[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Rules and Regulations]
[Pages 59249-59250]
[FR Doc No: 2013-23252]

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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2013-0468; FRL-9900-74-Region 9]

Revisions to the California State Implementation Plan, South
Coast Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing approval of revisions to the South Coast Air
Quality Management District (SCAQMD) portion of the California State
Implementation Plan (SIP). This action was proposed in the Federal
Register on June 24, 2013 and concerns volatile organic compound (VOC),
oxides of nitrogen (NOX), and particulate matter (PM)
emissions from open burning and wood-burning devices. We are approving
local rules that regulate these emission sources under the Clean Air
Act (CAA or the Act).

DATES: These rules will be effective on October 28, 2013.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2013-0468 for
this action. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California 94105-
3901. While all documents in the docket are listed at http://www.regulations.gov, some information may be publicly available only at
the hard copy location (e.g., copyrighted material, large maps, multi-
volume reports), and some may not be available in either location
(e.g., confidential business information (CBI)). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Christine Vineyard, EPA Region IX,
(415) 947-4125<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On June 24, 2013 (78 FR 37757), EPA proposed to approve the
following rules into the California SIP.

----------------------------------------------------------------------------------------------------------------
             Local agency                  Rule No.            Rule title             Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD................................             444  Open Burning............        05/03/13        06/11/13
SCAQMD................................             445  Wood Burning Devices....        05/03/13        06/11/13
----------------------------------------------------------------------------------------------------------------

    We proposed to approve these rules because we determined that they
complied with the relevant CAA requirements. Our proposed action
contains more information on the rules and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. EPA Action

    No comments were submitted. Therefore, as authorized in section
110(k)(3) of the Act, EPA is fully approving these rules into the
California SIP.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);

     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 25, 2013. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter], Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: August 22, 2013.
 Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(430) to read as
follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (430) New and amended regulations for the following APCD was
submitted on June 11, 2013 by the Governor's Designee.
    (i) Incorporation by Reference.
    (A) South Coast Air Quality Management District.
    (1) Rule 444, ``Open Burning,'' adopted on May 3, 2013.
    (2) Rule 445, ``Wood Burning Devices,'' adopted on May 3, 2013.

[FR Doc. 2013-23252 Filed 9-25-13; 8:45 am]
BILLING CODE 6560-50-P


 Forwarded by Tom Wall/ DC/ USEPA/ US on 12/ 18/ 02 05: 34 PM  Caroline Ejimofor 12/ 18/ 02 04: 24 PM To: 316b < 316b@ tetratech ffx. com> cc: Bruce Kent/ P2/ R8/ USEPA/ US@ EPA, Deborah Nagle/ DC/ USEPA/ US@ EPA, Ericp Nelson/ R1/ USEPA/ US@ EPA, Evelyn MacKnight/ R3/ USEPA/ US@ EPA, Isaac Chen/ R6/ USEPA/ US@ EPA, John Dunn/ WWPD/ R7/ USEPA/ US@ EPA, Karrie Jo Shell/ R4/ USEPA/ US@ EPA, Larry Merrill/ R3/ USEPA/ US@ EPA, Mark Stein/ R1/ USEPA/ US@ EPA, Moses Chang/ R2/ USEPA/ US@ EPA, Paulette Johnsey/ R6/ USEPA/ US@ EPA, Peter Howe/ R5/ USEPA/ US@ EPA, Phil Colarusso/ R1/ USEPA/ US@ EPA, Philip Sweeney/ R2/ USEPA/ US@ EPA, Robyn Stuber/ R9/ USEPA/ US@ EPA, Terry Oda/ R9/ USEPA/ US@ EPA, Tom Wall/ DC/ USEPA/ US@ EPA Subject: Re: 316( b) Help needed  From Deborah Nagle Deborah, For the Region 4 states that have done 316b analysis, an assumption is not made up front on the percentage of entrainment survival. They, typically, assess the entrainment at their facility and report the approximate survival percentages that their data indicate in their NPDES applications.

Hope this helps.

Caroline Ejimofor NPDES and Biosolids Permits Section Permits, Grants and Technical Assistance Branch EPA Water Management Division e mail address: Ejimofor. Caroline@ epa. gov phone number: 404 562 9209 fax number: 404 562 8692 316b < 316b@ tetratech f fx. com> Sent: 12/ 16/ 2002 04: 04 PM To: Bruce Kent/ P2/ R8/ USEPA/ US@ EPA, Caroline Ejimofor/ R4/ USEPA/ US@ EPA, Ericp Nelson/ R1/ USEPA/ US@ EPA, Evelyn MacKnight/ R3/ USEPA/ US@ EPA, Isaac Chen/ R6/ USEPA/ US@ EPA, John Dunn/ WWPD/ R7/ USEPA/ US@ EPA, Karrie Jo Shell/ R4/ USEPA/ US@ EPA, Terry Oda/ R9/ USEPA/ US@ EPA, Larry Merrill/ R3/ USEPA/ US@ EPA, Mark Stein/ R1/ USEPA/ US@ EPA, Moses Chang/ R2/ USEPA/ US@ EPA, Paulette Johnsey/ R6/ USEPA/ US@ EPA, Peter Howe/ R5/ USEPA/ US@ EPA, Phil Colarusso/ R1/ USEPA/ US@ EPA, Philip Sweeney/ R2/ USEPA/ US@ EPA, Robyn Stuber/ R9/ USEPA/ US@ EPA cc: Tom Wall/ DC/ USEPA/ US@ EPA, Deborah Nagle/ DC/ USEPA/ US@ EPA Subject: 316( b) Help needed  From Deborah Nagle I need some help from the field, concerning entrainment survival. We have been reviewing and critiqueing multiple entrainment survival studies for the 316( b) Phase II NODA. It is very important for us to know if States consider entrainment survival when making 316( b) determinations. For each State in your Region, I need you to apply one of the answers below:

ANSWERS 1. Does not consider entrainment survival at all 2. Assumes entrainment survival is 0% ( 100% mortality) 3. Assumes entrainment survival is X% ( fill in the number for X)

I need this information quickly this week if possible. Send partial information instead of waiting until you have information for all your states. Thanks for your help.

 Deborah


[Federal Register Volume 84, Number 98 (Tuesday, May 21, 2019)]
[Rules and Regulations]
[Pages 22961-22968]
[FR Doc No: 2019-10616]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No. 190513445-9445-01]
RIN 0694-AH86

Addition of Entities to the Entity List

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: In this rule, the Bureau of Industry and Security (BIS) amends
the Export Administration Regulations (EAR) by adding Huawei
Technologies Co., Ltd. (Huawei) to the Entity List. The U.S. Government
has determined that there is reasonable cause to believe that Huawei
has been involved in activities contrary to the national security or
foreign policy interests of the United States. BIS is also adding non-
U.S. affiliates of Huawei to the Entity List because those affiliates
pose a significant risk of involvement in activities contrary to the
national security or foreign policy interests of the United States.
Huawei will be listed on the Entity List under the destination of
China. This final rule also adds to the Entity List sixty-eight non-
U.S. affiliates of Huawei located in twenty-six destinations: Belgium,
Bolivia, Brazil, Burma, Canada, Chile, China, Egypt, Germany, Hong
Kong, Jamaica, Japan, Jordan, Lebanon, Madagascar, Netherlands, Oman,
Pakistan, Paraguay, Qatar, Singapore, Sri Lanka, Switzerland, Taiwan,
United Kingdom, and Vietnam.

