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。
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。
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: email@example.com