[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Page 80958]
[FR Doc No: 2011-33034]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4047-DR; Docket ID FEMA-2011-0001]

New Mexico; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New Mexico (FEMA-4047-DR), dated November 23, 2011,
and related determinations.

DATES: Effective Date: December 16, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New Mexico is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of November 23, 2011.

    Los Alamos County and the Pueblo of Cochiti for Public
Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-33034 Filed 12-23-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]
[Page 41399-41401]
[DOCID:fr18jy08-133]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Meeting Future Hazardous Materials
Transportation Safety Challenges

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of public workshop--``Transporting Hazardous Materials
Safely--the Next 100 Years.''

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SUMMARY: PHMSA is hosting a public workshop to identify and discuss
strategies for meeting emerging hazardous materials transportation
safety challenges, particularly in the development of innovative safety
solutions that provide the Department of Transportation, other federal
agencies, state agencies, the regulated community, and emergency
response organizations with flexible tools to manage and reduce safety
risks. The workshop will provide an opportunity for PHMSA and its
stakeholders to discuss the future direction of the hazardous materials
transportation safety program, with a focus on three broad themes: (1)
Safety, Risk Reduction, and Integrity

Management; (2) 21st Century Solutions: Using New Technology for
Improved Safety Controls/Improving Safety Controls for New Technology;
and (3) Achieving Balance and Effectiveness--Consistency and
Uniformity.

DATES: July 31, 2008, starting at 8:30 a.m.

ADDRESSES: The workshop will be held at the U.S. Department of Housing
and Urban Development Conference Facility, 451 7th Street, SW.,
Washington, DC 20410. For information on the facilities or to request
special accommodations at the workshop, please contact Ms. Maria Howard
by telephone or e-mail as soon as possible.

FOR FURTHER INFORMATION CONTACT: Ms. Maria Howard,<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>or LaToya Moore,<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>Office of Hazardous Materials Safety, Pipeline
and Hazardous Materials Safety Administration.

SUPPLEMENTARY INFORMATION: The U.S. Department of Transportation (DOT),
through PHMSA and other DOT operating administrations, is responsible
for a comprehensive, nationwide program designed to protect the Nation
from the risks to life, health, property, and the environment inherent
in the commercial transportation of hazardous materials. This year
marks the 100th anniversary of the hazardous materials transportation
safety program, which originated with enactment of the Transportation
of Explosives and Other Dangerous Articles Act (specifically, ``An Act
to promote the safe transportation in interstate commerce of explosives
and other dangerous articles'') on May 30, 1908. The Act charged the
Interstate Commerce Commission (ICC) with formulating binding
regulations ``in accord with the best known practicable means for
securing safety in transit, covering the packing, marking, loading,
handling while in transit, and the precautions necessary to determine
whether the material when offered is in proper condition to
transport.'' The Act specifically required the marking of every package
containing explosives ``or other dangerous articles'' and prohibited
false or deceptive markings, descriptions, or declarations.
    Since 1908, the federal program to minimize the risks associated
with the commercial transportation of hazardous materials has evolved
from its initial focus on the regulation of explosives to a broad and
comprehensive safety and security program applicable to a wide variety
of materials and articles shipped by multiple modes of transport across
interstate and international boundaries and overseen by an array of
federal and state agencies. Hazardous materials are essential to the
economy of the United States and the well-being of its people.
Hazardous materials fuel automobiles, and heat and cool homes and
offices, and are used for farming and medical applications and in
manufacturing, mining, and other industrial processes. More than 3
billion tons of regulated hazardous materials--including explosive,
poisonous, corrosive, flammable, and radioactive materials--are
transported in this country each year. Over 800,000 shipments of
hazardous materials move daily by plane, train, truck, or vessel in
quantities ranging from several ounces to many thousands of gallons.
These shipments frequently move through densely populated or sensitive
areas where the consequences of an incident could be loss of life or
serious environmental damage. Our communities, the public, and workers
engaged in hazardous materials commerce count on the safety and
security of these shipments.
    The system of controls and standards developed over the last 100
years has achieved considerable success in reducing the risks posed by
the commercial transportation of hazardous materials. As we look to the
future, we want to build on this success, particularly in the
development of innovative safety solutions that provide the agency, our
federal and state partners, the regulated community, and emergency
response officials with flexible tools to manage and reduce safety
risks.
    To this end, PHMSA is hosting a public workshop on July 31, 2008.
We are planning an interactive workshop that will engage our
stakeholders on a range of topics that we consider critical to the
future direction of the hazardous materials transportation safety
program. This workshop will provide an opportunity for our stakeholders
to suggest ways to improve on our vision and ideas for making the
vision a reality. Equally important, the workshop will provide a forum
for our stakeholders to identify common issues and problems and suggest
synergistic strategies for addressing them. We hope that the workshop
will surface a range of views on how to meet the challenges ahead,
focusing on three broad areas:

1. Safety, Risk Reduction, and Integrity Management

    With safety as our top priority, the hazardous materials
transportation safety program targets continued reduction in
transportation risk, even as the size and complexity of the system
grow. The program is challenged to quickly identify emerging risks and
develop innovative, flexible, and effective safety controls to address
those risks. For example, we are considering whether integrity
management principles could be effectively applied to hazardous
materials transportation activities to enhance safety. Integrity
management is a risk reduction program that promotes continuous
improvement in safety performance by requiring companies to collect and
use information to guide system-specific planning and implementation of
risk controls. PHMSA has successfully implemented integrity management
requirements under its Pipeline Safety program, achieving improved
safety performance without undue regulatory burden. Quality assurance
programs may also be an effective way to identify and address system-
wide safety risks.

2. 21st Century Solutions: New Technology for Improved Safety Controls/
Improving Safety Controls for New Technology

    A second set of challenges for the hazardous materials
transportation safety program reflects the opportunities and risks
posed by rapid technological advances. The safety controls developed
over the program's first 100 years need to keep pace with the demands
of our fast-moving, far-reaching economy and transportation systems. As
we embark on the program's second century, we are committed to
improving the quality, reliability, and timeliness of information
guiding all parts of the safety control system, including hazard
communication. Because of their capabilities to improve the speed,
accuracy, and efficiency of communications, wireless and electronic
data systems and tools are rapidly replacing paper-based systems for
documenting transactions, tracing shipments, and exchanging commercial
information. As the private sector and government agencies transition
to paperless systems, adherence to longstanding paper-based
requirements for hazardous materials transportation places an
increasing burden on the system, contributing to freight delays and
congestion. At the same time, reliance on paper-based communications
may limit the effectiveness of hazard communication and impair or delay
response to hazmat incidents and emergencies. Deploying new
communication technologies holds the promise of improving safety, even
as it reduces regulatory burdens and

improves the performance of the transportation system.
    A related challenge is to find ways to quickly develop and
implement appropriate safety controls for new materials or technologies
that are not covered by current regulatory requirements. Transportation
is key to promoting the development and widespread utilization of new
technologies. Government and industry must be able to address possible
safety risks associated with new materials or technologies without
undue delays in authorizing their transportation. One strategy may be
for a company to invest in independent, third-party analyses of safety
risks associated with a new material or technology that would then form
the basis for development of rigorous transportation controls that
would be approved by PHMSA pending promulgation of more general
regulatory requirements.

