Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 13179 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 744 

[Docket No. 210303–0036] 

RIN 0694–AI42 

Addition of Entities to the Entity List 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: In this final rule, the Bureau 

of Industry and Security (BIS) amends 

the Export Administration Regulations 

(EAR) to further implement U.S. 

sanctions on selected Burmese 

government ministries and related 

enterprises. Specifically, BIS amends 

the EAR by adding four entities to the 

Entity List under the destination of 

Burma. These four entities have been 

determined by the U.S. Government to 

be acting contrary to the national 

security or foreign policy interests of the 

United States. The actions in this rule 

support the United States Government’s 

efforts to promote a return to democracy 

in Burma following the February 1, 2021 

Burmese military coup. They also reflect 

the United States Government’s goal of 

supporting the people of Burma by 

preventing Burma’ military and security 

services from obtaining items subject to 

the EAR. 

DATES: This rule is effective March 8, 

2021. 

FOR FURTHER INFORMATION CONTACT: 

Chair, End-User Review Committee, 

Office of the Assistant Secretary, Export 

Administration, Bureau of Industry and 

Security, Department of Commerce, 

Phone: (202) 482–5991, Fax: (202) 482– 

3911, Email: ERC@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Entity List 

The Entity List (15 CFR, subchapter C, 

part 744, Supplement No. 4) identifies 

entities reasonably believed to be 

involved in, or to pose a significant risk 

of being or becoming involved in, 

activities contrary to the national 

security or foreign policy interests of the 

United States. The Export 

Administration Regulations (EAR) (15 

CFR parts 730–774) impose additional 

license requirements on, and limit the 

availability of most license exceptions 

for exports, reexports, and transfers (incountry) to listed entities. The license 

review policy for each listed entity is 

identified in the ‘‘License review 

policy’’ column on the Entity List, and 

the impact on the availability of license 

exceptions is described in the relevant 

Federal Register document adding 

entities to the Entity List. BIS places 

entities on the Entity List pursuant to 

part 744 (Control Policy: End-User and 

End-Use Based) and part 746 

(Embargoes and Other Special Controls) 

of the EAR. 

The End-User Review Committee 

(ERC), composed of representatives of 

the Departments of Commerce (Chair), 

State, Defense, Energy and, where 

appropriate, the Treasury, makes all 

decisions regarding additions to, 

removals from, or other modifications to 

the Entity List. The ERC makes all 

decisions to add an entry to the Entity 

List by majority vote and all decisions 

to remove or modify an entry by 

unanimous vote. The Departments 

represented on the ERC have approved 

these changes to the Entity List. 

Additions to the Entity List Made in 

Response to the February 1, 2021 

Military Coup in Burma 

BIS is making additions to the Entity 

List as part of a broader U.S. 

Government response to the February 1, 

2021 coup by the military in Burma, 

which overthrew Burma’s 

democratically-elected government, and 

the military’s subsequent arrest and 

detention of government leaders, human 

rights defenders, and journalists. On 

February 10, 2021, President Biden 

signed Executive Order (E.O.) 14014, 

‘‘Blocking Property With Respect to the 

Situation in Burma’’ (E.O. 14104) in 

which he declared a national emergency 

to address the threat posed to the United 

States by the situation in, and in 

relation to, Burma following the coup. 

See 86 FR 9429 (Feb. 12, 2021). 

Since February 10, 2021, BIS has 

taken action under the EAR to 

strengthen export controls on Burma 

and address the foreign policy and 

national security concerns that formed 

the basis for the issuance of E.O. 14104. 

On February 18, 2021, BIS published a 

rule in the Federal Register adopting a 

more restrictive review policy of a 

presumption of denial for license 

applications involving items subject to 

the EAR that require a license for export 

and reexport and that are destined for 

Burma’s Ministry of Defence, Ministry 

of Home Affairs, armed forces, or 

security services. The February 18, 2021 

rule also suspended the availability in 

part or in full of four license exceptions 

in part 740 of the EAR for items 

destined for Burma. See 86 FR 10011 

(Feb. 18, 2021). As part of an additional 

final rule, BIS imposed additional 

restrictions on Burma, including by 

removing the country from Country 

Group B, and placing it in the more 

restrictive Country Group D:1, and by 

adding it to the list of countries subject 

to defined ‘military end use’ and 

‘military end user’ restrictions. See 

supp. no. 1 to part 740 and §§ 742.4 and 

744.21 of the EAR. 

In this rule, BIS is taking additional 

steps in response to the situation in 

Burma. BIS is adding four entities, 

including specifically identified aliases, 

to the Entity List under the destination 

of Burma: The Ministry of Defence, the 

Ministry of Home Affairs, Myanmar 

Economic Corporation, and Myanmar 

Economic Holdings Limited. The 

actions in this rule support the United 

States Government’s efforts to promote 

a return to democracy in Burma. In 

particular, this rule enhances the U.S. 

