[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54982-54983]
[FR Doc No: 2021-21692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0669]

S1B(R1) Addendum to S1B Testing for Carcinogenicity of
Pharmaceuticals; International Council for Harmonisation; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``S1B(R1)
Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals''. The
draft guidance was prepared under the auspices of the International
Council for Harmonisation (ICH), formerly the International Conference
on Harmonisation. The draft guidance expands the testing scheme for
assessing human carcinogenic risk of small molecule pharmaceuticals by
introducing an additional approach that is not described in the
original S1B Guideline. The draft guidance is intended to offer an
integrative approach that provides specific weight of evidence (WoE)
criteria that inform whether or not a 2-year rat study adds value in
completing a human carcinogenicity risk assessment. The Addendum also
adds a plasma exposure ratio-based approach for setting the high dose
in the rasH2-Tg mouse model, while all other aspects of the
recommendations for high dose selection in S1C(R2) Guideline would
still apply.

DATES: Submit either electronic or written comments on the draft
guidance by December 6, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0669 for ``S1B(R1) Addendum to S1B Testing for
Carcinogenicity of Pharmaceuticals.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food

and Drug Administration, 10001 New Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The draft guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Timothy
McGovern, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6426, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``S1B(R1) Addendum to S1B Testing for Carcinogenicity of
Pharmaceuticals''. The guidance was prepared under the auspices of ICH.
ICH has the mission of achieving greater regulatory harmonization
worldwide to ensure that safe, effective, high-quality medicines are
developed, registered, and maintained in the most resource-efficient
manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In May 2021, the ICH Assembly endorsed the draft guideline entitled
``S1B(R1) Addendum to S1B Testing for Carcinogenicity of
Pharmaceuticals'' and agreed that the guideline should be made
available for public comment. The draft guideline is the product of the
Safety Expert Working Group of the ICH. Comments about this draft will
be considered by FDA and the Safety Expert Working Group.
    The draft guidance provides guidance on expanding the testing
scheme for assessing human carcinogenic risk of small molecule
pharmaceuticals by introducing an additional approach that is not
described in the original S1B Guideline and also adds a plasma exposure
ratio-based approach for setting the high dose in the rasH2-Tg mouse
model.
    This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``S1B(R1) Addendum to S1B Testing for
Carcinogenicity of Pharmaceuticals''. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001.

III. Electronic Access

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

    Dated: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21692 Filed 10-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36544-36545]
[FR Doc No: 2022-13105]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2006-0042]

CSA Group & Testing Certification Inc.: Application for Expansion
of Recognition

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

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the application of CSA Group &
Testing Certification Inc., for expansion of the recognition as a
Nationally Recognized Testing Laboratory (NRTL) and presents the
agency's preliminary finding to grant the application.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before July 5, 2022.

ADDRESSES: Submit comments by any of the following methods:
    Electronically: Submit comments and attachments electronically at
https://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for making electronic submissions.
    Docket: To read or download comments or other material in the
docket, go to https://www.regulations.gov or the OSHA Docket Office at
the above address. All documents in the docket (including this Federal
Register notice) are listed in the https://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the website. All submissions,
including copyrighted material, are available for inspection through
the OSHA Docket Office. Contact the OSHA Docket Office at (202) 693-
2350 (TTY<PHONE_NUMBER>) for assistance in locating docket
submissions. Please note: While OSHA's docket office is continuing to
accept and process submissions by regular mail, due to the COVID-19
pandemic, the Docket Office is closed to the public and not able to
receive submissions to the rulemaking record by express delivery, hand
delivery, and messenger service.
    Instructions: All submissions must include the agency name and the
OSHA docket number (OSHA-2006-0042). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials will be available online at
https://www.regulations.gov. Therefore, the agency cautions commenters
about submitting statements they do not want made available to the
public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data.
    Extension of comment period: Submit requests for an extension of
the comment period on or before July 5, 2022 to the Office of Technical
Programs and Coordination Activities, Directorate of Technical Support
and Emergency Management, Occupational Safety and Health
Administration, U.S. Department of Labor, 200 Constitution Avenue NW,
Room N-3653, Washington, DC 20210, or by fax to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, phone:<PHONE_NUMBER> or email:
[email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, phone:<PHONE_NUMBER> or email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    OSHA is providing notice that CSA Group Testing & Certification
Inc. (CSA), is applying for expansion of the current recognition as a
NRTL. CSA requests the addition of one test standard to the NRTL scope
of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes: (1)
the type of products the NRTL may test, with each type specified by the
applicable test standard; and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by a NRTL for initial recognition
and for an expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides a preliminary finding. In the second notice,
the agency provides a final decision on the application. These notices
set forth the NRTL's scope of recognition or modifications of that
scope. OSHA maintains an informational web page for each NRTL,
including CSA, which details the NRTL's scope of recognition. These
pages are available from the OSHA website at https://www.osha.gov/dts/otpca/nrtl/index.html.
    CSA currently has seven facilities (sites) recognized by OSHA for
product testing and certification, with the headquarters located at:
CSA Group Testing & Certification Inc., 178 Rexdale Boulevard,
Etobicoke, Ontario, M9W 1R3, Canada. A complete list of CSA's scope of
recognition is available at https://www.osha.gov/nationally-recognized-testing-laboratory-program/csa.

