83 FR 22842 - Revisions to the Unverified List (UVL)
DEPARTMENT OF COMMERCE
Bureau of Industry and Security Federal Register Volume 83, Issue 96 (May 17, 2018)
Bureau of Industry and Security
Federal Register Volume 83, Issue 96 (May 17, 2018)
| Page Range | 22842-22846 | |
| FR Document | 2018-10528 |
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)] [Rules and Regulations] [Pages 22842-22846] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10528] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 744 [Docket No. 180214174-8174-01] RIN 0694-AH54 Revisions to the Unverified List (UVL) AGENCY: Bureau of Industry and Security, Commerce. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) by adding thirty-three (33) persons to the Unverified List (``UVL'') and adding an additional address for one (1) person currently listed on the UVL. The thirty- three 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. A new address is added for one person as BIS has determined that this person is receiving exports from the United States at an additional address. DATES: This rule is effective May 17, 2018. FOR FURTHER INFORMATION CONTACT: Kevin Kurland, Director, Office of Enforcement Analysis, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-4255 or by email at [email protected]. SUPPLEMENTARY INFORMATION: Background The Unverified List, found in Supplement No. 6 to Part 744 to the EAR, 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 (i.e., legitimacy and reliability relating to the end use and end user of items subject to the EAR) BIS has been unable to verify through an end- use check. BIS may add persons to the UVL when BIS or federal officials acting on BIS's behalf have been unable to verify a foreign person's bona fides because 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. There are occasions where, for a number of reasons, end-use checks cannot be completed. These include reasons unrelated to the cooperation of the foreign party subject to the end-use check. 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, are prevented from scheduling such checks by a party to the transaction other than the foreign party that is the proposed subject of the end-use check, or refuse to schedule them in a timely manner. Under these circumstances, although BIS has an interest in informing the public of its inability to verify the foreign party's bona fides, there may not be sufficient information to add the foreign person at issue to the Entity List under Sec. 744.11 of the EAR (Criteria for revising the Entity List). In such circumstances, BIS may add the foreign person to the UVL. 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) of items subject to the EAR and indicates a risk that such items may be diverted to prohibited end uses and/or end users. However, BIS may not have sufficient information to establish that such persons are involved in activities described in parts 744 or 746 of the EAR, preventing the placement of the persons on the Entity List. In such circumstances, the foreign persons may be added to the Unverified List. As provided in Sec. 740.2(a)(17) of the EAR, the use of license exceptions for exports, reexports, and transfers (in-country) involving a party or parties to the transaction who are listed on the UVL is suspended. Additionally, under Sec. 744.15(b) of the EAR, there is 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) to such persons, when the exports, reexports and transfers (in-country) are not subject to a license requirement. 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 thirty-three (33) 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. The new entries consist of eleven persons located in China, twelve in Russia, five in the United Arab Emirates, two in Canada, and one person located in each of the following countries: Estonia, Finland, and Pakistan. Each listing is grouped within the UVL by country with each party's name(s) listed in alphabetical order under the country; each entry includes available alias(es) and address(es), as well as the Federal Register citation and the date the person was added to the UVL. The UVL is included in the Consolidated Screening List, available at www.export.gov. This rule also adds one additional address for one person currently listed on the UVL, Ling Ao Electronic Technology Co. Ltd, a.k.a. Voyage Technology (HK) Co., Ltd., a.k.a. Xuan [[Page 22843]] Qi Technology Co. Ltd., as BIS has determined that this person is receiving exports from the United States at an additional address. 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 May 17, 2018, pursuant to actual orders, may proceed to that UVL listed person under the previous license exception eligibility or without a license so long as the items have been exported from the United States, reexported or transferred (in-country) before June 18, 2018. Any such items not actually exported, reexported or transferred (in-country) before midnight on June 18, 2018 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 15, 2017, 82 FR 39005 (August 16, 2017) 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 this rule, which is adding 33 persons to the UVL and adding a new address for one (1) other person currently listed on the UVL, because this regulation involves a military or foreign affairs function of the United States under 5 U.S.C. 553(a)(1). BIS implements this rule to protect U.S. national security or foreign policy interests by requiring a license or, where no license is required, a UVL statement 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, the entities being added to the UVL by this action and the entity now receiving exports from the United States at an additional address would continue to be able to receive items without additional oversight by BIS 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 or amend their current entry on the UVL, and create an incentive for these persons to accelerate receiving items subject to the EAR in furtherance of activities contrary to the national security or foreign policy interests of the United States, and/or 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. 