[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Rules and Regulations]
[Pages 34217-34221]
[FR Doc No: 2014-14040]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 744 and 758

[Docket No. 140530464-4464-01]
RIN 0694-AG20

Export Administration Regulations (EAR): Addition of Certain
Persons to the Unverified List (UVL) and Making a Correction

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: The Bureau of Industry and Security (BIS) is amending the
Export Administration Regulations (EAR) by adding twenty-nine (29)
persons to the Unverified List (the ``Unverified List'' or UVL). The 29
persons are being added to the UVL on the basis that BIS could not
verify their bona fides because an end-use check could not be completed
satisfactorily for reasons outside the U.S. Government's control. In
addition, this rule reinserts a requirement for exporters to file an
Automated Export System (AES) record for all exports subject to the EAR
involving persons listed on the UVL following that provision's
inadvertent removal from the EAR.
    The UVL contains the names and addresses of foreign persons who are
or have been parties to a transaction, as that term is described in the
EAR, involving the export, reexport, or transfer (in-country) of items
subject to the EAR, and whose bona fides BIS has been unable to verify
through an end-use check. There is a suspension of license exceptions
for exports, reexports, and transfers (in-country) involving a party or
parties to the transaction who are listed on the UVL, and a requirement
for exporters, reexporters, and transferors to obtain (and keep a
record of) a UVL statement from a party or parties to the transaction
who are listed on the UVL before proceeding with exports, reexports,
and transfers (in-country) involving items subject to the EAR, but
where the item does not require a license.

DATES: Effective Date: This rule is effective: June 16, 2014.

FOR FURTHER INFORMATION CONTACT: Kevin Kurland, Director, Office of
Enforcement Analysis, Bureau of Industry and Security, Department of
Commerce, Phone:<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On August 21, 2008 (73 FR 49311), BIS expanded the scope of reasons
to add persons to the Entity List (Supplement No. 4 Part 744). That
rule amended Section 744.11 of the EAR to provide illustrative examples
of the types of conduct that the U.S. Government could determine are
contrary to U.S. national security or foreign policy interests for
purposes of changes to the Entity List. One example listed in that
section is, ``[p]reventing accomplishment of an end use check conducted
by or on behalf of BIS or the Directorate of Defense Trade Controls of
the Department of State by: precluding access to; refusing to provide
information about; or providing false or misleading information about
parties to the transaction or the item to be checked.''
    However, end-use checks sometimes cannot be completed for reasons
unrelated to the cooperation of the foreign party subject to the end-
use check. In such situations, BIS may add persons to the UVL where BIS
or federal officials acting on BIS's behalf have been unable to verify
a foreign person's bona fides (i.e., legitimacy and reliability
relating to the end use and end user of items subject to the EAR),
where an end-use check, such as a pre-license check (PLC) or a post-
shipment verification (PSV), cannot be completed satisfactorily for
such purposes for reasons outside the U.S. Government's control. For
example, BIS sometimes initiates end-use checks and cannot find a
foreign party at the address indicated on export documents, and cannot
locate the party by telephone or email. Additionally, BIS sometimes is
unable to conduct end-use checks when host government agencies do not
respond to requests to conduct end-use checks or refuse to schedule
them in a timely manner. Under these circumstances, there may not be a
basis to add the foreign persons at issue to the Entity List,
particularly if there is no nexus between the foreign person's conduct
and the failure to produce a complete, accurate and useful check (see
Sec.  744.11(b)(4) of the EAR (Criteria for revising the Entity List)).
    Furthermore, BIS sometimes conducts end-use checks but cannot
verify the bona fides of a foreign party. For example, BIS may be
unable to verify bona fides if during the conduct of an end-use check a
recipient of items subject to the EAR is unable to produce those items
for visual inspection or provide sufficient documentation or other
evidence to confirm the disposition of those items. The inability of
foreign persons subject to end-use checks to demonstrate their bona
fides raises concerns about the suitability of such persons as
participants in future exports, reexports, or transfers (in-country)
and indicates a risk that items subject to the EAR may be diverted to
prohibited end uses and/or end users. However, BIS may have
insufficient information to establish that such persons are involved in
activities described in Sec.  744.11 of the EAR, preventing the
placement of the persons on the Entity List. In such circumstances,
those foreign persons may be added to the Unverified List.
    On December 19, 2013 (78 FR 76741), BIS published a final rule that
amended the EAR by: (1) Requiring exporters to file an AES record for
all exports subject to the EAR involving persons listed on the UVL (see
Sec.  758.1(b)(8) of the EAR); (2) suspending the availability of
license exceptions for exports, reexports, and transfers (in-country)
involving persons listed on the UVL (see Sec.  740.2(a)(17) of the
EAR); (3) requiring exporters, reexporters and transferors (in-country)
to obtain and retain a UVL statement from UVL-listed persons before
proceeding with exports, reexports, and transfers (in-country) that are
not otherwise subject to a license requirement under the EAR involving
such persons (see Sec. Sec.  744.15 and 762.2(b) of the EAR); (4)
adding the UVL to Supplement No. 6 to Part 744, and (5) adding to the
EAR procedures to request removal or modification of a UVL entry (see
Sec.  744.15(d) of the EAR). That rule took effect on January 21, 2014.
    Supplement No. 6 to Part 744 (``the UVL'') contains the names and
addresses of foreign persons who are or have been parties to a
transaction, as that term is described in Sec.  748.5 of the EAR,
involving the export, reexport, or transfer (in-country) of items
subject to the EAR, and whose bona fides BIS has been unable to verify
through an end-use check.
    BIS adds a person to the UVL in accordance with the criteria set
forth in Sec.  744.15(c)(1) of the EAR. For example, in some instances,
BIS may not be able to conduct an end-use check, such as a PLC or a
PSV, at all because, among other potential reasons, BIS was unable to
locate or contact the subject of the check or the host government
declined to schedule the check in a timely manner. Alternatively, BIS
may not be able to complete a satisfactory end-use check because, inter
alia, the foreign party is unable to demonstrate its bona fides or the
disposition of the items in question during the end-use check. In
either circumstance, BIS may determine to add the foreign person to the
UVL.
    Requests for removal of a UVL entry must be made in accordance with
Sec.  744.15(d) of the EAR. Decisions regarding the removal or
modification of UVL listings will be made by the Deputy Assistant
Secretary for Export Enforcement, based on a demonstration by the
listed person of its bona fides.