II. General Background on the Application

    CSA submitted an application, dated September 24, 2021 (OSHA-2006-
0042-0027), to expand the recognition to include four additional test
standards. This notice covers the requested expansion to include UL
121201 only. The remaining standards in that application will be
covered in a future notice. The standard requested in the expansion
application and addressed here is a replacement standard for ISA
12.12.01, which is currently included in CSA's NRTL scope of
recognition. OSHA staff performed a detailed analysis of the
application packet and reviewed other pertinent information. OSHA did
not perform any on-site reviews in relation to this application.
    Table 1, below, lists one appropriate test standard found in CSA's
application for expansion for testing and certification of products
under the NRTL Program.

 Table 1--Proposed Appropriate Test Standard for Inclusion in CSA's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
       Test standard                     Test standard title
------------------------------------------------------------------------
UL 121201..................  Nonincendive Electrical Equipment for Use
                              in Class I and Class II, Division 2 and
                              Class III, Divisions 1 and 2 Hazardous
                              (Classified) Locations.
------------------------------------------------------------------------

III. Preliminary Findings on the Application

    CSA submitted an acceptable application for expansion of the scope
of recognition. OSHA's review of the application file, and pertinent
documentation, indicate that CSA has met the requirements prescribed by
29 CFR 1910.7 for expanding the recognition to include the addition of
the one test standard for NRTL testing and certification listed in
Table 1. This preliminary finding does not constitute an interim or
temporary approval of CSA's application.
    OSHA seeks comment on this preliminary determination.

IV. Public Participation

    OSHA welcomes public comment as to whether CSA meets the
requirements of 29 CFR 1910.7 for expansion of recognition as a NRTL.
Comments should consist of pertinent written documents and exhibits.
    Commenters needing more time to comment must submit a request in
writing, stating the reasons for the request by the due date for
comments. OSHA will limit any extension to 10 days unless the requester
justifies a longer time period. OSHA may deny a request for an
extension if it is not adequately justified.
    To review copies of the exhibits identified in this notice, as well
as comments submitted to the docket, contact the Docket Office,
Occupational Safety and Health Administration, U.S. Department of
Labor. These materials also are generally available online at https://www.regulations.gov under Docket No. OSHA-2006-0042 (for further
information, see the ``Docket'' heading in the section of this notice
titled ADDRESSES).
    OSHA staff will review all comments to the docket submitted in a
timely manner. After addressing the issues raised by these comments,
staff will make a recommendation to the Assistant Secretary of Labor
for Occupational Safety and Health on whether to grant CSA's
application for expansion of the scope of recognition. The Assistant
Secretary will make the final decision on granting the application. In
making this decision, the Assistant Secretary may undertake other
proceedings prescribed in Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of the final decision in the
Federal Register.

V. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice. Accordingly, the agency is issuing this notice pursuant to 29
U.S.C. 657(g)(2), Secretary of Labor's Order No. 8-2020 (85 FR 58393,
Sept. 18, 2020), and 29 CFR 1910.7.

