[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17188-17193]
[FR Doc No: 2014-06807]

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 DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0012]

Revision of OSHA's Policy for Incorporating New Test Standards
Into the List of Appropriate NRTL Program Test Standards

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of final decision.

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SUMMARY: In this notice, OSHA revises its existing policies regarding
the incorporation of new test standards into the Nationally Recognized
Testing Laboratory (NRTL) Program's list of appropriate test standards
and into NRTLs' scopes of recognition; and incorporates 72 test
standards into the NRTL Program's list of appropriate test standards.

DATES: The actions contained in this notice will become effective on
March 27, 2014.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. David Johnson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; telephone
(202) 693-2110; email<EMAIL_ADDRESS>    Copies of this Federal Register notice: Electronic copies of this
Federal Register notice are available at http://www.regulations.gov.
This Federal Register notice, as well as other relevant information, is
also available on OSHA's Web page at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    OSHA recognizes organizations that provide product-safety testing
and certification services to manufacturers. These organizations
perform testing and certification, for purposes of the NRTL Program, to
U.S. consensus-based product-safety test standards. OSHA does not
develop or issue these test standards, but generally relies on U.S.
standards-development organizations (SDOs) accredited by the American
National Standards Institute (ANSI). The products covered by the NRTL
Program consist of those items for which OSHA safety standards require
``certification'' by an NRTL. The requirements affect electrical
products and 38 other types of products.
    OSHA recognition of an organization as an NRTL signifies that the
organization meets the legal requirements in OSHA regulations at 29 CFR
1910.7 and the NRTL Program policies in CPL 1-0.3, ``NRTL Program
Policies, Procedures, and Guidelines,'' December 2, 1999
(``Directive''). Recognition is an acknowledgement by OSHA that the
NRTL has the capabilities to perform independent safety testing and
certification of the specific products covered within the NRTL's scope
of recognition. Recognition of an NRTL by OSHA also allows employers to
use products certified by that NRTL to meet those OSHA standards that
require product testing and certification (29 CFR 1910.7(a)).
    An NRTL's scope of recognition consists, in part, of specific test
standard(s) approved by OSHA for use by the NRTL. Pursuant to OSHA
regulations, the NRTL must first request to have a test standard
included in its scope of recognition. OSHA will grant the NRTL's
request only if the NRTL has the capability to test and examine
equipment \1\ and materials for workplace safety purposes and to
determine conformance with the test standard for each relevant item of
equipment or material that it lists, labels, or accepts (29 CFR
1910.7(b)(1)). Capability includes proper testing equipment and
facilities, trained staff, written testing procedures, calibration
programs, and quality-control programs. An

organization's recognition as an NRTL is, therefore, not for products,
but for appropriate test standards covering a type of product(s) (29
CFR 1910.7(b)(1)).
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    \1\ In this notice, OSHA uses the terms ``equipment'' and
``product'' or ``products'' interchangeably.
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    For OSHA to consider a test standard appropriate, the test standard
must be current and specify the safety requirements for a specific type
of product(s) (29 CFR 1910.7(c)). A test standard withdrawn by an SDO
is no longer considered an appropriate test standard (Directive, App.
C.XIV.B). It is OSHA's policy to remove acceptance of withdrawn test
standards by issuing a correction notice in the Federal Register for
all NRTLs recognized for the withdrawn test standards. However, OSHA
will recognize an NRTL for an appropriate replacement test standard if
the NRTL has the requisite testing and evaluation capability for
implementing the replacement test standard.
    One method that NRTLs may use to show such capability involves an
analysis to determine whether any testing and evaluation requirements
of existing test standards in an NRTL's scope are comparable (i.e., are
completely or substantially identical) to the requirements in the
replacement test standard. If OSHA's analysis shows the replacement
test standard does not require additional or different technical
capability than an existing test standard, the replacement test
standard is comparable to the existing test standard, and OSHA can add
the replacement test standard to affected NRTLs' scopes of recognition.
    If OSHA's analysis shows the replacement test standard requires an
additional or different technical capability than any existing test
standard, then the replacement test standard is not comparable to any
existing test standard. In such cases (i.e., when test standards are
not comparable), each affected NRTL that seeks to have OSHA add the
replacement test standard to the NRTL's scope of recognition must
provide information to OSHA that demonstrates its testing and
evaluation capability to implement that standard.
    In a November 25, 2013, Federal Register notice (78 FR 70349), OSHA
proposed: (1) Revising its existing policies regarding the
incorporation of new test standards into the NRTL Program's list of
appropriate test standards and into NRTLs' scopes of recognition; and
(2) incorporating new test standards into the NRTL Program's list of
appropriate test standards. The comment period for the public to submit
comments on these proposed actions ended on December 26, 2013.
    OSHA received four comments filed in a timely manner (OSHA-2013-
0012-0006, OSHA-2013-0012-0007, OSHA-2013-0012-0008, OSHA-2013-0012-
0009), and one comment filed after the comment period closed (OSHA-
2013-0012-0010), on its proposal. All comments are available for
viewing at www.regulations.gov under docket number OSHA-2013-0012. In
this final-decision notice, OSHA addresses these comments and adopts
its proposal with limited revision that reflects some commenters'
concerns. OSHA describes the proposal, comments, and its final decision
in more detail below.

II. Final Decision Revising Existing OSHA Policy

A. Revision to Existing Policy for Incorporating New Test Standards
Into the NRTL Program's List of Appropriate Test Standards

    In the November 25, 2013 Federal Register notice, OSHA proposed
revising its existing policy regarding the incorporation of new test
standards into the NRTL Program's list of appropriate test standards.
Pursuant to OSHA's existing policy, OSHA incorporates test standards
into the list of appropriate test standards only when OSHA processes an
NRTL's application for recognition (either initial or expansion), or
when OSHA incorporates into an NRTL's scope of recognition a comparable
replacement test standard for a withdrawn test standard (Directive,
Chapter 2; App. C.XIV.B). OSHA believes that the existing policy delays
the acceptance process for valid test standards, and proposed revising
the existing policy to expedite incorporation of new test standards
into the NRTL Program's list of appropriate test standards and into
NRTLs' scopes of recognition.
    OSHA becomes aware of new test standards through various avenues.
For example, OSHA becomes aware of new test standards by: (1)
Monitoring notifications issued by certain SDOs; (2) reviewing
applications by NRTLs or applicants seeking recognition to include a
new test standard in their scopes of recognition; and (3) obtaining
notification from manufacturers, manufacturing organizations, other
government agencies, or other parties that a new test standard may be
appropriate to add to its list of appropriate standards. Accordingly,
OSHA proposed to expand the existing process whereby it incorporates
new test standards into the NRTL Program's list of appropriate test
standards. Under the proposed policy, OSHA would not only include new
test standards in its list of appropriate test standards under the
conditions described by its existing policy, but would include new test
standards in the list when OSHA determined that such test standards are
appropriate to add to the list. OSHA may determine to include a new
test standard in the list, for example, if the test standard is for a
particular type of product that another test standard also covers,
covers a type of product that no standard previously covered, or be
otherwise new to the NRTL Program.
    Under the proposed policy, OSHA first would make a preliminary
determination that the new test standard is appropriate under the NRTL
Program regulations (29 CFR 1910.7(c)). The Agency then would
periodically issue a Federal Register notice proposing to include new
test standards that it identifies as appropriate in its list of
appropriate test standards. When an SDO withdraws test standards, OSHA
also may propose in a Federal Register notice that new test standards
replace withdrawn test standards in NRTLs' scopes of recognition. After
OSHA publishes the preliminary determination in a Federal Register
notice, it would give the public an opportunity to comment and, after
reviewing these comments and other record evidence, would issue, in the
Federal Register, a final determination.
    No commenter objected to this proposed policy revision. The
National Electrical Manufacturers Association (NEMA) and Underwriters
Laboratories, Inc. (UL), expressed support for the proposed policy
(OSHA-2013-0012-0008, OSHA-2013-0012-0009). Therefore, OSHA hereby
revises the policy, as proposed.
    NEMA asked that OSHA include the effective dates of test standards
in its list of appropriate test standards (OSHA-2013-0012-0008). In
explaining this comment, NEMA asserted that manufacturers and NRTLs use
the time between the publication and effective dates of a test standard
to become informed of the new requirements. While this might be the
case, OSHA currently does not evaluate test standards with future
effective dates for use in the NRTL Program. OSHA accepts a test
standard as appropriate only after the effective date of the standard.
    NEMA stated further that, in determining whether a test standard is
appropriate, OSHA should ``continue to rely primarily on U.S. standards
developers accredited by the American National Standards Institute
(ANSI),'' which ``provides reasonable assurance that the standard is a
good standard and likely to have wide use;''. NEMA then stated that
OSHA ``should only consider standards developed by organizations