Changes to the EAR

Supplement No. 6 to Part 744 (``the Unverified List'' or ``UVL'')

    This rule adds twenty-nine (29) persons to the UVL by amending
Supplement No. 6 to Part 744 of the EAR to include their names and
addresses. BIS adds these persons in accordance with the criteria for
revising the UVL set forth in Sec.  744.15(c) of the EAR. Each listing
is grouped by country, and accompanied by the party's name(s) and
address(es) as well as the Federal Register citation and date the
person was added to the UVL. The UVL is included in the Consolidated
Screening List, available at www.export.gov. Restrictions and
requirements for transactions that include listed persons on the UVL
are found in Sec.  744.15 of the EAR.

AES Record

    In addition, this rule contains a requirement for exporters to file
an AES record for all exports of tangible items subject to the EAR
involving persons listed on the UVL. That requirement was previously
proposed and made final in a rule published on December 19, 2013 (78 FR
76741), but inadvertently omitted in a corrections rule published on
January 29, 2014 (79 FR 4613). This rule corrects that error by
reinserting the AES filing requirement in Sec.  758.1(b)(8).

Savings Clause

    Shipments (1) removed from license exception eligibility or that
are now subject to requirements in Sec.  744.15 of the EAR as a result
of this regulatory action, (2) eligible for export, reexport, or
transfer (in-country) without a license before this regulatory action,
and (3) on dock for loading, on lighter, laden aboard an exporting
carrier, or en route aboard a carrier to a port of export, on June 16,
2014, pursuant to actual orders, may proceed to that UVL listed person

under the previous license exception eligibility or without a license
so long as they have been exported from the United States, reexported
or transferred (in-country) before July 16, 2014. Any such items not
actually exported, reexported or transferred (in-country) before
midnight, on July 16, 2014, are subject to the requirements in Sec.
744.15 of the EAR in accordance with this regulation.

Export Administration Act

    Since August 21, 2001, the Export Administration Act of 1979, as
amended, has been in lapse. However, the President, through 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, 2013, 78 FR 49107
(August 12, 2013) has continued the EAR in effect under the
International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.).
BIS continues to carry out the provisions of the Export Administration
Act, as appropriate and to the extent permitted by law, pursuant to
Executive Order 13222 as amended by Executive Order 13637.

