
[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2453-2458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 033

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
publication containing modifications the Agency is making to the list 
of standards FDA recognizes for use in premarket reviews (``FDA 
Recognized Consensus Standards''). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 033'' (``Recognition List Number: 033''), will assist 
manufacturers who elect to declare conformity with consensus standards 
to meet certain requirements for medical devices.

DATES: Submit either electronic or written comments concerning this 
document at any time. See section VII of this document for the 
effective date of the recognition of standards announced in this 
document.

ADDRESSES: Submit written requests for single copies of the document 
entitled ``Modifications to the List of Recognized Standards, 
Recognition List Number: 033'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send two self-
addressed adhesive labels to assist that office in processing your 
requests, or fax your request to 301-847-8149.
    Submit electronic comments concerning this document, or 
recommendations for additional standards for recognition, by email to 
standards@cdrh.fda.gov. Submit written comments to the contact person 
(see FOR FURTHER INFORMATION CONTACT). This document may also be 
accessed on FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of 
this document for electronic access to the searchable database for the 
current list of FDA recognized consensus standards, including 
Recognition List Number: 033 modifications and other standards related 
information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993-0002, 301-
796-6287.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 
514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains hypertext 
markup language (HTML) and portable document format (PDF) versions of 
the list of FDA Recognized Consensus Standards. Both versions are 
publicly accessible at the Agency's Internet site. See section VI of 
this document for electronic access information. Interested persons 
should review the

[[Page 2454]]

supplementary information sheet for the standard to understand fully 
the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 033

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in premarket submissions and other requirements for devices. We 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database, using the term 
``Recognition List Number: 033'' to identify these current 
modifications.
    In table 1 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others, if applicable; (2) the correction of errors made by FDA in 
listing previously recognized standards; and (3) the changes to the 
supplementary information sheets of recognized standards that describe 
revisions to the applicability of the standards.
    In section III of this document, FDA lists modifications the Agency 
is making that involve the initial addition of standards not previously 
recognized by FDA.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                          Replacement
          Old recognition No.             recognition        Title of standard \1\               Change
                                              No.
----------------------------------------------------------------------------------------------------------------
                                                  A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-60..................................  ..............  IEC 60601-2-12 (2001-10)        Withdrawn. Transition
                                                         Medical electrical equipment--  period expired. See 1-
                                                         Part 2-12: Particular           88.
                                                         requirements for the safety
                                                         of lung ventilators--Critical
                                                         care ventilators.
1-61..................................  ..............  IEC 60601-2-13 (2003-05)        Withdrawn. Transition
                                                         Medical electrical equipment--  period expired. See 1-
                                                         Part 2-13: Particular           82.
                                                         requirements for the safety
                                                         and essential performance of
                                                         anesthetic systems.
1-66..................................  ..............  ISO 9919:2005 Medical           Withdrawn. Transition
                                                         electrical equipment--          period expired. See 1-
                                                         Particular requirements for     85.
                                                         the basic safety and
                                                         essential performance of
                                                         pulse oximeter equipment for
                                                         medical use.