C. Achieving Balance and Effectiveness--Consistency and Uniformity

    A third challenge for the hazardous materials transportation safety
program is to identify integrated strategies for advancing safety that
involve the many regulatory agencies and non-federal jurisdictions with
hazardous materials oversight responsibilities. A number of federal
agencies, including the Environmental Protection Agency, the
Occupational Safety and Health Administration, the Bureau of Alcohol,
Tobacco, Firearms, and Explosives, and the Department of Homeland
Security, have regulatory authority over facilities that manufacture,
handle, and store hazardous materials outside of transportation. In
addition, state and local governments may elect to regulate facilities
that manufacture or store hazardous materials within their
jurisdictions. Because these agencies and authorities have different
interests and goals, regulated entities are sometimes confronted with a
myriad of differing and, perhaps, inconsistent requirements that impair
productivity and efficiency and could adversely affect safety. At the
same time, critical safety issues may not be addressed at all. A broad
strategy to more closely integrate all of these programs would enhance
system wide risk reduction through information and data sharing, early
identification of safety problems, and leveraging of resources.
    PHMSA invites all interested persons, including state and local
officials, emergency response personnel, and hazardous materials
shippers and carriers, to participate in this workshop. We would like
to use this forum to promote a dialogue among all interested
stakeholders to help us identify the most appropriate strategies for
identifying and addressing emerging transportation safety challenges.
If you wish to participate in the public workshop, you must provide
your name and organization to Ms. Maria Howard by telephone (202-366-
0225) or e-mail<EMAIL_ADDRESS>or Latoya Moore by telephone
(202-366-0656) or e-mail<EMAIL_ADDRESS>no later than July 24,
2008. Non-federal personnel must also provide the last five digits of
their social security numbers. Providing this information will
facilitate the security screening process for entry into the building
on the day of the workshop. Participants should plan to arrive at 8
a.m. and must present a picture ID to enter the building. Participants
do not need to prepare oral comments, but rather, be prepared to take
part in an open discussion on the issues outlined above.

    Issued in Washington, DC on July 15, 2008.
Theodore L. Willke,
Associate Administrator for Hazardous Materials Safety.
 [FR Doc. E8-16503 Filed 7-17-08; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19036-19037]
[FR Doc No: 2017-08266]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2307-078]

Alaska Electric Light & Power Company; Notice of Application
Ready for Environmental Analysis and Soliciting Comments,
Recommendations, Terms and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New license.
    b. Project No.: 2307-078.
    c. Date filed: August 31, 2016.
    d. Applicant: Alaska Electric Power & Light Company.
    e. Name of Project: Salmon and Annex Creek Hydroelectric Project.
    f. Location: On Salmon Creek and Annex Creek in the City and
Borough of Juneau, Alaska. The project occupies approximately 648.45
acres of federal lands located in the Tongass National Forest
administered by the US Forest Service and operates under an existing
license issued in 1988.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Ms. Christy Yearous, Project Manager, Alaska
Electric light & Power Company, 5601 Tonsgard Ct., Juneau, AK 99801-
7201; email<EMAIL_ADDRESS>    i. FERC Contact: Suzanne Novak at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice. The Commission strongly encourages electronic filing. Please
file comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-2307-078. The Commission's Rules of Practice require
all intervenors filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. This application has been accepted and is ready for
environmental analysis.
    l. The existing Salmon Creek Project consists of two developments:
The Salmon Creek Development and the Annex Creek Development. The
Salmon Creek Development consists of the following existing facilities:
(1) The 165-acre Salmon Creek Reservoir impounded by a 648-foot-long,
186-foot-high dam, with ten 5-foot-wide spillway bays; (2) a 1,500-
foot-long canal used to periodically divert water from tributary
streams into Salmon Creek Reservoir; (3) a 10-foot-wide, 11-foot high
intake structure with trashracks; (4) a 3-foot-diameter conduit that
conveys flows from the dam to the project valvehouse located
immediately downstream; (5) a 4,290-foot-long, 3.3- to -2-foot-diameter
penstock that conveys flows from the valvehouse to the decommissioned
Upper Powerhouse where it connects to an 11,303-foot-long, 3.5-foot-
diameter penstock that narrows to a 2.5-foot-diameter immediately
before entering the Lower Powerhouse; (6) the 57-foot-long, 44-foot-
wide, 32-foot-high Lower Powerhouse, which contains a 6.9-megawatt (MW)
impulse turbine; (7) an approximately 250-foot-long tailrace that flows
underneath Egan Drive and empties into a pond adjacent to the Douglas
Island Pink and Chum, Inc. hatchery; and (8) appurtenant facilities.
The Annex Creek Development consists of the following existing
facilities: (1) the 264-acre Upper Annex Lake, impounded by a 118-foot-
long, 20-foot-high dam with a 57-foot-wide spillway that discharges
flow in excess of those needed for generation into the 27-acre natural
Lower Annex Lake via a 0.15-mile-long outlet stream; (2) a 61-foot-
long, 6-foot-high timber saddle dam located just west of the main dam;
(3) a lake tap intake on Upper Annex Lake; (4) a 1,433-foot-long power
tunnel that narrows from 8 feet wide and 8 feet high at the intake to a
6.5-diameter tunnel at the project valvehouse; (5) the project
valvehouse containing the penstock intake; (6) the 7,097-foot-long,
3.5-foot-diameter penstock that narrows to a 2.8-foot-diameter before
it bifurcates at the powerhouse to provide flows to two impulse turbine
units with a total installed capacity of 3.675 MW; (7) the 67-foot-
long, 48-foot-wide, 40-foot-high powerhouse; (8) a tailrace that
discharges flows over a weir into Taku Inlet; (9) a 12.5-mile-long, 23-
kilovolt (kV) transmission line that conveys power to the Than
substation; and (10) appurtenant facilities. The project currently
operates to provide base load generation with an estimated annual
output of 53.8 gigawatt-hours. No changes to project operation or
facilities are proposed.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above. All filings must (1) bear
in all capital letters the title ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or ``PRESCRIPTIONS;''
(2) set forth in the heading the name of the applicant and the project
number of the application to which the filing responds; (3) furnish the
name, address, and telephone number of the person submitting the
filing; and (4) otherwise comply with the requirements of 18 CFR
385.2001 through 385.2005. All comments, recommendations, terms, and
conditions or prescriptions must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. Each
filing must be accompanied by proof of service on all persons listed on
the service list prepared by the Commission in this proceeding, in
accordance with 18 CFR 4.34(b), and 385.2010. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, contact FERC Online Support.
    n. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.
    o. Public notice of the filing of the initial development
application, which has already been given, established the

due date for filing competing applications or notices of intent. Under
the Commission's regulations, any competing development application
must be filed in response to and in compliance with public notice of
the initial development application. No competing applications or
notices of intent may be filed in response to this notice.

    Dated: April 18, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-08266 Filed 4-24-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 24 (Monday, February 8, 2021)]
[Notices]
[Pages 8631-8633]
[FR Doc No: 2021-02517]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ- OAR-2019-0588; FRL-10016-40-OAR]

Alternative Method for Calculating Off-Cycle Credits Under the
Light-Duty Vehicle Greenhouse Gas Emissions Program: Applications From
Nissan North America, Inc.