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 not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866.
    2. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public comment and a delay in effective date are inapplicable to the
provisions of this rule adding 29 persons to the UVL because those
provisions in the regulation involve military or foreign affairs. BIS
implements this rule to protect U.S. national security or foreign
policy interests by requiring a license for items being exported,
reexported, or transferred (in country) involving a party or parties to
the transaction who are listed on the UVL. If this rule were delayed to
allow for notice and comment and a delay in effective date, then
entities being added to the UVL by this action would continue to be
able to receive items without a license and to conduct activities
contrary to the national security or foreign policy interests of the
United States. In addition, publishing a proposed rule would give these
parties notice of the U.S. Government's intention to place them on the
UVL, and would create an incentive for these persons to either
accelerate receiving items subject to the EAR to conduct activities
that are contrary to the national security or foreign policy interests
of the United States, and/or to take steps to set up additional
aliases, change addresses, and other measures to try to limit the
impact of the listing once a final rule was published.
    The Department finds there is good cause under 5 U.S.C.
553(b)(3)(B) to waive the provisions of the Administrative Procedure
Act requiring prior notice and the opportunity for public comment to
the provision of this rule adding Section 758.1(b)(8) because they are
contrary to the public interest and unnecessary. The addition of that
paragraph was proposed by the Department on September 11, 2013 (78 FR
55664), and made final in a rule published on December 19, 2013 (78 FR
76741). The final rule went into effect on January 21, 2014. Due to an
oversight, that paragraph was mistakenly removed through the
publication of a rule (79 FR 4613) correcting paragraphs (1) through
(7) in Sec.  758.1(b). This rule corrects that inadvertent omission by
reinserting paragraph (b)(8).
    The Department finds that providing notice and comment is contrary
to the public interest because doing so would only cause confusion
about what exporters are required to do under the Regulations when
exporting items involving a parties or parties who are listed on the
Unverified List. Notice and an opportunity for the public to comment
are also unnecessary because, as discussed above, the Department
already published a proposed rule giving the public notice and the
opportunity to comment on this paragraph. Further, no other law
requires that a notice of proposed rulemaking and an opportunity for
public comment be given for this rule. 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.
    3. Notwithstanding any other provision of law, no person is
required to respond to, nor is 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 the following control
numbers: 0694-0088, 0694-0122, 0694-0134, and 0694-0137.
    This rule slightly increases public burden in a collection of
information approved by OMB under control number 0694-0088, which
authorizes, among other things, export license applications. The
removal of license exceptions for listed persons on the Unverified List
will result in increased license applications being submitted to BIS by
exporters. Total burden hours associated with the Paperwork Reduction
Act and OMB control number 0694-0088 are expected to increase
minimally, as the suspension of license exceptions will only affect
transactions involving persons listed on the Unverified List and not
all export transactions. Because license exceptions are restricted from
use, this rule decreases public burden in a collection of information
approved by OMB under control number 0694-0137 minimally, as this will
only affect specific individual listed persons. The increased burden
under 0694-0088 is reciprocal to the decrease of burden under 0694-
0137, and results in no change of burden to the public. This rule also
increases public burden in a collection of information under OMB
control number 0694-0122, as a result of the exchange of UVL statements
between private parties, and under OMB control number 0694-0134 as a
result of appeals from persons listed on the UVL for removal of their
listing. The total increase in burden hours associated with both of
these collections is expected to be minimal, as they involve a limited
number of persons listed on the UVL.
    4. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.

List of Subjects

15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

15 CFR Part 758

    Export clearance requirements.
    Accordingly, Parts 744 and 758 of the Export Administration
Regulations (15 CFR parts 730-774) are amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR Part 744 continues to read as
follows:

     Authority:  50 U.S.C. app. 2401 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, 2013, 78 FR
49107 (August 12, 2013); Notice of September 18, 2013, 78 FR 58151
(September 20, 2013); Notice of November 7, 2013, 78 FR 67289
(November 12, 2013); Notice of January 21, 2014, 79 FR 3721 (January
22, 2014).

0
2. Supplement No. 6 to Part 744 is revised to read as follows:

Supplement No. 6 to Part 744--Unverified List

    Exports, reexports, and transfers (in-country) involving parties to
the transaction who are listed in this supplement are subject to the
restrictions and requirements outlined in Sec.  744.15 of the EAR.