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 in 15 CFR Part 744 Exports, Reporting and recordkeeping requirements, Terrorism. Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730 through 774) is amended as follows: PART 744--[AMENDED] 0 1. The authority citation for part 744 continues to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. [[Page 22844]] 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 15, 2017, 82 FR 39005 (August 16, 2017); Notice of September 18, 2017, 82 FR 43825 (September 19, 2017); Notice of November 6, 2017, 82 FR 51971 (November 8, 2017); Notice of January 17, 2018, 83 FR 2731 (January 18, 2018). 0 2. Supplement No. 6 to Part 744 is amended by: 0 a. Adding two entries, in alphabetical order, for ``Canada''; 0 b. Adding eleven entries, in alphabetical order, under ``China''; 0 c. Adding one entry, in alphabetical order, under ``Estonia''; 0 d. Adding one entry, in alphabetical order, for ``Finland''; 0 e. Revising the entry for ``Ling Ao Electronic Technology Co. Ltd., a.k.a. Voyage Technology (HK) Co., Ltd., a.k.a. Xuan Qi Technology Co. Ltd.'' under ``Hong Kong''; 0 f. Adding one entry, in alphabetical order, for ``Pakistan''; 0 g. Adding twelve entries, in alphabetical order, under ``Russia''; and 0 h. Adding five entries, in alphabetical order, under ``United Arab Emirates''. The additions and revisions read as follows: Supplement No. 6 to Part 744--Unverified List * * * * * ------------------------------------------------------------------------ Federal Register Country Listed person and citation and date of address publication ------------------------------------------------------------------------ * * * * * * * CANADA.................... Laval Electronics, 83 FR ``[INSERT 3073 Rue Edmond- FEDERAL REGISTER Rostand, Laval, QC PAGE NUMBER], May H7P, Canada. 17, 2018.'' * * * * * * * Services GP Tek, 83 FR ``[INSERT a.k.a. Nouvelle FEDERAL REGISTER Option, 1305 Rue PAGE NUMBER], May Pise, Brossard, QC 17, 2018.'' J4W 2P7, Canada; and 203-760 Rue Galt, Montreal, QC H4G 2P7, Canada; and 6271 Rue Beaulieu, Montreal, QC, H4E 3E9, Canada. * * * * * * * CHINA..................... Changhe Aircraft 83 FR ``[INSERT Industries Group, FEDERAL REGISTER No. 539, Chaoyang PAGE NUMBER], May Road, Jingdezhen 17, 2018.'' City, Jiangxi Province, China. * * * * * * * Dandong Center for 83 FR ``[INSERT Food Control, No. 31- FEDERAL REGISTER 1 Zhongyang Avenue, PAGE NUMBER], May Dandong, China. 17, 2018.'' Institute of Geology, 83 FR ``[INSERT Chinese Academy of FEDERAL REGISTER Geological Sciences, PAGE NUMBER], May No. 26, Baiwanzhuang 17, 2018.'' Street, Beijing, 100037, China. * * * * * * * Jiangxi Hongdu 83 FR ``[INSERT Aviation Ind. Group, FEDERAL REGISTER The Nanchang PAGE NUMBER], May National High & New 17, 2018.'' Technology Development Zone, Jiangxi Province, Yaohu Nanchang, China. Jiujiang Jinxin 83 FR ``[INSERT Nonferrous Metals FEDERAL REGISTER Co, Ltd., Xunyang PAGE NUMBER], May Chem. Bldg, 17, 2018.'' Materials Factory, Xunyang District, Jiujiang City, China. Liupanshui Normal 83 FR ``[INSERT University, 19 FEDERAL REGISTER Minghu Road, PAGE NUMBER], May Zhongshan District, 17, 2018.'' Liupanshui, Guizhou, 553004, China. Nanchang University, 83 FR ``[INSERT No. 999 Xuefu FEDERAL REGISTER Avenue, Honggutan PAGE NUMBER], May New District, 17, 2018.'' Nanchang, 330031, China. Shanxi Hemu 83 FR ``[INSERT Industrial Co., FEDERAL REGISTER Ltd., Yongchang Rd, PAGE NUMBER], May Xianyang HiTech 17, 2018.'' Industries Development Zone, Shanxi, China. * * * * * * * Sino Superconductor 83 FR ``[INSERT Technology Company, FEDERAL REGISTER a.k.a. Zongyi PAGE NUMBER], May Superconductor 17, 2018.'' Technologies Co. Ltd., a.k.a. SinoHTS, 505 Nantian Bldg, 10, Xinxi Rd, Shangdi, Haidian, Beijing, China. Xinjiang East Hope 83 FR ``[INSERT New Energy Company FEDERAL REGISTER Ltd, Xinjiang East PAGE NUMBER], May Eco. Development 17, 2018.'' Zone, XinJiang, China. Yantai Salvage 83 FR ``[INSERT Bureau, No. 100 FEDERAL REGISTER Zhifudao East Road, PAGE NUMBER], May Zhifu District, 17, 2018.'' Yantai, Shandong, 264012, China. * * * * * * * ESTONIA................... Simms Marine Group 83 FR ``[INSERT OU, Sergey Ivanov, FEDERAL REGISTER Paavli str. \5/2\, PAGE NUMBER], May Tallinn, Estonia, 17, 2018.'' 10412. FINLAND................... Net Logistics JVM OY, 83 FR ``[INSERT a.k.a. Net Logistic FEDERAL REGISTER JVM OY, Eskolantie PAGE NUMBER], May 1, Helsinki, Finland 17, 2018.'' 