Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Rules and Regulations 36111 

industry of the business concern 

combined with its affiliates. 

* * * * * 

Dated: July 16, 2009. 

Karen Gordon Mills, 

Administrator. 

[FR Doc. E9–17323 Filed 7–17–09; 11:15 am] 

BILLING CODE 8025–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520 and 522 

[Docket No. FDA–2009–N–0270] 

Animal Drugs, Feeds, and Related 

Products; Withdrawal of Approval of 

New Animal Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations by removing 

those portions that reflect approval of 

two new animal drug applications 

(NADAs) and an abbreviated new 

animal drug application (ANADA). In a 

notice published elsewhere in this issue 

of the Federal Register, FDA is 

withdrawing approval of these NADAs 

and ANADA. 

DATES: This rule is effective August 3, 

2009. 

FOR FURTHER INFORMATION CONTACT: John 

Bartkowiak, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9079, email: john.bartkowiak@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following sponsors have requested that 

FDA withdraw approval of the two 

NADAs and ANADA listed in table 1 of 

this document because the products are 

no longer manufactured or marketed: 

TABLE 1. 

Sponsor NADA/ANADA Number 

Product (Drug) 

21 CFR Cite Affected 

(Sponsor Drug Labeler Code) 

Wellmark International, 1501 East Woodfield 

Rd., suite 200, West Schaumburg, IL 60173 

NADA 141–162 

Zodiac Fleatrol Flea Caps (S-methoprene) 

520.1390 (011536) 

IDEXX Pharmaceuticals, Inc., 7009 Albert 

Pick Rd., Greensboro, NC 27409 

NADA 141–178 

NAVIGATOR Paste (nitazoxanide) 

520.1498 (065274) 

Abbott Laboratories, North Chicago, IL 60064 ANADA 200–279 

KETAFLO Injection (ketamine HCl, USP) 

522.1222a (000074) 

In a notice published elsewhere in 

this issue of the Federal Register, FDA 

gave notice that approval of NADAs 

141–162 and 141–178, and ANADA 

200–279, and all supplements and 

amendments thereto, are withdrawn, 

effective August 3, 2009. As provided in 

the regulatory text of this document, the 

animal drug regulations are amended to 

reflect the withdrawal of approval. 

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 

522 

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 522 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. 

§ 520.1390 [Removed] 

■ 2. Remove § 520.1390. 

§ 520.1498 [Removed] 

■ 3. Remove § 520.1498. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 4. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

§ 522.1222a [Amended] 

■ 5. In paragraph (b) of § 522.1222a, 

remove ‘‘000074,’’. 

Dated: July 14, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–17409 Filed 7–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520 and 524 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Change of Sponsor 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for three new animal 

drug applications (NADAs) and one 

abbreviated new animal drug 

application (ANADA) from Virbac AH, 

Inc., to Cross Vetpharm Group Ltd. 

DATES: This rule is effective July 22, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Virbac 

AH, Inc., 3200 Meacham Blvd., Ft. 


jlentini on DSKJ8SOYB1PROD with RULES
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. 


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