office of food additive safety information for industry: steps to implementation of electronic...
Post on 20-Dec-2015
213 views
TRANSCRIPT
![Page 1: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/1.jpg)
Office of Food AdditiveOffice of Food Additive SafetySafety
Information for Industry: Steps to Implementation
of Electronic Submissions
![Page 2: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/2.jpg)
Email Questions to [email protected] 2
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.
![Page 3: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/3.jpg)
Email Questions to [email protected] 3
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
![Page 4: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/4.jpg)
Email Questions to [email protected] 4
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• Address Two Draft Guidance Documents Released 7/31/01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
![Page 5: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/5.jpg)
Email Questions to [email protected] 5
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
![Page 6: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/6.jpg)
Email Questions to [email protected] 6
ObjectivesObjectives
• Review the Key Aspects of the Food and Color Additive Guidance for e-Submissions
• Encourage Petitioners to Use Guidance to Submit Electronic Submissions
![Page 7: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/7.jpg)
Email Questions to [email protected] 7
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
![Page 9: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/9.jpg)
Email Questions to [email protected] 9
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
![Page 10: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/10.jpg)
Email Questions to [email protected] 10
Food Additive ApplicationFood Additive ApplicationFDA 3503 FDA 3503
![Page 14: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/14.jpg)
Email Questions to [email protected] 14
Administrative and Administrative and Environmental SectionsEnvironmental Sections
![Page 17: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/17.jpg)
Email Questions to [email protected] 17
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
![Page 18: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/18.jpg)
Email Questions to [email protected] 18
Administrative SubfolderAdministrative Subfolder
• Documents
» Administrative TOC.pdf
» Proposed Tolerances.pdf
» Proposed Regulation.pdf
• Folders
» Correspondence Folder
– Incoming Folder
– Supplement Cover.pdf
![Page 19: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/19.jpg)
Email Questions to [email protected] 19
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
![Page 20: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/20.jpg)
Email Questions to [email protected] 20
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
![Page 21: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/21.jpg)
Email Questions to [email protected] 21
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
![Page 22: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/22.jpg)
Email Questions to [email protected] 22
Safety SubfolderSafety Subfolder
• Documents
– Safety TOC.pdf
– Safety Summary.pdf
• Folders
– Studies
– References
![Page 23: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/23.jpg)
Email Questions to [email protected] 23
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
![Page 24: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/24.jpg)
Email Questions to [email protected] 24
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
![Page 25: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/25.jpg)
Email Questions to [email protected] 25
Environmental SubfolderEnvironmental Subfolder
• Documents
– Environmental TOC.pdf
– Environmental Assessment.pdf
– Categorical Exclusion.pdf
• Folders
– Studies
– References
![Page 26: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/26.jpg)
Email Questions to [email protected] 26
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
![Page 27: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/27.jpg)
Email Questions to [email protected] 27
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
![Page 28: Office of Food Additive Safety Information for Industry: Steps to Implementation of Electronic Submissions](https://reader036.vdocument.in/reader036/viewer/2022081519/56649d4d5503460f94a2b743/html5/thumbnails/28.jpg)
Email Questions to [email protected] 28
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