----------------------------------------------------------------------------------------------------------------
                                                B. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-38..................................  ..............  IEC 60601-2-34 (2000-10)        Withdrawn. Transition
                                                         Medical electrical equipment--  period expired. See 3-
                                                         Part 2-34: Particular           115.
                                                         requirements for the safety,
                                                         including essential
                                                         performance, of invasive
                                                         blood pressure monitoring
                                                         equipment.
----------------------------------------------------------------------------------------------------------------
                                                  C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-122.................................  ..............  IEC 60601-2-18:1996 Amendment   Withdrawn. Transition
                                                         1 2000 Medical electrical       period expired. See 4-
                                                         equipment--Part 2-18:           187.
                                                         Particular requirements for
                                                         the safety of endoscopic
                                                         equipment.
----------------------------------------------------------------------------------------------------------------
                                                   D. General
----------------------------------------------------------------------------------------------------------------
5-4...................................  ..............  IEC 60601-1 1988; Amendment 1,  Withdrawn. Transition
                                                         1991-11, Amendment 2, 1995      period expired. See 5-
                                                         Medical electrical equipment--  77.
                                                         Part 1: General requirements
                                                         for safety and essential
                                                         performance.
5-27..................................  ..............  IEC 60601-1-1:2000 Medical      Withdrawn.
                                                         electrical equipment--Part 1-
                                                         1: General requirements for
                                                         safety--Collateral standard:
                                                         Safety requirements for
                                                         medical electrical systems.
5-34..................................  ..............  IEC 60601-1-2 Medical           Withdrawn. Transition
                                                         electrical equipment--Part 1-   period expired. See 5-
                                                         2: General requirements for     53.
                                                         safety--Collateral standard:
                                                         Electromagnetic
                                                         compatibility--Requirements
                                                         and tests (Edition 2:2001
                                                         with Amendment 1:2004;
                                                         Edition 2.1) (Edition 2:2001
                                                         consolidated with Amendment
                                                         1:2004).
5-35..................................  ..............  ANSI/AAMI/IEC 60601-1-2:2001    Withdrawn. Transition
                                                         Medical electrical equipment--  period expired. See 5-
                                                         Part 1-2: General               54.
                                                         requirements for safety--
                                                         Collateral standard:
                                                         Electromagnetic
                                                         compatibility--Requirements
                                                         and tests.
5-41..................................  ..............  IEC 60601-1-4 Edition 1.1 2000- Withdrawn.
                                                         04 Medical electrical
                                                         equipment--Part 1-4: General
                                                         requirements for safety--
                                                         Collateral standard:
                                                         Programmable electrical
                                                         medical systems.

