19382 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Rules and Regulations 

once in the last 3 years and prior to the 

planting of the potatoes or root crops; 

(ii) Pale cyst nematode has not been 

found in the field; and 

(iii) No more than one pale cyst 

nematode host crop, as listed in 

§ 301.86–2(b), has been grown in the 

field in the last 3 years. 

Done in Washington, DC, this 23rd day of 

April 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–9724 Filed 4–28–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 748 

[Docket No. 090415662–9687–01] 

RIN 0694–AE61 

Additions and Revisions to the List of 

Approved End-Users and Respective 

Eligible Items for the People’s 

Republic of China (PRC) Under 

Authorization Validated End-User 

(VEU) 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: In this final rule, the Bureau 

of Industry and Security (BIS) amends 

the Export Administration Regulations 

(EAR) to add a name to the list of endusers for the People’s Republic of China 

(PRC) approved to receive exports, 

reexports and transfers of certain items 

under Authorization Validated EndUser (VEU). This rule also amends the 

EAR to add and revise eligible items and 

destinations for existing VEU 

authorizations. Specifically, this rule 

amends the EAR to authorize one 

additional VEU and identify its 

respective eligible items for export and 

reexport to the PRC. This rule also 

amends the authorizations of two preexisting VEUs in the PRC. Finally, this 

rule makes a modification to the listed 

name of an existing VEU in the PRC. In 

a final rule published in the Federal 

Register on June 19, 2007, BIS revised 

and clarified U.S. export control policy 

for the PRC, establishing Authorization 

VEU and identifying the PRC as the 

initial eligible destination. In a final rule 

published in the Federal Register on 

October 19, 2007, BIS published the 

names of the first five validated endusers in the PRC that were approved to 

receive certain specified items under 

Authorization VEU. 

DATES: This rule is effective April 29, 

2009. Although there is no formal 

comment period, public comments on 

this regulation are welcome on a 

continuing basis. 

ADDRESSES: You may submit comments, 

identified by RIN 0694–AE61 

(VEUPRCADE), by any of the following 

methods: 

E-mail: publiccomments@bis.doc.gov. 

Include ‘‘RIN 0694–AE61 

(VEUPRCADE)’’ in the subject line of 

the message. 

Fax: (202) 482–3355. Please alert the 

Regulatory Policy Division, by calling 

(202) 482–2440, if you are faxing 

comments. 

Mail or Hand Delivery/Courier: Sheila 

Quarterman, U.S. Department of 

Commerce, Bureau of Industry and 

Security, Regulatory Policy Division, 

14th Street & Pennsylvania Avenue, 

NW., Room 2705, Washington, DC 

20230, Attn: RIN 0694–AE61 

(VEUPRCADE). 

Send comments regarding the 

collection of information associated 

with this rule, including suggestions for 

reducing the burden to Jasmeet Seehra, 

Office of Management and Budget 

(OMB), by e-mail to 

jseehra@omb.eop.gov or by fax to (202) 

395–7285. Comments on this collection 

of information should be submitted 

separately from comments on the final 

rule (i.e., RIN 0694–AE61 

(VEUPRCADE))—all comments on the 

latter should be submitted by one of the 

three methods outlined above. 

FOR FURTHER INFORMATION CONTACT: 

Karen Nies-Vogel, Chairman, 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) 482–3811, or by email to kniesv@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Authorization Validated End-User 

(VEU): Additions and Modifications to 

the List of Approved End-Users, Eligible 

Items and Destinations 

Consistent with U.S. Government 

policy to facilitate trade for civilian endusers in the PRC, BIS amended the EAR 

in a final rule on June 19, 2007 (72 FR 

33646) by creating a new authorization 

for ‘‘validated end-users’’ (VEUs) 

located in eligible destinations to which 

eligible items (commodities, software 

and technology, except those controlled 

for missile technology or crime control 

reasons) may be exported, reexported or 

transferred under a general 

authorization instead of a license, in 

conformance with Section 748.15 of the 

EAR. 

Authorization VEU is a mechanism to 

facilitate increased high-technology 

exports to companies in the PRC and 

India that have a record of using such 

items responsibly. VEUs may obtain 

eligible items that are on the Commerce 

Control List without having to wait for 

their suppliers to obtain export licenses 

from BIS. A wide range of items are 

eligible for shipment under 

Authorization VEU. In addition to U.S. 

exporters, Authorization VEU may be 

used by foreign reexporters, and does 

not have an expiration date. 