DATES: Effective Date: This rule is effective May 16, 2019.

FOR FURTHER INFORMATION CONTACT: Director, Office of Exporter Services,
Bureau of Industry and Security, Department of Commerce, Phone: (949)
660-0144 or<PHONE_NUMBER> or email your inquiry to:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The Entity List (Supplement No. 4 to part 744) identifies entities
reasonably believed to be involved, or pose a significant risk of being
or becoming involved, in activities contrary to the national security
or foreign policy interests of the United States. The Export
Administration Regulations (EAR) (15 CFR, subchapter C, parts 730-774)
imposes additional license requirements on, and limits the availability
of most license exceptions for exports, reexports, and transfers (in-
country) to, listed entities. The license review policy for each listed
entity is identified in the ``License review policy'' column on the
Entity List, and the impact on the availability of license exceptions
is described in the relevant Federal Register notice 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.

ERC Entity List Decision

Additions to the Entity List

    Under Sec.  744.11(b) (Criteria for revising the Entity List) of
the EAR, persons for whom there is reasonable cause to believe, based
on specific and articulable facts, that the person has been involved,
is involved, or poses a significant risk of being or becoming involved
in activities that are contrary to the national security or foreign
policy interests of the United States and those acting on behalf of
such persons may be added to the Entity List.
    Pursuant to Sec.  744.11(b) of the EAR, the ERC has determined that
there is reasonable cause to believe that Huawei Technologies Co., Ltd.
(Huawei) has been involved in activities determined to be contrary to
the national security or foreign policy interests of the United States.
To illustrate, Huawei has been indicted in the U.S. District Court for
the Eastern District of New York on 13 counts of violating U.S. law
(Superseding Indictment), including violations of the International
Emergency Economic Powers Act (IEEPA), by knowingly and willfully
causing the export, reexport, sale and supply, directly and indirectly,
of goods, technology and services (banking and other financial
services) from the United States to Iran and the government of Iran
without obtaining a license from the Department of Treasury's Office of
Foreign Assets Control (OFAC), as required by OFAC's Iranian
Transactions and Sanctions Regulations (31 CFR part 560), and
conspiracy to violate IEEPA by knowingly and willfully conspiring to
cause the export, reexport, sale and supply, directly and indirectly,
of goods, technology and services (banking and other financial
services) from the United States to Iran and the government of Iran
without obtaining a license from OFAC as required by OFAC's Iranian
Transactions and Sanctions Regulations (31 CFR part 560). The
Superseding Indictment also alleges that Huawei and an Iranian-based
affiliate, working with others, knowingly and willfully conspired to
impair, impede, obstruct, and defeat, through deceitful and dishonest
means, the lawful government operations of OFAC.
    Further, Huawei's affiliates present a significant risk of acting
on Huawei's behalf to engage in such activities. Because the ERC has
determined that there is reasonable cause to believe that the
affiliates pose a significant risk of becoming involved in activities
contrary to the national security or foreign policy interests of the
United States due to their relationship with Huawei, this final rule
also adds to the Entity List sixty-eight non-U.S. affiliates of Huawei
located in twenty-six destinations: Belgium, Bolivia, Brazil, Burma,
Canada, Chile, China, Egypt, Germany, Hong Kong, Jamaica, Japan,
Jordan, Lebanon, Madagascar, Netherlands, Oman, Pakistan, Paraguay,
Qatar, Singapore, Sri Lanka, Switzerland,

Taiwan, United Kingdom, and Vietnam. Without the imposition of a
license requirement as to these affiliated companies, there is
reasonable cause to believe that Huawei would seek to use these
entities to evade the restrictions imposed by its addition to the
Entity List. As set forth in the Superseding Indictment filed in the
Eastern District of New York, Huawei participated along with certain
affiliates in the alleged criminal violations of U.S. law, including
one or more non-U.S. affiliates. The Superseding Indictment also
alleges that Huawei and affiliates acting on Huawei's behalf engaged in
a series of deceptive and obstructive acts designed to evade U.S. law
and to avoid detection by U.S. law enforcement.
    In light of the foregoing, Huawei and sixty-eight non-U.S.
affiliates of Huawei raise sufficient concern that prior review of
exports, reexports, or transfers (in-country) of items subject to the
EAR involving these entities, and the possible imposition of license
conditions or license denials on shipments to these entities, will
enhance BIS's ability to prevent activities contrary to the national
security or foreign policy interests of the United States.
    For all of the entities added to the Entity List in this final
rule, unless authorized by the Savings Clause 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. Similarly, no license
exceptions are available for exports, reexports, or transfers (in-
country) to the persons being added to the Entity List in this rule
except as allowed in the Savings Clause in this final rule.
    This final rule adds the following entity to the Entity List:

China

    (1) Huawei Technologies Co., Ltd. (Huawei), Bantian Huawei Base,
Longgang District, Shenzhen, 518129, China.
    This final rule also adds the following sixty-eight non-U.S.
affiliates of the entry above to the Entity List:

Belgium

    (1) Huawei Technologies Research & Development Belgium NV, Belgium.

Bolivia

    (1) Huawei Technologies (Bolivia) S.R.L., La Paz, Bolivia.

Brazil

    (1) Huawei do Brasil Telecomunicac[otilde]es Ltda, Sao Paulo,
Brazil.

Burma

    (1) Huawei Technologies (Yangon) Co., Ltd., Yangon, Burma.

Canada

    (1) Huawei Technologies Canada Co., Ltd., Markham, ON, Canada.

Chile

    (1) Huawei Chile S.A., Santiago, Chile.