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is requesting comment on applications from Nissan North
America, Inc., (Nissan) for off-cycle carbon dioxide (CO2)
credits under

EPA's light-duty vehicle greenhouse gas emissions standards. ``Off-
cycle'' emission reductions can be achieved by employing technologies
that result in real-world benefits, but where that benefit is not
adequately or entirely captured on the test procedures used by
manufacturers to demonstrate compliance with emission standards. EPA's
light-duty vehicle greenhouse gas program acknowledges these benefits
by giving automobile manufacturers several options for generating
``off-cycle'' carbon dioxide (CO2) credits. Under the
regulations, a manufacturer may apply for CO2 credits for
technologies that result in off-cycle benefits. In these cases, a
manufacturer must provide EPA with a proposed methodology for
determining the real-world off-cycle benefit. Nissan has submitted
applications that describe methodologies for determining off-cycle
credits from low-power-consumption compressor clutch technology. The
application for compressor clutch technology includes test data to
establish the 0.3 grams CO2/mile credit value compared to the industry
standard clutch with similar performance characteristics (circa 2012).
Nissan's application is limited to 2017 and later model year vehicles.
Pursuant to applicable regulations, EPA is making descriptions of the
manufacturers' off-cycle credit calculation methodologies available for
public comment.

DATES: Comments must be received on or before March 10, 2021.

ADDRESSES: Submit your comments referencing Docket ID No. EPA-HQ- OAR-
2019-0588, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: David Wright, Environmental Protection
Specialist, Office of Transportation and Air Quality, Compliance
Division, U.S. Environmental Protection Agency, 2000 Traverwood Drive,
Ann Arbor, MI 48105. Telephone:<PHONE_NUMBER>. Fax:<PHONE_NUMBER>.
Email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    EPA's light-duty vehicle greenhouse gas (GHG) program provides
three pathways by which a manufacturer may accrue off-cycle carbon
dioxide (CO2) credits for those technologies that achieve
CO2 reductions in the real world but where those reductions
are not adequately or entirely captured on the test used to determine
compliance with the CO2 standards, and which are not
otherwise reflected in the standards' stringency. The first pathway is
a predetermined list of credit values for specific off-cycle
technologies that may be used beginning in model year 2014.\1\ This
pathway allows manufacturers to use conservative credit values
established by EPA for a wide range of technologies, with minimal data
submittal or testing requirements. In cases where additional laboratory
testing can demonstrate emission benefits, a second pathway allows
manufacturers to use a broader array of emission tests (known as ``5-
cycle'' testing because the methodology uses five different testing
procedures) to demonstrate and justify off-cycle CO2
credits.\2\ The additional emission tests allow emission benefits to be
demonstrated over some elements of real-world driving not captured by
the GHG compliance tests, including high speeds, hard accelerations,
and cold temperatures. Credits determined according to either of these
methodologies do not undergo additional public review. The third and
last pathway allows manufacturers to seek EPA approval to use an
alternative methodology for determining the off-cycle CO2
credits.\3\ This option is only available if the benefit of the
technology cannot be adequately demonstrated using the 5-cycle
methodology. Manufacturers may also use this option for model years
prior to 2014 to demonstrate off-cycle CO2 reductions for
technologies that are on the predetermined list, or to demonstrate
reductions that exceed those available via use of the predetermined
list.
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    \1\ See 40 CFR 86.1869-12(b).
    \2\ See 40 CFR 86.1869-12(c).
    \3\ See 40 CFR 86.1869-12(d).
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    Under the regulations, a manufacturer seeking to demonstrate off-
cycle credits with an alternative methodology (i.e., under the third
pathway described above) must describe a methodology that meets the
following criteria:
     Use modeling, on-road testing, on-road data collection, or
other approved analytical or engineering methods;
     Be robust, verifiable, and capable of demonstrating the
real-world emissions benefit with strong statistical significance;
     Result in a demonstration of baseline and controlled
emissions over a wide range of driving conditions and number of
vehicles such that issues of data uncertainty are minimized;
     Result in data on a model type basis unless the
manufacturer demonstrates that another basis is appropriate and
adequate.
    Further, the regulations specify the following requirements
regarding an application for off-cycle CO2 credits:
     A manufacturer requesting off-cycle credits must develop a
methodology for demonstrating and determining the benefit of the off-
cycle technology, and carry out any necessary testing and analysis
required to support that methodology.
     A manufacturer requesting off-cycle credits must conduct
testing and/or prepare engineering analyses that demonstrate the in-use
durability of the technology for the full useful life of the vehicle.
     The application must contain a detailed description of the
off-cycle technology and how it functions to reduce CO2
emissions under conditions not represented on the compliance tests.
     The application must contain a list of the vehicle
model(s) which will be equipped with the technology.
     The application must contain a detailed description of the
test vehicles selected and an engineering analysis that supports the
selection of those vehicles for testing.
     The application must contain all testing and/or simulation
data required under the regulations, plus any other data the
manufacturer has considered in the analysis.
    Finally, the alternative methodology must be approved by EPA prior
to the manufacturer using it to generate credits. As part of the review
process defined by regulation, the alternative methodology submitted to
EPA for consideration must be made available for public comment.\4\ EPA
will consider public comments as part of its final

decision to approve or deny the request for off-cycle credits.
---------------------------------------------------------------------------

    \4\ See 40 CFR 86.1869-12(d)(2).
---------------------------------------------------------------------------

II. Off-Cycle Credit Applications

    Using the alternative methodology approach discussed above, Nissan
is applying for credits for model years 2017 and later. Nissan has
applied for off-cycle credits using the alternative demonstration
methodology pathway for the low-power-consumption clutch technology.
The application covers 2017 model year and later vehicles. The
methodologies described by Nissan are generally consistent with those
used by other manufacturers to determine similar credit values. The
requested credit value is 0.3 grams CO2/mile.

III. EPA Decision Process

    EPA has reviewed the applications for completeness and is now
making the applications available for public review and comment as
required by the regulations. The off-cycle credit applications
submitted by Nissan (with confidential business information redacted)
have been placed in the public docket (see ADDRESSES section above) and
on EPA's website at https://www.epa.gov/ve-certification/compliance-information-light-duty-greenhouse-gas-ghg-standards. EPA is providing a
30-day comment period on the applications for off-cycle credits
described in this notice, as specified by the regulations. The
manufacturers may submit a written rebuttal of comments for EPA's
consideration, or may revise an application in response to comments.
After reviewing any public comments and any rebuttal of comments
submitted by manufacturers, EPA will make a final decision regarding
the credit requests. An EPA decision regarding these off-cycle credit
requests will only apply to the vehicles and model years specified in
the applications submitted by each manufacturer. EPA will make its
decision available to the public by placing a decision document (or
multiple decision documents) in the docket and on EPA's website at
https://www.epa.gov/ve-certification/compliance-information-light-duty-greenhouse-gas-ghg-standards. An EPA decision to approve off-cycle
credit requests would only apply to the manufacturers, model years,
vehicles, and technologies specified in the credit applications. Such
decision would not apply to other vehicles or vehicles from other
manufacturers. While the broad methodologies used by these
manufacturers could potentially be used for other vehicles and by other
manufacturers, the vehicle specific data needed to demonstrate the off-
cycle emissions reductions would likely be different. In such cases, a
new application would be required, including an opportunity for public
comment.

    Dated: November 10, 2020.
Byron Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2021-02517 Filed 2-5-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Page 12382]
[FR Doc No: 2018-05753]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9975-73-OAR]

Meeting of the Mobile Sources Technical Review Subcommittee

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, notice is hereby given that the Mobile Sources Technical Review
Subcommittee (MSTRS) will meet on May 22, 2018. The MSTRS is a
subcommittee under the Clean Air Act Advisory Committee. This is an
open meeting. The meeting will include discussion of current topics and
presentations about activities being conducted by EPA's Office of
Transportation and Air Quality. The preliminary agenda for the meeting
and any notices about change in venue will be posted on the
Subcommittee's website: http://www2.epa.gov/caaac/mobile-sources-technical-review-subcommittee-mstrs-caaac. MSTRS listserv subscribers
will receive notification when the agenda is available on the
Subcommittee website. To subscribe to the MSTRS listserv, send an email
to [email protected].