00720; and Merituulentie 486, Port Mussalo, Kotka, Finland 48310. * * * * * * * HONG KONG................. * * * * * * [[Page 22845]] * * * * * * * Ling Ao Electronic 83 FR ``[INSERT Technology Co. Ltd, FEDERAL REGISTER a.k.a. Voyage PAGE NUMBER], May Technology (HK) Co., 17, 2018.'' Ltd. a.k.a. Xuan Qi Technology Co., Ltd., Room 17, 7/F, Metro Centre Phase 1, No. 32 Lam Hing St., Kowloon Bay, Kwun Tong, Hong Kong; and 15B, 15/F, Cheuk Nang Plaza, 250 Hennessy Road, Wanchai, Hong Kong; and Flat C, 11/F, Block No. 2, Camelpaint Bldg. 62 Hoi Yuen Street, Kwun Tong, Kowloon, Hong Kong; and Room C1-D, 6/F, Wing Hing Industrial Building 14 Hing Yip Street, Kwun Tong, Kowloon, Hong Kong; and Flat/ Rm. A30, 9/F Silvercorp International Tower, 707-713 Nathan Road, Mongkok, Kowloon, Hong Kong; and Room, 912A, 9/F. Witty Commercial Building, 1A-1L Tung Choi Street, Mongkok, Kowloon, Hong Kong; and Unit A, 7/F, King Yip Factory Bldg., 59 King Yip Street, Kwun Tong, Kowloon, Hong Kong; and Unit D, 16/F, One Capital Place, 18 Luard Road, Wanchi, Hong Kong. * * * * * * * PAKISTAN.................. Andleeb Associates, 83 FR ``[INSERT Sultan Complex, Abid FEDERAL REGISTER Majeed Road, PAGE NUMBER], May Rawalpindi, Pakistan. 17, 2018.'' * * * * * * * RUSSIA.................... Alliance EG Ltd., 83 FR ``[INSERT Leninsky Prospect FEDERAL REGISTER 139, Office 310, St. PAGE NUMBER], May Petersburg 198216, 17, 2018.'' Russia. Eltech Ltd., 3A, pl. 83 FR ``[INSERT Konstitutsii, Saint FEDERAL REGISTER Petersburg 196247, PAGE NUMBER], May Russia. 17, 2018.'' EFO Ltd., 83 FR ``[INSERT Politechnicheskaya FEDERAL REGISTER Street 21, Saint PAGE NUMBER], May Petersburg 192019, 17, 2018.'' Russia and 15A Novolitovskaya Str., Office 441, Saint Petersburg, Russia. Intercom Ltd., 83 FR ``[INSERT Kalinina Street 13, FEDERAL REGISTER Saint Petersburg PAGE NUMBER], May 198099, Russia. 17, 2018.'' * * * * * * * MT Systems, Kalinina 83 FR ``[INSERT Street 13, Saint FEDERAL REGISTER Petersburg 198099, PAGE NUMBER], May Russia. 17, 2018.'' * * * * * * * Radiofizika OAO, 83 FR ``[INSERT D.10. Ul. Geroev FEDERAL REGISTER Panfilovtsev, Moscow PAGE NUMBER], May 125363, Russia. 17, 2018.'' Romona Inc., Prospekt 83 FR ``[INSERT Mira 426, Yuzhno- FEDERAL REGISTER Sakhalinsk 693004, PAGE NUMBER], May Russia. 17, 2018.'' FSUE Rosmorport Far 83 FR ``[INSERT Eastern Basin FEDERAL REGISTER Branch, PAGE NUMBER], May Nizhneportovaya 17, 2018.'' Street 3, Primorskiy Territory, Vladivostok 690003, Russia. Sakhalin Energy 83 FR ``[INSERT Investment Company FEDERAL REGISTER Ltd., Dzerzhinskogo PAGE NUMBER], May Street 35, Yuzhno- 17, 2018.'' Sakhalinsk 693020, Russia. * * * * * * * SIC Dipaul, Bolshaya 83 FR ``[INSERT Monetnaya Street 16, FEDERAL REGISTER Saint Petersburg PAGE NUMBER], May 197101, Russia and 17, 2018.'' 5B, Rentgena ul., 197101, Saint. Tavrida 83 FR ``[INSERT Microelectronics, FEDERAL REGISTER Zelenaya Street 1, PAGE NUMBER], May Dolgoprudnyy, Moscow 17, 2018.'' 141700, Russia. VIP Technology Ltd., 83 FR ``[INSERT Bechtereva Street \3/ FEDERAL REGISTER 2\, Office 40, Saint PAGE NUMBER], May Petersburg 192019, 17, 2018.'' Russia. * * * * * * * UNITED ARAB EMIRATES...... * * * * * * * * * * * * * Alsaroud General 83 FR ``[INSERT Trading, a.k.a. FEDERAL REGISTER Alsaroud Ground PAGE NUMBER], May Trading Company, 17, 2018.'' a.k.a. Alsarroud General Trading LLC, Avenue 125, Street 2, Building 30/1, Industrial Area 17, Sharjah, UAE; and P.O. Box 35939, Sharjah, UAE; and 204 Shaikha Hind Bint Saqr Alqasemi Building, Near Etisalat Building, Almareja Street, Al Jubail, Sharjah, UAE. * * * * * * * Chepstow FZE, Office 83 FR ``[INSERT No. 12, Y Block, FEDERAL REGISTER P.O. Box 121227, PAGE NUMBER], May Sharjah Airport 17, 2018.'' International Free Zone, Sharjah, UAE. [[Page 22846]] * * * * * * * GenX Middle East FZE, 83 FR ``[INSERT a.k.a. GenX Systems FEDERAL REGISTER LLC, #510-511 Le PAGE NUMBER], May Solarium Building, 17, 2018.'' Dubai Silicon Oasis, Dubai, UAE; and P.O. Box 121225, Office M07, Al Zahra, Khaleed Bin Al Waleed Road, Bur Dubai, Dubai, UAE. Roudah Al Hayat 83 FR ``[INSERT General Trading FZE, FEDERAL REGISTER a.k.a. Rudha Al PAGE NUMBER], May Hayat General 17, 2018.'' Trading, a.k.a. Rouda Al Hayat General Trading, a.k.a. JSB Logistics, 406 Al Rhakaimi Building, Deira, Dubai, UAE; and #3204 Aspect Tower D, Sheikh Zayed Road, Dubai, UAE; and #1506 Aspect Tower D, Sheikh Zayed Road, Dubai, UAE and 901 Regal Tower, Business Bay, Dubai, UAE and 402 Al Fahad Building, Damascus Street, Dubai, UAE. * * * * * * * TEM International 83 FR ``[INSERT FZC, Dubai Silicon FEDERAL REGISTER Oasis Headquarters PAGE NUMBER], May Building, 4th Floor 17, 2018.'' C&D Wings, P.O. Box 341041, Dubai, UAE. * * * * * * * ------------------------------------------------------------------------ Dated: May 12, 2018. Richard E. Ashooh, Assistant Secretary for Export Administration. [FR Doc. 2018-10528 Filed 5-16-18; 8:45 am] BILLING CODE 3510-33-P
![22842 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations
Paragraph 6005 Class E Airspace Areas Background country) of items subject to the EAR and
Extending Upward From 700 Feet or More indicates a risk that such items may be
Above the Surface of the Earth. The Unverified List, found in
Supplement No. 6 to Part 744 to the diverted to prohibited end uses and/or
* * * * * EAR, contains the names and addresses end users. However, BIS may not have
ASO MS E5 Greenwood, MS [Amended] of foreign persons who are or have been sufficient information to establish that
parties to a transaction, as that term is such persons are involved in activities
Greenwood-Leflore Airport, MS
(Lat. 33°29′36″ N, long. 90°05′12″ W) described in § 748.5 of the EAR, described in parts 744 or 746 of the
Sidon VORTAC involving the export, reexport, or EAR, preventing the placement of the
(Lat. 33°27′50″ N, long. 90°16′38″ W) transfer (in-country) of items subject to persons on the Entity List. In such
That airspace extending upward from 700 the EAR, and whose bona fides (i.e., circumstances, the foreign persons may
feet above the surface within a 6.9-mile legitimacy and reliability relating to the be added to the Unverified List.
