
[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33756-33757]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13788]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Specification of the Unique Facility Identifier System for Drug 
Establishment Registration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax or email written comments on the collection of information 
by July 14, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0045. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Registration of Producers of Drugs and Listing of Drugs in Commercial 
Distribution (OMB Control Number 0910-0045)

    In the Federal Register of September 6, 2013 (78 FR 54899), FDA 
announced the availability of a draft guidance for industry entitled 
``Specification of the Unique Facility Identifier (UFI) System

[[Page 33757]]

for Drug Establishment Registration.'' Sections 701 and 702 of the Food 
and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 
112-144) 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 Federal, Food, Drug, and 
Cosmetic Act (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 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 edrls@fda.hhs.gov.
    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 files in a standard structured product labeling 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 guidance modifies 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. 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 
guidance also suggests that firms who want to submit an alternative 
identifier 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.
    In the Federal Register of September 6, 2013 (78 FR 54899), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received three comments that did not 
pertain to the information collection. Upon review of these comments 
FDA does not plan to revise the information collection.

    Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13788 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P


