38342 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Rules and Regulations 

§§ 510.600 and 524.1580b (21 CFR 

510.600 and 524.1580b) are amended to 

reflect the approval. 

In addition, FDA has found that the 

pioneer sponsor’s drug labeler code 

(DLC) was inadvertently omitted from 

§ 524.1580b during format changes in 

2005 (70 FR 50181; August 26, 2005). At 

this time, § 524.1580b is amended to 

include Squire Laboratories, Inc.’s DLC. 

Section 524.1580b is also amended to 

reflect current food safety warnings. 

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(a)(1) 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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 524 

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 parts 510 and 524 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), in the entry for ‘‘First 

Priority, Inc.’’ and in the table in 

paragraph (c)(2), in the entry for 

’’058829’’, remove ‘‘1585 Todd Farm 

Dr.’’ and in its place add ‘‘1590 Todd 

Farm Dr.’’. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 4. In § 524.1580b, add paragraph (b)(3) 

and revise paragraph (d)(3) to read as 

follows: 

§ 524.1580b Nitrofurazone ointment. 

* * * * * 

(b) * * * 

(3) See Nos. 017153 and 058829 for 

use on horses. 

* * * * * 

(d) * * * 

(3) Limitations. For use only on dogs, 

cats, and horses. Do not use in horses 

intended for human consumption. 

Federal law prohibits the use of this 

product in food-producing animals. In 

case of deep or puncture wounds or 

serious burns, use only as recommended 

by veterinarian. If redness, irritation, or 

swelling persists or increases, 

discontinue use; consult veterinarian. 

Dated: July 28, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–18337 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Parts 123, 124, 126, and 129 

[Public Notice: 6716] 

Amendment to the International Traffic 

in Arms Regulations: Congressional 

Certification Regarding South Korea 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: The Department of State is 

amending the International Traffic in 

Arms Regulations (ITAR) regarding 

Congressional certification for the 

Republic of Korea (also referred to as 

South Korea). South Korea is now in the 

same category as the countries in the 

North Atlantic Treaty Organization 

(NATO), Japan, Australia, and New 

Zealand concerning certification to 

Congress, requiring such certification 

prior to granting any license for export 

of major defense equipment sold under 

a contract in the amount of $25,000,000 

or more, or for defense articles or 

defense services sold under a contract in 

the amount of $100,000,000 or more, 

provided the transfer does not include 

any other countries. The ITAR is being 

amended at numerous sections to reflect 

these statutory changes and to update 

two provisions. 

DATES: Effective Date: This rule is 

effective August 3, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Director Charles B. Shotwell, Office of 

Defense Trade Controls Policy, 

Department of State, Telephone (202) 

663–2792 or Fax (202) 261–8199; E-mail 

DDTCResponseTeam@state.gov. ATTN: 

Regulatory Change, South Korea. 

SUPPLEMENTARY INFORMATION: Section 

203 of the Public Law 110–429 

amended, inter alia, Sections 

3(d)(3)(A)(i), 36(c), and 36(d)(2)(A) of 

the Arms Export Control Act by 

inserting ‘‘Republic of Korea’’ before 

‘‘New Zealand.’’ This amendment added 

South Korea to the category of countries 

for which higher dollar thresholds apply 

for mandatory certification to Congress 

in advance of approving the export or 

transfer of defense articles and defense 

services. South Korea is now in the 

same category as the countries in the 

North Atlantic Treaty Organization 

(NATO), Japan, Australia, and New 

Zealand concerning certification to 

Congress, requiring such certification 

prior to granting any license for export 

of major defense equipment sold under 

a contract in the amount of $25,000,000 

or more, or for defense articles or 

defense services sold under a contract in 

the amount of $100,000,000 or more, 

provided the transfer does not include 

any other countries. The ITAR is being 

amended at numerous sections, as 

described below, to reflect these 

statutory changes and to update two 

provisions. 

Section 123.9(e) of the ITAR is being 

amended to add ‘‘South Korea.’’ This 

section is also being amended to correct 

outdated information regarding the 

dollar limits for sales without prior 

written approval and to add New 

Zealand to the list of countries eligible 

for certain reexports or retransfers 

without prior written approval. 