    Signed at Washington, DC, on June 10, 2022.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2022-13105 Filed 6-16-22; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: October 12, 2010 (Volume 75, Number 196)]
[Rules and Regulations]
[Page 62462-62466]
[DOCID:fr12oc10-7]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 748

[Docket No. 100727314-0350-01]
RIN 0694-AE95

Additions to the List of Validated End-Users in the People's
Republic of China: Hynix Semiconductor China Ltd., Hynix Semiconductor
(Wuxi) Ltd. and Lam Research Corporation

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: In this final rule, the Bureau of Industry and Security amends
the Export Administration Regulations (EAR) to add three end-users,
Hynix Semiconductor (China) Ltd., Hynix Semiconductor (Wuxi) Ltd. and
Lam Research Corporation to the list of validated end-users in the
People's Republic of China (PRC). With this rule, exports, reexports
and transfers (in-country) of certain items to one facility of Hynix
Semiconductor (China) Ltd., one facility of Hynix Semiconductor (Wuxi)
Ltd. and nine facilities of Lam Research Corporation in the PRC are now
authorized under Authorization Validated End-User (VEU).

DATES: This rule is effective October 12, 2010. Although there is no
formal comment period, public comments on this regulation are welcome
on a continuing basis.

ADDRESSES: You may submit comments, identified by RIN 0694-AE95, by any
of the following methods:
    E-mail<EMAIL_ADDRESS>Include ``RIN 0694-AE95'' in the
subject line of the message.
    Fax:<PHONE_NUMBER>. Please alert the Regulatory Policy Division,
by calling<PHONE_NUMBER>, if you are faxing comments.
    Mail or Hand Delivery/Courier: Sheila Quarterman, U.S. Department
of Commerce, Bureau of Industry and Security, Regulatory Policy
Division, 14th Street & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230, Attn: RIN 0694-AE 95.
    Send comments regarding the collection of information associated
with this rule, including suggestions for reducing the burden, to
Jasmeet Seehra, Office of Management and Budget (OMB), by e-mail to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>. Comments
on this collection of information should be submitted separately from
comments on the final rule (i.e., RIN 0694-AE95)--- all comments on the
latter should be submitted by one of the three methods outlined above.

FOR FURTHER INFORMATION CONTACT: Karen Nies-Vogel, Chairman, End-User
Review Committee, Bureau of Industry and Security, U.S. Department of
Commerce, 14th Street & Pennsylvania Avenue, NW., Washington, DC 20230;
by telephone<PHONE_NUMBER>, or by e-mail to<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

Authorization Validated End-User (VEU): The List of Approved End-Users,
Eligible Items and Destinations in the People's Republic of China (PRC)

    Consistent with U.S. Government policy to facilitate trade for
civilian end-users in the PRC, BIS amended the EAR in a final rule on
June 19, 2007 (72 FR 33646) by creating a new authorization for
``validated end-users'' located in eligible destinations to which
eligible items may be exported, reexported or transferred under a
general authorization instead of a license, in conformance with section
748.15 of the EAR. Validated end-users may obtain eligible items that
are on the Commerce Control List, set forth in Supplement No. 1 to part
774 of the EAR, without having to wait for their suppliers to obtain
export licenses from BIS. Eligible items may include commodities,
software and technology, except those controlled for missile technology
or crime control reasons.
    Authorization VEU is a mechanism to facilitate increased high-
technology exports to companies in eligible destinations that have a
verifiable record of civilian uses for such items. The validated end-
users listed in Supplement No. 7 to Part 748 of the EAR were reviewed
and approved by the U.S. Government in accordance with the provisions
of Section 748.15 and Supplement Nos. 8 and 9 to Part 748 of the EAR.
In addition to U.S. exporters, Authorization VEU may be used by foreign
reexporters as well as by persons transferring in-country, and does not
have an expiration date. Currently, validated end-users are located in
the PRC and India.

Addition of Hynix Semiconductor China Ltd., Hynix Semiconductor (Wuxi)
Ltd. and Lam Research Corporation to the List of Validated End-Users in
the PRC and the Corporations' Respective ``Eligible Items (By ECCN)''
and ``Eligible Destinations''

    This final rule amends Supplement No. 7 to Part 748 of the EAR to
designate Hynix Semiconductor China Ltd. (HSCL), Hynix Semiconductor
(Wuxi) Ltd. (HSMC) and Lam Research Corporation (Lam), as validated
end-users, to identify the eligible facilities of HNSL, HSMC and Lam
and to identify the items that may be exported, reexported or
transferred (in-country) to HSCL's, HSMC's and Lam's specified eligible
facilities under Authorization VEU. The names and addresses of these
newly approved validated end-users and their eligible facilities are as
follows:

Validated End-Users

Hynix Semiconductor China Ltd.
Hynix Semiconductor (Wuxi) Ltd.
Lam Research Corporation.

Eligible Destination for Hynix Semiconductor China Ltd.

