[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Pages 54899-54901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21630]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Specification of the Unique 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Specification 
of the Unique Facility Identifier (UFI) System for Drug Establishment 
Registration.'' This draft guidance specifies the UFI system for 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).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 5, 2013. Submit either electronic or written 
comments concerning the proposed collection of information by November 
5, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; the 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448; or Communications 
Staff (HFV-12), Center for Veterinary Medicine, Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets

[[Page 54900]]

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, 
email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft 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 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, as amended, requires that each initial and annual 
drug establishment registration include a UFI (21 U.S.C. 360(b), (c), 
and (i)). This draft 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 this guidance.
    This draft guidance is intended solely to address the provisions in 
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 draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information that 
they conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal Agencies to provide a 
60-day notice in the Federal Register for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, FDA invites comments on the following topics: (1) 
Whether the proposed information collected is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimated burden of 
the proposed information collected, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Sections 701 and 702 of FDASIA direct the Secretary 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, as amended, requires that each initial and annual drug 
establishment registration include a UFI. The draft guidance specifies 
the UFI system as follows. At this time, FDA's preferred UFI for a drug 
establishment is the Data Universal Numbering System D-U-N-S (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 the Web site for Dun and Bradstreet. As explained in the 
guidance, however, if a company wants to use an alternative UFI for its 
drug establishment, it may contact FDA via email at [email protected].
    OMB has previously approved existing information collections 
associated with the electronic submission of initial and annual 
registration of domestic and foreign drug establishments, as described 
in part 207 (21 CFR part 207) and the guidance document ``Providing 
Regulatory Submissions in Electronic Format--Drug Establishment 
Registration and Drug Listing'' (the 2009 Guidance) (available at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072339.pdf), under 
OMB control number 0910-0045. The Food and Drug Administration 
Amendments Act of 2007 (Pub. L. 110-85) required that drug 
establishment registration and drug listing information must be 
submitted electronically unless a waiver is granted. As part of its 
recommendations to facilitate electronic submission of drug 
establishment registration information, as required by statute, the 
2009 guidance explained that FDA is adopting the use of extensible 
markup language (XML) files in a standard structured product labeling 
(SPL) format for the electronic submission of drug establishment 
registration and drug listing information. The 2009 guidance also 
explained that the automated submission process functions most 
efficiently and effectively when the information is provided in a 
standardized format with defined code sets and codes. In addition, the 
2009 guidance requested, among other things, the electronic submission 
of a site-specific DUNS number for each entity as part of the 
registration information submitted electronically. In FDA's experience, 
all firms currently registered with FDA under section 510 of the FD&C 
Act and part 207 have submitted their DUNS number as requested in the 
2009 guidance.
    The draft guidance addressed in this notice, ``Specification of the 
Unique Facility Identifier (UFI) System for Drug Establishment 
Registration,'' when finalized, would modify the currently approved 
information collections associated with drug establishment 
registration, consistent with subsequent statutory enactment. In July 
2012, Congress enacted FDASIA, sections 701 and 702 of which direct the 
Secretary 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, as amended, requires that each initial and annual 
drug establishment registration include a UFI. Because drug firms 
generally possess, and for those already registered, have previously 
provided, a DUNS number for each facility, FDA expects that consistent 
with the proposed UFI system, they will submit DUNS numbers as the UFIs 
for drug establishments. Although the change in statutory authority 
described in this document will alter the legal basis for submission of 
the DUNS number, it is not expected to have any other impact on the 
previously approved collection of information.

[[Page 54901]]

FDA expects that the DUNS number will continue to be submitted by the 
same respondents, with the same frequency, as part of the same 
electronic registration submission previously approved under the PRA, 
and the Agency will continue to use the information for the same 
purposes, in furtherance of its mission to protect the public health.
    While FDA anticipates that firms will submit DUNS as UFI, the draft 
guidance also instructs firms who want to submit an alternative 
identifier to contact FDA. FDA estimates that no more than one 
respondent per year will invoke this option. FDA estimates that it 
would require on average 1 hour for a company to contact FDA and 
identify its proposed alternative UFI. If FDA determines that the 
alternative is one the Agency's systems can accommodate, and that 
satisfies the statutory goal of uniquely identifying the firm's 
facilities, FDA anticipates that the firm would include that 
alternative UFI in place of the DUNS, with no net change in the burden 
of a registration submission. We invite comment on these estimates.

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: August 29, 2013.
Leslie Kux,
 Commissioner for Policy.
[FR Doc. 2013-21630 Filed 9-5-13; 8:45 am]
BILLING CODE 4160-01-P