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Office of Food Additive Safety

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

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Office of Food Additive Safety

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  1. Office of Food AdditiveSafety Information for Industry: Steps to Implementation of Electronic Submissions

  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. Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  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 Introduction To New Organization and Process • Address Two Draft Guidance Documents Released 7/31/01 • Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive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 Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  7. 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 Background Old Petition Process New Petition Process Email Questions to electronic_submissions@cfsan.fda.gov

  8. Review Process Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  10. Food Additive ApplicationFDA 3503 Email Questions to electronic_submissions@cfsan.fda.gov

  11. Chemical Identities Section Email Questions to electronic_submissions@cfsan.fda.gov

  12. Submission Information Email Questions to electronic_submissions@cfsan.fda.gov

  13. Chemistry and Safety Sections Email Questions to electronic_submissions@cfsan.fda.gov

  14. Administrative and Environmental Sections Email Questions to electronic_submissions@cfsan.fda.gov

  15. Signature Email Questions to electronic_submissions@cfsan.fda.gov

  16. Organization of Food and Color Additive Submissions Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  18. Administrative Subfolder • Documents • Administrative TOC.pdf • Proposed Tolerances.pdf • Proposed Regulation.pdf • Folders • Correspondence Folder • Incoming Folder • Supplement Cover.pdf Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  22. Safety Subfolder • Documents • Safety TOC.pdf • Safety Summary.pdf • Folders • Studies • References Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  25. Environmental Subfolder • Documents • Environmental TOC.pdf • Environmental Assessment.pdf • Categorical Exclusion.pdf • Folders • Studies • References Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  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 Email Questions to electronic_submissions@cfsan.fda.gov

  29. Questions? Email Questions to electronic_submissions@cfsan.fda.gov

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