Amendment to Existing Controls on Russia and Belarus Under the Export Administration Regulations (EAR) Adding New License Exception Medical Devices (MED); Corrections, 33224-33229 [2024-09076]
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Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Rules and Regulations
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Issued on March 29, 2024.
Victor Wicklund,
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[FR Doc. 2024–09087 Filed 4–26–24; 8:45 am]
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 91
[Docket No. FAA–2023–1836; Amdt. No. 91–
371B]
Inclusion of Additional Automatic
Dependent Surveillance-Broadcast
(ADS–B) Out Technical Standard
Orders; Incorporation by Reference;
Correction
Federal Aviation
Administration (FAA), U.S. Department
of Transportation (DOT).
ACTION: Direct final rule; correction.
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AGENCY:
On October 17, 2023, the
Federal Aviation Administration (FAA)
published the subject direct final rule in
the Federal Register, confirmed on
November 29, 2023. In that direct final
rule, the FAA redesignated two
paragraphs in one section of the Code of
15:46 Apr 26, 2024
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New paragraph
paragraph (i).
paragraph (h).
While the FAA discussed the
redesignation of paragraphs (h) and (i),
it failed to revise cross-references to
those paragraphs appearing elsewhere
in § 91.225. This document corrects
those errors.
List of Subjects in 14 CFR Part 91
Air traffic control, Aircraft, Airports,
Aviation safety, Incorporation by
reference, Transportation.
Accordingly, 14 CFR part 91 is
corrected by making the following
correcting amendments:
RIN 2120–AL70
VerDate Sep<11>2014
Old paragraph
paragraph (h) ............
paragraph (i) .............
BILLING CODE 4910–13–P
SUMMARY:
Federal Regulations but failed to amend
cross-references to those paragraphs.
This document corrects those errors.
DATES: This correction is effective April
29, 2024.
FOR FURTHER INFORMATION CONTACT: Juan
Sebastian Yanguas, Airspace Rules &
Regulations, AJV–P21, Federal Aviation
Administration, 800 Independence
Avenue SW, Washington, DC 20591;
telephone (202) 267–8783; email
Juan.S.Yanguas@faa.gov.
SUPPLEMENTARY INFORMATION: On
October 17, 2023, the Federal Aviation
Administration (FAA) published the
direct final rule, Inclusion of Additional
Automatic Dependent SurveillanceBroadcast (ADS–B) Out Technical
Standard Orders; Incorporation by
Reference, in the Federal Register.1 In
that direct final rule the FAA
incorporated by reference two new
Technical Standard Orders (TSOs), and
three RTCA documents—TSO–C166c,
TSO–C154d, section 2 of RTCA DO–
260C, RTCA DO–260C Change 1, and
section 2 of RTCA DO–282C into 14
CFR 91.225 and 91.227. The FAA
responded to comments and confirmed
the direct final rule on November 28,
2023.2
In the direct final rule, the FAA
amended § 91.225 by redesignating
paragraphs (h) and (i) as set out in the
following redesignation table:
PART 91—GENERAL OPERATING AND
FLIGHT RULES
1. The authority citation for part 91
continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g), 40101,
40103, 40105, 40113, 40120, 44101, 44111,
44701, 44704, 44709, 44711, 44712, 44715,
44716, 44717, 44722, 46306, 46315, 46316,
46504, 46506–46507, 47122, 47508, 47528–
1 88
2 88
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FR 71468; FR Doc. 2023–22710.
FR 83022.
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47531, 47534, Pub. L. 114–190, 130 Stat. 615
(49 U.S.C. 44703 note); articles 12 and 29 of
the Convention on International Civil
Aviation (61 Stat. 1180), (126 Stat. 11).
2. Amend § 91.225 by revising the
introductory text of paragraphs (d) and
(f) to read as follows:
■
§ 91.225 Automatic Dependent
Surveillance-Broadcast (ADS–B) Out
equipment and use.
*
*
*
*
*
(d) After January 1, 2020, except as
prohibited in paragraph (h)(2) of this
section or unless otherwise authorized
by ATC, no person may operate an
aircraft in the following airspace unless
the aircraft has equipment installed that
meets the requirements in paragraph (b)
of this section:
*
*
*
*
*
(f) Except as prohibited in paragraph
(h)(2) of this section, each person
operating an aircraft equipped with
ADS–B Out must operate this
equipment in the transmit mode at all
times unless—
*
*
*
*
*
Issued under the authority of 49 U.S.C.
106(f) in Washington, DC.
Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2024–08885 Filed 4–26–24; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 740, 744, 746, and 762
[Docket No. 240423–0115]
RIN 0694–AJ59
Amendment to Existing Controls on
Russia and Belarus Under the Export
Administration Regulations (EAR)
Adding New License Exception
Medical Devices (MED); Corrections
Bureau of Industry and
Security, Department of Commerce.
ACTION: Final rule.
AGENCY:
In this final rule, the Bureau
of Industry and Security (BIS) makes
changes to the Russia and Belarus
sanctions under the Export
Administration Regulations (EAR) to
add a new license exception for EAR99
medical devices and related parts,
components, accessories, and
attachments for use in or with medical
devices that are destined for both
countries and the temporarily occupied
Crimea region of Ukraine, or the covered
regions of Ukraine. The purpose of this
final rule is to authorize under a license
SUMMARY:
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exception certain exports, reexports,
and transfers (in-country) of ‘‘medical
devices’’ that are being regularly
approved and that advance U.S.
national security and foreign policy
interests. In addition, this final rule
makes two corrections to the EAR
related to Russia-related rules published
in January, and March, 2024 by
correcting an end-user control and
adding a cross-reference correction.
B. Overview of This Final Rule
In this final rule, BIS makes changes
to the Russia and Belarus sanctions
under the EAR to add a new license
exception for ‘‘medical devices’’ under
§ 740.23 (Medical Devices (MED)).
License Exception MED will authorize
the export, reexport, or transfer (in
country) of ‘‘medical devices’’
designated as EAR99 to or within
Russia, Belarus, the temporarily
DATES: This rule is effective on April 29, occupied Crimea region of Ukraine, or
the covered regions of Ukraine. Items
2024.
subject to the EAR that are not on the
FOR FURTHER INFORMATION CONTACT: For
Commerce Control List (CCL) in
questions on this final rule, contact
supplement no. 1 to part 774 of the EAR
Mark Salinas, Senior Export Policy
are designated as EAR99. License
Analyst, Foreign Policy Division,
Exception MED will also authorize
Bureau of Industry and Security,
‘‘parts,’’ ‘‘components,’’ ‘‘accessories,’’
Department of Commerce, Phone: 202–
and ‘‘attachments’’ designated as EAR99
482–4252, Email: mark.salinas@
that are exclusively for use in or with
bis.doc.gov.
‘‘medical devices’’ designated as EAR99.
The purpose of this final rule is to
For emails, include ‘‘License
create a new license exception that will
Exception MED’’ in the subject line.
authorize (subject to certain terms and
SUPPLEMENTARY INFORMATION:
conditions) certain exports, reexports,
and transfers (in-country) that BIS
I. Background
generally has been approving under the
A. Export Controls Implemented Against licensing application review policies set
Russia and Belarus
forth in §§ 746.5, 746.6, and 746.10 of
the EAR. New License Exception MED
In response to Russia’s February 2022 includes terms and conditions to ensure
full-scale invasion of Ukraine, BIS
that only those exports, reexports, and
imposed extensive sanctions on Russia
transfers (in-country) that are in U.S.
under the EAR as part of the final rule,
national security and foreign policy
‘‘Implementation of Sanctions Against
interests will be authorized.
