you to select from a list or add text items
that are then placed in a table. Below is an example.
To select from a list of options or to enter text responses into a table question
type, follow the instructions below.
Action
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1.
Click the Add icon.
2.
You will be prompted to either select from a list of
options or enter a response into a text field.
3.
If you wish to change your response, select (highlight)
the option in the table and click the delete icon. The
selection is deleted from the question list.
4.
Repeat steps 1 and 2 to make another selection or
enter text responses into the table.
Graphic
56
Subsection 4.1.3: Question Types – File Attachments
File
Attachment
Please see Section 6 FDA Recommendations for PDF File
Specifications to ensure you are meeting the FDA
recommendations for electronic files submitted and archived.
This question type allows you to attach a file as a response.
The question may contain a text editor that allows or requires
you to type additional information. In addition, this editor
may be a Rich Text Editor, which allows you to format what
you type (bold, underline), run spell check, or insert a table.
You may use this area to provide descriptive information or
clarification, such as “see page 15 of the attached user
manual.” You may be required to enter the attachment or
provide the descriptive text.
Note that the question itself may be restricted to only allow
certain file types to be attached (e.g., PDF only or a
combination, such as PDF and/or Excel file types only).
Attaching PDF files requires software capable of viewing
and/or printing PDF files (e.g., Adobe Acrobat). The first
time a PDF file is attached, the software will prompt you to
locate the application within the system that will be used to
view/print such files. (See below).
Once identified, the software will no longer prompt for this
information. For information on setting up your PDF Viewer,
see page 23.
Below is an example of a file attachment question with a
response properly attached. See instructions for correctly
attaching files in the subsequent section.
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Subsection 4.1.3: Question Types – File Attachments
Location of File
Attachment
Indicates Rich
Text Editor
How to Attach
a File to an
Attachment
Question Type
To attach a file as a response to an attachment question in eSubmitter, follow the
instructions outlined below.
Action
1.
Click the Add File icon to select the desired file to
attach as the question response. The File Attachment
Dialog wizard is displayed (as shown below).
2.
Step 1: Select the Method for Identifying the File
to Attach.
Graphic
File
Attachment
Dialog Box
In this step, choose the desired method for selecting
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Subsection 4.1.3: Question Types – File Attachments
the file to attach. The options are:
1. Choose a previously attached file from the master
list of previously attached files
OR
2. Select a new file from your computer or a
network drive that has not been previously
attached to the submission.
Note: The wizard defaults to the method “Select a
File from a List of Previously Attached Files”
if the master file list contains any files to
choose from. If there are no files in the master
file list, it will default to the method “Select a
New File from the Workstation or Network”.
If you would like to navigate to a location on
your computer and select a new file, click the
radio button to change the response in Step 1
to “Select a New File from the Workstation or
Network”.
3.
Step 2: Select the File to Attach According to the
Method Chosen -- Select a File from a List of
Previously Attached Files.
If the file can be located in the list of previously
attached files, select (highlight) the file from the list.
Select a File
from a List of
Previously
Attached Files
Continued on Next Page
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Subsection 4.1.3: Question Types – File Attachments
4.
Once a file in the list is highlighted, the Attach
Selected File button is activated in the bottom right
side of the dialog box.
Click the Attach Selected File button to properly
attach the selected file to the question response.
5.
Step 2: Select the File to Attach According to the
Method Chosen -- Select a New File from the
Workstation or Network.
If the file cannot be located in the master list, then the
method chosen in Step 1 must be “Select a New File
from the Workstation or Network”.
6.
Step 2 of the File Attachment dialog changes to
correspond with the method chosen (as shown
below).
Select a New
File from the
Workstation or
Network
Continued on Next Page
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Subsection 4.1.3: Question Types – File Attachments
7.
Click the file folder icon to the right of the Locate
File field.
You will see a Select File dialog box as shown below.
Select File
Dialog Box
8.
Verify that the correct file type is selected in the Files
of Type drop down located below the File Name
field. Only those files of the type chosen will appear
in the display pane for you to select. The Files of
Type is defaulted to Adobe Acrobat Files (.pdf).
Note: The Files of Type drop-down field may not be
enabled if the question has been set to restrict
the response to only allow a particular file type
(e.g., PDF only).
9.
Click the Look In drop-down menu to locate the
drive, such as Local Disk (C:), or folder where the file
you wish to attach is stored.
10. When you locate the desired file, click to select it
(highlight). The name of the file appears in File Name
(as shown below).
Continued on Next Page
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Subsection 4.1.3: Question Types – File Attachments
Select File
Dialog Box –
File Selected
11. Click Select. The Select File dialog box closes, and
you return to the New File dialog box.
12. Enter a title in Descriptive title (required entry) and a
description in General description, if desired.
13. Click OK. You return to the File Attachment Dialog
box. The PDF that you just added is automatically
displayed in the fields in Step 2.
14. Click Attach Selected File(s). You see the path
(location) of the file selected appear in the file
attachment question.
