Addition of Certain Entities to the Entity List

CourtIndustry And Security Bureau
Citation86 FR 60759
Record Number2021-24123
Published date04 November 2021
60759
Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Rules and Regulations
Issued in Des Moines, Washington, on
October 28, 2021.
B.G. Chew,
Acting Group Manager, Operations Support
Group, Western Service Center.
[FR Doc. 2021–23980 Filed 11–3–21; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 744
[Docket No. 211019–0210]
RIN 0694–AI64
Addition of Certain Entities to the
Entity List
AGENCY
: Bureau of Industry and
Security, Commerce.
ACTION
: Final rule.
SUMMARY
: This final rule amends the
Export Administration Regulations
(EAR) by adding four entities to the
Entity List. These four entities have
been determined by the U.S.
Government to be acting contrary to the
foreign policy and national security
interests of the United States and will be
listed on the Entity List under the
destinations of Israel, Russia, and
Singapore.
DATES
: This rule is effective November
4, 2021.
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
:
Background
Entity List
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. Bureau
of Industry and Security (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 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.
ERC Entity List Decisions
Additions to the Entity List
This rule implements the decision of
the ERC to add four entities to the Entity
List. The four entities are added based
on § 744.11 (License requirements that
apply to entities acting contrary to the
national security or foreign policy
interests of the United States) of the
EAR. The four entities are located in
Israel, Russia, and Singapore.
The ERC determined that NSO Group
and Candiru be added to the Entity List
based on § 744.11(b) of the EAR: Entities
for which there is reasonable cause to
believe, based on specific and
articulated 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 and those
acting on behalf of such entities.
Specifically, investigative information
has shown that the Israeli companies
NSO Group and Candiru developed and
supplied spyware to foreign
governments that used this tool to
maliciously target government officials,
journalists, businesspeople, activists,
academics, and embassy workers.
The ERC determined that Positive
Technologies, located in Russia, and
Computer Security Initiative
Consultancy PTE. LTD., located in
Singapore, be added to the Entity List
based on their engagement in activities
counter to U.S. national security.
Specifically, these entities traffic in
cyber exploits used to gain access to
information systems, threatening the
privacy and security of individuals and
organizations worldwide.
Pursuant to § 744.11(b) of the EAR,
the ERC determined that the conduct of
the above-described four 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 four entities and 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. In addition,
the ERC also determined that no license
exceptions should be available for
exports, reexports, or transfers (in-
country) to the persons being added to
the Entity List in this rule. The ERC
imposed a license review policy of a
presumption of denial for these four
entities. 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.
For the reasons described above, this
final rule adds the following four
entities to the Entity List and includes,
where appropriate, aliases:
Israel
Candiru; and
NSO Group
Russia
Positive Technologies
Singapore
Computer Security Initiative
Consultancy PTE. LTD.
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 4, 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.
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60760
Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Rules and Regulations
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 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 collections previously
approved by OMB under control
number 0694–0088, Simplified Network
Application Processing System, which
includes, among other things, license
applications and commodity
classification, and carries a burden
estimate of 29.6 minutes for a manual or
electronic submission for a total burden
estimate of 31,835 hours. 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,
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]
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 12, 2020, 85 FR 72897 (November
13, 2020).
2. Supplement No. 4 to part 744 is
amended:
a. Under ISRAEL, by adding in
alphabetical order entries for ‘‘Candiru’’
and ‘‘NSO Group’’;
b. Under RUSSIA, by adding in
alphabetical order an entry for ‘‘Positive
Technologies’’; and
c. Under SINGAPORE, by adding in
alphabetical order an entry for
‘‘Computer Security Initiative
Consultancy PTE. LTD.’’.
The additions read as follows:
Supplement No. 4 to Part 744—Entity
List
* * * * *
Country Entity License
requirement License
review policy Federal Register
citation
*******
ISRAEL ............. ******
Candiru, a.k.a., the following seven
aliases:
—Candiru Ltd.;
—DF Associates Ltd.;
—Grindavik Solutions Ltd.;
—Taveta Ltd.;
—Saito Tech Ltd.;
—Greenwick Solutions; and
—Tabatha Ltd.
All items subject to the
EAR. (See § 744.11 of
the EAR).
Presumption of denial ...... 86 FR [INSERT FR PAGE
NUMBER] November 4,
2021.
21 Haarbaa, Tel Aviv-Yafo, Israel
6473921.
******
NSO Group, 22 Galgalei Haplada,
Herzliya, Tel Aviv-Yafo, Israel
4672222.
All items subject to the
EAR. (See § 744.11 of
the EAR).
Presumption of denial ...... 86 FR [INSERT FR PAGE
NUMBER] November 4,
2021.
******
*******
RUSSIA ............ ******
Positive Technologies, 8
Preobrzhenskaya Square, Moscow,
Russia 107061.
All items subject to the
EAR. (See § 744.11 of
the EAR).
Presumption of denial ...... 86 FR [INSERT FR PAGE
NUMBER] November 4,
2021.
