If you are not a manufacturer of an item subject to FDA, then you may want to forward this reminder to your suppliers who are a manufacturer.

If you need it, the website is https://www.fda.gov/food/online-registration-food-facilities/food-facility-registration-user-guide-biennial-registration-renewal.

Please contact us if you have any questions.

Thank you.

No More ‘UNK’ for FDA Entries in July 2022

The Food and Drug Administration (FDA) told NCBFAA Regulatory Affairs Committee (RAC) members that use of the term “UNK” (representing “unknown”) will not be allowed for food imports in place of a valid DUNS number for in the Unique Facility Identifier field for the FSVP importer, starting July 2022.

The agency has already started targeted outreach by sending emails to customs brokers and importers who have used UNK. Use of the UNK was officially allowed as a temporary measure in 2017 when the FSVP requirements were first implemented to give importers time to adjust to the new requirements.

The process for obtaining a DUNS number can be lengthy. Customs brokers are encouraged to urge their clients to apply for a DUNS number now through the D & B Website line following:

https://www.dnb.com/duns-number.html?utm_medium=email&utm_source=govdelivery

The FDA is sending out notifications to advise the importing public who deal with food importations, that the “UNK” option (versus the actual report of a consignee’s DUNS number) is going to soon expire and importers will be required (in the near future) to supply their consignee / importers actual DUNS number within the entry record that your broker uses when transmitting your FDA data to Customs and to the Food & Drug Administration.   Please make sure that you work to obtain your DUNS number, or the DUNS number of your “ship to consignee / buyer” in the U.S.A.

We have attached a copy of the letter currently being distributed by the FDA as an advance advice notice to importers and non-resident importers.

FSVP and DUNS requirement UNKN notification letter

Preparing for the 2020 Biennial Registration Renewal

In preparation for the 2020 Biennial Registration Renewal period, we have a few tips:

• Ensure that your FURLS account is up to date with a valid password

Please visit https://www.access.fda.gov/ to access your account. If you have forgotten your Account ID and/or password, please select ‘Forgot Account ID’ and/or ‘Forgot Password’ to obtain your login information. If you have not accessed your account in over 90 days, you will be required to create a new password. Please visit https://www.fda.gov/food/online-registration-food-facilities/fda-industry-systems-account-management-guide for more information on managing your account or resetting your password. If you require further assistance, please call our FURLS Helpdesk at 1-800-216-7331 or 240-247-8804 or email FURLS@fda.gov. Due to the high call and email volume received during the renewal period, we encourage you to contact us in advance of the renewal period for account management assistance.

• Obtain or verify your facility unique facility identifier (UFI)

In accordance with 21 CFR 1.232(a)(2), beginning October 1, 2020, the facility’s UFI recognized as acceptable by FDA will be required to be submitted with the registration information. At this time, 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. Please visit the FDA DUNS Portal at https://fdadunslookup.com/ in order to obtain or verify your DUNS number. As a new user of the portal, you will need to create an account in order to access the portal. User guides and instructions can be found at https://fdadunslookup.com/FDA%20DUNS%20Portal%20User%20Guide.pdf. For assistance, we encourage users to create and log in to their account and initiate an inquiry from the portal.   For general DUNS inquiries, please email DUNSLookupSupport@dnb.com.

The 2020 Biennial Registration Renewal period begins October 1, 2020 and concludes on December 31, 2020. Please look for more information in the coming weeks.

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, 2018, you must renew your registration before December 31, 2018 and provide us with any updated information, if applicable.
• If you updated your food facility registration before October 1, 2018, you must renew your registration before December 31, 2018 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).

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/. Alternatively, you may submit your registration renewal via mail or fax using FDA Form 3537.

Form FDA 3537 is available for download at http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm073728.htm.

You can request the paper forms and submit completed forms by fax to 301-436-2804 or by mail to:

U.S. Food and Drug Administration

Food Facility Registration (HFS-681)

5001 Campus Drive

College Park, MD 20740.

You also may request the paper forms by phone at 1-800-216-7331 or 301-575-0156.

FDA encourages use of the electronic format at this time because it is more efficient, provides for immediate submission of the registration renewal.

The Amendments to Registration of Food Facilities final rule published in July 2016 updates FDA’s food facility registration requirements. This rule adds new provisions to the current regulations to codify certain provisions of the Food Safety Modernization Act (FSMA) that were self-implementing and effective upon enactment of FSMA and adds certain new requirements, including the requirement for registration submissions to contain the type of activity conducted at the facility for each food product category. Please visit http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm for more information about food facility registration and the 2016 biennial renewal including guidance documents and user guides for our Food Facility Registration Module (FFRM).

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 301-575-0156 if you require additional assistance.

A Canadian foreign Importer of Record is NOT to be considered for the FSVC as the U.S. importer / purchaser / buyer or recipient of the food products.  The DUNS# and additional FDA Registration Number must be that of the actual buyer in the USA.

Please contact our office for further information on this subject.

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, 2016, you must renew your registration before December 31, 2016 and provide us with any updated information, if applicable.
• If you updated your food facility registration before October 1, 2016, you must renew your registration before December 31, 2016 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).

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/. Alternatively, you may submit your registration renewal via mail or fax using FDA Form 3537.

Form FDA 3537 is available for download at http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm073728.htm.

You can request the paper forms and submit completed forms by fax to 301-436-2804 or by mail to:

U.S. Food and Drug Administration

Food Facility Registration (HFS-681)

5001 Campus Drive

College Park, MD 20740.

You also may request the paper forms by phone at 1-800-216-7331 or 301-575-0156.

FDA encourages use of the electronic format at this time because it is more efficient, provides for immediate submission of the registration renewal.

The Amendments to Registration of Food Facilities final rule published in July 2016 updates FDA’s food facility registration requirements. This rule adds new provisions to the current regulations to codify certain provisions of the Food Safety Modernization Act (FSMA) that were self-implementing and effective upon enactment of FSMA and adds certain new requirements, including the requirement for registration submissions to contain the type of activity conducted at the facility for each food product category. Please visit http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm for more information about food facility registration and the 2016 biennial renewal including guidance documents and user guides for our Food Facility Registration Module (FFRM).

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 301-575-0156 if you require additional assistance.