Russia Under the Export Administration
This final rule also makes conforming
Regulations (EAR)’’ (the Russia
changes to the EAR to reflect the
Sanctions Rule) (87 FR 12226, March 3,
addition of this new license exception.
2022). To address Belarus’s complicity
Lastly, this final rule makes two
in the invasion, BIS imposed similar
corrections to the EAR, consisting of:
sanctions on Belarus under the EAR in
one correction to an end-user control
a final rule, ‘‘Implementation of
under the EAR that was impacted by the
Sanctions Against Belarus’’ (‘‘Belarus
final rule, ‘‘Export Administration
Sanctions Rule’’) (87 FR 13048, March
Regulations End-User Controls:
6, 2022). During the last two years, BIS
Imposition of Restrictions on Certain
has published a number of additional
Persons Identified on the List of
final rules strengthening the export
Specially Designated Nationals and
controls on Russia and Belarus,
Blocked Persons (SDN List),’’ published
including measures undertaken in
March 21, 2024 (89 FR 20107); and a
coordination with U.S. allies and
cross-reference correction to the final
partners. Most recently, in March 2024,
rule, ‘‘Implementation of Additional
BIS amended the EAR to strengthen
Sanctions Against Russia and Belarus
export controls against Russia and other Under the Export Administration
destinations by expanding controls on
Regulations (EAR) and Refinements to
persons identified on the List of
Existing Controls,’’ published January
Specially Designated Nationals and
25, 2024 (89 FR 4804).
Blocked Persons (SDN List) (March 21,
The three sets of changes this final
2024, 89 FR 20107). As corrected by this rule makes are described in section II as
rule, as described below under section
follows:
II.C.1, § 744.8 of the EAR imposes
A. Addition of License Exception
licensing restrictions on exports,
Medical Devices (MED);
reexports, and transfers (in-country)
B. Conforming changes to the EAR
made in connection with persons
made in connection with the addition of
designated as SDNs by the Department
License Exception MED; and
C. Correction to the March 21, 2024,
of the Treasury’s Office of Foreign Asset
final rule addressing EAR controls for
Controls pursuant to several Russiacertain Specially Designated Nationals
related Executive Orders.
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33225
(SDNs) and correction to the January 25,
2024, Russia sanctions final rule.
II. Amendments to the EAR
A. Addition of License Exception
Medical Devices (MED)
In part 740 (License Exceptions), this
final rule adds a new license exception
to the EAR under § 740.23 (Medical
Devices (MED)).
1. Scope of License Exception MED
This final rule adds paragraph (a)
(Scope) to specify that License
Exception MED authorizes the export,
reexport, or transfer (in country) of
‘‘medical devices’’ designated as EAR99
to Russia, Belarus, the temporarily
occupied Crimea region of Ukraine, or
the covered regions of Ukraine. See the
Supplement No. 3 to Part 774—
Statements of Understanding under
paragraph (a) (Statement of
Understanding—medical equipment) for
guidance on classifying medical
equipment and the definition of
‘‘medical device’’ in § 772.1 of the EAR.
Exporters, reexporters, or transferors
that need assistance in classifying their
items to determine whether they are
designated as EAR99 may submit
classification requests to BIS using the
Simplified Network Application Process
(SNAR–R) available on the BIS website
at https://www.bis.doc.gov.
The second sentence of paragraph (a)
specifies that License Exception MED is
also available to authorize ‘‘parts,’’
‘‘components,’’ ‘‘accessories,’’ and
‘‘attachments’’ designated as EAR99 that
are exclusively for use in or with
‘‘medical devices’’ designated as EAR99.
Due to the importance of ‘‘parts,’’
‘‘components,’’ ‘‘accessories,’’ and
‘‘attachments’’ for the use of ‘‘medical
devices,’’ these commodities are also
included as part of this authorization.
The criterion ‘‘exclusively for use in or
with ‘‘medical devices’’ designated as
EAR99’’ is intended to limit the types of
‘‘parts,’’ ‘‘components,’’ ‘‘accessories,’’
and ‘‘attachments’’ that may be
exported, reexported, or transferred (incountry) under License Exception MED,
to those which are necessary for
replacement or maintenance in or with
medical devices, which will also reduce
the likelihood of diversion to industrial
or military end uses. The last sentence
of paragraph (a) specifies that License
Exception MED authorizes transactions
involving EAR99 designated items that
would otherwise require a license
pursuant to §§ 746.5, 746.6 or 746.10 of
the EAR, provided the terms and
conditions described in § 740.23 are
met.
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Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Rules and Regulations
License Exception MED does not
overcome any license requirements
imposed under § 746.8 or any other EAR
license requirement (e.g., those
specified under part 744) other than
those specified under §§ 746.5, 746.6, or
746.10. Additionally, as with any EAR
license exception, exports, reexports, or
transfers (in-country) under License
Exception MED may be restricted under
§ 740.2 (Restrictions on All License
Exceptions).
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2. Restrictions of License Exception
MED
This final rule adds paragraph (b)
(Restrictions) to specify that License
Exception MED does not authorize the
export, reexport, or transfer (in country)
of any item that meets the restrictions
under paragraph (b)(1), (2), or (3) of
§ 740.23. Paragraph (b)(1) specifies that
License Exception MED is not available
when a ‘‘proscribed person,’’ as defined
in § 772.1, is a party to the transaction
as described in § 748.5(c) through (f) of
the EAR. This final rule also includes an
illustrative list in a parenthetical phrase
that provides some examples of
‘‘proscribed persons’’ (including but not
limited to ‘military end users’ see
§§ 744.17(e) and 744.21(g)) or in
situations in which an entity on the
Entity List in supplement no. 4 to part
744 or on the Military End-User (MEU)
List) that are excluded from being
parties to the transaction. License
Exception MED may not be utilized to
help support the Russian industrial base
(in particular, the Russian medical
device industry) or enable ‘‘proscribed
persons’’ or entities to receive eligible
items. Paragraph (b)(2) restricts any
export, reexport, or transfers (incountry) destined to a ‘‘production’’
‘‘facility,’’ as those terms are defined in
§ 772.1. For the same reason, this final
rule under paragraph (b)(3) restricts any
export, reexport, or transfer (in-country)
destined to Russia, Belarus, the
temporarily occupied Crimea region of
Ukraine, or the covered regions of
Ukraine when the exporter, reexporter,
or transferor has ‘‘knowledge’’ that the
items are intended to develop or
produce items. This final rule also adds
a Note 1 to paragraphs (b)(2) and (3), to
specify that the assembly in a hospital
or other health care ‘‘facility’’ of a
finished ‘‘medical device’’ completely
‘‘produced’’ outside of Russia, Belarus,
the temporarily occupied Crimea region
of Ukraine, or the covered regions of
Ukraine for the sole purpose of using
that ‘‘medical device’’ at that facility is
not considered a ‘‘production’’ activity
for purposes of these two paragraphs.
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3. Verification Procedures for License
Exception MED
This final rule adds paragraph (c)
(Verification) to impose a requirement
on exporters, reexporters, and
transferors to maintain a system of
distribution that ensures that ‘‘medical
devices’’ are not delivered to
‘‘proscribed persons’’ or entities
engaged in the ‘‘production’’ of any
product. Exporters, reexporters, and
transferors are responsible for ensuring
that the items being exported,
reexported, or transferred (in-country)
are not diverted contrary to the terms
and conditions of License Exception
MED. The paragraph (c) text specifies
that the verification of the effectiveness
of the distribution system may entail
obtaining certain information from a
consignee (e.g., obtaining affirmations or
other documentation from a consignee
as part of an exporter, reexporter, or
transferor’s compliance program) for
ensuring that the use and disposition of
‘‘medical devices’’ received under
License Exception MED meet the
required terms and conditions.