Additional VEUs in the PRC and Their 

Respective ‘‘Eligible Items (By ECCN)’’ 

and ‘‘Eligible Destinations’’ 

This final rule amends Supplement 

No. 7 to Part 748 of the EAR to identify 

an additional company with eligible 

facilities in the PRC as a VEU and to 

identify the items that may be exported, 

reexported or transferred to it under 

Authorization VEU. This new entry is 

for Aviza Technology China. It lists 

Export Control Classification Numbers 

(ECCNs) 2B230, 3B001.c.1.a and 

3B001.e under ‘‘Eligible Items (By 

ECCN),’’ and includes the following 

facility names and addresses under 

‘‘Eligible Destination:’’ 

Aviza Technology China, Room B–1501, 

No. 188, Tomson Center, Zhang Yang 

Road, Shanghai, China 200122. 

Aviza Technology China, Room 612, 

International Business Center, No. 18, 

Hong Da North Road, Beijing 

Economics and Technology 

Development Area, Beijing, China. 

Beijing Bonded: CIES, Electronics 

Building, A23, Fuxing Road, Beijing, 

China 100036. 

Shanghai Bonded: SLC, Shanghai 

Industrial-Wailianfa International 

Logistics Co., Ltd., Address: 13F 

Waigaoqiao Building, 889 Yang Gao 

Road(N), Pudong, Shanghai, China. 

HMG Logistics (Chengdu) Co., Ltd., 

Floor 1, No. 5 Standard Warehouse, 

EPZ (West Area), Chengdu, China 

611731. 

Modifications to Existing VEU 

Authorizations 

This final rule also amends 

Supplement No. 7 to Part 748 of the 

EAR to implement requests received 

from existing VEUs for modifications in 

their authorizations to include 

additional eligible items and additional 

destinations, and to list a change of 

name for an existing VEU. Specifically, 

this rule makes the following 

amendments to Supplement No. 7 to 

Part 748: 


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Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Rules and Regulations 19383 

(1) The authorization for Applied 

Materials China, Ltd. now also includes 

ECCN 2B006.b.1.a under ‘‘Eligible Items 

(By ECCN)’’ and the following facility 

name and address under ‘‘Eligible 

Destination:’’ Applied Materials (Xi’an 

Ltd.), No. 28 Xin Xi Ave., Xi’an High 

Tech Park, Export Processing Zone, 

Xi’an Shanxi, China 710075. 

(2) Based upon notification from 

existing VEU BHA Aerocomposite Parts 

Co., Ltd. that the company’s name has 

legally been changed, the name ‘‘BHA 

Aerocomposite Parts Co., Ltd.’’ shown 

in Supplement No. 7 to Part 748 of the 

EAR prior to this rule has been changed 

to ‘‘Boeing Tianjin Composites Co. 

Ltd.,’’ under both the ‘‘Validated EndUser’’ and ‘‘Eligible Destination’’ 

columns. Further, the authorization for 

Boeing Tianjin Composites Co. Ltd., 

formerly BHA Aerocomposite Parts Co., 

Ltd., now also includes ECCN 2B001.b.2 

(limited to machine tools with 

accuracies no better than (i.e., less than) 

13 microns), and replaces ECCN 

2B001.e.1.a. with 2B001.e. under 

‘‘Eligible Items (By ECCN).’’ ECCN 

2B001.e. encompasses all parameters of 

its subparagraphs. 

With the publication of this final rule, 

the total number of VEUs in the PRC is 

six and the total number of eligible 

facilities is twenty. The VEUs listed in 

Supplement No. 7 to Part 748 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. 

Approving this new end-user as a 

VEU is expected to further facilitate 

exports to civil end-users in the PRC. 

Approval of this company also 

represents a significant savings of time 

for suppliers and end-users. 

Authorization VEU will eliminate the 

burden on exporters and reexporters of 

preparing license applications and on 

BIS for processing such applications, as 

exports and reexports will be made 

under general authorization instead of 

under license. This savings will enable 

exporters and reexporters to supply 

VEUs much more quickly, thus 

enhancing the competitiveness of the 

exporters, reexporters, and end-users in 

the PRC. 

To ensure appropriate facilitation of 

exports and reexports, on-site reviews of 

the VEUs may be warranted pursuant to 

paragraph 748.15(a)(2) and Section 7(iv) 

of Supplement No. 8 to Part 748 of the 

EAR. If such reviews are warranted, BIS 

will inform the PRC Ministry of 

Commerce. 

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 July 23, 

2008 (73 FR 43603, July 25, 2008), 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. This final rule has been determined 

to be not significant for the 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 

information displays a currently valid 

Office of Management and Budget 

(OMB) Control Number. This rule 

involves collections previously 

approved by the OMB under control 

number 0694–0088, ‘‘Multi-Purpose 

Application,’’ which carries a burden 

hour estimate of 58 minutes to prepare 

and submit form BIS–748; and for 

recordkeeping, reporting and review 

requirements in connection with 

Authorization Validated End-User, 

which carries an estimated burden of 30 

minutes per submission. This rule is 

expected to result in a decrease in 

license applications submitted to BIS. 

