76864 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 

(c) Conditions of use in dogs—(1) 

Amount. Administer 0.1 mg per 

kilogram of body weight once daily 

using the metered dose pump. 

(2) Indications for use. For the control 

of pain and inflammation associated 

with osteoarthritis in dogs. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 7. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.342 [Amended] 

■ 8. In § 558.342, in the table, in 

paragraph (e)(1)(xi), in the 

‘‘Limitations’’ column, revise the last 

sentence to read ‘‘Monensin provided 

by No. 000986 and tylosin provided by 

Nos. 000986 and 016592 in § 510.600(c) 

of this chapter.’’; and in the ‘‘Sponsor’’ 

column, add ‘‘016592’’. 

Dated: December 26, 2012. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2012–31397 Filed 12–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF STATE 

22 CFR Parts 120 and 126 

[Public Notice 8135] 

RIN 1400–AD26 

Amendment to the International Traffic 

in Arms Regulations: Afghanistan and 

Change to Policy on Prohibited 

Exports 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: The Department of State is 

amending the International Traffic in 

Arms Regulations (ITAR) to list 

Afghanistan as a major non-NATO ally, 

and to make available the use of two 

additional defense export license 

exemptions for proscribed destinations. 

DATES: Effective Date: This rule is 

effective December 31, 2012. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Candace M. J. Goforth, Director, Office 

of Defense Trade Controls Policy, U.S. 

Department of State, telephone (202) 

663–2792, or email 

DDTCResponseTeam@state.gov. ATTN: 

Regulatory Change, Afghanistan and 

126.1. 

SUPPLEMENTARY INFORMATION: On July 6, 

2012, President Obama exercised his 

authority under section 517 of the 

Foreign Assistance Act of 1961 (FAA) to 

designate the Islamic Republic of 

Afghanistan as a major non-NATO ally 

(MNNA) for purposes of the FAA and 

the Arms Export Control Act. This final 

rule amends ITAR § 120.32, which lists 

major non-NATO allies, to account for 

this designation. Section 126.1 is 

amended to except the exemptions at 

ITAR §§ 126.4 and 126.6 from the 

prohibitions therein and the text is 

further amended to clarify the 

requirements therein. Additionally, 

§ 126.1(g) is amended to clarify 

references to United Nations Security 

Council resolutions. 

Regulatory Analysis and Notices 

Administrative Procedure Act 

The Department of State is of the 

opinion that controlling the import and 

export of defense articles and services is 

a foreign affairs function of the United 

States Government and that rules 

implementing this function are exempt 

from sections 553 (rulemaking) and 554 

(adjudications) of the Administrative 

Procedure Act. Since the Department is 

of the opinion that this rule is exempt 

from 5 U.S.C. 553, it is the view of the 

Department that the provisions of 

section 553(d) do not apply to this 

rulemaking. Therefore, this rule is 

effective upon publication. The 

Department also finds that, given the 

national security issues surrounding 

U.S. policy towards Afghanistan, notice 

and public procedure on this rule would 

be impracticable, unnecessary, or 

contrary to the public interest; for the 

same reason, the rule will be effective 

immediately. 

Regulatory Flexibility Act 

Since the Department is of the 

opinion that this rule is exempt from the 

rulemaking provisions of 5 U.S.C. 553, 

it does not require analysis under the 

Regulatory Flexibility Act. 

Unfunded Mandates Act of 1995 

This rulemaking 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 rulemaking 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 rulemaking 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 rulemaking 

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 rulemaking. 

Executive Orders 12866 and 13563 

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, distributed impacts, and equity). 

These Executive Orders stress the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. This rule has been 

designated ‘‘significant regulatory 

actions,’’ although not economically 

significant, under section 3(f) of 

Executive Order 12866. Accordingly, 

this rule has been reviewed by the 

Office of Management and Budget 

(OMB). 

Executive Order 12988 

The Department of State has reviewed 

this rulemaking in light of sections 3(a) 

and 3(b)(2) of Executive Order 12988 to 

eliminate ambiguity, minimize 

litigation, establish clear legal 

standards, and reduce burden. 

Executive Order 13175 

The Department of State has 

determined that this rulemaking will 

not have tribal implications, will not 

impose substantial direct compliance 

costs on Indian tribal governments, and 

will not pre-empt tribal law. 

Accordingly, the requirement of 

Executive Order 13175 does not apply 

to this rulemaking. 

Paperwork Reduction Act 

This rule does not impose any new 

reporting or recordkeeping requirements 


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Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 76865 

subject to the Paperwork Reduction Act, 

44 U.S.C. Chapter 35. 

List of Subjects in 22 CFR Parts 120 and 

126 

Arms and munitions, Exports. 

Accordingly, for the reasons set forth 

above, Title 22, Chapter I, Subchapter 

M, parts 120 and 126 are amended as 

follows: 

PART 120—PURPOSE AND 

DEFINITIONS 

■ 1. The authority citation for part 120 

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. 2794; E.O. 11958, 42 FR 

4311; E.O. 13284, 68 FR 4075; 3 CFR, 1977 

Comp. p. 79; 22 U.S.C. 2651a; Pub. L. 105– 

261, 112 Stat. 1920; Pub. L. 111–266. 

■ 2. Section 120.32 is revised to read as 

follows: 

§ 120.32 Major non-NATO ally. 