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                                                                                Federal Register citation
                     Country                           Listed person and address       and date of publication
----------------------------------------------------------------------------------------------------------------
CHINA............................................  China National Plant Import/      79 FR [INSERT FR PAGE
                                                    Export Co., Room 2135, Jingxin    NUMBER], June 16, 2014.
                                                    Building A, No Dong San Huan
                                                    North Road, Beijing, China.
HONG KONG........................................  Brilliance Technology Ltd, Flat   79 FR [INSERT FR PAGE
                                                    A, 11/F, Adolfo Mansion, 114-     NUMBER], June 16, 2014.
                                                    116 Austin Road, Tsim Sha Tsui,
                                                    Kowloon, Hong Kong; and
                                                   Rm 1203, 12/F, Hip Kwan
                                                    Commercial Bldg., 38 Pitt
                                                    Street, Yau Ma Tei, Hong Kong.
                                                   Dynasense Photonics Co.,          79 FR [INSERT FR PAGE
                                                    Limited, Unit 2209, 22/F, Wu      NUMBER], June 16, 2014.
                                                    Chung House, 213 Queen's Road
                                                    East, Wanchai, Hong Kong.
                                                   Hi-Shine Technology (HK)          79 FR [INSERT FR PAGE
                                                    Limited, Flat D12, 11/F, King     NUMBER], June 16, 2014.
                                                    Yip Factory Bldg, 59 King Yip
                                                    Street, Kwun Tong, Kowloon,
                                                    Hong Kong; and
                                                   Room 603, 6/F, Hang Pont
                                                    Commercial Building, 31 Tonking
                                                    Street, Cheung Sha Wan,
                                                    Kowloon, Hong Kong.
                                                   Hong Kong Haimao Info-Tec         79 FR [INSERT FR PAGE
                                                    Development Co Ltd, Rm 1013B,     NUMBER], June 16, 2014.
                                                    Well Fung Ind. Center, Ta Chuen
                                                    Ping Street, Kwai Chung, Hong
                                                    Kong.
                                                   Lianqi (HK) Electronics Co Ltd,   79 FR [INSERT FR PAGE
                                                    Unit N, 3/F, Hopewell House,      NUMBER], June 16, 2014.
                                                    175 Hip Wo Street, KwunTong,
                                                    Kowloon, Hong Kong.
                                                   Lion Chip Electronics Ltd, Unit   79 FR [INSERT FR PAGE
                                                    N, 3/F, Hopewell House, 175 Hip   NUMBER], June 16, 2014.
                                                    Wo Street, KwunTong, Kowloon,
                                                    Hong Kong.
                                                   Maipu Communication Technology    79 FR [INSERT FR PAGE
                                                    Co Ltd, 7/F Kerry Warehouse, 36-  NUMBER], June 16, 2014.
                                                    42 Shan Mei St, Shatin, Hong
                                                    Kong.
                                                   Nano Tech International Co Ltd,   79 FR [INSERT FR PAGE
                                                    Unit 5, 27/F, Richmond            NUMBER], June 16, 2014.
                                                    Commercial Building, 109 Argyle
                                                    Street, Mongkok, Kowloon, Hong
                                                    Kong.
                                                   Narpel Technology Co., Limited,   79 FR [INSERT FR PAGE
                                                    Unit A, 6/F, Yip Fat Factory      NUMBER], June 16, 2014.
                                                    Building, Phase 1, No 77 Hoi
                                                    Yuen Road, Kwun Tong, Kowloon,
                                                    Hong Kong.
                                                   People Tele-com Group, Flat A,    79 FR [INSERT FR PAGE
                                                    11/F, Adolfo Mansion, 114-116     NUMBER], June 16, 2014.
                                                    Austin Road, Tsim Sha Tsui,
                                                    Kowloon, Hong Kong.
                                                   Powersun Electronics, Flat/Rm     79 FR [INSERT FR PAGE
                                                    502D, Hang Pont Commercial        NUMBER], June 16, 2014.
                                                    Building, 31 Tonkin Street,
                                                    Cheung Sha Wan, Kowloon, Hong
                                                    Kong.
                                                   Team Kingdom Limited, Unit 526,   79 FR [INSERT FR PAGE
                                                    5/F, Advanced Technology          NUMBER], June 16, 2014.
                                                    Centre, 2 Choi Fat Street,
                                                    Sheung Shui, New Territories,
                                                    Hong Kong.
                                                   Top-Rank Int Trade (HK), Room     79 FR [INSERT FR PAGE
                                                    201-202, Westin Centre, 26 Hung   NUMBER], June 16, 2014.
                                                    To Road, Kwun Tong, Hong Kong;
                                                    and
                                                   Units A&B, 15/F, Neich Tower,
                                                    128 Gloucester Road, Wanchai,
                                                    Hong Kong.
                                                   Tianao Electronics Limited, Rm    79 FR [INSERT FR PAGE
                                                    9, 7/F, Block G, East Sun         NUMBER], June 16, 2014.
                                                    Industrial Ctr, 16 Shing Yip
                                                    Street, Kwun Tong, Kowloon,
                                                    Hong Kong.
                                                   Vessel Technology Limited, Rm     79 FR [INSERT FR PAGE
                                                    2309, 23/F, Ho King Comm Ctr, 2-  NUMBER], June 16, 2014.
                                                    16 Fayuen St., Mongkok,
                                                    Kowloon, Hong Kong.
                                                   Win Electronics Limited, G/F, 26  79 FR [INSERT FR PAGE
                                                    Pau Chung Street, Tokwawan,       NUMBER], June 16, 2014.
                                                    Kowloon, Hong Kong; and
                                                   Rm 2309, 23/F, Ho King Comm Ctr,
                                                    2-16 Fayuen St., Mongkok,
                                                    Kowloon, Hong Kong.
                                                   Win-Semi International Ltd, Flat  79 FR [INSERT FR PAGE
                                                    6, 20/F, Mega Trade Centre, 1-9   NUMBER], June 16, 2014.
                                                    Mei Wan Street, Tsuen Wan, Hong
                                                    Kong; and
                                                   Unit 503, 5/F, Silvercord Tower
                                                    2, 30 Canton Road, Tsimshatsui,
                                                    Hong Kong.
                                                   Yashen (HK) Electronics, Flat R,  79 FR [INSERT FR PAGE
                                                    15/F, Phase 2, Goldfield          NUMBER], June 16, 2014.
                                                    Industrial Building, 144-150
                                                    Tai Lin Pai Road, Kai Chung,
                                                    New Territories, Hong Kong; and
                                                   Room N, 3/F, Mongkok Building,
                                                    97 Mongkok Road, Kowloon, Hong
                                                    Kong.
                                                   ZDAS (HK) Company, G/F, 16 Kwan   79 FR [INSERT FR PAGE
                                                    Tei North Tsuen Leung Yeuk Tau,   NUMBER], June 16, 2014.
                                                    Sha Tau Kok Road, Fanling, Hong
                                                    Kong; and
                                                   Room 1609, 16/F, Block B,
                                                    Veristrong Industrial Center,
                                                    34-36 Au Pui Wan Street,
                                                    FoTaan, Shatin, New
                                                    Territories, Hong Kong.
                                                   ZhongJie Electronics, G/F, 26     79 FR [INSERT FR PAGE
                                                    Pau Chung Street, Tokwawan,       NUMBER], June 16, 2014.
                                                    Kowloon, Hong Kong; and

