mdi Consultants, Inc
REMINDER
FDA Update – Human and Animal Food Facilities Biennial Registration Renewal
The FDA is reminding human and animal food facilities about this year’s biennial registration renewal period. These facilities, domestic and foreign, are that required to register with the U.S. FDA must renew their registration this year before December 31.
The FDA will consider a registration to be expired if the facility does not renew its registration. There is no fee associated with registration or renewal. Owners and operators of food facilities must submit their renewal information online through their FDA Industry Systems account, unless they have received a waiver to submit a paper submission.
The FDA has new requirements to go along with this year’s renewal. Beginning this year, all domestic and foreign facilities are required to submit a unique facility identifier (UFI) recognized as acceptable to the FDA in the facility’s registration. This will be used to verify the facility-specific address with the UFI matches address associated with the facility’s registration. The FDA is currently accepting the Data Universal Numbering System (DUNS) number as an acceptable UFI. The UFI field has been added to Section 2-Facility Name/Address Information of Form FDA 3537.
The DUNS number is managed by Dun & Bradstreet (D&B) and can be obtained or verified by visiting their website http://www.dnb.com/duns-number.html. The FDA expects registrants to provide their DUNS number with their registration or renewal before December 31, 2020, however, they recognize that their may be a delay in obtaining a DUNS number. To address the concerns with obtaining a DUNS number in a timely manner, the FDA has released a guidance document, Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period. Information is included in what to do in case a facility is unable to obtain a DUNS number prior to the end of the renewal period. Registrants will be allowed to enter “PENDING” in the UFI field of their registration in anticipation of not obtaining a DUNS number in time. Registrants will then have 90 days to obtain and submit a DUNS number and will receive reminders via email. Failure to do so will result in cancellation of the registration.
The FDA has provided more information and resources through their website for assistance.
- 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 Facilities can contact the FURLS Helpdesk by phone at 1-800-216-7331 or 204-247-8804, or by email at FURLS@fda.gov.
For any assistance with registration or renewal with the FDA or for a DUNS number, please email mdi Consultants at info@mdiconsultants.com RE: DUNS.