******
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60761
Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Rules and Regulations
Country Entity License
requirement License
review policy Federal Register
citation
*******
SINGAPORE .... ******
Computer Security Initiative
Consultancy PTE. LTD., a.k.a., the
following alias:
—COSEINC.
All items subject to the
EAR. (See § 744.11 of
the EAR).
Presumption of denial ...... 86 FR [INSERT FR PAGE
NUMBER] November 4,
2021.
102F Pasir Panjang Rd., #08–02,
Citilink Warehouse Complex, Singa-
pore 118530.
******
*******
* * * * *
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
[FR Doc. 2021–24123 Filed 11–3–21; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–631]
Schedules of Controlled Substances:
Placement of Isotonitazene in
Schedule I
AGENCY
: Drug Enforcement
Administration, Department of Justice.
ACTION
: Final amendment; final order.
SUMMARY
: With the issuance of this final
order, the Administrator of the Drug
Enforcement Administration is
permanently placing N,N-diethyl-2-(2-
(4-isopropoxybenzyl)-5-nitro-1H-
benzimidazol-1-yl)ethan-1-amine
(commonly known as
isotonitazene), including its isomers,
esters, ethers, salts, and salts of isomers,
esters, and ethers whenever the
existence of such isomers, esters, ethers,
and salts is possible within the specific
chemical designation, in schedule I of
the Controlled Substances Act. This
scheduling action discharges the United
States’ obligations under the Single
Convention on Narcotic Drugs (1961).
This action continues to impose the
regulatory controls and administrative,
civil, and criminal sanctions applicable
to schedule I controlled substances on
persons who handle (manufacture,
distribute, import, export, engage in
research or conduct instructional
activities with, or possess), or propose
to handle isotonitazene.
DATES
: Effective December 6, 2021.
FOR FURTHER INFORMATION CONTACT
:
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
SUPPLEMENTARY INFORMATION
:
Legal Authority
The United States is a party to the
1961 United Nations Single Convention
on Narcotic Drugs (Single Convention),
March 30, 1961, 18 U.S.T. 1407, 570
U.N.T.S. 151, as amended by the 1972
Protocol. Article 3, paragraph 7 of the
Single Convention requires that if the
Commission on Narcotic Drugs
(Commission) adds a substance to one of
the schedules of such Convention, and
the United States receives notification of
such scheduling decision from the
Secretary-General of the United Nations
(Secretary-General), the United States,
as a signatory Member State, is obligated
to control the substance under its
national drug control legislation. Under
21 U.S.C. 811(d)(1)), if control of a
substance is required ‘‘by United States
obligations under international treaties,
conventions, or protocols in effect on
October 27, 1970,’’ the Attorney General
must issue an order controlling such
drug under the schedule he deems most
appropriate to carry out such
obligations, without regard to the
findings required by 21 U.S.C. 811(a) or
812(b), and without regard to the
procedures prescribed by 21 U.S.C.
811(a) and (b). The Attorney General has
delegated scheduling authority under 21
U.S.C. 811 to the Administrator of the
Drug Enforcement Administration
(Administrator of DEA or
Administrator). 28 CFR 0.100.
Background
On August 20, 2020, DEA issued a
temporary scheduling order, placing
isotonitazene (N,N-diethyl-2-(2-(4-
isopropoxybenzyl)-5-nitro-1H-
benzimidazol-1-yl)ethan-1-amine), in
schedule I of the Controlled Substances
Act (CSA). 85 FR 51342. That order was
based on findings by the Acting
Administrator of DEA (Acting
Administrator) that the temporary
scheduling of this substance was
necessary to avoid an imminent hazard
to the public safety; the order was
codified at 21 CFR 1308.11(h)(48).
In November 2020, the Director-
General of the World Health
Organization recommended to the
Secretary-General that isotonitazene be
placed in Schedule I of the Single
Convention, as this substance has an
opioid mechanism of action and
similarity to drugs that are controlled in
Schedule I of the Single Convention
(i.e., isotonitazene is similar to drugs
such as morphine and fentanyl), and has
dependence and abuse potential. On
June 10, 2021, the Secretary-General
advised the Secretary of State of the
United States, by letter, that during its
64th session in April 2021, the
Commission voted to place
isotonitazene in Schedule I of the Single
Convention (CND Apr/64/1).
Isotonitazene
As discussed in the background
section, isotonitazene is temporarily
controlled in schedule I of the CSA
upon the Acting Administrator’s finding
it poses imminent hazard to the public
safety. Isotonitazene has a
pharmacological profile similar to
etonitazene (schedule I), fentanyl
(schedule II), and other schedule I and
II synthetic opioids that act as mu-
opioid receptor agonists. Because of the
pharmacological similarities of
isotonitazene to etonitazene (a potent
mu-opioid agonist), the use of
isotonitazene presents a high risk of
abuse and has negatively affected users
and communities. The abuse of
isotonitazene has been associated with
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