considered to be primary sources that are known to produce universally
acceptable standards representing good design.''
    OSHA considers the appropriateness of test standards on a case-by-
case basis. OSHA notes, however, that the NRTL Program regulation
constrains its discretion in this area; this regulation requires that,
for OSHA to accept a test standard, the test standard must, at a
minimum, ``provide an adequate level of safety'' (29 CFR 1910.7(d)).
Also pursuant to the regulation, OSHA generally accepts test standards
developed by SDOs accredited by ANSI (29 CFR 1910.7(c)). ANSI
accreditation ensures that the SDO meets the criteria required in the
regulation for OSHA to consider a test standard appropriate.\2\
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    \2\ The NRTL Program regulation provides that an ``appropriate
test standard'' is ``a document which specifies the safety
requirements for specific equipment or class of equipment and is:
(1) [r]ecognized in the United States as a safety standard providing
an adequate level of safety, and (2) [c]ompatible with and
maintained current with periodic revisions of applicable national
codes and installation standards, and (3) [d]eveloped by a standards
developing organization under a method providing for input and
consideration of views of industry groups, experts, users,
consumers, governmental authorities, and others having broad
experience in the safety field involved, or (4) [i]n lieu of
paragraphs (c) (1), (2), and (3), the standard is currently
designated as an American National Standards Institute (ANSI)
safety-designated product standard or an American Society for
Testing and Materials (ASTM) test standard used for evaluation of
products or materials'' (29 CFR 1910.7(c)).
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B. Revision to Policy for Expanding NRTLs' Scopes of Recognition

    Under existing OSHA policy, an NRTL must apply for an expansion of
recognition, pursuant to the procedures in 29 CFR 1910.7, App. A, if
the NRTL wants OSHA to incorporate into its scope of recognition a
replacement test standard that is not comparable to a test standard
that OSHA is removing from that NRTL's scope of recognition because,
for example, an SDO withdrew the predecessor test standard. In the
November 25, 2013, Federal Register notice, OSHA proposed modifying
this policy to provide for an abbreviated recognition process that
allows NRTLs currently recognized for the predecessor standard to
submit to OSHA, in lieu of an application for expansion, only
information that demonstrates that the NRTL has the capability to
perform the testing and evaluation required in the areas of the
replacement test standard that are not equivalent or comparable to the
standard being replaced.
    Therefore, under the new policy, when OSHA becomes aware of a
replacement test standard that is not comparable to a test standard
that OSHA is removing from an NRTL's scope of recognition, OSHA would
invite that NRTL, via email or letter, to submit specified information
that OSHA believes demonstrates the requisite testing and evaluation
capability. OSHA would include, in the letter or email, a comparability
table for the replacement test standard that details proposed
substantive differences between the existing and replacement test
standards that OSHA believes the NRTL must address for OSHA to
recognize the NRTL for the replacement standard. OSHA would follow the
procedures specified by 29 CFR 1910.7, App. A, in determining whether
it should incorporate the replacement test standard into the affected
NRTL's scope of recognition. OSHA then would issue a preliminary
determination in the Federal Register, provide the public an
opportunity to comment on the preliminary determination, and, after
reviewing the comments and other record evidence, issue a final
determination in the Federal Register on whether it will incorporate
the replacement test standard into the affected NRTL's scope of
recognition. In making a preliminary or final determination, OSHA also
would follow other applicable procedures specified by 29 CFR 1910.7,
App. A, such as requesting additional information, conducting
appropriate on-site reviews, or initiating special reviews. OSHA
believes the proposed policy would expedite the recognition process of
replacement test standards issued by SDOs.
    No commenter objected to the proposed policy revision. UL expressed
support for the proposed revision (OSHA-2013-0012-0009). In its
comments, UL asked that OSHA further revise its policy to allow the use
of the proposed abbreviated recognition process for new test standards
that have no relation to predecessor test standards currently in an
NRTL's scope of recognition (as opposed to replacement test standards
that would replace predecessor test standards that OSHA is removing
from the NRTL's scope of recognition). UL revised the language in the
proposed policy, in part, as follows:

    [W]hen an NRTL seeks the addition of a new standard to its
current scope of recognition, the NRTL may submit specified
information that demonstrates it has the requisite testing and
evaluation capability based on standards in its current scope of
recognition. The specified information would include reference to
existing standards in the NRTL's scope that require the capabilities
needed for the new standard. If necessary, the NRTL would also
identify substantive differences in needed capability between the
new standard and existing test standards in its scope of
recognition. The NRTL would provide information about its
capabilities for those substantive differences based on the current
OSHA NRTL application for scope expansion.

(Id.) According to UL, OSHA should require the application process
specified by 29 CFR 1910.7, App. A, only ``[f]or the rare situations
where an NRTL wishes to expand into new standards where it has little
or none of the needed capabilities'' (id.).

    OSHA is not adopting UL's revised language. Accordingly, the key
aspects of OSHA's new policy are that OSHA can now initiate the
recognition process when it becomes aware of a replacement test
standard that is not comparable to a test standard that it is removing
from an NRTL's scope of recognition, and OSHA will inform the NRTL, in
the first instance, of substantive differences between the existing and
replacement test standards that OSHA believes the NRTL must address for
OSHA to recognize the NRTL for the replacement standard. Under UL's
revised language, the NRTL, not OSHA, would initiate the recognition
process, and the NRTL, not OSHA, would inform OSHA of its capability to
perform the test standard.
    UL's revised language would not, therefore, significantly expedite
the recognition process for new test standards because UL's revised
language is substantially similar to the existing application process.
Neither OSHA's new policy, nor UL's revised language, would permit the
NRTL to avoid key procedural requirements of the application process.
Indeed, UL agrees, stating in its revised language that ``OSHA would
follow the procedures specified by 29 CFR 1910.7, App. A, in
determining whether it should incorporate the new test standard into
the NRTL's scope of recognition'' (id.). UL stated further in its
revised language, similar to what OSHA states in its new policy, that
``OSHA would issue a preliminary determination in the Federal Register,
provide the public an opportunity to comment on the preliminary
determination, and, after reviewing the comments and other record
evidence, issue a final determination in the Federal Register on
whether it will incorporate the new test standard into the affected
NRTL's scope of recognition,'' and ``in making a preliminary or final
determination, OSHA also would follow other applicable procedures
specified by 29 CFR 1910.7, App. A, such as requesting additional
information, conducting appropriate on-site reviews, or initiating
special reviews'' (id.).

