FDA was directed by Sections 701 and 702 of FDASIA that direct the Secretary (and by delegation FDA) to specify the UFI system for registration of domestic and foreign drug establishments. The Agency decided to manage the unique facility identifier for registration of domestic and foreign drug establishments. The DUNS number can be obtained at no charge
FDA notes in the Guidance that the “guidance reflects current thinking in light of data standards, information technology, and information management resources.” The Agency also indicated that it has been using the DUNS number ever since the implementation of the electronic drug registration and listing system was put in place. A copy of the Guidance can be found here. The Agency refers you to additional information on obtaining a DUNS number here.