This final rule under paragraph (c)
also provides another illustrative
example for how the verification of the
effectiveness of the distribution system
may be confirmed by the exporter,
reexporter, or transferor by conducting
periodic on-site spot checks. This final
rule includes criteria in a parenthetical
phrase that follows the phrase ‘or
performing periodic on-site spot-checks’
to provide illustrative examples of the
verification methods that may be
adopted to ensure the effectiveness of
the distribution system when an
exporter, reexporter, or transferor
decides to use conducting periodic onsite spot checks. Specifically, this final
rule specifies in that parenthetical
phrase that a verification system may
include periodic on-site spot-checks in
Russia, Belarus, the temporarily
occupied Crimea region of Ukraine, or
the covered regions of Ukraine, by the
exporter, reexporter, or transferor; an
internationally accredited auditing firm;
or by an internationally recognized nongovernmental humanitarian
organization.
4. Recordkeeping and Review of
Records Under License Exception MED
This final rule under paragraph (d)
(Recordkeeping and review of records),
specifies that in addition to complying
with the recordkeeping requirements in
part 762 of the EAR, that exporters,
reexporters, and transferors must
maintain records of verification, as
specified in paragraph (d), for 5 five
years, and, upon request, these records
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must be provided to BIS, or any other
official of the United States designated
by BIS, for review.
BIS estimates the new License
Exception MED under § 740.23 will
result in a reduction of 3,900 license
applications being submitted to BIS
annually.
B. Conforming Changes to the EAR for
Addition of License Exception MED
In § 746.5 (Russian and Belarusian
industry sector sanctions), this final rule
revises paragraph (c)’s (License
exceptions) introductory text, to add a
reference to new paragraph (c)(8)
(License Exception MED), an additional
license exception that may overcome
the license requirements set forth in this
section. This final rule also adds
paragraph (c)(8) (License Exception
MED), including adding a cross
reference to new § 740.23 of the EAR.
In § 746.6 (Temporarily occupied
Crimea region of Ukraine and covered
regions of Ukraine), this final rule adds
a new paragraph (c)(7) (License
Exception MED), including adding a
cross reference to new § 740.23 of the
EAR.
In § 746.10 (‘Luxury goods’ sanctions
against Russia and Belarus and Russian
and Belarusian oligarchs and malign
actors), this final rule revises paragraph
(c) (License Exceptions) introductory
text to add a reference to new paragraph
(c)(8) (License Exception MED) as an
additional license exception that may
overcome the license requirements in
paragraph (a)(1) of this section. This
final rule also adds paragraph (c)(8)
(License Exception MED), including
adding a cross reference to new § 740.23
of the EAR.
In § 762.2 (Records to be retained),
this final rule revises paragraph (b)
(Records retention references) to add a
new paragraph (b)(55) (§ 740.23, License
Exception MED) and makes two
conforming changes by revising
paragraph (b)(53) to remove the word
‘‘and’’ and revising paragraph (b)(54) to
replace the period with a semi-colon to
reflect the addition of new paragraph
(b)(55).
C. Correction to March 24, 2024 Final
Rule Imposing EAR Controls on Certain
Persons Identified on the SDN List and
Correction to January 25, 2024 Russia
Sanctions Final Rule
1. Correction to March 24, 2024 Final
Rule
This final rule makes a conforming
change correction to § 744.11 to reflect
the revisions made to § 744.8 in the
March 24, 2024, final rule, ‘‘Export
Administration Regulations End-User
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Controls: Imposition of Restrictions on
Certain Persons Identified on the List of
Specially Designated Nationals and
Blocked Persons (SDN List),’’ (89 FR
20107). Specifically, this final rule
removes the fourth sentence of
paragraph (b) introductory text that
specified that § 744.11 ‘‘may not be used
to place on the Entity List any party to
which exports or reexports require a
license pursuant to § 744.8, § 744.12,
§ 744.13, § 744.14, or § 744.18’’ because
it is no longer needed or accurate.
Sections 744.12 through 744.14 and
744.18 were reserved as of March 24,
2024. Note 2 to paragraph (a) of the
revised § 744.8 provides guidance that
the Entity List in supplement no. 4 to
part 744 includes certain persons that
have also been designated with certain
identifiers on the SDN List. Note 2
includes a cross reference that directs
persons to § 744.11 and supplement no.
4 to part 744 for requirements, including
license review policies, for these
entities, which take precedence over the
requirements in § 744.8.
2. Correction to January 25, 2024 Russia
Sanctions Final Rule
This final rule makes a cross-reference
correction to § 746.10 to add a reference
to paragraph (c)(7) to reflect that License
Exception CCD is intended to be
available to overcome the license
requirements under § 746.10(a)(1) as
described in the Background section of
the January 25, 2024, final rule,
‘‘Implementation of Additional
Sanctions Against Russia and Belarus
Under the Export Administration
Regulations (EAR) and Refinements to
Existing Controls,’’ published January
25, 2024 (89 FR 4804), but the
regulatory cross-reference was not
updated to reflect paragraph (c)(3) was
redesignated as paragraph (c)(7) in the
January 25, 2024 final rule. This final
rule corrects § 746.10(c) introductory
text to make a needed cross-reference
correction to specify that License
Exception CCD is available.
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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) (codified, as amended, at 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. To the extent it
applies to certain activities that are the
subject of this rule, the Trade Sanctions
Reform and Export Enhancement Act of
2000 (TSRA) (codified, as amended, at
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22 U.S.C. 7201–7211) also serves as
authority for this rule.
Rulemaking Requirements
1. BIS has examined the impact of this
rule as required by Executive Orders
12866, 13563, and 14094, which 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 (e.g., potential economic,
environmental, public, health, and
safety effects, distributive impacts, and
equity). Pursuant to E.O. 12866, as
amended, this final rule has not been
determined to be a ‘‘significant
regulatory action.’’
2. Notwithstanding any other
provision of law, no person is required
to respond to, nor shall any person 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 rule
involves the following OMB-approved
collections of information subject to the
PRA:
• OMB Control Number 0694–0088,
‘‘Multi-Purpose Application,’’ which
carries a burden hour estimate of 29.4
minutes for a manual or electronic
submission;
• OMB Control Number 0694–0096
‘‘Five Year Records Retention Period,’’
which carries a burden hour estimate of
less than one minute; and
• OMB Control Number 0607–0152
‘‘Automated Export System (AES)
Program,’’ which carries a burden hour
estimate of three minutes per electronic
submission.
This rule changes the respondent
burden for control number 0694–0088
by reducing the estimated number of
submissions by 3,900, which is
expected to reduce the current approved
estimates, which will result in a
reduction of 1,911 burden hours saved
and cost savings to the public of $72,618
under this collection. The respondent
burden under controls numbers 0694–
0096 and 0607–0152 are not anticipated
to change as a result of this final rule.
Current information regarding all
three collections of information—
including all background materials—can
be found at https://www.reginfo.gov/
public/do/PRAMain by using the search
function to enter either the title of the
collection or the OMB Control Number.
3. This rule does not contain policies
with federalism implications as that
term is defined in E.O. 13132.