radius of That That airspace That airspace end use and end user of items subject As provided in § 740.2(a)(17) of the
extending upward from 700 feet above the
to the EAR) BIS has been unable to EAR, the use of license exceptions for
surface within a 6.9-mile radius of exports, reexports, and transfers (in-
Greenwood-Leflore Airport and within 1.2 verify through an end-use check. BIS
may add persons to the UVL when BIS country) involving a party or parties to
miles each side of the Sidon VORTAC 079° the transaction who are listed on the
radial, extending from the 6.9-mile radius to or federal officials acting on BIS’s behalf
2 miles each side of the VORTAC. have been unable to verify a foreign UVL is suspended. Additionally, under
person’s bona fides because an end-use § 744.15(b) of the EAR, there is a
Issued in College Park, Georgia, on May 8, requirement for exporters, reexporters,
2018. check, such as a pre-license check (PLC)
or a post-shipment verification (PSV), and transferors to obtain (and keep a
Debra L. Hogan, record of) a UVL statement from a party
Acting Manager, Operations Support Group,
cannot be completed satisfactorily for
such purposes for reasons outside the or parties to the transaction who are
Eastern Service Center, Air Traffic listed on the UVL before proceeding
Organization. U.S. Government’s control.
There are occasions where, for a with exports, reexports, and transfers
[FR Doc. 2018–10389 Filed 5–16–18; 8:45 am] (in-country) to such persons, when the
number of reasons, end-use checks
BILLING CODE 4910–13–P
cannot be completed. These include exports, reexports and transfers (in-
reasons unrelated to the cooperation of country) are not subject to a license
the foreign party subject to the end-use requirement.
DEPARTMENT OF COMMERCE check. For example, BIS sometimes Requests for removal of a UVL entry
initiates end-use checks and cannot find must be made in accordance with
Bureau of Industry and Security § 744.15(d) of the EAR. Decisions
a foreign party at the address indicated
on export documents, and cannot locate regarding the removal or modification of
15 CFR Part 744 UVL listings will be made by the Deputy
the party by telephone or email.
[Docket No. 180214174–8174–01] Additionally, BIS sometimes is unable Assistant Secretary for Export
to conduct end-use checks when host Enforcement, based on a demonstration
RIN 0694–AH54 by the listed person of its bona fides.
government agencies do not respond to
Revisions to the Unverified List (UVL) requests to conduct end-use checks, are Changes to the EAR
prevented from scheduling such checks
AGENCY: Bureau of Industry and by a party to the transaction other than Supplement No. 6 to Part 744 (‘‘the
Security, Commerce. the foreign party that is the proposed Unverified List’’ or ‘‘UVL’’)
ACTION: Final rule. subject of the end-use check, or refuse This rule adds thirty-three (33)
SUMMARY: The Bureau of Industry and to schedule them in a timely manner. persons to the UVL by amending
Security (BIS) is amending the Export Under these circumstances, although Supplement No. 6 to Part 744 of the
Administration Regulations (EAR) by BIS has an interest in informing the EAR to include their names and
adding thirty-three (33) persons to the public of its inability to verify the addresses. BIS adds these persons in
Unverified List (‘‘UVL’’) and adding an foreign party’s bona fides, there may not accordance with the criteria for revising
additional address for one (1) person be sufficient information to add the the UVL set forth in § 744.15(c) of the
currently listed on the UVL. The thirty- foreign person at issue to the Entity List EAR. The new entries consist of eleven
three persons are being added to the under § 744.11 of the EAR (Criteria for persons located in China, twelve in
UVL on the basis that BIS could not revising the Entity List). In such Russia, five in the United Arab
verify their bona fides because an end- circumstances, BIS may add the foreign Emirates, two in Canada, and one
use check could not be completed person to the UVL. person located in each of the following
satisfactorily for reasons outside the Furthermore, BIS sometimes conducts countries: Estonia, Finland, and
U.S. Government’s control. A new end-use checks but cannot verify the Pakistan. Each listing is grouped within
address is added for one person as BIS bona fides of a foreign party. For the UVL by country with each party’s
has determined that this person is example, BIS may be unable to verify name(s) listed in alphabetical order
receiving exports from the United States bona fides if during the conduct of an under the country; each entry includes
at an additional address. end-use check a recipient of items available alias(es) and address(es), as
subject to the EAR is unable to produce well as the Federal Register citation and
DATES: This rule is effective May 17,
those items for visual inspection or the date the person was added to the
2018. provide sufficient documentation or UVL. The UVL is included in the
FOR FURTHER INFORMATION CONTACT: other evidence to confirm the Consolidated Screening List, available at
amozie on DSK3GDR082PROD with RULES
Kevin Kurland, Director, Office of disposition of those items. The inability www.export.gov.
