[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Rules and Regulations]
[Pages 67317-67324]
[FR Doc No: 2021-25808]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No.<PHONE_NUMBER>]
RIN 0694-AI60

Addition of Entities and Revision of Entries on the Entity List;
and Addition of Entity to the Military End-User (MEU) List

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 (BIS)
amends the Export Administration Regulations (EAR) by adding twenty-
seven entities to the Entity List. These twenty-seven entities have
been determined by the U.S. Government to be acting contrary to the
national security or foreign policy interests of the United States.
These entities will be listed on the Entity List under the destinations
of the People's Republic of China (China), Japan, Pakistan, and
Singapore. This rule also revises one existing entry on the Entity List
under the destination of China, adds addresses under the destination of
Taiwan for a listed entity, and corrects an entry under the destination
of China. In addition, this rule amends the EAR by adding one entity to
the Military End-User (MEU) List under the destination of Russia.

DATES: This rule is effective November 26, 2021.

FOR FURTHER INFORMATION CONTACT: Chair, End-User Review Committee,
Office of the Assistant Secretary, Export Administration, Bureau of
Industry and Security, Department of Commerce, Phone:<PHONE_NUMBER>,
Fax:<PHONE_NUMBER>, Email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Entity List (supplement no. 4 to part 744 of the EAR)
identifies entities for which there is reasonable cause to believe,
based on specific and articulable facts, that the entities have been
involved, are involved, or pose a significant risk of being or becoming
involved in activities contrary to the national security or foreign
policy interests of the United States. The EAR (15 CFR parts 730-774)
impose additional license requirements on, and limit the availability
of most license exceptions for, exports, reexports, and transfers (in-
country) to listed entities. The license review policy for each listed
entity is identified in the ``License Review Policy'' column on the
Entity List, and the impact on the availability of license exceptions
is described in the relevant Federal Register document adding entities
to the Entity List. BIS places entities on the Entity List pursuant to
part 744 (Control Policy: End-User and End-Use Based) and part 746
(Embargoes and Other Special Controls) of the EAR.
    The MEU List (supplement no. 7 to part 744 of the EAR) identifies
entities that have been determined by the End-User Review Committee
(ERC) to be `military end users' pursuant to Sec.  744.21 of the EAR.
That section imposes additional license requirements on, and limits the
availability of most license exceptions for, exports, reexports, and
transfers (in-country) to listed entities on the MEU List, as specified
in supplement no. 7 to part 744 and in Sec.  744.21 of the EAR.
Entities are listed on the MEU List under the destinations of Burma,
China, Russia, or Venezuela. The license review policy for each listed
entity is identified in the introductory text of the MEU List
(supplement no. 7 to part 744) and in Sec.  744.21(e) of the EAR. The
MEU List's introductory text and Sec.  744.21 of the EAR also specify
the scope of the license requirements and limitations on the use of EAR
license exceptions.
    The ERC, composed of representatives of the Departments of Commerce
(Chair), State, Defense, Energy and, where appropriate, the Treasury,
makes all decisions regarding additions to, removals from, or other
modifications to the Entity List and the MEU List. The ERC makes all
decisions to add an entry to the Entity List and MEU List by majority
vote and all decisions to remove or modify an entry by unanimous vote.

Entity List Decisions

A. Additions to the Entity List

    Under Sec.  744.11(b) (Criteria for revising the Entity List) of
the EAR, entities for which there is reasonable cause to believe, based
on specific and articulable facts, that the entities have been
involved, are involved, or pose a significant risk of being or becoming
involved in activities that are contrary to the national security or
foreign policy interests of the United States, and those acting on
behalf of such entities, may be added to the Entity List. Paragraphs
(b)(1) through (5) of Sec.  744.11 provide an illustrative list of
activities that could be considered contrary to the national security
or foreign policy interests of the United States.
    This rule implements the decision of the ERC to add twenty-seven
entities to the Entity List. These twenty-seven entities will be listed
on the Entity List under the destinations of China, Japan, Pakistan,
and Singapore. The ERC made the decision to add the twenty-seven
entities identified below under the standard set forth in Sec.
744.11(b) of the EAR.
    Specifically, the ERC decided to add three affiliates of Corad
Technology Limited, an entity added to the Entity List under China
(with a Hong Kong address) on August 14, 2019 (84 FR 40241), as
follows: One affiliate in China (Corad Technology (Shenzhen) Ltd.); one
affiliate in Singapore (Corad Technology Pte Ltd.); and one affiliate
in Japan (Corad Technology Japan K.K.). These three affiliates of Corad
Technology Limited have been involved in sales of technology from the
United States and other Western nations to Iran's military and space
programs, Democratic People's Republic of Korea (North Korea) front
companies, and Chinese government and defense industry subordinate
entities. BIS is also adding a reference under Taiwan to one of Corad
Technology Limited's offices, the Corad Taiwan Representative Office,
which has also been involved in such technology sales. Identifying the
office in this manner provides notice to the public that the office is
subject to the Entity List licensing requirements that apply to Corad
Technology Limited. BIS is also making a conforming change to the entry
for Corad Technology Limited located in Hong Kong that directs the
public to the two addresses for the Corad Taiwan Representative Office
in Taiwan.
    The ERC decided to add the following five entities: Hangzhou
Zhongke Microelectronics Co., Ltd., Hunan Goke Microelectronics, New
H3C Semiconductor Technologies Co., Ltd., Xi'an Aerospace Huaxun
Technology, and Yunchip Microelectronics, all located in China, for
their support of the military modernization of the People's Liberation
Army.
    The ERC decided to add three entities in China (Hefei National
Laboratory for Physical Sciences at Microscale, QuantumCTek Co., and
Shanghai QuantumCTeck Co., Ltd.) to the Entity List for acquiring and
attempting to acquire U.S.-origin items in support of military
applications.

    The ERC decided to add Shaanxi Zhi En Electromechanical Technology
Co., Ltd. located in China; and Q&N Traders, U.H.L. Company, Jiuding
Refrigeration & Air-conditioning Equipment Co (Pvt) Ltd, K-SOFT
Enterprises, Seljuk Traders (SMC-Private) Limited, Global Tech
Engineers, Asay Trade & Supplies, and Jade Machinery Pvt. Ltd., all
located in Pakistan, to the Entity List based on their contributions to
Pakistan's unsafeguarded nuclear activities.
    The ERC decided to add Poly Asia Pacific Ltd. (PAPL) and Peaktek
Company Ltd., both entities located in China, to the Entity List based
on its contributions to Pakistan's unsafeguarded nuclear activities.
The ERC also decided to add Al-Qertas, located in Pakistan, to the
Entity List based on their contributions to Pakistan's unsafeguarded
nuclear activities.
    The ERC decided to add Broad Engineering located in Pakistan to the
Entity List based on its contributions to Pakistan's ballistic missile
program.
    The ERC decided to add Prime Tech, located in Pakistan, and two of
its employees, Muhammad Ashraf and Muhammad Farrukh, also located in
Pakistan, to the Entity List for procuring items subject to the EAR on
behalf of Techlinks, an entity located in Pakistan that was added to
the Entity List in September 2018, without the licenses required by
Sec.  744.11(a) of the EAR. See 83 FR 44824 (September 4, 2018; 84 FR
61538 (November 13, 2019)).
    Pursuant to Sec.  744.11(b) of the EAR, the ERC determined that the
conduct of the above-described twenty-seven entities raises sufficient
concerns that prior review, via the imposition of a license requirement
for exports, reexports, or transfers (in-country) of all items subject
to the EAR involving these twenty-seven entities, is appropriate. The
ERC also determined that the possible issuance of license denials or
the possible imposition of license conditions on shipments to these
entities will enhance BIS's ability to prevent violations of the EAR or
otherwise protect U.S. national security or foreign policy interests.
    For the twenty-seven entities added to the Entity List in this
final rule described under this section, Section A, Additions to the
Entity List, BIS imposes a license requirement that applies to all
items subject to the EAR. In addition, no license exceptions are
available for exports, reexports, or transfers (in-country) to the
persons being added to the Entity List in this rule. BIS imposes a
license review policy of a presumption of denial for these twenty-seven
entities.
    For the reasons described above, this final rule adds the following
twenty-seven entities to the Entity List:

