office of food additive safety
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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 - PowerPoint PPT PresentationTRANSCRIPT
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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• Address Two Draft Guidance Documents Released 7/31/01— Providing Regulatory Submissions to Office of Food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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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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Administrative and Administrative and Environmental SectionsEnvironmental Sections
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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