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, 34221-34222 [2014-14041]
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Federal Register / Vol. 79, No. 115 / Monday, June 16, 2014 / Rules and Regulations
Federal Register citation and date
of publication
Country
Listed person and address
RUSSIA ...................................
Rm 2309, 23/F, Ho King Comm Ctr, 2–16 Fayuen St., Mongkok,
Kowloon, Hong Kong.
JSC Voentelecom, Bolshaya Olenya Str. 15A, Moscow, Russia ...............
Nasosy Ampika, 3-ya Institutskaya St. Bld. 15, Moscow, Russia ..............
Nuclin LLC, Serebryakova Proezd 14, Moscow, Russia ............................
SDB IRE RAS, 1 Vvedenskogo Square, Fryazino, Russia ........................
UNITED ARAB EMIRATES ....
34221
Security 2 Business Academy, a.k.a. S2BA, a.k.a. Academy of Business
Security, Deguninskaya Street 10, Moscow, Russia; and
Novoslobodskaya Str. 14/19, Moscow, Russia.
Doubair General Trading Co. LLC, P.O. Box 30239, Dubai, UAE .............
Golden Business FZE, Warehouse #FZS1 AN08, Jebel Ali Free Zone,
Dubai, UAE; and
P.O. Box 263128, Dubai, UAE.
World Heavy Equipment, Industrial Area 10, Ras Al Khaimah, UAE; and
79 FR [INSERT
BER], June 16,
79 FR [INSERT
BER], June 16,
79 FR [INSERT
BER], June 16,
79 FR [INSERT
BER], June 16,
79 FR [INSERT
BER], June 16,
FR PAGE
2014.
FR PAGE
2014.
FR PAGE
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FR PAGE
2014.
FR PAGE
2014.
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79 FR [INSERT
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79 FR [INSERT
BER], June 16,
FR PAGE NUM2014.
FR PAGE NUM2014.
NUMNUMNUMNUM-
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]
DEPARTMENT OF COMMERCE
3. The authority citation for 15 CFR
Part 758 continues to read as follows:
Bureau of Industry and Security
■
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).
15 CFR Part 748
[Docket No. 140406409–01]
RIN 0694–AG15
§ 758.1 The Electronic Export Information
(EEI) filing to the Automated Export System
(AES)
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:
4. Section 758.1 is amended by adding
paragraph (b)(8) to read as follows:
■
*
*
*
*
(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]
emcdonald on DSK67QTVN1PROD with RULES
BILLING CODE 3510–33–P
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Jkt 232001
Bureau of Industry and
Security, Commerce.
ACTION: Correcting amendment.
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
SUMMARY:
PO 00000
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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
E:\FR\FM\16JNR1.SGM
16JNR1
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.
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
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SUMMARY:
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16:01 Jun 13, 2014
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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
PO 00000
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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
E:\FR\FM\16JNR1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Rules and Regulations]
[Pages 34221-34222]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14041]
-----------------------------------------------------------------------
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]
0
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
[[Page 34222]]
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]
0
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:
0
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
0
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