Enforcement Analysis, Bureau of of foreign persons subject to end-use This rule also adds one additional
Industry and Security, Department of checks to demonstrate their bona fides address for one person currently listed
Commerce, Phone: (202) 482–4255 or by raises concerns about the suitability of on the UVL, Ling Ao Electronic
email at UVLRequest@bis.doc.gov. such persons as participants in future Technology Co. Ltd, a.k.a. Voyage
SUPPLEMENTARY INFORMATION: exports, reexports, or transfers (in- Technology (HK) Co., Ltd., a.k.a. Xuan
VerDate Sep<11>2014 16:58 May 16, 2018 Jkt 244001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\17MYR1.SGM 17MYR1](https://thefederalregister.org/doc/83_FR_22938/page/1.svg)
![Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations 22843
Qi Technology Co. Ltd., as BIS has 2. The provisions of the involves collections previously
determined that this person is receiving Administrative Procedure Act (5 U.S.C. approved by OMB under the following
exports from the United States at an 553) requiring notice of proposed control numbers: 0694–0088, 0694–
additional address. rulemaking, the opportunity for public 0122, 0694–0134, and 0694–0137.
comment and a delay in effective date This rule slightly increases public
Savings Clause
are inapplicable to this rule, which is burden in a collection of information
Shipments (1) removed from license adding 33 persons to the UVL and approved by OMB under control
exception eligibility or that are now adding a new address for one (1) other number 0694–0088, which authorizes,
subject to requirements in § 744.15 of person currently listed on the UVL, among other things, export license
the EAR as a result of this regulatory because this regulation involves a applications. The removal of license
action; (2) eligible for export, reexport, military or foreign affairs function of the exceptions for listed persons on the
or transfer (in-country) without a license United States under 5 U.S.C. 553(a)(1). Unverified List will result in increased
before this regulatory action; and (3) on BIS implements this rule to protect U.S. license applications being submitted to
dock for loading, on lighter, laden national security or foreign policy BIS by exporters. Total burden hours
aboard an exporting carrier, or en route interests by requiring a license or, where associated with the Paperwork
aboard a carrier to a port of export, on no license is required, a UVL statement Reduction Act and OMB control number
May 17, 2018, pursuant to actual orders, for items being exported, reexported, or 0694–0088 are expected to increase
may proceed to that UVL listed person transferred (in country) involving a minimally, as the suspension of license
under the previous license exception party or parties to the transaction who exceptions will only affect transactions
eligibility or without a license so long are listed on the UVL. If this rule were involving persons listed on the
as the items have been exported from delayed to allow for notice and Unverified List and not all export
the United States, reexported or comment and a delay in effective date, transactions. Because license exceptions
transferred (in-country) before June 18, the entities being added to the UVL by are restricted from use, this rule
2018. Any such items not actually this action and the entity now receiving decreases public burden in a collection
exported, reexported or transferred (in- exports from the United States at an of information approved by OMB under
country) before midnight on June 18, additional address would continue to be control number 0694–0137 minimally,
2018 are subject to the requirements in able to receive items without additional as this will only affect specific
§ 744.15 of the EAR in accordance with oversight by BIS and to conduct individual listed persons. The increased
this regulation. activities contrary to the national burden under 0694–0088 is reciprocal to
Export Administration Act security or foreign policy interests of the the decrease of burden under 0694–
United States. In addition, publishing a 0137, and results in no change of
Since August 21, 2001, the Export proposed rule would give these parties
Administration Act of 1979, as burden to the public. This rule also
notice of the U.S. Government’s increases public burden in a collection
amended, has been in lapse. However, intention to place them on the UVL or
the President, through Executive Order of information under OMB control
amend their current entry on the UVL, number 0694–0122, as a result of the
13222 of August 17, 2001, 3 CFR, 2001 and create an incentive for these
Comp., p. 783 (2002), as amended by exchange of UVL statements between
persons to accelerate receiving items private parties, and under OMB control
Executive Order 13637 of March 8, subject to the EAR in furtherance of
2013, 78 FR 16129 (March 13, 2013), number 0694–0134, as a result of
activities contrary to the national appeals from persons listed on the UVL
and as extended by the Notice of August security or foreign policy interests of the
15, 2017, 82 FR 39005 (August 16, 2017) for removal of their listing. The total
United States, and/or take steps to set increase in burden hours associated
has continued the EAR in effect under up additional aliases, change addresses,
the International Emergency Economic with both of these collections is
and other measures to try to limit the expected to be minimal, as they involve
Powers Act (50 U.S.C. 1701 et seq.). BIS impact of the listing once a final rule
continues to carry out the provisions of a limited number of persons listed on
was published. the UVL.
the Export Administration Act, as Further, no other law requires that a 4. This rule does not contain policies
appropriate and to the extent permitted notice of proposed rulemaking and an with Federalism implications as that
by law, pursuant to Executive Order opportunity for public comment be
term is defined in Executive Order
13222 as amended by Executive Order given for this rule. Because a notice of
13132.