                                                   Rm 2309, 23/F, Ho King Comm Ctr,
                                                    2-16 Fayuen St., Mongkok,
                                                    Kowloon, Hong Kong.
RUSSIA...........................................  JSC Voentelecom, Bolshaya Olenya  79 FR [INSERT FR PAGE
                                                    Str. 15A, Moscow, Russia.         NUMBER], June 16, 2014.
                                                   Nasosy Ampika, 3-ya               79 FR [INSERT FR PAGE
                                                    Institutskaya St. Bld. 15,        NUMBER], June 16, 2014.
                                                    Moscow, Russia.
                                                   Nuclin LLC, Serebryakova Proezd   79 FR [INSERT FR PAGE
                                                    14, Moscow, Russia.               NUMBER], June 16, 2014.
                                                   SDB IRE RAS, 1 Vvedenskogo        79 FR [INSERT FR PAGE
                                                    Square, Fryazino, Russia.         NUMBER], June 16, 2014.
                                                   Security 2 Business Academy,      79 FR [INSERT FR PAGE
                                                    a.k.a. S2BA, a.k.a. Academy of    NUMBER], June 16, 2014.
                                                    Business Security, Deguninskaya
                                                    Street 10, Moscow, Russia; and
                                                   Novoslobodskaya Str. 14/19,
                                                    Moscow, Russia.
UNITED ARAB EMIRATES.............................  Doubair General Trading Co. LLC,  79 FR [INSERT FR PAGE
                                                    P.O. Box 30239, Dubai, UAE.       NUMBER], June 16, 2014.
                                                   Golden Business FZE, Warehouse    79 FR [INSERT FR PAGE
                                                    FZS1 AN08, Jebel Ali     NUMBER], June 16, 2014.
                                                    Free Zone, Dubai, UAE; and
                                                   P.O. Box 263128, Dubai, UAE.
                                                   World Heavy Equipment,            79 FR [INSERT FR PAGE
                                                    Industrial Area 10, Ras Al        NUMBER], June 16, 2014.
                                                    Khaimah, UAE; and
                                                   World Equipment Trading L.L.C,
                                                    Industrial Area 10, Ras Al
                                                    Khaimah, UAE.
----------------------------------------------------------------------------------------------------------------

PART 758--[AMENDED]

0
3. The authority citation for 15 CFR Part 758 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
8, 2013, 78 FR 49107 (August 12, 2013).

