1. eSubmitter “Basics” - Brief Introduction to Your eSubmitter Tool June 5, 2014

2.  Electronic, question-based tool that permits the creation and submission of information  Originally developed in Center for Devices and Radiological Health (CDRH)  Now used by six centers (CBER, CDER, CDRH, CFSAN, CTP, and CVM)  Templates/data capturing forms (question and answer, file attachment capability) walk you through the process of compiling a complete and structured submission to FDA  Required information is clearly identified  Business rule logic require you to complete sections based on previous responses  Ensures all components are included  Standardizes and simplifies the process where possible 2 CVM ONADE eSubmitter Overview

3.  Default installation location is C:\Program Files\eSub  If desired, this location can be changed to a network drive (see user manual)  The application stores the data and output files in the following location:  Windows XP or earlier: o C:\Documents and Settings\eSub_Home\  Windows Vista & Windows 7: o C:\Users\Public\eSub_Home\  User must have write access to the eSubmitter output directory 3 eSubmitter Configuration

4.  eSubmitter requires that you know the document type (and your document number), submission type, and submission classification code of the submission you wish to build  A unique Submission ID is created by the following matrix of codes: o Document Type: one letter (I, J, A, N, V, G) o Document Number: up to 6 digits (000000) o Submission Type: one letter (A, B, E, P, Z, etc.) o Submission Number: up to 4 digits (0000) o Submission Classification Code: two letters (EF, HF, etc.)  When unsure, please ask your CVM ONADE Project Manager o Once you start building your submission, you cannot change the unique Submission ID (i.e., you will have to start over) 4 Starting Your Submission

5. Navigating the Intro Screen 5 Menu Options Pane Primary Screen Area Menu Bar Tool Bar Message Tabs Navigation Bar

6. eSubmitter User Interface 6 Expert Layout (Outline View) Expert view provides an outline section on the left and the primary screen area on the right, divided by the splitter bar Simple Layout (Full Screen View) Simple view displays a full primary screen with navigation bar at the bottom

7.  Check Mark (green) indicates no required information is missing  Question Mark (blue) indicates at least one item of required data is missing  Exclamation Point (red) indicates a critical required response  Dot (blue) indicates a required response  Light Bulb (yellow) indicates that a hint is available. Click to display the hint 7 User Interface Continued…

8.  Auto-Save: When enabled, eSubmitter automatically saves your submission  Layout: Allows you to set whether you want eSubmitter to open in simple or expert layout  Networking: Allows you to set file locking when using the software on a network  File Location: Allows you to change the location where your submission (data) files are saved and the location where packaged submission (output) files are generated  File Viewer: Allows you to identify the application that you will use to viewPDF documents  Messages: If enabled, provides navigational prompts as you move between screens  Memory: Allows you to change memory settings to support packaging of large submissions 8 eSubmitter User Preferences

9.  Tools Menu:  Address and Contact Books  Submission File List  Assign Submission ID (for archival purposes)  Tool Bar:  Provides icon tools similar to an MS Word application (Open, Close, Save, Cut, Copy, Paste, etc.) in addition to eSubmitter specific tools (e.g., package files for submission icon) 9 Tool Bar and Menu Options

10.  Missing Data Report  Displays the missing data that must be entered before the files are packaged for submission  Digital Signature  Guides the user through applying their self-signed ADOBE digital signature during the packaging process  Packaging Process  Walks the user through the packaging of the data files and file attachments for submissions  Administrative Cover Form (instead of Form FDA 356v) 10 Packaging Submission Data