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4. Pursuant to section 1762 of ECRA
(50 U.S.C. 4821), this action is exempt
from the Administrative Procedure Act
(APA) (5 U.S.C. 553) requirements for
notice of proposed rulemaking,
opportunity for public participation,
and delay in effective date. While
section 1762 of ECRA provides
sufficient authority for such an
exemption, this action is also
independently exempt from these APA
requirements because it involves a
military or foreign affairs function of the
United States (5 U.S.C. 553(a)(1)).
5. Because neither the Administrative
Procedure Act nor any other law
requires that notice of proposed
rulemaking and an opportunity for
public comment be given for this rule,
the analytical requirements of the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.) are not applicable. Accordingly,
no Final Regulatory Flexibility Analysis
is required and none has been prepared.
List of Subjects
15 CFR Part 740
Administrative practice and
procedure, Exports, Reporting and
recordkeeping requirements.
15 CFR Part 744
Exports, Reporting and recordkeeping
requirements, Terrorism
15 CFR Part 746
Exports, Reporting and recordkeeping
requirements.
15 CFR Part 762
Administrative practice and
procedure, Business and industry,
Confidential business information,
Exports, Reporting and recordkeeping
requirements.
For the reasons stated in the
preamble, parts 740, 744, 746, and 762
of the Export Administration
Regulations (15 CFR parts 730 through
774) are amended as follows:
PART 740—LICENSE EXCEPTIONS
1. The authority citation for part 740
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.
7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025,
3 CFR, 2001 Comp., p. 783.
2. Part 740 is amended by adding
§ 740.23 to read as follows.
■
§ 740.23
MEDICAL DEVICES (MED).
(a) Scope. License Exception MED
authorizes the export, reexport, or
transfer (in country) of ‘‘medical
devices’’ designated as EAR99 to or
within Russia, Belarus, the temporarily
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occupied Crimea region of Ukraine, or
the covered regions of Ukraine (as
specified in § 746.6(a)(2) of the EAR).
See Supplement no. 3 to part 774—
Statements of Understanding under
paragraph (a) (Statement of
Understanding—medical equipment) for
guidance on classifying medical
equipment and the definition of
‘‘medical device’’ in § 772.1 of the EAR.
License Exception MED also authorizes
the export, reexport, or transfer (in
country) to or within Russia, Belarus,
the temporarily occupied Crimea region
of Ukraine, or the covered regions of
Ukraine of ‘‘parts,’’ ‘‘components,’’
‘‘accessories,’’ and ‘‘attachments’’
designated as EAR99 that are
exclusively for use in or with ‘‘medical
devices’’ designated as EAR99. This
license exception authorizes
transactions involving items designated
as EAR99 that would otherwise require
a license pursuant to §§ 746.5, 746.6 or
746.10 of the EAR, subject to the terms
and conditions described in this section.
For ‘‘parts,’’ ‘‘components,’’
‘‘accessories,’’ and ‘‘attachments’’
authorized under License Exception
MED, such replacement ‘‘parts,’’
‘‘components,’’ ‘‘accessories,’’ and
‘‘attachments’’ may only be exported,
reexported, or transferred (in-country) if
they also meet the additional
requirements under paragraphs (a)(1)
and (2) of this section:
(1) The ‘‘part,’’ ‘‘component,’’
‘‘accessory,’’ or ‘‘attachment’’ is being
exported, reexported, or transferred (incountry) solely to replace a broken or
nonoperational ‘‘part,’’ ‘‘component,’’
‘‘accessory,’’ or ‘‘attachment’’ for use in
or with a ‘‘medical device’’ that falls
within the scope of paragraph (a) of this
section, or the export, reexport, or
transfer (in-country) of such
replacement ‘‘parts,’’ ‘‘components,’’
‘‘accessories,’’ and ‘‘attachments’’ is
necessary and ordinarily incident to the
proper preventative maintenance of
such a ‘‘medical device;’’ and
(2) The number of replacement
‘‘parts,’’ ‘‘components,’’ ‘‘accessories,’’
and ‘‘attachments’’ that are exported,
reexported, transferred (in-country), and
stored in Russia, Belarus, the
temporarily occupied Crimea region of
Ukraine, or the covered regions of
Ukraine does not exceed the number of
corresponding operational ‘‘parts,’’
‘‘components,’’ ‘‘accessories,’’ and
‘‘attachments’’ currently in use in or
with the relevant medical devices in
Russia, Belarus, the temporarily
occupied Crimea region of Ukraine, or
the covered regions of Ukraine.
(b) Restrictions. This license
exception does not authorize the export,
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reexport, or transfer (in country) of any
item:
(1) To a ‘‘proscribed person’’
(including but not limited to ‘military
end users’ (see §§ 744.17(e) and
744.21(g)) or in situations in which an
entity on the Entity List in supplement
no. 4 to part 744 or on the Military EndUser (MEU) List) is a party to the
transaction as described in § 748.5(c)
through (f) of the EAR;
(2) Destined to a ‘‘production’’
‘‘facility;’’ or
(3) When you have ‘‘knowledge’’ that
the item is intended to develop or
produce items.
Note 1 to paragraphs (b)(2) and (3): The
assembly in a hospital or other health care
facility of a finished ‘‘medical device’’
completely ‘‘produced’’ outside of Russia,
Belarus, the temporarily occupied Crimea
region of Ukraine, or the covered regions of
Ukraine’’ for the sole purpose of using that
‘‘medical device’’ at that facility is not
considered a ‘‘production’’ activity for
purposes of the restrictions under paragraphs
(b)(2) and (3) of this section.
(c) Verification. Exporters,
reexporters, and transferors must
maintain a system of distribution that
ensures that ‘‘medical devices’’ and
‘‘parts,’’ ‘‘components,’’ ‘‘accessories,’’
or ‘‘attachments’’ are not delivered to
‘‘proscribed persons’’ or entities
engaged in the ‘‘production’’ of any
product. Verification of the effectiveness
of the distribution system may entail
obtaining certain information from a
consignee (e.g., obtaining affirmations or
other documentation from a consignee,
or performing periodic on-site spotchecks (e.g., conducting such
verification by staff of the exporter,
reexporter, or transferor; an
internationally accredited auditing firm;
or an internationally recognized nongovernmental humanitarian
organization in Russia, Belarus, the
temporarily occupied Crimea region of
Ukraine, or the covered regions of
Ukraine to conduct such verification).
(d) Recordkeeping and review or
inspection of records. In addition to
complying with the recordkeeping
requirements in part 762 of the EAR,
exporters, reexporters, and transferors
must maintain records of verification, as
specified in paragraph (c) of this
section, for 5 years and, upon request,
provide records to BIS, or any other
official of the United States designated
by BIS, for review or inspection.
PART 744—CONTROL POLICY: ENDUSER AND END-USE BASED
3. The authority citation for part 744
continues to read as follows:
■
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
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, 202); Notice of
November 8, 2022, 87 FR 68015, 3 CFR, 2022
Comp., p. 563; Notice of September 7, 2023,
88 FR 62439 (September 11, 2023).
§ 744.11
[Amended]
4. Section 744.11 is amended by
removing the fourth sentence of
paragraph (b) introductory text.
■
PART 746—EMBARGOES AND OTHER
SPECIAL CONTROLS
5. The authority citation for 15 CFR
part 746 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.
287c; Sec 1503, Pub. L. 108–11, 117 Stat. 559;
22 U.S.C. 2151 note; 22 U.S.C. 6004; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O.
12854, 58 FR 36587, 3 CFR, 1993 Comp., p.