    OSHA notes also that its new policy preserves an NRTL's rights,
under existing procedures, to file an application for recognition of
new or replacement test standards. Moreover, OSHA currently allows
NRTLs, through the existing application process, to provide
comparability assessments as an abbreviated method to demonstrate an
NRTL's capability to meet the requirements of an appropriate test
standard. Using this process, the NRTL provides a detailed explanation
of comparability as part of its application for the test standard.
Therefore, UL's revised language is unnecessary.

III. Final Decision Adding Test Standards to the NRTL Program's List of
Appropriate Test Standards

    Table 1, below, lists test standards that OSHA is adding to the
NRTL Program under the new policy. OSHA preliminarily determined, as
specified in the November 25, 2013, Federal Register notice (see 78 FR
70349), that these test standards are appropriate test standards and
proposed to include these test standards in the NRTL Program's list of
appropriate test standards.
    No commenter objected to the proposal to include these test
standards in the NRTL Program's list of appropriate test standards. UL
and NEMA expressed support for the proposal (OSHA-2013-0012-0008, OSHA-
2013-0012-0009). OSHA, therefore, with one minor revision discussed in
the following paragraph, is making a final determination that these
test standards are appropriate test standards, and, therefore, is
adding these test standards to the NRTL Program's list of appropriate
test standards.
    In the proposal, OSHA described one test standard as AAMI ES 60601-
1, ``Medical Electrical Equipment--Part 1-2: General requirements for
Basic Safety and Essential Performance-Collateral Standard:
Electromagnetic Compatibility (third edition).'' Several commenters
stated that OSHA listed the incorrect designation and title for this
test standard (OSHA-2013-0012-0006, OSHA-2013-0012-0007, OSHA-2013-
0012-0009). OSHA concurs with these commenters and, in the final table,
describes the test standard as ``ANSI/AAMI ES60601-1:2005/(R)2012,
Medical electrical equipment, Part 1: General requirements for basic
safety and essential performance (with amendments).''
    Mr. Dale Hallerberg stated that the list of appropriate standards
should include, in addition to ANSI/AAMI ES60601-1:2005/(R)2012,
standards that are collateral to ANSI/AAMI ES60601-1:2005/(R)2012, such
as ANSI/AAMI ES60601-1-2 through ANSI/AAMI ES60601-1-12 (OSHA-2013-
0012-0007). Moreover, UL asked that OSHA consider incorporating 13
additional test standards in the NRTL Program's list of appropriate
test standards (OSHA-2013-0012-0009). Finally, the Crane Power Line
Safety Organization (CPLSO), in a late-filed comment, asked OSHA to
consider incorporating CPLSO 14, which addresses testing crane
insulating-link devices, in the NRTL Program's list of appropriate test
standards (OSHA-2013-0012-0010). These recommended additions are beyond
the scope of the present action. OSHA will, however, consider whether
these recommended additions are appropriate test standards when it
proposes additions to the list of appropriate test standards in a
future Federal Register notice.

  Table 1--Test Standards OSHA Is Adding to the NRTL Program's List of
                       Appropriate Test Standards
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        Test standard                     Test standard title
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ANSI/AAMI ES60601-1:2005/      Medical electrical equipment, Part 1:
 (R)2012.                       General requirements for basic safety
                                and essential performance (with
                                amendments).
ISA 60079-0..................  Explosive Atmospheres--Part 0: Equipment--
                                General Requirements.
ISA 60079-1..................  Explosive Atmospheres--Part 1: Equipment
                                Protection by Flameproof Enclosures
                                ``d''.
ISA 60079-2..................  Explosive Atmospheres--Part 2: Equipment
                                Protection by Pressurized Enclosures
                                ``p''.
ISA 60079-5..................  Explosive Atmospheres--Part 5: Equipment
                                Protection by Powder Filling ``q''.
ISA 60079-6..................  Explosive Atmospheres--Part 6: Equipment
                                Protection by Oil Immersion ``o''.
ISA 60079-7..................  Explosive Atmospheres--Part 7: Equipment
                                Protection by Increased Safety ``e''.
ISA 60079-11.................  Explosive Atmospheres--Part 11: Equipment
                                Protection by Intrinsic Safety ``i''.
ISA 60079-15.................  Explosive Atmospheres--Part 15: Equipment
                                Protection by Type of Protection ``n''.
ISA 60079-18.................  Explosive Atmospheres--Part 18: Equipment
                                Protection by Encapsulation ``m''.
ISA 60079-26.................  Explosive Atmospheres--Part 26: Equipment
                                for Use in Class I, Zone 0 Hazardous
                                (Classified) Locations.
ISA 60079-28.................  Explosive Atmospheres--Part 28:
                                Protection of Equipment and Transmission
                                Systems Using Optical Radiation.
ISA 60079-31.................  Explosive Atmospheres--Part 31: Equipment
                                Dust Ignition Protection by Enclosure
                                ``t''.
ISA 61241-0..................  Electrical Apparatus for Use in Zone 20,
                                Zone 21 and Zone 22 Hazardous
                                (Classified) Locations--General
                                Requirements.
ISA 61241-1..................  Electrical Apparatus for Use in Zone 21
                                and Zone 22 Hazardous (Classified)
                                Locations--Protection by Enclosures
                                ``tD''.
ISA 61241-2..................  Electrical Apparatus for Use in Zone 21
                                and Zone 22 Hazardous (Classified)
                                Locations--Protection by Pressurization
                                ``pD''.
ISA 61241-11.................  Electrical Apparatus for Use in Zone 20,
                                Zone 21 and Zone 22 Hazardous
                                (Classified) Locations--Protection by
                                Intrinsic Safety ``iD''.
ISA 61241-18.................  Electrical Apparatus for Use in Zone 20,
                                Zone 21 and Zone 22 Hazardous
                                (Classified) Locations--Protection by
                                Encapsulation ``mD''.
UL 50E.......................  Enclosures for Electrical Equipment,
                                Environmental Considerations.
UL 448B......................  Residential Fire Pumps Intended for One-
                                and Two-Family Dwellings and
                                Manufactured Homes.
UL 448C......................  Stationary, Rotary-Type, Positive-
                                Displacement Pumps for Fire Protection
                                Service.
UL 962A......................  Furniture Power Distribution Units.
UL 1004-1....................  Rotating Electrical Machines--General
                                Requirements.
UL 1008A.....................  Medium-Voltage Transfer Switches.
UL 1691......................  Single Pole Locking-Type Separable
                                Connectors.
UL 1990......................  Nonmetallic Underground Conduit with
                                Conductors.
UL 2108......................  February 27, 2004 Low Voltage Lighting
                                Systems.

