Document ID: FDA-2013-D-0984-0007
Agency: fda
Document Type: Notice
Title: Specification of the Unique Facility Identifier System for Drug
Establishment Registration; Guidance for Industry; Availability
Posted Date: 2014-11-06T05:00Z

[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Pages 65977-65978]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0984]

Specification of the Unique Facility Identifier System for Drug 
Establishment Registration; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Specification of the 
Unique Facility Identifier (UFI) System for Drug Establishment 
Registration.'' This guidance specifies the UFI system for registration 
of domestic and foreign drug establishments. The guidance addresses 
provisions set forth in the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act), as amended by the Food and Drug Administration Safety and 
Innovation Act (FDASIA). This guidance finalizes the draft guidance 
issued on September 6, 2013.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993; or the Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the

[[Page 65978]]

Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul Loebach, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2262, Silver Spring, MD 20993-0002, 
edrls@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Specification of the Unique Facility Identifier (UFI) System 
for Drug Establishment Registration.'' In July 2012, FDASIA was signed 
into law (Pub. L. 112-144). Sections 701 and 702 of FDASIA direct the 
Secretary of Health and Human Services (and by delegation, FDA) to 
specify the UFI system for registration of domestic and foreign drug 
establishments. Once the UFI system is specified, section 510 of the 
FD&C Act (21 U.S.C. 360), as amended, requires that each initial and 
annual drug establishment registration include a UFI (21 U.S.C. 360(b), 
(c), and (i)). This guidance is intended solely to address sections 701 
and 702 of FDASIA. Although section 703 of FDASIA mandates the use of 
the same UFI system (specified for drug establishment registration) to 
identify excipient manufacturers in product listings, this guidance 
does not address implementation of section 703 of FDASIA.
    This guidance specifies the UFI system for registration of domestic 
and foreign drug establishments. At this time, FDA's preferred UFI for 
a drug establishment is the Data Universal Numbering System (DUNS) 
number, assigned and managed by Dun and Bradstreet. The DUNS number is 
available free of charge to all drug establishments and may be obtained 
by visiting Dun and Bradstreet's Web site at http://www.dnb.com/. (FDA 
has verified the Web site address, but FDA is not responsible for any 
subsequent changes to the Web site after this document publishes in the 
Federal Register.) This guidance reflects the Agency's current thinking 
in light of data standards, information technology, and information 
management resources. As these variables change over time, FDA may 
revisit the guidance.
    In the Federal Register of September 6, 2013 (78 FR 54899), FDA 
announced the availability of the draft guidance entitled 
``Specification of the Unique Facility Identifier (UFI) System for Drug 
Establishment Registration.'' The notice gave the public an opportunity 
to comment by November 5, 2013. FDA carefully considered all comments 
received in preparing the guidance. No substantive changes were made in 
finalizing the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
Agency's current thinking on specification of the UFI system for drug 
establishment registration. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections 
of information have been approved under OMB control number 0910-0045.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or http://www.regulations.gov.

    Dated: November 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26397 Filed 11-5-14; 8:45 am]
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