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FDA Draft Guidance for Industry Regulatory Submissions to OFAS, Part I Introduction

蒋千琴 3/4/2022 浏览 275 FDA 美国

标准简介

Draft Guidance for Industry Regulatory Submissions to OFAS, Part I Introduction[附网盘链接]由FDA于过去发布，适用于美国。

标准截图

Draft Guidance for Industry Regulatory Submissions to OFAS, Part I Introduction[附网盘链接]
Draft Guidance for Industry Regulatory Submissions to OFAS, Part I Introduction[附网盘链接](截图)

 

标准文档说明

标准文档类型为Draft Guidance for Industry Regulatory Submissions to OFAS, Part I Introduction[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Draft-Not for Implementation 1

Guidance for Industry Providing Regulatory Submissions to the Office of Food Additive Safety in Electronic or Paper Format 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). 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. 6

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