FDA provides additional time to submit DUNS number as part of the 2020 facility registration renewal

Hogan Lovells

The U.S. Food and Drug Administration (FDA) released a guidance document on 1 December 2020 announcing an enforcement policy related to submission of a facility’s Unique Facility Identifier (UFI) as part of the 2020 biennial FDA food facility registration renewal period. Under earlier FDA guidance, the agency recognized use of a facility-specific Dun & Bradstreet Data Universal Numbering System (DUNS) number as an acceptable UFI. However, the new guidance provides that if a facility is unable to obtain the required DUNS number associated with their specific facility before the 31 December 2020 registration deadline, facilities may instead enter “PENDING” in the UFI field and then update the registration with the DUNS information within 90 days.

The FDA requires all registered food facilities to renew their registration biennially in each even-numbered year. The current renewal period began 1 October 2020 and runs through 11:59 p.m. on 31 December 2020.1 There is a new component of facility registration renewal this year: Facilities are required to provide a UFI recognized as acceptable by FDA as part of their registration renewal. In August 2018, the FDA issued guidance recognizing the DUNS number as an acceptable UFI for purpose of food facility registration.2 The DUNS number must be associated with the specific facility, not the company’s corporate headquarters. DUNS numbers are assigned and managed by Dun & Bradstreet and are available free of charge.

On 1 December, the FDA announced through guidance that while it expects all registrants to provide their DUNS number with their registration or renewal submission, the agency recognizes that there may be a delay in obtaining the number, based on stakeholder feedback.3 Accordingly, the FDA intends to allow registrants to enter “PENDING” in the UFI field of their registration if they anticipate that they will not be able to obtain a DUNS number before the conclusion of the 2020 biennial renewal period on 31 December 2020. Users will then have 90 days to obtain and submit a DUNS number to the FDA. Failure to update the registration with a valid DUNS number will result in cancellation of the registration. In turn, this can have commercial impacts and regulatory consequences.

Next steps

We will continue to monitor updates related to food facility registration. 

 

References

1 FDA Food Facility Registration User Guide: Biennial Registration Renewal (Updated 1 December 2020) available at https://www.fda.gov/food/online-registration-food-facilities/food-facility-registration-user-guide-biennial-registration-renewal?utm_medium=email&utm_source=govdelivery.

2 FDA Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (August 2018) available at https://www.fda.gov/media/85043/download.

3 FDA Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period: Guidance for Industry (December 2020) available at https://www.fda.gov/media/143997/download.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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