Additions to the Entity List; Amendment To Confirm Basis for Adding Certain Entities to the Entity List Includes Foreign Policy Interest of Protection of Human Rights Worldwide, 18983-18987 [2023-06663]
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18983
Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Rules and Regulations
TABLE 13 TO PARAGRAPH (F)(1) TO § 431.97—MINIMUM EFFICIENCY STANDARDS FOR VARIABLE REFRIGERANT FLOW
MULTI-SPLIT AIR CONDITIONERS AND HEAT PUMPS—Continued
Cooling capacity
Heating type 1
Efficiency level
Compliance date:
equipment
manufactured on
and after . . .
≥65,000 Btu/h and <135,000 Btu/h ......
≥135,000 Btu/h and <760,000 Btu/h ....
All .....................................................
Without Heat Recovery ...................
With Heat Recovery ........................
12.0 EER, 4.2 COP .....
10.0 EER, 3.9 COP .....
9.8 EER, 3.9 COP .......
October 29, 2003.
October 29, 2013.
October 29, 2013.
Equipment type
1 VRF multi-split heat pumps (air-cooled) with heat recovery fall under the category of ‘‘All Other Types of Heating’’ unless they also have electric resistance heating, in which case it falls under the category for ‘‘No Heating or Electric Resistance Heating.’’
(2) Each variable refrigerant flow air
conditioner or heat pump (except aircooled systems with cooling capacity
less than 65,000 Btu/h) manufactured
on or after January 1, 2024, must meet
the applicable minimum energy
efficiency standard level(s) set forth in
table 14 of this section.
TABLE 14 TO PARAGRAPH (F)(2) TO § 431.97—UPDATED MINIMUM EFFICIENCY STANDARDS FOR VARIABLE REFRIGERANT
FLOW MULTI-SPLIT AIR CONDITIONERS AND HEAT PUMPS
Equipment type
Size category
Heating type
VRF Multi-Split Air Conditioners (Air-Cooled) ........
≥65,000 and <135,000 Btu/h ....................
≥135,000 and <240,000 Btu/h ..................
≥240,000 Btu/h and <760,000 Btu/h ........
≥65,000 and <135,000 Btu/h ....................
All ..............................................................
All ..............................................................
All ..............................................................
Heat Pump without Heat Recovery ..........
Heat Pump with Heat Recovery ...............
Heat Pump without Heat Recovery ..........
Heat Pump with Heat Recovery ...............
Heat Pump without Heat Recovery ..........
Heat Pump with Heat Recovery ...............
Heat Pump without Heat Recovery ..........
Heat Pump with Heat Recovery ...............
Heat Pump without Heat Recovery ..........
Heat Pump with Heat Recovery ...............
Heat Pump without Heat Recovery ..........
Heat Pump with Heat Recovery ...............
Heat Pump without Heat Recovery ..........
Heat Pump with Heat Recovery ...............
VRF Multi-Split Heat Pumps (Air-Cooled) .............
≥135,000 and <240,000 Btu/h ..................
≥240,000 Btu/h and <760,000 Btu/h ........
VRF Multi-Split Heat Pumps (Water-Source) ........
<65,000 Btu/h ...........................................
≥65,000 and <135,000 Btu/h ....................
≥135,000 and <240,000 Btu/h ..................
≥240,000 Btu/h and <760,000 Btu/h ........
*
*
*
*
*
[FR Doc. 2023–06178 Filed 3–29–23; 8:45 a.m.]
BILLING CODE 6450–01–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 744
[Docket No. 230324–0084]
RIN 0694–AJ20
Additions to the Entity List;
Amendment To Confirm Basis for
Adding Certain Entities to the Entity
List Includes Foreign Policy Interest of
Protection of Human Rights Worldwide
Background
Bureau of Industry and
Security, Department of Commerce.
ACTION: Final rule.
AGENCY:
In this rule, the Bureau of
Industry and Security (BIS) amends the
Export Administration Regulations
(EAR) by adding eleven entities to the
Entity List under the destinations of
Burma, the People’s Republic of China
(China), Nicaragua, and Russia. These
eleven entities have been determined by
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SUMMARY:
VerDate Sep<11>2014
15:57 Mar 29, 2023
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the U.S. Government to be acting
contrary to the national security or
foreign policy interests of the United
States. In this rule, BIS also amends the
EAR to explicitly confirm that the
foreign policy interest of protecting
human rights worldwide is a basis for
adding entities to the Entity List.
DATES: This rule is effective on March
28, 2023.
FOR FURTHER INFORMATION CONTACT:
Chair, End-User Review Committee,
Office of the Assistant Secretary for
Export Administration, Bureau of
Industry and Security, Department of
Commerce, Phone: (202) 482–5991,
Email: ERC@bis.doc.gov.
