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GUIDANCE DOCUMENT

Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period March 2021

Final Level 2 Guidance
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

This guidance provides information on how you may comply with FDA’s requirement to provide a unique facility identifier (UFI) recognized as acceptable by FDA when you submit your food facility registration or renewal in the Food Facility Registration Module (FFRM). This guidance also provides information on what to do if you are unable to timely obtain a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number prior to the end of the biennial renewal period, December 31, 2020. 

This guidance supersedes the guidance of the same title dated December 2020. This guidance revises section III. to extend the period of the enforcement policy for the rest of the 2020 biennial registration renewal cycle for facilities that are unable, or anticipate that they will be temporarily unable, to provide a DUNS number with their registration or renewal. This guidance also describes our intent not to enforce the associated verification requirements for the remainder of this 2020 biennial registration renewal cycle.

In this guidance, the terms “you,” “your,” or “registrant,” are used to refer to the owner, operator, or agent in charge of a facility that manufactures/processes, packs, or holds food for consumption in the United States.

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA’s guidance documents, including this guidance, 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.

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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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