FDA Reminds Human and Animal Food Facilities About This Year’s Biennial Registration Renewal Period and Provides Updated Guidance on How to Obtain and Submit a DUNS Number
December 1, 2020
U.S. and foreign human and animal food facilities that are required to register with the U.S. Food and Drug Administration must renew their registration this year before December 31.
The FDA will consider the registration of a food facility to be expired if the facility does not renew its registration by December 31, 2020. There is no fee associated with registration or renewal. Owners and operators of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver to submit a paper submission.
Starting this year all facilities must include a unique facility identifier (UFI) recognized as acceptable to the FDA with the registration submission. The requirement is being introduced in accordance with the 2016 rulemaking implementing the food facility registration provisions in the Food, Drug & Cosmetic Act. 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. To date, the FDA recognizes the Data Universal Numbering System (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. The UFI field has been added to Section 2-Facility Name/Address Information of Form FDA 3537.
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.
The FDA has made the following materials available to help facilities register and renew their registration.
- Registration of Food Facilities
- Food Facility Biennial Registration Renewal Fact Sheet
- Online Food Facility Registration User Guide - Biennial Renewal
- Small Entity Compliance Guide: Registration of Food Facilities
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (seventh edition)
- Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration
Food facility registration helps the FDA determine the location and source of foodborne illness outbreak or potential bioterrorism incidents, and also helps the agency quickly notify facilities that may be affected. Food facility registration requirements were initiated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and amended by the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA’s requirements include additional information that facilities must submit, and a requirement that food facilities renew their registrations every other year. In 2016, the FDA issued a final rule updating its registration regulation, which updated FDA’s regulations to include FSMA and other requirements.
Food facilities with questions can contact the FURLS Helpdesk: by phone 1-800-216-7331 or 240-247-8804; or by email at [email protected].When contacting the FDA by phone, please note that there might be long hold times during the renewal period. Likewise, there may also be a delay in the time it takes the FDA to respond to emails due to the significant increase in call and email volume that FDA receives during the registration renewal period.