40804 Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Rules and Regulations 

$100,000 to stay in business. ARSA 

maintains that measuring the impact on 

small businesses based on annual 

revenues is not appropriate. ARSA 

asserts that the FAA should measure 

economic impact based on profits. The 

FAA has reviewed ARSA’s suggestion 

and determined that it is not 

appropriate for this analysis. Use of 

annual revenues is consistent with the 

SBA’s measure of the impact on small 

businesses. See 13 CFR 121.106; 

121.201. Thus, based on the projected 

costs for the smallest of entities that 

could be affected by this final rule, the 

FAA concludes no firm would incur a 

significant economic impact. 

Accordingly, although a substantial 

number of small businesses are 

impacted by this rule, because the 

economic impact is not significant, 

under 5 U.S.C. 605(b), I certify, as the 

FAA Administrator, that this rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Issued in Washington, DC, on July 7, 2011. 

J. Randolph Babbitt, 

Administrator, Federal Aviation 

Administration. 

[FR Doc. 2011–17472 Filed 7–7–11; 4:15 pm] 

BILLING CODE P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 748 

[Docket No. 110413240–1255–02] 

RIN 0694–AF23 

Technical Amendment to the 

Authorization Validated End-User 

Regulations of the Export 

Administration Regulations 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: In this rule, the Bureau of 

Industry and Security (BIS) amends the 

Export Administration Regulations 

(EAR), 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 

Destinations—to add a column that lists 

Federal Register citations for the 

respective entries. This rule does not 

make any substantive changes to 

Supplement No. 7 or elsewhere in the 

EAR. 

DATES: This rule is effective July 12, 

2011. 

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) 

482–3911, or e-mail: ERC@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Authorization Validated End-User 

(VEU) 

BIS amended the EAR in a final rule 

on June 19, 2007 (72 FR 33646), creating 

a new authorization for ‘‘validated endusers’’ (VEUs) located in eligible 

destinations to which eligible items may 

be exported, reexported, or transferred 

(in-country) under a general 

authorization instead of a license, in 

conformance with section 748.15 of the 

EAR. 

VEUs may obtain eligible items that 

are on the Commerce Control List, set 

forth in Supplement No. 1 to Part 774 

of the EAR, without having to wait for 

their suppliers to obtain export licenses 

from BIS. Eligible items may include 

commodities, software, and technology, 

except those controlled for missile 

technology or crime control reasons. 

The VEUs listed in Supplement No. 7 

to Part 748 of the EAR were reviewed 

and approved by the U.S. Government 

in accordance with the provisions of 

section 748.15 and Supplement Nos. 8 

and 9 to Part 748 of the EAR. The EndUser Review Committee (ERC), 

composed of representatives from the 

Departments of State, Defense, Energy 

and Commerce, and other agencies, as 

appropriate, is responsible for 

administering the VEU program. A 

unanimous vote by the ERC is required 

to authorize VEU status for a candidate 

or to add eligible items to an existing 

authorization. Majority vote of the ERC 

is required to remove VEU authorization 

or to remove eligible items from an 

existing authorization. 

In addition to U.S. exporters, 

Authorization VEU may be used in 

accordance with the provisions of the 

EAR by foreign reexporters and by 

persons transferring in-country, and it 

does not have an expiration date. VEUs 

are subject to regular reviews, based on 

information available to the United 

States government, to ensure that items 

shipped under Authorization VEU are 

used for civilian purposes. In addition, 

VEUs are subject to on-site reviews as 

warranted. 

As of the date of this rule, pursuant 

to section 748.15(b) of the EAR, VEUs 

are only located in the PRC and India. 

Amendment to Supplement No.7 to Part 

748 of the EAR 

In this final rule, BIS amends the 

EAR, 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 

Destinations to add a column that lists 

Federal Register citations for the 

respective entries. This rule does not 

make any substantive changes to 

Supplement No.7 or elsewhere in the 

EAR. 

The Federal Register citation that 

appears first for each VEU in the new 

column added to Supplement No. 7 

indicates the initial date on which the 

authorization for that listed VEU and its 

respective list of approved ‘‘Eligible 

Items’’ and ‘‘Eligible Destinations’’ were 

published in the Federal Register and 

became effective. Subsequent citations 

indicate the dates on which 

amendments to a VEU’s authorization 

were published in the Federal Register 

and became effective. 