China

     Corad Technology (Shenzhen) Ltd.;
     Hangzhou Zhongke Microelectronics Co., Ltd.;
     Hefei National Laboratory for Physical Sciences at
Microscale;
     Hunan Goke Microelectronics;
     New H3C Semiconductor Technologies Co., Ltd.;
     Peaktek Company Ltd.;
     Poly Asia Pacific Ltd., (PAPL);
     QuantumCTek Co., Ltd.;
     Shaanxi Zhi En Electromechanical Technology Co., Ltd.;
     Shanghai QuantumCTek Co., Ltd.;
     Xi'an Aerospace Huaxun Technology; and
     Yunchip Microelectronics.

Japan

     Corad Technology Japan K.K.

Pakistan

     Al-Qertas;
     Asay Trade & Supplies;
     Broad Engineering (Pakistan);
     Global Tech Engineers;
     Jade Machinery Pvt. Ltd.;
     Jiuding Refrigeration & Air-conditioning Equipment Co
(Pvt) Ltd.;
     K-SOFT Enterprises;
     Muhammad Ashraf;
     Muhammad Farrukh;
     Prime Tech;
     Q&N Traders;
     Seljuk Traders (SMC-Private) Limited; and
     U.H.L. Company.

Singapore

     Corad Technology Pte Ltd.

    The acronym ``a.k.a.,'' which is an abbreviation of ``also known
as,'' is used in entries on the Entity List to identify aliases,
thereby assisting exporters, reexporters, and transferors in
identifying entities on the Entity List.

B. Revision to the Entity List

    This rule implements a modification to one existing entry for
``Corad Technology Limited,'' first added to the Entity List under the
destination of China on August 14, 2019 (84 FR 40241 (August 14,
2019)). Specifically, this rule modifies the entry for this entity by
adding a parenthetical sentence that directs the public to the Corad
Taiwan Representative Office's addresses in Taiwan. This rule also
revises the Entity List under Taiwan to add a reference to the Corad
Taiwan Representative office and its addresses.

C. Correction to the Entity List

    This rule implements a correction to one existing entry on the
Entity List under the destination of China. The correction is to the
entity ``Shenzhen Cobber Information Technology Co., Ltd.'' This entity
was added to the Entity List on July 12, 2021 (86 FR 36499 (July 12,
2021)) (``the July 12 rule''). The July 12 rule inadvertently included
a semicolon in the middle of one of the six aliases, ``Shenzhen Kehao
Information; Technology Co., Ltd.,'' thereby raising a question as to
the name of this alias and whether BIS intended to list two separate
aliases. This rule removes the semicolon from this alias, resulting in
the corrected name, ``Shenzhen Kehao Information Technology Co.,
Ltd.,'' and clarifying that BIS listed only six aliases in total.

ERC MEU List Decision

Addition to the MEU List

    Under Sec.  744.21(b) of the EAR, BIS may inform persons either
individually by specific notice, through amendment to the EAR published
in the Federal Register, or through a separate notice published in the
Federal Register, that a license is required for specific exports,
reexports, or transfers (in-country) of any item because there is an
unacceptable risk of use in or diversion to a `military end use' or
`military end user' in Burma, China, Russia, or Venezuela. Under Sec.
744.21(b)(1) of the EAR, BIS may identify entities subject to this
additional prohibition under paragraph (b) that have been determined by
the ERC to be a `military end user' pursuant to Sec.  744.21. These
entities will be added to supplement no. 7 to part 744 (`Military End-
User' (MEU) List) in Federal Register notices published by BIS.
    This rule implements the decision of the ERC to add one entity to
the MEU List. This entity, the Moscow Institute of Physics and
Technology, will be listed on the MEU List under the destination of
Russia. The ERC made the decision to add this entity under the standard
set forth in Sec.  744.21 of the EAR, including the criteria for what
constitutes a `military end use' under paragraph (f) and `military end
user' under paragraph (g). Specifically, the ERC determined to add the
entity on the basis of its production of military end-use products for
a military end-user.
    The license requirement for this entity applies to the export,
reexport, or transfer (in-country) of any item subject to the EAR
listed in supplement no. 2 to part 744. For this entity, BIS imposes a
license review policy of a presumption of denial as set forth in Sec.
744.21(e) of the EAR.
    No license exceptions apart from License Exception GOV (items

authorized under Sec.  740.11(b)(2)(i) and (ii) of the EAR) are
available for exports, reexports, or transfers (in-country) to listed
entities on the MEU List for items specified in supplement no. 2 to
part 744.
    The acronym ``a.k.a.,'' which is an abbreviation of ``also known
as,'' is used in entries on the MEU List to identify aliases, thereby
assisting exporters, reexporters, and transferors in identifying
entities on the MEU List.
    For the reasons described above, this rule adds the following one
entity to the MEU List:

Russia

     Moscow Institute of Physics and Technology.
Savings Clause
    Shipments of items removed from eligibility for a License Exception
or export, reexport, or transfer (in-country) without a license (NLR)
as a result of this regulatory action that were en route aboard a
carrier to a port of export, reexport, or transfer (in-country), on
November 26, 2021, pursuant to actual orders for export, reexport, or
transfer (in-country) to or within a foreign destination, may proceed
to that destination under the previous eligibility for a License
Exception or export, reexport, or transfer (in-country) without a
license (NLR).

Export Control Reform Act of 2018

    On August 13, 2018, the President signed into law the John S.
McCain National Defense Authorization Act for Fiscal Year 2019, which
included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-
4852). ECRA provides the legal basis for BIS's principal authorities
and serves as the authority under which BIS issues this rule.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This final rule has been designated to be not significant
for purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to or 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. This regulation involves
collections previously approved by OMB under control number 0694-0088,
Simplified Network Application Processing System, which includes, among
other things, license applications, and carries a burden estimate of
29.6 minutes for a manual or electronic submission. Total burden hours
associated with the PRA and OMB control number 0694-0088 are not
expected to increase as a result of this rule.
    3. This rule does not contain policies with federalism implications
as that term is defined in Executive Order 13132.
    4. Pursuant to section 1762 of ECRA (see 50 U.S.C. 4821), this
action is exempt from the Administrative Procedure Act (5 U.S.C. 553)
requirements for notice of proposed rulemaking, opportunity for public
participation, and delay in effective date.
    5. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq., are not applicable.
Accordingly, no regulatory flexibility analysis is required and none
has been prepared.

List of Subjects in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, part 744 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR part 744 is revised to read as
follows:

    Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p.
608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026,
61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3
CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp.,
p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice
of September 15, 2021, 86 FR 52069 (September 17, 2021); Notice of
November 10, 2021, 86 FR 62891 (November 12, 2021).