This question type allows you to attach multiple files as a
Multiple
response. Below is an example of an attachment question with
File
Attachments a file attachment included. In the image below, the green plus
sign is still enabled after attaching a file, indicating that
additional files may be attached as the response.
To attach multiple PDF files to an attachment question, follow
the same instructions listed under How to Attach a File to an
Attachment Question Type beginning on page 58.
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Subsection 4.1.3: Question Types – File Attachments
Scroll Bar to
view additional
details on files
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Subsection 4.1.4: Question Types – Guidance Documents
Guidance
Documents
Select a
Guidance
Document
This question type allows you to select the guidance
documents that you used to prepare your submission, as well
as provides space for you to add supporting text if necessary.
Below is an example of a guidance document question.
To select a guidance document, follow the instructions below.
Action
1.
Graphic
Click the Add Guidance icon. The Guidance
Document Filter Dialog box is displayed (as shown
below).
Guidance
Document
Filter Dialog
Box
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Subsection 4.1.4: Question Types – Guidance Documents
2.
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On this dialog box, you have several options for
searching for a particular guidance document:
•
In the Title text box, you can type the title of
the desired document (if you know what it is).
•
If you do not know the title of the document,
select the applicable office from the Office list
box.
•
On the Division list box, select the desired
division.
•
Click Clear Filter to delete your selections
and begin a new search.
3.
Depending on which method you used, one or more
guidance documents will appear in the Guidance
Documents matching the specified filter criteria
area of the screen
4.
Use the scroll bar to see information about the found
guidance documents.
5.
If you are connected to the Internet and have Adobe
Acrobat installed, click to select a desired document,
and click View Guidance to see the selection.
6.
To move a guidance document to Guidance
Documents currently selected area of the screen:
•
Click to select (highlight) a particular guidance
document.
•
Click Select. The selected document appears
in Guidance Documents currently selected
area of the screen.
•
Repeat the above two items for each desired
guidance document.
•
Click Delete to remove a guidance document
from your selection.
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Subsection 4.1.4: Question Types – Guidance Documents
7.
Click OK when you have made your selections.
You return to the guidance document question with
your selection appearing. Below is an example of a
guidance document question containing a response.
Guidance
Document
Containing a
Response
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Subsection 4.1.5: Question Types – Text Fields and
Messages
Memo
(Multi Line
Text)
This question type provides an area for you to enter several
lines of text (as shown below).
The question may contain a Rich Text Editor which allows
you to format what you type (bold, underline), run spell
check, or insert a table. The tool bar for the Rich Text Editor
will appear after you click in the text area to begin typing.
Text,
Single
Line
Message
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This question type allows you to type in text as a response. Below
shows an example of a text question.
This question type provides information to you as you
complete a submission. You may see several different types
of messages as you progress through your submission.
Different examples of the message types are listed below:
•
Information Message
•
Error Message
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Subsection 4.1.4: Question Types – Guidance Documents
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Note Message
•
Confirmation Message
•
Warning Message
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Subsection 4.1.6: Question Types – Product Codes
Product
Code
(Single)
This question type allows you to search for and then identify
the product code that is assigned to your product or device. If
applicable, you are able to search for the device class, device
panel, and particular CFR section. The response to this
question is for a single product code. Below is an example of
a product code question.
Note: The Product Code is specific to those filing with the
Center for Devices and Radiological Health.
Enter a ThreeLetter Code in
the Product
Code Question
To enter a three-letter code in the product code question, follow the instructions
below:
Search for a
Three-Letter
Code by
Keyword
To search for a three-letter code by keyword, follow the instructions below:
• If you know the three-letter code assigned to your product/device, enter it
in the text field. The remaining fields are automatically filled in for you.
• If you wish to remove your entry, click the delete icon (
).
• If you do not know the three-letter code, see the instructions below to
search for the code.
• If you are selecting a product code for a radiation emitting product and do
not see an appropriate code, enter RZZ.
Action
1.
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Graphic
Click the Select Item icon. A Product Code Filter
Dialog box is displayed.
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Subsection 4.1.6: Question Types – Product Codes
Continued on Next Page
Product Code
Filter Dialog
Box
2.
Enter a keyword to search the database. You will be
provided a list of product codes from which to choose
in the Matching Product Codes portion of the dialog
box.
3.
To further refine your search, if desired:
•
Click the Device Class drop-down list and
make a selection.
•
Click the Classification Panel drop-down list
and make a selection.
•
) next to
Click the Select Item icon (
the Identifier (under C.F.R. Selection) and
make a selection.
•
Click
to remove entries and
start the search over again.
Continued on Next Page
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Subsection 4.1.6: Question Types – Product Codes
4.
Click to highlight the best match to your
product/device, and click
. You return
to the submission screen and the product code
question. The remaining fields in the product code
question are filled in for you (as shown below).
This question type allows you to identify other product codes
Product
applicable to the submission. Below is an example of a multiple
Codes
(Multiple) product code question.
Add Product
Codes
To add product codes, follow the instructions below:
Action
1.
Graphic
Click the Add Product Code icon. You see the
Product Codes Filter Dialog box (as shown below).
