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• Address Two Draft Guidance Documents Released 7/31/01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?