0
4. Section 758.1 is amended by adding paragraph (b)(8) to read as
follows:

Sec.  758.1  The Electronic Export Information (EEI) filing to the
Automated Export System (AES)

* * * * *
    (b) * * *
    (8) For all exports of tangible items subject to the EAR where
parties to the transaction, as described in Sec.  748.5(d) through (f)
of the EAR, are listed on the Unverified List (Supplement 6 to Part 744
of the EAR), regardless of value or destination.
* * * * *

    Dated: June 11, 2014.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2014-14040 Filed 6-13-14; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 87, Number 191 (Tuesday, October 4, 2022)]
[Notices]
[Pages 60158-60159]
[FR Doc No: 2022-21510]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2021-0643; FRL-9128-02-OAR]

Notice of Determination: Petitions Granted Under Subsection (i)
of the American Innovation and Manufacturing Act of 2020

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The purpose of this notice is to alert the public of the
Environmental Protection Agency's (EPA) decision to grant two petitions
submitted under the American Innovation and Manufacturing Act of 2020.
The two petitions request that the Environmental Protection Agency
restrict the use of certain regulated substances, as defined in the
Act, in certain commercial refrigeration applications, pursuant to its
authority under the Act to promulgate rules that restrict, fully,
partially, or on a graduated schedule, the use of a regulated substance
in the sector or subsector in which the regulated substance is used.
The Agency is also using this notice to inform the public of how it
will treat two additional submissions by the Air-Conditioning, Heating,
and Refrigeration Institute under this subsection.

DATES: EPA granted the two petitions referenced in this notice via
letters signed on September 19, 2022.

FOR FURTHER INFORMATION CONTACT: Allison Cain, Stratospheric Protection
Division, Office of Atmospheric Programs (6205A), Environmental
Protection Agency, telephone number:<PHONE_NUMBER>; email address:
[email protected]. You may also visit EPA's website at https://www.epa.gov/climate-hfcs-reduction for further information.

SUPPLEMENTARY INFORMATION:

I. Background

    Subsection (i) of the American Innovation and Manufacturing Act of
2020 (AIM Act or the Act),\1\ entitled ``Technology Transitions,''
provides that the Administrator may by rule restrict, fully, partially,
or on a graduated schedule, the use of a regulated substance in the
sector or subsector in which the regulated substance is used. Under
subsection (i)(3) a person may petition the Environmental Protection
Agency (EPA) to promulgate a rule for the restriction on use of a
regulated substance \2\ in a sector or subsector, and the Act states
that the petition shall include a request that the Administrator
negotiate with stakeholders in accordance with subsection (i)(2)(A).
Once EPA receives a petition, the AIM Act directs the Agency to make
petitions publicly available within 30 days of receipt and to grant or
deny the petition within 180 days of receipt, taking the factors listed
in subsection (i)(4) into account to the extent practicable.
---------------------------------------------------------------------------

    \1\ The AIM Act was enacted as section 103 in Division S,
Innovation for the Environment, of the Consolidated Appropriations
Act, 2021 (Pub. L. 116-260) (codified at 42 U.S.C. 7675).116-260).
    \2\ The Act provides that ``regulated substance'' refers to
those substances included in the list of regulated substances in
subsection (c)(1) of the Act and those substances that the
Administrator has designated as a regulated substance under
subsection (c)(3). Subsection (c)(1) lists 18 saturated
hydrofluorocarbons (HFCs), and by reference their isomers not so
listed, as regulated substances. This is the current list of
regulated substances, as no additional substances have been
designated as regulated substances under subsection (c)(3).
---------------------------------------------------------------------------