UL 2208......................  Solvent Distillation Units.
UL 2238......................  Cable Assemblies and Fittings for
                                Industrial Control and Signal
                                Distribution.
UL 2239......................  Hardware for the Support of Conduit,
                                Tubing, and Cable.
UL 2438......................  Outdoor Seasonal-Use Cord-Connected
                                Wiring Devices.
UL 2560......................  Emergency Call Systems for Assisted
                                Living and Independent Living
                                Facilities.
UL 2572......................  Mass Notification Systems.
UL 2577......................  Suspended Ceiling Grid Low Voltage
                                Systems and Equipment.
UL 2586......................  Hose Nozzle Valves.
UL 2738......................  Induction Power Transmitters and
                                Receivers for Use with Low Energy
                                Products.
UL 6142......................  Small Wind Turbine Systems.
UL 6420......................  Equipment Used for System Isolation and
                                Rated as a Single Unit.
UL 60079-0...................  Explosive Atmospheres--Part 0: Equipment--
                                General requirements.
UL 60079-1...................  Explosive Atmospheres--Part 1: Equipment
                                Protection by Flameproof Enclosures `d'.
UL 60079-11..................  Explosive Atmospheres--Part 11: Equipment
                                Protection by Intrinsic Safety `i'.
UL 60079-15..................  Explosive Atmospheres--Part 15: Equipment
                                Protection by Type of Protection `n'.
UL 60079-18..................  Explosive Atmospheres--Part 18: Equipment
                                Protection by Encapsulation ``m''.
UL 60079-5...................  Explosive Atmospheres--Part 5: Equipment
                                Protection by Powder Filling `q'.
UL 60079-6...................  Explosive Atmospheres--Part 6: Equipment
                                Protection by Oil Immersion `o'.
UL 60079-7...................  Explosive Atmospheres--Part 7: Equipment
                                Protection by Increased Safety `e'.
UL 60335-2-40................  Household and Similar Electrical
                                Appliances, Part 2: Particular
                                Requirements for Electrical Heat Pumps,
                                Air-Conditioners and Dehumidifiers.
UL 60730-2-2.................  Automatic Electrical Controls for
                                Household and Similar Use; Part 2
                                Particular Requirements for Thermal
                                Motor Protectors.
UL 60745-1...................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 1: General Requirements.
UL 60745-2-1.................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-1: Particular
                                Requirements for Drills and Impact
                                Drills.
UL 60745-2-13................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-13: Particular
                                Requirements For Chain Saws.
UL 60745-2-14................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-14: Particular
                                Requirements for Planers.
UL 60745-2-15................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-15: Particular
                                Requirements for Hedge Trimmers.
UL 60745-2-17................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-17: Particular
                                Requirements for Routers and
                                Trimmers.\1\
UL 60745-2-19................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-19: Particular
                                Requirements For Jointers.
UL 60745-2-21................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-21: Particular
                                Requirements For Drain Cleaners.
UL 60745-2-22................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-22: Particular
                                Requirements For Cut-Off Machines.
UL 60745-2-3.................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-3: Particular
                                Requirements for Grinders, Polishers and
                                Disk-Type Sanders.
UL 60745-2-5.................  Hand-Held Motor-Operated Electric Tools--
                                Safety--Part 2-5: Particular
                                Requirements for Circular Saws.
UL 60947-4-1A................  Low Voltage Switchgear and Controlgear--
                                Part 4-1: Contactors and Motor-starters--
                                Electromechanical Contractors and Motor-
                                starters.
UL 60947-5-2.................  Low-voltage Switchgear and Controlgear--
                                Part 5-2: Control Circuit Devices and
                                Switching Elements--Proximity Switches.
UL 60950-1...................  Information Technology Equipment Safety--
                                Part 1: General Requirements.
UL 60950-21..................  Information Technology Equipment--Safety--
                                Part 21: Remote Power Feeding.
UL 60950-22..................  Information Technology Equipment Safety--
                                Part 22: Equipment to be Installed
                                Outdoors.
UL 60950-23..................  Information Technology Equipment Safety--
                                Part 23: Large Data Storage Equipment.
UL 61010-031.................  Electrical Equipment for Measurement,
                                Control, and Laboratory Use; Part 031:
                                Safety Requirements for Hand-Held Probe
                                Assemblies for Electrical Measurement
                                and Test.
UL 61010-1...................  Electrical Equipment for Measurement,
                                Control, and Laboratory Use; Part 1:
                                General Requirements.
UL 61010-2-030...............  Safety Requirements for Electrical
                                Equipment for Measurement, Control, and
                                Laboratory Use--Part 2-030: Particular
                                Requirements for Testing and Measuring
                                Circuits.
UL 61058-1...................  Switches for Appliances--Part 1: General
                                Requirements.
UL 61800-5-1.................  Adjustable Speed Electrical Power Drive
                                Systems--Part 5-1: Safety Requirements--
                                Electrical, Thermal and Energy.
UL 62275.....................  Cable Management Systems--Cable Ties for
                                Electrical Installations.
UL 62368-1...................  Audio/Video, Information and
                                Communication Technology Equipment--Part
                                1: Safety Requirements.
------------------------------------------------------------------------

VI. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2)), Secretary of Labor's Order

No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on March 24, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-06807 Filed 3-26-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: July 21, 2009 (Volume 74, Number 138)]
[Notices]
[Page 35866-35867]
[DOCID:fr21jy09-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL09-63-000]

City of Orangeburg, SC; Notice of Filing

July 13, 2009.
    Take notice that on July 2, 2009, the City of Orangeburg, South
Carolina (City of Orangeburg), pursuant section 205(a) of the Public
Utility Regulatory Policies Act, 16 U.S.C. 824a-l(a), and Rule
207(a)(5) of the Federal Energy Regulatory Commission's (Commission)
Rules of Practice and Procedure, 18 CFR 385.207(a)(5), filed a petition
for declaratory requesting that the Commission exempt the Orangeburg
Department of Public Utilities and other affected electric facilities
from the policy and practice announced by the North Carolina Utilities
Commission (NCUC) in its March 30, 2009 Order E-7, Sub 858 (NCUC
Order). The City of Orangeburg also seeks a petition for declaratory
order stating that the policy announced in the NCUC Order is preempted
by the Commission's exclusive jurisdiction over wholesale power sales,
transmission and rates under sections 201(a), 201(b), 205, and 206 of
the Federal Power Act, 16 U.S.C. 824(a), 824(b), 824d, and 824e.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC.

There is an ``eSubscription'' link on the Web site that enables
subscribers to receive e-mail notification when a document is added to
a subscribed docket(s). For assistance with any FERC Online service,
please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll
free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 3, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-17239 Filed 7-20-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)]
[Proposed Rules]
[Pages 33165-33167]
[FR Doc No: 2018-15183]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0343]
RIN 1625-AA00

Safety Zone, S99 Alford Street Bridge--Emergency Grid Replacement
Project, Mystic River, Charlestown and Everett, MA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a temporary safety zone
for the navigable waters within 150-yards of the S99 Alford Street
Bridge, at mile 1.4 on the Mystic River between Charlestown and
Everett, Massachusetts from October 1, 2018 through April 30, 2019. The
safety zone is necessary to protect personnel, vessels and the marine
environment from potential hazards created during the emergency
replacement of the steel grid deck on all four bascule spans of the S99
Alford Street Bridge. This proposed rule would prohibit vessels and
persons from being in the safety zone unless authorized by the Captain
of the Port Boston or a designated representative. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before August 16, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0343 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Mark Cutter, Waterways Management
Division, U.S. Coast Guard Sector Boston, telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On April 6, 2018, the City of Boston notified the Coast Guard that
the Massachusetts Department of Transportation's Highways Division will
be conducting emergency repairs to the S99 Alford Street Drawbridge at
mile 1.4 on the Mystic River between Charlestown and Everett
Massachusetts from May 2018 through the summer of 2019. The emergency
repairs consist of replacing the steel grid bridge decking on all four
bascule spans. To complete these repairs by the summer of 2019 and
still maintain regional transportation, each side span of the bascule
bridge will need to be closed at different times. To make the necessary
repairs, workers will need to use barges in the waterway underneath the
bridge span to access the side spans. Bridge span closures and use of
the waterway underneath the bridge to effectuate the repairs are
scheduled to commence on October 1, 2018, and be completed by April 30,
2019.
    Hazards from bridge span closures and use of the waterway
underneath include heavy lift operations, falling equipment and
materials, and construction vessels. The Captain of the Port (COTP)
Boston has determined that potential hazards associated with the bridge
repairs would be a safety concern for anyone in or on Mystic River
waters within 150-yards of the bridge. No vessel or person will be
permitted to enter the safety zone without obtaining permission from
the COTP Boston or a designated representative. The Coast Guard will
notify the public through the Massachusetts Bay Harbor Safety Committee
meetings, Boston's Port Operators Group meetings, and Local Notice to
Mariners. Moreover, the Coast Guard would issue a Safety Marine
Information Broadcast via marine channel 16 (VHF-FM) fourteen (14) days
in advance of the commencement of the Safety Zone. If the project is
completed before April 30, 2019, enforcement of the safety zone will be
suspended and notice given to the public to the greatest extent
possible.
    The purpose of this rulemaking is to protect personnel, vessels and
the marine environment from potential hazards created during repairs on
the