Hynix Semiconductor China Ltd., Lot K7/K7-1, Export Processing Zone,
Wuxi, Jiangsu, PR China.

Eligible Destination for Hynix Semiconductor (Wuxi) Ltd.

Hynix Semiconductor (Wuxi) Ltd., Lot K7/K7-1, Export Processing Zone,
Wuxi, Jiangsu, PR China.

Eligible Items That May Be Exported, Reexported or Transferred (In-
Country) to the Two Eligible Destinations (Facilities) Under HSCL's and
HSMC's Validated End-User Authorizations

Equipment for the manufacturing of semiconductor devices or materials
classified under Export Control Classification Numbers (ECCNs) 3B001.a,
3B001.b, 3B001.c, 3B001.d, 3B001.e, and 3B001.f.

Eligible Destinations for Lam Research Corporation

Lam Research (Shanghai) Service Co., 1st Floor, Area C, Hua Hong
Science & Technology Park, 177 Bi Bo Road, Zhangjiang Hi-Tech Park,
Pudong, Shanghai, China 201203.
Lam Research Shanghai Co., Ltd., No. 1 Jilong Rd., Room 424-2,
Waigaoqiao Free Trade Zone, Shanghai, China 200131.
Lam Research International Sarl (Shanghai TSS), c/o HMG Logistic
(Shanghai) Co., Ltd., No.55, West Shang Feng Road, Tangzhen, Pudong New
Area, Shanghai, China 201203.
Lam Research Shanghai Co., Ltd. (Shanghai WGQ Bonded Warehouse), No.
55, Fei la Road, Waigaoqiao Free Trade Zone, Pudong New Area, Shanghai,
China 200131.
Lam Research Co., Ltd. (Beijing Branch), Room 322 Dadi Mansion, No. 18
Hongda Beilu, Beijing Economic & Technological Development Area,
Beijing, China 100176.
Lam Research Co., Ltd. (Wuxi Representative Office), 5E, Bldg. C,
International Science & Technology Park, 2 Taishan Road, WND,
Wuxi, Jiangsu, China 214028.
Lam Research International Sarl (Wuxi EPZ Bonded Warehouse), c/o HMG
WHL Logistic (Wuxi) Co., Ltd., F1, Area 4, No. 1, Plot J3, No. 5
Gaolang East Road, Export Processing Zone, Wuxi, China 214028,
Lam Research Co., Ltd. (Wuhan Representative Office), Room 1810,
Guanggu International Building B,

456 Luoyu Road, East-Lake Hi-Tech Development Zone, Wuhan City, Hubei
Province, China 430074.
Lam Research International Sarl (Wuhan TSS), c/o HMG Wuhan Logistic
Co., Ltd., 1st--2nd Floor, No. 5 Building, Hua Shi Yuan Er Road,
Optical Valley Industry Park, East-Lake Hi-Tech Development Zone, Wuhan
City, Hubei Province, China 430223.

Eligible Items That May Be Exported, Reexported or Transferred (In-
Country) to the Nine Eligible Destinations (Facilities) Under Lam's
Validated End-User Authorization

Items classified under Export Control Classification Numbers (ECCNs)
2B230, 2B350.c, 2B350.d, 2B350.g, 2B350.h, 2B350.i, 3B001.c, 3B001.e
(items controlled under 3B001.c and 3B001.e are limited to parts and
components) 3D001, 3D002 (limited to ``software'' specially designed
for the ``use'' of stored program controlled items classified under
ECCN 3B001), and 3E001 (limited to ``technology'' according to the
General Technology Note for the ``development'' of equipment controlled
by ECCN 3B001).
    Approving these end-users as validated end-users is expected to
further facilitate exports to civilian end-users in the PRC, and is
expected to result in a significant savings of time and resources for
suppliers and the eligible facilities. Authorization VEU eliminates the
burden on exporters and reexporters of preparing individual license
applications, as exports, reexports and transfers (in-country) of
eligible items to these facilities may now be made under general
authorization instead of under individual licenses. With this change,
exporters and reexporters can supply validated end-users in the PRC
much more quickly, thus enhancing the competitiveness of the exporters,
reexporters, and end-users in the PRC.
    To ensure appropriate facilitation of exports and reexports, on-
site reviews of validated end-users may be warranted pursuant to
paragraph 748.15(f)(2) and section 7(iv) of Supplement No. 8 to Part
748 of the EAR. If such reviews are warranted, BIS will inform the PRC
Ministry of Commerce.
    Since August 21, 2001, the Export Administration Act has been in
lapse and the President, through Executive Order 13222 of August 17,
2001 (3 CFR, 2001 Comp., p. 783 (2002)), as extended most recently by
the Notice of August 12, 2010 (75 FR 50681 (August 16, 2010), has
continued the EAR in effect under the International Emergency Economic
Powers Act. BIS continues to carry out the provisions of the Act, as
appropriate and to the extent permitted by law, pursuant to Executive
Order 13222.