Total burden hours associated with the 

Paperwork Reduction Act and Office of 

Management and Budget control 

number 00694–0088 are not expected to 

increase significantly as a result of this 

rule. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined under Executive Order 

13132. 

4. The provisions of the 

Administrative Procedure Act requiring 

notice of proposed rulemaking, the 

opportunity for public participation, 

and a delay in effective date, are 

inapplicable because this regulation 

involves a military and foreign affairs 

function of the United States (5 U.S.C. 

553(a)(1)). 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 

Administrative Procedure Act 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. Although there is no formal 

comment period, public comments on 

this regulation are welcome on a 

continuing basis. Comments should be 

submitted to Sheila Quarterman, 

Regulatory Policy Division, Bureau of 

Industry and Security, U.S. Department 

of Commerce, 14th Street & 

Pennsylvania Avenue, NW., Room 2705, 

Washington, DC 20230 

List of Subjects in 15 CFR Part 748 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

■ Accordingly, part 748 of the Export 

Administrative 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 

July 23, 2008, 73 FR 43603 (July 25, 2008). 

■ 2. Supplement No. 7 to Part 748 is 

amended by: 

■ a. Revising the entry for ‘‘Applied 

Materials China, Ltd.’’; 

■ b. Adding, in alphabetical order, an 

entry for ‘‘Aviza Technology China’’; 

and 

■ c. Revising the entry for ‘‘BHA 

Aerocomposite Parts Co., Ltd.’’. 

The revisions and addition read as 

follows: 


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19384 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Rules and Regulations 

SUPPLEMENT NO. 7 T PART 748—AUTHORIZATION VALIDATED END-USER (VEU); LIST OF VALIDATED END-USERS, 

RESPECTIVE ITEMS ELIGIBLE FOR EXPORT, REEXPORT AND TRANSFER AND ELIGIBLE DESTINATIONS

Validated end-user Eligible items (by ECCN) Eligible destination 

Applied Materials China, Ltd. 2B006.b.1.a; 2B230; 2B350.g.3; 3B001.b.1; 3B001.c.2; 

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

Applied Materials China, Ltd.—Shanghai Depot c/o 

Shanghai Applied Materials Technical Service Center, 368 Zhang Jiang Road, Pudong Zhangjiang HiTech Park, Shanghai, China 201203. 

Applied Materials China, Ltd.—Beijing Depot c/o Beijing 

Applied Materials Technical Service Center Bldg. 9, 

Area A, No. 1 North Di Sheng Street, BDA Beijing, 

China 100176. 

Applied Materials China, Ltd.—Wuxi Depot c/o 

Sinotrans Jiangsu Group Fuchang Co. J5 A–B Wuxi 

Export Processing Zone, 287 Gaolang Road, Wuxi 

New District, Wuxi Jiangsu China 214028. 

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

High Tech Park 

Export Processing Zone, Xi’an Shanxi, China 710075. 

Aviza Technology China ...... 2B230; 3B001.c.1.a; 3B001.e ......................................... Aviza Technology China, Room B–1501, No. 188, 

Tomson Center, Zhang Yang Road, Shanghai, China 

200122. 

Aviza Technology China, Room 612, International Business Center, No. 18, Hong Da North Road, Beijing 

Economics and Technology Development Area, Beijing, China. 

Beijing Bonded: CIES, Electronics Building, A23, 

Fuxing Road, Beijing, China 100036. 

Shanghai Bonded: SLC, Shanghai Industrial—Wailianfa 

International Logistics Co., Ltd., Address: 13F 

Waigaoqiao Building 889 Yang Gao Road (N), 

Pudong, Shanghai, China. 

HMG Logistics (Chengdu) Co., Ltd., Floor 1, No. 5 

Standard Warehouse, EPZ (West Area), Chengdu, 

China 611731. 

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. 

* * * * * * * 


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Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Rules and Regulations 19385 

Dated: April 24, 2009. 

Matthew S. Borman, 

Acting Assistant Secretary for Export 

Administration. 

[FR Doc. E9–9817 Filed 4–28–09; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 201 

[Docket No. FDA–1977–N–0013] (formerly 

Docket No. 1977N–0094L) 

RIN 0910–AF36 

Organ-Specific Warnings; Internal 

Analgesic, Antipyretic, and 

Antirheumatic Drug Products for Overthe-Counter Human Use; Final 

Monograph 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

final rule to require important new 

organ-specific warnings and related 

labeling for over-the-counter (OTC) 

internal analgesic, antipyretic, and 

antirheumatic (IAAA) drug products. 

The new labeling informs consumers 

about the risk of liver injury when using 

acetaminophen and the risk of stomach 

bleeding when using nonsteroidal antiinflammatory drugs (NSAIDS). The new 

labeling is required for all OTC IAAA 

drug products whether marketed under 

an OTC drug monograph or an approved 

new drug application (NDA). 