0
2. Supplement No. 4 to part 744 is amended:
0
a. Under CHINA, PEOPLE'S REPUBLIC OF:
0
i. By revising the entry for ``Corad Technology Limited'';
0
ii. By adding in alphabetical order entries for ``Corad Technology
(Shenzhen) Ltd.,'' ``Hangzhou Zhongke Microelectronics Co., Ltd.,''
``Hefei National Laboratory for Physical Sciences at Microscale,''
``Hunan Goke Microelectronics,'' ``New H3C Semiconductor Technologies
Co., Ltd.,'' ``Peaktek Company Ltd.,'' ``Poly Asia Pacific Ltd.,
(PAPL),'' ``QuantumCTek Co., Ltd.,'' ``Shaanxi Zhi En Electromechanical
Technology Co., Ltd.,'' and ``Shanghai QuantumCTek Co., Ltd.'';
0
iii. By revising the entry for ``Shenzhen Cobber Information Technology
Co., Ltd.''; and
0
iv. By adding in alphabetical order entries for ``Xi'an Aerospace
Huaxun Technology'' and ``Yunchip Microelectronics'';
0
b. Under JAPAN, by adding in alphabetical order, an entry for ``Corad
Technology Japan K.K.;''
0
c. Under PAKISTAN, by adding in alphabetical order, entries for ``Al-
Qertas,'' ``Asay Trade & Supplies,'' ``Broad Engineering (Pakistan),''
``Global Tech Engineers,'' ``Jade Machinery Pvt. Ltd.,'' ``Jiuding
Refrigeration & Air-conditioning Equipment Co (Pvt) Ltd.,'' ``K-SOFT
Enterprises,'' ``Muhammad Ashraf,'' ``Muhammad Farrukh,'' ``Prime
Tech,'' ``Q&N Traders,'' ``Seljuk Traders (SMC-Private) Limited,'' and
``U.H.L. Company'';
0
d. Under SINGAPORE, by adding in alphabetical order, entry for ``Corad
Technology Pte Ltd.''; and
0
e. Under TAIWAN, by adding in alphabetical order, an entry for ``Corad
Taiwan Representative Office.''
    The additions and revisions read as follows:

Supplement No. 4 to Part 744--Entity List

* * * * *

----------------------------------------------------------------------------------------------------------------
                                                                              License review    Federal Register
        Country                     Entity             License requirement        policy            citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
CHINA, PEOPLE'S                                                 * * * * * *
 REPUBLIC OF.
                         Corad Technology Limited,     All items subject    Presumption of     84 FR 40241, 8/14/
                          a.k.a., the following one     to the EAR. (See     denial.            19, 85 FR 83769,
                          alias:                        Sec.   744.11 of                        12/23/20. 86 FR
                         --Corad Technology (China)     the EAR).                               [INSERT FR PAGE
                          Limited.                                                              NUMBER] 11/26/
                         Unit 1306, 13/F, Nanyang                                               21.
                          Plaza 57 Hung To Road Kwun
                          Tong, Hong Kong; and Room
                          K, 5/F, Winner Factory
                          Building No. 55 Hung To
                          Road Kwun Tong Kowloon,
                          Hong Kong. (See also
                          addresses under Taiwan for
                          this entry, which is listed
                          as Corad Taiwan
                          Representative Office).
                         Corad Technology (Shenzhen)   All items subject    Presumption of     86 FR [INSERT FR
                          Ltd., a.k.a., the following   to the EAR. (See     denial.            PAGE NUMBER] 11/
                          one alias:                    Sec.   744.11 of                        26/21.
                         --Corad Technology Ltd.        the EAR).
                          (Shenzhen).
                         Rm 0919 1# Xinye Bldg, NO388
                          Tianlin Road, Shanghai,
                          China 518033.
                                                                * * * * * *
                         Hangzhou Zhongke              All items subject    Presumption of     86 FR [INSERT FR
                          Microelectronics Co., Ltd.,   to the EAR. (See     denial.            PAGE NUMBER] 11/
                          10th Floor, Chuangxin         Sec.   744.11 of                        26/21.
                          Building, No. 3850 Jiangnan   the EAR).
                          Ave., High-Tech Binjiang
                          District, Hangzhou City,
                          Zhejiang Province, China.
                                                                * * * * * *
                         Hefei National Laboratory     All items subject    Presumption of     86 FR [INSERT FR
                          for Physical Sciences at      to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Microscale, a.k.a., the       Sec.   744.11 of                        26/21.
                          following two aliases:        the EAR).
                         --National Research Center
                          for Microscale; and
                         --Microscale National
                          Research Center.
                         No. 96, Jinzhai Road, Hefei   ...................
                          National Laboratory for
                          Physical Sciences at the
                          Microscale, University of
                          Science & Technology of
                          China, Hefei, Anhui, 230026
                          China.
                                                                * * * * * *
                         Hunan Goke Microelectronics,  All items subject    Presumption of     86 FR [INSERT FR
                          a.k.a., the following two     to the EAR. (See     denial.            PAGE NUMBER] 11/
                          aliases:                      Sec.   744.11 of                        26/21.
                         --Hunan Guoke                  the EAR).
                          Microelectronics; and
                         --Guokewei.
                         No. 9, South Section of
                          Dongshi Road, Quantang
                          Street, Changsha Economic
                          and, Technological
                          Development Zone, China;
                          and, Room 812, 8th Floor,
                          No. 1, No. 26 Jiannei
                          Street, Dongcheng District,
                          Beijing, China, and, 1305-
                          1308, Building 1, Xunmei
                          Technology Plaza, No. 8,
                          Keyuan Road, Shenzhen,
                          China.
                                                                * * * * * *
                         New H3C Semiconductor         All items subject    Presumption of     86 FR [INSERT FR
                          Technologies Co., Ltd., No.   to the EAR. (See     denial.            PAGE NUMBER] 11/
                          1, Floor 1, Unit 1,           Sec.   744.11 of                        26/21.
                          Building 4, No. 219,          the EAR).
                          Tianhua 2nd Rd., Chengdu
                          High-Tech Zone, China
                          (Sichuan) Pilot Free Trade
                          Zone, China; and
                         Beijing Branch--Room 401,
                          4th Floor, Building 1, No.
                          8 Yard, Yongjia North Road,
                          Haidian District, Beijing,
                          China; and Shanghai Branch--
                          No. 666 Shengxia Rd., 122
                          Yindong Rd., China
                          (Shanghai) Pilot Free Trade
                          Zone, China.
                                                                * * * * * *