[[Page 2455]]

 
5-49..................................  ..............  IEC 60601-1-8 First edition     Withdrawn. Transition
                                                         2003-08 Medical electrical      period expired. See 5-
                                                         equipment--Part 1-8: General    76.
                                                         requirements for safety--
                                                         Collateral standard: General
                                                         requirements, tests, and
                                                         guidance for alarm systems in
                                                         medical electrical equipment
                                                         and medical electrical
                                                         systems.
5-60..................................  ..............  IEC 60601-1-2 Int. 1 Third      Withdrawn. See 5-53.
                                                         edition/I-SH 01:2007 Medical
                                                         electrical equipment--Part 1-
                                                         2: General requirements for
                                                         basic safety and essential
                                                         performance--Collateral
                                                         standard: Electromagnetic
                                                         compatibility--Requirements
                                                         and tests, interpretation
                                                         sheet.
5-77..................................  ..............  ANSI/AAMI ES60601-1:2005/       Transition period
                                                         (R)2012 and A1:2012, C1:2009/   extended.
                                                         (R)2012 and A2:2010/(R)2012
                                                         (Consolidated Text), Medical
                                                         electrical equipment--Part 1:
                                                         General requirements for
                                                         basic safety and essential
                                                         performance (IEC 60601-
                                                         1:2005, MOD).
----------------------------------------------------------------------------------------------------------------
                                   E. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-9...................................  ..............  IEC 60601-2-21 First edition    Withdrawn. Transition
                                                         1994-02 Medical electrical      period expired. See 6-
                                                         equipment--Part 2: Particular   300.
                                                         requirements for the safety
                                                         of infant radiant warmers.
6-29..................................  ..............  IEC 60601-2-19 First edition    Withdrawn. Transition
                                                         1990-12 Medical electrical      period expired. See 6-
                                                         equipment--Part 2: Particular   298.
                                                         requirements for safety of
                                                         baby incubators.
6-32..................................  ..............  IEC 60601-2-20 First edition    Withdrawn. Transition
                                                         1990-12 Medical electrical      period expired. See 6-
                                                         equipment--Part 2: Particular   299.
                                                         requirements for safety of
                                                         transport incubators.
6-146.................................  ..............  ANSI/AAMI/IEC 60601-2-21 First  Withdrawn. Transition
                                                         edition 1994-02 and Amendment   period expired. See 6-
                                                         1:2000 Medical electrical       227.
                                                         equipment--Part 2: Particular
                                                         requirements for safety of
                                                         infant radiant warmers.
6-182.................................  ..............  IEC 60601-2-38 First edition    Withdrawn. Transition
                                                         1996-10 and Amendment 1:1999    period expired. See 6-
                                                         Medical electrical equipment--  233.
                                                         Part 2-38: Particular
                                                         requirements for the safety
                                                         of electrically operated
                                                         hospital beds.
6-197.................................  ..............  IEC 60601-2-2 Ed. 1.0 Medical   Withdrawn. Transition
                                                         electrical equipment--Part 2-   period expired. See 6-
                                                         2: Particular requirements      228.
                                                         for the safety of high-
                                                         frequency surgical equipment.
----------------------------------------------------------------------------------------------------------------
                                                  F. Neurology
----------------------------------------------------------------------------------------------------------------
17-5..................................  ..............  IEC 60601-2-10 First edition    Withdrawn. Transition
                                                         1987, Amendment 1 2001-09       period expired. See 17-
                                                         Medical electrical equipment--  11.
                                                         Part 2-10: Particular
                                                         requirements for the safety
                                                         of nerve and muscle
                                                         stimulators.
----------------------------------------------------------------------------------------------------------------
                                           G. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-4...................................  ..............  IEC 60601-2-16 Second edition   Withdrawn. Transition
                                                         1998-02 Medical electrical      period expired. See 9-
                                                         equipment--Part 2-16:           80.
                                                         Particular requirements for
                                                         the safety of haemodialysis,
                                                         haemodiafiltration, and
                                                         haemofiltration equipment.
9-42..................................  ..............  IEC 60601-2-18 Second edition   Withdrawn. Transition
                                                         1996-08, Amendment 1 2000-07    period expired. See 9-
                                                         Medical electrical equipment--  61.
                                                         Part 2-18: Particular
                                                         requirements for the safety
                                                         of endoscopic equipment.
9-46..................................  ..............  IEC 60601-2-2 Fourth edition    Withdrawn. Transition
                                                         2006-07 Medical electrical      period expired. See 9-
                                                         equipment--Part 2-2:            62.
                                                         Particular requirements for
                                                         the safety of high frequency
                                                         surgical equipment.
----------------------------------------------------------------------------------------------------------------
                                                  H. Radiology
----------------------------------------------------------------------------------------------------------------
12-34.................................  ..............  IEC 60601-2-7 Second edition    Withdrawn. Transition
                                                         1998-02 Medical electrical      period expired. See 12-
                                                         equipment--Part 2-7:            251.
                                                         Particular requirements for
                                                         the safety of high-voltage
                                                         generators of diagnostic x
                                                         ray generators.