Since August 21, 2001, the Export 

Administration Act has been in lapse 

and the President, through Executive 

Order 13222 of August 17, 2001 (3 CFR, 

2001 Comp. p. 783 (2002)), as extended 

most recently by the Notice of August 

16, 2010 (75 FR 50681, August 16, 

2010), has continued the EAR in effect 

under the International Emergency 

Economic Powers Act. BIS continues to 

carry out the provisions of the Act, as 

appropriate and to the extent permitted 

by law, pursuant to Executive Order 

13222. 

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 been determined to be not 

significant for purposes of Executive 

Order 12866. 

2. Notwithstanding any other 

provisions of law, no person is required 

to respond to nor be 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 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Rules and Regulations 40805 

information displays a currently valid 

Office of Management and Budget 

(OMB) Control Number. This rule does 

not involve a collection of information, 

and, therefore, does not implicate 

requirements of the PRA. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined under Executive Order 

13132. 

4. The Department finds that there is 

good cause under 5 U.S.C. 553(b)(A) and 

(B) to waive the provisions of the 

Administrative Procedure Act (APA) 

requiring prior notice and the 

opportunity for public comment 

because they are unnecessary. This rule 

is procedural, which is exempted from 

the notice and comment requirements of 

the APA. This rule only adds a column 

to the existing Supplement No. 7 to Part 

748 of the EAR for purposes of 

providing Federal Register citations for 

entries in the Supplement to the public. 

Because these revisions are not 

substantive changes, it is unnecessary to 

provide notice and opportunity for 

public comment. In addition, the 30-day 

delay in effectiveness required by 5 

U.S.C. 553(d) is not applicable because 

this rule is not a substantive rule. 

Further, no other law requires that a 

notice of proposed rulemaking and an 

opportunity for public comment be 

given for this final rule. Because a 

notice of proposed rulemaking and an 

opportunity for public comment are not 

required to be given for this rule under 

the APA or by any other law, the 

analytical requirements of the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.) are not applicable. Therefore, 

this regulation is issued in final form. 

List of Subjects in 15 CFR Part 748 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

Accordingly, part 748 of the Export 

Administration Regulations (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 FR 

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

August 12, 2010 (75 FR 50681 (August 16, 

2010), 

■ 2. Supplement No. 7 to Part 748 is 

revised to read as follows: 

AUTHORIZATION VALIDATED END-USER (VEU): LIST OF VALIDATED END-USERS, RESPECTIVE ITEMS ELIGIBLE FOR

EXPORT, REEXPORT AND TRANSFER, AND ELIGIBLE DESTINATIONS

Country Validated end-user Eligible items (by ECCN) Eligible destination Federal Register 

citation 

China (People’s Republic of).Advanced Micro Devices China, Inc.3D002, 3D003, 3E001 (limited to ‘‘technology’’ for items classified under 3C002 

and 3C004 and ‘‘technology’’ for use during the International Technology Roadmap 

for Semiconductors (ITRS) process for 

items classified under ECCNs 3B001 and 

3B002), 3E002 (limited to ‘‘technology’’ for 

use during the ITRS process for items 

classified under ECCNs 3B001 and 

3B002), 3E003.e (limited to the ‘‘development’’ and ‘‘production’’ of integrated circuits for commercial applications), 4D001, 

4D002, 4D003 and 4E001 (limited to the 

‘‘development’’ of products under ECCN 

4A003).

AMD Technologies (China) Co., Ltd., No. 

88, Su Tong Road, Suzhou, China 

215021.

Advanced Micro Devices (Shanghai) Co., 

Ltd., Buildings 46, 47, 48 & 49, River 

Front Harbor, Zhangjiang Hi-Tech Park, 

1387 Zhangdong Rd., Pudong, Shanghai, 

201203.

AMD Technology Development (Beijing) 

Co., Ltd., 18F, North Building, Raycom 

Infotech, Park Tower C, No. 2 Science Institute South Rd., Zhong Guan Cun, 

Haidian District, Beijing, China 100190.

75 FR 25763, 5/10/ 

10. 76 FR 2802, 

1/18/11. 

Applied Materials 

(China), Inc.

