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Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety March 2010


Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition, Office of Food Additive Safety

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.

Download the Draft Guidance Document

Related Information

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.

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