13637. proposed rulemaking and an
opportunity for public comment are not List of Subjects in 15 CFR Part 744
Rulemaking Requirements
required to be given for this rule by 5 Exports, Reporting and recordkeeping
1. Executive Orders 13563 and 12866 U.S.C. 553, or by any other law, the
direct agencies to assess all costs and requirements, Terrorism.
analytical requirements of the
benefits of available regulatory Accordingly, part 744 of the Export
Regulatory Flexibility Act, 5 U.S.C. 601
alternatives and, if regulation is et seq., are not applicable. Accordingly, Administration Regulations (15 CFR
necessary, to select regulatory no regulatory flexibility analysis is parts 730 through 774) is amended as
approaches that maximize net benefits required and none has been prepared. follows:
(including potential economic, 3. Notwithstanding any other
PART 744—[AMENDED]
environmental, public health and safety provision of law, no person is required
effects, distributive impacts, and to respond to, nor is subject to a penalty ■ 1. The authority citation for part 744
equity). Executive Order 13563 for failure to comply with, a collection continues to read as follows:
emphasizes the importance of of information, subject to the
amozie on DSK3GDR082PROD with RULES
quantifying both costs and benefits, of Authority: 50 U.S.C. 4601 et seq.; 50
requirements of the Paperwork
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;
reducing costs, of harmonizing rules, Reduction Act of 1995 (44 U.S.C. 3501 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
and of promoting flexibility. This rule et seq.) (PRA), unless that collection of U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR,
has not been designated a ‘‘significant information displays a currently valid 1978 Comp., p. 179; E.O. 12851, 58 FR 33181,
regulatory action,’’ under section 3(f) of Office of Management and Budget 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
Executive Order 12866. (OMB) Control Number. This regulation FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.
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![22844 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations
12947, 60 FR 5079, 3 CFR, 1995 Comp., p. ■ a. Adding two entries, in alphabetical ■ f. Adding one entry, in alphabetical
356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 order, for ‘‘Canada’’; order, for ‘‘Pakistan’’;
Comp., p. 228; E.O. 13099, 63 FR 45167, 3 ■ b. Adding eleven entries, in
CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR ■ g. Adding twelve entries, in
alphabetical order, under ‘‘China’’; alphabetical order, under ‘‘Russia’’; and
44025, 3 CFR, 2001 Comp., p. 783; E.O.
■ c. Adding one entry, in alphabetical
13224, 66 FR 49079, 3 CFR, 2001 Comp., p. ■ h. Adding five entries, in alphabetical
786; Notice of August 15, 2017, 82 FR 39005 order, under ‘‘Estonia’’;
■ d. Adding one entry, in alphabetical order, under ‘‘United Arab Emirates’’.
(August 16, 2017); Notice of September 18,
2017, 82 FR 43825 (September 19, 2017); order, for ‘‘Finland’’; The additions and revisions read as
Notice of November 6, 2017, 82 FR 51971 ■ e. Revising the entry for ‘‘Ling Ao follows:
(November 8, 2017); Notice of January 17, Electronic Technology Co. Ltd., a.k.a.
2018, 83 FR 2731 (January 18, 2018). Voyage Technology (HK) Co., Ltd., a.k.a. Supplement No. 6 to Part 744—
■2. Supplement No. 6 to Part 744 is Xuan Qi Technology Co. Ltd.’’ under Unverified List
amended by: ‘‘Hong Kong’’; * * * * *
Country Listed person and address Federal Register citation and date of publication
* * * * * * *
CANADA ........... Laval Electronics, 3073 Rue Edmond-Rostand, Laval, QC 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
H7P, Canada. May 17, 2018.’’
* * * * * * *
Services GP Tek, a.k.a. Nouvelle Option, 1305 Rue Pise, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Brossard, QC J4W 2P7, Canada; and 203–760 Rue Galt, May 17, 2018.’’
Montreal, QC H4G 2P7, Canada; and 6271 Rue Beaulieu,
Montreal, QC, H4E 3E9, Canada.
* * * * * * *
CHINA .............. Changhe Aircraft Industries Group, No. 539, Chaoyang Road, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Jingdezhen City, Jiangxi Province, China. May 17, 2018.’’
* * * * * * *
Dandong Center for Food Control, No. 31–1 Zhongyang Ave- 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
nue, Dandong, China. May 17, 2018.’’
Institute of Geology, Chinese Academy of Geological 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Sciences, No. 26, Baiwanzhuang Street, Beijing, 100037, May 17, 2018.’’
China.
* * * * * * *
Jiangxi Hongdu Aviation Ind. Group, The Nanchang National 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
High & New Technology Development Zone, Jiangxi Prov- May 17, 2018.’’
ince, Yaohu Nanchang, China.
Jiujiang Jinxin Nonferrous Metals Co, Ltd., Xunyang Chem. 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Bldg, Materials Factory, Xunyang District, Jiujiang City, May 17, 2018.’’
China.
Liupanshui Normal University, 19 Minghu Road, Zhongshan 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
District, Liupanshui, Guizhou, 553004, China. May 17, 2018.’’
Nanchang University, No. 999 Xuefu Avenue, Honggutan 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
New District, Nanchang, 330031, China. May 17, 2018.’’
Shanxi Hemu Industrial Co., Ltd., Yongchang Rd, Xianyang 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
HiTech Industries Development Zone, Shanxi, China. May 17, 2018.’’