2B006.b, 2B230, 2B350.g.3, 2B350.i, 

3B001.b, 3B001.c, 3B001.d, 3B001.e, 

3B001.f, 3C001, 3C002, 3D002 (limited to 

‘‘software’’ specially designed for the 

‘‘use’’ of stored program controlled items 

classified under ECCN 3B001) 2B006.b, 

2B230, 2B350.g.3, 2B350.i, 3B001.b, 

3B001.c, 3B001.d, 3B001.e, 3B001.f, 

3C001, 3C002, 3D002 (limited to ‘‘software’’ specially designed for the ‘‘use’’ of 

stored program controlled items classified 

under ECCN 3B001), and 3E001 (limited 

to ‘‘technology’’ according to the General 

Technology Note for the ‘‘development’’ or 

‘‘production’’ of items controlled by ECCN 

3B001).

Applied Materials South East Asia Pte. 

Ltd.—Shanghai Depot c/o Shanghai Applied Materials Technical Service Center 

No. 2667 Zuchongzhi Road, Shanghai, 

China 201203.

Applied Materials South East Asia Pte. 

Ltd.—Beijing Depot c/o Beijing Applied 

Materials Technical Service Center No. 1 

North Di Sheng Street, BDA Beijing, 

China 100176.

Applied Materials South East Asia Pte. 

Ltd.—Wuxi Depot c/o Sinotrans Jiangsu 

Fuchang Logistics Co., Ltd. 1 Xi Qin 

Road, Wuxi Export Processing Zone 

Wuxi, Jiangsu, China 214028.

Applied Materials (China), Inc.—Shanghai 

Depot No. 2667, Zuchongzhi Road 

Shanghai, China 201203.

72 FR 59164, 10/19/ 

07. 74 FR 19382, 

4/29/09. 75 FR 

27185, 5/14/10. 

Applied Materials South East Asia Pte. 

Ltd.—Wuhan Depot c/o Wuhan Optics 

Valley Import & Export Co., Ltd. No. 101 

Guanggu Road East Lake High-Tec Development Zone Wuhan, Hubei, China 

430074.

Applied Materials (China), Inc.—Beijing 

Depot No. 1 North Di Sheng Street, BDA 

Beijing, China 100176.

Applied Materials (Xi’an) Ltd. No. 28 Xin Xi 

Ave., Xi’an High Tech Park Export Processing Zone Xi’an, Shaanxi, China 

710075.


jdjones on DSK8KYBLC1PROD with RULES
40806 Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Rules and Regulations 

AUTHORIZATION VALIDATED END-USER (VEU): LIST OF VALIDATED END-USERS, RESPECTIVE ITEMS ELIGIBLE FOR

EXPORT, REEXPORT AND TRANSFER, AND ELIGIBLE DESTINATIONS—Continued 

Country Validated end-user Eligible items (by ECCN) Eligible destination Federal Register 

citation 

Boeing Tianjin Composites Co. Ltd.1A002.a; 1B001.f; 1C010.b; 1C010.e; 

1D001 (limited to ‘‘software’’ specially designed or modified for the ‘‘development’’, 

‘‘production’’ or ‘‘use’’ of equipment controlled by 1B001.f) 1E001 (limited to 

‘‘technology’’ according to the General 

Technology Note for the ‘‘development’’ or 

‘‘production’’ of items controlled by 

1A002.a, 1B001.f, 1C010.b & .e, and 

2B001.a); 2B001.b.2 (limited to machine 

tools with accuracies no better than (i.e., 

less than) 13 microns); 2B001.e; 2D001 

(limited to ‘‘software,’’ other than that controlled by 2D002, specially designed or 

modified for the ‘‘development’’, ‘‘production’’ or ‘‘use’’ of equipment controlled by 

2B001.b.2 and 2B001.e); 2D002 (limited 

to ‘‘software’’ for electronic devices, even 

when residing in an electronic device or 

system, enabling such devices or systems 

to function as a ‘‘numerical control’’ unit, 

capable of coordinating simultaneously 

more than 4 axes for ‘‘contouring control’’ 

controlled by 2B001.b.2 and 2B001.e).

Boeing Tianjin Composites Co. Ltd., No. 4– 

388 Heibei Road, Tanggu Tianjin, China.

72 FR 59164, 10/19/ 

07. 74 FR 19382, 

4/29/09. 

CSMC Technologies 

Corporation.

1C350.c.3, 1C350.c.11, 2B230.a, 2B230.b, 

2B350.f, 2B350.g, 2B350.h, 3B001.c.1.a, 

3B001.c.2.a, 3B001.e 3B001.h (except for 

multilayer masks with a phase shift layer 

designed to produce ‘‘space qualified’’ 

semiconductor devices), 3C002.a, and 

3C004.