614; E.O. 12918, 59 FR 28205, 3 CFR, 1994
Comp., p. 899; E.O. 13222, 66 FR 44025, 3
CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR
26751, 3 CFR, 2004 Comp., p 168;
Presidential Determination 2003–23, 68 FR
26459, 3 CFR, 2004 Comp., p. 320;
Presidential Determination 2007–7, 72 FR
1899, 3 CFR, 2006 Comp., p. 325; Notice of
May 8, 2023, 88 FR 30211 (May 10, 2023).
6. Section 746.5 is amended by
revising paragraph (c) introductory text
and adding paragraph (c)(8), to read as
follows:
■
§ 746.5 Russian and Belarusian industry
sector sanctions.
*
*
*
*
*
(c) License exceptions. No license
exceptions may overcome the license
requirements set forth in this section,
except the license exceptions identified
in paragraphs (c)(2), (7), and (8) of this
section.
*
*
*
*
*
(8) License Exception MED (§ 740.23
of the EAR).
■ 7. Section 746.6 is amended by adding
paragraph (c)(7), to read as follows:
§ 746.6 Temporarily occupied Crimea
region of Ukraine and covered regions of
Ukraine.
*
*
*
*
*
(c) * * *
(7) License Exception MED (§ 740.23
of the EAR).
*
*
*
*
*
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8. Section 746.10 is amended by
revising paragraph (c) introductory text
and adding paragraph (c)(8), to read as
follows:
■
§ 746.10 ‘Luxury goods’ sanctions against
Russia and Belarus and Russian and
Belarusian oligarchs and malign actors.
*
*
*
*
*
(c) License exceptions. No license
exceptions may overcome the license
requirements in paragraph (a)(1) of this
section except the license exceptions
identified in paragraphs (c)(1) through
(3), (c)(7) and (8) of this section.
*
*
*
*
*
(8) License Exception MED (§ 740.23
of the EAR).
PART 762—RECORDKEEPING
9. The authority citation for 15 CFR
part 746 continues to read as follows:
■
Electronic Submissions
Authority: 50 U.S.C. 4801–4852; 50 U.S.C.
4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783.
10. Section 762.2 is amended by:
a. Revising paragraphs (b)(53) and
(54), and
■ b. Adding paragraph (b)(55).
The revisions and addition read as
follows:
■
■
§ 762.2
Records to be retained.
*
*
*
*
*
(b) * * *
(53) § 750.7(c)(2), Notification of name
change by advisory opinion request;
(54) § 748.13, Certain Hong Kong
import and export licenses; and
(55) § 740.23, License Exception MED.
*
*
*
*
*
Thea D. Rozman Kendler,
Assistant Secretary for Export
Administration.
[FR Doc. 2024–09076 Filed 4–25–24; 8:45 am]
BILLING CODE 3510–JT–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 161, 164, 184, and 186
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[Docket No. FDA–2024–D–1669]
Revocation of Uses of Partially
Hydrogenated Oils in Foods: Guidance
for Industry; Small Entity Compliance
Guide; Availability
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notification of availability.
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Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Food and Drug Administration
AGENCY:
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry entitled
‘‘Revocation of Uses of Partially
Hydrogenated Oils in Foods: Guidance
for Industry; Small Entity Compliance
Guide.’’ The small entity compliance
guide (SECG) is intended to help small
entities comply with our regulations
after we revoked specific requirements
pertaining to the use of partially
hydrogenated oils in certain foods or as
a direct or indirect food substance.
DATES: The announcement of the
guidance is published in the Federal
Register on April 29, 2024.
ADDRESSES: You may submit either
electronic or written comments on FDA
guidances at any time as follows:
SUMMARY:
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
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Instructions: All submissions received
must include the Docket No. FDA–
2024–D–1669 for ‘‘Revocation of Uses of
Partially Hydrogenated Oils in Foods:
Guidance for Industry; Small Entity
Compliance Guide.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the SECG to the Office of Food
Additive Safety, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-
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]]>Agencies
[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Rules and Regulations]
[Pages 33224-33229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09076]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 740, 744, 746, and 762
[Docket No. 240423-0115]
RIN 0694-AJ59
Amendment to Existing Controls on Russia and Belarus Under the
Export Administration Regulations (EAR) Adding New License Exception
Medical Devices (MED); Corrections
AGENCY: Bureau of Industry and Security, Department of Commerce.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: In this final rule, the Bureau of Industry and Security (BIS)
makes changes to the Russia and Belarus sanctions under the Export
Administration Regulations (EAR) to add a new license exception for
EAR99 medical devices and related parts, components, accessories, and
attachments for use in or with medical devices that are destined for
both countries and the temporarily occupied Crimea region of Ukraine,
or the covered regions of Ukraine. The purpose of this final rule is to
authorize under a license
[[Page 33225]]
exception certain exports, reexports, and transfers (in-country) of
``medical devices'' that are being regularly approved and that advance
U.S. national security and foreign policy interests. In addition, this
final rule makes two corrections to the EAR related to Russia-related
rules published in January, and March, 2024 by correcting an end-user
control and adding a cross-reference correction.
DATES: This rule is effective on April 29, 2024.
FOR FURTHER INFORMATION CONTACT: For questions on this final rule,
contact Mark Salinas, Senior Export Policy Analyst, Foreign Policy
Division, Bureau of Industry and Security, Department of Commerce,
Phone: 202-482-4252, Email: [email protected].
For emails, include ``License Exception MED'' in the subject line.
SUPPLEMENTARY INFORMATION:
I. Background
A. Export Controls Implemented Against Russia and Belarus
In response to Russia's February 2022 full-scale invasion of
Ukraine, BIS imposed extensive sanctions on Russia under the EAR as
part of the final rule, ``Implementation of Sanctions Against Russia
Under the Export Administration Regulations (EAR)'' (the Russia
Sanctions Rule) (87 FR 12226, March 3, 2022). To address Belarus's
complicity in the invasion, BIS imposed similar sanctions on Belarus
under the EAR in a final rule, ``Implementation of Sanctions Against
Belarus'' (``Belarus Sanctions Rule'') (87 FR 13048, March 6, 2022).
During the last two years, BIS has published a number of additional
final rules strengthening the export controls on Russia and Belarus,
including measures undertaken in coordination with U.S. allies and
partners. Most recently, in March 2024, BIS amended the EAR to
strengthen export controls against Russia and other destinations by
expanding controls on persons identified on the List of Specially
Designated Nationals and Blocked Persons (SDN List) (March 21, 2024, 89
FR 20107). As corrected by this rule, as described below under section
II.C.1, Sec. 744.8 of the EAR imposes licensing restrictions on
exports, reexports, and transfers (in-country) made in connection with
persons designated as SDNs by the Department of the Treasury's Office
of Foreign Asset Controls pursuant to several Russia-related Executive
Orders.
B. Overview of This Final Rule
In this final rule, BIS makes changes to the Russia and Belarus
sanctions under the EAR to add a new license exception for ``medical
devices'' under Sec. 740.23 (Medical Devices (MED)). License Exception
MED will authorize the export, reexport, or transfer (in country) of
``medical devices'' designated as EAR99 to or within Russia, Belarus,
the temporarily occupied Crimea region of Ukraine, or the covered
regions of Ukraine. Items subject to the EAR that are not on the
Commerce Control List (CCL) in supplement no. 1 to part 774 of the EAR
are designated as EAR99. License Exception MED will also authorize
``parts,'' ``components,'' ``accessories,'' and ``attachments''
designated as EAR99 that are exclusively for use in or with ``medical
devices'' designated as EAR99.