* * * * * * *
Sino Superconductor Technology Company, a.k.a. Zongyi 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Superconductor Technologies Co. Ltd., a.k.a. SinoHTS, May 17, 2018.’’
505 Nantian Bldg, 10, Xinxi Rd, Shangdi, Haidian, Beijing,
China.
Xinjiang East Hope New Energy Company Ltd, Xinjiang East 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Eco. Development Zone, XinJiang, China. May 17, 2018.’’
Yantai Salvage Bureau, No. 100 Zhifudao East Road, Zhifu 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
District, Yantai, Shandong, 264012, China. May 17, 2018.’’
* * * * * * *
ESTONIA .......... Simms Marine Group OU, Sergey Ivanov, Paavli str. 5⁄2, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Tallinn, Estonia, 10412. May 17, 2018.’’
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FINLAND .......... Net Logistics JVM OY, a.k.a. Net Logistic JVM OY, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Eskolantie 1, Helsinki, Finland 00720; and Merituulentie May 17, 2018.’’
486, Port Mussalo, Kotka, Finland 48310.
* * * * * * *
HONG KONG ... * * * * * *
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![Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations 22845
Country Listed person and address Federal Register citation and date of publication
* * * * * * *
Ling Ao Electronic Technology Co. Ltd, a.k.a. Voyage Tech- 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
nology (HK) Co., Ltd. a.k.a. Xuan Qi Technology Co., Ltd., May 17, 2018.’’
Room 17, 7/F, Metro Centre Phase 1, No. 32 Lam Hing
St., Kowloon Bay, Kwun Tong, Hong Kong; and 15B, 15/F,
Cheuk Nang Plaza, 250 Hennessy Road, Wanchai, Hong
Kong; and Flat C, 11/F, Block No. 2, Camelpaint Bldg. 62
Hoi Yuen Street, Kwun Tong, Kowloon, Hong Kong; and
Room C1–D, 6/F, Wing Hing Industrial Building 14 Hing Yip
Street, Kwun Tong, Kowloon, Hong Kong; and Flat/Rm.
A30, 9/F Silvercorp International Tower, 707–713 Nathan
Road, Mongkok, Kowloon, Hong Kong; and Room, 912A,
9/F. Witty Commercial Building, 1A–1L Tung Choi Street,
Mongkok, Kowloon, Hong Kong; and Unit A, 7/F, King Yip
Factory Bldg., 59 King Yip Street, Kwun Tong, Kowloon,
Hong Kong; and Unit D, 16/F, One Capital Place, 18 Luard
Road, Wanchi, Hong Kong.
* * * * * * *
PAKISTAN ........ Andleeb Associates, Sultan Complex, Abid Majeed Road, Ra- 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
walpindi, Pakistan. May 17, 2018.’’
* * * * * * *
RUSSIA ............ Alliance EG Ltd., Leninsky Prospect 139, Office 310, St. Pe- 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
tersburg 198216, Russia. May 17, 2018.’’
Eltech Ltd., 3A, pl. Konstitutsii, Saint Petersburg 196247, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Russia. May 17, 2018.’’
EFO Ltd., Politechnicheskaya Street 21, Saint Petersburg 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
192019, Russia and 15A Novolitovskaya Str., Office 441, May 17, 2018.’’
Saint Petersburg, Russia.
Intercom Ltd., Kalinina Street 13, Saint Petersburg 198099, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Russia. May 17, 2018.’’
* * * * * * *
MT Systems, Kalinina Street 13, Saint Petersburg 198099, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Russia. May 17, 2018.’’
* * * * * * *
Radiofizika OAO, D.10. Ul. Geroev Panfilovtsev, Moscow 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
125363, Russia. May 17, 2018.’’
Romona Inc., Prospekt Mira 426, Yuzhno-Sakhalinsk 693004, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Russia. May 17, 2018.’’
FSUE Rosmorport Far Eastern Basin Branch, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Nizhneportovaya Street 3, Primorskiy Territory, Vladivostok May 17, 2018.’’
690003, Russia.
Sakhalin Energy Investment Company Ltd., Dzerzhinskogo 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Street 35, Yuzhno-Sakhalinsk 693020, Russia. May 17, 2018.’’
* * * * * * *
SIC Dipaul, Bolshaya Monetnaya Street 16, Saint Petersburg 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
197101, Russia and 5B, Rentgena ul., 197101, Saint. May 17, 2018.’’
Tavrida Microelectronics, Zelenaya Street 1, Dolgoprudnyy, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Moscow 141700, Russia. May 17, 2018.’’
VIP Technology Ltd., Bechtereva Street 3⁄2, Office 40, Saint 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Petersburg 192019, Russia. May 17, 2018.’’
* * * * * * *
UNITED ARAB * * * * * *
EMIRATES.
* * * * * * *
Alsaroud General Trading, a.k.a. Alsaroud Ground Trading 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Company, a.k.a. Alsarroud General Trading LLC, Avenue May 17, 2018.’’
125, Street 2, Building 30/1, Industrial Area 17, Sharjah,
UAE; and P.O. Box 35939, Sharjah, UAE; and 204 Shaikha
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Hind Bint Saqr Alqasemi Building, Near Etisalat Building,
Almareja Street, Al Jubail, Sharjah, UAE.
* * * * * * *
Chepstow FZE, Office No. 12, Y Block, P.O. Box 121227, 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Sharjah Airport International Free Zone, Sharjah, UAE. May 17, 2018.’’