                         Peaktek Company Ltd., Room    All items subject    Presumption of     86 FR [INSERT FR
                          803, Chevalier Building, 45-  to the EAR. (See     denial.            PAGE NUMBER] 11/
                          51 Chatham Road, South        Sec.   744.11 of                        26/21.
                          Kowloon, Hong Kong.           the EAR).
                                                                * * * * * *
                         Poly Asia Pacific Ltd.,       All items subject    Presumption of     86 FR [INSERT FR
                          (PAPL), a.k.a., the           to the EAR. (See     denial.            PAGE NUMBER] 11/
                          following alias:              Sec.   744.11 of                        26/21.
                         --Beijing Oriental Vision      the EAR).
                          Petroleum Technology
                          Company Limited (OVTEK-P).
                         Room 1103, Hang Seng Mongkok
                          Building, 677 Nathan Road,
                          Mongkok, Kowloon Hong Kong;
                          and
                         Suite 803, Tower A. Olympic
                          City, Fortune Centre,
                          Beiyuan Road, Chaoyan,
                          District Beijing, China.
                                                                * * * * * *
                         QuantumCTek Co., Ltd.,        All items subject    Presumption of     86 FR [INSERT FR
                          a.k.a., the following four    to the EAR. (See     denial.            PAGE NUMBER] 11/
                          aliases:                      Sec.   744.11 of                        26/21.
                         --HKUST National Shield        the EAR).
                          Quantum Technology Co.,
                          Ltd.;
                         --HKUST Guodun Quantum
                          Technology Co., Ltd.;
                         --National Shield Quantum;
                          and
                         --Anhui Quantum
                          Communication Technology
                          Co., Ltd.
                         Floor 1, 3, 4, 5, 6, 7 of
                          Building D3, 800 Wangjiang
                          West Road, High-tech Zone,
                          Hefei, Anhui, 230088,
                          China.
                                                                * * * * * *
                         Shaanxi Zhi En                All items subject    Presumption of     86 FR [INSERT FR
                          Electromechanical             to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Technology Co., Ltd., Room    Sec.   744.11 of                        26/21.
                          11905, Floor 19, Building     the EAR).
                          1, Daminggong, Wanda Plaza,
                          Taihua North Road, Weiyang
                          District, Xian City,
                          Shaanxi Province, China.
                                                               * * * * * **
                         Shanghai QuantumCTek Co.,     All items subject    Presumption of     86 FR [INSERT FR
                          Ltd., a.k.a., the following   to the EAR. (See     denial.            PAGE NUMBER] 11/
                          one alias:                    Sec.   744.11 of                        26/21.
                         --Shanghai Guodun Quantum      the EAR).
                          Information Technology Co.,
                          Ltd.,
                         3rd Floor, Building 10, 2388
                          Xiupu Road, Pudong New
                          Area, Shanghai, 201315,
                          China; and 99 Xiupu Road,
                          Pudong New Area, Shanghai
                          201206, China.
                                                                * * * * * *
                         Shenzhen Cobber Information   All items subject    Case-by-case       86 FR 36499, 7/12/
                          Technology Co., Ltd.,         to the EAR. (See     review for ECCNs   21.
                          a.k.a., the following six     Sec.   744.11 of     1A004.c,          86 FR [INSERT FR
                          aliases:                      the EAR).            1A004.d, 1A995,    PAGE NUMBER] 11/
                         --X-Face;                                           1A999.a, 1D003,    26/21.
                         --XFaceTech;                                        2A983, 2D983,
                         --Shenzhen Kehao Information                        and 2E983, and
                          Technology Co., Ltd.;                              for EAR99 items
                         --Shenzhen Kepa Information                         described in the
                          Technology;                                        Note to ECCN
                         --Kezhen; and                                       1A995; case-by-
                         --Cobber.                                           case review for
                         6th Floor, Block B, Shenzhen                        items necessary
                          Production and Research                            to detect,
                          Base, Huazhong University                          identify and
                          of Science and Technology,                         treat infectious
                          No. 9 Yuexing 3rd Road,                            disease; and
                          Nanshan District, Shenzhen,                        presumption of
                          Shenzhen, China.                                   denial for all
                                                                             other items
                                                                             subject to the
                                                                             EAR.
                                                                * * * * * *
                         Xi'an Aerospace Huaxun        All items subject    Presumption of     86 FR [INSERT FR
                          Technology, a.k.a., the       to the EAR. (See     denial.            PAGE NUMBER] 11/
                          following one alias:          Sec.   744.11 of                        26/21.
                         --Aerospace Huaxun.            the EAR).

                         10th Floor, Block C, Xi'an
                          National Digital Publishing
                          Base, No. 996 Tiangu 7th
                          Road, Yuhua Street Office,
                          High-Tech Zone, Xi'an,
                          China; and 3F, Huihao
                          International, No. 58, Keji
                          2rd Road, High-Tech Zone,
                          Xi'an City, Shaanxi,
                          Province 710075, China; and
                          No. 1061-1, Section 1, East
                          Second Ring, Hehuayuan St.,
                          Furong District, Changsha
                          City, Hunan Province,
                          China.
                                                                * * * * * *
                         Yunchip Microelectronics,     All items subject    Presumption of     86 FR [INSERT FR
                          a.k.a., the following one     to the EAR. (See     denial.            PAGE NUMBER] 11/
                          alias:                        Sec.   744.11 of                        26/21.
                         --Suzhou Yunxin                the EAR).
                          Microelectronics
                          Technology.
                         Kunshan Huaqiao town double
                          International Business
                          Center, Building 40 Room 7-
                          8, chamber 41, chamber 42,
                          China; and
                         6th Floor, Building 7,
                          Shuanglian International
                          Business Center, 1255
                          Shangyin Road, Huaqiao,
                          Kunshan City, Jiangsu
                          Province, China.
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
JAPAN..................  Corad Technology Japan K.K.,  All items subject    Presumption of     86 FR [INSERT FR
                          1-1 Tsunaskimakamicho,        to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Kohoku-Ku, Yokohama 223-      Sec.   744.11 of                        26/21.
                          0055 Japan.                   the EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
PAKISTAN...............                                         * * * * * *
                         Al-Qertas, 794 Park Lane,     All items subject    Presumption of     86 FR [INSERT FR
                          Chaklala Scheme-III,          to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Rawalpindi, Pakistan.         Sec.   744.11 of                        26/21.
                                                        the EAR).
                                                                * * * * * *
                         Asay Trade & Supplies, 6,     All items subject    Presumption of     86 FR [INSERT FR
                          Nafees Market, A-87 Road,     to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Rawalpindi, Pakistan.         Sec.   744.11 of                        26/21.
                                                        the EAR).
                                                                * * * * * *
                         Broad Engineering             All items subject    Presumption of     86 FR [INSERT FR
                          (Pakistan), House 130,        to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Street No. 109, G-11/3,       Sec.   744.11 of                        26/21.
                          Islamabad, Pakistan.          the EAR).
                                                                * * * * * *
                         Global Tech Engineers,        All items subject    Presumption of     86 FR [INSERT FR
                          Office Number 1, 1st Floor,   to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Al Mairaj Center Street       Sec.   744.11 of                        26/21.
                          Number 1, Sector G-11/1,      the EAR).
                          Islamabad, Pakistan.
                                                                * * * * * *
                         Jade Machinery Pvt. Ltd.,     All items subject    Presumption of     86 FR [INSERT FR
                          109-A, St # 4 Cavalry         to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Ground, Lahore, Punjab        Sec.   744.11 of                        26/21.
                          54000, Pakistan.              the EAR).
                                                                * * * * * *
                         Jiuding Refrigeration & Air-  All items subject    Presumption of     86 FR [INSERT FR
                          conditioning Equipment Co     to the EAR. (See     denial.            PAGE NUMBER] 11/
                          (Pvt) Ltd.,                   Sec.   744.11 of                        26/21.
                         107 Sughra Tower, F-11         the EAR).
                          Markaz Islamabad, Pakistan.
                                                                * * * * * *
                         K-SOFT Enterprises, Office    All items subject    Presumption of     86 FR [INSERT FR
                          No. 10, First Floor, Al-      to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Hafeez Tower, MM Alam Road,   Sec.   744.11 of                        26/21.
                          Gulberg, Lahore, Pakistan.    the EAR).
                                                                * * * * * *