Major non-NATO ally, as defined in 

section 644(q) of the Foreign Assistance 

Act of 1961 (22 U.S.C. 2403(q)), means 

a country that is designated in 

accordance with section 517 of the 

Foreign Assistance Act of 1961 (22 

U.S.C. 2321(k)) as a major non-NATO 

ally for purposes of the Foreign 

Assistance Act of 1961 and the Arms 

Export Control Act (22 U.S.C. 2151 et 

seq. and 22 U.S.C. 2751 et seq.). The 

following countries are designated as 

major non-NATO allies: Afghanistan 

(see § 126.1(g) of this subchapter), 

Argentina, Australia, Bahrain, Egypt, 

Israel, Japan, Jordan, Kuwait, Morocco, 

New Zealand, Pakistan, the Philippines, 

Thailand, and Republic of Korea. 

Taiwan shall be treated as though it 

were designated a major non-NATO 

ally. 

PART 126—GENERAL POLICIES AND 

PROVISIONS 

■ 3. 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; Sec. 1225, 

Pub. L. 108–375; Sec. 7089, Pub. L. 111–117; 

Pub. L. 111–266; Section 7045, Pub. L. 112– 

74; Section 7046, Pub. L. 112–74. 

■ 4. Section 126.1 is amended by 

revising paragraphs (a) and (g) to read as 

follows: 

§ 126.1 Prohibited exports, imports, and 

sales to or from certain countries. 

(a) General. It is the policy of the 

United States to deny licenses and other 

approvals for exports and imports of 

defense articles and defense services 

destined for or originating in certain 

countries. This policy applies to 

Belarus, Cuba, Eritrea, Iran, North 

Korea, Syria, and Venezuela. This 

policy also applies to countries with 

respect to which the United States 

maintains an arms embargo (e.g., Burma, 

China, and the Republic of the Sudan) 

or whenever an export would not 

otherwise be in furtherance of world 

peace and the security and foreign 

policy of the United States. Information 

regarding certain other embargoes 

appears elsewhere in this section. 

Comprehensive arms embargoes are 

normally the subject of a State 

Department notice published in the 

Federal Register. The exemptions 

provided in this subchapter, except 

§§ 123.17, 126.4, and 126.6 of this 

subchapter or when the recipient is a 

U.S. Government department or agency, 

do not apply with respect to defense 

articles or defense services originating 

in or for export to any proscribed 

countries, areas, or persons identified in 

this section. 

* * * * * 

(g) Afghanistan. It is the policy of the 

United States to deny licenses or other 

approvals for exports and imports of 

defense articles and defense services, 

destined for or originating in 

Afghanistan, except that a license or 

other approval may be issued, on a caseby-case basis, for the Government of 

Afghanistan or coalition forces. In 

addition, the names of individuals, 

groups, undertakings, and entities 

subject to arms embargoes, due to their 

affiliation with the Taliban, Al-Qaida, or 

those associated with them, are 

published in lists maintained by the 

United Nations Security Council’s 

Sanctions Committees (established 

pursuant to United Nations Security 

Council resolutions (UNSCR) 1267, 

1988, and 1989). 

* * * * * 

Dated: December 18, 2012. 

Rose E. Gottemoeller, 

Acting Under Secretary, Arms Control and 

International Security, Department of State. 

[FR Doc. 2012–31217 Filed 12–28–12; 8:45 am] 

BILLING CODE 4710–25–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AO58 

Copayments for Medications in 2013 

AGENCY: Department of Veterans Affairs. 

ACTION: Interim final rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) amends its medical 

regulations concerning the copayment 

required for certain medications. But for 

this rulemaking, beginning on January 1, 

2013, the copayment amount would 

increase based on a formula set forth in 

regulation. The maximum annual 

copayment amount payable by veterans 

would also increase. For 2012, VA 

‘‘froze’’ the copayment amount for 

veterans in VA’s health care system 

enrollment priority categories 2 through 

6, but allowed copayments to increase 

based on the regulatory formula for 

veterans in priority categories 7 and 8. 

However, that formula did not trigger an 

increase in the copayment amount for 

veterans in priority categories 7 and 8. 

This rulemaking freezes copayments at 

the current rate for veterans in priority 

categories 2 through 8 for 2013, and 

thereafter resumes increasing 

copayments in accordance with the 

regulatory formula. 

DATES: Effective Date: This rule is 

effective on December 31, 2012. 

Comments must be received on or 

before March 1, 2013. 

ADDRESSES: Written comments may be 

submitted by email through http:// 

www.regulations.gov; by mail or handdelivery to Director, Regulation Policy 

and Management (02REG), Department 

of Veterans Affairs, 810 Vermont 

Avenue NW., Room 1068, Washington, 

DC 20420; or by fax to (202) 273–9026. 

(This is not a toll-free number.) 

Comments should indicate that they are 

submitted in response to ‘‘RIN 2900– 

AO58, Copayments for Medications in 

2013.’’ Copies of comments received 

will be available for public inspection in 

the Office of Regulation Policy and 

Management, Room 1063B, between the 

hours of 8:00 a.m. and 4:30 p.m. 

Monday through Friday (except 

holidays). Please call (202) 461–4902 for 

an appointment. (This is not a toll-free 

number.) In addition, during the 

comment period, comments may be 

viewed online through the Federal 

Docket Management System (FDMS) at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Kristin Cunningham, Director, Business 

Policy, Chief Business Office, 810 

Vermont Avenue NW., Washington, DC 

20420, (202) 461–1599. (This is not a 

toll-free number.) 

SUPPLEMENTARY INFORMATION: Under 38 

U.S.C. 1722A(a), VA must require 

veterans to pay a $2 copayment for each 

30-day supply of medication furnished 

on an outpatient basis for the treatment 

of a non-service-connected disability or 


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