CSMC Technologies Fab 1 Co., Ltd., 14 

Liangxi Road, Wuxi, Jiangsu 214061, 

China.

CSMC, Technologies Fab 2 Co., Ltd., Block 

86, 87, Wuxi National Hi-New Tech Industrial Development Zone, Wuxi, Jiangsu 

214061, China.

Wuxi CR Semiconductor Wafers and Chips 

Co., Ltd., 14 Liangxi Road, Wuxi, Jiangsu 

214061, China.

76 FR 2802, 1/18/11. 

76 FR 37634, 6/28/ 

11. 

Grace Semiconductor 

Manufacturing Corporation.

1C350.c.3, 1C350.d.7, 2B230, 2B350.d.2, 

2B350.g.3, 2B350.i.4, 3B001.a.1, 

3B001.b, 3B001.c, 3B001.d, 3B001.e, 

3B001.f, 3B001.h, 3C002, 3C004, 5B002, 

and 5E002 (limited to production technology for integrated circuits controlled by 

ECCNs 5A002 or 5A992 that have been 

successfully reviewed under the 

encryption review process specified in 

sections 740.17(b)(2) or 740.17(b)(3) and 

742.15 of the EAR; Note also the guidance on cryptographic interfaces (OCI) in 

section 740.17(b) of the EAR).

1399 Zuchongzhi Road Zhangjiang Hi-Tech 

Park Shanghai, PR China 201203.

75 FR 2435, 1/15/10. 

Hynix Semiconductor 

China Ltd.

3B001.a, 3B001.b, 3B001.c, 3B001.d, 

3B001.e, and 3B001.f.

Hynix Semiconductor China Ltd. Lot K7/K7– 

1, Export Processing Zone Wuxi, Jiangsu, 

PR China.

75 FR 62462, 10/12/ 

10. 

Hynix Semiconductor 

(Wuxi) Ltd.

3B001.a, 3B001.b, 3B001.c, 3B001.d, 

3B001.e, and 3B001.f.

Hynix Semiconductor (Wuxi) Ltd., Lot K7/ 

K7–1, Export Processing Zone, Wuxi, 

Jiangsu, PR, China.

75 FR 62462, 10/12/ 

10. 

Lam Research Corporation.2B230, 2B350.c, 2B350.d, 2B350.g, 

2B350.h, 2B350.i, 3B001.c, 3B001.e 

(items controlled under 3B001.c and 

3B001.e are limited to parts and components), 3D001, 3D002 (limited to ‘‘software’’ specially designed for the ‘‘use’’ of 

stored program controlled items classified 

under ECCN 3B001), and 3E001 (limited 

to ‘‘technology’’ according to the General 

Technology Note for the ‘‘development’’ of 

equipment controlled by ECCN 3B001).

Lam Research (Shanghai) Service Co., 1st 

Floor, Area C, Hua Hong Science & Technology Park, 177 Bi Bo Road Zhangjiang 

Hi-Tech Park, Pudong, Shanghai, China 

201203.

Lam Research Shanghai Co., Ltd., No. 1 

Jilong Rd., Room 424–2, Waigaoqiao 

Free Trade Zone, Shanghai, China 

200131.

Lam Research International Sarl (Shanghai 

TSS), c/o HMG Logistic (Shanghai), Co., 

Ltd., No. 55, West Shang Feng Road, 

Tangzhen, Pudong New Area, Shanghai, 

China 201203.

75 FR 62462, 10/12/ 

10. 

Lam Research Shanghai Co., Ltd., (Shanghai WGQ Bonded Warehouse), No. 55, 

Fei la Road, Waigaoqiao Free Trade 

Zone, Pudong New Area, Shanghai, 

China 200131.

Lam Research Co., Ltd. (Beijing Branch), 

Room 322 Dadi Mansion, No. 18 Hongda 

Beilu Beijing Economic & Technological 

Development Area, Beijing, China 100176.