Section 123.15 of the ITAR entitled 

‘‘Congressional certification pursuant to 

Section 36(c) of the Arms Export 

Control Act’’ is being amended to add 

‘‘South Korea’’ at sections 123.15(a)(1), 

123.15(a)(2), and 123.15(b). 

Section 124.11 of the ITAR entitled 

‘‘Congressional certification pursuant to 

Section 36(d) of the Arms Export 

Control Act’’ is being amended to add 

‘‘South Korea’’ at section 124.11(b). 

Section 126.8 of the ITAR entitled 

‘‘Proposals to foreign persons relating to 

significant military equipment’’ is being 


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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Rules and Regulations 38343 

amended to add ‘‘South Korea’’ at 

section 126.8(a)(ii). 

Part 129 of the ITAR regarding 

brokering activities is being amended at 

section 129.6(b)(2) to add ‘‘South 

Korea’’ to the category of NATO, Japan, 

Australia, and New Zealand for 

purposes of an exemption from prior 

written approval. 

Sections 129.7(a)(1)(vii) and 

129.7(a)(2) are being amended to add 

‘‘South Korea’’ to the category of NATO, 

Japan, Australia, and New Zealand or 

purposes of defining brokering activities 

requiring prior written approval. 

Regulatory Analysis and Notices 

Administrative Procedure Act 

This amendment involves a foreign 

affairs function of the United States and, 

therefore, is not subject to the 

procedures contained in 5 U.S.C. 553 

and 554. 

Regulatory Flexibility Act 

Since this amendment is not subject 

to the notice-and-comment procedures 

of 5 U.S.C. 553, it does not require 

analysis under the Regulatory 

Flexibility Act. 

Unfunded Mandates Reform Act of 1995 

This amendment does not involve a 

mandate that will result in the 

expenditure by State, local, and Tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

in any year and it will not significantly 

or uniquely affect small governments. 

Therefore, no actions were deemed 

necessary under the provisions of the 

Unfunded Mandates Reform Act of 

1995. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This amendment has been found not 

to be a major rule within the meaning 

of the Small Business Regulatory 

Enforcement Fairness Act of 1996. 

Executive Orders 12372 and 13132 

This amendment will not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, in 

accordance with Executive Order 13132, 

it is determined that this amendment 

does not have sufficient federalism 

implications to require consultations or 

warrant the preparation of a federalism 

summary impact statement. The 

regulations implementing Executive 

Order 12372 regarding 

intergovernmental consultation on 

Federal programs and activities do not 

apply to this amendment. 

Executive Order 12866 

This amendment is exempt from 

review under Executive Order 12866, 

but has been reviewed internally by the 

Department of State to ensure 

consistency with the purposes thereof. 

Paperwork Reduction Act 

This rule does not impose any new 

reporting or recordkeeping requirements 

subject to the Paperwork Reduction Act, 

44 U.S.C. Chapter 35. 

List of Subjects 

22 CFR Parts 123 and 126 

Arms and munitions, Exports. 

22 CFR Parts 124 and 129 

Arms and munitions, Exports, 

Technical assistance. 

■ Accordingly, for the reasons set forth 

above, Title 22, Chapter I, Subchapter 

M, parts 123, 124, 126, and 129 are 

amended as follows: 

PART 123—LICENSES FOR THE 

EXPORT OF DEFENSE ARTICLES 

■ 1. The authority citation for part 123 

continues to read as follows: 

Authority: Secs. 2, 38, and 71, Pub. L. 90– 

629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 

2797); 22 U.S.C. 2753; E.O. 11958, 42 FR 

4311; 3 CFR, 1977 Comp. p. 79; 22 U.S.C. 

2651a; 22 U.S.C. 2776; Pub. L. 105–261, 112 

Stat. 1920; Sec. 1205(a), Pub. L. 107–228. 

■ 2. Section 123.9 is amended by 

revising paragraphs (e) introductory text 

and (e)(2) to read as follows: 

§ 123.9 Country of ultimate destination 

and approval of reexports or retransfers. 

