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Final Reminder! 2016 FDA Food Facility Registration!


The 2016 Biennial FDA Food Facility Registration Renewal Period is underway.

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. FDA will consider a registration for a food facility to be expired if the registration is not renewed as required (21 CFR 1.241(b)). FDA will consider a food facility with an expired registration to have failed to register in accordance with section 415 (21 CFR 1.241(b)). The failure to register a food facility in accordance with section 415 is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)).

·         If you registered 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. In addition, FDA will now verify that the person identified as the U.S. Agent for a foreign facility agreed to serve as the U.S agent. In accordance with 21 CFR 1.231(a)(5) and (b)(7), FDA will not confirm a registration or provide a registration number until the person identified as the U.S. agent for a foreign facility confirms that person has agreed to serve as the U.S. agent. If we do not receive confirmation from the U.S. agent within 30 days of the renewal submission, a new submission will be required. 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.

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