SUPPLEMENTARY INFORMATION:
The Entity List (supplement no. 4 to
part 744 of the EAR (15 CFR parts 730
through 774)) 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, pursuant
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to § 744.11(b). The EAR impose
additional license requirements on, and
limit the availability of, most license
exceptions for exports, reexports, and
transfers (in-country) when a listed
entity is a party to the transaction. 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 that
added the entity to the Entity List. The
Bureau of Industry and Security (BIS)
places entities on the Entity List
pursuant to parts 744 (Control Policy:
End-User and End-Use Based) and 746
(Embargoes and Other Special Controls)
of the EAR.
The End-User Review Committee
(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. The ERC makes all
decisions to add an entry to the Entity
List by majority vote and makes all
decisions to remove or modify an entry
by unanimous vote.
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Entity List Decisions
A. Additions to the Entity List
The ERC determined to add two
entities, Aviatech and Aviazapchast,
under the destination of Russia, and
three entities, Miya Win, Myanmar New
Era Trading Company, and Suntac
Group, under the destination of Burma,
to the Entity List for engaging in
activities contrary to U.S. foreign policy
interests. These additions are being
made because Aviatech, Avizapchast,
Miya Win, Myanmar New Era Trading
Company, and Suntac Group sell,
procure, and service military equipment
that enables Burma’s military regime to
carry out human rights abuses, as well
as brutal aerial attacks that have killed
and injured civilians. These activities
are contrary to the foreign policy
interests of the United States under
§ 744.11(b) of the EAR. For these five
entities, BIS imposes a license
requirement for all items subject to the
EAR and will review license
applications under a presumption of
denial.
The ERC determined to add the
Nicaraguan National Police (NNP) to the
Entity List under the destination of
Nicaragua for engaging in activities
contrary to U.S. foreign policy interests.
This addition is being made because the
NNP is responsible for or complicit in,
or has directly or indirectly engaged in,
serious human rights abuses in
Nicaragua. These activities are contrary
to the foreign policy interests of the
United States under § 744.11(b) of the
EAR. For this entity, BIS imposes a
license requirement for all items subject
to the EAR and will review license
applications under a presumption of
denial.
The ERC determined to add the
following five entities: Luopu Haishi
Dingxin Electronic Technology Co.,
Ltd., Moyu Haishi Electronic
Technology Co., Ltd., Pishan Haishi
Yong’an Electronic Technology Co.,
Ltd., Urumqi Haishi Xin’an Electronic
Technology Co., Ltd., and Yutian Haishi
Meitian Electronic Technology Co., Ltd.,
to the Entity List under the destination
of China, for engaging in activities
contrary to U.S. foreign policy interests.
These additions are being made because
Luopu Haishi Dingxin Electronic
Technology Co., Ltd., Moyu Haishi
Electronic Technology Co., Ltd., Pishan
Haishi Yong’an Electronic Technology
Co., Ltd., Urumqi Haishi Xin’an
Electronic Technology Co., Ltd., and
Yutian Haishi Meitian Electronic
Technology Co., Ltd. have been
implicated in human rights violations
and abuses in the implementation of
China’s campaign of repression, mass
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arbitrary detention and high-technology
surveillance against the Uyghur people
and members of other Muslim minority
groups in the Xinjiang Uyghur
Autonomous Region (XUAR). These
activities are contrary to the foreign
policy interests of the United States
under § 744.11(b) of the EAR. For these
five entities, BIS imposes a license
requirement for all items subject to the
EAR and will review license
applications under a presumption of
denial.
For the reasons described above, this
final rule adds the following eleven
entities to the Entity List and includes,
where appropriate, aliases:
Burma
• Miya Win International Ltd.,
• Myanmar New Era Trading Company
Ltd., and
• Suntac Group.
China
• Luopu Haishi Dingxin Electronic
Technology Co., Ltd.,
• Moyu Haishi Electronic Technology
Co., Ltd.,
• Pishan Haishi Yong’an Electronic
Technology Co., Ltd.,
• Urumqi Haishi Xin’an Electronic
Technology Co., Ltd., and
• Yutian Haishi Meitian Electronic
Technology Co., Ltd.,
Nicaragua
• Nicaraguan National Police (NNP).
Russia
• Aviatech Supply Ltd., and
• Aviazapchast PLC.
B. Amendment to § 744.11—License
Requirements That Apply to Entities
Acting or at Significant Risk of Acting
Contrary to the National Security or
Foreign Policy Interests of the United
States: Explicit Inclusion of Protection
of Human Rights To Further U.S.
Foreign Policy Interests
As part of BIS’s ongoing review and
update of the EAR to further the foreign
policy interest of protecting human
rights, consistent with the Export
Control Reform Act of 2018 (ECRA), in
this rule BIS amends the ‘‘Criteria for
revising the Entity List’’ paragraph (b)
introductory text and the ‘‘is informed’’
provisions of paragraph (c)(3)
(Additional prohibition on persons
informed by BIS) of § 744.11 to
explicitly confirm a longstanding
position that the protection of human
rights throughout the world is a foreign
policy interest considered in assessing
whether the activities of an entity—and
those acting on behalf of such entity are
contrary to the national security or
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foreign policy of the United States. This
amendment is consistent with the
foreign policy objectives set forth at 50
U.S.C. 4811(2)(D), which include the
protection of human rights and
promotion of democracy.