DATES: Tuesday, May 22, 2018 from 9:00 a.m. to 4:30 p.m. Registration
begins at 8:30 a.m.

ADDRESSES: The meeting is currently scheduled to be held at DoubleTree
by Hilton in Crystal City, 300 Army Navy Drive, Arlington, VA 22202.
However, this date and location are subject to change and interested
parties should monitor the Subcommittee website (above) for the latest
logistical information.

FOR FURTHER INFORMATION CONTACT: Courtney McCubbin, Designated Federal
Officer, Transportation and Climate Division, Mailcode 6406A, U.S. EPA,
1200 Pennsylvania Ave. NW, Washington, DC 20460; Ph:<PHONE_NUMBER>;
email: [email protected]. Background on the work of the
Subcommittee is available at: https://www.epa.gov/caaac/mobile-sources-technical-review-subcommittee-mstrs-caaac Individuals or organizations
wishing to provide comments to the Subcommittee should submit them to
Ms. McCubbin at the address above by May 8, 2018. The Subcommittee
expects that public statements presented at its meetings will not be
repetitive of previously submitted oral or written statements.

SUPPLEMENTARY INFORMATION: During the meeting, the Subcommittee may
also hear progress reports from some of its workgroups as well as
updates and announcements on activities of general interest to
attendees.
    For Individuals with Disabilities: For information on access or
services for individuals with disabilities, please contact Ms. McCubbin
(see above). To request accommodation of a disability, please contact
Ms. McCubbin, preferably at least 10 days prior to the meeting, to give
EPA as much time as possible to process your request.

    Dated: March 13, 2018.
Christopher Grundler,
Director, Office of Transportation and Air Quality, Office of Air and
Radiation.
[FR Doc. 2018-05753 Filed 3-20-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Pages 10530-10532]
[FR Doc No: 2014-04014]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1619]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by March
27, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0606.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements--21 CFR Part
111 (OMB Control Number 0910-0606)--Extension

    On October 25, 1994, the Dietary Supplement Health and Education
Act (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA, among other
things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section
402(g)(2) of the FD&C Act provides, in part, that the Secretary of
Health and Human Services may, by regulation, prescribe good
manufacturing practices for dietary supplements. Section 402(g) of the
FD&C Act also stipulates that such regulations will be modeled after
CGMP regulations for food and may not impose standards for which there
are no current, and generally available, analytical methodologies.
Section 402(g)(1) of the FD&C Act states that a dietary supplement is
adulterated if ``it has been prepared, packed, or held under conditions
that do not meet current good manufacturing practice regulations.''
Under section 701(a) of the FD&C Act (21 U.S.C. 371), FDA may issue
regulations necessary for the efficient enforcement of the FD&C Act. In
the Federal Register of June 25, 2007 (72 FR 34752) (the June 25, 2007,
final rule), FDA published a final rule that established, in part 111
(21 CFR part 111), the minimum CGMP necessary for activities related to
manufacturing, packaging, labeling, or holding dietary supplements to
ensure the quality of the dietary supplement.
    Records are an indispensable component of CGMP. The records
required by FDA's regulations in part 111 provide the foundation for
the planning, control, and improvement processes that constitute a
quality control system. Implementation of these processes in a
manufacturing operation serves as the backbone to CGMP. The records
show what is to be manufactured; what was, in fact, manufactured; and
whether the controls that the manufacturer put in place to ensure the
identity, purity, strength, and composition and limits on contaminants
and to prevent adulteration were effective. Further, records will show
whether and what deviations from control processes occurred, facilitate
evaluation and corrective action concerning these deviations
(including, where necessary, whether associated batches of product
should be recalled from the marketplace), and enable a manufacturer to
assure that the corrective action was effective. In addition, by
establishing recordkeeping requirements, FDA can ensure that industry
follows CGMP during manufacturing, packaging, labeling, or holding
operations. The regulations in part 111 establish the minimum
manufacturing practices necessary to ensure that dietary supplements
are manufactured, packaged, labeled, or held in a manner that will
ensure the quality of the dietary supplements during manufacturing,
packaging, labeling, or holding operations.
    The recordkeeping requirements of the regulations include
establishing written procedures and maintaining records pertaining to:
(1) Personnel; (2) sanitation; (3) calibration of instruments and
controls; (4) calibration, inspection, or checks of automated,
mechanical, or electronic equipment; (5) maintaining, cleaning, and
sanitizing equipment and utensils and other contact surfaces; (6) water
used that may become a component of the dietary supplement; (7)
production and process controls; (8) quality control; (9) components,
packaging, labels, and product received for packaging and labeling;
(10) master manufacturing and batch production; (11) laboratory
operations; (12) manufacturing operations; (13) packaging and labeling
operations; (14) holding and distributing operations; (15) returned
dietary supplements; and (16) product complaints.
    Description of Respondents: Manufacturers, dietary supplement
manufacturers, packagers and repackagers, labelers and re-labelers,
holders, distributors, warehousers, exporters, importers, large
businesses, and small businesses engaged in the dietary supplement
industry.
    The recordkeeping requirements of the regulations in part 111 are
set forth in each subpart. In table 1 we list the annual burdens
associated with recordkeeping, as described in the June 25, 2007, final
rule. For some provisions listed in table 1, we did not estimate the
number of records per recordkeeper because recordkeeping occasions
consist of frequent brief entries of dates, temperatures, monitoring
results, or documentation that specific actions were taken. Information
might be recorded a few times a day, week, or month. When the records
burden involves frequent brief entries, we entered 1 as the default for
the number of records per recordkeeper. For example, many of the
records listed under Sec.  111.35 in table 1, such as Sec.
111.35(b)(2) (documentation, in individual equipment logs, of the date
of the use, maintenance, cleaning, and sanitizing of equipment),
involve many short sporadic entries over the course of the year,
varying across equipment and plants in the industry. We did not attempt
to estimate the actual number of recordkeeping occasions for these
provisions, but instead entered an estimate of the average number of
hours per year. We entered the default value of 1 as the number of
records per recordkeeper for these and similar provisions. For Sec.
111.35, the entry for number of records is 1 as a default representing
a large number of brief recordkeeping occasions.
    In many rows of table 1, we list a burden under a single provision
that covers the written procedures or records described in several
provisions. For example, the burden of the batch production records
listed in table 1 under Sec.  111.260 includes the burden for records
listed under Sec.  111.255 because the batch production records must
include those records.
    The number of records for batch production records (and other
records kept on a batch basis in table 1) equals the annual number of
batches. The estimated burden for records kept by batch includes both
records kept for every batch and records kept for some, but not all,
batches. We use the annual number of batches as the number of records
that will not necessarily be kept for every batch, such as test results
or material review and disposition records, because such records are
part of records, if they are necessary, that will be kept for every
batch.
    In the Federal Register of December 19, 2013 (78 FR 76836), FDA
published a 60-day notice requesting public

