GUIDANCE DOCUMENT
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part X Appendices March 2010
Not for implementation. Contains non-binding recommendations.
Contains Nonbinding Recommendations
Draft — Not for Implementation
March 2010
Table of Contents and Introduction (Part I)
Information for all regulatory submissions
- Part I: Introduction
- Part II: Common Elements
- Part III: General Considerations - Electronic Format
- Part IX: FDA References
- Part X: Appendices
- Quick Links to Forms, Instructions and Downloadable Folders
Regulatory submissions for program areas
- Part IV: Food or Color Additive Submissions
- Part V: Food Contact Substance Submissions
- Part VI: GRAS Notices
- Part VII: Biotechnology Final Consultations
- Part VIII: New Protein Consultations
All parts [Printable PDF Version]
X. Appendices
- Appendix 1: Instructions for Completing Form FDA 3503 Food/ Color Additives and Master Files (PDF - 39KB)
- Appendix 2: Food and Color Additive Petition and Master File Form FDA 3503 (PDF - 1.26MB)
- Appendix 3a: Instructions for Completing Food Contact Substance Form FDA 3480 (PDF - 289KB)
- Appendix 3b: Instructions for Completing Food Contact Substance Form FDA 3480-A for Amendments (PDF - 134KB)
- Appendix 4a: Notification for New Use of a Food Contact Substance under Premarket Notification submission Form FDA 3480: (PDF - 112KB)
- Appendix 4b: Notification for New Use of a Food Contact Substance under Premarket Notification submission Form FDA 3480-A for amendments (PDF - 154KB)
- Appendix 5: Instructions for Completing GRAS Notice Form FDA 3667 (PDF - 57KB)
- Appendix 6: GRAS Notice Form FDA 3667 (PDF - 138KB)
- Appendix 7: Instructions for Completing Biotechnology Notification Form FDA 3665 (PDF -28KB)
- Appendix 8: Biotechnology Final Consultation Form FDA 3665 (PDF - 812KB)
- Appendix 9: Instructions for Completing New Protein Consultation Form FDA 3666 (PDF - 46KB)
- Appendix 10: New Protein Consultation Form FDA 3666 (PDF - 105KB)
- Appendix 11: Definition of Regulatory Submissions and Terms (PDF - 31KB)
- Appendix 12: Conventions for Naming Files and Folders in an Electronic Submission (PDF - 138KB)
- Appendix 13: List of Abbreviations and Acronyms (PDF - 18KB)
- Appendix 14: Creating Reference Hyperlinks in E-submission Documents (PDF - 67KB)
- Appendix 15: Links to Downloadable Foldering Structures (PDF - 1.88KB)
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.