    The Agency has received two petitions under subsection (i) of the
AIM Act requesting that EPA promulgate rules to restrict the use of
hydrofluorocarbons in certain commercial refrigeration applications.\3\
These petitions were submitted by the Air-conditioning, Heating, and
Refrigeration Institute, et. al (hereby, ``AHRI'') on March 24, 2022,
and the International Institute for Ammonia Refrigeration, et. al
(hereby, ``IIAR'') on May 23, 2022. After reviewing information
provided by the petitioners and relevant information related to the
``Factors for Determination'' in subsection (i)(4) of the AIM Act, EPA
granted the two petitions.\4\ The March 24, 2022, and May 23, 2022,
petitions requested restrictions on the use of HFCs in sectors and
subsectors that were also the subject of the petitions that EPA granted
on October 7, 2021.
---------------------------------------------------------------------------

    \3\ Links to copies of these petitions and other petitions
received to date can be found in the table at https://www.epa.gov/climate-hfcs-reduction/petitions-under-aim-act. EPA has a docket
(Docket ID EPA-HQ-OAR-2021-0289-0044), where all subsection (i)
petitions are posted, and where the public may submit information
related to those petitions.
    \4\ The letters granting the two petitions are available in the
docket for this action.
---------------------------------------------------------------------------

    EPA is also clarifying the treatment of two letters AHRI sent to
EPA on August 19, 2021, and October 12, 2021.\5\ EPA initially included
these letters on the

Agency's website as new petitions. However, after further review EPA
determined that these two AHRI letters are addenda to AHRI's petitions
that EPA granted on October 7, 2021. EPA made this determination
because the subsectors listed in these letters were identical to those
covered by the already-granted AHRI petitions and because EPA received
the August and October 2021 letters before or very near in time to the
Agency's action granting the initial set of petitions.
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    \5\ EPA has a docket (Docket ID EPA-HQ-OAR-2021-0289-0044),
where all subsection (i) petitions are posted, and where the public
may submit information related to those petitions.
---------------------------------------------------------------------------

II. What happens after EPA grants a petition?

    Where the Agency grants a petition submitted under subsection (i)
of the AIM Act, the statute requires that EPA promulgate a final rule
not later than two years from the date the Agency grants the petition.
Per subsection (i)(1) of the AIM Act, EPA may issue rules that
restrict, fully, partially, or on a graduated schedule, the use of a
regulated substance in the sector or subsector in which the regulated
substance is used. The Act establishes that no rule developed under
subsection (i) may take effect earlier than one year after the rule
promulgation date. In addition, prior to issuing a proposed rule under
subsection (i), EPA must consider negotiating with stakeholders in the
sector or subsector in accordance with negotiated rulemaking
procedures.\6\ If the Agency decides not to undertake a negotiated
rulemaking, the AIM Act requires the Agency to publish an explanation
of its decision not to use that procedure.
---------------------------------------------------------------------------

    \6\ The negotiated rulemaking procedure is provided under
subchapter III of chapter 5 of title 5, United States Code (commonly
known as the ``Negotiated Rulemaking Act of 1990'').
---------------------------------------------------------------------------

    As noted, all four of the requests for restrictions on the use of
HFCs (i.e., the two petitions granted on September 19, 2022, and the
two letters considered as addenda) addressed sectors and subsectors
that are the subject of an upcoming Notice of Proposed Rulemaking
(NPRM) that was initiated by the prior petitions granted by the
Administrator on October 7, 2021. In that rulemaking EPA will consider
proposed restrictions in the same sectors and subsectors covered by the
May and March petitions and the two letters considered as addenda. EPA
is therefore considering addressing all four of the newer requests for
restrictions in the same upcoming proposal. EPA issued a notice
informing the public of the Agency's consideration of using the
negotiated rulemaking procedure for the sectors and subsectors
addressed in the petitions granted on October 7, 2021, and the Agency's
decision to not use these procedures.\7\ Because the AIM Act subsection
(i)(2)(A) requires that EPA consider negotiating with stakeholders
using the negotiated rulemaking procedure ``[b]efore proposing a rule
for the use of a regulated substance for a sector or subsector,'' EPA's
prior consideration and decision not to use negotiated rulemaking
applies to the petitions addressed in this notice, which request
restrictions on sectors and subsectors for which EPA already considered
negotiated rulemaking.
---------------------------------------------------------------------------

    \7\ EPA issued a separate notice in the Federal Register
regarding its consideration of using negotiated rulemaking
procedures for a rulemaking that responds to granted and partially
granted petitions (December 29, 2021; 86 FR 74080).

