FDA Biennial Registration Renewal

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FDA Biennial Registration Renewal

The following is a U.S. Customs & Border Protection message we are forwarding to you as a courtesy. The 2018 Biennial Registration Renewal Period begins Monday, October 1, 2018. 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 update 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/. Please note that you must first create or have an existing FURLS account to access the module and submit your renewal. 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 240-247-8804. FDA encourages use of the electronic format because it is more efficient and provides immediate submission of the registration renewal if a confirmation is not required as outlined in 21 CFR 1.231. This year, the abbreviated renewal process is available for facilities that do not have information changes under 21 CFR 1.232 since the submission of the preceding registration, registration renewal, or update (see 21 CFR 1.230(c)). If you use the abbreviated registration renewal process, you must confirm that no changes have been made to the information required under 21 CFR 1.232 since you submitted the preceding registration, registration renewal, or update, and you must certify that the information submitted is truthful and accurate. This option is available on both paper and electronic submissions and must include the submitters name. Please visit http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm for more information about food facility registration and the 2018 biennial renewal including guidance documents and user guides for our Food Facility Registration Module (FFRM). Also beginning October 1st, human food facilities that meet the definition of a “qualified facility” in part 117 and are subject to modified requirements of the preventive control rule will be able to submit the qualified facility attestation forms electronically via the Qualified Facility Attestation Module. For more information on qualified facility attestations, please visit https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/QualifiedFacilityAttestation/default.htm. 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. Beginning January 4, 2020, you must submit your registration, registration renewal, updates, and cancellations to FDA electronically unless FDA has granted a waiver from such requirement (see 21 CFR 1.231(a)(2) and (b), 1.234(d), and 1.235(d)). 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. The preceding message is a U.S. Customs & Border Protection announcement.  If you have any questions, please feel free to contact your Norman Krieger Representative for more information.




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