Office of Food Additive Safety
description
Transcript of Office of Food Additive Safety
Office of Food AdditiveOffice of Food Additive SafetySafety
Information for Industry: Steps to Implementation
of Electronic Submissions
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Overview by Dr. Alan Rulis, Director, Overview by Dr. Alan Rulis, Director, Office of Food Additive SafetyOffice 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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Electronic Submissions ReadinessElectronic 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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Introduction To New Introduction To New Organization and ProcessOrganization 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• Address Two Draft Guidance Documents Released 7/31/01— Providing Regulatory Submissions to Office of Food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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Introduction to New Organization Introduction to New Organization and Process - Continuedand 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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ObjectivesObjectives
• 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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BackgroundBackground
• Paper Copy of Petition in Triplicate or Quadruplicate
• One Paper Copy in New Format
or
• One e-Submission with Signed Application Form
» CD-ROM
» Diskettes/Zip Disk
» Electronic Tape
Old Petition Process New Petition Process
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Review ProcessReview Process
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Guidance Overview: Guidance Overview: Technical PerspectiveTechnical 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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Food Additive ApplicationFood Additive ApplicationFDA 3503 FDA 3503
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Chemical Identities SectionChemical Identities Section
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Submission InformationSubmission Information
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Chemistry and Safety SectionsChemistry and Safety Sections
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Administrative and Administrative and Environmental SectionsEnvironmental Sections
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SignatureSignature
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Organization of Food and Color Additive Submissions
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Main FolderMain 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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Administrative SubfolderAdministrative Subfolder
• Documents» Administrative TOC.pdf
» Proposed Tolerances.pdf
» Proposed Regulation.pdf
• Folders» Correspondence Folder
– Incoming Folder
– Supplement Cover.pdf
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Chemistry SubfolderChemistry 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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Chemistry Studies FolderChemistry 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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Chemistry References FolderChemistry 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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Safety SubfolderSafety Subfolder
• Documents– Safety TOC.pdf
– Safety Summary.pdf
• Folders– Studies
– References
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Safety Studies FoldersSafety 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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Safety References FolderSafety 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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Environmental SubfolderEnvironmental Subfolder
• Documents– Environmental
TOC.pdf
– Environmental Assessment.pdf
– Categorical Exclusion.pdf
• Folders– Studies
– References
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Supplements and AmendmentsSupplements 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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Updating the Roadmap FileUpdating 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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SummarySummary
• 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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Questions?Questions?