Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations 4779 

§ 746.6 Crimea region of Ukraine. 

(a) License requirements—(1) General 

prohibition. As authorized by Section 6 

of the Export Administration Act of 

1979, a license is required to export or 

reexport any item subject to the EAR, 

other than food and medicine 

designated as EAR99, to the Crimea 

region of Ukraine. The ‘Crimea region of 

Ukraine’ includes the land territory in 

that region as well as any maritime area 

over which sovereignty, sovereign 

rights, or jurisdiction is claimed based 

on purported sovereignty over that land 

territory. This license requirement 

includes transfers within the Crimea 

region. 

(b) License review policy. 

Applications will be reviewed with a 

presumption of denial, except for items 

authorized under OFAC UkraineRelated General License No. 4 which 

will be reviewed on a case-by-case basis. 

(c) License exceptions. You may 

export, reexport or transfer (in-country) 

without a license if your transaction 

meets all the applicable terms and 

conditions of any of the license 

exception paragraphs specified in this 

paragraph (c). To determine scope and 

eligibility requirements, you will need 

to refer to the sections or specific 

paragraphs of part 740 (License 

Exceptions). Read each license 

exception carefully, as the provisions 

available for countries subject to 

sanctions are generally narrow. 

(1) TMP for items for use by the news 

media as set forth in § 740.9(a)(9) of the 

EAR. 

(2) GOV for items for personal or 

official use by personnel and agencies of 

the U.S. Government, the International 

Atomic Energy Agency (IAEA), or the 

European Atomic Energy Community 

(Euratom) as set forth in § 740.11(a) and 

(b)(2) of the EAR. 

(3) GFT for gift parcels and 

humanitarian donations as set forth in 

§ 740.12. 

(4) TSU for operation technology and 

software for lawfully exported 

commodities as set forth in § 740.13(a) 

and sales technology as set forth in 

§ 740.13 (b) of the EAR. 

(5) BAG for exports of items by 

individuals leaving the United States as 

personal baggage as set forth in 

§ 740.14(a) through (d) of the EAR. 

(6) AVS for civil aircraft and vessels 

as set forth in § 740.15(a)(4) and (d) of 

the EAR. 

PART 772—[AMENDED] 

■ 7. The authority citation for 15 CFR 

part 738 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 

7, 2014, 79 FR 46959 (August 11, 2014). 

■ 8. Section 772.1 is amended by 

revising the definition for the term 

‘‘Food’’ to read as follows: 

§ 772.1 Definitions of terms as used in the 

Export Administration Regulations (EAR). 

* * * * * 

Food. Specific to exports and 

reexports to North Korea, Syria and 

Crimea region of Ukraine, food means 

items that are consumed by and provide 

nutrition to humans and animals, and 

seeds, with the exception of castor bean 

seeds, that germinate into items that 

will be consumed by and provide 

nutrition to humans and animals. (Food 

does not include alcoholic beverages.) 

* * * * * 

Dated: January 23, 2015. 

Eric L. Hirschhorn, 

Under Secretary of Commerce for Industry 

and Security. 

[FR Doc. 2015–01638 Filed 1–28–15; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 744 

[Docket No. 141104925–4925–01] 

RIN 0694–AG35 

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 fourteen (14) persons, removing 

one person, and updating the addresses 

of other persons listed on the Unverified 

List (the ‘‘Unverified List’’ or UVL). The 

14 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. One person 

is removed from the UVL based on BIS’s 

ability to verify that person’s bona fides 

through the successful completion of an 

end-use check. Also, new addresses are 

added for two listed persons on the 

UVL. 

DATES: Effective date: This rule is 

effective: January 29, 2015. 

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 UVLRequest@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

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 § 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 enduse 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 (i.e., 

legitimacy and reliability relating to the 

end use and end user of items subject 

to the EAR) 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. 