The purpose of this final rule is to create a new license exception
that will authorize (subject to certain terms and conditions) certain
exports, reexports, and transfers (in-country) that BIS generally has
been approving under the licensing application review policies set
forth in Sec. Sec. 746.5, 746.6, and 746.10 of the EAR. New License
Exception MED includes terms and conditions to ensure that only those
exports, reexports, and transfers (in-country) that are in U.S.
national security and foreign policy interests will be authorized.
This final rule also makes conforming changes to the EAR to reflect
the addition of this new license exception.
Lastly, this final rule makes two corrections to the EAR,
consisting of: one correction to an end-user control under the EAR that
was impacted by the final rule, ``Export Administration Regulations
End-User Controls: Imposition of Restrictions on Certain Persons
Identified on the List of Specially Designated Nationals and Blocked
Persons (SDN List),'' published March 21, 2024 (89 FR 20107); and a
cross-reference correction to the final rule, ``Implementation of
Additional Sanctions Against Russia and Belarus Under the Export
Administration Regulations (EAR) and Refinements to Existing
Controls,'' published January 25, 2024 (89 FR 4804).
The three sets of changes this final rule makes are described in
section II as follows:
A. Addition of License Exception Medical Devices (MED);
B. Conforming changes to the EAR made in connection with the
addition of License Exception MED; and
C. Correction to the March 21, 2024, final rule addressing EAR
controls for certain Specially Designated Nationals (SDNs) and
correction to the January 25, 2024, Russia sanctions final rule.
II. Amendments to the EAR
A. Addition of License Exception Medical Devices (MED)
In part 740 (License Exceptions), this final rule adds a new
license exception to the EAR under Sec. 740.23 (Medical Devices
(MED)).
1. Scope of License Exception MED
This final rule adds paragraph (a) (Scope) to specify that License
Exception MED authorizes the export, reexport, or transfer (in country)
of ``medical devices'' designated as EAR99 to Russia, Belarus, the
temporarily occupied Crimea region of Ukraine, or the covered regions
of Ukraine. See the Supplement No. 3 to Part 774--Statements of
Understanding under paragraph (a) (Statement of Understanding--medical
equipment) for guidance on classifying medical equipment and the
definition of ``medical device'' in Sec. 772.1 of the EAR. Exporters,
reexporters, or transferors that need assistance in classifying their
items to determine whether they are designated as EAR99 may submit
classification requests to BIS using the Simplified Network Application
Process (SNAR-R) available on the BIS website at https://www.bis.doc.gov.
The second sentence of paragraph (a) specifies that License
Exception MED is also available to authorize ``parts,'' ``components,''
``accessories,'' and ``attachments'' designated as EAR99 that are
exclusively for use in or with ``medical devices'' designated as EAR99.
Due to the importance of ``parts,'' ``components,'' ``accessories,''
and ``attachments'' for the use of ``medical devices,'' these
commodities are also included as part of this authorization. The
criterion ``exclusively for use in or with ``medical devices''
designated as EAR99'' is intended to limit the types of ``parts,''
``components,'' ``accessories,'' and ``attachments'' that may be
exported, reexported, or transferred (in-country) under License
Exception MED, to those which are necessary for replacement or
maintenance in or with medical devices, which will also reduce the
likelihood of diversion to industrial or military end uses. The last
sentence of paragraph (a) specifies that License Exception MED
authorizes transactions involving EAR99 designated items that would
otherwise require a license pursuant to Sec. Sec. 746.5, 746.6 or
746.10 of the EAR, provided the terms and conditions described in Sec.
740.23 are met.
[[Page 33226]]
License Exception MED does not overcome any license requirements
imposed under Sec. 746.8 or any other EAR license requirement (e.g.,
those specified under part 744) other than those specified under
Sec. Sec. 746.5, 746.6, or 746.10. Additionally, as with any EAR
license exception, exports, reexports, or transfers (in-country) under
License Exception MED may be restricted under Sec. 740.2 (Restrictions
on All License Exceptions).
2. Restrictions of License Exception MED
This final rule adds paragraph (b) (Restrictions) to specify that
License Exception MED does not authorize the export, reexport, or
transfer (in country) of any item that meets the restrictions under
paragraph (b)(1), (2), or (3) of Sec. 740.23. Paragraph (b)(1)
specifies that License Exception MED is not available when a
``proscribed person,'' as defined in Sec. 772.1, is a party to the
transaction as described in Sec. 748.5(c) through (f) of the EAR. This
final rule also includes an illustrative list in a parenthetical phrase
that provides some examples of ``proscribed persons'' (including but
not limited to `military end users' see Sec. Sec. 744.17(e) and
744.21(g)) or in situations in which an entity on the Entity List in
supplement no. 4 to part 744 or on the Military End-User (MEU) List)
that are excluded from being parties to the transaction. License
Exception MED may not be utilized to help support the Russian
industrial base (in particular, the Russian medical device industry) or
enable ``proscribed persons'' or entities to receive eligible items.
Paragraph (b)(2) restricts any export, reexport, or transfers (in-
country) destined to a ``production'' ``facility,'' as those terms are
defined in Sec. 772.1. For the same reason, this final rule under
paragraph (b)(3) restricts any export, reexport, or transfer (in-
country) destined to Russia, Belarus, the temporarily occupied Crimea
region of Ukraine, or the covered regions of Ukraine when the exporter,
reexporter, or transferor has ``knowledge'' that the items are intended
to develop or produce items. This final rule also adds a Note 1 to
paragraphs (b)(2) and (3), to specify that the assembly in a hospital
or other health care ``facility'' of a finished ``medical device''
completely ``produced'' outside of Russia, Belarus, the temporarily
occupied Crimea region of Ukraine, or the covered regions of Ukraine
for the sole purpose of using that ``medical device'' at that facility
is not considered a ``production'' activity for purposes of these two
paragraphs.
3. Verification Procedures for License Exception MED
This final rule adds paragraph (c) (Verification) to impose a
requirement on exporters, reexporters, and transferors to maintain a
system of distribution that ensures that ``medical devices'' are not
delivered to ``proscribed persons'' or entities engaged in the
``production'' of any product. Exporters, reexporters, and transferors
are responsible for ensuring that the items being exported, reexported,
or transferred (in-country) are not diverted contrary to the terms and
conditions of License Exception MED. The paragraph (c) text specifies
that the verification of the effectiveness of the distribution system
may entail obtaining certain information from a consignee (e.g.,
obtaining affirmations or other documentation from a consignee as part
of an exporter, reexporter, or transferor's compliance program) for
ensuring that the use and disposition of ``medical devices'' received
under License Exception MED meet the required terms and conditions.
This final rule under paragraph (c) also provides another
illustrative example for how the verification of the effectiveness of
the distribution system may be confirmed by the exporter, reexporter,
or transferor by conducting periodic on-site spot checks. This final
rule includes criteria in a parenthetical phrase that follows the
phrase `or performing periodic on-site spot-checks' to provide
illustrative examples of the verification methods that may be adopted
to ensure the effectiveness of the distribution system when an
exporter, reexporter, or transferor decides to use conducting periodic
on-site spot checks. Specifically, this final rule specifies in that
parenthetical phrase that a verification system may include periodic
on-site spot-checks in Russia, Belarus, the temporarily occupied Crimea
region of Ukraine, or the covered regions of Ukraine, by the exporter,
reexporter, or transferor; an internationally accredited auditing firm;
or by an internationally recognized non-governmental humanitarian
organization.
4. Recordkeeping and Review of Records Under License Exception MED
This final rule under paragraph (d) (Recordkeeping and review of
records), specifies that in addition to complying with the
recordkeeping requirements in part 762 of the EAR, that exporters,
reexporters, and transferors must maintain records of verification, as
specified in paragraph (d), for 5 five years, and, upon request, these
records must be provided to BIS, or any other official of the United
States designated by BIS, for review.
