36112 Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Rules and Regulations 

Worth, TX 76137, has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, the following 

three approved NADAs and one 

approved ANADA to Cross Vetpharm 

Group Ltd., Broomhill Rd., Tallaght, 

Dublin 24, Ireland: 

Application No. (NADA/ANADA) 21 CFR Section Product Name 

007–076 520.2325a Sulfa-Nox (sulfaquinoxaline) Liquid 

008–244 520.2325a Sulfa-Nox (sulfaquinoxaline) Concentrate 

049–729 520.2261a PURINA Sulfa (sulfamethazine) 

200–318 524.1193 VIRBAMEC (ivermectin) Pour-On 

Accordingly, the agency is amending 

the regulations in 21 CFR 520.2261a, 

520.2325a, and 524.1193 to reflect the 

transfer of ownership. 

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 Parts 520 and 

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 520 and 524 are 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. 

§ 520.2261a [Amended] 

■ 2. In paragraph (a) of § 520.2261a, 

remove ‘‘051311 and 053501’’ and in its 

place add ‘‘053501 and 061623’’. 

§ 520.2325a [Amended] 

■ 3. In paragraph (a)(2) of § 520.2325a, 

remove ‘‘051311’’ and in its place add 

‘‘061623’’. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 4. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

§ 524.1193 [Amended] 

■ 5. In paragraph (b) of § 524.1193 

remove ‘‘051311’’ and in numerical 

sequence add ‘‘061623’’. 

Dated: July 14, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–17356 Filed 7–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Part 41 

[Public Notice: 6676] 

Foreign Officials: Definition of 

Immediate Family Members, as 

Amended 

AGENCY: State Department. 

ACTION: Final rule. 

SUMMARY: As authorized the 

Immigration and Nationality Act this 

rule amends the definition of 

‘‘immediate family’’ for the Foreign 

Government Official nonimmigrant visa 

category. 

DATES: Effective Date: This rule is 

effective July 22, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Lauren A. Prosnik, Legislation and 

Regulations Division, Visa Services, 

Department of State, 2401 E Street, NW., 

Room L–603D, Washington, DC 20520– 

0106, (202) 663–1202, e-mail 

(ProsnikLA@state.gov). 

SUPPLEMENTARY INFORMATION: 

Why is the Department promulgating 

this rule? 

The Secretary of State has the 

authority and responsibility for the 

execution of the foreign policy of the 

United States. In the exercise of this 

authority and responsibility, this rule 

amends the definition of ‘‘immediate 

family’’ for the Foreign Government 

Official category of nonimmigrants as 

authorized by section 101(a)(15)(A) of 

the Immigration and Nationality Act [8 

U.S.C 1101]. The term ‘‘immediate 

family’’ previously required that 

immediate family members other than 

the spouse and unmarried sons and 

daughters be related to the principal or 

spouse by blood, marriage or adoption. 

The definition now includes, upon 

authorization from the Department on a 

case by case basis, any other alien who 

is not a member of some other 

household; will reside regularly in the 

household of the principal alien; and is 

recognized as a family member of the 

principal alien by the sending 

Government as demonstrated by 

eligibility for rights and benefits from 

that Government, such as the issuance 

of a diplomatic or official passport or 

travel or other allowances. This will 

allow the Department greater flexibility 

in responding to requests by foreign 

governments to issue a diplomatic visa 

to a person who regularly resides with 

and is a member of the household of a 

qualified principal alien and is 

considered by the principal alien and 

the sending Government to be a member 

of the immediate family of the principal 

alien. 

Regulatory Findings 

Administrative Procedure Act 

This regulation involves a foreign 

affairs function of the United States and, 

therefore, in accordance with 5 U.S.C. 

553(a)(1), is not subject to the rule 

making procedures set forth at 5 U.S.C. 

553. 

Regulatory Flexibility Act/Executive 

Order 13272: Small Business 

Because this final rule is exempt from 

notice and comment rulemaking under 

5 U.S.C. 553, it is exempt from the 

regulatory flexibility analysis 

requirements set forth at sections 603 

and 604 of the Regulatory Flexibility 

Act (5 U.S.C. 603 and 604). Nonetheless, 

consistent with section 605(b) of the 

Regulatory Flexibility Act (5 U.S.C. 

605(b)), the Department certifies that 

this rule will not have a significant 

economic impact on a substantial 

number of small entities. This 

regulation does not affect any small 

entities, as defined in 5 U.S.C. 601(6). 

The Unfunded Mandates Reform Act of 

1995 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UFMA), 

Public Law 104–4, 109 Stat. 48, 2 U.S.C. 

1532, generally requires agencies to 

prepare a statement before proposing 

any rule that may result in an annual 

expenditure of $100 million or more by 

State, local, or tribal governments, or by 

the private sector. This rule will not 

result in any such expenditure, nor will 

it significantly or uniquely affect small 

governments. 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Rules and Regulations 36113 

The Small Business Regulatory 

Enforcement Fairness Act of 1996 

This rule is not a major rule as 

defined by 5 U.S.C. 804, for purposes of 

congressional review of agency 

rulemaking under the Small Business 

Regulatory Enforcement Fairness Act of 

1996, Public Law 104–121. This rule 

will not result in an annual effect on the 

economy of $100 million or more; a 

major increase in costs or prices; or 

adverse effects on competition, 

employment, investment, productivity, 

innovation, or the ability of United 

States-based companies to compete with 

foreign based companies in domestic 

and import markets. 