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Subsection 4.1.6: Question Types – Product Codes
Product Code
Filter Dialog
Box
Enter Multiple
Three-Letter
Codes in the
Product Code
Question
2.
Enter Product Code and Product Code Name in the
appropriate sections.
3.
Click OK.
To enter multiple three-letter codes in the product code question, follow the
instructions below:
Note: The Product Code is specific to those filing with the Center for Devices
and Radiological Health.
Action
1.
Graphic
If you know the three-letter code assigned to your
product/device, enter it in the Product Code text box.
You see the product code/device appear in Product
Codes matching the specified filter criteria (as
shown below).
Continued on Next Page
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Subsection 4.1.6: Question Types – Product Codes
2.
Click Select. The product/device appears in Product
Codes currently selected (as shown below).
3.
Repeat steps 1 and 2 to continue to add product codes.
OR
•
If you do not know the three-letter code, see
the instructions below to search for the code.
OR
•
Click OK to return to the multiple product
codes question.
Search Multiple To search for multiple three-letter codes by keyword, follow the instructions
Codes by
below:
Keyword
Action
1.
Graphic
Enter a keyword in Product Code Name to search the
database. You will be provided a list of product codes
from which to choose in the in Product Codes
matching the specified filter criteria portion of the
dialog box.
Continued on Next Page
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Subsection 4.1.6: Question Types – Product Codes
2.
To further refine your search, if desired:
•
Click the Device Class drop-down list and
make a selection.
•
Click the Classification Panel drop-down list
and make a selection.
•
Click the Select Item icon (
) next to
the Identifier (under C.F.R. Selection) and
make a selection.
•
to remove entries and
Click
start the search over again.
3.
Click to highlight the best match to your
product/device, and click Select. The product/device
appears in Product Codes currently selected.
4.
Repeat steps 1 and 2 to continue to add product codes.
OR
Click Delete to remove a product code from the
selection.
5.
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Click OK to return to the multiple product codes
question, which shows your selections.
74
Subsection 4.1.7: Question Types – Standards
Standards
Add a Standard
This question type allows you to select a standard for your
submission from the list of recognized standards. Below is
an example of a standards question.
To add a standard, follow the instructions below:
Action
Graphic
1.
Click the Add Standards icon. You see the Standards
Filter Dialog box (as shown below).
2.
Enter title in Title Reference to search the database.
Standard Filter
Dialog Box
Continued on Next Page
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Subsection 4.1.7: Question Types – Standards
3.
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To further refine your search, if desired:
•
Click the Category drop-down list and make
a selection.
•
Click the Organization drop-down list and
make a selection.
•
Click
to remove entries and
start the search over again.
4.
Click to highlight the best match to your
product/device, and click Select. The standard appears
in Standards matching the specified filter criteria.
5.
When you are finished adding standards, click OK.
You return to the standards question.
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Subsection 4.1.8: Question Types – Sections as Tables
Sections
as
Tables
with a
Tabbed
View
Entire sections may appear as a table. This is referred to as a tabular
view. The tabbed view format is indicated by a row of buttons for
New, Delete, Delete All, an up arrow, and a down arrow. Directly
below this row of buttons is the actual table (as shown below).
You also see a List and Details tabs. Click the New button to add an
item to the table. You see a screen containing questions for you to
answer. An example is shown below.
To see the items in the table, click Details. If you accidentally enter a
blank into the table, (by clicking New, not responding to any
questions, and then clicking Details), you will see a line of colored
blank spaces. Select the line of colored spaces and click the Delete
button to remove the item from the table.
Continued on Next Page
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Subsection 4.1.9: Data Relationships Across Screens
Sections
as
Tables
with a
Panel
View
Similar to the tabbed view, in the panel view, entire sections may
appear as a table. This format is indicated by a row of buttons for
Add New, Delete, Delete All, an up arrow, and a down arrow.
Directly below this row of buttons is the actual table (as shown
below).
The up and down arrow, as seen below, will allow you to select a
specific row when you have multiple entries. You can be sure that the
appropriate row is selected as the row will be highlighted in blue and
there will be an arrow in the right hand column. Please note the Item
number column as this will be discussed in the List and Detail tab
below.
You also see a List and Details tabs. Click the New button to add an
item to the table. You see a screen containing questions for you to
answer. An example is shown below.
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Subsection 4.1.8: Question Types – Sections As Tables
To see the items in the table, click Details. If you accidentally enter a
blank into the table, (by clicking Add New, not responding to any
questions, and then clicking Details), you will see a line of colored
blank spaces. Select the line of colored spaces and click the Delete
button to remove the item from the table.
If you have added multiple entries, you will note that in the Detail or
in the Add New view, the Item Number, highlighted below, will
change based on the Item Number as seen in the List view above.
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Subsection 4.1.9: Data Relationships Across Screens
Relationships
Across
Parent and
Child
Screens
Some tabbed and/or panel screens may be linked together through a
parent/child relationship. If this parent/child relationship exists, you
will see a header bar on the child screens, as seen below, indicating
which list item within the parent table you are currently entering data
for. These child screens will be repeated for each list entry in the
parent table, as necessary.