BIS is amending this provision to
confirm this foreign policy interest and
its potential application to the Entity
List, similar to the current illustrative
list of examples of activities that could
lead to an entity’s addition to the Entity
List, as set forth in § 744.11(b)(1)–(5) of
the EAR. This amendment is consistent
with the recent decision by the United
States Court of Appeals for the District
of Columbia Circuit in Changji Esquel
Textile Co. Ltd. v. Raimondo, 40 F.4th
716 (2022), which affirmed BIS’s
authority to add parties to the Entity
List for human rights-related reasons. In
that case, the Court found that ‘‘[a]dding
human-rights violators to the Entity List
falls comfortably within’’ the scope of
50 U.S.C. 4813(a)(16), which authorizes
the Secretary of Commerce to
‘‘undertake any other action as is
necessary to carry out this subchapter
that is not otherwise prohibited by law,’’
and that it did not ‘‘discern any clear
and mandatory prohibition on adding
entities to the [Entity] List for humanrights abuses, particular given the
breadth of section 4813(a)(16) and the
deference we owe to the Executive
Branch in matters of foreign affairs.’’ Id.
at 723, 725.
Further, and as noted by the Court in
the Esquel decision (Id. at 720), years
before the enactment of ECRA, BIS
made explicit reference in its Entity List
rules to the agency’s longstanding
authority to take action under the Entity
List to address human rights concerns.
For example, the background sections of
two Entity List rules published in
November 2012 and April 2014,
respectively, each cite a range of
‘‘grounds for inclusion,’’ among them
‘‘activities contrary to U.S. national
security or foreign policy interests,
including terrorism and export control
violations involving abuse of human
rights’’ (77 FR 71,097 (Nov. 29, 2012));
79 FR 21,394 (Apr. 16, 2014)). These
rules relied upon authority set forth in
the Export Administration Act of 1979,
as amended, (50 U.S.C. 4601–4623
(Supp. III 2015)), specifically, Section 6
(Foreign Policy Controls). This
provision’s Congressional supporters
intended that foreign policy controls
apply to human rights concerns,
including ‘‘changing the human rights
policy of another country.’’ H.R. Rep.
No. 96–200, at 7 (1979) (Comm. Rep.).
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Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Rules and Regulations
Savings Clause
For the changes being made in this
final rule, shipments of items removed
from eligibility for a License Exception
or export, reexport, or transfer (incountry) 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 March 28, 2023, 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) before April 27,
2023. Any such items not actually
exported, reexported, or transferred (incountry) before midnight, on April 27,
2023, require a license in accordance
with this final rule.
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
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1. This rule has been determined 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 an information collection
approved by OMB under control
number 0694–0088, Simplified Network
Application Processing System. BIS
does not anticipate a change to the
burden hours associated with this
collection as a result of this rule.
Information regarding the collection,
including all supporting materials, can
be accessed at https://www.reginfo.gov/
public/do/PRAMain.
Country
*
BURMA
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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 the
Export Control Reform Act of 2018, 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 through 774) is amended as
follows:
PART 744—CONTROL POLICY: ENDUSER AND END-USE BASED
1. The authority citation for 15 CFR
part 744 continues 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 19, 2022,
87 FR 57569 (September 21, 2022); Notice of
November 8, 2022, 87 FR 68015 (November
10, 2022).
2. Section 744.11 is amended by
revising the last sentence of paragraph
(b) introductory text and the first
sentence of paragraph (c)(3) to read as
follows:
■
§ 744.11 License Requirements that Apply
to Entities Acting or at Significant Risk of
Acting Contrary to The National Security or
Foreign Policy Interests of the United
States.
*
*
*
Entity
*
(b) * * * Paragraphs (b)(1) through
(5) of this section provide an illustrative
list of activities that could be or
represent a significant risk of being
contrary to the national security or
foreign policy interests of the United
States, including the foreign policy
interest of the protection of human
rights throughout the world.
*
*
*
*
*
(c) * * *
(3) The export, reexport, or transfer
(in-country) of specified items to a
certain party because there is reasonable
cause to believe, based on specific and
articulable facts, that the entity has been
involved, is involved, or poses 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, including
the foreign policy interest of the
protection of human rights throughout
the world, and those acting on behalf of
such entity. * * *
3. Supplement no. 4 to part 744 is
amended by:
■ a. Under BURMA, adding entries in
alphabetical order for ‘‘Miya Win
International Ltd.,’’ ‘‘Myanmar New Era
Trading Company Ltd.,’’ and ‘‘Suntac
Group’’;
■ b. Under CHINA, PEOPLE’S
REPUBLIC OF, adding entries in
alphabetical order for ‘‘Luopu Haishi
Dingxin Electronic Technology Co.,
Ltd.,’’ ‘‘Moyu Haishi Electronic
Technology Co., Ltd.,’’ ‘‘Pishan Haishi
Yong’an Electronic Technology Co.,
Ltd.,’’ ‘‘Urumqi Haishi Xin’an Electronic
Technology Co., Ltd.,’’ and ‘‘Yutian
Haishi Meitian Electronic Technology
Co., Ltd.’’;
■ c. Adding in alphabetical order the
destination of NICARAGUA under the
Country Column, and the entry
‘‘Nicaraguan National Police (NNP)’’;
and
■ d. Under RUSSIA, adding entries in
alphabetical order for ‘‘Aviatech Supply
Ltd.’’ and ‘‘Aviazapchast PLC’’.