S99 Alford Street Bridge, at mile 1.4 on the Mystic River between
Charlestown and Everett Massachusetts. The Coast Guard proposes this
rulemaking is under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The Coast Guard proposes to establish a safety zone starting at
12:01 a.m. on October 1, 2018, and to make it effective to 11:59 p.m.
on April 30, 2019. The safety zone would cover all navigable waters
within 150-yards of the S99 Alford Street Bridge, at mile 1.4 on the
Mystic River between Charlestown and Everett Massachusetts. The
duration of the zone is intended to ensure the safety of vessels, the
maritime public, construction workers, and these navigable waters
during the repairs on the S99 Alford Street Bridge over the main
channel of the Mystic River. No vessel or person would be permitted to
enter the safety zone without obtaining permission from the COTP Boston
or a designated representative.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. We expect the
adverse economic impact of this proposed rule to be minimal since we
will provide ample notice of the safety zone effective dates and
vessels will be able to enter safety zone when construction equipment
is not occupying the channel. Although this regulation may have some
adverse impact on the public, the potential impact will be minimal
because boating season for vessels on the Mystic River usually
concludes around mid-October and consequently the amount of traffic in
this waterway during the effective period for the safety zone is
limited.
    This safety zone is of similar dimension and a shorter duration to
the one established in 2011 (73916 FR/Vol. 77, NO. 239) for the
original rehabilitation of the bridge. The regulatory text we are
proposing appears at the end of this document.
    Notification of the emergency repairs to the Alford Street
Drawbridge and the associated safety zone will be made to mariners
through the Massachusetts Bay Harbor Safety Committee meetings,
Boston's Port Operators Group meetings, and Local Notice to Mariners.
Moreover, the Coast Guard would issue a Safety Marine Information
Broadcast via marine channel 16 (VHF-FM) fourteen (14) days in advance
of the commencement of the Safety Zone. The rule would allow vessels to
seek permission to enter the zone when the channel is not being occupy
by construction equipment.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01 and Commandant Instruction M16475.1D, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary
determination that this action is one of a category of actions that do
not individually or cumulatively have a significant effect on the human
environment. This proposed rule

involves the establishment of a temporary safety zone extending 150
yards around a bridge to complete emergency repairs to the S99 Alford
Street Bridge during a seven month period when boating traffic is
minimal on the Mystic River. Normally such actions are categorically
excluded from further review under paragraph L60(a) of Appendix A,
Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add a new Sec.  165.T01-0343 to read as follows:

Sec.  165.T01-0343   Safety Zone, S99 Alford Street Bridge--Emergency
Grid Replacement Project, Mystic River, Charlestown and Everett MA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Mystic River between Charlestown and Everett,
Massachusetts from surface to bottom, within 150-yards of the S99
Alford Street Bridge, at mile 1.4 on the Mystic River between
Charlestown and Everett, Massachusetts.
    (b) Definitions. As used in this section--
    Designated representative means any Coast Guard commissioned,
warrant, petty officer, or any federal, state, or local law enforcement
officer who has been designated by the Captain of the Port (COTP)
Boston, to act on his or her behalf. The designated representative may
be on an official patrol vessel or may be on shore and will communicate
with vessels via VHF-FM radio or loudhailer. In addition, members of
the Coast Guard Auxiliary may be present to inform vessel operators of
this regulation.
    Official patrol vessels means any Coast Guard, Coast Guard
Auxiliary, state, or local law enforcement vessels assigned or approved
by the COTP Boston to enforce this section.
    (c) Enforcement period. This section is enforceable 24 hours a day
from 12:01 a.m. on October 1, 2018, through 11:59 p.m. on April 30,
2019. When enforced as deemed necessary by the COTP Boston, vessels
will be prohibited from entering this safety zone during the emergency
grid replacement on the bridge.
    (d) Regulations. The general regulations contained in 33 CFR
165.23, as well as the following regulations, apply:
    (1) No person or vessel may enter or remain in this safety zone
without the permission of the COTP Boston or the COTP's designated
representatives. However, any person or vessel permitted to enter the
safety zone must comply with the directions and orders of the COTP
Boston or the COTP's designated representatives.
    (2) To obtain permission required by this regulation, individuals
may reach the COTP Boston or a COTP designated representative via
Channel 16 (VHF-FM) or<PHONE_NUMBER> (Sector Boston Command Center).
    (3) Penalties. Those who violate this section are subject to the
penalties set forth in 33 U.S.C. 1232.

    Dated: July 11, 2018.
Eric. J. Doucette,
Captain, U.S. Coast Guard Captain of the Port Boston.
[FR Doc. 2018-15183 Filed 7-16-18; 8:45 am]
 BILLING CODE 9110-04-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

There are a number of issues that I feel can't be solved as fast as the FDA has proposed. There are a number of questions and a lot of research that still needs to be done and communicated.  This is not a issue that will lend itself to a quick fix.  My rights are on the line and I would like you to consider all possible choices, one of these being a delay in the commenting period.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and would be glad to discuss this issue further.  Thank you.


[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45225-45226]
[FR Doc No: 2023-14905]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0559]

Postmarketing Studies and Clinical Trials: Determining Good Cause
for Noncompliance With Section 505(o)(3)(E)(ii) of the Federal Food,
Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Postmarketing Studies and Clinical Trials: Determining Good Cause for
Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug,
and Cosmetic Act.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to require certain postmarketing studies and clinical
trials for prescription drugs at the time of approval or after approval
if FDA becomes aware of new safety information. This draft guidance
describes the factors FDA considers when determining whether an
applicant has demonstrated good cause for failure to comply with the
timetable for completion of studies or clinical trials required under
the provisions. This draft guidance also provides information on
relevant procedures, including how an applicant should communicate with
FDA regarding compliance with these required studies and trials and
describes actions FDA may take for noncompliance with the requirements.