End-use checks cannot be completed 

for a number of reasons, including 

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 persons at issue to the Entity 

List under § 744.11 of the EAR (Criteria 

for revising the Entity List). In such 

circumstances, BIS may add the foreign 

persons 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 


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4780 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations 

exports, reexports, or transfers (incountry) and indicates a risk that items 

subject to the EAR 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 part 744 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 § 740.2(a)(17) of the 

EAR, the use of license exceptions for 

exports, reexports, and transfers (incountry) involving a party or parties to 

the transaction who are listed on the 

UVL is suspended. Additionally, under 

§ 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 (incountry) are not subject to a license 

requirement. 

Requests for removal of a UVL entry 

must be made in accordance with 

§ 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’’) 

Among other things, this rule adds 

fourteen (14) 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 § 744.15(c) of the 

EAR. The new entries consist of eleven 

persons located in Hong Kong, two 

persons located in Pakistan, and one 

person located in the United Arab 

Emirates. Each listing is grouped within 

the UVL by country, and accompanied 

by the party’s name(s), 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 new addresses for 

two current UVL persons, Narpel 

Technologies, Ltd. and Powersun 

Electronics, both located in Hong Kong. 

BIS has determined that these persons 

are receiving U.S. exports at addresses 

other than those originally included in 

their UVL entries. 

Lastly, this rule removes from the 

UVL one company, Dynasense 

Photonics Co., Ltd. in Hong Kong, based 

on BIS’s ability to confirm its bona fides 

through the successful completion of an 

end-use check. The removal of the 

above referenced person from the UVL 

eliminates the restrictions against the 

use of license exceptions and the 

requirements specific to exports, 

reexports and transfers (in-country) not 

otherwise requiring a license to the 

person, as described in § 744.15 of the 

EAR. However, the removal of this 

person from the UVL does not relieve 

persons proposing to export, reexport or 

transfer (in-country) items subject to the 

EAR to the removed person of other 

obligations under part 744 of the EAR or 

under other parts of the EAR. Neither 

the removal of a person from the UVL 

nor the removal of UVL-based 

restrictions and requirements relieves a 

person of the obligation to obtain a 

license if the person knows that an 

export or reexport of any item subject to 

the EAR is destined to an end user or 

end use set forth in part 744 other than 

§ 744.15 of the EAR. Additionally, this 

removal does not relieve persons of 

their obligation to apply for export, 

reexport or in-country transfer licenses 

required by other provisions of the EAR. 

BIS strongly urges the use of 

Supplement No. 3 to part 732 of the 

EAR, ‘‘BIS’s ‘Know Your Customer’ 

Guidance and Red Flags,’’ when persons 

are involved in transactions that are 

subject to the EAR. 

Savings Clause 

Shipments (1) removed from license 

exception eligibility or that are now 

subject to requirements in § 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 

January 29, 2015, 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 March 2, 

2015. Any such items not actually 

exported, reexported or transferred (incountry) before midnight, on March 2, 

2015, are subject to the requirements in 

§ 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 

7, 2014, 79 FR 46959 (August 11, 2014) 

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 14 persons, removing one 

person, and updating the addresses of 

two other persons listed on the UVL, 

because this regulation involves 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, the entities being added 

to the UVL by this action and those 

entities operating at previously unlisted 

addresses 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 


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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations 4781 

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 removing one person from the UVL 

because doing so is contrary to the 

public interest and unnecessary. The 

removal is being made following the 

completion of a successful end-use 

check. If the rule were to be delayed to 

allow for public comment, U.S. 

exporters may face unnecessary 

economic losses as they turn away 

potential sales because the customer 

remained a listed person on the UVL 

even after BIS was able to verify that 

entity’s bona fides through an end-use 

check. By publishing without prior 

notice and comment, BIS allows the 

entity to receive U.S. exports as quickly 

as possible following their cooperation 

in a successful end-use check. By 

quickly removing entities from the UVL 

following the successful completion of 

an end-use check, BIS encourages other 

entities to cooperate in end-use checks 

requested by BIS. 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 730–774) is amended as follows: 

PART 744—[AMENDED] 

■ 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 January 21, 2014, 79 FR 3721 

(January 22, 2014); Notice of August 7, 2014, 

79 FR 46959 (August 11, 2014); Notice of 

September 17, 2014, 79 FR 56475 (September 

19, 2014); Notice of November 7, 2014, 79 FR 

67035 (November 12, 2014). 