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Rules and Regulations 40807 

AUTHORIZATION VALIDATED END-USER (VEU): LIST OF VALIDATED END-USERS, RESPECTIVE ITEMS ELIGIBLE FOR

EXPORT, REEXPORT AND TRANSFER, AND ELIGIBLE DESTINATIONS—Continued 

Country Validated end-user Eligible items (by ECCN) Eligible destination Federal Register 

citation 

Lam Research Co., Ltd. (Wuxi Representative Office), 5E, Bldg. C International 

Science & Technology Park, #2 Taishan 

Road, WND, Wuxi, Jiangsu, China 

214028.

Lam Research International Sarl (Wuxi EPZ 

Bonded Warehouse) c/o HMG WHL Logistic (Wuxi) Co., Ltd., F1, Area 4, No. 1, 

Plot J3, No. 5 Gaolang East Road, Export 

Processing Zone, Wuxi, China 214028.

Lam Research Co., Ltd. (Wuhan Representative Office), Room 1810, Guanggu International Building B, 456 Luoyu Road, 

East-Lake Hi-Tech Development Zone, 

Wuhan City, Hubei Province, China 

430074.

Lam Research International Sarl (Wuhan 

TSS), c/o HMG Wuhan Logistic Co., Ltd., 

1st—2nd Floor, No. 5 Building, Hua Shi 

Yuan Er Road, Optical Valley Industry 

Park, East-Lake Hi-Tech Development 

Zone, Wuhan City, Hubei Province, China 

430223.

National Semiconductor Corporation.3A001.a.5.a.1; 3A001.a.5.a.2; 

3A001.a.5.a.3; 3A001.a.5.a.4; 

3A001.a.5.a.5; 3A001.a.5.b.

National Semiconductor Hong Kong Limited, 

Beijing Representative Office, Room 604, 

CN Resources Building, No. 8 

Jianggumenbei A, Beijing, China 100005.

72 FR 59164, 10/19/ 

07. 72 FR 61512, 

10/31/07. 

National Semiconductor Hong Kong Limited, 

Shanghai Representative Office, Room 

903–905 Central Plaza, No. 227 Huangpi 

Road North, Shanghai, China 200003.

National Semiconductor Hong Kong Limited, 

Shenzhen Representative Office, Room 

1709 Di Wang Commercial Centre, Shung 

Hing Square, 5002 Shenna Road East, 

Shenzhen, China 518008.

Semiconductor Manufacturing International Corporation.1C350.c.3; 1C350.d.7; 2B006.b.1; 2B230; 

2B350.d.2; 2B350.g.3; 2B350.i.4; 

3B001.a; 3B001.b; 3B001.c; 3B001.d; 

3B001.e; 3B001.f; 3C001; 3C002; 3C004; 

5B002; 5E002 (limited to ‘‘technology’’ according to the General Technology Note 

for the ‘‘production’’ of integrated circuits 

controlled by ECCN 5A002 that has been 

successfully reviewed under the 

encryption review process specified in 

§§ 740.17.b.2 or 740.17.b.3 and 742.15 of 

the EAR).

Semiconductor Manufacturing International 

(Shanghai) Corporation, 18 Zhang Jiang 

Rd., Pudong New Area, Shanghai, China 

201203.

Semiconductor Manufacturing International 

(Tianjin) Corporation, 19 Xing Hua Avenue, Xi Qing Economic Development 

Area, Tianjin, China 300385.

Semiconductor Manufacturing International 

(Beijing) Corporation, No. 18 Wen Chang 

Road, Beijing Economic-Technological 

Development Area, Beijing, China 100176.

72 FR 59164, 10/19/ 

07. 75 FR 67029, 

11/1/10. 

Semiconductor Manufacturing International 

(Chengdu) Corporation, Assembly and 

Testing (AT2) Facility, 8–8 Kexin Road, 

Export Processing Zone (West Area), 

Chengdu, China 611731.

Shanghai Hua Hong 

NEC Electronics 

Company, Ltd.

1C350.c.3; 1C350.d.7; 2B230; 2B350.d.2; 

2B350.g.3; 2B350.i.4; 3B001.c.2; 3C002; 

3C004.

Headquarters and Fab. 1 of HHNEC, No. 

1188 Chuan Qiao Rd., Pu Dong, Shanghai, China 201206.

Fab. 2 of HHNEC, No. 668 Guo Shou Jing 

Rd., Zhang Jiang High Tech Park, Pu 

Dong, Shanghai, China 201203.

72 FR 59164, 10/19/ 

07. 