The parent/child relationship can also be seen when in expert view.
As mentioned on page 34, the expert view allows the user to navigate
through the form using an outline tree located on the left side of the
screen. As seen below, the “Brand Logo and Registered Trademark”
is a subfolder to the “List of Tobacco Products (By Brands) folder”.
The subfolder is the child. .
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Subsection 4.1.8: Question Types – Sections As Tables
As you enter information into the parent and child screens, the user
will use the List view and the headers to understand the relationship
between the data. Changing the parent screens will cause the child
screens to change. Please see below for an example.
In the expert view on the left, you see the parent folder named “List
of Tobacco Products (By Brands)”, below, and the parent folder’s
corresponding simple screen.
In the right side of the screen seen above, the product category
cigarette is selected. As you move through to the child folder “SubBrand Details (Packaging Level” and after entering the appropriate
data, you will see the following information in the List view.
Note that a new header is displayed in green that reminds you which
parent, in this case the product category and brand, you are entering
information for.
Once you enter information for one sub-brand and have reached the
end of the parent/child relationship, a dialogue box, as seen below,
will prompt the user if they would like to:
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enter a new parent, (e.g., product category and brand)
•
enter a new child to the parent (e.g., the sub-brand),
•
or continue on to the next section.
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Subsection 4.1.9: Data Relationships Across Screens
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Subsection 4.2: Saving Submission Entries or Changes
Introduction
While moving through the submission, any changes made to question responses
are automatically updated within memory (e.g., the user made a change to a
question response, went to another section of the submission, and returned to
see that the changes to the response were still in effect). If you have auto-save
turned off in Preferences, these changes are only saved permanently when you
select the Save option from the tool bar or File menu. Therefore, follow the
same guidance that you would use when saving data in other software. In other
words, whenever you have entered an amount of data that would be frustrating
to have to re-enter, select the save option. For information on changing autosave preferences, see page 18.
Note: The software will remind you to save if data has been changed and you
are about to perform an operation that would result in losing your
changes, such as opening another submission or exiting the application.
To save a submission, follow the instructions below:
Action
1.
Graphic
Click File > Save.
OR
Click the Save icon on the tool bar.
If you do not finish entering information into a
submission in one session, you may return to it at
another time. See Reopening an Existing
Submission on page 31.
2.
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If you wish to close the submission, click File >
Close. The Intro Screen is then displayed.
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Subsection 4.3: Completing a Submission
Introduction
To complete a submission, you must identify if any data is missing from your
report (and then enter the required data), package the files for submission, find
the necessary files on your computer, and copy the files onto a CD or transmit
via the Electronic Submissions Gateway (ESG).
Missing Data
You will only be able to package files for submission as long as no required
data is missing from the submission. To determine if any data is missing, you
will generate a Missing Data Report. To proceed, the desired submission
should be open and displayed on your computer screen.
Note: All report outputs are generated as Rich Text and require an application
capable of viewing Rich Text output, such as a WEB browser, the full
version of Adobe Acrobat (not Acrobat Reader), or Microsoft Word.
To determine if required data is missing from the submission, follow the
instructions below:
Action
1.
Graphic
From the menu bar, click Output > Missing Data
Report. The Report Output Dialog box is displayed
(as shown below).
Report Output
Dialog Box
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Subsection 4.3: Completing a Submission
2.
On this dialog box:
•
Select the desired application to view the
output in Rich Text:
•
Click the option button: Default Browser or
Other HTML Viewer (The default setting is
your Web Browser.)
⇒ If you selected Other HTML
Viewer, the Select button becomes
enabled. Click the Select button.
You see the Select HTML Viewer
Application File dialog box (as
shown below).
Select HTML
Viewer
Application File
Dialog Box
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Subsection 4.3: Completing a Submission
3.
•
Click in the Look In box to navigate to the
executable (.EXE) of the application to view
the HTML. For example, if you want to view
the missing data output report in Word 2002,
you would navigate using the following path:
C: > Programs > Microsoft Office > Microsoft
Office > Office 10> WINWORD.EXE
The following screens display an example for the
navigation sequence to find Word 2002’s executable
(winword.exe):
Finding Word’s Executable File (Navigation 1)
Finding Word’s Executable File (Navigation 2)
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Subsection 4.3: Completing a Submission
Finding Word’s Executable File (Navigation 3)
Finding Word’s Executable File (Navigation 4)
4.
Click Select. You return to the Report Output Dialog
box with your selection showing (as shown below).
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Subsection 4.3: Completing a Submission
Report Output
Dialog Box
5.
Select the desired shading of the report: click the radio
button for either Grayscale or Color.
6.
Select the desired font size: click the radio button for
either Small Font or Large Font (which is
approximately 10 pt).
7.
When you are finished making selections, click OK.
The eSubmitter software generates the report in Rich
Text, which opens for viewing in the application that
you selected. The missing data output report will
either state that there is no data missing or identify the
missing data that must be entered (as shown below)
before the files are packaged for submission.