■ 2. Supplement No. 6 to Part 744 is 

amended by: 

■ a. Removing the entry for ‘‘Dynasense 

Photonics Co., Limited’’; 

■ b. Revising the entry for ‘‘Narpel 

Technology Co., Limited’’; 

■ c. Revising the entry for ‘‘Powersun 

Electronics’’; 

■ d. Adding an entry for ‘‘Pakistan’’; 

and 

■ e. Adding 11 entries, in alphabetical 

order, under ‘‘Hong Kong’’; and 

■ f. Adding an entry, in alphabetical 

order, under the ‘‘United Arab 

Emirates’’. 

The revisions and additions read as 

follows: 

Supplement No. 6 to Part 744— 

Unverified List 

* * * * * 

Country Listed person and address Federal Register citation 

and date of publication 

*******

HONG KONG ....................... AST Technology Group (HK) Ltd., Flat 6, 20/F, Mega Trade Centre, 1–9 Mei Wan 

Street, Tsuen Wan, Hong Kong; and Unit 2209, 22/F, Wu Chung House, 213, 

Queen’s Road East, Wan Chai, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

Daystar Electric (HK) Ltd., Flat D, 19/F, Waylee Industrial Centre, 30–38 Tsuen 

King Circuit, Tsuen Wan, New Territories, Hong Kong; and 9/F Kam Chung 

Commercial Building, 19–21 Hennessy Road, Wanchai, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 


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4782 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations 

Country Listed person and address Federal Register citation 

and date of publication 

Ditis Hong Kong Ltd., Room 227–228, 2/F, Metre Centre II, 21 Lam Hing Street, 

Kowloon Bay, Kowloon, Hong Kong; and Rooms 1318–1320, Hollywood Plaza, 

610 Nathan Road, Mong Kok, Kowloon, Hong Kong; and Room 205, 2/F, Sunley 

Centre, 9 Wing Yin Street, Kwai Chung, New Territories, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

E-Chips Technology, Unit 4, 7/F, Bright Way Tower, No. 33 Mong Kok Road, Mong 

Kok, Kowloon, Hong Kong.

80 FR [INSERT FR PAGE] 

January 29, 2015. 

GS Technology Ltd., a.k.a. GS Technology Group Ltd., Flat 6, 20/F, Mega Trade 

Centre, 1–9 Mei Wan Street, Tsuen Wan, New Territories, Hong Kong; and Unit 

D, 16/F, Cheuk Nang Plaza, 250 Hennessy Road, Wanchai, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

Hong Kong U.Star Electronics Technology Co., Ltd., Room 28, 8/F, Shing Yip Industrial Building, 19–21 Shing Yip Street, Kwun Tong, Kowloon, Hong Kong; and 

Unit 5, 27/F, Richmond Commercial Building, 109 Argyle Street, Mong Kok, 

Kowloon, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

Hongbo Industrial Technology, Unit 3, 9/F, Shing Yip Industrial Building, 19–21 

Shing Yip Street, Kwun Tong, Kowloon, Hong Kong; and Unit 04, 7/F, Bright 

Way Tower, No. 33, Mong Kok Road, Kowloon, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

Ling Ao Electronic Technology Co. Ltd., a.k.a. Voyage Technology (HK) Co. Ltd., 

Room 17, 7/F, Metro Centre Phase 1, No. 32 Lamhing St., Kowloon Bay, Hong 

Kong; and 15B, 15/F, Cheuk Nang Plaza, 250 Hennessy Road, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

Microlink Communication Ltd., Room 806, 8/F, Kenbo Commercial Building, No. 

