Join AFI and in addition to having a reliable registration agent, you'll regularly receive e-mail with news on issues in the U.S. food import industry from AFI, the voice of the U.S. food industry. The Registration Call Center is staffed from 8:30 a.m. to 5:50 p.m., Eastern Time during Federal work days. FDA define small business as a business with $100 million or less in gross receipts or sales, including receipts or sales from its affiliates. Starting this year all domestic and foreign facilities must submit a unique facility identifier (UFI) recognized as acceptable to the FDA in the facility’s registration. Registration of Food Facilities and Other Submissions, Recalls, Market Withdrawals and Safety Alerts, Registration of Food Facilities and Other Submissions, Food Facility Biennial Registration Renewal Fact Sheet, Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF), Infant Formula Registration & Submissions, New Dietary Ingredient (NDI) Notification Electronic Submissions, Structure/Function Claim Notification for Dietary Supplements Electronic Submissions, Guidance & Regulation (Food and Dietary Supplements), Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period, FURLS Food Facility Registration Module(FFRM), Questions and Answers Regarding Food Facility Registration, Small Entity Compliance Guide: Registration of Food Facilities, Food Facility Registration User Guide: Biennial Renewal, FURLS Food Facility Registration Module (FFRM). It is important to note that there is a new component of facility registration renewal. In addition, if the registration that must be renewed is not linked to the account, users must have the registration number and PIN in order to access the registration and have it renewed. This most recent edition reflects updates made to the registration provisions in the FD&C Act that were made following the passage of FSMA. Go . Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. The U.S. FDA Registration Renewal period CLOSED on December 31, If you did not renew by the deadline, you must re-register with FDA. Restoration Fee . The registration is deemed expired and FDA will cancel any existing registration in its entirety. Other useful resources for small food businesses, startups, and entrepreneurs: An official website of the United States government, : The establishment registration is valid till December 31st of next year. 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. Food facilities are required to renew their registration every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year. Re-register or verify that your registration was renewed for : FDA Industry Systems (FIS) was created to facilitate making submissions to FDA, including registrations, listings, and other notifications. FDA Registration Renewal Season Opens October 1 . All food importers and foreign food manufacturers must renew their registrations by December 31, 2020. ... Request Your Driver History Abstract. Email: Furls@fda.gov. College Park, MD 20740 5001 Campus Drive GENERAL INFORMATION. To address stakeholder concerns with obtaining a DUNS number in a timely manner, the FDA has released guidance with information on what facilities should do if they are unable to obtain a DUNS number prior to the end of the renewal period. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. Annual - on anniversary date of original submission . When are food facilities required to renew their registration? At this time, the FDA recognizes the Data Universal Numbering System D-U-N-S(DUNS) number as an acceptable UFI. The following materials are also available: An official website of the United States government, : DUNS numbers can be obtained or verified by visiting D&B’s website at http://www.dnb.com/duns-number.html or by phone at 866-705-5711. When contacting the FDA by phone, please anticipate long hold times during the renewal period. According to the U.S. FDA, beginning of October 1st, 2020 all registered food facilities must submit an FDA-recognized form of UFI during the 2020 food facility registration renewal period. Drug establishment registration and renewal is mandatory for US and non US companies, including prescription , OTC and API manufacturer, testing and packaging facilities. FDA cosmetic registration (VCRP) renewal. § 350d] requires food facilities that are 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. Surcharge. The FDA Food Facility renewal for 2021-2022 is now active. In response to previous customer feedback, we have included the addition of a callback feature on our lines and have implemented an announcement of the estimated hold time. 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