Office of Food Additive Safety

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 Introduction To New Organization and Process • Address Two Draft Guidance Documents Released 7/31/01 • Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive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