FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration through December 2022 (R13273436196R,C508C)

         Domestic and foreign facilities that manufacture, processes, pack, or hold food for human or animal consumption in the United States are required to register with the U.S. Food and Drug Administration. In addition, every two years these same facilities must renew their registration before December 31. The latest biennial registration renewal period ended on December 31, 2020; however, the FDA had previously allowed facilities more time to obtain and submit a unique facility identifier (UFI) with their registration submission, a requirement that began during the 2020 biennial registration renewal period. Now the FDA is further extending the time period to obtain and submit a UFI until December 31, 2022.

        The requirement to include a UFI began during this past biennial registration renewal period and was introduced in accordance with the 2016 rule implementing the food facility registration provisions in the Federal Food, Drug & Cosmetic Act. The requirement applies to both new facilities registering for the first time, and those submitting a registration renewal. The UFI will be used by FDA to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. At this time, the FDA recognizes the DUNS number as an acceptable UFI for food facility registration. The DUNS number is assigned and managed by Dun & Bradstreet (D&B). DUNS numbers can be obtained or confirmed by visiting D&B’s website at http://www.dnb.com/duns-number.html. The UFI field has been added to Section 2-Facility Name/Address Information of Form FDA 3537, Food Facility Registration.

        After hearing concerns from stakeholders about obtaining a DUNS number in a timely manner, the FDA released guidance on December 1, 2020 with information on what facilities should do if they were unable to obtain a DUNS number prior to the end of the renewal period ending on December 31. The guidance explained that the FDA intended to allow registrants to enter “PENDING” in the UFI field of their registration if they did not anticipate they could obtain a DUNS number in time. The FDA also explained that failure to update the registration with a valid DUNS number within 90 days would result in cancellation of the registration for failure to renew in accordance with 21 CFR 1.230(b).

       The FDA understands that for some, a DUNS number has remained difficult to obtain. FDA now intends to allow registrants additional time until the end of the next registration cycle on December 31, 2022 to submit a DUNS number as part of the UFI requirement. This will help to avoid unnecessary cancellations of registrations due to any difficulties registrants may have with obtaining a valid DUNS number; and allow the FDA to maintain the integrity of its food facility inventory. During this time, FDA intends to continue to allow registrants to enter “PENDING” in the UFI field of their registration if they have not obtained a DUNS number. The FDA also does not intend to cancel any registrations for facilities with UFIs that cannot be verified at this time.

       As noted in our 2018 Registration Q&A Guidance, food facilities that would like FDA to consider the use of an alternative identifier other than DUNS or that have questions about registration can contact the FURLS Helpdesk。

食品和药物管理局将食品设施注册的**设施标识要求的灵活性延长至2022年12月（R13273436196R，C508C）

       在美国制造、加工、包装或存放供人或动物食用的食品的国内外设施必须在美国食品和药物管理局注册。此外，这些设施每两年必须在12月31日前更新注册。*新的两年期注册续展期于2020年12月31日结束；然而，FDA此前允许设施有更多时间在提交注册时获得并提交**设施标识（UFI），这一要求始于2020年两年期注册续展期。现在FDA正在进一步延长获取和提交UFI的时间，直到2022年12月31日。

       纳入UFI的要求始于上一个两年一次的注册续展期，是根据2016年实施《联邦食品、药品和化妆品法》中食品设施注册规定的规则引入的。该要求适用于首次注册的新设施和提交注册续期的设施。食品和药品管理局将使用UFI来验证与UFI相关的设施特定地址是否与设施注册相关的地址相同。在这个时候，FDA承认DUNS号是食品设施注册的可接受UFI。邓氏编号由邓&布拉德街（D&B）分配和管理。邓氏号码可通过访问D&B的网站获得或确认http://www.dnb.com/duns-number.html。UFI字段已添加到FDA 3537表“食品设施注册”的第2节“设施名称/地址信息”中。

       在听取了利益相关者对及时获得DUNS编号的担忧后，FDA于2020年12月1日发布了指南，其中说明了如果在12月31日结束的续约期结束前无法获得DUNS编号，工厂应采取的措施。该指南解释说，FDA打算允许注册者在注册的UFI字段中输入“待定”，如果他们没有预料到他们可以及时获得DUNS号码。FDA还解释说，如果未能在90天内用有效的DUNS号更新注册，将导致因未能按照21 CFR 1.230（b）更新而取消注册。

       FDA了解到，对于一些人来说，DUNS数字仍然很难获得。FDA现在打算允许注册者在2022年12月31日下一个注册周期结束前有更多的时间提交DUNS号码，作为UFI要求的一部分。这将有助于避免由于注册人在获得有效的邓氏编号方面可能遇到的任何困难而导致不必要的注册取消；并使FDA能够保持其食品设施库存的完整性。在此期间，FDA打算继续允许注册者在其注册的UFI字段中输入“待定”，如果他们没有获得DUNS号码。FDA也不打算取消目前无法核实的UFIs设施的任何注册。

       如2018年注册问答指南所述，希望食品和药物管理局考虑使用除DUNS以外的替代标识符或对注册有疑问的食品设施可联系安测检测公司，电话：400-611-6855   或E-mail: hzance@163.com

      注：翻译上如有误，敬请指正，谢谢！