India ........................... GE India .................... AIFACS Bldg., 1 Rafi Marg, New Delhi 110 

001 India.

74 FR 31620, 7/2/09. 

74 FR 68147, 12/ 

23/09. 

For GEITC: 

1C002.a.1, 1C002.a.2, 1C002.b.1.a and 

1C002.b.1.b, 1E001, 2E983, 

9E003.a.1, 9E003.a.4, 9E003.a.5, 

9E003.a.6, 9E003.a.8, and 9E003.c.

GE India Technology Centre Private Ltd. 

(GEITC) 122, EPIP, Phase II, Hoodi Village, Whitefield Road, Bangalore, 

Karnataka 560066 India.

For BEC: 

1C002.a.1, 1C002.a.2, 1C002.b.1.a, 

1C002.b.1.b, 1E001, 9E003.a.1, 

9E003.a.2, 9E003.a.4, 9E003.a.5, 

9E003.a.6, 9E003.a.8, and 9E003.c.

Bangalore Engineering Centre (BEC), c/o 

GE India Technology Centre Private Ltd. 

(GEITC), 122, EPIP, Phase II, Hoodi Village, Whitefield Road, Bangalore, 

Karnataka 560066 India.


jdjones on DSK8KYBLC1PROD with RULES
40808 Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Rules and Regulations 

Dated: July 1, 2011. 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2011–17494 Filed 7–11–11; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2011–N–0003] 

Oral Dosage Form New Animal Drugs; 

Amprolium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an original abbreviated new 

animal drug application (ANADA) filed 

by Cross Vetpharm Group Ltd. The 

original ANADA provides for the use of 

amprolium soluble powder for the 

treatment of coccidiosis in chickens and 

turkeys. 

DATES: This rule is effective July 12, 

2011. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–170), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, 

e-mail: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Cross 

Vetpharm Group Ltd., Broomhill Rd., 

Tallaght, Dublin 24, Ireland, filed 

ANADA 200–488 for the use of 

AMPROMED–P (amprolium) for 

poultry, a water-soluble powder used 

for the treatment of coccidiosis in 

chickens and turkeys. Cross Vetpharm 

Group Ltd.’s AMPROMED–P for Poultry 

is approved as a generic copy of 

Huvepharma AD’s AMPROL 128 

(amprolium) 20% Soluble Powder, 

approved under NADA 33–165. The 

ANADA is approved as of May 23, 2011, 

and the regulations in 21 CFR 520.100 

are amended to reflect the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, between 

9 a.m. and 4 p.m., Monday through 

Friday. 

FDA has determined under 21 CFR 

25.33 that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 

5 U.S.C. 801–808. 

List of Subjects in 21 CFR Part 520 

Animal drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. In § 520.100, paragraph (b)(4) is 

revised to read as follows: 

§ 520.100 Amprolium. 

* * * * * 

(b) * * * 

(4) No. 061623 for use of product 

described in paragraph (a)(2) of this 

section as in paragraphs (d)(1) and (d)(2) 

of this section. 

* * * * * 

Dated: June 30, 2011. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2011–17465 Filed 7–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2011–0507] 

RIN 1625–AA00 

Safety Zones; Fireworks Within the 

Sector Boston Captain of the Port 

Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing temporary safety zones 

within the Sector Boston Captain of the 

Port (COTP) Zone for various fireworks 

displays. These safety zones are 

necessary to provide for the safety of life 

on navigable waters during these 

fireworks events. Entering into, 

transiting through, mooring or 

anchoring within these zones is 

prohibited unless authorized by the 

COTP or the designated on-scene 

representative. 

DATES: This rule is effective in the CFR 

on July 12, 2011 through 11:59 p.m. 

September 9, 2011. This rule is effective 

with actual notice for purposes of 

enforcement beginning at 8:30 p.m. June 

27, 2011. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2011– 

0507 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2011–0507 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ They 

are also available for inspection or 

copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or e-mail MST1 David Labadie 

of the Waterways Management Division, 

U.S. Coast Guard Sector Boston; 

telephone 617–223–3010, e-mail 

david.j.labadie@uscg.mil. If you have 

questions on viewing material related to 

the docket, call Renee V. Wright, 

Program Manager, Docket Operations, 

telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule. The safety 

zones listed in this rule are associated 

with annual fireworks events. The Coast 

Guard intends to make these safety 

zones permanent regulations and has 

submitted a NPRM for submission to the 

Federal Register requesting public 


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