FDA Update: 2020 Biennial FDA Food Facility Registration Biennial Renewal Notification

Food companies please note

The 2020 Biennial Registration Renewal Period began October 1, 2020 and concludes on December 31, 2020.

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 350d] requires food facilities 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.

• If you register your food facility before October 1, 2020, you must renew your registration before December 31, 2020 and provide us with any updated information, if applicable.
• If you updated your food facility registration before October 1, 2020, you must renew your registration before December 31, 2020 and provide us with any updated information, if applicable.
• As a reminder, if you are the new owner of a registered food facility, the previous owner is required to cancel the food facility’s registration within 60 calendar days of the change of ownership and you must re-register the facility reflecting the new ownership (see 21 CFR 1.234 and 1.235).
• There is no fee associated with registration or renewal.

The owner, operator, or agent in charge of the facility, or a person authorized by one of them, can submit a facility's registration renewal electronically at http://www.access.fda.gov/. Please note that you must first create or have an existing FURLS account to access the module and submit your renewal.

In accordance with 21 CFR 1.232(a)(2), effective October 1, 2020, all facilities must include a unique facility identifier (UFI) recognized as acceptable by FDA with their registration information. To date, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI. DUNS numbers are assigned and managed by Dun & Bradstreet and is available free of charge. Please visit the FDA DUNS Portal at https://fdadunslookup.com/ in order to obtain or verify your DUNS number. You will be required to provide your UFI in “Section 2- Facility Name/Address Information” of your registration.

Please visit: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm for more information about food facility registration and the 2020 biennial renewal including guidance documents and user guides for our Food Facility Registration Module (FFRM).

Also, if you have submitted a qualified facility attestation before October 1, 2020, you must re-submit your attestation before December 31, 2020(21 CFR 117.205(c)(2)(ii)). Please re-submit your attestation electronically via the Qualified Facility Attestation Module also at http://www.access.fda.gov/. Please ensure that your registration is renewed before re-submitting your qualified facility attestation.

Please remember that this renewal process repeats every two years on even-numbered years from October 1 through December 31. You may wish to set a reminder.

Please contact the FDA Industry Systems Help Desk at furls@fda.gov, toll-free in the USA 1-800-216-7331, or 240-247-8804 if you require additional assistance. 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.

If you have any further questions about this update, please feel free to email mdi Consultants at info@mdiconsultants.com RE: Renewal.