Rule2024-09076

Amendment to Existing Controls on Russia and Belarus Under the Export Administration Regulations (EAR) Adding New License Exception Medical Devices (MED); Corrections

Primary source

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Published
April 29, 2024
Effective
April 29, 2024

Issuing agencies

Commerce DepartmentIndustry and Security Bureau

Abstract

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 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.

Full Text

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<title>Federal Register, Volume 89 Issue 83 (Monday, April 29, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09076]


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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.

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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: <a href="/cdn-cgi/l/email-protection#ed808c9f86c39e8c8184838c9ead8f849ec389828ec38a829b"><span class="__cf_email__" data-cfemail="6904081b02471a08050007081a290b001a470d060a470e061f">[email&#160;protected]</span></a>.
    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 <a href="https://www.bis.doc.gov">https://www.bis.doc.gov</a>.
    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:
    <bullet> OMB Control Number 0694-0088, ``Multi-Purpose 
Application,'' which carries a burden hour estimate of 29.4 minutes for 
a manual or electronic submission;
    <bullet> OMB Control Number 0694-0096 ``Five Year Records Retention 
Period,'' which carries a burden hour estimate of less than one minute; 
and
    <bullet> 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 
<a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a> 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


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Indexed from Federal Register on April 29, 2024.

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