                         Muhammad Ashraf, Office No.   All items subject    Presumption of     86 FR [INSERT FR
                          11, 1st., Floor MICCOP        to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Center, 1-Mozang Road,        Sec.   744.11 of                        26/21.
                          Lahore-54000, Pakistan; and   the EAR).
                          699 Khayaban-e-Suhrwardy,
                          Abpara Market, Islamabad
                          44000 Pakistan.
                         Muhammad Farrukh, Office No.  All items subject    Presumption of     86 FR [INSERT FR
                          11, 1st., Floor MICCOP        to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Center, 1-Mozang Road,        Sec.   744.11 of                        26/21.
                          Lahore-54000, Pakistan.       the EAR).
                                                                * * * * * *
                         Prime Tech, Office No. 11,    All items subject    Presumption of     86 FR [INSERT FR
                          1st., Floor MICCOP Center,    to the EAR. (See     denial.            PAGE NUMBER] 11/
                          1-Mozang Road, Lahore-        Sec.   744.11 of                        26/21.
                          54000, Pakistan; and 699      the EAR).
                          Khayaban-e-Suhrwardy,
                          Abpara Market, Islamabad
                          44000 Pakistan.
                                                                * * * * * *
                         Q&N Traders, Office 1, Flat   All items subject    Presumption of     86 FR [INSERT FR
                          2, Anjum Plaza, Near TCS      to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Centre, New Mall Chowk,       Sec.   744.11 of                        26/21.
                          Bahria Enclave Road,          the EAR).
                          Islamabad, Pakistan.
                                                                * * * * * *
                         Seljuk Traders (SMC-Private)  All items subject    Presumption of     86 FR [INSERT FR
                          Limited, Ch. Zakir House,     to the EAR. (See     denial.            PAGE NUMBER] 11/
                          Main Tamma Road, Next to      Sec.   744.11 of                        26/21.
                          Jinnah Muslim Law College,    the EAR).
                          P.O. Tarlai Kalan
                          Islamabad, 45550, Pakistan.
                                                                * * * * * *
                         U.H.L. Company, 8/35 Arkay    All items subject    Presumption of     86 FR [INSERT FR
                          Square, Sharah-e-Liaquat,     to the EAR. (See     denial.            PAGE NUMBER] 11/
                          New Chali, Karachi,           Sec.   744.11 of                        26/21.
                          Pakistan.                     the EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
SINGAPORE..............                                         * * * * * *
                         Corad Technology Pte Ltd.,    All items subject    Presumption of     86 FR [INSERT FR
                          10 UBI Crescent, #04-43 UBI   to the EAR. (See     denial.            PAGE NUMBER] 11/
                          TechPark, Singapore,          Sec.   744.11 of                        26/21.
                          408564; and 11 Kallang Pl,    the EAR).
                          03-04, Whampoa, Singapore.
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
TAIWAN.................                                         * * * * * *
                         Corad Taiwan Representative   All items subject    Presumption of     86 FR [INSERT FR
                          Office, 1A, No. 30 Jiazheng   to the EAR. (See     denial.            PAGE NUMBER] 11/
                          9th St., Zhubei City,         Sec.   744.11 of                        26/21.
                          Hsinchu County 30274; and     the EAR).
                         3F-1, No. 1008, Sec. 4,
                          Johngsing Rd., Jhudong
                          Township, Hsinchu County,
                          310 Taiwan. (See also
                          addresses under China for
                          this entry, which is listed
                          as Corad Technology
                          Limited).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

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

* * * * *

0
3. Supplement No. 7 to part 744 is amended under RUSSIA by adding in
alphabetical order an entry for ``Moscow Institute of Physics and
Technology'' to read as follows:

Supplement No. 7 to Part 744--``Military End-User'' (MEU) List

* * * * *

------------------------------------------------------------------------
                                                        Federal Register
            Country                     Entity              citation
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
RUSSIA........................                 * * * * * *

                                Moscow Institute of     86 FR [INSERT FR
                                 Physics and             PAGE NUMBER] 11/
                                 Technology, a.k.a.,     26/21.
                                 the following two
                                 aliases:
                                --MIPT; and...........
                                --MFTI................
                                Dolgoprudny Campus: 9
                                 Institutskiy per.,
                                 Dolgoprudny, Moscow
                                 Region 141701,
                                 Russia; and.
                                Zhukovsky Campus:
                                 Ulitsa Gagarina 16,
                                 Zhukovsky, Moscow
                                 Region 140180,
                                 Russia; and.
                                Moscow Campus 1
                                 Stroyeniye 1,
                                 Klimentovsky
                                 Pereulok, Moscow
                                 Region 115184, Russia.
                                               * * * * * *
------------------------------------------------------------------------

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

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2021-25808 Filed 11-24-21; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12735-12737]
[FR Doc No: 2022-04709]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0861]

OSHA Strategic Partnership Program (OSPP) for Worker Safety and
Health; Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

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

ACTION: Request for public comments.

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

SUMMARY: OSHA solicits public comments concerning the proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the OSHA Strategic
Partnership Program (OSPP) for Worker Safety and Health.

DATES: Comments must be submitted (postmarked, sent, or received) by
May 6, 2022.

ADDRESSES:
    Electronically: You may submit comments, including attachments,
electronically at http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the instructions online for submitting comments.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov. Documents in the docket are
listed in the http://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<PHONE_NUMBER> (TTY<PHONE_NUMBER>)
for assistance in locating docket submissions.
    Instructions: All submissions must include the agency name and the
OSHA docket number for this Federal Register notice (OSHA-2011-0861).
OSHA will place comments and requests to speak, including personal
information, in the public docket, which may be available online.
Therefore, OSHA cautions interested parties about submitting personal
information such as Social Security numbers and birthdates. For further
information on submitting comments, see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Seleda Perryman or Theda Kenney,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of the continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with a minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining said information (29 U.S.C. 657).
    The OSPP allows OSHA to enter into an extended, voluntary,
cooperative relationship with groups of employers, employees, and
representatives (sometimes including other stakeholders, and sometimes
involving only one employer) to encourage, assist, and recognize their
efforts to eliminate serious hazards and to achieve a high level of
worker safety and health that goes beyond what historically has been
achieved from traditional enforcement methods. Each OSHA Strategic
Partnership (OSP) determines what information will be needed,
determining the best collection method, and clarifying how the
information will be used. At a minimum, each OSP must identify baseline
injury and illness data corresponding to all summary line items on the
OSHA 300 logs and must track changes at either the worksite level or
participant-aggregate level. An OSP may also include other measures of
success, such as training activity, self-inspections, and/or workers'
compensation data. In this regard, the information collection
requirements for the OSPP are used by the agency to gauge the
effectiveness of programs, identify needed improvements, and ensure
that resources are being used effectively and appropriately.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the agency's functions,
including whether the information is useful;
     the accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     the quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    The agency is requesting an adjustment increase of 4,466 burden
hours of the previous approval from 14,014 to 18,480 hours. The
increase in burden is a result of increase in the number of employers
and participants.
    Type of Review: Extension of a currently approved collection.
    Title: OSHA Strategic Partnership Program (OSPP) for Worker Safety
and Health.
    OMB Control Number: 1218-0244.
    Affected Public: Businesses or other for-profits.
    Total Number of Responses: 3,040.
    Frequency of Responses: On occasion.
    Average Time: Various.
    Estimated Total Burden Hours: 18,480.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. 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 docket by hand, express mail, messenger, and courier service. All
comments, attachments, and other material must identify the agency name
and the OSHA docket number for this ICR (Docket No. OSHA-2011-0861).
You may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or a facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify electronic comments by
your name, date, and the docket number so the agency can attach them to
your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments.
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information, such as their social security number
and date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office.
    Information on using the http://www.regulations.gov website to
submit comments and access the docket is available at the website's
``User Tips'' link. Contact the OSHA Docket Office for information
about materials not available from the website and for assistance in
using the internet to locate docket submissions.

V. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the

preparation of this notice. The authority for this notice is the
Paperwork Reduction Act of 1995 (44 U.S.C. 3506 et seq.) and Secretary
of Labor's Order No. 1-2012 (77 FR 3912).

    Signed at Washington, DC, on February 25, 2022.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2022-04709 Filed 3-4-22; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: December 17, 2007 (Volume 72, Number 241)]
[Notices]
[Page 71392]
[DOCID:fr17de07-53]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER07-1236-000; ER07-1236-001; ER07-1236-002]

Yuma Cogeneration Associates; Notice of Issuance of Order

December 10, 2007.
    Yuma Cogeneration Associates (Yuma) filed an application for
market-based rate authority, with an accompanying market-based rate
tariff. The proposed market-based rate tariff provides for the sale of
energy, capacity and ancillary services at market-based rates. Yuma so
requested waivers of various Commission regulations. In particular,
Yuma requested that the Commission grant blanket approval under 18 CFR
part 34 of all future issuances of securities and assumptions of
liability by Yuma.
    On December 4, 2007, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development-West, granted the requests
for blanket approval under Part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by Yuma, should file a protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing protests is
January 7, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Yuma is authorized to issue securities
and assume obligations or liabilities as a guarantor, indorser, surety,
or otherwise in respect of any security of another person; provided
that such issuance or assumption is for some lawful object within the
corporate purposes of Yuma, compatible with the public interest, and is
reasonably necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Yuma's issuance of securities or assumptions of
liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also 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
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a) (1) (iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-24306 Filed 12-14-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17439-17440]
[FR Doc No: 2015-07438]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0838]

Procedures for Meetings of the Medical Devices Advisory
Committee; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Procedures for Meetings
of the Medical Devices Advisory Committee.'' The Center for Devices and
Radiological Health (CDRH) is issuing this guidance to provide
additional information regarding the processes for meetings of the
Medical Devices Advisory Committee panels other than the Dispute
Resolution Panel (DRP). This guidance describes the general
circumstances in which CDRH consults with a panel, the process for
exchange of information between CDRH, the members of the panel,
industry, and the public, and the conduct of panel meetings. This
guidance supplements existing FDA Agency-wide guidance on the conduct
of Advisory Committee meetings. This draft guidance is not final nor is
it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 1, 2015.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Procedures for Meetings of the Medical Devices Advisory Committee''
to the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: James Swink, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1609, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    CDRH is issuing this draft guidance to provide additional
information regarding the processes for meetings of the Medical Devices
Advisory Committee panels other than the DRP. The term ``panel,'' as
used in this guidance, refers to the panels established under the
Medical Devices Advisory Committee charter excluding the DRP. This
guidance describes the

general circumstances in which CDRH consults with a panel of the
Medical Devices Advisory Committee, the process for exchange of
information between CDRH, the members of the panel, industry, and the
public, and the conduct of panel meetings. The Medical Devices Advisory
Committee includes 17 panels other than the DRP (Ref. 1). The panels,
according to their specialty area and authorization, advise the
Commissioner of Food and Drugs in discharging responsibilities as they
relate to assuring the safety and effectiveness of medical devices, and
as required, any other product for which FDA has regulatory
responsibility.
    This draft guidance is intended to provide more comprehensive
information for industry and for CDRH staff on the processes associated
with a panel meeting held for any of the reasons identified in the
guidance. Once final, this guidance will replace the ``Guidance on
Amended Procedures for Advisory Panel Meetings'' (Ref. 2) and the
guidance document entitled ``Panel Review of Premarket Approval
Applications #P91-2 blue book memo'' (Ref. 3). This guidance
supplements existing FDA Agency-wide guidance on the conduct of
Advisory Committee meetings.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the panel
meeting process for medical devices. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov. Persons unable to download an electronic
copy of ``Procedures for Meetings of the Medical Devices Advisory
Committee'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 413 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 860 have been approved under OMB control
number 0910-0138; the collections of information in 21 CFR part 814
have been approved under OMB control number 0910-0231; and the
collections of information in 21 CFR part 814, subpart H have been
approved under OMB control number 0910-0332.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

    1. CDRH's Medical Devices Advisory Committee, available at
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm.
    2. ``Guidance for Industry and FDA Staff: Guidance on Amended
Procedures for Advisory Panel Meetings,'' July 2000, available at
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073726.pdf.
    3. ``Panel Review of Premarket Approval Applications #P91-2
(blue book memo),'' May 1991, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081363.htm.

    Dated: March 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07438 Filed 3-31-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 201 (Tuesday, October 18, 2011)]
[Notices]
[Pages 64337-64338]
[FR Doc No: 2011-26862]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-7-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline LLC submits tariff filing per
154.204: Negotiated Rate 2011-10-05 Concord to be effective 10/6/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5043.
    Comment Date: 5 p.m. Eastern Time on Monday, October 17, 2011.

    Docket Numbers: RP12-8-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Midcontinent Express Pipeline LLC submits tariff
filing per 154.204: Tariff Clean Up Filing to be effective 11/5/2011.
    Filed Date: 10/06/2011.
    Accession Number: 20111006-5079.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 18, 2011.

    Docket Numbers: RP12-9-000.
    Applicants: Natural Gas Pipeline Company of America LLC.

    Description: Penalty Revenue Crediting Report of Natural Gas
Pipeline Company of America LLC.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5043.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 19, 2011.

    Docket Numbers: RP12-10-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Trunkline Gas Company, LLC submits tariff filing per
154.204: Negotiated Rates Filing, to be effective 10/8/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5085.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 19, 2011.

    Docket Numbers: RP12-11-000.
    Applicants: Gas Transmission Northwest LLC.
    Description: Gas Transmission Northwest LLC submits tariff filing
per 154.204, to be effective 6/27/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5099.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 19, 2011.

    Docket Numbers: RP12-12-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Trailblazer Pipeline Company LLC submits tariff filing
per 154.204: Negotiated Rate Filing--Shell Energy to be effective 9/1/
2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5113.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 19, 2011.

    Docket Numbers: RP12-13-000.
    Applicants: Williston Basin Interstate Pipeline Company.
    Description: Williston Basin Interstate Pipeline Company submits
tariff filing per 154.204: New Injection/Withdrawal Language to be
effective 11/10/2011.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5010.
    Comment Date: 5 p.m. Eastern Time on Monday, October 24, 2011.

    Docket Numbers: CP11-550-000.
    Applicants: Colorado Interstate Gas Company.
    Description: Petition to Amend Certificate Order of Colorado
Interstate Gas Company.
    Filed Date: 09/23/2011.
    Accession Number: 20110923-5103.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 19, 2011.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP11-2456-001.
    Applicants: Empire Pipeline, Inc.
    Description: Empire Pipeline, Inc. submits tariff filing per
154.205(b): Changes--Tioga Expansion Project--Update to be effective
10/28/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5062.
    Comment Date: 5 p.m. Eastern Time on Monday, October 17, 2011.

