Federal Register / Vol. 79, No. 115 / Monday, June 16, 2014 / Rules and Regulations 34221 

Country Listed person and address Federal Register citation and date 

of publication 

Rm 2309, 23/F, Ho King Comm Ctr, 2–16 Fayuen St., Mongkok, 

Kowloon, Hong Kong. 

RUSSIA ................................... JSC Voentelecom, Bolshaya Olenya Str. 15A, Moscow, Russia ............... 79 FR [INSERT FR PAGE NUMBER], June 16, 2014. 

Nasosy Ampika, 3-ya Institutskaya St. Bld. 15, Moscow, Russia .............. 79 FR [INSERT FR PAGE NUMBER], June 16, 2014. 

Nuclin LLC, Serebryakova Proezd 14, Moscow, Russia ............................ 79 FR [INSERT FR PAGE NUMBER], June 16, 2014. 

SDB IRE RAS, 1 Vvedenskogo Square, Fryazino, Russia ........................ 79 FR [INSERT FR PAGE NUMBER], June 16, 2014. 

Security 2 Business Academy, a.k.a. S2BA, a.k.a. Academy of Business 

Security, Deguninskaya Street 10, Moscow, Russia; and 

79 FR [INSERT FR PAGE NUMBER], June 16, 2014. 

Novoslobodskaya Str. 14/19, Moscow, Russia. 

UNITED ARAB EMIRATES .... Doubair General Trading Co. LLC, P.O. Box 30239, Dubai, UAE ............. 79 FR [INSERT FR PAGE NUMBER], June 16, 2014. 

Golden Business FZE, Warehouse #FZS1 AN08, Jebel Ali Free Zone, 

Dubai, UAE; and 

79 FR [INSERT FR PAGE NUMBER], June 16, 2014. 

P.O. Box 263128, Dubai, UAE. 

World Heavy Equipment, Industrial Area 10, Ras Al Khaimah, UAE; and 79 FR [INSERT FR PAGE NUMBER], June 16, 2014. 

World Equipment Trading L.L.C, Industrial Area 10, Ras Al Khaimah, 

UAE. 

PART 758—[AMENDED] 

■ 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). 

■ 4. Section 758.1 is amended by adding 

paragraph (b)(8) to read as follows: 

§ 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 § 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 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 748 

[Docket No. 140406409–01] 

RIN 0694–AG15 

Amendments to Existing Validated 

End-User Authorizations in the 

People’s Republic of China: Samsung 

China Semiconductor Co. Ltd and 

Semiconductor Manufacturing 

International Corporation; Correction 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Correcting amendment. 

SUMMARY: Bureau of Industry and 

Security (BIS) published a final rule in 

the Federal Register on May 29, 2014 

(79 FR 30713), amending existing 

authorizations in the Export 

Administration Regulations (EAR) for 

Validated End-Users (VEUs) Samsung 

China Semiconductor Co. Ltd. (Samsung 

China) and Semiconductor 

Manufacturing International 

Corporation (SMIC) in the People’s 

Republic of China. BIS is correcting an 

inadvertent typographical error in a 

citation included in the list of eligible 

items for SMIC in the May 29 final rule. 

BIS also makes a conforming change. 

DATES: This correction is effective June 

16, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Karen Nies-Vogel, Chair, End-User 

Review Committee, Bureau of Industry 

and Security, U.S. Department of 

Commerce, 14th Street & Pennsylvania 

Avenue NW., Washington, DC 20230; by 

telephone: (202) 482–5991, fax: (202) 

482–3991, or email: ERC@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: Bureau of 

Industry and Security (BIS) published a 

final rule in the Federal Register on 

May 29, 2014 (79 FR 30713), which 

amended existing authorizations in the 

Export Administration Regulations 

(EAR) for Validated End-Users (VEUs) 

Samsung China Semiconductor Co. Ltd. 

(Samsung China) and Semiconductor 

Manufacturing International 

Corporation (SMIC) in the People’s 

Republic of China. Specifically, BIS 

amended Supplement No. 7 to Part 748 

of the EAR to change the address of the 

facility used by Samsung China. In 

addition, BIS added a facility to the list 

of eligible destinations and an item to 

the list of eligible items for SMIC. BIS 

is correcting an inadvertent 

typographical error in the second 

citation included in the list of eligible 

items for SMIC in the May 29 final rule. 

BIS also makes a conforming change by 

updating the citation in the ‘‘Federal 

Register Citation’’ column in the entry 

for SMIC. 

