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Fda Submission Templates - PDF by tru12399

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									CVM eSubmitter Workshop
               October 21, 2010

 Office of New Animal Drug Evaluation (ONADE)
          Center for Veterinary Medicine
Ground Rules
 Discuss Adobe Connect Pod arrangement and
 use
   Discuss different pods and Q&A procedures
 Questions will be addressed prior to the
 morning break, break before lunch, and breaks
 during afternoon breakout sessions
 Questions not addressed during the workshop
 will be answered and posted on the CVM
 eSubmitter website along with the recording of
 the morning workshop

                                                  2
Workshop Presenters
 Charles Andres, PhD
      Business Process Improvement Manager - ONADE
 Stacey Gore, DVM
      Veterinary Medical Officer – Division of Therapeutic Drugs for Food
      Animals (HFV-130)
 Katherine Weld, MS, PhD
      Team Leader – Division of Generic Animal Drugs (HFV-170)
 Scott Fontana, PhD
      Regulatory Information Specialist – ONADE




                                                                        3
  Morning Session Agenda
9 am – Noon
  9:00-9:30 am: Ground Rules, Opening Remarks, and Background on eSubmitter
     Development and Use of STARS Codes - Chuck Andres

  9:30-9:50 am: Development of INAD and NADA eSubmitter Templates - Stacey Gore

  9:50-10:10 am: Development of JINAD and ANADA eSubmitter Templates - Katherine Weld

  10:10-10:30 am: Development of GC and VMF eSubmitter Templates - Scott Fontana

  10:30-10:50 am: Q&A

  10:50-11:00 am: BREAK

  11:00-11:30 am: Brief eSubmitter Demonstration - Scott Fontana

  11:30-11:45 am: eSubmitter Beta testing and Transition Period - Chuck Andres

  11:45-12:00 pm: Q&A

Noon – 1 pm (Lunch Break)
     (Address technical difficulties with eSubmitter)

                                                                                   4
Opening Remarks
 Goals of the Animal Drug User Fee Act
 (ADUFA) Reauthorization of 2009
   One of the 10 ADUFA workshops agreed to
   under ADUFA
   Provide an electronic submission tool to the
   industry within 24 months after appropriations are
   passed
     Develop the tool with input from the regulated
     industry
     Develop an online review environment



                                                      5
Background
Electronic Document Submission and Review
(EDSR) System
   Collection of tools and systems that make up both
   the electronic submission and review systems at
   CVM
     Electronic Submission Gateway (ESG) – FDA
     gateway for electronic communication with outside
     parties
     Electronic Submission System (ESS) – CVM
     system used to receive sponsor submissions and to
     send CVM electronic responses
     eSubmitter – tool used by firms to build electronic
     submissions to be transmitted to CVM/ONADE
     Submission Tracking and Reporting System
     (STARS) – CVM’s corporate database/tracking
     system

                                                     6
Overview of STARS Nomenclature
 STARS relies on the following matrix of
 codes to create a unique Submission ID:
   Document Type: one letter (I, J, A, N, V, G)
   Document Number: up to 6 digits (000000)
   Submission Type: one letter (A, B, E, P, Z, etc.)
   Submission Number: up to 4 digits (0000)
   Submission Classification Code: two letters
   (EF, HF, etc.)



                                                 7
Overview of STARS Nomenclature
(cont’d)

  So, a human food safety protocol submitted to an
  INAD may look like this when coded into STARS:
  I-123456-E-0025-HF
     where (I) is for INAD, 123456 is the INAD
     number, E is for protocol, 0025 is the
     submission number and HF is for human food
  STARS submission matrix is available from your
  Project Manager in ONADE




                                                8
Overview of eSubmitter for
CVM/ONADE

  Developed originally in Center for Devices and Radiological
  Health (CDRH)
  Along with CDRH, is currently being used in the Center for
  Biologics Evaluation and Research and the Center for
  Tobacco Products
  Is an electronic, question-based tool that permits the
  creation and submission of information to ONADE
     It is eXtensible Markup Language (XML) - based with JAVA
     front-end
         JAVA component does not interact with other JAVA software
         within Windows operating systems
     Implements standards such that all submissions of the same
     type “look” the same to the CVM reviewer, regardless of firm


                                                                     9
Overview of eSubmitter for
CVM/ONADE (cont’d)

 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
 CVM ONADE eSubmitter is a collection of
 templates developed from over 2000 hours of
 requirement gathering sessions with CVM subject
 matter experts
    In those sessions, questions were developed as well
    as the business rules that were used in eSubmitter to
    move you from question to question and screen to
    screen