    Docket Numbers: RP10-1018-002.
    Applicants: Paiute Pipeline Company.
    Description: Paiute Pipeline Company submits tariff filing per:
Place Facilities into Service re: Docket CP10-41 to be effective N/A.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5058.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 19, 2011.

    Docket Numbers: RP11-2577-001.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, Inc. submits tariff filing per
154.205(b): DTI--Abandonment of X-71 and X-72 Amendment to be effective
11/1/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5028.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 19, 2011.

    Docket Numbers: RP11-2652-001.
    Applicants: ANR Pipeline Company.
    Description: ANR Pipeline Company submits tariff filing per
154.205(b): Amended Filing to RP11-2652 to be effective 11/1/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5072.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 19, 2011.

    Docket Numbers: RP11-2638-001.
    Applicants: Midwestern Gas Transmission Company.
    Description: Midwestern Gas Transmission Company submits tariff
filing per 154.205(b): Amendment to Non-Conforming Agreements (BP et
al) to be effective 11/1/2011.
    Filed Date: 10/06/2011.
    Accession Number: 20111006-5121.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 18, 2011.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: October 11, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-26862 Filed 10-17-11; 8:45 am]
BILLING CODE 6717-01-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2009-0547; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; West
Virginia; Determination of Clean Data for the 1997 Fine Particulate
Matter Standard

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to determine that the West Virginia portions
of three nonattainment areas for the 1997 fine particulate (PM2.5)
National Ambient Air Quality Standard (NAAQS) have clean data for the
1997 PM2.5 NAAQS.  These are Berkeley County, part of the
Hagerstown-Martinsburg MD-WV nonattainment area; Wood County, part of
the Parkersburg-Marietta WV-OH nonattainment area;  and Marshall County
and Ohio County, part of the  Wheeling WV-OH nonattainment area,
hereinafter referred to in this notice as the West Virginia portions of
the Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling PM2.5
nonattainment areas.  This proposed determination is based upon quality
assured, quality controlled, and certified ambient air monitoring data
that show that these areas have monitored attainment of the 1997 PM2.5
NAAQS based on 2006 - 2008 data.  In addition, quality controlled and
quality assured monitoring data for 2009 that are available in the EPA
Air Quality System (AQS) database, but not yet certified, show these
areas continue to have clean data for the 1997 PM2.5 NAAQS.  If this
proposed determination is made final, the requirements for these areas
to submit an attainment demonstration, associated reasonably available
measures, a reasonable further progress plan, contingency measures, and
other planning State Implementation Plans (SIPs) related to attainment
of the standard shall be suspended for so long as the area continues to
meet the 1997 PM2.5 NAAQS.

DATES: Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2009-0547 by one of the following methods:

 www.regulations.gov.  Follow the on-line instructions for submitting
comments.

B.    	E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.    	Mail:  EPA- R03-OAR-2009-0547, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.   	Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket’s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2009-0547.  EPA's policy is that all comments received will
be included in the public docket without change, and

may be made available online at   HYPERLINK "http://www.regulations.gov"
 www.regulations.gov , including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.  Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov website is an “anonymous access” system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment.  If you send an
e-mail comment directly to EPA without going through
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet.  If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit.  If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.  Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT:  Marilyn Powers,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  Throughout this document whenever “we,”
“us,” or “our” is used, we mean EPA.

Organization of this document.  The following outline is provided to aid
in locating information in this preamble.

I.    What Action is EPA Taking?

II.   What is the Effect of This Action?

III.  What is the Background for This Action?

IV.  What is EPA’s Analysis of the Relevant Air Quality Data?

V.   Proposed Action

VI.  Statutory and Executive Order Reviews

I.  What Action is EPA Taking?

EPA is proposing to determine that the West Virginia portions of the
Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling PM2.5
nonattainment areas have clean data for the 1997 PM2.5 NAAQS.  This
determination is based upon quality assured, quality controlled, and
certified ambient air monitoring data that show these areas have
monitored attainment of the 1997 PM2.5 NAAQS based on 2006 – 2008
data.  In addition, quality controlled and quality assured monitoring
data for 2009 that are available in the EPA AQS database, but not yet
certified, show this area continues to attain the 1997 PM2.5 NAAQS.

II.  What is the Effect of This Action?

If this determination is made final, under the provisions of EPA’s
PM2.5 implementation rule (see 40 CFR section 51.1004(c)), the
requirements for the West Virginia portions of the Hagerstown-
Martinsburg, Parkersburg-Marietta, and Wheeling PM2.5 nonattainment
areas to submit an attainment demonstration, associated reasonably
available control measures, a reasonable further progress plan,
contingency measures, and any other planning SIPs related to attainment
of the 1997 PM2.5 NAAQS would be suspended for so long as these areas
continue to meet the 1997 PM2.5 NAAQS.

As further discussed below, the proposed determination would:  (1) for
the West Virginia portions of the Hagerstown- Martinsburg,
Parkersburg-Marietta, and Wheeling PM2.5 nonattainment areas, suspend
the requirements to submit an attainment demonstration, associated
reasonably available control measures (RACM) (including reasonably
available control technologies (RACT)), a reasonable further progress
(RFP) plan, contingency measures, and any other planning SIPs related to
attainment of  the 1997 PM2.5 NAAQS; (2) continue until such time, if
any, that EPA subsequently determines that these areas have violated the
1997 PM2.5 NAAQS; (3) be separate from, and not influence or otherwise
affect, any future designation determination or requirements for the
Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling areas based
on the 2006 PM2.5 NAAQS; and (4) remain in effect regardless of whether
EPA designates these areas as nonattainment areas for purposes of the
2006 PM2.5 NAAQS.  Furthermore, as described below, any such final
determination would not be equivalent to the redesignation of the area
to attainment based on the 1997 PM2.5 NAAQS.

If this rulemaking is finalized and EPA subsequently determines, after
notice-and-comment rulemaking in the Federal Register, that these areas
have violated the 1997 PM2.5 NAAQS, the basis for the suspension of the
specific requirements, set forth at 40 CFR section 51.1004(c), would no
longer exist, and these areas would thereafter have to address the
pertinent requirements.

EPA’s determination that the air quality data for these areas shows
clean data for the 1997 PM2.5 NAAQS, as proposed in this Federal
Register notice, is not equivalent to the redesignation of the areas to
attainment.  This proposed action, if finalized, would not constitute a
redesignation to attainment under section 107(d)(3) of the Clean Air Act
(CAA), because we would not yet have an approved maintenance plan for
these areas as required under section 175A of the CAA, nor a
determination that these areas have met the other requirements for
redesignation.  The designation status of these areas would remain
nonattainment for the 1997 PM2.5 NAAQS until such time as EPA determines
that these areas meet the CAA requirements for redesignation to
attainment.

This proposed action, if finalized, is limited to a determination that
the West Virginia portions of the Hagerstown-Martinsburg,
Parkersburg-Marietta, and Wheeling PM2.5 nonattainment areas have clean
data for the 1997 PM2.5 NAAQS.  The 1997 PM2.5 NAAQS became effective on
July 18, 1997 (62 FR 36852) and are set forth at 40 CFR section 50.7.
The 2006 PM2.5 NAAQS, which became effective on December 18, 2006 (71 FR
61144) are set forth at 40 CFR section 50.13.  At this point, EPA is
currently in the process of making designation determinations, as
required by CAA section 107(d)(1), for the 2006 PM2.5 NAAQS.  EPA has
not made any designation determination for the Hagerstown-Martinsburg,
Parkersburg-Marietta, and Wheeling areas based on the 2006 PM2.5 NAAQS.
This proposed determination, and any final determination, will have no
effect on, and is not related to, any future designation determination
that EPA may make based on the 2006 PM2.5 NAAQS for the
Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling areas.
Conversely, any future designation determination of the
Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling areas, based
on the 2006 PM2.5 NAAQS, will not have any effect on the determination
proposed by this notice.

