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  1. Registration of Food Facilities and Other Submissions

Food Facility Biennial Registration Renewal Fact Sheet

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2020 Food Facility Biennial Registration Renewal

October 1, 2020 12:01AM through December 31, 2020 11:59PM

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.

Please be advised that “updating” your registration is a different function than “renewing” your registration. During the renewal period, you will not see the “Update” button listed on the FFRM main menu, until the registration is renewed. If a registration is not renewed by 11:59 PM on December 31, 2020, the registration is considered expired and will be removed from your account.

In addition, starting this year all facilities must include a unique facility identifier (UFI) recognized as acceptable to FDA with the registration submission To date, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet. DUNS numbers can be obtained or verified visiting D&B’s website at http://www.dnb.com/duns-number.html.

While the FDA expects all registrants to provide their DUNS number with their registration or renewal submission before December 31, 2020, 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, the FDA has released guidance, Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period, with information on what facilities should do if they are unable to obtain a DUNS number prior to the end of the renewal period. The guidance explains that the FDA intends to allow registrants to enter “PENDING” in the UFI field of their registration if they anticipate that they will not be able to obtain a DUNS number in time. Users will then have 90 days to obtain and submit a DUNS number and will receive reminders via email. Failure to update the registration with a valid DUNS number will result in cancellation of the registration.

If you have any further questions please contact the FURLS Helpdesk: by phone 1-800-216-7331 or 240-247-8804; or by email at FURLS@fda.gov.


Food facilities that are required to register with the U.S. Food and Drug Administration must renew their registration by December 31, 2020. This fact sheet provides information about this biennial food facility registration renewal period.

When are food facilities required to renew their registration?

Food facilities are required to renew their registration every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year. This year’s renewal period began October 1, 2020 and ends December 31, 2020. Facilities registered before October 1, 2020 must renew their registration.

What happens if facilities don’t renew their registration?

The FDA will consider a registration for a food facility to be expired if the registration is not renewed as required. The FDA will consider a food facility with an expired registration as having failed to meet their registration requirements, which is prohibited under the FD&C Act. The FDA will cancel a facility’s registration if it has failed to renew as required. If a registration is cancelled for failure to renew, and the facility is required to register and is still operating, the facility can re-register.

Is there a fee that must be paid?

No. There is no fee for registration or renewal.

Are there any new requirements with this year’s renewal?

Yes. Starting this year all domestic and foreign facilities must submit a unique facility identifier (UFI) recognized as acceptable to the FDA in the facility’s registration. The UFI will be used to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. At this time, the FDA recognizes the Data Universal Numbering System D-U-N-S(DUNS) number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet (D&B). DUNS numbers can be obtained or verified by visiting D&B’s website at http://www.dnb.com/duns-number.html or by phone at 866-705-5711. The UFI field has been added to Section 2-Facility Name/Address Information of Form FDA 3537.

What should a facility do if they have trouble obtaining a DUNS number prior to the end of the renewal period?

While the FDA expects all registrants to provide their DUNS number with their registration or renewal submission before December 31, 2020, 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, the FDA has released guidance with information on what facilities should do if they are unable to obtain a DUNS number prior to the end of the renewal period. The guidance explains that the FDA intends to allow registrants to enter “PENDING” in the UFI field of their registration if they anticipate that they will not be able to obtain a DUNS number in time. Users will then have 90 days to obtain and submit a DUNS number and will receive reminders via email. Failure to update the registration with a valid DUNS number within 90 days will result in cancellation of the registration.

How can food facilities go about renewing their registration?

Food facilities, or individuals authorized by the food facility, must renew their registration electronically via FURLS Food Facility Registration Module(FFRM), unless the FDA has granted a waiver from the electronic submission requirement. Users must have an FDA Industry Systems (FIS) account ID and password in order to access the system. In addition, if the registration that must be renewed is not linked to the account, users must have the registration number and PIN in order to access the registration and have it renewed. If the FDA has granted a waiver, forms can be requested and submitted in the following ways:

U.S. Food and Drug Administration Food Facility Registration (HFS-681)
5001 Campus Drive
College Park, MD 20740

Telephone: 1-800 216-7331 or 240-247-8804
Fax: 301-436-2804 
Email: Furls@fda.gov

When contacting the FDA by phone, please anticipate long hold times during the renewal period. Likewise, please anticipate a delay in the time it takes FDA to respond to e-mails due to the significant increase in call and email volume that FDA receives during the registration renewal period. In response to previous customer feedback, we have included the addition of a callback feature on our lines and have implemented an announcement of the estimated hold time.

Are there any resources available to help facilities with this process?

Yes. The FDA has a number of resources available to help facilities register and renew their registration. This includes the seventh edition of our Questions and Answers Regarding Food Facility Registration guidance to help the owners and operators of food facilities better understand the registration requirements. This most recent edition reflects updates made to the registration provisions in the FD&C Act that were made following the passage of FSMA. Also, our supplemental draft guidance to the seventh edition includes questions and answers that clarify our thinking about the registration requirements when multiple entities are sharing physical space.

The following materials are also available:

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