                                                        10
The eSubmitter Submission

 A single ZIP file that contains all of the
 answers to questions within a structured
 XML file including any file attachment(s)
 Protected by an Adobe digital signature
 applied when the submission is
 packaged
   Once the submission is packaged, it can’t be
   altered


                                              11
Permitted eSubmitter Attachments
 PDF for reports, labeling, etc.
 SAS Xport files (XPT) for data
 Non-proprietary XML files for data
   Can’t use the MS Word “save-as” function

 Why limit attachment types?
   CVM to maintain readability of submissions
   throughout the records life and in accordance
   with Federal record schedules


                                              12
Transmission of eSubmitter
ZIP file to FDA
 Same as with the current PDF SmartForms
   Either using your current WebTrader account or your
   Gateway-to-Gateway method
   Will receive receipt and STARS Submission ID with
   validated submissions


 What’s New with eSubmitter?
   Will receive all final action correspondence
   electronically through WebTrader or Gateway-to-
   Gateway method
       Protocol concurrences, technical section completes,
       approval letters, etc.

                                                         13
Development of INAD and NADA
eSubmitter Templates


          Stacey Gore




                               14
INAD / NADA
Template Development
 Multiple meetings, iterations, and ideas to
 edit questions, hints, lay-outs
 Input from all divisions within ONADE
 Customized to divisional needs and team
 needs
 Even the 1% was considered

Customized for the animal health industry


                                               15
INAD / NADA
Template Development (cont’d)

Templates are available for all submission
types for both INADs and NADAs
New INAD and NADA files (A-0000) can be
created by sponsor
Minor and End-Review Amendments will
be submitted through eSubmitter
Allows for Minor Use and Minor Species
(MUMS) designation requests and reports

                                        16
Goals

 Ensure all parts are provided and may
 minimize the number of minor
 amendments
 Eliminate need for paper (i.e., save trees
 and postage costs)
 Standardize where possible (contact
 information, product description)
 Share similar information across
 templates
                                          17
Template Complexity
 Simple
   Protocols
   Data submissions
 Complex
   Chemistry, Manufacturing and Controls
   (CMC)
     Example: Question-based Review (QbR)
   Environmental submissions



                                            18
Submission Process

 Current Process
   Cover letter
   Core submission
   Form FDA 356v (if applicable)
 eSubmitter
   Question based
   Eliminates the need for a cover letter and
   Form FDA 356v


                                                19
Intuitive Submission Building
 When to address
   Environmental requirements (within different
   submissions)
   Form FDA 356v (eSubmitter Administrative
   Cover Form)
 How to build an Administrative NADA
 (when some technical sections are
 complete)
 Built-in questions and prompts for
 referencing other files and applications
 (INAD, NADA, PMF, VMF, etc.)
                                                  20
Enhanced Customer Service

 Simplified the process where possible
   Contact information and address
   management
   Amended Food-Use Authorization (when
   changing number of animals)
   Submission received by appropriate review
   division the first time




                                               21
Breakout Session 1 Agenda
  1:00 pm – 4:00 pm
               INAD/NADA Submissions
    I/E/HF – Human Food Safety protocol submission
             Q&A (10 min)
    I/P/TS – Target Animal Safety technical section
             Q&A (10 min)
    N/C/CS – CBE 30 Chemistry Supplement
             Q&A (10 min)
    N/B/CA – Chemistry Annual Report/Manufacturing
            and Chemistry Stability Report (MCSR)
             Q&A (10 min)
    I/B/OT – Drug Shipment Notice
             Q&A (10 min)
    N/A/OT – Original NADA with Labeling
             Q&A (10 min)
                                                      22
Development of JINAD and
ANADA eSubmitter Templates


         Katherine Weld




                             23
JINAD / ANADA and eSubmitter

While the world of generic new animal drug
submissions is unique, eSubmitter still
provides us with submission templates that
make sending in a generic submission or
application much easier.




                                         24
JINAD / ANADA and eSubmitter
 The business rules and logic that we have
 incorporated into the generics portion of
 eSubmitter are built on:
   Current requirements (regulations, guidance)
      Example: Form FDA 356v
          The information and certifications that were in the form
          are now built into eSubmitter
   Reduce frequently seen issues
     Recode submissions
     Divide multiple requests into separate
     submissions



                                                                     25
JINAD / ANADA and eSubmitter

CVM recognizes that determining what to
include in a submission can sometimes be
challenging, eSubmitter was designed by
us for you so that you can walk through
preparing a submission and not leave out
any required information.