* * * * * 

(e) Reexports or retransfers of U.S.- 

origin components incorporated into a 

foreign defense article to NATO, NATO 

agencies, a government of a NATO 

country, or the governments of 

Australia, Japan, New Zealand, or South 

Korea, are authorized without the prior 

written approval of the Directorate of 

Defense Trade Controls, provided: 

* * * * * 

(2) The U.S.-origin components are 

not significant military equipment, the 

items are not major defense equipment 

sold under contract in the amount of 

$25,000,000 ($25 million) or more; the 

articles are not defense articles or 

defense services sold under a contract in 

the amount of $100,000,000 ($100 

million) or more; and are not identified 

in part 121 of this subchapter as Missile 

Technology Control Regime (MTCR) 

items; and 

* * * * * 

■ 3. Section 123.15 is amended by 

revising paragraphs (a)(1), (a)(2), and (b) 

to read as follows: 

§ 123.15 Congressional certification 

pursuant to Section 36(c) of the Arms 

Export Control Act. 

(a) * * * 

(1) A license for the export of major 

defense equipment sold under a 

contract in the amount of $14,000,000 or 

more, or for defense articles and defense 

services sold under a contract in the 

amount of $50,000,000 or more to any 

country that is not a member country of 

the North Atlantic Treaty Organization 

(NATO), or Australia, Japan, New 

Zealand, or South Korea that does not 

authorize a new sales territory; or 

(2) A license for export to a country 

that is a member country of the North 

Atlantic Treaty Organization (NATO), or 

Australia, Japan, New Zealand, or South 

Korea of major defense equipment sold 

under a contract in the amount of 

$25,000,000 or more, or for defense 

articles and defense services sold under 

a contract in the amount of 

$100,000,000 or more and provided the 

transfer does not include any other 

countries; or 

* * * * * 

(b) Unless an emergency exists which 

requires the proposed export in the 

national security interests of the United 

States, approval may not be granted for 

any transaction until at least 15 calendar 

days have elapsed after receipt by the 

Congress of the certification required by 

22 U.S.C. 2776(c)(1) involving the North 

Atlantic Treaty Organization, any 

member country of the Organization, or 

Australia, Japan, New Zealand, or South 

Korea or at least 30 calendar days have 

elapsed for any other country; in the 

case of a license for an export of a 

commercial communications satellite 

for launch from, and by nationals of, the 

Russian Federation, Ukraine, or 

Kazakhstan, until at least 15 calendar 

days after the Congress receives such 

certification. 

* * * * * 

PART 124—AGREEMENTS, OFFSHORE PROCUREMENT AND OTHER 

DEFENSE SERVICES 

■ 4. The authority citation for part 124 

continues to read as follows: 

Authority: Secs. 2, 38, and 71, Pub. L. 90– 

629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 

2797); E.O. 11958, 42 FR 4311; 3 CFR 1977 

Comp. p. 79; 22 U.S.C. 2651a; 22 U.S.C. 2776; 

Pub. L. 105–261. 

■ 5. Section 124.11 is amended by 

revising paragraph (b) to read as follows: 


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38344 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Rules and Regulations 

§ 124.11 Congressional certification 

pursuant to Section 36(d) of the Arms 

Export Control Act. 

* * * * * 

(b) Unless an emergency exists which 

requires the immediate approval of the 

agreement in the national security 

interests of the United States, approval 

may not be granted until at least 15 

calendar days have elapsed after receipt 

by the Congress of the certification 

required by 22 U.S.C. 2776(d)(1) 

involving the North Atlantic Treaty 

Organization, any member country of 

that Organization, or Australia, Japan, 

New Zealand, or South Korea or at least 

30 calendar days have elapsed for any 

other country. Approvals may not be 

granted when the Congress has enacted 

a joint resolution prohibiting the export. 

* * * * * 

PART 126—GENERAL POLICIES AND 

PROVISIONS 

■ 6. The authority citation for part 126 

continues to read as follows: 

Authority: Secs. 2, 38, 40, 42, and 71, Pub. 

L. 90–629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 

2780, 2791, and 2797); E.O. 11958, 42 FR 

4311; 3 CFR 1977 Comp. p. 79; 22 U.S.C. 