comment on the proposed collection of information. No comments were
received.
    FDA estimates the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
         21 CFR Section             Number of      records per    Total annual         per          Total hours
                                  recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
111.14, records of personnel             15,000               4          60,000              1            60,000
 practices, including
 documentation of training.....
111.23, records of physical              15,000               1          15,000              0.2           3,000
 plant sanitation practices,
 including pest control and
 water quality.................
111.35, records of equipment                400               1             400             12.5           5,000
 and utensils calibration and
 sanitation practices..........
111.95, records of production               250               1             250             45            11,250
 and process control systems...
111.140, records that quality               240            1163         279,120              1           279,120
 control personnel must make
 and keep......................
111.180, records associated                 240            1163         279,120              1           279,120
 with components, packaging,
 labels, and product received
 for packaging and labeling as
 a dietary supplement..........
111.210, requirements for what              240               1             240              2.5             600
 the master manufacturing
 record must include...........
111.260, requirements for what              145            1408         204,160              1           204,160
 the batch record must include.
111.325, records that quality               120               1             120             15             1,800
 control personnel must make
 and keep for laboratory
 operations....................
111.375, records of the written             260               1             260              2               520
 procedures established for
 manufacturing operations......
111.430, records of the written              50               1              50             12.6             630
 procedures for packaging and
 labeling operations...........
111.475, records of product              15,000               1          15,000              0.4           6,000
 distribution and procedures
 for holding and distributing
 operations....................
111.535, records for returned               110               4             440             13.5           5,940
 dietary supplements...........
111.570, records regarding                  240             600         144,000              0.5          72,000
 product complaints............
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ...............         929,140
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The average burden per recordkeeping estimates in table 1 are based
on those in the June 25, 2007, final rule, which were based on our
institutional experience with other CGMP requirements and on data
provided by Research Triangle Institute in the ``Survey of
Manufacturing Practices in the Dietary Supplement Industry'' cited in
that rule.
    The estimates in table 1 of the number of firms affected by each
provision of part 111 are based on the percentage of manufacturers,
packagers, labelers, holders, distributors, and warehousers that
reported in the survey that they have not established written standard
operating procedures or do not maintain records that were later
required by the June 25, 2007, final rule. Because we do not have
survey results for general warehouses, we entered the approximate
number of facilities in that category for those provisions covering
general facilities. For the dietary supplement industry, the survey
estimated that 1,460 firms would be covered by the final rule,
including manufacturers, packagers, labelers, holders, distributors,
and warehousers. The time estimates include the burden involved in
documenting that certain requirements are performed and in
recordkeeping. We used an estimated annual batch production of 1,408
batches per year to estimate the burden of requirements that are
related to the number of batches produced annually, such as Sec.
111.260, ``What must the batch production record include?'' The
estimate of 1,408 batches per year is near the midpoint of the number
of annual batches reported by survey firms.
    The length of time that CGMP records must be maintained is set
forth in Sec.  111.605. Table 1 reflects the estimated burdens for
written procedures, record maintenance, periodically reviewing records
to determine if they may be discarded, and for any associated
documentation for that activity for records that are required under
part 111. We have not included a separate estimate of burden for those
sections that require maintaining records in accordance with Sec.
111.605, but have included those burdens under specific provisions for
keeping records. For example, Sec.  111.255(a) requires that the batch
production records be prepared every time a batch is manufactured, and
Sec.  111.255(d) requires that batch production records be kept in
accordance with Sec.  111.605. The estimated burdens for both Sec.
111.255(a) and (d) are included under Sec.  111.260 (what the batch
record must include).

    Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04014 Filed 2-24-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Rules and Regulations]
[Pages 50538-50542]
[FR Doc No: 2014-19978]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0573; Directorate Identifier 2014-NM-091-AD;
Amendment 39-17955; AD 2014-17-02]
RIN 2120-AA64

Airworthiness Directives; Honeywell ASCa Inc. Emergency Locator
Transmitters Installed on Various Transport Category Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2013-18-09 for
certain Honeywell ASCa Inc. emergency locator transmitters (ELTs)
installed on various transport category airplanes. AD 2013-18-09
required various one-time general visual inspections of the ELT
transmitter units (TUs), and corrective actions if necessary. This new
AD corrects the manufacturer's name in the AD applicability and adds a
source of approval for an installation. AD 2013-18-09 was prompted by a
fire on a parked and unoccupied airplane; preliminary information
indicated combustion in the area of the ELT TU. This new AD was
prompted by the identification of an error in the applicability of AD
2013-18-09. We are issuing this AD to detect and correct discrepancies
of the battery wiring installation inside the TU, which could result in
an electrical short and possible ignition source.

DATES: This AD becomes effective September 9, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 3,
2013 (78 FR 57253, September 18, 2013).
    We must receive comments on this AD by October 9, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For Honeywell service information identified in this AD, contact
Honeywell ASCa Inc., Customer and Product Support, Customer Support
Operations, 3333 Unity Drive, Mississauga, ON, Canada L5L 3S6;
telephone:<PHONE_NUMBER> (toll-free U.S.A./Canada); telephone: 602-365-
3099 (international) email<EMAIL_ADDRESS>Internet:
www.myaerospace.com. For Boeing service information identified in this
AD, contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0573; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,
Avionics and Services Branch, ANE-172, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On September 6, 2013, we issued AD 2013-18-09, Amendment 39-17582
(78 FR 57253, September 18, 2013). AD 2013-18-09 applied to certain
Honeywell ASCa Inc. ELTs installed on various transport category
airplanes. AD 2013-18-09 was prompted by a fire on a parked and
unoccupied airplane; preliminary information indicated combustion in
the area of the ELT TU. AD 2013-18-09 required various one-time general
visual inspections of the ELT TUs), and corrective actions if
necessary. We issued AD 2013-18-09 to detect and correct discrepancies
of the battery wiring installation inside the TU, which could result in
an electrical short and possible ignition source.
    Since we issued AD 2013-18-09, Amendment 39-17582 (78 FR 57253,
September 18, 2013), we discovered a typographical error in the
applicability. Paragraph (c) of AD 2013-18-09 identified ELTs
manufactured by ``Honeywell ASCs Inc.'' The correct name for the
manufacturer is Honeywell ASCa Inc. In all other locations in AD 2013-
18-09, the manufacturer's name was correct. This error has been
corrected in this AD. We have revised paragraph (c) of this AD
accordingly.
    Although we have revised the compliance time for the ELT TU
inspections (as specified in paragraph (g) of this AD and AD 2013-18-
09, Amendment 39-17582 (78 FR 57253, September 18, 2013)), no further
work is required for airplanes in compliance with the requirements of
AD 2013-18-09.
    We have revised the compliance language in paragraphs (k)(1),
(k)(2), and (k)(3) of this AD to start from the effective date of this
AD.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced in AD 2013-18-09, Amendment 39-17582 (78 FR
57253, September 18, 2013). We are issuing this AD because we evaluated
all pertinent information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

FAA's Determination of the Effective Date

    Since this AD merely corrects a typographical error in the
applicability of AD 2013-18-09, Amendment 39-17582 (78 FR 57253,
September 18, 2013), and includes another source of approval for an
installation, notice and opportunity for public comment before issuing
this AD are unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2014-0573; Directorate
Identifier 2014-NM-091-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 3,832 ELTs installed on transport
category airplanes of U.S. registry. We estimate the following costs to
comply with this AD:
    The actions that were required by AD 2013-18-09, Amendment 39-17582
(78 FR 57253, September 18, 2013), and are retained in this AD, take
about 1 work-hour per product, at an average labor rate of $85 per
work-hour. Based on these figures, the estimated cost of the actions
required by AD 2013-18-09 on U.S. operators is $325,720, or $85 per
product.
    We have received no definitive data that would enable us to provide
cost estimates for additional required actions, as the time required to
accomplish those actions is specific to the airplane.
    The changes included in this AD add no additional economic burden.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2013-18-09, Amendment 39-17582 (78 FR 57253, September 18, 2013), and
adding the following new AD:

2014-17-02 Honeywell ASCa Inc.: Amendment 39-17955. Docket No. FAA-
2014-0573; Directorate Identifier 2014-NM-091-AD.