Cynthia A. Newberg,
Director, Stratospheric Protection Division.
[FR Doc. 2022-21510 Filed 10-3-22; 8:45 am]
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[Federal Register Volume 79, Number 203 (Tuesday, October 21, 2014)]
[Rules and Regulations]
[Pages 62825-62826]
[FR Doc No: 2014-25006]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0910]

Drawbridge Operation Regulation; Houma Navigation Canal, Houma,
Terrebonne Parish, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the SR 661 Swing Bridge across the
Houma Navigation Canal, mile 36.0, in Houma, Terrebonne Parish,
Louisiana. This deviation allows the bridge to remain closed to
navigation for up to four hours at a time during daylight hours for the
purpose of conducting necessary maintenance and repairs to the
drawbridge.

DATES: This deviation is effective from October 23, 2014 to January 7,
2015.

ADDRESSES: The docket for this deviation, [USCG-2014-0910] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this rulemaking. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Jim Wetherington, Bridge
Administration Branch, Coast Guard, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Louisiana Department of Transportation
and Development (LDOTD) requested a temporary deviation from the
operating schedule of the SR 661 Swing Bridge across the Houma
Navigation Canal, mile 36.0, in Houma, Terrebonne Parish, Louisiana.
The deviation was requested for the purpose of conducting necessary
repairs, including reinstallation of structural and mechanical
components of the bridge. Exact dates for the maintenance and repairs
requiring this deviation are not yet known. Local Notices to Mariners
(LNM) and Broadcast Notices to Mariners (BNM) will provide at least 48
hours notification before the deviation begins.
    In accordance with 33 CFR 117.455, the bridge currently opens on
signal; except that, the draw need not open for the passage of vessels
Monday through Friday except Federal holidays from 6:30 a.m. to 8:30
a.m., from 11:45 a.m. to 12:15 p.m., from 12:45 p.m. to 1:15 p.m., and
from 4:30 p.m. until 6 p.m. This deviation allows the draw of the SR
661 Swing Bridge across the Houma Navigation Canal, mile 36.0, in
Houma, Terrebonne Parish, Louisiana, to remain closed to navigation for
up to four hours each day between 6 a.m. and 8 p.m. for a 17 day
period. This 17 day period will occur sometime between October 23, 2014
and January 7, 2015. During this deviation, the bridge will remain open
to navigation from 8 p.m. through 6 a.m. daily. During these closures,
the contractor will make every effort to minimize the delays to
mariners as well as maintain the bridge in the open-to-navigation
position all times when that repair work is not being conducted. These
repairs require the bridge to be removed from power and operated by air
tuggers in order for the work to be done. These repairs are necessary
for the continued operation of the bridge.
    The vertical clearance of the swing bridge in the closed-to-
navigation position is 1.0 foot and unlimited in the open-to-navigation
position. Navigation on the waterway consists primarily of commercial
tugs and recreational craft. Vessels able to pass through the bridge in
the closed positions may do so at any time. The bridge will be able to
open for emergencies and there is no immediate alternate route. The
Coast Guard will provide waterway users the dates and times affected
through LNMs and BNMs throughout this temporary change in operating
schedule for the bridge so that vessels can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: October 2, 2014.
David M. Frank,
Bridge Administrator.
[FR Doc. 2014-25006 Filed 10-20-14; 8:45 am]
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[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Pages 83411-83412]
[FR Doc No: 2023-26247]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-0928]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Lupkynis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Lupkynis and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by January 29, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 28, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

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-2022-E-0928 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; LUPKYNIS.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 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 Sec.  10.20 (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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for

example, half the testing phase must be subtracted as well as any time
that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product Lupkynis
(voclosporin). Lupkynis is indicated in combination with a background
immunosuppressive therapy regimen for the treatment of adult patients
with active lupus nephritis. Subsequent to this approval, the USPTO
received a patent term restoration application for Lupkynis (U.S.
Patent No. 7,332,472) from Aurinia Pharmaceuticals Inc., and the USPTO
requested FDA's assistance in determining the patent's eligibility for
patent term restoration. In a letter dated September 21, 2022, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of Lupkynis represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Lupkynis is 7,584 days. Of this time, 7,338 days occurred during the
testing phase of the regulatory review period, while 246 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
April 20, 2000. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on April
20, 2000.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: May 22, 2020.
FDA has verified the applicant's claim that the new drug application
(NDA) for Lupkynis (NDA 213716) was initially submitted on May 22,
2020.
    3. The date the application was approved: January 22, 2021. FDA has
verified the applicant's claim that NDA 213716 was approved on January
22, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26247 Filed 11-28-23; 8:45 am]
BILLING CODE 4164-01-P