                                           26
JINAD / ANADA and eSubmitter
 Required information is clearly identified
 Required information must be provided in
 order to move through the submission,
 for example:
   A certificate of analysis in a request for a
   bioequivalence waiver is required. You will
   be prompted to include it as part of the
   submission building. If not provided, you
   cannot package the submission. The Missing
   Data Report will tell you its missing.


                                              27
JINAD / ANADA and eSubmitter
 By designing the business rules in the software,
 you will readily see what is required when
 preparing the different types of submissions and
 applications
 Having all the necessary pieces and only the
 necessary pieces on the receiving end, will
 allow us to be more efficient in our review work




                                               28
JINAD / ANADA and eSubmitter
 For example: If you are working on
 patent certification information in
 eSubmitter, you will see the list of
 possible certifications or statements.
 Once you select one, you can see what
 the certification or statement means (in
 plain language). So if you have selected
 the wrong certification, you can go back
 and change your answer.


                                        29
JINAD / ANADA and eSubmitter
 The core questions for eSubmitter remain the
 same each time you start a new submission
 regardless of type
 The number of questions you will answer and
 level of detail you will provide when preparing
 your submission will vary depending upon the
 submission type
 In every case, we have worked to design the
 templates so you can walk easily through what
 is required

                                                   30
Breakout Session 2 Agenda
  1:00 pm – 4:00 pm
             JINAD/ANADA Submissions
     J/R/OT – Waiver of Bioequivalence
          Q&A (10 min)
     J/P/PE – Patent and Exclusivity Technical Section
          Q&A (10 min)
     A/A/OT – Original ANADA
          Q&A (10 min)
     A/C/NL – Labeling Supplement
          Q&A (10 min)
     A/B/CA – Chemistry Annual Report/Manufacturing
           and Chemistry Stability Report (MCSR)
          Q&A (10 min)
                                                         31
Development of GC and VMF
eSubmitter Templates


          Scott Fontana




                            32
General Correspondence Files

 General Correspondence (GC) is an
 administrative file that contains the firm
 and agency records that are not specific
 to a new animal drug file or application
 CVM uses this administrative file to store
 User Fee waiver requests from firms
 GC files are also used for MUMS
 Designation Requests and Reports



                                          33
Template Development - GC
 General Correspondence (GC) templates were
 designed to allow maximum flexibility due to the
 wide variety of submissions
 The Animal Drug User Fee Act (ADUFA) and
 Animal Generic Drug User Fee Act (AGDUFA)
 fee waiver submissions will be submitted to
 established GC files
   One GC file will accept ALL ADUFA fee waivers
   One GC file will accept ALL AGDUFA fee waivers
 GC files can be used for MUMS Designation
 Requests and Reports (INAD submission path
 is preferred)


                                                    34
User Fee Waivers

 When submitting User Fee Waivers you
 will need to submit to the following
 established files:
   G-003126 for ADUFA
   G-003409 for AGDUFA




                                        35
Veterinary Master Files
 eSubmitter will allow for all types of
 submissions to Veterinary Master Files
 (Type II, III, IV, and V), primarily for
 Chemistry, Manufacturing and Controls
 information
 This includes:
   Original Submissions
   Annual Reports
   Supplements


                                            36
Template Development - VMF
 Veterinary Master File (VMF) template
 development was based on the
 Question-based Review (QbR) elements
 established by CVM’s Division of
 Manufacturing Technologies
 Letters of Authorization and Lists of
 Authorized users should now be
 submitted separately as a V/G/OT
 submission


                                         37
VMF Submissions
 Supplements (V/C/OT) will include:
   Responses to Incomplete Items
   Annual Reports
      Including Complete Updates
   Supplemental Information
 General Correspondence (V/G/OT)
   Used for submissions to the VMF not classified
   elsewhere
   Letters of Authorization
   List of Authorized Users




                                                    38
Breakout Session 3 Agenda
  1:00 pm – 4:00 pm
                 VMF/GC Submissions
    V/C/OT – VMF Annual Update, CMC submission
           Q&A (10 min)
    G/G/TM – Terminate File (Document) Request
           Q&A (10 min)
    G/C/ES – Establishment Fee waiver
           Q&A (10 min)
    G/Z/OO – Meeting Request, ONADE Other
           Q&A (10 min)