BIS estimates the new License Exception MED under Sec. 740.23 will
result in a reduction of 3,900 license applications being submitted to
BIS annually.
B. Conforming Changes to the EAR for Addition of License Exception MED
In Sec. 746.5 (Russian and Belarusian industry sector sanctions),
this final rule revises paragraph (c)'s (License exceptions)
introductory text, to add a reference to new paragraph (c)(8) (License
Exception MED), an additional license exception that may overcome the
license requirements set forth in this section. This final rule also
adds paragraph (c)(8) (License Exception MED), including adding a cross
reference to new Sec. 740.23 of the EAR.
In Sec. 746.6 (Temporarily occupied Crimea region of Ukraine and
covered regions of Ukraine), this final rule adds a new paragraph
(c)(7) (License Exception MED), including adding a cross reference to
new Sec. 740.23 of the EAR.
In Sec. 746.10 (`Luxury goods' sanctions against Russia and
Belarus and Russian and Belarusian oligarchs and malign actors), this
final rule revises paragraph (c) (License Exceptions) introductory text
to add a reference to new paragraph (c)(8) (License Exception MED) as
an additional license exception that may overcome the license
requirements in paragraph (a)(1) of this section. This final rule also
adds paragraph (c)(8) (License Exception MED), including adding a cross
reference to new Sec. 740.23 of the EAR.
In Sec. 762.2 (Records to be retained), this final rule revises
paragraph (b) (Records retention references) to add a new paragraph
(b)(55) (Sec. 740.23, License Exception MED) and makes two conforming
changes by revising paragraph (b)(53) to remove the word ``and'' and
revising paragraph (b)(54) to replace the period with a semi-colon to
reflect the addition of new paragraph (b)(55).
C. Correction to March 24, 2024 Final Rule Imposing EAR Controls on
Certain Persons Identified on the SDN List and Correction to January
25, 2024 Russia Sanctions Final Rule
1. Correction to March 24, 2024 Final Rule
This final rule makes a conforming change correction to Sec.
744.11 to reflect the revisions made to Sec. 744.8 in the March 24,
2024, final rule, ``Export Administration Regulations End-User
[[Page 33227]]
Controls: Imposition of Restrictions on Certain Persons Identified on
the List of Specially Designated Nationals and Blocked Persons (SDN
List),'' (89 FR 20107). Specifically, this final rule removes the
fourth sentence of paragraph (b) introductory text that specified that
Sec. 744.11 ``may not be used to place on the Entity List any party to
which exports or reexports require a license pursuant to Sec. 744.8,
Sec. 744.12, Sec. 744.13, Sec. 744.14, or Sec. 744.18'' because it
is no longer needed or accurate. Sections 744.12 through 744.14 and
744.18 were reserved as of March 24, 2024. Note 2 to paragraph (a) of
the revised Sec. 744.8 provides guidance that the Entity List in
supplement no. 4 to part 744 includes certain persons that have also
been designated with certain identifiers on the SDN List. Note 2
includes a cross reference that directs persons to Sec. 744.11 and
supplement no. 4 to part 744 for requirements, including license review
policies, for these entities, which take precedence over the
requirements in Sec. 744.8.
2. Correction to January 25, 2024 Russia Sanctions Final Rule
This final rule makes a cross-reference correction to Sec. 746.10
to add a reference to paragraph (c)(7) to reflect that License
Exception CCD is intended to be available to overcome the license
requirements under Sec. 746.10(a)(1) as described in the Background
section of the January 25, 2024, final rule, ``Implementation of
Additional Sanctions Against Russia and Belarus Under the Export
Administration Regulations (EAR) and Refinements to Existing
Controls,'' published January 25, 2024 (89 FR 4804), but the regulatory
cross-reference was not updated to reflect paragraph (c)(3) was
redesignated as paragraph (c)(7) in the January 25, 2024 final rule.
This final rule corrects Sec. 746.10(c) introductory text to make a
needed cross-reference correction to specify that License Exception CCD
is available.
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) (codified, as
amended, at 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. To the extent it applies to certain activities that
are the subject of this rule, the Trade Sanctions Reform and Export
Enhancement Act of 2000 (TSRA) (codified, as amended, at 22 U.S.C.
7201-7211) also serves as authority for this rule.
Rulemaking Requirements
1. BIS has examined the impact of this rule as required by
Executive Orders 12866, 13563, and 14094, which 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 (e.g., potential economic, environmental, public,
health, and safety effects, distributive impacts, and equity). Pursuant
to E.O. 12866, as amended, this final rule has not been determined to
be a ``significant regulatory action.''
2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person 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 rule
involves the following OMB-approved collections of information subject
to the PRA:
OMB Control Number 0694-0088, ``Multi-Purpose
Application,'' which carries a burden hour estimate of 29.4 minutes for
a manual or electronic submission;
OMB Control Number 0694-0096 ``Five Year Records Retention
Period,'' which carries a burden hour estimate of less than one minute;
and
OMB Control Number 0607-0152 ``Automated Export System
(AES) Program,'' which carries a burden hour estimate of three minutes
per electronic submission.
This rule changes the respondent burden for control number 0694-
0088 by reducing the estimated number of submissions by 3,900, which is
expected to reduce the current approved estimates, which will result in
a reduction of 1,911 burden hours saved and cost savings to the public
of $72,618 under this collection. The respondent burden under controls
numbers 0694-0096 and 0607-0152 are not anticipated to change as a
result of this final rule.
Current information regarding all three collections of
information--including all background materials--can be found at
https://www.reginfo.gov/public/do/PRAMain by using the search function
to enter either the title of the collection or the OMB Control Number.
3. This rule does not contain policies with federalism implications
as that term is defined in E.O. 13132.
4. Pursuant to section 1762 of ECRA (50 U.S.C. 4821), this action
is exempt from the Administrative Procedure Act (APA) (5 U.S.C. 553)
requirements for notice of proposed rulemaking, opportunity for public
participation, and delay in effective date. While section 1762 of ECRA
provides sufficient authority for such an exemption, this action is
also independently exempt from these APA requirements because it
involves a military or foreign affairs function of the United States (5
U.S.C. 553(a)(1)).
5. Because neither the Administrative Procedure Act nor any other
law requires that notice of proposed rulemaking and an opportunity for
public comment be given for this rule, the analytical requirements of
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not
applicable. Accordingly, no Final Regulatory Flexibility Analysis is
required and none has been prepared.
List of Subjects
15 CFR Part 740
Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.
15 CFR Part 744
Exports, Reporting and recordkeeping requirements, Terrorism
15 CFR Part 746
Exports, Reporting and recordkeeping requirements.
15 CFR Part 762
Administrative practice and procedure, Business and industry,
Confidential business information, Exports, Reporting and recordkeeping
requirements.
For the reasons stated in the preamble, parts 740, 744, 746, and
762 of the Export Administration Regulations (15 CFR parts 730 through
774) are amended as follows:
PART 740--LICENSE EXCEPTIONS
0
1. The authority citation for part 740 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. 7201 et seq.; E.O. 13026, 61 FR
58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR,
2001 Comp., p. 783.
0
2. Part 740 is amended by adding Sec. 740.23 to read as follows.
Sec. 740.23 MEDICAL DEVICES (MED).
