Enforcement Policy for Providing an 
Acceptable Unique Facility Identifier 
(UFI) for the 2020 Food Facility 
Registration Biennial Renewal Period: 
Guidance for Industry 
 
 
Additional copies are available from:  
Office of Compliance 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740 
 
http://www.fda.gov/FoodGuidances 
 
 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to http://www.regulations.gov.  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. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration  
Center for Food Safety and Applied Nutrition 
 
 
 
March 2021  
Table of Contents 
 
 
 
I.  Introduction 
 
II.  Background 
 
III.  Discussion 
 
 
2 
  Enforcement Policy for Providing an 
Acceptable Unique Facility Identifier 
(UFI) for the 2020 Food Facility 
Registration Biennial Renewal Period: 
Guidance for Industry1 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA, we, or 
the Agency) on this topic. It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
 
I.  Introduction 
 
This guidance provides information on how you may comply with FDAs 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. 
 
 
1 This guidance has been prepared by the Office of Compliance in the Center for Food Safety and Applied 
Nutrition at the U.S. Food and Drug Administration. 
3 
  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.  
FDAs 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. 
 
 
II.  Background 
 
Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d) requires 
domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal 
consumption in the United States to register with FDA.  The FDA Food Safety Modernization 
Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the food facility 
registration requirements in section 415 of the FD&C Act to require domestic and foreign 
facilities submit certain additional new information to FDA and to renew their registrations every 
other year, during the period beginning on October 1 and ending on December 31 of each even-
numbered year.  FDA issued a final rule that revised FDAs Food Facility Registration regulation 
on July 14, 2016 (81 FR 45912). 
 
The Food Facility Registration regulation was established in Title 21 of the Code of Federal 
Regulations, Part 1, subpart H, and specifies who the Food Facility Registration requirements 
apply to and establishes various requirements.  Among other requirements, 21 CFR 1.232(a)(2) 
of the Food Facility Registration regulation requires that starting October 1, 2020, facilities are 
required to provide a UFI recognized as acceptable by FDA.  In addition, 21 CFR 1.231(a)(3) 
and (b)(5) of the Food Facility Registration regulation provides that FDA will not confirm a 
facilitys registration or registration renewal until FDA verifies the accuracy of its UFI and 
verifies that the facility-specific address associated with the UFI is the same address associated 
with the facilitys registration. The Food Facility Regulation provides that FDA will not confirm 
a registration or provide a facility with a registration number until FDA verifies the accuracy of 
the facility's UFI and verifies that the facility-specific address associated with the UFI is the 
same address associated with the registration. 21 CFR 1.231(a)(3); 1.231(b)(5). 
 
In August 2018, FDA issued guidance recognizing the DUNS number as an acceptable UFI for 
the Food Facility Registration regulation (see https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/guidance-industry-questions-and-answers-
regarding-food-facility-registration-seventh-edition).    
 
This guidance provides information on how registrants may obtain and provide a UFI even if 
they were unable to obtain a UFI before December 31, 2020. 
 
III.  Discussion 
 
Following the implementation of the UFI requirement on October 1, 2020, FDA received 
feedback from stakeholders of their concerns with obtaining the DUNS number before the 
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  conclusion of the 2020 biennial renewal period on December 31 for those registrants whose 
registration(s) are due for renewal.  
 
While FDA expects all registrants to provide their DUNS number with their registration or 
renewal submission, the Agency recognizes that there may be a delay in obtaining a DUNS 
number.  To address stakeholder concerns with obtaining a DUNS number in a timely manner, 
FDA intends to allow registrants who anticipate that they will be temporarily unable to provide a 
DUNS number with their registration or renewal to enter PENDING in the UFI field2 of their 
registration.  This temporary entry will allow for registrations and renewals to be submitted even 
if the registrant has not yet provided a DUNS number.  In addition, FDA intends not to enforce 
the requirement in 21 CFR 1.231(a)(3) and (b)(5) to verify the accuracy of the UFI submitted by 
registrants.  Upon submission, the registrant will have until December 31, 2022,3 to update their 
registration with their DUNS number.  Failure to update the registration with a valid DUNS 
number by the end of the next biennial registrational renewal cycle will result in cancellation of 
the registration for failure to renew in accordance with 21 CFR 1.230(b). 
 
The DUNS number can be obtained by contacting D&B by phone at 866-705-5711 or by visiting 
D&Bs website at http://www.dnb.com/duns-number.html.  
 
  
 
2 The UFI field is in Section 2  Facility Name/Address Information of Form FDA 3537. 
3 FDA initially provided this enforcement discretion for 90 days. But upon hearing from stakeholders that additional 
time may be required to obtain DUNS numbers, FDA is extending this policy until December 31, 2022. 
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