Government’s efforts to ensure that 

items subject to the EAR are not 

available to Burma’s Ministry of Defence 

and the Ministry of Home Affairs, the 

entities responsible for the coup, or the 

two commercial entities owned and 

operated by the Ministry of Defence, 

Myanmar Economic Corporation and 

Myanmar Economic Holdings Limited, 

which provide revenue for the Ministry 

of Defence. 

The departments represented on the 

ERC reviewed and applied § 744.11(b) 

(Criteria for revising the Entity List) in 

making the determination to add these 

four entities to the Entity List. Under 

paragraph (b), persons for whom there is 

reasonable cause to believe, based on 

specific and articulable facts, that they 

have been involved, are involved, or 

pose a significant risk of being or 

becoming involved in activities that are 

contrary to the national security or 

foreign policy interests of the United 

States, along with those acting on behalf 

of such persons, may be added to the 

Entity List. Paragraphs (b)(1) through (5) 

of § 744.11 provide an illustrative list of 

activities that could be contrary to the 

national security or foreign policy 

interests of the United States. For each 

of the four entities identified below, the 

ERC made the requisite determination 

based on the standard set forth in 

§ 744.11(b). The four entities added to 

the Entity List in this rule are involved 

in activities that are contrary to the 

national security and foreign policy of 

the United States by being involved in, 

or supporting, the military coup in 

Burma. 

For the four entities added to the 

Entity List in this final rule, BIS 

imposes a license requirement for all 

items subject to the EAR and a license 

review policy of presumption of denial. 

In addition, no license exceptions are 

available for exports, reexports, or 

transfers (in-country) to the persons 

being added to the Entity List in this 

rule. The acronym ‘‘a.k.a.’’ (also known 


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13180 Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 

as) is used in entries on the Entity List 

to identify aliases, thereby assisting 

exporters, reexporters, and transferors in 

identifying entities on the Entity List. 

For the reasons described above, this 

final rule adds the following four 

entities to the Entity List. 

Burma 

• Ministry of Defence; 

• Ministry of Home Affairs; 

• Myanmar Economic Corporation; 

and 

• Myanmar Economic Holdings 

Limited. 

Savings Clause 

Shipments of items removed from 

eligibility for a License Exception or 

export or reexport without a license 

(NLR) as a result of this regulatory 

action that were en route aboard a 

carrier to a port of export or reexport, on 

March 8, 2021, pursuant to actual orders 

for export or reexport to a foreign 

destination, may proceed to that 

destination under the previous 

eligibility for a License Exception or 

export or reexport without a license 

(NLR). 

Export Control Reform Act of 2018 

On August 13, 2018, President Donald 

J. Trump signed into law the John S. 

McCain National Defense Authorization 

Act for Fiscal Year 2019, which 

included the Export Control Reform Act 

of 2018 (ECRA) (50 U.S.C. 4801–4852) 

that provides the legal basis for BIS’s 

principal authorities and serves as the 

authority under which BIS issues this 

rule. 

Rulemaking Requirements 

Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule 

has been determined to be not 

significant for purposes of Executive 

Order 12866. 

Notwithstanding any other provision 

of law, no person is required to respond 

to or be subject to a penalty for failure 

to comply with a collection of 

information, subject to the requirements 

of the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.) (PRA), unless 

that collection of information displays a 

currently valid Office of Management 

and Budget (OMB) Control Number. 

This regulation involves collections 

previously approved by OMB under 

control number 0694–0088, Simplified 

Network Application Processing 

System, which includes, among other 

things, license applications, and carries 

a burden estimate of 42.5 minutes for a 

manual or electronic submission. Total 

burden hours associated with the PRA 

and OMB control number 0694–0088 

are not expected to increase as a result 

of this rule. 

This rule does not contain policies 

with Federalism implications as that 

term is defined in Executive Order 

13132. 

Pursuant to section 1762 of the Export 

Control Reform Act of 2018, this action 

is exempt from the Administrative 

Procedure Act (5 U.S.C. 553) 

requirements for notice of proposed 

rulemaking, opportunity for public 

participation, and delay in effective 

date. 

Because a notice of proposed 

rulemaking and an opportunity for 

public comment are not required to be 

given for this rule by 5 U.S.C. 553, or 

by any other law, the analytical 

requirements of the Regulatory 

Flexibility Act, 5 U.S.C. 601, et seq., are 

not applicable. Accordingly, no 

regulatory flexibility analysis is required 

and none has been prepared. 

List of Subjects in 15 CFR Part 744 

Exports, Reporting and recordkeeping 

requirements, Terrorism. 

Accordingly, part 744 of the Export 

Administration Regulations (15 CFR 

parts 730–774) is amended as follows: 

PART 744—[AMENDED] 

■ 1. The authority citation for 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 18, 2020, 

85 FR 59641 (September 22, 2020); Notice of 

November 12, 2020, 85 FR 72897 (November 

13, 2020). 