Executive Order 12866 

The Department of State has reviewed 

this regulation to ensure its consistency 

with the regulatory philosophy and 

principles set forth in Executive Order 

12866 and has determined that the 

benefits of the regulation justify its 

costs. The Department does not consider 

the regulation to be an economically 

significant action within the scope of 

section 3(f)(1) of the Executive Order 

since it is not likely to have an annual 

effect on the economy of $100 million 

or more or to adversely affect in a 

material way the economy, a sector of 

the economy, competition, jobs, the 

environment, public health or safety, or 

state, local or tribal governments or 

communities. 

Executive Orders 12372 and 13132: 

Federalism 

This regulation will not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. Nor will the rule 

have federalism implications warranting 

the application of Executive Orders No. 

12372 and No. 13132. 

Executive Order 12988: Civil Justice 

Reform 

The Department has reviewed the 

legislation in light of sections 3(a) and 

3(b)(2) of Executive Order No. 12988 to 

eliminate ambiguity, minimize 

litigation, establish clear legal 

standards, and reduce burden. 

Paperwork Reduction Act 

This rule does not impose information 

collection requirements under the 

provisions of the Paperwork Reduction 

Act, 44 U.S.C., Chapter 35. 

List of Subjects in 22 CFR Part 41 

Aliens, Foreign officials, Immigration, 

Nonimmigrants, Passports and visas. 

■ For the reasons set forth in the 

preamble, the Department of State 

amends 22 CFR part 41 as follows: 

PART 41—[AMENDED] 

■ 1. Revise paragraph (a)(3) of § 41.21 is 

to read as follows: 

§ 41.21 Foreign Officials—General. 

(a) * * * 

(3) Immediate family, as used in INA 

101(a)(15)(A), 101(a)(15)(G), and 

212(d)(8), and in classification under 

the NATO–1 through NATO–5 visa 

symbols, means the spouse and 

unmarried sons and daughters, whether 

by blood or adoption, who are not 

members of some other household, and 

who will reside regularly in the 

household of the principal alien. Under 

the INA 101(a)(15)(A) and 101(a)(15)(G) 

visa classifications, ‘‘immediate family’’ 

also includes individuals who: 

(i) Are not members of some other 

household; 

(ii) Will reside regularly in the 

household of the principal alien; 

(iii) Are recognized as immediate 

family members of the principal alien 

by the sending Government as 

demonstrated by eligibility for rights 

and benefits, such as the issuance of a 

diplomatic or official passport, or travel 

or other allowances; and 

(iv) Are individually authorized by 

the Department. 

* * * * * 

Dated: July 14, 2009. 

Michael D. Kirby, 

Acting Assistant Secretary for Consular 

Affairs, Department of State. 

[FR Doc. E9–17262 Filed 7–21–09; 8:45 am] 

BILLING CODE 4710–06–P 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 948 

[WV–115–FOR; OSM–2009–0006] 

West Virginia Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement (OSM), 

Interior. 

ACTION: Interim rule with request for 

comments. 

SUMMARY: We are approving, on an 

interim basis, an amendment to the 

West Virginia regulatory program (the 

West Virginia program) under the 

Surface Mining Control and 

Reclamation Act of 1977 (SMCRA or the 

Act). West Virginia revised its Surface 

Coal Mining and Reclamation Act to 

effect changes concerning its alternative 

bonding system. The tax provisions of 

the amendment are intended to increase 

and extend the special reclamation tax, 

subject to biennial review by the 

legislature, and remove the additional 

tax. We are approving the increase and 

extension of the special reclamation tax, 

at the rate of fourteen and four-tenths 

cents per ton of clean coal mined, for 

deposit in the Special Reclamation 

Fund and the Special Reclamation 

Water Trust Fund, on an interim basis, 

with our approval becoming effective 

upon publication of this interim rule. 

DATES: Effective Date: This rule is 

effective July 22, 2009. Comment Date: 

We will accept written comments until 

4 p.m., local time August 21, 2009. If 

requested, we will hold a public hearing 

on August 17, 2009. We will accept 

requests to speak until 4 p.m., local time 

on August 6, 2009. 

ADDRESSES: You may submit written 

comments by any of the following two 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. The proposed rule 

has been assigned Docket ID: OSM– 

2009–0006. If you would like to submit 

comments through the Federal 

eRulemaking Portal, go to http:// 

www.regulations.gov and do the 

following. Click on the ‘‘Advanced 

Docket Search’’ button on the right side 

of the screen. Type in the Docket ID 

OSM–2009–0006 and click the 

‘‘Submit’’ button at the bottom of the 

page. The next screen will display the 

Docket Search Results for the 

rulemaking. If you click on OSM–2009– 

0006, you can view the proposed rule 

and submit a comment. You can also 

view supporting material and any 

comments submitted by others. 

• Mail/Hand Delivery: Mr. Roger W. 

Calhoun, Director, Charleston Field 

Office, Office of Surface Mining 

Reclamation and Enforcement, 1027 

Virginia Street, East, Charleston, West 

Virginia 25301. Please include the rule 

identifier (WV–115–FOR) with your 

written comments. 

Instructions: All submissions received 

must include the agency Docket ID 

(OSM–2009–0006) for this rulemaking. 

For detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see ‘‘IV. 

Public Comment Procedures’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document. You may also request to 

speak at a public hearing by any of the 

methods listed above or by contacting 

the individual listed under FOR FURTHER

INFORMATION CONTACT. 


jlentini on DSKJ8SOYB1PROD with RULES