335–339 Queen’s Road West, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

Milectronic Communication Ltd., Room 2912, Tower 2, Times Square, 1 Matheson 

Street, Causeway Bay, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

Narpel Technology Co., Limited, Unit A, 6/F, Yip Fat Factory Building, Phase 1, No 

77 Hoi Yuen Road, Kwun Tong, Kowloon, Hong Kong; and Room 4C, 8/F, Sunbeam Centre, 27 Shing Yip Street, Kwun Tong, Kowloon, Hong Kong; and Room 

1905, Nam Wo Hong Building, 148 Wing Lok Street, Sheung Wan, Hong Kong.

79 FR 34217, 06/16/14, 80 

FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

* * * * * * * 

Powersun Electronics, Flat/Rm 502D, Hang Pont Commercial Building, 31 Tonkin 

Street, Cheung Sha Wan, Kowloon, Hong Kong; and G/F and G/M, Winner 

Godown Building, 1–9 Sha Tsui Road, Tsuen Wan, New Territories, Hong Kong.

79 FR 34217, 06/16/14, 80 

FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

Suke Logistics Ltd., Flat 6, 20/F, Mega Trade Centre, 1–9 Mei Wan Street, Tsuen 

Wan, New Territories, Hong Kong.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

PAKISTAN ............................ Fauji Fertilizer Company Ltd., 156 The Mall Rawalpindi Cantt, Pakistan ................... 80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

T.M.A. International, a.k.a. TMA International, a.k.a. Tahir Asad Industries Pvt. Ltd., 

a.k.a. T.A. Industries Pvt. Ltd., 45–B, Ahmed Block, New Garden Town, Lahore, 

Pakistan; and 417 Gulshan Block, Iqbal Town, Lahore, Pakistan.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******

UNITED ARAB EMIRATES Rich Star General Trading LLC, #203 The Atrium Centre, Khalid bin Waleed Road, 

Bur Dubai, Dubai, UAE; and P.O. Box 181977, Dubai, UAE.

80 FR [INSERT FR PAGE 

NUMBER] January 29, 

2015. 

*******


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations 4783 

Dated: January 23, 2015. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2015–01639 Filed 1–28–15; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2013–N–0234] 

Effective Date of Requirement for 

Premarket Approval for Automated 

External Defibrillator Systems 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

issuing a final order to require the filing 

of premarket approval applications 

(PMA) for automated external 

defibrillator (AED) systems, which 

consist of an AED and those AED 

accessories necessary for the AED to 

detect and interpret an 

electrocardiogram and deliver an 

electrical shock (e.g., pad electrodes, 

batteries, adapters, and hardware keys 

for pediatric use). 

DATES: This order is effective on January 

29, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Linda Ricci, Center for Devices and 

Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 1314, 

Silver Spring, MD 20993, 301–796– 

6325, linda.ricci@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (Pub. L. 101–629), the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115), the Medical 

Device User Fee and Modernization Act 

of 2002 (Pub. L. 107–250), the Medical 

Devices Technical Corrections Act (Pub. 

L. 108–214), the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85), and the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA) (Pub. L. 112– 

144), among other amendments, 

established a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the FD&C Act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, reflecting the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513(d) of the FD&C Act 

(21 U.S.C. 360c(d)), devices that were in 

commercial distribution before the 

enactment of the 1976 amendments, 

May 28, 1976 (generally referred to as 

‘‘preamendments devices’’), are 

classified after FDA has: (1) Received a 

recommendation from a device 

classification panel (an FDA advisory 

committee); (2) published the panel’s 

recommendation for comment, along 

with a proposed regulation classifying 

the device; and (3) published a final 

regulation classifying the device. FDA 

has classified most preamendments 

devices under these procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

‘‘postamendments devices’’) are 

automatically classified by section 

513(f) of the FD&C Act (21 U.S.C. 