DATES: Effective Date: This final rule is 

effective April 29, 2010. 

Compliance Date: The compliance 

date for all products subject to this final 

rule, including products with annual 

sales less than $25,000, is April 29, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Arlene Solbeck, Center for Drug 

Evaluation and Research , Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, MS 5411, 

Silver Spring, MD 20993, 301–796– 

2090. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Overview of This Document 

II. Rulemaking History for OTC IAAA 

Drug Products 

A. Rulemakings Published Before the 

2006 Proposed Rule 

B. 2006 Proposed Rule 

III. Labeling Required for All OTC 

Internal Analgesics 

A. PDP 

B. Drug Facts 

C. Immediate Container 

IV. Labeling Required for OTC 

Acetaminophen 

A. Liver Warning 

B. Concomitant Use Warning 

C. Liver Disease Warning 

D. Drug Interaction Warning 

E. Warnings for Certain SubPopulations 

V. Labeling Required for OTC NSAIDs 

A. Warnings 

B. Labeling Specific to Aspirin 

VI. Analysis of Impacts 

VII. Paperwork Reduction Act of 1995 

VIII. Environmental Impact 

IX. Federalism 

X. References 

Glossary 

(The definitions of terms used 

throughout this document are included 

in this glossary because these terms are 

likely to be unfamiliar to many readers.) 

AERS: FDA’s Adverse Event 

Reporting System; a database of adverse 

events reported to FDA for drugs and 

medical devices 

Acute Liver Failure: Severe liver 

injury without a history of chronic liver 

disease that is associated with 

coagulopathy and encephalopathy 

ALT: Alanine aminotransferase; a 

liver enzyme that is often tested to 

evaluate individuals for liver disease 

AST: Aspartate aminotransferase; a 

liver enzyme that is often tested to 

evaluate individuals for liver disease 

CFR: The Code of Federal 

Regulations; list of regulations created 

by the executive departments and 

agencies of the Federal Government 

GRAS/E: Generally recognized as safe 

and effective 

GSH: Glutathione; tripeptide (protein 

fragment) necessary for acetaminophen 

metabolism to avoid accumulation of 

the toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI) 

HIV: Human immunodeficiency virus; 

a retrovirus that can lead to acquired 

immunodeficiency syndrome (AIDS) 

IAAA: Internal analgesic, antipyretic, 

and antirheumatic drug products 

INR: International normalized ratio; 

measurement that evaluates the ability 

of blood to clot 

IU/L: International units per liter 

NAQPI: N-acetyl-p-benzo-quinone 

imine; a harmful by-product of 

acetaminophen metabolism that can 

cause severe liver injury 

NDA: New Drug Application; 

application needed for approval of a 

new drug by the FDA prior U.S. 

marketing 

NSAIDs: Nonsteroidal antiinflammatory drugs (such as aspirin and 

ibuprofen) 

PDP: Principal display panel; part of 

a label that is most likely to be 

displayed, presented, shown, or 

examined under customary conditions 

of display for retail sale. 

I. Overview of This Document 

This document addresses comments 

and data in the 19 submissions that we 

received in response to the December 

26, 2006 (proposed rule) (71 FR 77314), 

which is described in section II of this 

document. The submissions comment 

on the labeling that we proposed for 21 

CFR parts 201 and 343 as well as other 

issues where specific comments were 

sought in the 2006 proposed rule. The 

proposed rule asked for comments on 

issues related to the following: 

• The safe and effective daily dose of 

acetaminophen 

• Daily dose recommendation for 

alcohol abusers 

• Combination products of 

acetaminophen combined with 

methionine or acetylcysteine 

• Package size and configuration 

limitations with acetaminophen 

products 

• Label warnings for individuals with 

Human Immunodeficiency Virus (HIV) 

• Drug interactions between 

acetaminophen and warfarin 

This document states our final 

conclusions on the labeling 

requirements in 21 CFR part 201 and 

requires that manufacturers include this 

labeling on their OTC IAAA drug 

products by the effective date identified 

in this document (see DATES). We are 

currently evaluating data and 

information regarding the remaining 

issues discussed in the proposed rule, 

some of which include the following: 

• Safe daily dose for acetaminophen 

(healthy users) 

• Safe daily dose for acetaminophen 

users with chronic liver disease 

• Safe daily dose for acetaminophen 

with alcohol use 

• Appropriate dosage for 

acetaminophen efficacy 

• Package size restrictions for OTC 

IAAA drug products 

• Pediatric dosing for OTC IAAA 

drug products 

• Various warnings for OTC IAAA 

drug products that were proposed in 21 

CFR part 343 but not part 21 CFR part 

201 

• Acetaminophen-narcotic 

combinations 

• Combinations of acetaminophen 

and N-acetylcysteine (NAC) or 

methionine 

• Prescription labeling for OTC IAAA 

drug products 


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