[[Page 2456]]

 
12-54.................................  ..............  IEC 60601-2-8 Edition 1.1 1999- Withdrawn. Transition
                                                         04 Medical electrical           period expired. See 12-
                                                         equipment--Part 2-8:            254.
                                                         Particular requirements for
                                                         the safety of therapeutic x
                                                         ray equipment operating in
                                                         the range 10 kilovolt (kV) to
                                                         1 millivolt (mV).
12-63.................................  ..............  IEC 60601-2-43 Edition 1.0      Withdrawn. Transition
                                                         2000-06 Medical electrical      period expired. See 12-
                                                         equipment--Part 2-43:           202.
                                                         Particular requirements for
                                                         the safety of x ray equipment
                                                         for interventional procedures.
12-120................................  ..............  IEC 60601-2-44 Edition 2.1      Withdrawn. Transition
                                                         2002-11 Medical electrical      period expired. See 12-
                                                         equipment--Part 2-44:           256.
                                                         Particular requirements for
                                                         the safety of x ray equipment
                                                         for computed tomography.
12-126................................  ..............  IEC 60601-2-28 First Edition    Withdrawn. Transition
                                                         1.0 1993-03 Medical             period expired. See 12-
                                                         electrical equipment--Part 2-   204.
                                                         28: Particular requirements
                                                         for the safety of x ray
                                                         source assemblies and x ray
                                                         tube assemblies for medical
                                                         diagnosis.
12-127................................  ..............  60601-2-32 First edition 1994-  Withdrawn. Transition
                                                         03 Medical electrical           period expired. See 12-
                                                         equipment--Part 2-32:           201.
                                                         Particular requirements for
                                                         the safety of associated
                                                         equipment of x ray equipment.
12-133................................  ..............  IEC 60601-2-11 Second edition   Withdrawn. Transition
                                                         1997-08, Amendment 1, 2004-07   period expired. See 12-
                                                         Medical electrical equipment--  255.
                                                         Part 2-11: Particular
                                                         requirements for the safety
                                                         of gamma beam therapy
                                                         equipment.
12-147................................  ..............  IEC 60601-2-5 Edition 2.0 2000- Withdrawn. Transition
                                                         07 Medical electrical           period expired. See 12-
                                                         equipment--Part 2-5:            205.
                                                         Particular requirements for
                                                         the safety of ultrasonic
                                                         physiotherapy equipment.
12-152................................  ..............  IEC 60601-2-1 Second edition    Withdrawn. Transition
                                                         1998-06, Amendment 1 2002-05    period expired. See 12-
                                                         Medical electrical equipment--  206.
                                                         Part 2-1: Particular
                                                         requirements for the safety
                                                         of electron accelerators in
                                                         the range 1 megaelectronvolts
                                                         (MeV) to 50 MeV.
12-178................................  ..............  IEC 60601-2-45 Edition 2.0      Withdrawn. Transition
                                                         2001-05 Medical electrical      period expired. See 12-
                                                         equipment--Part 2-45:           236.
                                                         Particular requirements for
                                                         the safety of mammographic x
                                                         ray equipment and
                                                         mammographic stereotactic
                                                         devices.
12-189................................  ..............  IEC 60601-2-33 Edition 2.2      Withdrawn. Transition
                                                         2008-04 Medical electrical      period expired. See 12-
                                                         equipment--Part 2-33:           207.
                                                         Particular requirements for
                                                         the safety of magnetic
                                                         resonance equipment for
                                                         medical diagnosis.
12-197................................  ..............  IEC 60601-2-22 Second edition   Withdrawn. Transition
                                                         1995-11 Medical electrical      period expired. See 12-
                                                         equipment--Part 2-22:           208.
                                                         Particular requirements for
                                                         the safety of diagnostic and
                                                         therapeutic laser equipment.
12-198................................  ..............  IEC 60601-2-37 First edition    Withdrawn. Transition
                                                         2007-01, Amendment 1 2004-08,   period expired. See 12-
                                                         Amendment 2 2005-11 Medical     209.
                                                         electrical equipment--Part 2-
                                                         37: Particular requirements
                                                         for the basic safety and
                                                         essential performance of
                                                         ultrasonic medical diagnostic
                                                         and monitoring equipment.
12-199................................  ..............  IEC 60601-1-3 First edition     Withdrawn. Transition
                                                         1994-07 Medical electrical      period expired. See 12-
                                                         equipment--Part 1-3: General    210.
                                                         requirements for safety--3.
                                                         Collateral standard: General
                                                         requirements for radiation
                                                         protection in diagnostic x
                                                         ray equipment.
12-200................................  ..............  IEC 60601-2-29 Second edition   Withdrawn. Transition
                                                         1999-01 Medical electrical      period expired. See 12-
                                                         equipment--Part 2-29:           211.
                                                         Particular requirements for
                                                         the safety of radiotherapy
                                                         simulators.
12-207................................  ..............  IEC 60601-2-33 Edition 3.0      Transition period
                                                         2010-03, Medical electrical     extended.
                                                         equipment--Part 2-33:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         magnetic resonance equipment
                                                         for medical diagnostic.
12-208................................  ..............  IEC 60601-2-22 Third edition    Transition period
                                                         2007-05 Medical electrical      extended.
                                                         equipment--Part 2-22:
                                                         Particular requirements for
                                                         basic safety and essential
                                                         performance of surgical,
                                                         cosmetic, therapeutic, and
                                                         diagnostic laser equipment.