                                                 39
Questions?




             40
Acknowledgments
 Aila Albrecht       Stacey Gore
 Chuck Andres        Joan Gotthardt
 Dorothy Bailey      Diane Heinz
 Ruth Barratt        Jill Kay
 Dan Benz            Robin Keyser
 Angela Clarke       Karen Lampe
 Howard Conrad       Rosilend Lawson
 Hung Dang           Meg Oeller
 Sophia Donaldson    Sharon Ricciardo
 Danielle Drummond   Marty Schoenemann
 Steve Edgar         Danielle Sholly
 Chuck Eirkson       Eric Silberhorn
 Holly Erdely        Brad Smith
 Scott Fontana       Veronica Taylor
 Marshall Gagne      Katherine Weld
 Petra Garosi        Karen Wheless
                                         41
BREAK


   We will return with the
  presentations at 11:00 am




                              42
eSubmitter Introduction

         Scott Fontana
eSubmitter Configuration
 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:
       C:\Documents and Settings\eSub_Home\
    Windows Vista & Windows 7:
       C:\Users\Public\eSub_Home\

 Important Note: User must have write access to the
 eSubmitter output directory


                                                           44
             Navigating the Intro Screen
                    Menu Bar
      Tool
      Bar

                                           Navigation
                                              Bar



                                             Message
                                              Tabs
 Menu
Options
 Pane

                                             Primary
                                             Screen
                                              Area




                                             45
     eSubmitter User Interface
  Expert Layout (Outline View)     Simple Layout (Full Screen View)




Expert view provides an outline section on the left and the primary
screen area on the right, divided by the splitter bar.
Simple view displays a full primary screen with navigation bar at
the bottom.
                                                                      46
  User Interface Continued…




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.
                                                                          47
    eSubmitter User Preferences




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 view PDF 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.
                                                                                           48
Tool Bar and Menu Options
Tools Menu:
  Address & 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)



                                                    49
   Packaging Submission Data

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 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)


                                                               50
Packaging – What Not to Do
What Not to Do:
 Include additional files outside of the ZIP file
 after packaging
 Add documents to the ZIP file after
 packaging
 Manipulate any of the files within the ZIP file
 after packaging
 Move file attachments prior to packaging
 Send the ZIP file to CVM on a CD ROM or
 other storage media
                                               51
Brief eSubmitter Demonstration

Demonstrate eSubmitter template




                                  52
Beta Test Program and Transition Period



             Chuck Andres




                                          53
Beta Test Program
 Following this workshop, CVM will be
 seeking up to 9 volunteer companies to
 test send and receive system capabilities
 The eSubmitter Beta test will begin 3
 weeks following the workshop and last
 for approximately 3 weeks
 Participant requirements include:
   Have established ESG and ESS accounts
   A commitment to complete the assigned test
   scripts prior to test completion date

                                            54
Beta Test Program (cont’d)

 Interested companies should email
 Chuck Andres at
 charles.andres@fda.hhs.gov by COB
 October 29, 2010
    Include: Name, firm name, email address,
    and phone number
      If more than one individual within a firm will be
      participating, CVM will need the above
      information on each test person



                                                          55
Transition Period to eSubmitter
 Launch eSubmitter tool in March, 2011
 Acceptance of PDF SmartForms will NOT
 be permitted after September 30, 2011
 Submissions currently pending within
 ONADE during transition period will be
 handled in the format in which they were
 received
   Pending paper and PDF SmartForms submissions
   will be treated as they are now
      Paper response
      Printed copy of a digitally-signed letter

                                                  56
Paper Submissions           (after eSubmitter implementation)



All incoming paper submissions will be
scanned by CVM’s Document Control Unit
  Permits electronic review by CVM reviewers
  However, you will receive a paper response
When you use eSubmitter, we want you to be
              “ALL IN”
  Extremely inefficient for ONADE to work in a dual,
  electronic/paper environment




                                                                57
Public Comment Period
 Published Federal Register Notice
   Vol. 75, No. 185 / Friday, September 24,
   2010
 Encourage comments on eSubmitter tool
 from an IT compatibility perspective as
 well as submission template content
 Comments should be submitted to the
 Docket: FDA–2010–N–0481
 Comment period ends December 31,
 2010
                                              58
Questions?




             59
LUNCH BREAK

  Will resume workshop into
 breakout sessions at 1:00 pm




                                60

								
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