List of Subjects 15 CFR Part 748 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

Accordingly, part 748 of the EAR (15 

CFR parts 730–774) is amended as 

follows: 

PART 748—[AMENDED] 

■ 1. The authority citation for 15 CFR 

part 748 continues to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; E.O. 13026, 61 FR 58767, 

3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 


emcdonald on DSK67QTVN1PROD with RULES
34222 Federal Register / Vol. 79, No. 115 / Monday, June 16, 2014 / Rules and Regulations 

FR 44025, 3 CFR, 2001 Comp., p. 783; Notice 

of August 8, 2013, 78 FR 49107 (August 12, 

2013). 

Supplement No. 7 to Part 748— 

[AMENDED] 

■ 2. Supplement No. 7 to Part 748— 

Authorization Validated End-User 

(VEU): List of Validated End-Users, 

Respective Items Eligible for Export, 

Reexport and Transfer, and Eligible 

Destination is amended by: 

■ a. Removing ‘‘748.15’’ in the list of 

items in the ‘‘Eligible items (By ECCN)’’ 

column for ‘‘Semiconductor 

Manufacturing International 

Corporation’’ and add in its place 

‘‘742.15’’; and 

■ b. Adding the citation ‘‘79 FR 

[INSERT PAGE NUMBER], June 16, 

2014’’ at the end of the list of citations 

in the ‘‘Federal Register Citation’’ 

column for ‘‘Semiconductor 

Manufacturing International 

Corporation’’. 

Eileen M. Albanese, 

Acting Director, Office of Exporter Services. 

[FR Doc. 2014–14041 Filed 6–13–14; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2014–N–0655] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Nonabsorbable Expandable 

Hemostatic Sponge for Temporary 

Internal Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

nonabsorbable expandable hemostatic 

sponge for temporary internal use into 

class II (special controls). The special 

controls that will apply to the device are 

identified in this order and will be part 

of the codified language for the 

nonabsorbable expandable hemostatic 

sponge for temporary internal use 

classification. The Agency is classifying 

the device into class II (special controls) 

in order to provide a reasonable 

assurance of safety and effectiveness of 

the device. 

DATES: This order is effective July 16, 

2014. The classification was applicable 

April 3, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Kelley Burridge, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G425, Silver Spring, 

MD 20993–0002, 301–796–7630. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

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

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or 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, 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) of the regulations. 

Section 513(f)(2) of the FD&C Act, as 

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144, July 9, 

2012), provides two procedures by 

which a person may request FDA to 

classify a device under the criteria set 

forth in section 513(a)(1). Under the first 

procedure, the person submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified and, 

within 30 days of receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

the person requests a classification 

under section 513(f)(2). Under the 

second procedure, rather than first 

submitting a premarket notification 

under section 510(k) of the FD&C Act 

and then a request for classification 

under the first procedure, the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence and requests a classification 

under section 513(f)(2) of the FD&C Act. 

If the person submits a request to 

classify the device under this second 

procedure, FDA may decline to 

undertake the classification request if 

FDA identifies a legally marketed device 

that could provide a reasonable basis for 

review of substantial equivalence with 

the device or if FDA determines that the 

device submitted is not of ‘‘lowmoderate risk’’ or that general controls 

would be inadequate to control the risks 

and special controls to mitigate the risks 

cannot be developed. 

In response to a request to classify a 

device under either procedure provided 

by section 513(f)(2) of the FD&C Act, 

FDA will classify the device by written 

order within 120 days. This 

classification will be the initial 

classification of the device. 

On January 30, 2013, RevMedx, Inc., 

submitted a request for classification of 

XSTAT under section 513(f)(2) of the 

FD&C Act. The manufacturer 

recommended that the device be 

classified into class II (Ref. 1). 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

request in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices into class II 

if general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. After review of the 

information submitted in the de novo 

request, FDA determined that the device 

can be classified into class II with the 

establishment of special controls. FDA 

believes these special controls, in 

addition to general controls, will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on April 3, 2014, FDA 

issued an order to the requestor 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding § 878.4452. 

Following the effective date of this 

final classification administrative order, 

any firm submitting a premarket 

notification (510(k)) for a nonabsorbable 

expandable hemostatic sponge for 

temporary internal use will need to 

comply with the special controls named 

in the final administrative order. 

The device is assigned the generic 

name nonabsorbable expandable 

hemostatic sponge for temporary 

internal use, and it is identified as a 

prescription device intended to be 

placed temporarily into junctional, noncompressible wounds, which are not 

amenable to tourniquet use, to control 

bleeding until surgical care is acquired. 

The sponges expand upon contact with 

blood to fill the wound cavity and 

provide a physical barrier and pressure 

that facilitates formation of a clot. The 

device consists of sterile nonabsorbable 

radiopaque compressed sponges and 


emcdonald on DSK67QTVN1PROD with RULES