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Subsection 4.3: Completing a Submission
8.
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After you have verified that no data is missing from
the submission, you are ready to package your files
for submission.
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
Packaging
Submission
Files
After completing the submission and verifying that there is no information
missing, you are ready to package the files for submission. To proceed, the
eSubmitter application should be open, and the finished submission displayed
on your computer screen.
Package Files
for Submission
To package files for submission, follow the instructions below.
Action
Graphic
1.
Click Output > Package Files for Submission
from the menu bar.
2.
If data is missing, see the warning (as shown
below).
3.
If the submission has all required data, the Packaging
Files Dialog box is displayed (as shown below).
Within the Packaging Files Dialog box you will be
prompted to move through a series of steps detailed
below.
Warning
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
Packaging Files
Dialog Box
Step 1:
Overview and
Package File
Information
This section contains a brief overview of the packaging process. Follow the
instructions below.
Action
1.
Graphic
Specify the submission package file name.
¾
The Package File Name (.zip) text box
identifies the default zip file name for the
submission. (eSubmitter automatically
uses the submission name for the zip file.)
Make a note of the name for the zip file.
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
2.
Specify the submission output location.
i. The Package Output Location identifies the
file folder where the zip file is located. Make
a note of the output location.
ii. To change the location click the file folder
icon (as shown below), locate the desired
location, and click Select.
3.
Click Next to proceed to Step 2: File Attachment
Verification.
Step 2: File
Attachment
Verification
This section lists all file attachments used in the submission.
Continued on Next Page
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
Action
1.
Check the list to ensure that all of the appropriate
file attachments are listed (only files referenced in
responses will be included). See above for an
example.
2.
Check the question counts to confirm that the files
are attached.
¾
Graphic
NOTE: If a file appears to be missing from
the list, go to the Submission File List
within eSubmitter (File Menu > Tools >
Submission File List). In the Master File
List, ensure that each file is attached to a
question. A zero in the Question Count
column indicates that the file is not attached
to a specific question and therefore will not
be included in the packaged submission.
3.
Check the file dates, size, and locations to ensure
the correct versions of the files are provided.
4.
Click Next to proceed to Step 3 and continue
packaging the submission.
OR
Click Previous to go back to Step 1.
OR
Cancel and exit the Package File Dialog box.
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
Step 3:
Transmission
Approach,
Submittal
Letter, and
Packaging
This section will differ based on the submission you are filing.
If a specific step listed below does not appear in the dialog box on your screen,
this is because it does not apply. Please skip the instructions and move to the
next step displayed on the Packaging Files Dialog box. Below is an example
of what may appear in Step 3.
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
Select
Transition
Approach (may
or may not be
applicable)
Choose the selected approach to send your submission to FDA.
¾
The first approach is the traditional CD and signed cover letter
mailed to FDA. See below for an example.
¾
The second approach is only to be used when sending your
submission through the FDA Electronic Submission Gateway
(ESG).
NOTE: If you plan to send your submission through the ESG,
you will need to register to use the ESG and set up an account.
Please see FDA ESG for more information regarding the ESG.
In addition, if the Attach Signed Submittal Letter is
available, you must have the capability to scan your signed
cover letter in the subsequent Output Submittal Letter step
(see below).
Output Submittal
Letter (may or
may not be
applicable)
Follow the instructions below for the Output Submittal Letter.
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
Action
1.
2.
Click the
shown below.
Graphic
button, as
a. Ensure that your submittal letter is
accurate.
b. Print and sign the submittal letter.
c. Prepare to mail the submittal letter
(for CD transmission approach)
OR
d. Scan the submittal letter (for
Gateway transmission approach)
and note the location where you
store the file (you will need to
navigate to this location in the next
step).
3.
Click on the folder icon (see below) to attach the
signed submittal letter that has been scanned.
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
4.
Produce
Submission
Package
(Always
available)
Once you have located the signed cover letter, click
Select to attach the file to the packaging dialog box.
The signed cover letter path should appear (as
shown below).
To produce a submission package, follow the instructions below.
Action
1.
2.
Graphic
Click on
to initiate the
packaging of the zip file (as shown below).
NOTE: Once the submission has packaged
successfully, the status bar will indicate that the
packaging is complete (as shown below).
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
3.
Step 4: Transmit
Submission Package
Click Next to proceed to Step 4 to view the
transmission instructions related to your
submission.
This section provides confirmation that the submission files have been
successfully packaged. The submission is ready to be sent to FDA. Follow
the instructions below.
Action
1.
Graphic
Read the instructions provided. These instructions
may vary depending on the approach selected in
Step 3 (if the option was applicable). See below.
Transmit
Submission
Package
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
2.
Click Done to close the Packaging Files Dialog
box.
OR
Click Previous to return to Step 3.