(a) Effective Date

    This AD becomes effective September 9, 2014.

(b) Affected ADs

    This AD replaces AD 2013-18-09, Amendment 39-17582 (78 FR 57253,
September 18, 2013).

(c) Applicability

    This AD applies to Honeywell ASCa Inc. emergency locator
transmitters (ELTs) Model RESCU 406AF and 406AFN with transmitter
unit (TU) part numbers (P/Ns) 1152682-1, -2, and -3, installed on
transport category airplanes, certificated in any category, but not
limited to the airplanes identified in table 1 to paragraph (c) of
this AD.

      Table 1 to Paragraph (C) of This AD--Affected Airplane Models
------------------------------------------------------------------------
           Manufacturer                        Airplane model
------------------------------------------------------------------------
(1) The Boeing Company............  (i) 717-200 airplanes.
                                    (ii) 727, 727C, 727-100, 727-100C,
                                     727-200, and 727-200F series
                                     airplanes.
                                    (iii) 737-100, -200, -200C, -300, -
                                     400, -500, -600, -700, -700C, -800,
                                     -900, and -900ER series airplanes.
                                    (iv) 747-100, -100B, -100B SUD, -
                                     200B, -200C, -200F, -300, -400, -
                                     400D, and -400F series airplanes;
                                     and 747SR, 747SP, 747-8F, and 747-8
                                     series airplanes.
                                    (v) 757-200, -200PF, -200CB, and -
                                     300 series airplanes.
                                    (vi) 767-200, -300, -300F, and -
                                     400ER series airplanes.
                                    (vii) 777-200, -200LR, -300, -300ER,
                                     and 777F series airplanes.
                                    (viii) 787-8 airplanes.
                                    (ix) MD-11 and MD-11F airplanes.
                                    (x) DC-9-81 (MD-81), DC-9-82 (MD-
                                     82), DC-9-83 (MD-83), and DC-9-87
                                     (MD-87) airplanes.
                                    (xi) MD-88 airplanes.
                                    (xii) MD-90-30 airplanes.
(2) Lockheed Martin Corporation/    382, 382B, 382E, 382F, 382G, and
 Lockheed Martin Aeronautics         382J airplanes.
 Company.
(3) Airbus........................  (i) A300 B2-1A, B2-1C, B2K-3C, B2-
                                     203, B4-2C, B4-103, and B4-203
                                     airplanes.
                                    (ii) A300 B4-601, B4-603, B4-620,
                                     and B4-622 airplanes.
                                    (iii) A300 B4-605R and B4-622R
                                     airplanes.
                                    (iv) A300 F4-605R and F4-622R
                                     airplanes.
                                    (v) A300 C4-605R Variant F
                                     airplanes.
                                    (vi) A310-203, -204, -221, -222, -
                                     304, -322, -324, and -325
                                     airplanes.
                                    (vii) A320-111, -211, -212, -214, -
                                     231, -232, and -233 airplanes.
                                    (viii) A321-111, -112, -131, -211, -
                                     212, -213, -231, and -232
                                     airplanes.
                                    (ix) A330-223F and -243F airplanes.
                                    (x) A330-201, -202, -203, -223, and
                                     243 airplanes.
                                    (xi) A330-301, -302, -303, -321, -
                                     322, -323, -341, -342, and -343
                                     airplanes.
                                    (xii) A340-211, -212, and -213
                                     airplanes.
                                    (xiii) A340-311, -312, and -313
                                     airplanes.
                                    (xiv) A340-541 airplanes.
                                    (xv) A340-642 airplanes.
                                    (xvi) A380-800 series airplanes.
(4) ATR--GIE Avions de Transport    (i) ATR42-200, -300, -320, and -500
 R[eacute]gional.                    airplanes.
                                    (ii) ATR72-101, -201, -102, -202, -
                                     211, -212, and -212A airplanes.
(5) Dassault Aviation.............  FALCON 7X airplanes.
------------------------------------------------------------------------

(d) Subject

    Air Transport Association (ATA) of America Code 23,
Communications.

(e) Reason

    This AD was prompted by a fire on a parked and unoccupied
airplane; preliminary information indicated combustion in the area
of the ELT TU. We are issuing this AD to detect and correct
discrepancies of the battery wiring installation inside the TU,
which could result in an electrical short and possible ignition
source.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Inspection With New Compliance Time

    This paragraph restates the requirements of paragraph (g) of AD
2013-18-09, Amendment 39-17582 (78 FR 57253, September 18, 2013),
with a new compliance time. For any ELT TU with any serial number
identified in paragraph 1.A., ``Effectivity,'' including the serial
numbers identified in the Note in paragraph 1.A., of Honeywell Alert
Service Bulletin 1152682-23-A22, Revision 1, dated August 8, 2013:
Within 120 days after the effective date of this AD, do the actions
specified in paragraphs (g)(1) and (g)(2) of this AD.
    (1) Remove the TU from the airplane.
    (2) Do one-time general visual inspections of the ELT TU, in
accordance with the Accomplishment Instructions of Honeywell Alert
Service Bulletin 1152682-23-A22, Revision 1, dated August 8, 2013.

(h) Retained TU/Battery Pack Return Provisions With New Compliance Time

    This paragraph restates the requirements of paragraph (h) of AD
2013-18-09, Amendment 39-17582 (78 FR 57253, September 18, 2013),
with a new compliance time. During any inspection required by this
AD, if any discrepancy is found that is unacceptable or exceeds
limits as specified in Honeywell Alert Service Bulletin 1152682-23-
A22, Revision 1, dated August 8, 2013: At the applicable time
specified in paragraph (h)(1) or (h)(2) of this AD, return the TU or
battery pack, as applicable, to Honeywell ASCa Inc., Customer and
Product Support, Customer Support Operations, 3333 Unity Drive,
Mississauga, ON, Canada L5L 3S6; telephone:<PHONE_NUMBER> (toll-free
U.S.A./Canada); telephone:<PHONE_NUMBER> (international) email:
<EMAIL_ADDRESS>Internet: www.myaerospace.com.
    (1) If the inspection was done on or after the effective date of
this AD: Within 10 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Within 10 days after the effective date of this AD.

(i) Retained Post-Inspection Actions With No Changes

    This paragraph restates the requirements of paragraph (i) of AD
2013-18-09, Amendment 39-17582 (78 FR 57253, September 18, 2013),
with no changes. Before further flight after accomplishing the
actions required by paragraph (g) of this AD: Perform all applicable
return to service actions, in accordance with the Accomplishment
Instructions of Honeywell Alert Service Bulletin 1152682-23-A22,
Revision 1, dated August 8, 2013. Install a TU that is identified in
paragraph 3.F.(2) or 3.F.(3) of Honeywell Alert Service Bulletin
1152682-23-A22, Revision 1, dated August 8, 2013.

(j) Retained Parts Installation Limitations With Revised Installation
Method Approval

    This paragraph restates the limitations specified by paragraph
(j) of AD 2013-18-09, Amendment 39-17582 (78 FR 57253, September 18,
2013), with a revised installation method approval. After
installation or replacement of the TU as required by this AD or as
specified in paragraph (k) of this AD, no person may install an ELT
TU battery unless it is installed using a method approved by either
the Manager, New York ACO, FAA; or TCCA (or its delegated agent).