The additions read as follows:
■
Supplement No. 4 to Part 744—Entity
List
*
*
License requirement
*
*
*
License review policy
*
Federal Register citation
*
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15:57 Mar 29, 2023
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CHINA, PEOPLE’S REPUBLIC OF
NICARAGUA
VerDate Sep<11>2014
Entity
License requirement
License review policy
Federal Register citation
Miya Win International Ltd., 3rd street,
Thit Sarhousing, No.3/401, (8) Ward,
South Okkalapatownship, Yangon
Region,
Burma,
11091;
and
Kokkineresidence Street, No.12/B,
Shwe Taungkyar (2) Ward, Bahan
Township, Yangon Region, Burma,
11201.
*
*
Myanmar New Era Trading Company
Ltd., Bo Myint Swe Street, No. (B/
193), Aung Chan Thar (2) Ward,
Thanlyin Township, Yangon Region,
Burma, 01–655200.
*
*
Suntac Group, a.k.a., the following one
alias:
-Suntac International Trading Co.; and
-Suntac Group of Companies.
151 (B) Thiri Mingalar Lane, Mayangon
Township, Yangon, Burma.
*
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
Presumption of denial ......
88 FR [INSERT FR PAGE
NUMBER ] 3/30/2023.
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
*
*
Presumption of denial ......
*
88 FR [INSERT FR PAGE
NUMBER] 3/30/2023.
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
*
*
Presumption of denial ......
*
88 FR [INSERT FR PAGE
NUMBER] 3/30/2023.
*
*
*
*
*
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*
*
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*
Luopu Haishi Dingxin Electronic Technology Co., Ltd., a.k.a., the following
two aliases:
-Luo Pu District HaiShi Ding Xin Electronic Technology Co., Ltd.; and
-Luopu County Haishi Dingxin Electronic Technology Co., Ltd.
No.8, South Side, National Highway
315, Luopu County Petroleum Company Hotan Prefecture, Xinjiang,
848201 China.
*
*
Moyu Haishi Electronic Technology
Co., Ltd., No. 7, Yinhe North Road,
Moyu County Hotan Prefecture,
Xinjiang, 848100 China.
*
*
Pishan Haishi Yong’an Electronic Technology Co., Ltd., a.k.a., the following
two aliases:
-PiShan Haishi YongAn Electronic
Technology Co., Ltd.; and
-Pishan Haishi Yongan Electronic
Technology Co., Ltd.
No. 28, Guma North Road, Pishan
County, Hotan Prefecture, Xinjiang,
845150 China.
*
*
Urumqi Haishi Xin’an Electronic Technology Co., Ltd., Room 5010–5021,
Block A, Yingke Plaza, No. 217
Gaoxin Street, Xinshi District, Hightech Industrial Development Zone
Wulumuqi, Xinjiang, 830011 China.
*
*
Yutian Haishi Meitian Electronic Technology Co., Ltd., No. 9, Tuanjie
Road, Yutian County Hotan Prefecture, Xinjiang, 848499 China.
*
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
Presumption of denial ......
88 FR [INSERT FR PAGE
NUMBER ] 3/30/2023.
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
*
*
Presumption of denial ......
*
88 FR [INSERT FR PAGE
NUMBER ] 3/30/2023.
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
*
*
Presumption of denial ......
*
88 FR [INSERT FR PAGE
NUMBER ] 3/30/2023.
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
*
*
Presumption of denial ......
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
*
*
Presumption of denial ......
Nicaraguan National Police (NNP),
4PJP+GFP, Managua 11132, Nicaragua.
For all items subject to
the EAR. (See § 744.11
of the EAR)
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Country
Entity
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RUSSIA
*
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*
*
*
*
*
*
License review policy
*
*
*
Aviatech Supply Ltd., a.k.a., the following two aliases:
-Aviatech; and
-Aviatechexport Ltd.
630123, Aeroport St. Build.1A, 3rd
Floor, Novosibirsk, Russia.
Aviazapchast PLC, 48, Ivana Franko
Street, Moscow, 121351, Russia.
*
*
License requirement
*
[FR Doc. 2023–06663 Filed 3–28–23; 4:15 pm]
BILLING CODE 3510–33–P
SECURITIES AND EXCHANGE
COMMISSION
*
88 FR [INSERT FR PAGE
NUMBER]
3/30/2023
For all items subject to
the EAR. (See § 744.11
of the EAR)
*
Presumption of denial ......