Printing,
Locating, and
Copying Files
The following instructions do not apply if you are transmitting your submission
via the Electronic Submissions Gateway. Please see FDA ESG for Gateway
transmission instructions. If you are transmitting your electronic submission on
CD, follow the instructions below:
After packaging the files for submission, locate the packaged zip file on your
computer and copy it onto a CD. In addition, you will need to mail the signed
submittal letter (printed in Step 3 of the eSubmitter Packaging Submission
Files Process). NOTE: For an OIVD submission, the truth and accuracy
statement is part of the letter.
Locate the
Submission
Files on the
Computer’s
Hard Drive
To locate submission files on the computer’s hard drive, follow the instructions
below.
Action
1.
2.
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Use Windows Explorer to navigate to the label for the computer’s
installed hard drive, e.g., Local Disk (C:). For example, on a computer
with Windows 2000:
•
Open Windows Explorer.
•
Double-click My Computer to display its contents.
•
Look for the label of the computer’s installed hard drive. For
example, (C:).
Double-click on the label for the hard drive to display its contents.
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Subsection 4.3.1: Completing a Submission (Packaging
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3.
Navigate to and double-click on the Program Files file folder to open.
4.
Navigate to and double-click on the eSub file folder to open.
5.
Double-click on the output file folder to open. The zip file that you
created in Packaging Submission Files appears. Do not modify the zip
file after it is generated by eSubmitter.
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Subsection 4.3.1: Completing a Submission (Packaging
Submission Files)
6.
This step will differ based on the submission you are filing. Some
programs accept a digital signature and submission via the Electronic
Submissions Gateway and others require submission via CD-ROM and
handwriting signatures. As of October 2009, the following is
acceptable for each participating program:
CDRH Programs:
OIVD's 510(k): Digital signatures are not accepted at this time for
OIVD 510(k) submissions. In the future, the digital signature will be
available in conjunction with the FDA Electronic Submissions
Gateway (ESG).
Radiological Health Reports and Correspondence: Digital signatures
are accepted and required when utilizing the FDA ESG to submit
reports and correspondence. See note below regarding the FDA ESG.
RadHealth Submissions utilizing the eSubmitter software may still also
be burned to CD and mailed to CDRH in lieu of using the ESG.
eMDR MedWatch 3500A Form: The eMDR program accepts digital
signatures and utilizes the FDA ESG or transmission of the submission
package. eMDR submissions may only be sent through the FDA
Gateway.
CBER Program:
OBRR BLA Pilot Submissions: Digital signatures are accepted and
required for signing the necessary FDA OMB forms (Form 356h and
Form 2567, when applicable). However, the pilot program does not
accept submissions via the FDA Electronic Submissions Gateway at
this time. You must be registered with CBER as a pilot participant to
submit BLA submissions via eSubmitter. Please contact
[email protected] if you are not registered and
are interested in participating.
CTP Program:
Tobacco Establishment Registration, Product Listing and Health Data
Submissions: Digital signatures are accepted and required when
utilizing the FDA Electronic Submission Gateway to submit
registration, listing and additional health data.
For additional information, please refer to the Quick Guide “Packaging
and Transmission Guidelines for Participating eSubmitter Programs”
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Subsection 5: Menu Bar - Output
Introduction
The Output menu includes commands
related to the output of reports for
submission information. For complete
information on getting a submission ready
to send to FDA, see Completing a
Submission on page 84.
Note: All report outputs are generated as
Rich Text and require an application capable of viewing output, such as a WEB
browser, the full version of Adobe Acrobat (not Acrobat Reader), or Microsoft
Word.
Output Menu
Commands
Each command on the Output menu is described below.
Tool
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Function
Missing
Data
Report
Provides a list of required questions that you have not yet
answered. The list is provided in Rich Text format. You can
save the report file at any time. However, you will not be able to
package a submission file to submit to FDA until there is no
missing data. For complete information, see Completing a
Submission on page 84.
Blank
Report
Form
Views/prints a blank submission form in Rich Text.
Submission
Report
Views/prints out the submission report with your entries in Rich
Text.
Submittal
Letter
Provides a formatted cover letter in Rich Text for you to sign
that identifies your file and must be submitted along with the
CD and any hardcopy of the report (if required) to FDA.
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Section 5: FDA Recommended PDF File Specifications
Introduction
Regulations in 21 CFR Part 11 require that the Agency be able to generate from
any document provided in electronic format an accurate and complete paper
copy that is both legible ("human readable") and suitable for inspection, review,
and copying. Therefore, documents submitted in electronic format should:
•
•
•
•
Enable the user to easily view a clear and legible copy of the information
Enable the user to print each document page by page, as it would have
been provided in paper, maintaining fonts, special orientations, table
formats, and page numbers
Include a well-structured table of contents and allow the user to navigate
easily through the submission
Allow the user to copy text and images electronically into common word
processing documents
To achieve the above goals, you should submit all electronic documents in
Portable Document Format (PDF). PDF is an open, published format created by
Adobe Systems Incorporated (http://www.adobe.com). You do not need to use a
product from Adobe or from any specific company to produce your PDF
documents. PDF has been accepted as a standard for providing documents in
electronic format by the International Conference on Harmonization (ICH).
