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					Office of Food Additive Safety


               Information for Industry:
                 Steps to Implementation
                  of Electronic Submissions
       Overview by Dr. Alan Rulis,
    Director, Office of Food Additive
                  Safety
• Launch Electronic Submissions
• Accelerate the Rate of Review of Direct Food and Color
  Petitions
• Encourage Companies to Participate in Pre-Petition
  Consultations
• E-Submissions Component of Larger Program
   » Food Additive Regulatory Management (FARM)
• Publish Future Guidance on Food Contact Notifications,
  Generally Recognized as Safe Notices, and Biotechnology
  Notifications.




              Email Questions to electronic_submissions@cfsan.fda.gov   2
          Electronic Submissions
                Readiness

• Open for Business
• All Submissions are Converted to Electronic Format
• E-Submissions Made in Accordance with the New
  Petition Organization will Make Our Job More Efficient




             Email Questions to electronic_submissions@cfsan.fda.gov   3
          Introduction To New
        Organization and Process

• Address Two Draft Guidance Documents Released
  7/31/01
   — Providing Regulatory Submissions to Office of Food
     Additive Safety in Electronic Format for Food Additive
     and Color Additive Petitions
   — Providing Regulatory Submissions to Office of Food
     Additive Safety in Electronic Format – General
     Considerations
• Suggestions on the Best Way to Submit Petitions
  in Electronic Format - not Requirements




              Email Questions to electronic_submissions@cfsan.fda.gov   4
   Introduction to New Organization
        and Process - Continued
• Advantages to New Organization of Petition and
  Submitting Petitions in Electronic Format
   » Fits with OFAS’s Electronic Systems for Handling the Petition
     Review
   » Expedites Processing
   » Increases the Accuracy of the Files OFAS Reviews
   » Helps OFAS Reviewers Find and Understand All of the
     Information Submitted in the Petition




               Email Questions to electronic_submissions@cfsan.fda.gov   5
                   Objectives

• Review the Key Aspects of the Food and Color
  Additive Guidance for e-Submissions
• Encourage Petitioners to Use Guidance to Submit
  Electronic Submissions




            Email Questions to electronic_submissions@cfsan.fda.gov   6
                        Background


    Old Petition Process                  New Petition Process
•    Paper Copy of Petition in            •   One Paper Copy in New
     Triplicate or Quadruplicate              Format
                                                             or
                                          •   One e-Submission with
                                              Signed Application Form
                                               » CD-ROM
                                               » Diskettes/Zip Disk
                                               » Electronic Tape




                  Email Questions to electronic_submissions@cfsan.fda.gov   7
    Review Process




Email Questions to electronic_submissions@cfsan.fda.gov   8
          Guidance Overview:
         Technical Perspective
• Roadmap.pdf Serves as the Organizer
• Standard Formats are Used to Submit Documents and
  Data
   » Acrobat (Portable Document Format - PDF)
      – Entire Petition in PDF; Duplicate Information in Other
        Formats:
          – Statistical Analysis System (SAS)
          – Chemical Structure Formats.

• Process Allows for Systematically Placing Files in
  Predetermined Folders



             Email Questions to electronic_submissions@cfsan.fda.gov   9
Food Additive Application
       FDA 3503




   Email Questions to electronic_submissions@cfsan.fda.gov   10
Chemical Identities Section




   Email Questions to electronic_submissions@cfsan.fda.gov   11
Submission Information




 Email Questions to electronic_submissions@cfsan.fda.gov   12
Chemistry and Safety Sections




    Email Questions to electronic_submissions@cfsan.fda.gov   13
Administrative and Environmental
            Sections




      Email Questions to electronic_submissions@cfsan.fda.gov   14
             Signature




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Organization of Food and Color
   Additive Submissions




   Email Questions to electronic_submissions@cfsan.fda.gov   16
                         Main Folder

• Folders
   » Administrative Folder
   » Chemistry Folder
   » Safety Folder
   » Environmental Folder

