The U.S. Food and Drug Administration recently issued new guidance following its decision to grant a two-year extension for companies to obtain and submit a unique facility identifier with respect to the 2020 Biennial Registration/Renewal period.
Section 415 of the Federal Food, Drug, and Cosmetic Act requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA or renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.
Among other requirements, the regulations stipulate that beginning October 1, 2020, applicants must provide a Unique Facility Identifier recognized as acceptable by FDA.
Presently, FDA only recognizes the Data Universal Numbering System (D‑U‑N‑S®) number for this purpose. Such UFI/DUNS numbers are assigned and managed by Dun & Bradstreet via the FDA DUNS Portal and must be verified for accuracy before being confirmed by the FDA.
Note: If you are a new user of the portal, you will first need to create an account in order to gain access. User guides and instructions in this regard can be found here.
Delays Experienced & Temporary Measures
Following implementation of the new UFI requirement last October, FDA says that feedback received from stakeholders prior to the end of the year reported widespread delays in obtaining the necessary DUNS number; though not stated, presumably due to factors associated with the ongoing pandemic.
In view of this situation, FDA states that while it expects all registrants to provide a DUNS number with their registration or renewal submission, that until the end of the next registration cycle, it intends to allow those who anticipate they will temporarily be unable to provide one with their registration or renewal to instead enter “PENDING” in the UFI field. This temporary entry will allow for registrations and renewals to be submitted for now even without a DUNS number.
The FDA also says it does not intend to enforce the regulatory requirement that calls for the agency to verify the accuracy of UFIs submitted by registrants.
FDA’s latest guidance states that once submitted, registrants will now have until December 31, 2022, to update their registration with the required DUNS number.
Note: Failure to update the registration with a valid DUNS number by the end of the next biennial registration/renewal cycle will result in cancellation of the registration for failure to renew in accordance with Code of Federal Regulations, Title 21.
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