360c(f)) into class III without any FDA 

rulemaking process. Those devices 

remain in class III and require 

premarket approval unless, and until, 

the device is reclassified into class I or 

II or FDA issues an order finding the 

device to be substantially equivalent, in 

accordance with section 513(i) of the 

FD&C Act (21 U.S.C. 360c(i)), to a 

predicate device that does not require 

premarket approval. The Agency 

determines whether new devices are 

substantially equivalent to predicate 

devices by means of premarket 

notification procedures in section 510(k) 

of the FD&C Act (21 U.S.C. 360(k)) and 

part 807 (21 CFR part 807). 

A preamendments device that has 

been classified into class III and devices 

found substantially equivalent by means 

of premarket notification (510(k)) 

procedures to such a preamendments 

device or to a device within that type 

(both the preamendments and 

substantially equivalent devices are 

referred to as preamendments class III 

devices) may be marketed without 

submission of a premarket approval 

application (PMA) until FDA issues a 

final order under section 515(b) of the 

FD&C Act (21 U.S.C. 360e(b)) requiring 

premarket approval or until the device 

is subsequently reclassified into class I 

or class II. Section 515(b)(1) of the FD&C 

Act (21 U.S.C. 360e(b)(1)) directs FDA to 

issue an order requiring premarket 

approval for a preamendments class III 

device. 

Although, under the FD&C Act, the 

manufacturer of a class III 

preamendments device may respond to 

the call for PMAs by filing a PMA or a 

notice of completion of a product 

development protocol (PDP), in 

practice, the option of filing a notice of 

completion of a PDP has not been used. 

For simplicity, although corresponding 

requirements for PDPs remain available 

to manufacturers in response to a final 

order under section 515(b) of the FD&C 

Act (21 U.S.C. 360e(b)), this document 

will refer only to the requirement for the 

filing and receiving approval of a PMA. 

On July 9, 2012, FDASIA was enacted. 

Section 608(a) of FDASIA (126 Stat. 

1056) amended section 513(e) of the 

FD&C Act (21 U.S.C. 360c(e)), changing 

the mechanism for reclassifying a device 

from rulemaking to an administrative 

order. Section 608(b) of FDASIA 

amended section 515(b) of the FD&C Act 

(21 U.S.C. 360e(b)) changing the 

mechanism for requiring premarket 

approval for a preamendments class III 

device from rulemaking to an 

administrative order. 

Section 515(b)(1) of the FD&C Act sets 

forth the process for issuing a final 

order. Specifically, prior to the issuance 

of a final order requiring premarket 

approval for a preamendments class III 

device, the following must occur: (1) 

Publication of a proposed order in the 

Federal Register; (2) a meeting of a 

device classification panel described in 

section 513(b) of the FD&C Act; and (3) 

consideration of comments from all 

affected stakeholders, including 

patients, payers, and providers. 

Section 515(b)(3) of the FD&C Act 

provides that FDA shall, after the close 

of the comment period on the proposed 

order, consideration of any comments 

received, and a meeting of a device 

classification panel described in section 

513(b) of the FD&C Act, issue a final 

order to require premarket approval or 

publish a document terminating the 

proceeding together with the reasons for 

such termination. 

A preamendments class III device 

may be commercially distributed 

without a PMA until 90 days after FDA 

issues a final order (a final rule issued 

under section 515(b) of the FD&C Act 

prior to the enactment of FDASIA is 

considered to be a final order for 

purposes of section 501(f) of the FD&C 

Act (21 U.S.C. 351(f))) requiring 

premarket approval for the device, or 30 

months after final classification of the 

device under section 513 of the FD&C 

Act, whichever is later. For AED 

systems, the later of these two time 

periods is the 90-day period. Therefore, 

section 501(f)(2)(B) of the FD&C Act (21 

U.S.C. 351(f)(2)(B)) requires that a PMA 


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