[[Page 2457]]

 
12-210................................  ..............  IEC 60601-1-3 Edition 2.0 2008- Transition period
                                                         01 Medical electrical           extended.
                                                         equipment--Part 1-3: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Radiation protection in
                                                         diagnostic x ray equipment.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 2 of this document, FDA provides the listing of new 
entries and consensus standards added as modifications to the list of 
recognized standards under Recognition List Number: 033.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                          Reference No.
        Recognition No.          Title of standard \1\      and date
------------------------------------------------------------------------
                               A. General
------------------------------------------------------------------------
5-78..........................  Medical electrical      ANSI/AAMI
                                 equipment--Part 1:      ES60601-1:2005/
                                 General requirements    (R)2012 and
                                 for basic safety and    C1:2009/(R)2012
                                 essential performance   and A2:2010/
                                 (IEC 60601-1:2005,      (R)2012
                                 MOD).                   (Consolidated
                                                         Text).
------------------------------------------------------------------------
                              B. Radiology
------------------------------------------------------------------------
12-257........................  Medical electrical      IEC 60601-2-44
                                 equipment--Part 2-44:   Edition 3.0
                                 Particular              2009-02.
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of x ray equipment
                                 for computed
                                 tomography.
------------------------------------------------------------------------
12-268........................  Medical electrical      IEC 60601-2-22
                                 equipment--Part 2-22:   Edition 3.1
                                 Particular              2012-10.
                                 requirements for
                                 basic safety and
                                 essential performance
                                 of surgical,
                                 cosmetic, therapeutic
                                 and diagnostic laser
                                 equipment.
12-269........................  Medical electrical      IEC 60601-1-3
                                 equipment--Part 1-3:    Edition 2.1
                                 General requirements    2013-04.
                                 for basic safety and
                                 essential
                                 performance--Collater
                                 al standard:
                                 radiation protection
                                 in diagnostic x ray
                                 equipment.
12-271........................  Medical electrical      IEC 60601-2-33
                                 equipment--Part 2-33:   Edition 3.1
                                 Particular              2013-04.
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of magnetic resonance
                                 equipment for medical
                                 diagnosis.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed directly at our 
Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. We will incorporate the modifications and 
revisions described in this notice into the database and, upon 
publication in the Federal Register, this recognition of consensus 
standards will be effective. We will announce additional modifications 
and revisions to the list of recognized consensus standards, as needed, 
in the Federal Register once a year, or more often if necessary. 
Beginning with Recognition List Number: 033, we will no longer be 
announcing minor revisions to the list of recognized consensus 
standards such as technical contact person, relevant guidance, 
processes affected, Code of Federal Regulations citations, and product 
codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to the contact 
person (see FOR FURTHER INFORMATION CONTACT). To be properly 
considered, such recommendations should contain, at a minimum, the 
following information: (1) Title of the standard, (2) any reference 
number and date, (3) name and address of the national or international 
standards development organization, (4) a proposed list of devices for 
which a declaration of conformity to this standard should routinely 
apply, and (5) a brief identification of the testing or performance or 
other characteristics of the device(s) that would be addressed by a 
declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains a site on the Internet for easy 
access to information including text, graphics, and files that you may 
download to a personal computer with access to the Internet. Updated on 
a regular basis, the CDRH home page includes the guidance as well as 
the current list of recognized standards and other standards-related 
documents. After publication in the Federal Register, this notice 
announcing ``Modification to the List of Recognized Standards, 
Recognition List Number: 033'' will be available on the CDRH home page. 
You may access the

[[Page 2458]]

CDRH home page at http://www.fda.gov/MedicalDevices.
    You may access ``Guidance on the Recognition and Use of Consensus 
Standards,'' and the searchable database for ``FDA Recognized Consensus 
Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

VII. Submission of Comments and Effective Date

    Interested persons may submit either electronic comments concerning 
this document, or recommendations for additional standards for 
recognition, by email to standards@cdrh.fda.gov or written comments to 
the contact person (see FOR FURTHER INFORMATION CONTACT). 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. FDA 
will consider any comments received in determining whether to amend the 
current listing of modifications to the list of recognized standards, 
Recognition List Number: 033. These modifications to the list of 
recognized standards are effective upon publication of this notice in 
the Federal Register.

    Dated: January 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00477 Filed 1-13-14; 8:45 am]
BILLING CODE 4160-01-P