China

    (1) Beijing Huawei Digital Technologies Co., Ltd., Beijing, China;
    (2) Chengdu Huawei High-Tech Investment Co., Ltd., Chengdu,
Sichuan, China;
    (3) Chengdu Huawei Technologies Co., Ltd., Chengdu, Sichuan, China;
    (4) Dongguan Huawei Service Co., Ltd., Dongguan, Guangdong, China;
    (5) Dongguan Lvyuan Industry Investment Co., Ltd., Dongguan,
Guangdong, China;
    (6) Gui'an New District Huawei Investment Co., Ltd., Guiyang,
Guizhou, China;
    (7) Hangzhou Huawei Digital Technology Co., Ltd., Hangzhou,
Zhejiang, China;
    (8) HiSilicon Optoelectronics Co., Ltd., Wuhan, Hubei, China;
    (9) HiSilicon Technologies Co., Ltd (HiSilicon), Bantian Longgang
District, Shenzhen, 518129, China.
    (10) HiSilicon Tech (Suzhou) Co., Ltd., Suzhou, Jiangsu, China;
    (11) Huawei Device Co., Ltd., Dongguan, Guangdong, China;
    (12) Huawei Device (Dongguan) Co., Ltd., Dongguan, Guangdong,
China;
    (13) Huawei Device (Shenzhen) Co., Ltd., Shenzhen, Guangdong,
China;
    (14) Huawei Digital Technologies (Suzhou) Co., Ltd., Suzhou,
Jiangsu, China;
    (15) Huawei Machine Co., Ltd., Dongguan, Guangdong, China;
    (16) Huawei Software Technologies Co., Ltd., Nanjing, Jiangsu,
China;
    (17) Huawei Technical Service Co., Ltd., China;
    (18) Huawei Technologies Service Co., Ltd., Langfang, Hebei, China;
    (19) Huawei Training (Dongguan) Co., Ltd., Dongguan, Guangdong,
China;
    (20) Huayi Internet Information Service Co., Ltd., Shenzhen,
Guangdong, China;
    (21) North Huawei Communication Technology Co., Ltd., Beijing,
China;
    (22) Shanghai Haisi Technology Co., Ltd., Shanghai, China;
    (23) Shanghai Huawei Technologies Co. Ltd., Shanghai, China;
    (24) Shanghai Mossel Trade Co., Ltd., Shanghai, China;
    (25) Shenzhen Huawei Technical Services Co., Ltd., Shenzhen,
Guangdong, China;
    (26) Shenzhen Huawei Terminal Commercial Co., Ltd., Shenzhen,
Guangdong, China;
    (27) Shenzhen Huawei Training School Co., Ltd., Shenzhen,
Guangdong, China;
    (28) Shenzhen Huayi Loan Small Loan Co., Ltd., Shenzhen, Guangdong,
China;
    (29) Shenzhen Legrit Technology Co., Ltd., Shenzhen, Guangdong,
China;
    (30) Shenzhen Smartcom Business Co., Ltd., Shenzhen, Guangdong,
China;
    (31) Suzhou Huawei Investment Co., Ltd., Suzhou, Jiangsu, China;
    (32) Wuhan Huawei Investment Co., Ltd., Wuhan, Hubei, China;
    (33) Xi'an Huawei Technologies Co., Ltd., Xi'an, Shaanxi, China;
    (34) Xi'an Ruixin Investment Co., Ltd., Xi'an, Shaanxi, China; and
    (35) Zhejiang Huawei Communications Technology Co., Ltd., Hangzhou,
Zhejiang, China.

Egypt

    (1) Huawei Technology, Cairo, Egypt.

Germany

    (1) Huawei Technologies Deutschland GmbH, Germany.

Hong Kong

    (1) Huawei Device (Hong Kong) Co., Limited, Tsim Sha Tsui, Kowloon,
Hong Kong;
    (2) Huawei International Co., Limited, Hong Kong;
    (3) Huawei Tech. Investment Co., Limited, Hong Kong;
    (4) Huawei Technologies Co. Ltd., Tsim Sha Tsui, Kowloon, Hong
Kong;
    (5) Hua Ying Management Co. Limited, Tsim Sha Tsui, Kowloon, Hong
Kong; and
    (6) Smartcom (Hong Kong) Co., Limited, Sheung Wan, Hong Kong;

Jamaica

    (1) Huawei Technologies Jamaica Company Limited, Kingston, Jamaica.

Japan

    (1) Huawei Technologies Japan K.K., Japan.

Jordan

    (1) Huawei Technologies Investment Co. Ltd., Amman, Jordan.

Lebanon

    (1) Huawei Technologies Lebanon, Beirut, Lebanon.

Madagascar

    (1) Huawei Technologies Madagascar Sarl, Antananarivo, Madagascar.

Netherlands

    (1) Huawei Technologies Co[ouml]peratief U.A., Netherlands.

Oman

    (1) Huawei Tech Investment Oman LLC, Muscat, Oman.

Pakistan

    (1) Huawei Technologies Pakistan (Private) Limited, Islamabad,
Pakistan.

Paraguay

    (1) Huawei Technologies Paraguay S.A., Asuncion, Paraguay.

Qatar

    (1) Huawei Tech Investment Limited, Doha, Qatar.

Singapore

    (1) Huawei International Pte. Ltd., Singapore.

Sri Lanka

    (1) Huawei Technologies Lanka Company (Private) Limited, Colombo,
Sri Lanka.

Switzerland

    (1) Huawei Technologies Switzerland AG, Liebefeld, Bern,
Switzerland.

Taiwan

    (1) Xunwei Technologies Co., Ltd., Taipei, Taiwan.

United Kingdom

    (1) Huawei Global Finance (UK) Limited, Great Britain;
    (2) Proven Glory, British Virgin Islands; and
    (3) Proven Honour, British Virgin Islands.

Vietnam

    (1) Huawei Technologies (Vietnam) Company Limited, Hanoi, Vietnam;
and
    (2) Huawei Technology Co. Ltd., Hanoi, Vietnam.

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 May 16, 2019, 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, 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) (Title XVII,
Subtitle B of Pub. L. 115-232 (132 Stat. 2210); 50 U.S.C. 4801 et
seq.), which provides the legal basis for BIS's principal authorities
and serves as the authority under which BIS issues this rule. As set
forth in sec. 1768 of ECRA, all delegations, rules, regulations,
orders, determinations, licenses, or other forms of administrative
action that have been made, issued, conducted, or allowed to become
effective under the Export Administration Act of 1979 (50 U.S.C. 4601
et seq.) (as in effect prior to August 13, 2018 and as continued in
effect pursuant to the International Emergency Economic Powers Act (50
U.S.C. 1701 et seq.) and Executive Order 13222 of August 17, 2001, 3
CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of
March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the
Notice of August 8, 2018, 83 FR 39871 (August 13, 2018)), or the Export
Administration Regulations, and are in effect as of August 13, 2018,
shall continue in effect according to their terms until modified,
superseded, set aside, or revoked under the authority of ECRA.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been determined to be not significant for
purposes of Executive Order 12866. This rule is not an Executive Order
13771 regulatory action because this rule is not significant under
Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to nor 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. You may send comments
regarding the collection of information associated with this rule,
including suggestions for reducing the burden, to Jasmeet K. Seehra,
Office of Management and Budget (OMB), by email to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. Pursuant to sec. 1762 of ECRA, this action is exempt from the
Administrative Procedure Act (5 U.S.C. 553) requirements for notice of
proposed rulemaking, opportunity for public participation, and delay in
effective date.
    5. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq., are not applicable.
Accordingly, no regulatory flexibility analysis is required and none
has been prepared.