Rulemaking Requirements

    1. This final rule has been determined to be not significant for
the purposes of Executive Order 12866.
    2. This rule involves collections previously approved by the OMB
under control number 0694-0088, ``Multi-Purpose Application,'' which
carries a burden hour estimate of 58 minutes to prepare and submit form
BIS-748; and for recordkeeping, reporting and review requirements in
connection with Authorization Validated End-User, which carries and
estimated burden of 30 minutes per submission. This rule is expected to
result in a decrease in license applications submitted to BIS. Total
burden hours associated with the Paperwork Reduction Act and Office of
Management and Budget control number 0694-0088 are not expected to
increase significantly as a result of this rule.
    Notwithstanding any other provisions of law, no person is required
to respond to nor be subject to a penalty for failure to comply with a
collection of information, subject to the requirements of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that
collection of information displays a currently valid Office of
Management and Budget (OMB) Control Number.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. Pursuant to the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(B), BIS finds good cause to waive requirements that the rule be
subject to notice and the opportunity for public comment because such
notice and comment here are unnecessary. In determining whether to
grant validated end-user designations, a committee of U.S. Government
agencies evaluates information about candidate companies and
commitments made by candidate companies, the nature and terms of which
are set forth in 15 CFR part 748, Supplement No. 8. The criteria for
evaluation by the committee are set forth in 15 CFR Sec.  748.15(a)(2).
    The information, commitments and criteria for this extensive review
were all established through the notice of proposed rulemaking and
public comment process (71 FR 38313, July 2, 2006 and 72 FR 33646, June
19, 2007). Given the similarities between the authorizations provided
under Validated End-User (VEU) and export licenses (as discussed
further below), the publication of this information does not establish
any new policy; in publishing this final rule, BIS is simply adding
validated end-users within the established regulatory framework of the
VEU program. Further, this rule does not abridge the rights of the
public or eliminate the public's option to export under any of the
forms of authorization set forth in the EAR.
    Publication of this rule in other than final form is unnecessary
because the authorization granted in the rule is similar to that
granted to exporters for individual licenses, which do not undergo
public review. Individual license application applicants and VEU
authorization applicants both provide the U.S. Government with
confidential business information. This information is extensively
reviewed according to the criteria for VEU authorizations, as set out
in 15 CFR 748.15(a)(2). Like individual export licenses, VEU
applications are vetted by an interagency committee drawing on public
and non-public sources, including licensing data, and measured against
the VEU authorization criteria. The authorizations granted under the
VEU program, and through individual export licenses, involve
interagency deliberation according to set criteria. Given the thorough
nature of the review, and in light of the parallels between this
process and the non-public review of license applications, public
comment on this authorization prior to publication is unnecessary.
Moreover, as noted above, the criteria and process for authorizing VEUs
were developed with public comments; allowing additional public comment
on this individual VEU authorization, which was determined according to
those criteria, is therefore unnecessary.
    Section 553(d) of the APA generally provides that rules may not
take effect earlier than 30 days after they are published in the
Federal Register. However, section 553(d)(1) of the APA provides that a
substantive rule which grants or recognizes an exemption or relieves a
restriction, may take effect earlier. Today's final rule grants an
exemption from licensing procedures, so we make this final rule
effective immediately.
    No other law requires that a notice of proposed rulemaking and an
opportunity for public comment be given for this final rule. Because a
notice of proposed rulemaking and an opportunity for public comment are
not required to be given for this rule under the Administrative
Procedure Act or by any other law, the analytical requirements of the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are

not applicable and no regulatory flexibility analysis has been
prepared.

List of Subjects in 15 CFR Part 748

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

0
Accordingly, part 748 of the Export Administration Regulations (15 CFR
Parts 730-774) is amended as follows:

PART 748--[AMENDED]

0
1. The authority citation for 15 CFR Part 748 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 12, 2010, 75
FR 50681 (August 16, 2010).