88 FR [INSERT FR PAGE
NUMBER ] 3/30/2023.
*
*
*
*
*
BILLING CODE 0099–10–P
General Rules and Regulations,
Securities Exchange Act of 1934
CFR Correction
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
revision of the Code of Federal
Regulations.
■ In Title 17 of the Code of Federal
Regulations, Part 240, revised as of
April 1, 2022, in section 240.13e–100,
reinstate the paragraphs at the end of
the section following ‘‘Item 16.
Exhibits’’ to read as follows:
§ 240.13e–100 Schedule 13E–3,
Transaction statement under section 13(e)
of the Securities Exchange Act of 1934 and
Rule 13e–3 (§ 240.13e–3) thereunder.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA–2021–N–0310]
RIN 0910–AI32
Medical Devices; Orthopedic Devices;
Classification of Spinal Spheres for
Use in Intervertebral Fusion
Procedures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or Agency) is
issuing a final rule to classify spinal
spheres for use in intervertebral fusion
procedures (an unclassified,
preamendments device) into class III for
which FDA is separately requiring the
lllllllllllllllllllll filing of a premarket approval
application (PMA). FDA has determined
(Signature)
lllllllllllllllllllll that general controls and special
controls together are insufficient to
(Name and title)
lllllllllllllllllllll provide reasonable assurance of safety
and effectiveness for this device.
(Date)
DATES
: This rule is effective May 1,
Instruction to Signature: The
2023.
statement must be signed by the filing
person or that person’s authorized
ADDRESSES: For access to the docket to
representative. If the statement is signed read background documents or
SUMMARY:
*
*
*
*
Signature. After due inquiry and to
the best of my knowledge and belief, I
certify that the information set forth in
this statement is true, complete and
correct.
lotter on DSK11XQN23PROD with RULES1
*
VerDate Sep<11>2014
15:57 Mar 29, 2023
Jkt 259001
PO 00000
*
*
*
Presumption of denial ......
[FR Doc. 2023–06701 Filed 3–29–23; 8:45 am]
17 CFR Part 240
*
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
on behalf of a person by an authorized
representative (other than an executive
officer of a corporation or general
partner of a partnership), evidence of
the representative’s authority to sign on
behalf of the person must be filed with
the statement. The name and any title of
each person who signs the statement
must be typed or printed beneath the
signature. See § 240.12b–11 with respect
to signature requirements.
*
Thea D. Rozman Kendler,
Assistant Secretary for Export
Administration.
Federal Register citation
Frm 00023
Fmt 4700
Sfmt 4700
*
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this final rule, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Constance Soves, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1656, Silver Spring,
MD 20993–0002, 301–796–6951,
Constance.Soves@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the
Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used
Acronyms in This Document
III. Background
A. History of This Rulemaking
B. Summary of Comments to the Proposed
Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA
Response
A. Introduction
B. Description of Comments and FDA
Response
VI. Effective/Compliance Dates
VII. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With
Indian Tribal Governments
XII. Reference
I. Executive Summary
A. Purpose of the Final Rule
FDA is classifying spinal spheres for
use in intervertebral fusion procedures
(spinal spheres), which are unclassified,
preamendments devices, into class III. A
E:\FR\FM\30MRR1.SGM
30MRR1
Agencies
[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Rules and Regulations]
[Pages 18983-18987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06663]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 744
[Docket No. 230324-0084]
RIN 0694-AJ20
Additions to the Entity List; Amendment To Confirm Basis for
Adding Certain Entities to the Entity List Includes Foreign Policy
Interest of Protection of Human Rights Worldwide
AGENCY: Bureau of Industry and Security, Department of Commerce.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: In this rule, the Bureau of Industry and Security (BIS) amends
the Export Administration Regulations (EAR) by adding eleven entities
to the Entity List under the destinations of Burma, the People's
Republic of China (China), Nicaragua, and Russia. These eleven 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.
In this rule, BIS also amends the EAR to explicitly confirm that the
foreign policy interest of protecting human rights worldwide is a basis
for adding entities to the Entity List.
DATES: This rule is effective on March 28, 2023.
FOR FURTHER INFORMATION CONTACT: Chair, End-User Review Committee,
Office of the Assistant Secretary for Export Administration, Bureau of
Industry and Security, Department of Commerce, Phone: (202) 482-5991,
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Background
The Entity List (supplement no. 4 to part 744 of the EAR (15 CFR
parts 730 through 774)) 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, pursuant to Sec. 744.11(b). The EAR impose additional license
requirements on, and limit the availability of, most license exceptions
for exports, reexports, and transfers (in-country) when a listed entity
is a party to the transaction. 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 that
added the entity to the Entity List. The Bureau of Industry and
Security (BIS) places entities on the Entity List pursuant to parts 744
(Control Policy: End-User and End-Use Based) and 746 (Embargoes and
Other Special Controls) of the EAR.
The End-User Review Committee (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. The ERC makes
all decisions to add an entry to the Entity List by majority vote and
makes all decisions to remove or modify an entry by unanimous vote.