Recommended
PDF File
Specifications
The following recommendations will help you create PDF files with the
appropriate specifications to ensure that we can review and archive the
electronic file attachments.
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Section 5: FDA Recommended PDF File Specifications
PDF Area
Version
Plug Ins
Page Size
and
Margins
Page
Orientation
Fonts
Recommended PDF Specification
The PDF files must be compatible with Adobe Acrobat 5.0 or greater without
the use of additional plug-ins other than those provide by Adobe as part of
Acrobat. We should not need any additional software to read and navigate the
PDF files. There are features in Adobe Acrobat 8.0 that cannot be supported. If
you would like to submit Adobe Acrobat 8.0 files, please contact technical
support at [email protected] to ensure you do not use a feature that is
unsupported.
It is acceptable to use plug-ins to assist in the creation of a submission.
However, the review of the submission should not require the use of any plugins other than any provided by Adobe as part of Acrobat, and must be
compatible with Adobe Acrobat 5.0 or greater.
The print area for pages should fit on a sheet of paper that is 8.5 inches by 11
inches. You should allow a margin of at least 1.5 inch on the left margin and 1
inch on all other sides to avoid obscuring information if the pages are
subsequently printed and bound.
Pages should be properly oriented. For example, you should set the page
orientation of landscape pages to landscape prior to saving the PDF document
in final form to ensure correct page presentation. Landscape pages (including
tables) should be oriented such that the header and footer of the document align
with the right edge of the page.
PDF viewing software automatically substitutes a font to display text if the font
used to create the text is unavailable on the reviewer’s computer. Font
substitution can affect a document’s appearance and structure, and in some
cases it can affect the information conveyed by a document. We cannot
guarantee the availability of any one font. Therefore, you should embed all
fonts you are using in the PDF files to ensure that those fonts will always be
available to the reviewer. When embedding fonts, all characters for the font
should be embedded (not just a subset of the fonts being used in the document).
One problem associated with embedding fonts is that embedding requires
additional computer storage space. Three techniques to help limit the storage
space taken by embedding fonts:
•
Limit the number of fonts used in each document
•
Use only True Type or Adobe Type 1 fonts
•
Avoid customized fonts.
Resizing a document because the contents are too small to read is inefficient.
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Section 5: FDA Recommended PDF File Specifications
We believe that Times New Roman, 12-point font, is adequate in size for
reading narrative text. This is the preferred font. Although sometimes tempting
for use in tables and charts, fonts smaller than 12-points should be avoided
whenever possible. We recommend the use of a black font color.
Blue font may be used or hypertext links. If a font color other than black is
used, avoid light colors that do not print well on grayscale printers. It is
advised that you test the color reproduction prior to submission by printing
sample pages from the document using a grayscale printer.
Page
Numbering
In addition to font colors, keep formatting simple in tables. When extracting a
table from the PDF document, the use of light or white font color will not allow
the transfer of text back into some word processing documents.
If a submission includes more than one document, you need not provide
pagination for the entire submission. Include page numbers only for individual
documents.
It is easier to navigate though an electronic document if the page numbers for
the document and the PDF file are the same. To accomplish this, the initial
page of the paper document should be numbered page 1.
File Size
An electronic submission can have one or multiple file attachments. There is
not a limitation of the total size of the submission, but each file should be
limited to 50MB in file size. There are several ways to compress file size,
including but not limited to: performing Optical Character Recognition,
reducing file size in Adobe and creating logical section breaks.
If you have questions about file size, please contact technical support at
[email protected] to ensure the file size is acceptable.
Document
Properties:
Description
Tab
Document
Properties:
Initial View
Tab
In the Document Properties box, the Initial View tab can also be found. In the
Document Options section, all PDF files should set the Show field as
Bookmarks Panel and Page. If there are no bookmarks, set the initial view as
Page only. Set the Page Layout and Magnification fields to default.
Document
Properties:
Security
PDF files are stored as original documents and will not be altered from their
original form. Remove any security settings, read-only, or password protection
used on the files. Files submitted with security settings will not be accepted.
Document properties are used to search for individual documents and to
identify the document when found. To modify document properties, from the
tool bar navigate to File Document Properties.
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Section 5: FDA Recommended PDF File Specifications
Indexing
PDF
Documents
Full text indexes are used to help find specific documents and/or to search for
text within documents. When a document or group of documents is indexed, all
words and numbers in the file and all information stored in the Document
Information fields are stored in special index files that are functionally
accessible using the search tools available in Acrobat.
Portions of a document that are imaged are not indexed. Even if the document
only contains images, the text in the Document Information fields of the file
will be indexed. All PDF files should be full-text searchable prior to submitting
to the FDA.
Bookmarks
and
Hypertext
Links
Bookmarks and hyperlinks should be used to assist the reviewers in navigating
through the content of the submission. If you used either bookmarks or
hypertext links, consider the following:
•
Use meaningful bookmarks (e.g., the title of the section, name of a
study, data set, or facility). This will aid the reviewer in locating
information and navigating the submission.