0
2. Supplement No. 7 to Part 748 is amended by adding three entries,
``Hynix Semiconductor China Ltd.'', ``Hynix Semiconductor (Wuxi)
Ltd.'', and ``Lam Research Corporation'', in ``China (People's Republic
of)'' in alphabetical order to read as follows:

SUPPLEMENT NO. 7 TO PART 748--AUTHORIZATION VALIDATED END-USER (VEU);
LIST OF VALIDATED END-USERS, RESPECTIVE ITEMS ELIGIBLE FOR EXPORT,
REEXPORT AND TRANSFER AND ELIGIBLE DESTINATIONS

--------------------------------------------------------------------------------------------------------------------------------------------------------
               Country                   Validated end-user      Eligible items (by ECCN)                       Eligible destination
--------------------------------------------------------------------------------------------------------------------------------------------------------
China (People's Republic of)
                                                                      * * * * * * *
                                      Hynix Semiconductor      3B001.a, 3B001.b, 3B001.c,   Hynix Semiconductor China Ltd. Lot K7/K7-1, Export
                                       China Ltd.               3B001.d, 3B001.e, and        Processing Zone Wuxi, Jiangsu, PR China.
                                                                3B001.f.
                                      Hynix Semiconductor      3B001.a, 3B001.b, 3B001.c,   Hynix Semiconductor (Wuxi) Ltd., Lot K7/K7-1, Export
                                       (Wuxi) Ltd.              3B001.d, 3B001.e, and        Processing Zone, Wuxi, Jiangsu, PR, China.
                                                                3B001.f.
                                      Lam Research             2B230, 2B350.c, 2B350.d,     Lam Research (Shanghai) Service Co., 1st Floor, Area C, Hua
                                       Corporation.             2B350.g, 2B350.h, 2B350.i,   Hong Science & Technology Park, 177 Bi Bo Road Zhangjiang
                                                                3B001.c, 3B001.e (items      Hi-Tech Park, Pudong, Shanghai, China 201203.
                                                                controlled under 3B001.c    Lam Research Shanghai Co., Ltd., No. 1 Jilong Rd., Room 424-
                                                                and 3B001.e are limited to   2, Waigaoqiao Free Trade Zone, Shanghai, China 200131.
                                                                parts and components),      Lam Research International Sarl (Shanghai TSS), c/o HMG
                                                                3D001, 3D002 (limited to     Logistic (Shanghai), Co., Ltd., No.55, West Shang Feng Road
                                                                ``software'' specially       , Tangzhen, Pudong New Area, Shanghai, China 201203.
                                                                designed for the ``use''    Lam Research Shanghai Co., Ltd., (Shanghai WGQ Bonded
                                                                of stored program            Warehouse), No. 55, Fei la Road, Waigaoqiao Free Trade
                                                                controlled items             Zone, Pudong New Area, Shanghai, China 200131.
                                                                classified under ECCN       Lam Research Co., Ltd. (Beijing Branch), Room 322 Dadi
                                                                3B001), and 3E001 (limited   Mansion, No. 18 Hongda Beilu Beijing Economic &
                                                                to ``technology''            Technological Development Area, Beijing, China 100176.
                                                                according to the General    Lam Research Co., Ltd. (Wuxi Representative Office), 5E,
                                                                Technology Note for the      Bldg. C International Science & Technology Park, 2
                                                                ``development'' of           Taishan Road, WND, Wuxi, Jiangsu, China 214028.
                                                                equipment controlled by     Lam Research International Sarl (Wuxi EPZ Bonded Warehouse)
                                                                ECCN 3B001).                 c/o HMG WHL Logistic (Wuxi) Co., Ltd., F1, Area 4, No. 1,
                                                                                Plot J3, No. 5 Gaolang East Road, Export Processing Zone,
                                                                                Wuxi, China 214028.
                                                                                Lam Research Co., Ltd. (Wuhan Representative Office), Room
                                                                                1810, Guanggu International Building B, 456 Luoyu Road,
                                                                                East-Lake Hi-Tech Development Zone, Wuhan City, Hubei
                                                                                Province, China 430074.
                                                                                Lam Research International Sarl (Wuhan TSS), c/o HMG Wuhan
                                                                                Logistic Co., Ltd., 1st--2nd Floor, No. 5 Building, Hua Shi
                                                                                Yuan Er Road, Optical Valley Industry Park, East-Lake Hi-
                                                                                Tech Development Zone, Wuhan City, Hubei Province, China
                                                                                430223.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: October 4, 2010.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2010-25438 Filed 10-8-10; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 86, Number 18 (Friday, January 29, 2021)]
[Notices]
[Page 7551]
[FR Doc No: 2021-01968]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4881-029]