[[Page 18984]]
Entity List Decisions
A. Additions to the Entity List
The ERC determined to add two entities, Aviatech and Aviazapchast,
under the destination of Russia, and three entities, Miya Win, Myanmar
New Era Trading Company, and Suntac Group, under the destination of
Burma, to the Entity List for engaging in activities contrary to U.S.
foreign policy interests. These additions are being made because
Aviatech, Avizapchast, Miya Win, Myanmar New Era Trading Company, and
Suntac Group sell, procure, and service military equipment that enables
Burma's military regime to carry out human rights abuses, as well as
brutal aerial attacks that have killed and injured civilians. These
activities are contrary to the foreign policy interests of the United
States under Sec. 744.11(b) of the EAR. For these five entities, BIS
imposes a license requirement for all items subject to the EAR and will
review license applications under a presumption of denial.
The ERC determined to add the Nicaraguan National Police (NNP) to
the Entity List under the destination of Nicaragua for engaging in
activities contrary to U.S. foreign policy interests. This addition is
being made because the NNP is responsible for or complicit in, or has
directly or indirectly engaged in, serious human rights abuses in
Nicaragua. These activities are contrary to the foreign policy
interests of the United States under Sec. 744.11(b) of the EAR. For
this entity, BIS imposes a license requirement for all items subject to
the EAR and will review license applications under a presumption of
denial.
The ERC determined to add the following five entities: Luopu Haishi
Dingxin Electronic Technology Co., Ltd., Moyu Haishi Electronic
Technology Co., Ltd., Pishan Haishi Yong'an Electronic Technology Co.,
Ltd., Urumqi Haishi Xin'an Electronic Technology Co., Ltd., and Yutian
Haishi Meitian Electronic Technology Co., Ltd., to the Entity List
under the destination of China, for engaging in activities contrary to
U.S. foreign policy interests. These additions are being made because
Luopu Haishi Dingxin Electronic Technology Co., Ltd., Moyu Haishi
Electronic Technology Co., Ltd., Pishan Haishi Yong'an Electronic
Technology Co., Ltd., Urumqi Haishi Xin'an Electronic Technology Co.,
Ltd., and Yutian Haishi Meitian Electronic Technology Co., Ltd. have
been implicated in human rights violations and abuses in the
implementation of China's campaign of repression, mass arbitrary
detention and high-technology surveillance against the Uyghur people
and members of other Muslim minority groups in the Xinjiang Uyghur
Autonomous Region (XUAR). These activities are contrary to the foreign
policy interests of the United States under Sec. 744.11(b) of the EAR.
For these five entities, BIS imposes a license requirement for all
items subject to the EAR and will review license applications under a
presumption of denial.
For the reasons described above, this final rule adds the following
eleven entities to the Entity List and includes, where appropriate,
aliases:
Burma
Miya Win International Ltd.,
Myanmar New Era Trading Company Ltd., and
Suntac Group.
China
Luopu Haishi Dingxin Electronic Technology Co., Ltd.,
Moyu Haishi Electronic Technology Co., Ltd.,
Pishan Haishi Yong'an Electronic Technology Co., Ltd.,
Urumqi Haishi Xin'an Electronic Technology Co., Ltd., and
Yutian Haishi Meitian Electronic Technology Co., Ltd.,
Nicaragua
Nicaraguan National Police (NNP).
Russia
Aviatech Supply Ltd., and
Aviazapchast PLC.
B. Amendment to Sec. 744.11--License Requirements That Apply to
Entities Acting or at Significant Risk of Acting Contrary to the
National Security or Foreign Policy Interests of the United States:
Explicit Inclusion of Protection of Human Rights To Further U.S.
Foreign Policy Interests
As part of BIS's ongoing review and update of the EAR to further
the foreign policy interest of protecting human rights, consistent with
the Export Control Reform Act of 2018 (ECRA), in this rule BIS amends
the ``Criteria for revising the Entity List'' paragraph (b)
introductory text and the ``is informed'' provisions of paragraph
(c)(3) (Additional prohibition on persons informed by BIS) of Sec.
744.11 to explicitly confirm a longstanding position that the
protection of human rights throughout the world is a foreign policy
interest considered in assessing whether the activities of an entity--
and those acting on behalf of such entity are contrary to the national
security or foreign policy of the United States. This amendment is
consistent with the foreign policy objectives set forth at 50 U.S.C.
4811(2)(D), which include the protection of human rights and promotion
of democracy.
BIS is amending this provision to confirm this foreign policy
interest and its potential application to the Entity List, similar to
the current illustrative list of examples of activities that could lead
to an entity's addition to the Entity List, as set forth in Sec.
