Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions

Questions to 2 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.

Questions to 3 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

Questions to 4 Introduction To New Organization and Process Address Two Draft Guidance Documents Released 7/31/01 —Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive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

Questions to 5 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

Questions to 6 Objectives Review the Key Aspects of the Food and Color Additive Guidance for e-Submissions Encourage Petitioners to Use Guidance to Submit Electronic Submissions

Questions to 7 Background 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

Questions to 8 Review Process

Questions to 9 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

Questions to 10 Food Additive Application FDA 3503

Questions to 11 Chemical Identities Section

Questions to 12 Submission Information

Questions to 13 Chemistry and Safety Sections

Questions to 14 Administrative and Environmental Sections

Questions to 15 Signature

Questions to 16 Organization of Food and Color Additive Submissions

Questions to 17 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

Questions to 18 Administrative Subfolder Documents »Administrative TOC.pdf »Proposed Tolerances.pdf »Proposed Regulation.pdf Folders »Correspondence Folder –Incoming Folder –Supplement Cover.pdf

Questions to 19 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

Questions to 20 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

Questions to 21 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

Questions to 22 Safety Subfolder Documents –Safety TOC.pdf –Safety Summary.pdf Folders –Studies –References

Questions to 23 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

Questions to 24 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

Questions to 25 Environmental Subfolder Documents –Environmental TOC.pdf –Environmental Assessment.pdf –Categorical Exclusion.pdf Folders –Studies –References

Questions to 26 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

Questions to 27 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

Questions to 28 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

Questions to 29 Questions?