(k) Retained Acceptable Prior Actions for Certain Airplanes

    This paragraph restates the provisions specified by paragraph
(k) of AD 2013-18-09, Amendment 39-17582 (78 FR 57253, September 18,
2013), with revised compliance language.
    (1) For The Boeing Company Model 787-8 airplanes identified in
AD 2013-15-07, Amendment 39-17523 (78 FR 45054, July 26, 2013):
Accomplishment of the applicable requirements of AD 2013-15-07
before the effective date of this AD, is acceptable for compliance
with the requirements of paragraphs (g), (h), and (i) of this AD.
    (2) This paragraph provides credit for the applicable actions
required by paragraphs (g), (h), and (i) of this AD, if those
actions were performed before the effective date of this AD, using
Honeywell Alert Service Bulletin 1152682-23-A22, dated August 1,
2013, which is not incorporated by reference in this AD.
    (3) This paragraph provides credit for the actions required by
paragraphs (g), (h), and (i) of this AD, if the applicable actions
specified in the service information identified in paragraphs
(k)(3)(i) through (k)(3)(vi) of this AD were performed before the
effective date of this AD, using the applicable service information
identified in paragraphs (k)(3)(i) through (k)(3)(vi) of this AD.
This service information is not incorporated by reference in this
AD.
    (i) For The Boeing Company Model 717-200 airplanes: Boeing Multi
Operator Message MOM-MOM-13-0597-01B, dated July 28, 2013.
    (ii) For The Boeing Company Model 737-600, -700, -700C, -800, -
900, and -900ER series airplanes: Boeing Multi Operator Message MOM-
MOM-13-0593-01B, dated July 28, 2013.
    (iii) For The Boeing Company Model 747-400, -400D, and -400F
series airplanes: Boeing Multi Operator Message MOM-MOM-13-0594-01B,
dated July 28, 2013.
    (iv) For The Boeing Company Model 767 airplanes: Boeing Multi
Operator Message MOM-MOM-13-0595-01B, dated July 28, 2013.
    (v) For The Boeing Company Model 777 airplanes: Boeing Multi
Operator Message MOM-MOM-13-0596-01B, dated July 28, 2013.
    (vi) For The Boeing Company Model 787-8 airplanes: Boeing Multi
Operator Message MOM-MOM-13-0570-01B, dated July 19, 2013; or Boeing
Multi Operator Message MOM-MOM-13-0590-01B, dated July 26, 2013.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO, ANE-170, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the ACO, send it to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7300; fax<PHONE_NUMBER>. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD. AMOCs approved previously for AD
2013-18-09, Amendment 39-17582 (78 FR 57253, September 18, 2013),
are approved as AMOCs for the corresponding provisions of this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA approved. Corrective actions are considered
FAA approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2013-25, dated August 15,
2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2014-0573.
    (2) Boeing service information identified in this AD that is not
incorporated by reference may be obtained from Boeing Commercial
Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC
2H-65, Seattle, WA 98124-2207; telephone<PHONE_NUMBER>, extension 1;
fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (3) Honeywell service information identified in this AD that is
not incorporated by reference is available at the addresses
identified in paragraphs (n)(4) and (n)(5) of this AD.

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
October 3, 2013 (78 FR 57253, September 18, 2013).
    (i) Honeywell Alert Service Bulletin 1152682-23-A22, Revision 1,
dated August 8, 2013.
    (ii) Reserved.
    (4) For Honeywell service information identified in this AD,
contact Honeywell ASCa Inc., Customer and Product Support, Customer
Support Operations, 3333 Unity Drive, Mississauga, ON, Canada L5L
3S6; telephone:<PHONE_NUMBER> (toll-free U.S.A./Canada); telephone:
602-365-3099 (international) email<EMAIL_ADDRESS>
Internet: www.myaerospace.com.
    (5) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on August 13, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-19978 Filed 8-22-14; 8:45 am]
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[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Pages 46300-46303]
[FR Doc No: 2011-19479]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 027

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 027'' (Recognition List Number: 027), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

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

ADDRESSES: Submit written requests for single copies of ``Modifications
to the List of Recognized Standards, Recognition List Number: 027'' to
the Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD
20993-0002. Send two self-addressed adhesive labels to assist that
office in processing your requests, or fax your request to 301-847-
8149. Submit written comments concerning this document, or
recommendations for additional standards for recognition, to the
contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic
comments by e-mail<EMAIL_ADDRESS>This document may also be
accessed on FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 027 modifications and other standards related
information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301-
796-6574.

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as
published in the Federal Register, are identified in table 1 as
follows.

      Table 1--Previous Publications of Standard Recognition Lists
------------------------------------------------------------------------

------------------------------------------------------------------------
February 25, 1998 (63 FR 9561)............  March 31, 2006 (71 FR
                                             16313).
October 16, 1998 (63 FR 55617)............  June 23, 2006 (71 FR 36121).
July 12, 1999 (64 FR 37546)...............  November 3, 2006 (71 FR
                                             64718).
November 15, 2000 (65 FR 69022)...........  May 21, 2007 (72 FR 28500).
May 7, 2001 (66 FR 23032).................  September 12, 2007 (72 FR
                                             52142).
January 14, 2002 (67 FR 1774).............  December 19, 2007 (72 FR
                                             71924).
October 2, 2002 (67 FR 61893).............  September 9, 2008 (73 FR
                                             52358)
April 28, 2003 (68 FR 22391)..............  March 18, 2009 (74 FR
                                             11586).
March 8, 2004 (69 FR 10712)...............  September 8, 2009 (74 FR
                                             46203).
June 18, 2004 (69 FR 34176)...............  May 5, 2010 (75 FR 24711).
October 4, 2004 (69 FR 59240).............  June 10, 2010 (75 FR 32943).
May 27, 2005 (70 FR 30756)................  October 4, 2010 (75 FR
                                             61148).
November 8, 2005 (70 FR 67713)............  March 14, 2011 (76 FR
                                             13631).
------------------------------------------------------------------------

    These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains ``hypertext
markup language (HTML)'' and ``portable document format (PDF)''
versions of the list of ``FDA Recognized Consensus Standards.'' Both
versions are publicly accessible at the Agency's Internet site. See
section VI of this document for electronic access information.
Interested persons should review the supplementary information sheet
for the standard to understand fully the extent to which FDA recognizes
the standard.

II. Modifications to the List of Recognized Standards--Recognition List
Number: 027

    FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in satisfying premarket reviews and other requirements for devices.
FDA will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 027'' to identify these current
modifications.
    In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others; (2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
    In section III of this document, FDA lists modifications the Agency
is making that involve the initial addition of standards not previously
recognized by FDA.