744.11(b)(1)-(5) of the EAR. This amendment is consistent with the
recent decision by the United States Court of Appeals for the District
of Columbia Circuit in Changji Esquel Textile Co. Ltd. v. Raimondo, 40
F.4th 716 (2022), which affirmed BIS's authority to add parties to the
Entity List for human rights-related reasons. In that case, the Court
found that ``[a]dding human-rights violators to the Entity List falls
comfortably within'' the scope of 50 U.S.C. 4813(a)(16), which
authorizes the Secretary of Commerce to ``undertake any other action as
is necessary to carry out this subchapter that is not otherwise
prohibited by law,'' and that it did not ``discern any clear and
mandatory prohibition on adding entities to the [Entity] List for
human-rights abuses, particular given the breadth of section
4813(a)(16) and the deference we owe to the Executive Branch in matters
of foreign affairs.'' Id. at 723, 725.
Further, and as noted by the Court in the Esquel decision (Id. at
720), years before the enactment of ECRA, BIS made explicit reference
in its Entity List rules to the agency's longstanding authority to take
action under the Entity List to address human rights concerns. For
example, the background sections of two Entity List rules published in
November 2012 and April 2014, respectively, each cite a range of
``grounds for inclusion,'' among them ``activities contrary to U.S.
national security or foreign policy interests, including terrorism and
export control violations involving abuse of human rights'' (77 FR
71,097 (Nov. 29, 2012)); 79 FR 21,394 (Apr. 16, 2014)). These rules
relied upon authority set forth in the Export Administration Act of
1979, as amended, (50 U.S.C. 4601-4623 (Supp. III 2015)), specifically,
Section 6 (Foreign Policy Controls). This provision's Congressional
supporters intended that foreign policy controls apply to human rights
concerns, including ``changing the human rights policy of another
country.'' H.R. Rep. No. 96-200, at 7 (1979) (Comm. Rep.).
[[Page 18985]]
Savings Clause
For the changes being made in this final rule, 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 March 28, 2023, 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) before April 27, 2023.
Any such items not actually exported, reexported, or transferred (in-
country) before midnight, on April 27, 2023, require a license in
accordance with this final rule.
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. This rule has been determined 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 an
information collection approved by OMB under control number 0694-0088,
Simplified Network Application Processing System. BIS does not
anticipate a change to the burden hours associated with this collection
as a result of this rule. Information regarding the collection,
including all supporting materials, can be accessed at https://www.reginfo.gov/public/do/PRAMain.
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 the Export Control Reform Act of
2018, 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 through 774) is amended as follows:
PART 744--CONTROL POLICY: END-USER AND END-USE BASED
0
1. The authority citation for 15 CFR part 744 continues 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 19, 2022, 87 FR 57569 (September 21, 2022); Notice of
November 8, 2022, 87 FR 68015 (November 10, 2022).
0
2. Section 744.11 is amended by revising the last sentence of paragraph
(b) introductory text and the first sentence of paragraph (c)(3) to
read as follows:
Sec. 744.11 License Requirements that Apply to Entities Acting or at
Significant Risk of Acting Contrary to The National Security or Foreign
Policy Interests of the United States.
* * * * *
(b) * * * Paragraphs (b)(1) through (5) of this section provide an
illustrative list of activities that could be or represent a
significant risk of being contrary to the national security or foreign
policy interests of the United States, including the foreign policy
interest of the protection of human rights throughout the world.
* * * * *
(c) * * *
(3) The export, reexport, or transfer (in-country) of specified
items to a certain party because there is reasonable cause to believe,
based on specific and articulable facts, that the entity has been
involved, is involved, or poses 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, including the foreign
policy interest of the protection of human rights throughout the world,
and those acting on behalf of such entity. * * *
0
3. Supplement no. 4 to part 744 is amended by:
0
a. Under BURMA, adding entries in alphabetical order for ``Miya Win
International Ltd.,'' ``Myanmar New Era Trading Company Ltd.,'' and
``Suntac Group'';
0
b. Under CHINA, PEOPLE'S REPUBLIC OF, adding entries in alphabetical
order for ``Luopu Haishi Dingxin Electronic Technology Co., Ltd.,''
``Moyu Haishi Electronic Technology Co., Ltd.,'' ``Pishan Haishi
Yong'an Electronic Technology Co., Ltd.,'' ``Urumqi Haishi Xin'an
Electronic Technology Co., Ltd.,'' and ``Yutian Haishi Meitian
Electronic Technology Co., Ltd.'';
0
c. Adding in alphabetical order the destination of NICARAGUA under the
Country Column, and the entry ``Nicaraguan National Police (NNP)''; and
0
d. Under RUSSIA, adding entries in alphabetical order for ``Aviatech
Supply Ltd.'' and ``Aviazapchast PLC''.
The additions read as follows:
Supplement No. 4 to Part 744--Entity List
* * * * *
----------------------------------------------------------------------------------------------------------------
License review Federal Register
Country Entity License requirement policy citation
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
BURMA * * * * * *
[[Page 18986]]
Miya Win International Ltd., For all items Presumption of 88 FR [INSERT FR
3rd street, Thit subject to the denial. PAGE NUMBER ] 3/
Sarhousing, No.3/401, (8) EAR. (See Sec. 30/2023.