List of Subjects in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, part 744 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR part 744 is revised to read as
follows:

    Authority: Pub. L. 115-232, Title XVII, Subtitle B (132 Stat.
2210); 50 U.S.C. 4801 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. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; 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 August 8, 2018, 83 FR 39871
(August 13, 2018); Notice of September 19, 2018, 83 FR 47799
(September 20, 2018). Notice of November 8, 2018, 83 FR 56253
(November 9, 2018); Notice of January 16, 2019, 84 FR 127 (January
18, 2019).

0
2. Supplement No. 4 to part 744 is amended:
0
a. By adding in alphabetical order a heading for Belgium and one
Belgian

entity, ``Huawei Technologies Research & Development Belgium NV''.
0
b. By adding in alphabetical order a heading for Bolivia and one
Bolivian entity, ``Huawei Technologies (Bolivia) S.R.L.''.
0
c. By adding in alphabetical order a heading for Brazil and one
Brazilian entity, ``Huawei do Brasil Telecomunicac[otilde]es Ltda''.
0
d. By adding in alphabetical order a heading for Burma and one Burmese
entity, ``Huawei Technologies (Yangon) Co., Ltd.''.
0
e. Under Canada, by adding in alphabetical order, one Canadian entity,
``Huawei Technologies Canada Co., Ltd''.
0
f. By adding in alphabetical order a heading for Chile and one Chilean
entity, ``Huawei Chile S.A.''.
0
g. Under China, People's Republic of, by adding in alphabetical order,
thirty-six Chinese entities: ``Beijing Huawei Digital Technologies Co.,
Ltd.'', ``Chengdu Huawei High-Tech Investment Co., Ltd.'', ``Chengdu
Huawei Technologies Co., Ltd.'', ``Dongguan Huawei Service Co., Ltd.'',
``Dongguan Lvyuan Industry Investment Co., Ltd.'', ``Gui'an New
District Huawei Investment Co., Ltd.'', ``Hangzhou Huawei Digital
Technology Co., Ltd.'', ``HiSilicon Optoelectronics Co., Ltd.'',
``HiSilicon Technologies Co., Ltd (HiSilicon)'', ``HiSilicon Tech
(Suzhou) Co., Ltd.'', ``Huawei Device Co., Ltd.'', ``Huawei Device
(Dongguan) Co., Ltd.'', ``Huawei Device (Shenzhen) Co., Ltd.'',
``Huawei Digital Technologies (Suzhou) Co., Ltd.'', ``Huawei Machine
Co., Ltd.'', ``Huawei Software Technologies Co., Ltd.'', ``Huawei
Technical Service Co., Ltd.'', ``Huawei Technologies Co., Ltd.'',
``Huawei Technologies Service Co., Ltd.'', ``Huawei Training (Dongguan)
Co., Ltd.'', ``Huayi internet Information Service Co., Ltd.'', ``North
Huawei Communication Technology Co., Ltd.'', ``Shanghai Haisi
Technology Co., Ltd.'', ``Shanghai Huawei Technologies Co. Ltd.'',
``Shanghai Mossel Trade Co., Ltd.'', ``Shenzhen Huawei Technical
Services Co., Ltd.'', ``Shenzhen Huawei Terminal Commercial Co.,
Ltd.'', ``Shenzhen Huawei Training School Co., Ltd.'', ``Shenzhen Huayi
Loan Small Loan Co., Ltd.'', ``Shenzhen Legrit Technology Co., Ltd.'',
``Shenzhen Smartcom Business Co., Ltd.'', ``Suzhou Huawei Investment
Co., Ltd.'', ``Wuhan Huawei Investment Co., Ltd.'', ``Xi'an Huawei
Technologies Co., Ltd.'', ``Xi'an Ruixin Investment Co., Ltd.'', and
``Zhejiang Huawei Communications Technology Co., Ltd.''.
0
h. Under Egypt, by adding in alphabetical order, one Egyptian entity,
``Huawei Technology''.
0
i. Under Germany, by adding in alphabetical order, one German entity,
``Huawei Technologies Deutschland GmbH''.
0
j. Under Hong Kong, by adding in alphabetical order, six Hong Kong
entities, ``Huawei Device (Hong Kong) Co., Limited'', ``Huawei
International Co., Limited'', ``Huawei Tech. Investment Co., Limited'',
``Huawei Technologies Co. Ltd.'', ``Hua Ying Management Co. Limited'',
and ``Smartcom (Hong Kong) Co., Limited''.
0
k. By adding in alphabetical order a heading for Jamaica and one
Jamaican entity, ``Huawei Technologies Jamaica Company Limited''.
0
l. By adding in alphabetical order a heading for Japan and one Japanese
entity, ``Huawei Technologies Japan K.K.''.
0
m. By adding in alphabetical order a heading for Jordan and one
Jordanian entity, ``Huawei Technologies Investment Co. Ltd.''.
0
n. By adding in alphabetical order, under Lebanon, one Lebanese entity,
``Huawei Technologies Lebanon''.
0
o. By adding in alphabetical order a heading for Madagascar and one
Malagasy entity, ``Huawei Technologies Madagascar Sarl''.
0
p. Under Netherlands, by adding in alphabetical order, one Dutch
entity, ``Huawei Technologies Co[ouml]peratief U.A.''.
0
q. By adding in alphabetical order a heading for Oman and one Omani
entity, ``Huawei Tech Investment Oman LLC''.
0
r. Under Pakistan, by adding in alphabetical order, one Pakistani
entity, ``Huawei Technologies Pakistan (Private) Limited''.
0
s. By adding in alphabetical order a heading for Paraguay and one
Paraguayan entity, ``Huawei Technologies Paraguay S.A.''.
0
t. By adding in alphabetical order a heading for Qatar and one Qatari
entity, ``Huawei Tech Investment Limited''.
0
u. Under Singapore, by adding in alphabetical order, one Singaporean
entity, ``Huawei International Pte. Ltd.''.
0
v. By adding in alphabetical order a heading for Sri Lanka and one
Sinhalese entity, ``Huawei Technologies Lanka Company (Private)
Limited''.
0
w. Under Switzerland, by adding in alphabetical order, one Swiss
entity, ``Huawei Technologies Switzerland AG''.
0
x. Under Taiwan, by adding in alphabetical order, one Taiwanese entity,
``Xunwei Technologies Co., Ltd.''
0
y. Under United Kingdom, by adding in alphabetical order, three British
entities, ``Huawei Global Finance (UK) Limited'', ``Proven Glory'', and
``Proven Honour''.
0
z. By adding in alphabetical order a heading for Vietnam and two
Vietnamese entities, ``Huawei Technologies (Vietnam) Company Limited''
and ``Huawei Technology Co. Ltd.''.
    The additions read as follows:

Supplement No. 4 to Part 744--Entity List

* * * * *

----------------------------------------------------------------------------------------------------------------
                                                                              License review    Federal Register
        Country                     Entity             License requirement        policy            citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
BELGIUM................  Huawei Technologies Research  For all items        Presumption of     84 FR [INSERT FR
                          & Development Belgium NV,     subject to the       denial.            PAGE NUMBER] May
                          Belgium.                      EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
BOLIVIA................  Huawei Technologies           For all items        Presumption of     84 FR [INSERT FR
                          (Bolivia) S.R.L., La Paz,     subject to the       denial.            PAGE NUMBER] May
                          Bolivia.                      EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
BRAZIL.................  Huawei do Brasil              For all items        Presumption of     84 FR [INSERT FR
                          Telecomunicac[otilde]es       subject to the       denial.            PAGE NUMBER] May
                          Ltda, Sao Paulo, Brazil.      EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
BURMA..................  Huawei Technologies (Yangon)  For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Yangon, Burma.     subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
CANADA.................                                         * * * * * *
                         Huawei Technologies Canada    For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Markham, ON,       subject to the       denial.            PAGE NUMBER] May
                          Canada.                       EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
CHILE..................  Huawei Chile S.A., Santiago,  For all items        Presumption of     84 FR [INSERT FR
                          Chile.                        subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
CHINA, PEOPLE'S                                                 * * * * * *
 REPUBLIC OF.
                         Beijing Huawei Digital        For all items        Presumption of     84 FR [INSERT FR
                          Technologies Co., Ltd.,       subject to the       denial.            PAGE NUMBER] May
                          Beijing, China.               EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Chengdu Huawei High-Tech      For all items        Presumption of     84 FR [INSERT FR
                          Investment Co., Ltd.,         subject to the       denial.            PAGE NUMBER] May
                          Chengdu, Sichuan, China.      EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Chengdu Huawei Technologies   For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Chengdu,           subject to the       denial.            PAGE NUMBER] May
                          Sichuan, China.               EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Dongguan Huawei Service Co.,  For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Dongguan, Guangdong,    subject to the       denial.            PAGE NUMBER] May
                          China.                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Dongguan Lvyuan Industry      For all items        Presumption of     84 FR [INSERT FR
                          Investment Co., Ltd.,         subject to the       denial.            PAGE NUMBER] May
                          Dongguan, Guangdong, China.   EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Gui'an New District Huawei    For all items        Presumption of     84 FR [INSERT FR
                          Investment Co., Ltd.,         subject to the       denial.            PAGE NUMBER] May
                          Guiyang, Guizhou, China.      EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Hangzhou Huawei Digital       For all items        Presumption of     84 FR [INSERT FR
                          Technology Co., Ltd.,         subject to the       denial.            PAGE NUMBER] May
                          Hangzhou, Zhejiang, China.    EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         HiSilicon Optoelectronics     For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Wuhan, Hubei,      subject to the       denial.            PAGE NUMBER] May
                          China.                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         HiSilicon Technologies Co.,   For all items        Presumption of     84 FR [INSERT FR
                          Ltd (HiSilicon), Bantian      subject to the       denial.            PAGE NUMBER] May
                          Longgang District,            EAR. (See Sec.                          21, 2019.
                          Shenzhen, 518129, China.      744.11 of the
                                                        EAR).
                         HiSilicon Tech (Suzhou) Co.,  For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Suzhou, Jiangsu,        subject to the       denial.            PAGE NUMBER] May
                          China.                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Device Co., Ltd.,      For all items        Presumption of     84 FR [INSERT FR
                          Dongguan, Guangdong, China.   subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Device (Dongguan)      For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Dongguan,          subject to the       denial.            PAGE NUMBER] May
                          Guangdong, China.             EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Device (Shenzhen)      For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Shenzhen,          subject to the       denial.            PAGE NUMBER] May
                          Guangdong, China.             EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Digital Technologies   For all items        Presumption of     84 FR [INSERT FR
                          (Suzhou) Co., Ltd., Suzhou,   subject to the       denial.            PAGE NUMBER] May
                          Jiangsu, China.               EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Machine Co., Ltd.,     For all items        Presumption of     84 FR [INSERT FR
                          Dongguan, Guangdong, China.   subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Software Technologies  For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Nanjing,           subject to the       denial.            PAGE NUMBER] May
                          Jiangsu, China.               EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Technologies Co.,      For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Bantian Huawei Base,    subject to the       denial.            PAGE NUMBER] May
                          Longgang District,            EAR. (See Sec.                          21, 2019.
                          Shenzhen, 518129, China.      744.11 of the
                                                        EAR).
                         Huawei Technical Service      For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., China.             subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Technologies Service   For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Langfang, Hebei,   subject to the       denial.            PAGE NUMBER] May
                          China.                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Training (Dongguan)    For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Dongguan,          subject to the       denial.            PAGE NUMBER] May
                          Guangdong, China.             EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huayi Internet Information    For all items        Presumption of     84 FR [INSERT FR
                          Service Co., Ltd.,            subject to the       denial.            PAGE NUMBER] May
                          Shenzhen, Guangdong, China.   EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).