DATES: Submit either electronic or written comments on the draft
guidance by September 12, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-0559 for ``Postmarketing Studies and Clinical Trials:
Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii)
of the Federal Food, Drug, and Cosmetic Act.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5367, Silver Spring, MD 20993,<PHONE_NUMBER>, or Diane
Maloney, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Postmarketing Studies and Clinical Trials: Determining Good
Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal
Food, Drug, and Cosmetic Act.'' This draft guidance provides
information for holders of applications for human prescription drugs
that are required to conduct postmarketing studies or clinical trials
under section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3). Section
505(o), added by the Food and Drug Administration Amendments Act of
2007 (FDAAA), authorizes FDA to require certain postmarketing studies
for prescription drugs at the time of approval or after approval if FDA
becomes aware of new safety information. These postmarketing studies
and clinical trials are also referred to as postmarketing requirements
(PMRs) or FDAAA PMRs.
    An applicant required to conduct a PMR must provide certain
information to FDA, including a timetable for study or clinical trial
completion and periodic reports on the status of the study or clinical
trial. If an applicant fails to comply with the timetable or fails to
submit periodic status reports, FDA considers the applicant to be in
violation of section 505(o)(3) of the FD&C Act, unless the applicant
has demonstrated good cause for its PMR noncompliance. Under section
505(o)(3)(E)(ii) of the FD&C Act, FDA is responsible for determining
what constitutes good cause for PMR noncompliance. Violations of
requirements under this section are subject to enforcement action,
including pursuant to sections 505(o)(1) (charges under section 505 of
the FD&C Act), 502(z) (21 U.S.C. 332(z)) (misbranding charges), and
303(f)(4)(A) (21 U.S.C. 333(f)(4)(A)) (civil monetary penalties).
    This draft guidance describes the factors FDA considers when
determining whether an applicant has demonstrated good cause for its
noncompliance with the timetable for PMR completion. This draft
guidance also provides information on relevant procedures including how
to communicate with FDA regarding PMR compliance, submission of an
explanation of the circumstances that led to noncompliance, and how FDA
notifies an applicant of a determination of noncompliance, and
describes the enforcement actions FDA can take for PMR noncompliance.
Although this draft guidance primarily addresses noncompliance with the
timetable for completion of PMR milestones, any violation of a
requirement under section 505(o)(3)(E)(ii) of the FD&C Act is subject
to enforcement action, in the absence of a demonstration of good cause.
    Section 505(o) of the FD&C Act applies only to prescription drugs
approved under section 505(b) of the FD&C Act and biological drug
products approved under section 351 of the Public Health Service
Act.\1\ This draft guidance does not apply to nonprescription drugs,
including nonprescription drugs that are approved under a new drug
application, or to generic drugs approved under section 505(j) of the
FD&C Act.
---------------------------------------------------------------------------

    \1\ See section 505(o)(2)(B) of the FD&C Act.
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    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 current thinking of FDA on
``Postmarketing Studies and Clinical Trials: Determining Good Cause for
Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug,
and Cosmetic Act.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314, including the submission of status
reports of postmarketing study commitments under Sec.
314.81(b)(2)(vii), have been approved under OMB control number 0910-
0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14905 Filed 7-13-23; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES DATE: May 27th, 2003 SUBJECT: Pentachloronitrobenzene ( PCNB). ( List A, Case No. 0128) The Outcome of the HED Metabolism Assessment Review Committee Held on April 16th, 2003 to discuss residues of concern in risk assessment and tolerance expression of Pentachloronitrobenzene ( PCNB). Chemical 056502.

FROM: Mohsen Sahafeyan, Chemist, Reregistration Branch 2 Laurence Chitlik, Toxicologist, Toxicology Branch Health Effects Division ( 7509C)

THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division ( 7509C) and Christine Olinger, Chair of HED MARC Reregistration Branch I Health Effects Division ( 7509C)

TO: Yan W. Donovan, Chemist, RAB1/ HED ( 7509C) MARC Executive Secretary cc: Diana Locke, HED/ RRB2 Individuals in Attendance Members attended: Christine Olinger, Alberto Protzel, Richard Loranger, Leung Cheng, William Wassell, John Doherty, Leonard Keifer, P. V. Shah, Norman Birchfield.

Members in Absentia: Yan Donovan, Sheila Piper Non Members: Cheryl Sutton, Diana Locke, Mohsen Sahafeyan, Elizabeth Doyle, David Soderberg, Laurence Chitlik ( conference call), George Kramer Page  2 Material Reviewed The Metabolism Assessment Review Committee ( MARC) met on April 16th, 2003 to determine the residues of concern and the tolerance expression for plants and livestock, as well as degradates of concern in water. The MARC reviewed the major and minor metabolites of pentachloronitrobenzene ( PCNB) identified in three plant metabolism studies ( peanuts, potatoes, and cabbage), livestock ( ruminant and poultry) metabolism study, rotational crop studies ( lettuce, turnip roots and tops, and wheat), available field trial data, and information on environmental persistence and degradation of PCNB. The MARC also reviewed the available rat metabolism studies.

Plants and Rotational Crops : For the primary crops, plant metabolism studies on peanuts, potato, and cabbage [ study deemed unacceptable] indicated that the major identified radioactive residues ( i. e.

10% total radioactive residue or TRR) were PCNB, S ( pentachlorophenyl) malonycysteine ( PCP MalCys), N malonyl S( tetrachloroaminophenyl) cysteine, tetrachlorophenyl methyl sulfoxide ( TCPM sulfoxide), and tetrachlorophenyl methyl sulfone ( TCPM sulfone). Other residues comprising

10% of the TRR were not identified or characterized in the cabbage study. However, for peanut five metabolites and for potato thirty six metabolite residues were identified. As all of the identified plant metabolites of PCNB in primary crops are poly chlorinated phenyl compounds, all of these compounds ( including minor metabolites) are of concern.

For rotational crops, numerous metabolites were identified in just about all crop parts studied in the confined rotational crop study. The crop parts studied included: turnip root and tops from 365 days after soil treatment ( DAT), lettuce ( 30, 120, and 365 DAT), wheat forage ( 30 and 120 DAT), wheat grain ( 30, 120, and 365 DAT), and wheat straw ( 120 DAT). As all of the identified metabolites in rotational crops are poly chlorinated phenyl compounds, all of these compounds ( including minor metabolites) are of concern.

The residues of concern for tolerance setting purposes in primary and rotational crops are PCNB, pentachloraniline ( PCA), and pentachlorothioisole ( PCTA) as all of these compounds are recoverable by the multiresidue methods of PAM I. The residues of concern for risk assessment for primary and rotational crops are PCNB and all identified metabolites ( including minor metabolites). The MARC further recommends that the review team determine the ratio of total identified residues to parent plus PCA and PCTA and apply this factor to the residue data to estimate the levels for risk assessment. The team should determine whether there are adequate metabolism and/ or confined rotational crop data to determine such ratio. If adequate data are not available for this task, then the review team may need to request additional metabolism data. This may be the case for cabbage like crops since the cabbage metabolism study did not adequately identify the metabolites. A rotational crop study of turnip root after 365 days ( the only time interval studied) also may not be the primary substitute for metabolites that were not identified in cabbage study since the elapsed time between application and planting ( 365 days) is Page  3 too long. As an alternative, the Total Radioactive Residue from cabbage metabolism study ( 18 ppm) can be used as the total concentration of residues of concern in cabbage like crops taking into account the similarity of use pattern. This method would not underestimate the residues.

Livestock  ruminants and poultry: Studies concerning the metabolism of PCNB in lactating goats and poultry were submitted. The major identified metabolites in ruminant tissues included PCA, pentachlorothiophenol ( PCTP), tetrachlorothioanisole ( TCTA), N( pentachloroaniline) glucuronide ( PCA Gluc), and glucuronide of N hydroxypentachloroaniline ( NOHPCA Gluc). The major identified metabolites in poultry tissues included PCNB, PCA, pentachlorothiophenol ( PCTA), pentachlorothioanisole sulfoxide ( PCTA sulfoxide), TCA sulfoxide, tetrachlorophenyl methyl sulfone ( TCP methyl sulfone) and tetrachloroaniline methyl sulfoxide ( TCA sulfoxide isomers). As all of the identified metabolites are poly chlorinated phenyl compounds, all of these compounds ( including minor metabolites) are of concern.

The residues of concern for tolerance setting purposes in livestock are PCNB, PCA, and PCTA. The residues of concern for risk assessment for livestock are PCNB and all identified metabolites. The MARC further recommends that the review team determine the ratio of total identified residues to parent plus PCA and PCTA. The team should determine whether there are adequate metabolism data to determine such ratio. If adequate data are not available for this task, then the review team may need to request additional metabolism data.