Ward, South 744.11 of the EAR)
Okkalapatownship, Yangon
Region, Burma, 11091; and
Kokkineresidence Street,
No.12/B, Shwe Taungkyar (2)
Ward, Bahan Township,
Yangon Region, Burma,
11201.
* * * * * *
Myanmar New Era Trading For all items Presumption of 88 FR [INSERT FR
Company Ltd., Bo Myint Swe subject to the denial. PAGE NUMBER] 3/
Street, No. (B/193), Aung EAR. (See Sec. 30/2023.
Chan Thar (2) Ward, 744.11 of the EAR)
Thanlyin Township, Yangon
Region, Burma, 01-655200.
* * * * * *
Suntac Group, a.k.a., the For all items Presumption of 88 FR [INSERT FR
following one alias: subject to the denial. PAGE NUMBER] 3/
-Suntac International EAR. (See Sec. 30/2023.
Trading Co.; and 744.11 of the EAR)
-Suntac Group of Companies.
151 (B) Thiri Mingalar Lane,
Mayangon Township, Yangon,
Burma.
* * * * * *
----------------------------------------------------------------------------------------------------------------
CHINA, PEOPLE'S * * * * * *
REPUBLIC OF
Luopu Haishi Dingxin For all items Presumption of 88 FR [INSERT FR
Electronic Technology Co., subject to the denial. PAGE NUMBER ] 3/
Ltd., a.k.a., the following EAR. (See Sec. 30/2023.
two aliases: 744.11 of the EAR)
-Luo Pu District HaiShi Ding
Xin Electronic Technology
Co., Ltd.; and
-Luopu County Haishi Dingxin
Electronic Technology Co.,
Ltd.
No.8, South Side, National
Highway 315, Luopu County
Petroleum Company Hotan
Prefecture, Xinjiang,
848201 China.
* * * * * *
Moyu Haishi Electronic For all items Presumption of 88 FR [INSERT FR
Technology Co., Ltd., No. subject to the denial. PAGE NUMBER ] 3/
7, Yinhe North Road, Moyu EAR. (See Sec. 30/2023.
County Hotan Prefecture, 744.11 of the EAR)
Xinjiang, 848100 China.
* * * * * *
Pishan Haishi Yong'an For all items Presumption of 88 FR [INSERT FR
Electronic Technology Co., subject to the denial. PAGE NUMBER ] 3/
Ltd., a.k.a., the following EAR. (See Sec. 30/2023.
two aliases: 744.11 of the EAR)
-PiShan Haishi YongAn
Electronic Technology Co.,
Ltd.; and
-Pishan Haishi Yongan
Electronic Technology Co.,
Ltd.
No. 28, Guma North Road,
Pishan County, Hotan
Prefecture, Xinjiang,
845150 China.
* * * * *
Urumqi Haishi Xin'an For all items Presumption of 88 FR [INSERT FR
Electronic Technology Co., subject to the denial. PAGE NUMBER ] 3/
Ltd., Room 5010-5021, Block EAR. (See Sec. 30/2023.
A, Yingke Plaza, No. 217 744.11 of the EAR)
Gaoxin Street, Xinshi
District, High-tech
Industrial Development Zone
Wulumuqi, Xinjiang, 830011
China.
* * * * *
Yutian Haishi Meitian For all items Presumption of 88 FR [INSERT FR
Electronic Technology Co., subject to the denial. PAGE NUMBER ] 3/
Ltd., No. 9, Tuanjie Road, EAR. (See Sec. 30/2023.
Yutian County Hotan 744.11 of the EAR)
Prefecture, Xinjiang,
848499 China.
* * * * * *
----------------------------------------------------------------------------------------------------------------
NICARAGUA Nicaraguan National Police For all items Presumption of 88 FR [INSERT FR
(NNP), 4PJP+GFP, Managua subject to the denial. PAGE NUMBER ] 3/
11132, Nicaragua. EAR. (See Sec. 30/2023.
744.11 of the EAR)
----------------------------------------------------------------------------------------------------------------
[[Page 18987]]
* * * * * * *
----------------------------------------------------------------------------------------------------------------
RUSSIA * * * * * *
Aviatech Supply Ltd., For all items Presumption of 88 FR [INSERT FR
a.k.a., the following two subject to the denial. PAGE NUMBER]
aliases: EAR. (See Sec. 3/30/2023
-Aviatech; and 744.11 of the EAR)
-Aviatechexport Ltd.
630123, Aeroport St.
Build.1A, 3rd Floor,
Novosibirsk, Russia.
Aviazapchast PLC, 48, Ivana For all items Presumption of 88 FR [INSERT FR
Franko Street, Moscow, subject to the denial. PAGE NUMBER ] 3/
121351, Russia. EAR. (See Sec. 30/2023.
744.11 of the EAR)
* * * * *
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Thea D. Rozman Kendler,
Assistant Secretary for Export Administration.
[FR Doc. 2023-06663 Filed 3-28-23; 4:15 pm]
BILLING CODE 3510-33-P