                                               Table 2--Modifications to the List of Recognized Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Replacement
           Old recognition No.               recognition                   Title of standard \1\                                  Change
                                                 No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. Cardiovascular:

    3-75.................................  ..............  ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/    Extent of recognition, Type of
                                                            A1:2003 Manual, electronic or automated                standard.
                                                            sphygmomanometers.
    3-78.................................  ..............  ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical       Extent of recognition and Type of
                                                            equipment--Part 2-30: Particular requirements for      standard.
                                                            the basic safety and essential performance of
                                                            automated noninvasive sphygmomanometers.
    3-80.................................  ..............  ANSI/AAMI/ISO 81060-1:2007 Non-invasive                Extent of recognition and Type of
                                                            sphygmomanometers--Part 1: Requirements and test       standard.
                                                            methods for non-automated measurement type.
    3-81.................................  ..............  ANSI/AAMI/ISO 81060-2:2009 Non-invasive                Extent of recognition and Type of
                                                            sphygmomanometers--Part 2: Clinical validation of      standard.
                                                            automated measurement type.
B. General:
    5-64.................................            5-65  ANSI/AAMI/ISO 80369-1: 2010 Small bore connectors for  Withdrawn and replaced with newer
                                                            liquids and gases in health care applications--Part    version.
                                                            1: General requirements.
C. Materials:
    8-101................................  ..............  ASTM F2118-03 (Reapproved 2009), Standard Test Method  Contact Person.
                                                            for Constant Amplitude of Force Controlled Fatigue
                                                            Testing of Acrylic Bone Cement.
D. Ophthalmic:
    10-43................................  ..............  ISO 11979-8 Second Edition 2006-07-01 Ophthalmic       Extent of recognition.
                                                            implants--Intraocular lenses--Part 8: Fundamental
                                                            requirements.
    10-56................................  ..............  ANSI Z80.12-2007 Ophthalmics--Multifocal Intraocular   Title, Extent of recognition.
                                                            Lenses.
    10-57................................  ..............  ANSI Z80.13-2007 Ophthalmics--Phakic Intraocular       Title, Extent of recognition.
                                                            Lenses..
E. Orthopedics:
    11-79................................  ..............  ISO 7206-8:1995, Implants for Surgery--Partial and     Withdrawn. See item 11-225.
                                                            Total Hip Joint Prostheses--Part 8: Endurance
                                                            Performance of Stemmed Femoral Components with
                                                            Application of Torsion.
    11-220...............................  ..............  ASTM F 2068-09, Standard Specification for Femoral     Extent of Recognition, Type of
                                                            Prostheses--Metallic Implants.                         standard and Related CFR Citations
                                                                                and Procodes.
F. Sterility:
    14-228...............................  ..............  ANSI/AAMI/ISO 11135-1:2007 Sterilization of health     Relevant Guidance.
                                                            care products--Ethylene oxide--Part 1: Requirements
                                                            for development, validation and routine control of a
                                                            sterilization process for medical devices.
    14-295...............................  ..............  ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical   Relevant Guidance.
                                                            devices--Information to be provided by the
                                                            manufacturer for the processing of resterilizable
                                                            medical devices.
    14-119...............................          14-311  ANSI/AAMI ST55:2010 Table-top steam sterilizers......  Withdrawn and replaced with newer
                                                                                version.
14-280...................................          14-312  ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text)      Withdrawn and replaced with newer
                                                            Comprehensive guide to steam sterilization and         version.
                                                            sterility assurance in health care facilities.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 027.

                                                Table 3--New Entries to the List of Recognized Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Recognition No.                            Title of standard \1\                                   Reference No. and date
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. Anesthesia:
    1-85..............................  Medical electrical equipment--Part 2-61:            ISO 80601-2-61 First edition 2011-04-01.
                                         Particular requirements for basic safety and
                                         essential performance of pulse oximeter equipment.
B. Dental/ENT:
    4-195.............................  Dentistry-Implants-Dynamic fatigue test for         ISO 14801 Second Edition 2007-11-15.
                                         endosseous dental implants.
C. General:

    5-66..............................  Medical electrical equipment--Part 1-10: General    IEC 60601-1-10 Edition 1.0 2007-11.
                                         requirements for basic safety and essential
                                         performance--Collateral Standard: Requirements
                                         for the development of physiologic closed-loop
                                         controllers.
    5-67..............................  Medical devices--Application of usability           ANSI/AAMI/IEC 62366:2007.
                                         engineering to medical devices.
D. General Hospital/General Plastic
 Surgery:
    6-253.............................  Hoists for the transfer of disabled persons--       ISO 10535 Second edition 2006-12-15.
                                         Requirements and test methods.
E. IVD:
    7-219.............................  Quality Assurance for Design Control and            CLSI I/LA28-A2.
                                         Implementation of Immunohistochemistry Assays;
                                         Approved Guideline--Second Edition.
    7-220.............................  Quantitative D-dimer for the Exclusion of Venous    CLSI H59-A.
                                         Thromboembolic Disease; Approved Guideline.
F. Nanotechnology:
    18-2..............................  Standard Guide for Handling Unbound Engineered      ASTM E 2535-07.
                                         Nanoscale Particles in Occupational Settings.
G. OB-GYN/GU:
    9-67..............................  Standard Test Method for Determining Compatibility  ASTM D7661-10.
                                         of Personal Lubricants with Natural Rubber Latex
                                         Condoms.
    9-68..............................  Male condoms--Requirements and test methods for     ISO 23409 First edition 2011-02-15.
                                         condoms made from synthetic materials.
H. Ophthalmic:
    10-64.............................  Ophthalmics Optics--Intraocular Lenses............  ANSI Z80.7-2002.
    10-65.............................  Ophthalmic instruments--Endoilluminators--          ISO 15752 Second edition 2010-01-15.
                                         Fundamental requirements and test methods for
                                         optical radiation safety.
    10-66.............................  Optics and photonics--Operation microscopes--Part   ISO 10936-2 Second edition 2010-01-15.
                                         2: Light hazard from operation microscopes used
                                         in ocular surgery.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      I. Orthopedic
--------------------------------------------------------------------------------------------------------------------------------------------------------
11-225................................  Implants for surgery--Partial and total hip joint   ISO 7206-4 Third edition 2010-06-15.
                                         prostheses--Part 4: Determination of endurance
                                         properties and performance of stemmed femoral
                                         components.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      J. Radiology
--------------------------------------------------------------------------------------------------------------------------------------------------------
12-227................................  Ultrasonics--Pulse-echo scanners--Part 1:           IEC 61391-1 First edition 2006-07.
                                         Techniques for calibrating spatial measurement
                                         systems and measurement of system point-spread
                                         function response.
12-228................................  Ultrasonics--Pulse-echo scanners--Part 2:           IEC 61391-2 Edition 1.0 2010-01.
                                         Measurement of maximum depth of penetration and
                                         local dynamic range.
12-229................................  Medical electrical equipment--Radiation dose        IEC PAS 61910-1 First edition 2007-07.
                                         documentation--Part 1: Equipment for radiography
                                         and radioscopy.
12-230................................  Primary user controls for interventional            NEMA XR 24-2008.
                                         angiography x-ray equipment.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA recognized consensus
standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and minor revisions described in this notice into the database and,
upon publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.

V. Recommendation of Standards for Recognition by FDA

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

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH

home page includes the guidance as well as the current list of
recognized standards and other standards related documents. After
publication in the Federal Register, this notice announcing
``Modification to the List of Recognized Standards, Recognition List
Number: 027'' will be available on the CDRH home page. You may access
the CDRH home page at http://www.fda.gov/MedicalDevices.
    You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
    This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) either electronic or written comments
regarding this document. It is only necessary to send one set of
comments. It is no longer necessary to sent two copies of mailed
comments. Comments are to be identified with the docket number found in
brackets in the heading of this document. FDA will consider any
comments received in determining whether to amend the current listing
of modifications to the list of recognized standards, Recognition List
Number: 027. These modifications to the list or recognized standards
are effective upon publication of this notice in the Federal Register.

    Dated: July 28, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19479 Filed 8-1-11; 8:45 am]
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