Part X Appendices

Guidance for Industry
Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety

Contains Nonbinding Recommendations

March 2010

Draft Guidance

Return to Table of Contents and Part I (Introduction)

Draft-Not for Implementation

X. Appendices

• Appendix 1:   Instructions for Completing Form FDA 3503 Food/ Color Additives and Master Files
• Appendix 2:   Food and Color Additive Petition and Master File Form FDA 3503 (available in PDF)
• Appendix 3a: Instructions for Completing Food Contact Substance Form FDA 3480
• Appendix 3b: Instructions for Completing Food Contact Substance Form FDA 3480-A for Amendments
• Appendix 4a: Notification for New Use of a Food Contact Substance under Premarket Notification submission Form FDA 3480: (available in PDF)
• Appendix 4b: Notification for New Use of a Food Contact Substance under Premarket Notification submission Form FDA 3480-A for amendments (available in PDF)
• Appendix 5:   Instructions for Completing GRAS Notice Form FDA 3667
• Appendix 6:   GRAS Notice Form FDA 3667 (available in PDF)
• Appendix 7:   Instructions for Completing Biotechnology Notification Form FDA 3665
• Appendix 8:   Biotechnology Final Consultation Form FDA 3665 (available in PDF)
• Appendix 9:   Instructions for Completing New Protein Consultation Form FDA 3666
• Appendix 10: New Protein Consultation Form FDA 3666 (available in PDF)
• Appendix 11: Definition of Regulatory Submissions and Terms
• Appendix 12: Conventions for Naming Files and Folders in an Electronic Submission
• Appendix 13: List of Abbreviations and Acronyms
• Appendix 14: Creating Reference Hyperlinks in E-submission Documents
• Appendix 15: Links to Downloadable Foldering Structures