Ada County, Fulcrum, LLC, Barber Pool Hydro, LLC; Notice of
Application for Partial Transfer of License and Soliciting Comments,
Motions To Intervene, and Protests

    On October 28, 2020 and supplemented on January 19, 2021, Ada
County, (transferor), Fulcrum, LLC (co-licensee) and Barber Pool Hydro,
LLC (transferee) filed jointly an application for partial transfer of
license for the Barber Dam Hydroelectric Project No. 4881. The project
is located on the Boise, Columbia and Snake rivers, Ada County, Idaho.
    The applicants seek Commission approval to partially transfer the
license for the Barber Dam Hydroelectric Project from the transferor to
the transferee and keeping Fulcrum, LLC and Barber Pool Hydro, LLC as
co-licensees.
    Applicants Contact: For transferor: Board of Ada County
Commissioners, c/o Ada County Prosecuting Attorney, Ms. Lorna K.
Jorgensen, Civil Division, 200 W Front Street, Room 3191, Boise, ID
83702, Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    For co-licensee: Fulcrum, LLC, c/o Mr. Randall Osteen, General
Counsel, Portfolio Companies, Hull Street Energy, LLC, 4747 Bethesda
Ave., Suite 1220, Bethesda, MD 20814, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    For transferee: Barber Pool Hydro, LLC, c/o Ted S. Sorenson,
Manager, P.O. Box 1855, Idaho Falls, ID 83403, Phone:<PHONE_NUMBER>,
Email<EMAIL_ADDRESS>325f5b405b535a7246415d40575c415d5c1c5c5746.
    FERC Contact: Anumzziatta Purchiaroni,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests 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, you may submit a paper copy.
Submissions sent via U.S. Postal Service must be addressed to, Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Room 1A, Washington, DC 20426. Submissions sent via any
other carrier must be addressed to, Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include docket
number P-4881-029. Comments emailed to Commission staff are not
considered part of the Commission record.

    Dated: January 25, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-01968 Filed 1-28-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 14, 2010 (Volume 75, Number 71)]
[Rules and Regulations]
[Page 19199-19201]
[DOCID:fr14ap10-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1108; Directorate Identifier 2009-NM-131-AD;
Amendment 39-16260; AD 2010-08-05]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A330-200, A330-300, and
A340-300 Series Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    It was noticed in production that in the area between frame (FR)
C53.9 and FR C55 RH [right-hand], the distance between the route 9R
of the In-Flight Entertainment system and the wire harness for the
Lower Deck-Mobile Crew Rest system provisions is too small.
    This limited distance may cause chafing between the affected
electrical harness 6581VB and the harness 5495VB or 6938VB.
    This condition, if not corrected, could lead to the short
circuit of wires dedicated to oxygen, which, in case of emergency,
could result in a large number of passenger oxygen masks not being
supplied with oxygen, possibly causing personal injuries.
* * * * *

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective May 19, 2010.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 19, 2010.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on December 1, 2009 (74
FR 62711). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    It was noticed in production that in the area between frame (FR)
C53.9 and FR C55 RH [right-hand], the distance between the route 9R
of the In-Flight Entertainment system and the wire harness for the
Lower Deck-Mobile Crew Rest system provisions is too small.
    This limited distance may cause chafing between the affected
electrical harness 6581VB and the harness 5495VB or 6938VB.
    This condition, if not corrected, could lead to the short
circuit of wires dedicated to oxygen, which, in case of emergency,
could result in a large number of passenger oxygen masks not being
supplied with oxygen, possibly causing personal injuries.
    For the reasons described above, this AD requires the
installation of a stirrup on the terminal block 5507VT between
FR53.9 and FR54, and the re-routing of the wiring route 9R.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Support for the NPRM

    Northwest Airlines states that it has reviewed the NPRM and
supports the action.

Request To Correct Paragraph Identifier

    Airbus requests that we correct the paragraph identifiers specified
in the applicability statement of the NPRM, changing ``* * * paragraphs
(c)(1)(i) and (c)(1)(ii) * * *'' of the NPRM to ``* * * paragraphs
(c)(1) and (c)(2) * * *'' in this final rule.
    We have corrected the paragraph identifiers in this final rule.

