Office of Food Safety Additives

Report
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.
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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
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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• Address Two Draft Guidance Documents Released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
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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
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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
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6
Background
Old Petition Process
•
Paper Copy of Petition in
Triplicate or Quadruplicate
New Petition Process
•
One Paper Copy in New
Format
or
•
One e-Submission with
Signed Application Form
» CD-ROM
» Diskettes/Zip Disk
» Electronic Tape
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7
Review Process
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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
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9
Food Additive Application
FDA 3503
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10
Chemical Identities Section
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11
Submission Information
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12
Chemistry and Safety Sections
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13
Administrative and Environmental
Sections
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14
Signature
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15
Organization of Food and Color
Additive Submissions
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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
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17
Administrative Subfolder
• Documents
» Administrative TOC.pdf
» Proposed Tolerances.pdf
» Proposed Regulation.pdf
• Folders
» Correspondence Folder
– Incoming Folder
– Supplement
Cover.pdf
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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
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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
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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
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21
Safety Subfolder
• Documents
– Safety TOC.pdf
– Safety Summary.pdf
• Folders
– Studies
– References
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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
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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
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24
Environmental Subfolder
• Documents
– Environmental
TOC.pdf
– Environmental
Assessment.pdf
– Categorical
Exclusion.pdf
• Folders
– Studies
– References
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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
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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
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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
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28
Questions?
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29

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