Water: Environmental fate data suggest that PCNB is persistent and slightly mobile to immobile in most soils. The major degradates identified in the fate studies are PCA, PCTA, and pentachlorobenzene ( PCB), but only PCA was present at > 10% of the applied radioactivity. Pentachlorophenyl ( PCP) was identified under anaerobic conditions in one of the studies. PCP is a B2 carcinogen ( Q1 * = 0.12 ( mg/ kg/ day) 1 The residues of concern in drinking water are PCNB, PCA, and PCP as PCA was the only identified metabolite which comprised > 10% of the applied radioactivity and PCP is of known toxicity. If the review team are unable to model for PCP then the team should characterize the available data for PCP and determine the level at which it is of concern for cancer.

Summary of MARC Decision As all the metabolites of PCNB are poly chlorinated phenyl compounds and thus of toxicological concern, the MARC decision was that PCNB and all its metabolites ( including minor metabolites) are of concern in plants and animal commodities. Because of lack of monitoring data as well as field trial data on every metabolite of PCNB in plants and animals, MARC members suggested using metabolism studies in plants and animals to derive a ratio of all residues of concern to those residues in tolerance expression ( PCNB, PCA, PCTA) which are recovered by a multi residue method and using that ratio to estimate the concentration of residues of concern from field trial or monitoring data. The following Table summarizes the MARC decisions for residues of concern and tolerance expression of PCNB. Page  4 Chemical: PCNB ( pentachloronitrobenzene)

Date: 16 April 2003 Residues of Concern Matrix For Risk Assessment For Tolerance Expression Plants  Primary crops Parent plus all identified metabolites Parent, PCA, PCTA Plants  Rotational crops Parent plus all identified metabolites Parent, PCA, PCTA Livestock  Ruminant Parent plus all identified metabolites Parent, PCA, PCTA Livestock Poultry Parent plus all identified metabolites Parent, PCA, PCTA Water Parent, PCA, and PCP N/ A PCA = pentachloraniline. PCTA = pentachlorothioisole or methyl pentachlorophenyl sulfide. PCP = pentachlorophenol cc: SF, RF, List A File, Mohsen Sahafeyan, D. Locke ( RRB2) RDI: C. Olinger: 5/ 27/ 03; A. Nielsen 5/ 27/ 03 7509C: RRB2: CM 2: Room 712D: 305 6872: PCNB


1 MEMORANDUM DATE: January 8, 2004 SUBJECT: Engine Operation at Colorado State University ( CSU)

FROM: Tanya Ali Alpha Gamma Technologies, Inc.

TO: Sims Roy, EPA OAQPS ESD Combustion Group The purpose of this memorandum is to demonstrate that the 2 stroke lean burn ( 2SLB) engine and 4 stroke lean burn ( 4SLB) engine operating conditions during EPA's testing at Colorado State University ( CSU) are representative of 2SLB and 4SLB engine operating conditions in the field.

Background On December 19, 2002, EPA proposed national emission standards for hazardous air pollutants ( NESHAP) for stationary reciprocating internal combustion engines ( RICE) ( 67 FR 77830). During the public comment period, EPA received comments stating that the data from the testing of the 2SLB and 4SLB engines at CSU should be disallowed. Comments received indicated that certain parameters such as the oxygen levels, exhaust temperatures, and nitrogen oxides ( NOx) levels are not typical and that the 2SLB and 4SLB engines tested at CSU are not representative of engines in industry. A more complete summary of the comments EPA received on this issue can be found in the memorandum entitled " Response to Public Comments on Proposed Stationary Reciprocating Internal Combustion Engines NESHAP," available from EPA's docket ( Docket ID Nos. OAR 2002 0059 or A 95 35). In order to develop a response to these comments, EPA reviewed the Emissions Database to compare the oxygen levels, exhaust temperatures, and NOx levels from the 2SLB and 4SLB engines tested at CSU to other 2SLB and 4SLB test results in the Emissions Database.

Review of Emissions Database In order to respond to comments that certain engine operating parameters for the 2SLB and 4SLB engines tested at CSU were not typical of engines operating in the field, EPA reviewed the Emissions Database and compared the oxygen levels, exhaust 2 temperatures, and NOx levels observed at CSU to these parameters for other engines, tested elsewhere. The results of this review and comparison are described in the following sections.

Oxygen Levels The EPA received comments that the range of oxygen levels observed at CSU were not typical of 2SLB and 4SLB engines. The EPA examined the Emissions Database which contains oxygen levels for engines tested at other locations besides CSU.

For 2SLB engines, the average oxygen level for non CSU tests was 14.4 percent. The minimum and maximum oxygen levels for non CSU tests were 7 and 19 percent, respectively. The average oxygen level for the 2SLB engine tested at CSU was 15 percent. The minimum and maximum oxygen levels for the 2SLB engine tested at CSU were about 14 and 16 percent, respectively. As these numbers indicate, the oxygen levels observed at CSU for the 2SLB engine are not beyond the range of oxygen levels observed for other 2SLB engines. The EPA, therefore, disagrees with the commenter that the oxygen levels observed at CSU at not typical of other 2SLB engines.

For 4SLB engines, the EPA also disagrees with the commenter. The average oxygen level for the 4SLB engines in the Emissions Database that were not tested at CSU was 10.2 percent. The minimum and maximum oxygen levels for these engines were 4.5 and 17 percent, respectively. The average oxygen level for the 4SLB engine tested at CSU was 9.9 percent. The minimum and maximum oxygen levels for the 4SLB engine tested at CSU were about 9 and 10.5, respectively. As before, these numbers indicate that the oxygen levels observed at CSU for the 4SLB engine are within the range of oxygen levels observed for other 4SLB engines. The EPA, therefore, believes that the oxygen levels for the 4SLB engine tested at CSU are typical of other 4SLB engines.

Exhaust Temperatures The EPA also received comments that the exhaust temperatures for the 2SLB and 4SLB engines tested at CSU were not typical of other 2SLB and 4SLB engines. The EPA reviewed the Emissions Database and compared exhaust temperatures of other 2SLB and 4SLB engines not tested at CSU to the exhaust temperatures observed at CSU.

For 2SLB engines, the average exhaust temperature for engines not tested at CSU was 623

F. The exhaust temperatures for these engines ranged from 455

F to 1,092

F. In comparison, for the 2SLB engine tested at CSU, the average exhaust temperature was 535

F, with a minimum temperature of 450

F and a maximum temperature of 595

F. The exhaust temperatures observed at CSU for the 2SLB engine tested are not significantly different than the exhaust temperatures measured for 2SLB engines tested 3 elsewhere. For this reason, EPA disagrees with the commenter that the exhaust temperatures measured at CSU for the 2SLB engine tested are not typical of other 2SLB engines.

For 4SLB engines, the average exhaust temperature for engines not tested at CSU was 839

F. The minimum and maximum exhaust temperatures for these engines were 592

F and 1,190

F, respectively. In comparison, the average exhaust temperature for the 4SLB engine tested at CSU was 723

F. For this engine, the minimum and maximum exhaust temperatures were 663

F and 767

F, respectively. The range of exhaust temperatures observed at CSU for the 4SLB engine is within the range of exhaust temperatures for other 4SLB engines. The EPA, therefore, disagrees with the commenter that the exhaust temperatures for the 4SLB engines tested at CSU are not typical of other 4SLB engines.

NOx Levels Comments received stated that the NOx levels measured at CSU for the 2SLB and 4SLB engines tested were extremely low. One commenter stated that the range of engine operating conditions in the testing of the 2SLB engine and quite probably the 4SLB engine is far leaner than the leanest engine in the pipeline RICE fleet. The commenter stated that this is indicated by the extremely low NOx emissions. In response to this comment, EPA looked at the NOx levels for the 2SLB and 4SLB engines tested at CSU and compared the NOx levels to the NOx levels of other 2SLB and 4SLB engines in the Emissions Database.