                                                                * * * * * *
                         North Huawei Communication    For all items        Presumption of     84 FR [INSERT FR
                          Technology Co., Ltd.,         subject to the       denial.            PAGE NUMBER] May
                          Beijing, China.               EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Shanghai Haisi Technology     For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Shanghai, China.   subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Shanghai Huawei Technologies  For all items        Presumption of     84 FR [INSERT FR
                          Co. Ltd., Shanghai, China.    subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Shanghai Mossel Trade Co.,    For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Shanghai, China.        subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Shenzhen Huawei Technical     For all items        Presumption of     84 FR [INSERT FR
                          Services Co., Ltd.,           subject to the       denial.            PAGE NUMBER] May
                          Shenzhen, Guangdong, China.   EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Shenzhen Huawei Terminal      For all items        Presumption of     84 FR [INSERT FR
                          Commercial Co., Ltd.,         subject to the       denial.            PAGE NUMBER] May
                          Shenzhen, Guangdong, China.   EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Shenzhen Huawei Training      For all items        Presumption of     84 FR [INSERT FR
                          School Co., Ltd., Shenzhen,   subject to the       denial.            PAGE NUMBER] May
                          Guangdong, China.             EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Shenzhen Huayi Loan Small     For all items        Presumption of     84 FR [INSERT FR
                          Loan Co., Ltd., Shenzhen,     subject to the       denial.            PAGE NUMBER] May
                          Guangdong, China.             EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Shenzhen Legrit Technology    For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Shenzhen,          subject to the       denial.            PAGE NUMBER] May
                          Guangdong, China.             EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Shenzhen Smartcom Business    For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Shenzhen,          subject to the       denial.            PAGE NUMBER] May
                          Guangdong, China.             EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Suzhou Huawei Investment      For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Suzhou, Jiangsu,   subject to the       denial.            PAGE NUMBER] May
                          China.                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Wuhan Huawei Investment Co.,  For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Wuhan, Hubei, China.    subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Xi'an Huawei Technologies     For all items        Presumption of     84 FR [INSERT FR
                          Co., Ltd., Xi'an, Shaanxi,    subject to the       denial.            PAGE NUMBER] May
                          China.                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Xi'an Ruixin Investment Co.,  For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Xi'an, Shaanxi,         subject to the       denial.            PAGE NUMBER] May
                          China.                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Zhejiang Huawei               For all items        Presumption of     84 FR [INSERT FR
                          Communications Technology     subject to the       denial.            PAGE NUMBER] May
                          Co., Ltd., Hangzhou,          EAR. (See Sec.                          21, 2019.
                          Zhejiang, China.              744.11 of the
                                                        EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
EGYPT..................                                         * * * * * *
                         Huawei Technology, Cairo,     For all items        Presumption of     84 FR [INSERT FR
                          Egypt.                        subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
GERMANY................                                         * * * * * *
                         Huawei Technologies           For all items        Presumption of     84 FR [INSERT FR
                          Deutschland GmbH, Germany.    subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
HONG KONG..............                                         * * * * * *
                         Huawei Device (Hong Kong)     For all items        Presumption of     84 FR [INSERT FR
                          Co., Limited, Tsim Sha        subject to the       denial.            PAGE NUMBER] May
                          Tsui, Kowloon, Hong Kong.     EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei International Co.,     For all items        Presumption of     84 FR [INSERT FR
                          Limited, Hong Kong.           subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).

                         Huawei Tech. Investment Co.,  For all items        Presumption of     84 FR [INSERT FR
                          Limited, Hong Kong.           subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Technologies Co.       For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Tsim Sha Tsui,          subject to the       denial.            PAGE NUMBER] May
                          Kowloon, Hong Kong.           EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Hua Ying Management Co.       For all items        Presumption of     84 FR [INSERT FR
                          Limited, Tsim Sha Tsui,       subject to the       denial.            PAGE NUMBER] May
                          Kowloon, Hong Kong.           EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
                         Smartcom (Hong Kong) Co.,     For all items        Presumption of     84 FR [INSERT FR
                          Limited, Sheung Wan, Hong     subject to the       denial.            PAGE NUMBER] May
                          Kong.                         EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
JAMAICA................  Huawei Technologies Jamaica   For all items        Presumption of     84 FR [INSERT FR
                          Company Limited, Kingston,    subject to the       denial.            PAGE NUMBER] May
                          Jamaica.                      EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
JAPAN..................  Huawei Technologies Japan     For all items        Presumption of     84 FR [INSERT FR
                          K.K., Japan.                  subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
JORDAN.................  Huawei Technologies           For all items        Presumption of     84 FR [INSERT FR
                          Investment Co. Ltd., Amman,   subject to the       denial.            PAGE NUMBER] May
                          Jordan.                       EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
LEBANON................                                         * * * * * *
                         Huawei Technologies Lebanon,  For all items        Presumption of     84 FR [INSERT FR
                          Beirut, Lebanon.              subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
MADAGASCAR.............  Huawei Technologies           For all items        Presumption of     84 FR [INSERT FR
                          Madagascar Sarl,              subject to the       denial.            PAGE NUMBER] May
                          Antananarivo, Madagascar.     EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
NETHERLANDS............                                         * * * * * *
                         Huawei Technologies           For all items        Presumption of     84 FR [INSERT FR
                          Co[ouml]peratief U.A.,        subject to the       denial.            PAGE NUMBER] May
                          Netherlands.                  EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
OMAN...................  Huawei Tech Investment Oman   For all items        Presumption of     84 FR [INSERT FR
                          LLC, Muscat, Oman.            subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
PAKISTAN...............                                         * * * * * *
                         Huawei Technologies Pakistan  For all items        Presumption of     84 FR [INSERT FR
                          (Private) Limited,            subject to the       denial.            PAGE NUMBER] May
                          Islamabad, Pakistan.          EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
PARAGUAY...............  Huawei Technologies Paraguay  For all items        Presumption of     84 FR [INSERT FR
                          S.A., Asuncion, Paraguay.     subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
QATAR..................  Huawei Tech Investment        For all items        Presumption of     84 FR [INSERT FR
                          Limited, Doha, Qatar.         subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
SINGAPORE..............                                         * * * * * *
                         Huawei International Pte.     For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Singapore.              subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
SRI LANKA..............  Huawei Technologies Lanka     For all items        Presumption of     84 FR [INSERT FR
                          Company (Private) Limited,    subject to the       denial.            PAGE NUMBER] May
                          Colombo, Sri Lanka.           EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
SWITZERLAND............                                         * * * * * *
                         Huawei Technologies           For all items        Presumption of     84 FR [INSERT FR
                          Switzerland AG, Liebefeld,    subject to the       denial.            PAGE NUMBER] May
                          Bern, Switzerland.            EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
TAIWAN.................                                         * * * * * *
                         Xunwei Technologies Co.,      For all items        Presumption of     84 FR [INSERT FR
                          Ltd., Taipei, Taiwan.         subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
UNITED KINGDOM.........                                         * * * * * *
                         Huawei Global Finance (UK)    For all items        Presumption of     84 FR [INSERT FR
                          Limited, Great Britain.       subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                               * * * * * * *
                         Proven Glory, British Virgin  For all items        Presumption of     84 FR [INSERT FR
                          Islands                       subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Proven Honour, British        For all items        Presumption of     84 FR [INSERT FR
                          Virgin Islands.               subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                                                               * * * * * * *
VIETNAM................  Huawei Technologies           For all items        Presumption of     84 FR [INSERT FR
                          (Vietnam) Company Limited,    subject to the       denial.            PAGE NUMBER] May
                          Hanoi, Vietnam.               EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
                         Huawei Technology Co. Ltd.,   For all items        Presumption of     84 FR [INSERT FR
                          Hanoi, Vietnam.               subject to the       denial.            PAGE NUMBER] May
                                                        EAR. (See Sec.                          21, 2019.
                                                        744.11 of the
                                                        EAR).
----------------------------------------------------------------------------------------------------------------

    Dated: May 16, 2019.
Wilbur Ross,
Secretary of Commerce.
[FR Doc. 2019-10616 Filed 5-16-19; 4:15 pm]
 BILLING CODE 3510-33-P


[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Pages 56847-56848]
[FR Doc No: 2014-22600]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Receipt of Noise Compatibility Program and Request for Review;
Key West International Airport, Key West, Florida

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces that it is
reviewing a proposed Noise

Compatibility Program that was submitted for Key West International
Airport under the provisions of 49 U.S.C. 47504 et. Seq (the Aviation
Safety and Noise Abatement Act hereinafter referred to as ``the Act'')
and 14 CFR part 150 by Monroe County. This program was submitted
subsequent to a determination by FAA that the associated Noise Exposure
Maps submitted under 14 CFR part 150 for Key West International Airport
were in compliance with applicable requirements effective December 19,
2013, and was published in the Federal Register on December 27, 2013.
The proposed Noise Compatibility Program will be approved or
disapproved on or before March 14, 2015.