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Country Listed person and address Federal Register citation and date of publication
* * * * * * *
GenX Middle East FZE, a.k.a. GenX Systems LLC, #510–511 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Le Solarium Building, Dubai Silicon Oasis, Dubai, UAE; May 17, 2018.’’
and P.O. Box 121225, Office M07, Al Zahra, Khaleed Bin
Al Waleed Road, Bur Dubai, Dubai, UAE.
Roudah Al Hayat General Trading FZE, a.k.a. Rudha Al 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Hayat General Trading, a.k.a. Rouda Al Hayat General May 17, 2018.’’
Trading, a.k.a. JSB Logistics, 406 Al Rhakaimi Building,
Deira, Dubai, UAE; and #3204 Aspect Tower D, Sheikh
Zayed Road, Dubai, UAE; and #1506 Aspect Tower D,
Sheikh Zayed Road, Dubai, UAE and 901 Regal Tower,
Business Bay, Dubai, UAE and 402 Al Fahad Building, Da-
mascus Street, Dubai, UAE.
* * * * * * *
TEM International FZC, Dubai Silicon Oasis Headquarters 83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
Building, 4th Floor C&D Wings, P.O. Box 341041, Dubai, May 17, 2018.’’
UAE.
* * * * * * *
Dated: May 12, 2018. industry and will eliminate private costs paragraph (1)(B), FDA may exempt a
Richard E. Ashooh, and expenditures required to comply class II device from the requirement to
Assistant Secretary for Export with certain Federal regulations. All submit a report under section 510(k) of
Administration. other class II devices classified under the FD&C Act upon its own initiative or
[FR Doc. 2018–10528 Filed 5–16–18; 8:45 am] FDA’s surgical apparel classification a petition of an interested person, if
BILLING CODE 3510–33–P regulation continue to be subject to FDA determines that a report under
premarket notification requirements. section 510(k) is not necessary to assure
FDA is also amending the codified the safety and effectiveness of the
DEPARTMENT OF HEALTH AND language for the surgical apparel devices device. To do so, FDA must publish in
HUMAN SERVICES classification regulation to reflect this the Federal Register notice of its intent
final determination. to exempt the device, or of the petition,
Food and Drug Administration DATES: This order is effective May 17, and provide a 60-calendar day period
2018. for public comment. Within 120 days
21 CFR Part 878 after the issuance of the notice, FDA
FOR FURTHER INFORMATION CONTACT: shall publish an order in the Federal
[Docket No. FDA–2017–N–4919] Aftin Ross, Center for Devices and Register that sets forth its final
Radiological Health, Food and Drug determination regarding the exemption
Medical Devices; Exemption From Administration, 10903 New Hampshire
Premarket Notification: Class II of the device that was the subject of the
Ave, Bldg. 66, Rm. 5402, Silver Spring, notice.
Devices; Surgical Apparel MD 20993, 301–796–5679, email:
Aftin.Ross@fda.hhs.gov. II. Factors FDA May Consider for
AGENCY: Food and Drug Administration,
SUPPLEMENTARY INFORMATION:
Exemption
HHS.
ACTION: Final order. There are a number of factors FDA
I. Statutory Background
may consider to determine whether a
SUMMARY: The Food and Drug Section 510(k) of the Federal Food, 510(k) is necessary to provide
Administration (FDA or Agency) is Drug, and Cosmetic Act (FD&C Act) (21 reasonable assurance of the safety and
publishing this final order to exempt U.S.C. 360(k)) and the implementing effectiveness of a class II device. These
certain surgical apparel from premarket regulations, 21 CFR part 807, subpart E, factors are discussed in the January 21,
notification requirements, subject to require persons who intend to market a 1998, Federal Register notice (63 FR
conditions and limitations. FDA is new device to submit and obtain 3142) and subsequently in the guidance
limiting the exemption to single-use, clearance of a premarket notification the Agency issued on February 19, 1998,
disposable respiratory protective (510(k)) containing information that entitled ‘‘Procedures for Class II Device
devices (RPD) used in a healthcare allows FDA to determine whether the Exemptions From Premarket
setting and worn by healthcare new device is ‘‘substantially equivalent’’ Notification; Guidance for Industry and
personnel during procedures to protect within the meaning of section 513(i) of CDRH Staff’’ (‘‘Class II 510(k)
both the patient and the healthcare the FD&C Act (21 U.S.C. 360c(i)) to a Exemption Guidance’’) (Ref. 1).
personnel from the transfer of legally marketed device that does not Accordingly, FDA generally considers
microorganisms, body fluids, and require premarket approval. the following factors to determine
particulate material. These devices, The 21st Century Cures Act (Pub. L. whether a 510(k) is necessary for class
commonly referred to as N95 filtering 114–255) (Cures Act) was signed into II devices: (1) The device does not have
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facepiece respirators (FFRs) and surgical law on December 13, 2016. Section 3054 a significant history of false or
N95 respirators (herein collectively of the Cures Act amended section misleading claims or of risks associated
referred to as N95s) are currently 510(m) of the FD&C Act. As amended, with inherent characteristics of the
regulated by FDA under product code section 510(m)(2) of the FD&C Act device; (2) characteristics of the device
MSH. This exemption will decrease provides that, 1 calendar day after the necessary for its safe and effective
regulatory burden on the medical device date of publication of the final list under performance are well established; (3)
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Document Created: 2018-05-17 00:50:37
Document Modified: 2018-05-17 00:50:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective May 17, 2018. | |
| Contact | Kevin Kurland, Director, Office of Enforcement Analysis, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-4255 or by email at [email protected] | |
| FR Citation | 83 FR 22842 | |
| RIN Number | 0694-AH54 | |
| CFR Associated | Exports; Reporting and Recordkeeping Requirements and Terrorism |
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