■ 2. Supplement No. 4 to part 744 is 

amended under Burma by adding in 

alphabetical order entries for ‘‘Ministry 

of Defence,’’ ‘‘Ministry of Home 

Affairs,’’ ‘‘Myanmar Economic 

Corporation,’’ and ‘‘Myanmar Economic 

Holdings Limited’’ to read as follows: 

Supplement No. 4 to Part 744—Entity 

List 

* * * * * 

Country Entity License 

requirement 

License 

review policy 

Federal Register 

Citation 

*******

BURMA.

******

Ministry of Defence, a.k.a., the following two aliases: 

—Ministry of Defense; and 

—MoD. 

Building 24, Nay Pyi Taw, Burma. 

For all items subject to 

the EAR. (See § 744.11 

of the EAR). 

Presumption of denial. ..... 86 FR [INSERT FR PAGE 

NUMBER], 3/8/2021. 

Ministry of Home Affairs, a.k.a., the following one alias: 

—MOHA. 

Building 10, Nay Pyi Taw, Burma. 

For all items subject to 

the EAR. (See § 744.11 

of the EAR). 

Presumption of denial ...... 86 FR [INSERT FR PAGE 

NUMBER], 3/8/2021. 


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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 13181 

Country Entity License 

requirement 

License 

review policy 

Federal Register 

Citation 

Myanmar Economic Corporation, a.k.a., 

the following one alias: 

—MEC. 

Corner of Ahlone Road and Strand 

Road, Ahlone Township, Yangon, 

Myanmar. 

For all items subject to 

the EAR. (See § 744.11 

of the EAR). 

Presumption of denial ...... 86 FR [INSERT FR PAGE 

NUMBER], 3/8/2021. 

Myanmar Economic Holdings Limited, 

a.k.a., the following eight aliases: 

—MEHL; 

—Myanma Economic Holdings Limited; 

—Myanma Economic Holdings Public 

Company Limited; 

—Myanmar Business Holdings Public 

Company Limited; 

—Myanmar Economic Holdings Public 

Company Limited; 

—UMEH; 

—Union of Myanmar Economic Holdings Company Limited; and 

—Union of Myanmar Economic Holdings Limited. 

189–191 Maha Bandoola Road, 

Botahtaung Township, Yangon, 

Burma. 

For all items subject to 

the EAR. (See § 744.11 

of the EAR). 

Presumption of denial ...... 86 FR [INSERT FR PAGE 

NUMBER], 3/8/2021. 

* * * * * * * 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2021–04794 Filed 3–4–21; 4:15 pm] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 516, 520, 522, 524, 

526, 529, 556, and 558 

[Docket No. FDA–2020–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Change of 

Sponsor 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the animal drug regulations to 

reflect application-related actions for 

new animal drug applications (NADAs) 

and abbreviated new animal drug 

applications (ANADAs) during April, 

May, and June 2020. FDA is informing 

the public of the availability of 

summaries of the basis of approval and 

of environmental review documents, 

where applicable. The animal drug 

regulations are also being amended to 

improve the accuracy and readability of 

the regulations. 

DATES: This rule is effective March 8, 

2021. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–5689, 

george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Approval Actions 

FDA is amending the animal drug 

regulations to reflect approval actions 

for NADAs and ANADAs during April, 

May, and June 2020, as listed in table 1. 

In addition, FDA is informing the public 

of the availability, where applicable, of 

documentation of environmental review 

required under the National 

Environmental Policy Act (NEPA) and, 

for actions requiring review of safety or 

effectiveness data, summaries of the 

basis of approval (FOI Summaries) 

under the Freedom of Information Act 

(FOIA). These public documents may be 

seen in the office of the Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. Persons 

with access to the internet may obtain 

these documents at the CVM FOIA 

Electronic Reading Room: https://

www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing 

exclusivity and patent information may 

be accessed in FDA’s publication, 

Approved Animal Drug Products Online 

(Green Book) at: https://www.fda.gov/ 

animal-veterinary/products/approvedanimal-drug-products-green-book. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2020 

Approval date File No. Sponsor Product name Species Effect of the action Public 

documents 

April 2, 2020 ..... 141–527 Bayer HealthCare LLC, 

Animal Health Division, 

P.O. Box 390, Shawnee 

Mission, KS 66201.

BAYTRIL 100–CA1 

(enrofloxacin) Injectable 

Solution.

Cattle .............. Conditional approval for the treatment 

of clinical anaplasmosis in certain 

classes of cattle.

FOI Summary. 

April 10, 2020 ... 141–533 Boehringer Ingelheim Animal Health USA, Inc., 

3239 Satellite Blvd., Duluth, GA 30096.

ASERVO EQUIHALER 

(ciclesonide inhalation 

spray).

Horses ............ Original approval for the management 

of clinical signs associated with severe equine asthma in horses.

FOI Summary. 


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