DATES: Effective Date: The effective date of the start of FAA's review
of the associated noise compatibility program is September 15, 2014.
The public comment period ends November 14, 2014.

FOR FURTHER INFORMATION CONTACT: Allan Nagy, Federal Aviation
Administration, Orlando Airports District Office, 5950 Hazelton
National Drive, Suite 400, Orlando, Florida 32822,<PHONE_NUMBER>.
Comments on the proposed Noise Ccompatibility Program should also be
submitted to the above office.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA is
reviewing a proposed Noise Compatibility Program for Key West
International Airport which will be approved or disapproved on or
before March 14, 2015. This notice also announces the availability of
this program for public review and comment.
    An airport operator who has submitted Noise Exposure Maps that are
found by FAA to be in compliance with the requirements of Title 14 Code
of Federal Regulations (CFR) part 150, may submit a Noise Compatibility
Program for FAA approval which sets forth the measures the operator has
taken or proposes to reduce existing non-compatible uses and prevent
the introduction of additional non-compatible uses.
    The FAA has formally received the Noise Compatibility Program for
Key West International Airport, effective on September 15, 2014. The
airport operator has requested that the FAA review this material and
that the noise mitigation measures to be implemented jointly by the
airport and surrounding communities, be approved as a Noise
Compatibility Program under Section 47504 of the Act. Preliminary
review of the submitted material indicates that it conforms to the
requirements for the submittal of Noise Compatibility Programs, but
that further review will be necessary prior to approval or disapproval
of the program. The formal review period, limited by law to a maximum
of 180 days, will be completed on or before March 14, 2015.
    The FAA's detailed evaluation will be conducted under the
provisions of 14 CFR part 150, Section 150.33. The primary
considerations in the evaluation process are whether the proposed
measures may reduce the level of aviation safety or create an undue
burden on interstate or foreign commerce, and whether they are
reasonably consistent with obtaining the goal of reducing existing non-
compatible land uses and preventing the introduction of additional non-
compatible land uses.
    Interested persons are invited to comment on the proposed program
with specific reference to these factors. All comments relating to
these factors, other than those properly addressed to local land use
authorities, will be considered by the FAA to the extent practicable.
Copies of the Noise Exposure Maps, the FAA's evaluation of the maps,
and the proposed Noise Compatibility Program are available for
examination at the following locations: Federal Aviation
Administration, Orlando Airports District Office, 5950 Hazelton
National Drive, Suite 400, Orlando, Florida 32822.
    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Orlando, Florida, on September 15, 2014.
Bart Vernace,
 Manager, Orlando Airports District Office.
[FR Doc. 2014-22600 Filed 9-22-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 39 (Thursday, February 27, 2020)]
[Notices]
[Pages 11371-11373]
[FR Doc No: 2020-03945]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0625]

Improving 510(k) Submission Preparation and Review: Voluntary
Electronic Submission Template and Resource Pilot Program; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Devices and Radiological Health (CDRH or Center) is announcing its
voluntary Electronic Submission Template and Resource (eSTAR) Pilot
Program. The eSTAR Pilot Program is voluntary and intends to improve
consistency and efficiency in both industry's preparation and FDA's
review of premarket notification (510(k)) submissions. During the
voluntary eSTAR Pilot Program, pilot participants will have the
opportunity to provide input to FDA on eSTAR.

DATES: FDA is seeking participation in the voluntary eSTAR Pilot
Program beginning February 27, 2020. See section I.A. for instructions
on how to submit a request to participate. The voluntary eSTAR Pilot
Program will select up to nine participants who best match the
selection criteria. This pilot program will begin February 27, 2020.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    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

    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.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-0625 for ``Voluntary eSTAR Pilot Program.'' 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.
     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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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-2015-09-18/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.

FOR FURTHER INFORMATION CONTACT: Jacqueline Gertz, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993, 240-402-
9677, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Medical Device User Fee Amendments of 2012 (MDUFA III)
Commitment Letter from the Secretary of Health and Human Services to
Congress, FDA committed to streamlining review processes by moving
beyond paper-based review (Ref. 1). Under section 745A(b) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1),
added by section 1136 of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), an electronic copy (eCopy) is
required for certain premarket submission types, including 510(k)
submissions. FDA provided additional information about the submissions
subject to the eCopy requirements in section 745A(b) of the FD&C Act
and recommendations about the use of eCopy generally in a guidance
initially issued in 2013 (Ref. 2), and subsequently published a final
rule in the Federal Register of December 16, 2019 (84 FR 68334)
amending FDA's regulations, where appropriate, to reflect the
requirement of a single submission in electronic format, including the
use of eCopy requirements.
    In the Medical Device User Fee Amendments of 2017 (MDUFA IV)
Commitment Letter from the Secretary of Health and Human Services to
Congress (Ref. 3), FDA committed to developing ``electronic submission
templates that will serve as guided

submission preparation tools for industry to improve submission
consistency and enhance efficiency in the review process.'' In
addition, section 745A(b) of the FD&C Act, as amended by section 207 of
the FDA Reauthorization Act of 2017 (Pub. L. 115-52), also requires
that presubmissions and submissions for devices, including 510(k)
submissions, be submitted in such electronic format as specified in
guidance by FDA.
    eCopies are an electronic version of a medical device submission
created and submitted on a CD, DVD, or flash drive. eSubmissions are
submission packages produced by an electronic submission template
(e.g., eSubmitter, eSTAR) that contains all the structured and
unstructured data of a complete submission. FDA considers both eCopies
and eSubmissions to be submissions in electronic format.
    As a first step in the transition to submissions solely in
electronic format, FDA used the eSubmitter platform to develop an
electronic submission template for 510(k) submissions. It is a free
tool, and its use is optional. The eSubmitter application includes an
electronic submission template that is a collection of questions, text,
logic, and prompts that guides a user through preparation of a 510(k)
submission. Upon completion, the resulting submission package contains
all the structured and unstructured data of a complete 510(k)
submission. This platform and submission process is currently being
piloted through the ``Quality in 510(k) Review Program Pilot'' (Ref. 4)
for the submission of traditional and abbreviated 510(k)s for devices
that are reviewed by CDRH and fall under selected product codes.
    Based on the experience with the eSubmitter platform, FDA has
developed eSTAR, which includes similar benefits as eSubmitter, as well
as additional benefits. Similar to eSubmitter, eSTAR includes the
following benefits: Automation (e.g., form construction, autofilling);
content and structure that is complementary to CDRH internal review
templates; integration of multiple resources (e.g., guidances,
databases); guided construction for each submission section; automatic
verification (i.e., FDA does not intend to conduct a Refuse to Accept
(RTA) review (Ref. 5); and it is free to use. In comparison to
eSubmitter, eSTAR contains the following additional benefits:

 More intuitive interface
 no special software installation (if the user has Adobe
Acrobat or similar software already installed)
 support for images and dynamic pop-up messages
 mobile device and Apple iOS support
 ability to comment when converted to a static PDF
 ability to share (e.g., email) an eSTAR file that is in the
process of being constructed
 no necessary packaging process

    FDA is announcing and soliciting participation from 510(k)
submitters for the voluntary eSTAR Pilot Program. Data collected
through the pilot program will help inform FDA on how to improve eSTAR.

A. Voluntary eSTAR Pilot Program Participation

    FDA seeks participation in the voluntary eSTAR Pilot Program
beginning February 27, 2020. The voluntary eSTAR Pilot Program will
select up to nine participants who provide a holistic representation of
the medical device industry and meet the selection criteria.
    Companies that may be eligible to participate in this voluntary
eSTAR Pilot Program are limited to those firms following the procedures
set out in section I.B and that also meet all the selection qualities
that follow:
    1. Intent to submit a traditional, special, or abbreviated 510(k)
for a medical device (not a combination product) using eSTAR within 3
months of acceptance to the voluntary eSTAR Pilot Program;
    2. willing to provide feedback on eSTAR as outlined in section I.C.
of this document; and
    3. intent to submit at least one 510(k) for a device that contacts
body tissue and includes software.
    At its discretion, FDA may withdraw a manufacturer from the
voluntary eSTAR Pilot Program for not carrying out any of the
commitments mentioned previously.

B. Procedure

    To be considered for the voluntary eSTAR Pilot Program, a company
should submit a statement of interest for participation to
<EMAIL_ADDRESS>The statement of interest should include
agreement to the selection qualities listed in section I.A. of this
document, as well as a description of the device in enough detail to
allow verification that it is not a combination product, and that it is
a software enabled tissue contacting device.
    The following captures the proposed process for the voluntary eSTAR
Pilot Program:
    1. FDA will collect statements of interest for participation in the
pilot program beginning February 27, 2020.
    The statement of interest should include:

 Agreement to the selection qualities listed in section I.A of
this document
 the size of the company by specifying the number of personnel
and the amount of revenue per year
 the device(s) that is/are likely to be submitted during the
pilot program using eSTAR

    2. FDA will select no more than nine participants, who best meet
the selection criteria and who reflect the broad spectrum of device
manufacturers, including companies that develop a range of products.
Enrollment in the pilot program will be ongoing throughout the duration
of the program. FDA will apply lessons learned from the initial
participants in the pilot program to refine the eSTAR tool with
participants.
    3. FDA intends to notify the manufacturer via email if the
manufacturer is enrolled as a participant in the voluntary eSTAR Pilot
Program.
    4. The enrolled manufacturer should download eSTAR from the
following website: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-program-pilots. Note: eSTAR should not be
submitted to FDA unless the sponsor is a pilot participant.
    5. Directions for preparing and submitting an eSTAR to FDA are in
the final section of the eSTAR pdf. We recommend that you use Adobe
Acrobat with eSTAR.
    6. If eligible and enrolled as a participant, the manufacturer
should submit a 510(k) submission prepared and verified using eSTAR
within the timeframe identified in the selection criteria in section
I.A. of this document.
    7. Once the eSTAR-prepared 510(k) is received by FDA, FDA does not
intend to conduct the RTA process. The remainder of the procedure will
be conducted according to the FDA guidance ``The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications'' (Ref.
6) and the procedures identified in 21 CFR part 807, subpart E.
However, if the contents of any attachment or text field are irrelevant
to the purpose of the attachment or text field (e.g., the Device
Description attachment does not contain any descriptive information
about the device) we may put your submission on hold, and request this
particular information only, before beginning a comprehensive review.
    8. Following completion of the review of 510(k)s in the voluntary
eSTAR Pilot Program, participating manufacturers will have the
opportunity to provide individual feedback on the voluntary

eSTAR Pilot Program through the procedures outlined on the voluntary
eSTAR Pilot Program website. Non-pilot participants are welcome to
submit feedback to the Docket (see ADDRESSES).
    During the voluntary eSTAR Pilot Program, CDRH staff intends to be
available to answer questions or concerns that may arise.

C. Targeted Questions

    FDA requests responses to the following questions about eSTAR from
pilot program participants and stakeholders outside the pilot who want
to submit comments to the docket.
    (1) Is eSTAR able to integrate into your organization's business
process?
    (2) Are you able to open eSTAR, and are you able to add values to
the structured data fields, as well as add attachments? Once entered
and added, are the data retained after closing and reopening eSTAR?
    (3) If you use Assistive Technology, are you able to navigate
through and complete eSTAR?
    (4) If eSTAR is not intuitive to use, why?
    (5) Is the organization and content in eSTAR as expected, or do you
have suggestions for improvement?
    (6) Is eSTAR able to accommodate PDF attachments that are of the
size you typically would provide in a submission?
    (7) If all the required questions (indicated by red or green
indicators) are provided values, and all the required attachments are
added, does eSTAR properly indicate it is complete on the first page,
and are all the sections listed in the ``Completed'' column in the
final section?
    (8) Do you have any suggestions to improve the effectiveness of
eSTAR in its purpose, or suggestions to improve the usability?

II. Paperwork Reduction Act of 1995

    This notice refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 807, subpart E have been approved under OMB control number
0910-0120.

III. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES), and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. MDUFA III Commitment Letter, available at: https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
2. FDA Guidance for Industry and FDA Staff ``eCopy Program for
Medical Device Submissions,'' dated October 10, 2013. This document
was superseded by the guidance of the same title dated December 16,
2019, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.
3. MDUFA IV Commitment Letter, available at: https://www.fda.gov/media/102699/download.
4. Quality in 510(k) Review Program Pilot, available at: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-program-pilots#quik.
5. FDA Guidance for Industry and FDA Staff ``Refuse to Accept Policy
for 510(k)s,'' dated September 13, 2019, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks.
6. FDA Guidance for Industry and FDA Staff ``The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications
[510(k)],'' dated July 28, 2014, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k.

    Dated: February 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03945 Filed 2-26-20; 8:45 am]
BILLING CODE 4164-01-P