If this proposed determination is made final and the
Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling nonattainment
areas continue to demonstrate attainment with the 1997 PM2.5 NAAQS, the
requirements for the West Virginia portions of the
Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling nonattainment
areas to submit an attainment demonstration, associated reasonably
available control measures, a reasonable further progress plan,
contingency measures, and any other planning SIPs related to attainment
of the 1997 PM2.5 NAAQS would remain suspended, regardless of whether
EPA designates this area as a nonattainment area for purposes of the
2006 PM2.5 NAAQS.  Once the area is designated for the 2006 NAAQS, it
will have to meet all applicable requirements for that designation.

III.  What is the Background for This Action?

On July 18, 1997 (62 FR 36852), EPA established a health-based PM2.5
NAAQS at 15.0 micrograms per cubic meter (µg/m3) based on a 3-year
average of annual mean PM2.5 concentrations, and a twenty-four hour
standard of 65 µg/m3 based on a 3-year average of the 98th percentile
of 24-hour concentrations.  EPA established the standards based on
significant evidence and numerous health studies demonstrating that
serious health effects are associated with exposures to particulate
matter.  The process for designating areas following promulgation of a
new or revised NAAQS is contained in section 107(d)(1) of the CAA.  EPA
and State air quality agencies initiated the monitoring process for the
1997 PM2.5 NAAQS in 1999, and developed all air quality monitors by
January 2001.  On January 5, 2005 (70 FR 944), EPA published its air
quality designations and classifications for the 1997 PM2.5 NAAQS based
upon air quality monitoring data from those monitors for calendar years
2001-2003.  These designations became effective on April 5, 2005.  The
Hagerstown-Martinsburg nonattainment area (Berkeley County, WV and
Washington County, MD), the Parkersburg-Marietta nonattainment area
(Wood County, WV and Washington County, OH), and the Wheeling
nonattainment area (Marshall County, WV, Ohio County, WV, and Belmont
County, OH) were designated nonattainment for the 1997 PM2.5 NAAQS (see
40 CFR part 81).

IV.  What is EPA’s Analysis of the Relevant Air Quality Data?

EPA has reviewed the ambient air monitoring data for PM2.5, consistent
with the requirements contained in 40 CFR part 50 and recorded in the
EPA AQS database for the Hagerstown-Martinsburg, Parkersburg-Marietta,
and Wheeling PM2.5 nonattainment areas from 2006 to the present time. On
the basis of that review, EPA has concluded that these areas are meeting
the 1997 PM2.5 NAAQS based on 2006 – 2008 data.  In addition, quality
controlled and quality assured monitoring data for 2009 that are
available in the EPA AQS database, but not yet certified, show these
areas continue to attain the 1997 PM2.5 NAAQS.

Under EPA regulations at 40 CFR Part 50, section 50.7:

(1) The annual primary and secondary PM2.5 standards are met when the
annual arithmetic mean concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 15.0 µg/m3;

(2) The 24-hour primary and secondary PM2.5 standards are met when the
98th percentile 24-hour concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 65 µg/m3.

Tables 1.a, 1.b, and 1.c show the 2006 – 2008 design values for the
1997 Annual PM2.5 NAAQS for the Hagerstown-Martinsburg,
Parkersburg-Marietta, and Wheeling nonattainment area monitors,
respectively.  Table 2.a, 2.b, and 2.c show the 2006 - 2008 design
values for the 1997 24-Hour PM2.5 NAAQS for these same respective
monitors.  All design values in the tables are in micrograms per cubic
inch (µg/m3).

Table 1.a - Annual Design Values for Hagerstown-Martinsburg MD-WV

Location	AQS site ID	1997 Annual PM2.5  Standard	2006 – 2008 Design
Values

Berkeley County, WV	540030003	15	14.9

Washington County, MD	240430009	15	12.2

Table 1.b - Annual Design Values for Parkersburg-Marietta WV-OH

Location	AQS site ID	1997 Annual PM2.5   Standard	2006 – 2008 Design
Values

Wood County	541071002	15	14.6

Note:  There are no PM2.5 monitors in the Ohio portion of this
nonattainment area.

Table 1.c - Annual Design Values for Wheeling WV-OH

Location	AQS site ID	1997 Annual PM2.5  Standard	2006 – 2008 Design
Values

Marshal County, WV	540511002	15	14.2

Ohio County, WV	540690010	15	13.7

Note:  There are no PM2.5 monitors in the Ohio portion of this
nonattainment area.

Table 2.a - 24-Hour Design Values for Hagerstown-Martinsburg MD-WV

Location	AQS site ID	1997 24-Hour PM2.5  Standard	2006 – 2008

Design Values

Berkeley County, WV	540030003	65	31

Washington County, MD	240430009	65	30

Table 2.b - 24-Hour Design Values for Parkersburg-Marietta WV-OH

Location	AQS site ID	1997 24-Hour PM2.5  Standard	2006 – 2008

Design Values

Wood County, WV	541071002	65	34

Note:  There are no PM2.5 monitors in the Ohio portion of this
nonattainment area.

Table 2.c - 24-Hour Design Values for Wheeling WV-OH

Location	AQS site ID	1997 24-Hour PM2.5  Standard	2006 – 2008

Design Values

Marshall County, WV	540511002	65	34

Ohio County, WV	540690010	65	31

Note:  There are no PM2.5 monitors in the Ohio portion of this
nonattainment area.

EPA’s review of these data indicate that the Martinsburg-Hagerstown
MD-WV, Parkersburg-Marietta WV-OH, and Wheeling WV-OH nonattainment
areas have met and continue to meet the 1997 PM2.5 NAAQS.  EPA is
soliciting public comments on the issues discussed in this document.
These comments will be considered before taking final action.

V.   Proposed Action

EPA is proposing to determine that the West Virginia portions of the
Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling nonattainment
areas have clean data for the 1997 PM2.5 NAAQS.  As provided in 40 CFR
section 51.1004(c), if EPA finalizes this determination, it would
suspend the requirements for these areas to submit an attainment
demonstration, associated reasonably available control measures, a
reasonable further progress plan, contingency measures, and any other
planning SIPs related to attainment of the 1997 PM2.5 NAAQS so long as
these areas continue to attain the 1997 PM2.5 NAAQS.

VI. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  Accordingly,
this action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law.  For that reason, this proposed action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR 43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355, May 22, 2001);

is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
Clean Air Act; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this proposed determination that the West Virginia portions
of the Hagerstown-Martinsburg, Parkersburg-Marietta, and Wheeling
nonattainment areas have clean data for the 1997 PM2.5 standard does not
have tribal implications as specified by Executive Order 13175 (65 FR
67249, November 9, 2000), because the SIP is not approved to apply in
Indian country located in the state, and EPA notes that it will not
impose substantial direct costs on tribal governments or preempt tribal
law.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Particulate matter,
Reporting and recordkeeping requirements.

Authority: 42 U.S.C. 7401 et seq.

                    Judith M. Katz for

                    William C. Early

_July 23, 2009________
__________________________

Dated:
            William C. Early, Acting

                 Regional Administrator,

                 Region III.

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