Request To Clarify the Proposed Applicability

    Airbus requests that we clarify the applicability in paragraph
(c)(ii)(A) of the NPRM (now paragraph (c)(2)(i) of this final rule), to
specify the Model A330 airplanes.
    We agree to clarify the applicability. We have clarified the
applicability statement from ``For all models, except

Model A340-311, A340-312, and A340-313 airplanes,'' to ``For Model
A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -
341, -342, and -343 airplanes'' in this final rule.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We determined that these
changes will not increase the economic burden on any operator or
increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Explanation of Change to Costs of Compliance

    After the NPRM was issued, we reviewed the figures we have used
over the past several years to calculate AD costs to operators. To
account for various inflationary costs in the airline industry, we find
it necessary to increase the labor rate used in these calculations from
$80 per work hour to $85 per work hour. The cost impact information,
below, reflects this increase in the specified hourly labor rate.

Costs of Compliance

    We estimate that this AD will affect 43 products of U.S. registry.
We also estimate that it will take about 3 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $66 per product.
Where the service information lists required parts costs that are
covered under warranty, we have assumed that there will be no charge
for these parts. As we do not control warranty coverage for affected
parties, some parties may incur costs higher than estimated here. Based
on these figures, we estimate the cost of this AD to the U.S. operators
to be $13,803, or $321 per product.

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 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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 the NPRM, 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 adding the following new AD:

2010-08-05 Airbus: Amendment 39-16260. Docket No. FAA-2009-1108;
Directorate Identifier 2009-NM-131-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective May 19,
2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A330-201, -202, -203, -223,
-243, -301, -302, -303, -321, -322, -323, -341, -342, and -343
airplanes; and Airbus Model A340-311, -312, and -313 airplanes;
certificated in any category; all manufacturer serial numbers;
modified in production by modifications identified in both
paragraphs (c)(1) and (c)(2) of this AD; excluding those on which
Airbus Modification 57744 has been embodied in production.
    (1) Airbus Modification 40379; and
    (2) One of the following Airbus modifications, as applicable:
    (i) For Model A330-201, -202, -203, -223, -243, -301, -302, -
303, -321, -322, -323, -341, -342, and -343 airplanes: Modification
49894, 51304, 52048, 52712, 53559, 53732, 54115, 55632, or 55722.
    (ii) For Model A340-311, A340-312, and A340-313 airplanes:
Modification 51603, 53400, or 55024.

Subject

    (d) Air Transport Association (ATA) of America Code 92.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    It was noticed in production that in the area between frame (FR)
C53.9 and FR C55 RH [right-hand], the distance between the route 9R
of the In-Flight Entertainment system and the wire harness for the
Lower Deck-Mobile Crew Rest system provisions is too small.
    This limited distance may cause chafing between the affected
electrical harness 6581VB and the harness 5495VB or 6938VB.

    This condition, if not corrected, could lead to the short
circuit of wires dedicated to oxygen, which, in case of emergency,
could result in a large number of passenger oxygen masks not being
supplied with oxygen, possibly causing personal injuries.
    For the reasons described above, this AD requires the
installation of a stirrup on the terminal block 5507VT between
FR53.9 and FR54, and the re-routing of the wiring route 9R.

Actions and Compliance

    (f) Within 24 months after the effective date of this AD, unless
already done: Install a stirrup on the terminal block 5507VT between
FR53.9 and FR54 and modify the wiring route 9R in accordance with
the Accomplishment Instructions of Airbus Mandatory Service Bulletin
A330-92-3080, dated November 12, 2008; or Airbus Mandatory Service
Bulletin A340-92-4080, dated November 12, 2008; as applicable.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference 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.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2009-0076, dated April 6, 2009; Airbus Mandatory Service
Bulletin A330-92-3080, dated November 12, 2008; and Airbus Mandatory
Service Bulletin A340-92-4080, dated November 12, 2008; for related
information.

Material Incorporated by Reference

    (i) You must use Airbus Mandatory Service Bulletin A330-92-3080,
dated November 12, 2008; or Airbus Mandatory Service Bulletin A340-
92-4080, dated November 12, 2008; as applicable; to do the actions
required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; e-mail<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the 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/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on April 1, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-8182 Filed 4-13-10; 8:45 am]
BILLING CODE 4910-13-P