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FDA Renewals – 2016

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 31of 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 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 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 https://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 https://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 https://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 A & A at customerservice@www.aacb.com, or 1-800-663-4270 if you require additional assistance.

NOTE: All details pertaining to CARM R2 processes are based on the current information available at the time of writing. As this is subject to change, it’s recommended you periodically check in with the CBSA or your customs broker.