• Documents
   » Roadmap.pdf
   » Cover.pdf
   » Executive Summary.pdf
   » FAP or CAP Submission
     Application.pdf

              Email Questions to electronic_submissions@cfsan.fda.gov   17
            Administrative Subfolder

• Documents
   » Administrative TOC.pdf
   » Proposed Tolerances.pdf
   » Proposed Regulation.pdf

• Folders
   » Correspondence Folder
      – Incoming Folder
            – Supplement
              Cover.pdf




              Email Questions to electronic_submissions@cfsan.fda.gov   18
                Chemistry Subfolder

• Documents:
   » Chemistry TOC.pdf
   » Identity.pdf
   » Exposure.pdf
   » Intended Technical Effect.pdf
   » Analytical and Methodology.pdf
   » Method of Manufacture.pdf
   » Use.pdf
   » Specifications.pdf
• Subfolders:
   » Studies
   » References
               Email Questions to electronic_submissions@cfsan.fda.gov   19
         Chemistry Studies Folder

• Each Study Report
  Should be Provided as a
  Separate PDF File
• All Studies Should be
  Placed into a Single
  Folder Named Studies
• The Studies Folder
  Should be Placed in the
  Chemistry Subfolder




            Email Questions to electronic_submissions@cfsan.fda.gov   20
      Chemistry References Folder

• Each Reference Should
  be Provided as a
  Separate PDF File
• All References Should
  be Placed into a Single
  Folder Named
  References
• The References Folder
  Should be Placed in the
  Chemistry Subfolder



             Email Questions to electronic_submissions@cfsan.fda.gov   21
                  Safety Subfolder

• Documents
      – Safety TOC.pdf
      – Safety Summary.pdf

• Folders
      – Studies
      – References




             Email Questions to electronic_submissions@cfsan.fda.gov   22
             Safety Studies Folders

• Studies Categories
   » Make a Studies Folder for Each Type of Safety Study Included
     in a Petition
   » Make Each Study a Single PDF File
   » Place The Study in the Appropriate Topic Folder




              Email Questions to electronic_submissions@cfsan.fda.gov   23
         Safety References Folder

• Each Reference should be
  Provided as a Separate
  PDF File
• All References Should be
  Placed into a Single Folder
  Named References
• The References Folder
  Should be Placed in the
  Safety Subfolder




             Email Questions to electronic_submissions@cfsan.fda.gov   24
            Environmental Subfolder

• Documents
      – Environmental
        TOC.pdf
      – Environmental
        Assessment.pdf
      – Categorical
        Exclusion.pdf

• Folders
      – Studies
      – References




             Email Questions to electronic_submissions@cfsan.fda.gov   25
     Supplements and Amendments

• Petitioner places Supplement or Amendment Cover
  Letter in the Administrative/Correspondence/Incoming
  Folder
• Cover Letter Should Include Hypertext Links to the
  Data in the Appropriate Folder
   » Chemistry
   » Safety
   » Environmental




              Email Questions to electronic_submissions@cfsan.fda.gov   26
        Updating the Roadmap File

• Submission Amendments and Supplements are
  Accompanied by an Updated and Complete
  Roadmap.pdf
• Updated Roadmap.pdf Is Imported into FARM as Part
  of Original Module
   » Links of New Roadmap.pdf Provides Hyperlinks to All Files
      – Original Files
      – Supplemental or Amended Files




              Email Questions to electronic_submissions@cfsan.fda.gov   27
                            Summary

• Submissions
   » New Culture for OFAS and Industry
   » Files and Forms
   » Roadmap.pdf - Improves Organization and Productivity

• Folder Structure
   » Chemistry, Safety, Environmental

• Tools - Acrobat PDF, SAS, Chemical Structures
• Supplements and/or Amendments




              Email Questions to electronic_submissions@cfsan.fda.gov   28
        Questions?




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