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for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety; Draft Guidance

Table of Contents
Part I Introduction

Contains Nonbinding Recommendations

March 2010

Draft Guidance

[Printable PDF Version]

You may submit written or electronic comments regarding this guidance at any time.  Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the title of the guidance document. 

Additional copies are available from:
Office of Food Additive Safety (HFS-200)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD  20740
(Tel) 301-436-1200 (Updated phone: 240-402-1200)
http://www.fda.gov/FoodGuidances

  U.S.Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
March 2010

Contains Nonbinding Recommendations

Draft — Not for Implementation

Table of Contents

1. Introduction
2. Elements Common to All Regulatory Submissions
   1. General
   2. Forms
   3. Amendments, Updates, and Supplements
   4. Table of Contents
   5. Information that is Exempt from Disclosure under the Freedom of Information Act (FOIA)
   6. Cover Letter
   7. References
3. General Considerations about Regulatory Submissions in Electronic Format
   1. General Information
   2. Transmission of a Regulatory Submission in Electronic Format
   3. File Formats and Names in an Electronic Regulatory Submission
   4. Roadmaps
   5. Organization of an Electronic Regulatory Submission
   6. Preparation of Amendments, Updates, and Supplements in Electronic Format
   7. Electronic Signatures
4. Information Specific to Food or Color Additive Petition Submissions
   1. General Information about Petition Submissions
   2. Petition Submissions in Electronic Format
   3. Electronic Amendments and Updates to Petition Submissions
   4. Food and Color Master Files
5. Information Specific to Food Contact Notification Submissions and Pre-Notification Consultation Submissions
   1. General Information about Food Contact Notification Submissions
   2. Food Contact Notification Submissions in Electronic Format
   3. Electronic Amendments to Food Contact Notifications
   4. Pre-Notification Consultations and Food Master Files for Food Contact Substances
6. Information Specific to Generally Recognized as Safe Notice Submissions
   1. General Information about Generally Recognized as Safe Notice Submissions
   2. Generally Recognized as Safe Notice Submissions in Electronic Format
   3. Electronic Amendments and Supplements to GRAS Notice Submissions
7. Information Specific to Biotechnology Final Consultation Submissions
   1. General Information about Biotechnology Final Consultation Submissions
   2. Biotechnology Final Consultation Submissions in Electronic Format
   3. Electronic Amendments and Supplements to Biotechnology Final Consultation Submissions
8. Information Specific to New Protein Consultation Submissions
   1. General Information about New Protein Consultation Submissions
   2. New Protein Consultation Submissions in Electronic Format
   3. Electronic Amendments and Supplements to New Protein Consultation Submissions
9. FDA Web Site References
   1. Administrative Information Web Site References
   2. Chemistry Information Web Site References
   3. Safety Study Information Web Site References
   4. Environmental Information Web Site References
   5. Biotechnology Information Web Site References
10. Appendices

Contains Nonbinding Recommendations

Draft — Not for Implementation

Guidance for Industry
Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety^[1]
Draft Guidance

This guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction

This guidance document is intended to assist industry in transmitting regulatory submissions to the Office of Food Additive Safety (OFAS) in CFSAN at FDA.  Although the guidance applies regardless of whether you transmit the submission in electronic format or in paper format, many of the details of this guidance are directed to specific format features associated with transmitting a submission in electronic format.

This guidance applies to the following types of regulatory submissions to OFAS:

• Food Additive Petition (FAP);
• Color Additive Petition (CAP);
• Food Master File (FMF);
• Color Master File (CMF);
• Food Contact Notification (FCN);
• Pre-Notification Consultation for a Food Contact Substance (PNC);
• Generally Recognized As Safe (GRAS) notice;
• Final Consultation for Food Derived From New Plant Varieties (Biotechnology Final Consultation); and
• Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (New Protein Consultation).

OFAS receives other types of submissions in addition to the submissions listed above.  For example, OFAS receives “Threshold of Regulation” submissions in accordance with 21 CFR 170.39 and “Notification for a Food Contact Formulation” submissions in accordance with 21 CFR 170.106.  This document does not provide any specific recommendations regarding these submissions because the number of these types of submissions is small.  If you have questions about preparing a submission other than those listed above, you should contact us at the telephone number provided on the first page of this document.  

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

1. This guidance has been prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.