For 2SLB engines, EPA compared the NOx levels of 2SLB engines with NOx control. The EPA could not make a comparison of NOx levels for 2SLB engines without NOx control since the 2SLB engine at CSU was equipped with a pre combustion chamber  a technology that alters the combustion process to reduce NOx. The average NOx level for the 2SLB engine tested at CSU was 101 parts per million ( ppm). The NOx levels for this engine ranged from 8 to 314 ppm. In comparison, the average NOx level from other 2SLB engines in the Emissions Database with NOx controls was 106 ppm. The NOx levels ranged from 19 to 288 ppm. As the numbers show, the NOx levels at CSU were not beyond the range of NOx levels observed for other engines in the field and the average NOx level at CSU was very close to the average NOx level for other 2SLB engines. The EPA, therefore, disagrees with the commenter and believes that the NOx levels measured at CSU for the 2SLB engine are not extremely low compared to other 2SLB engines tested elsewhere and does not believe the 2SLB engine tested at CSU is particularly leaner than other 2SLB engines in the pipeline RICE fleet.

For 4SLB engines, EPA again compared the NOx levels of 4SLB engines with NOx control. The average NOx level for the 4SLB engine tested at CSU was 62 ppm. The range of NOx levels observed at CSU for the 4SLB engine was 37 to 106 ppm. In 4 comparison, the average NOx level from other 4SLB engines in the Emissions Database was 83 ppm. The NOx levels ranged from 31 to 372 ppm. The NOx levels observed at CSU for the 4SLB engine tested are not beyond the range of NOx levels measured at other facilities with 4SLB engines. In fact, the numbers show that the NOx levels seen at CSU for the 4SLB engine are within the range of NOx levels for other engines operating in the field. The EPA, therefore, disagrees with the commenter and believes the test results from the 4SLB engine tested at CSU are representative and the NOx levels do not indicate that the engine was significantly leaner than other 4SLB engines in the field.

Conclusion Based on the analysis EPA performed, which consisted of analyzing the Emissions Database to compare engine operating parameters of the 2SLB and 4SLB engines tested at CSU and the engine operating parameters of other 2SLB and 4SLB engines that are in the Emissions Database, EPA believes the engine operating parameters at CSU were appropriate. The analysis presented in this memorandum shows that the oxygen levels, exhaust temperatures, and NOx levels measured at CSU for the 2SLB and 4SLB engines tested are within the levels measured for other 2SLB and 4SLB engines tested elsewhere. The test results obtained at CSU for the 2SLB and 4SLB engine are therefore representative and should not be excluded EPA's emission standards analysis.


[Federal Register Volume 79, Number 55 (Friday, March 21, 2014)]
[Notices]
[Pages 15799-15800]
[FR Doc No: 2014-06215]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2014-0018]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on an extension of a currently
approved collection.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes one collection of information for which
NHTSA intends to seek OMB approval.

DATES: Comments must be received on or before May 20, 2014.

ADDRESSES: Comments must refer to the docket notice numbers cited at
the beginning of this notice and be submitted to Docket Management,
Room W12-140, Ground Level, 1200 New Jersey Avenue SE., Washington, DC
20590 by any of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Agency Web site: http://dms.dot.gov. Follow the
instructions for submitting comments on the Docket Management System.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590.
     Hand Delivery/Courier: 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal Holidays.
Telephone: 1-800-647-5527.
    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://dms.dot.gov including any personal information provided.
    Docket: For access to the docket to read background documents or
comments received, go to http://dms.dot.gov at any time or to Room W12-
140 on the ground level of the DOT Building, 1200 New Jersey Avenue
SE., West Building, Ground Floor, Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Carlita
Ballard, NHTSA 1200 New Jersey Avenue SE., Room W43-439, NVS-131,
Washington, DC 20590. Ms. Ballard's telephone number is<PHONE_NUMBER>.
Please identify the relevant collection of information by referring to
its OMB Control Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information.
    The OMB has promulgated regulations describing what must be
included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;

    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected and;
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Title: Petitions for Exemption From the Vehicle Theft Prevention
Standard (49 CFR Part 543).
    OMB Control Number: 2127-0542.
    Form Number: None.
    Affected Public: Motor vehicle manufacturers.
    Requested Expiration Date of Approval: Three years from approval
date.
    Abstract: Manufacturers of passenger vehicle lines may petition the
agency for an exemption from Part 541 requirements, if the line is
equipped with an anti-theft device as standard equipment and meets
agency criteria. Device must be as effective as parts-marking.
    Estimated Annual Burden: 1,826.
    Number of Respondents: 11.
    49 U.S.C. Chapter 331 requires the Secretary of Transportation to
promulgate a theft prevention standard to provide for the
identification of certain motor vehicles and their major replacement
parts to impede motor vehicle theft. 49 U.S.C. Section 33106 provides
for an exemption to this identification process by petitions from
manufacturers who equip covered vehicles with standard original
equipment antitheft devices, which the Secretary determines are likely
to be as effective in reducing or deterring theft as parts-marking.
NHTSA may exempt a vehicle line from the parts marking requirement, if
the manufacturer installs an antitheft device as standard equipment on
the entire vehicle line for which it seeks an exemption and NHTSA
determines that the antitheft device is likely to be as effective in
reducing and deterring motor vehicle theft as compliance with the
parts-marking requirements. In accordance with 49 U.S.C. 33106, after
model year (MY) 2000, the number of new exemptions is contingent on a
finding by the Attorney General as part of its long-range review of
effectiveness. After consulting with DOJ, the agency decided it could
continue granting one exemption per model year pending the results of
the long-term review.
    In a final rule published on April 6, 2004, the Federal Motor
Vehicle Theft Prevention Standard was extended to include all passenger
cars and multipurpose passenger vehicles with a gross vehicle rating of
6,000 pounds or less, and to light duty trucks with major parts that
are interchangeable with a majority of the covered major parts of
multipurpose passenger vehicles. Consistent with this DOJ consultation,
the April 6, 2004 final rule amended the general requirements of
Section 543.5 of Chapter 49 of the Code of Federal Regulations,
allowing a manufacturer to petition NHTSA to grant an exemption for one
additional line of its passenger motor vehicles from the requirements
of the theft prevention standard for each model year after MY 1996. The
final rule became effective September 1, 2006.
    Prior to September 1, 2006, manufacturers were only allowed to
petition NHTSA for high-theft vehicles lines. In its April 6, 2004
final rule, the agency amended part 543 to allow vehicle manufacturers
to file petitions to exempt all vehicle lines that would become subject
to parts-marking requirements beginning with the effective date of the
final rule. As a result of this amendment, vehicle manufacturers are
allowed to file petitions to exempt all vehicles lines that would
become subject to the parts-marking requirements regardless of their
theft status (high or low). While there are approximately 21 vehicle
manufacturers, 33 petitions for exemption from the parts-marking
requirements have been received by the agency for MYs 2013-2015,
averaging approximately 11 responses per year. We anticipate this to
remain the average number of yearly responses received by the agency.
    NHTSA estimates that the average hours per submittal will be 166,
for a total annual burden of 1,826. NHTSA estimates that the cost
associated with the burden hours is a $39.49 per hour, for a total cost
of approximately $72,109.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

Lori K. Summers,
Director, Office of Crashworthiness Standards.
[FR Doc. 2014-06215 Filed 3-20-14; 8:45 am]
BILLING CODE 4910-59-P