•
Bookmark references can be created for the heading of a section,
subsection or title of figures and tables within the document. In general,
including a bookmark to the main table of contents for a submission or
item is helpful. Make the bookmark hierarchy identical to the table of
contents.
•
Use hyperlinks within the file. Hyperlinks are used to improve
navigation through PDF documents and are encouraged. Hyperlinks can
be designated by rectangles using thin lines or by blue text or you can
use invisible rectangles for hypertext links in a table of contents to
avoid obscuring text. Hyperlinks throughout the body of the document
to supporting annotations, related sections, references, appendices,
tables, or figures that are not located on the same page are helpful and
improve navigation efficiency. When creating bookmarks and
hyperlinks, the magnification setting should be set to Inherit Zoom so
that the destination page displays at the same magnification level that
the reviewer is using for the rest of the document.
Important Note: Hyperlinks between individual PDF document files are not
currently supported and any absolute links that reference across files will not
work.
In general, for documents with a table of contents, provide bookmarks and
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Section 5: FDA Recommended PDF File Specifications
hypertext links for each item listed in the table of contents including all tables,
figures, publications, other references, and appendices. These bookmarks and
hypertext links are essential for the efficient navigation through documents.
Optical
PDF documents produced by scanning paper documents are usually inferior to
Character
those produced from an electronic source document such as MS Word.
Recognition Scanned documents are more difficult to read and do not allow the reviewers to
search or copy and paste text for editing. The use of scanned documents should
be avoided if at all possible. If scanning cannot be avoided, the following is
highly recommended:
•
Perform optical character recognition (OCR) on all scanned documents
so that the text is searchable
•
Check to see that the content has been correctly converted.
If the source document is only available on paper, it should be scanned at
resolutions that will ensure the pages are legible both on the computer screen
and when printed. At the same time, remember to limit the file size to be less
than 50MB. We recommend scanning at a resolution of 300 dots per inch (dpi)
to balance legibility and file size. We discourage the use of grayscale or color
because of file size. After scanning, avoid re-sampling to a lower resolution.
For files with images and photographs:
Also, when creating PDF files containing images, you should not
resample images. Re-sampling does not preserve all of the pixels in the
original. For photographs, the image should be obtained with a
resolution of 600 dpi. If black and white photos are submitted, consider
8-bit gray scale images. If color photos are submitted, consider 24-bit
RGB Color Model images. A captured image should not be subjected to
non-uniform scaling (i.e., sizing).
Files with scanned images and photographs tend to be large in file size.
Please do not exceed 50MB for a single file. Consider multiple files for
these types of documents.
Note: Scanned tables and graphs cannot be extracted easily if scanned.
Most OCR programs will distort the data in tables and graphs. Convert
MS Word documents to PDF, as this method usually retains the
formatting.
For a paper document with handwritten notes:
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Section 5: FDA Recommended PDF File Specifications
Paper documents containing handwritten notes should be scanned at
300 dpi. These handwritten notes should be made in black ink for
clarity.
If you have questions about creating electronic copies, please contact technical
support at [email protected] to ensure that the format is acceptable prior
to developing your submission.
Naming
PDF Files
We are recommending names for folders and selected files in individual
guidances for specific submission types. For uniformity, we hope that you use
our specific naming conventions when they are provided. Reviewers are
trained to look for these folders and files, and using the recommended names
should help avoid misunderstandings, improve communication, and speed the
review of a submission.
When we do not specify a file name, you can use file names up to 32 characters
in length with a 3-character extension. Do not use punctuation, spaces, or
other nonalphanumeric symbols in file names when naming the files for
attachments. For example, do not use slashes (/) (\), tildes (~), asterisks (*),
periods (.), brackets [ ], single quotation marks (‘), double quotation marks (“)
or parentheses ( ). Once the file is attached to a question, it can be selected as
an attachment to other questions, if appropriate.
The eSubmitter tool supports the following file types:
•
•
•
•
•
•
•
•
•
Portable Document Format Files (.pdf)
Excel Files (.xls, .csv)
SAS System XPORT Files (.xpt)
Media Files (.wmv, .avi)
Image Files (.gif, .tif, .jpg)
Extensible Markup Language Files (.xml, .dtd)
Archive/Compressed Files (.zip)
Standard Generalized Markup Language Files (.sgml)
MDL Molfiles Files (.mol)
However, based on the application or report you are submitting, the question(s)
may have restrictions on which file types you are allowed to attach. For
example, some questions may allow you to attach any of the file types
supported be eSubmitter and some may only allow you to attach PDF and
Excel files as the questions response or supporting documentation.
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Section 5: FDA Recommended PDF File Specifications
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Section 6: User Support
Introduction
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For technical assistance for the eSubmitter software, an email can be sent to
[email protected]. In the email, please be sure to provide the
company name and contact information where a response can be sent.
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| File Type | application/pdf |
| File Title | Microsoft Word - eSubmissionUserManual.doc |
| Author | Ricky.Brathwaite |
| File Modified | 2009-11-04 |
| File Created | 2009-10-15 |