2651a; 22 U.S.C. 287c; E.O. 12918, 59 FR 

28205, 3 CFR, 1994 Comp. p. 899. 

■ 7. Section 126.8 is amended by 

revising paragraph (a)(1)(ii) to read as 

follows: 

§ 126.8 Proposals to foreign persons 

relating to significant military equipment. 

(a) * * * 

(1) * * * 

(ii) The equipment is intended for use 

by the armed forces of any foreign 

country other than a member of the 

North Atlantic Treaty Organization, 

Australia, Japan, New Zealand, or South 

Korea; and 

* * * * * 

PART 129—REGISTRATION AND 

LICENSING OF BROKERS 

■ 8. The authority citation for part 129 

continues to read as follows: 

Authority: Sec. 38, Pub. L. 104–164, 110 

Stat. 1437, (22 U.S.C. 2778). 

■ 9. Section 129.6 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 129.6 Requirements for license/approval. 

(b) * * * 

(1) * * * 

(2) Brokering activities that are 

arranged wholly within and destined 

exclusively for the North Atlantic Treaty 

Organization, any member country of 

that Organization, Australia, Japan, New 

Zealand, or South Korea, except in the 

case of the defense articles or defense 

services specified in § 129.7(a) of this 

subchapter, for which prior approval is 

always required. 

■ 10. Section 129.7 is amended by 

revising paragraphs (a)(1)(vii) and (a)(2) 

introductory text to read as follows: 

§ 129.7 Prior approval (license). 

(a) * * * 

(1) * * * 

(vii) Foreign defense articles or 

defense services (other than those that 

are arranged wholly within and 

destined exclusively for the North 

Atlantic Treaty Organization, Australia, 

Japan, New Zealand, or South Korea 

(see §§ 129.6(b)(2) and 129.7(a)). 

(2) Brokering activities involving 

defense articles or defense services 

covered by, or of a nature described by 

Part 121, of this subchapter, in addition 

to those specified in § 129.7(a), that are 

designated as significant military 

equipment under this subchapter, for or 

from any country not a member of the 

North Atlantic Treaty Organization, 

Australia, Japan, New Zealand, or South 

Korea whenever any of the following 

factors are present: 

* * * * * 

Dated: June 19, 2009. 

Rose E. Gottemoeller, 

Assistant Secretary, Verification, Compliance 

and Implementation, Department of State. 

[FR Doc. E9–18332 Filed 7–31–09; 8:45 am] 

BILLING CODE 4710–25–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 62 

[EPA–R03–OAR–2009–0482; FRL–8938–6] 

Approval and Promulgation of State 

Air Quality Plans For Designated 

Facilities and Pollutants, West Virginia; 

Control of Emissions From 

Commercial and Industrial Solid Waste 

Incinerator Units, Plan Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to approve a revision to the West 

Virginia (WV) commercial and 

industrial solid waste incinerator 

(CISWI) 111(d)/129 plan (the ‘‘plan’’). 

The revision contains a modified WV 

Department of Environmental 

Protection, Division of Air Quality 

(DAQ) rule that streamlines and 

consolidates the state’s regulatory 

structure (WV45CSR6, 18 and 24) for 

incinerator units and incorporates 

applicable Clean Air Act (CAA), section 

129, requirements into one rule, 

WV45CSR18. This approval action 

relates only to CISWI units. The 

streamlining of the state’s regulatory 

structure of its incinerator rules is not 

an EPA requirement. 

DATES: This rule is effective October 2, 

2009 without further notice, unless EPA 

receives adverse written comment by 

September 2, 2009. If EPA receives such 

comments, it will publish a timely 

withdrawal of the direct final rule in the 

Federal Register and inform the public 

that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2009–0482 by one of the 

following methods: 

A. http://www.regulations.gov. Follow 

the on-line instructions for submitting 

comments. 

B. E-mail: E-mail: http:// 

wilkie.walter@epa.gov. 

C. Mail: EPA–R03–OAR–2009–0482, 

Walter Wilkie, Chief, Air Quality 

Analysis Branch, Mailcode 3AP22, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2009– 

0482 EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 


sroberts on DSKD5P82C1PROD with RULES