(a) Scope. License Exception MED authorizes the export, reexport,
or transfer (in country) of ``medical devices'' designated as EAR99 to
or within Russia, Belarus, the temporarily
[[Page 33228]]
occupied Crimea region of Ukraine, or the covered regions of Ukraine
(as specified in Sec. 746.6(a)(2) of the EAR). See Supplement no. 3 to
part 774--Statements of Understanding under paragraph (a) (Statement of
Understanding--medical equipment) for guidance on classifying medical
equipment and the definition of ``medical device'' in Sec. 772.1 of
the EAR. License Exception MED also authorizes the export, reexport, or
transfer (in country) to or within Russia, Belarus, the temporarily
occupied Crimea region of Ukraine, or the covered regions of Ukraine of
``parts,'' ``components,'' ``accessories,'' and ``attachments''
designated as EAR99 that are exclusively for use in or with ``medical
devices'' designated as EAR99. This license exception authorizes
transactions involving items designated as EAR99 that would otherwise
require a license pursuant to Sec. Sec. 746.5, 746.6 or 746.10 of the
EAR, subject to the terms and conditions described in this section. For
``parts,'' ``components,'' ``accessories,'' and ``attachments''
authorized under License Exception MED, such replacement ``parts,''
``components,'' ``accessories,'' and ``attachments'' may only be
exported, reexported, or transferred (in-country) if they also meet the
additional requirements under paragraphs (a)(1) and (2) of this
section:
(1) The ``part,'' ``component,'' ``accessory,'' or ``attachment''
is being exported, reexported, or transferred (in-country) solely to
replace a broken or nonoperational ``part,'' ``component,''
``accessory,'' or ``attachment'' for use in or with a ``medical
device'' that falls within the scope of paragraph (a) of this section,
or the export, reexport, or transfer (in-country) of such replacement
``parts,'' ``components,'' ``accessories,'' and ``attachments'' is
necessary and ordinarily incident to the proper preventative
maintenance of such a ``medical device;'' and
(2) The number of replacement ``parts,'' ``components,''
``accessories,'' and ``attachments'' that are exported, reexported,
transferred (in-country), and stored in Russia, Belarus, the
temporarily occupied Crimea region of Ukraine, or the covered regions
of Ukraine does not exceed the number of corresponding operational
``parts,'' ``components,'' ``accessories,'' and ``attachments''
currently in use in or with the relevant medical devices in Russia,
Belarus, the temporarily occupied Crimea region of Ukraine, or the
covered regions of Ukraine.
(b) Restrictions. This license exception does not authorize the
export, reexport, or transfer (in country) of any item:
(1) To a ``proscribed person'' (including but not limited to
`military end users' (see Sec. Sec. 744.17(e) and 744.21(g)) or in
situations in which an entity on the Entity List in supplement no. 4 to
part 744 or on the Military End-User (MEU) List) is a party to the
transaction as described in Sec. 748.5(c) through (f) of the EAR;
(2) Destined to a ``production'' ``facility;'' or
(3) When you have ``knowledge'' that the item is intended to
develop or produce items.
Note 1 to paragraphs (b)(2) and (3): The assembly in a hospital
or other health care facility of a finished ``medical device''
completely ``produced'' outside of Russia, Belarus, the temporarily
occupied Crimea region of Ukraine, or the covered regions of
Ukraine'' for the sole purpose of using that ``medical device'' at
that facility is not considered a ``production'' activity for
purposes of the restrictions under paragraphs (b)(2) and (3) of this
section.
(c) Verification. Exporters, reexporters, and transferors must
maintain a system of distribution that ensures that ``medical devices''
and ``parts,'' ``components,'' ``accessories,'' or ``attachments'' are
not delivered to ``proscribed persons'' or entities engaged in the
``production'' of any product. Verification of the effectiveness of the
distribution system may entail obtaining certain information from a
consignee (e.g., obtaining affirmations or other documentation from a
consignee, or performing periodic on-site spot-checks (e.g., conducting
such verification by staff of the exporter, reexporter, or transferor;
an internationally accredited auditing firm; or an internationally
recognized non-governmental humanitarian organization in Russia,
Belarus, the temporarily occupied Crimea region of Ukraine, or the
covered regions of Ukraine to conduct such verification).
(d) Recordkeeping and review or inspection of records. In addition
to complying with the recordkeeping requirements in part 762 of the
EAR, exporters, reexporters, and transferors must maintain records of
verification, as specified in paragraph (c) of this section, for 5
years and, upon request, provide records to BIS, or any other official
of the United States designated by BIS, for review or inspection.
PART 744--CONTROL POLICY: END-USER AND END-USE BASED
0
3. The authority citation for 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, 202); Notice of
November 8, 2022, 87 FR 68015, 3 CFR, 2022 Comp., p. 563; Notice of
September 7, 2023, 88 FR 62439 (September 11, 2023).
Sec. 744.11 [Amended]
0
4. Section 744.11 is amended by removing the fourth sentence of
paragraph (b) introductory text.
PART 746--EMBARGOES AND OTHER SPECIAL CONTROLS
0
5. The authority citation for 15 CFR part 746 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. 287c; Sec 1503, Pub. L. 108-11, 117
Stat. 559; 22 U.S.C. 2151 note; 22 U.S.C. 6004; 22 U.S.C. 7201 et
seq.; 22 U.S.C. 7210; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p.
614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222,
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3
CFR, 2004 Comp., p 168; Presidential Determination 2003-23, 68 FR
26459, 3 CFR, 2004 Comp., p. 320; Presidential Determination 2007-7,
72 FR 1899, 3 CFR, 2006 Comp., p. 325; Notice of May 8, 2023, 88 FR
30211 (May 10, 2023).
0
6. Section 746.5 is amended by revising paragraph (c) introductory text
and adding paragraph (c)(8), to read as follows:
Sec. 746.5 Russian and Belarusian industry sector sanctions.
* * * * *
(c) License exceptions. No license exceptions may overcome the
license requirements set forth in this section, except the license
exceptions identified in paragraphs (c)(2), (7), and (8) of this
section.
* * * * *
(8) License Exception MED (Sec. 740.23 of the EAR).
0
7. Section 746.6 is amended by adding paragraph (c)(7), to read as
follows:
Sec. 746.6 Temporarily occupied Crimea region of Ukraine and covered
regions of Ukraine.
* * * * *
(c) * * *
(7) License Exception MED (Sec. 740.23 of the EAR).
* * * * *
[[Page 33229]]
0
8. Section 746.10 is amended by revising paragraph (c) introductory
text and adding paragraph (c)(8), to read as follows:
Sec. 746.10 `Luxury goods' sanctions against Russia and Belarus and
Russian and Belarusian oligarchs and malign actors.
* * * * *
(c) License exceptions. No license exceptions may overcome the
license requirements in paragraph (a)(1) of this section except the
license exceptions identified in paragraphs (c)(1) through (3), (c)(7)
and (8) of this section.
* * * * *
(8) License Exception MED (Sec. 740.23 of the EAR).
PART 762--RECORDKEEPING
0
9. The authority citation for 15 CFR part 746 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.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783.
0
10. Section 762.2 is amended by:
0
a. Revising paragraphs (b)(53) and (54), and
0
b. Adding paragraph (b)(55).
The revisions and addition read as follows:
Sec. 762.2 Records to be retained.
* * * * *
(b) * * *
(53) Sec. 750.7(c)(2), Notification of name change by advisory
opinion request;
(54) Sec. 748.13, Certain Hong Kong import and export licenses;
and
(55) Sec. 740.23, License Exception MED.
* * * * *
Thea D. Rozman Kendler,
Assistant Secretary for Export Administration.
[FR Doc. 2024-09076 Filed 4-25-24; 8:45 am]
BILLING CODE 3510-JT-P
