New Animal Drugs; Change of Sponsor, 36111-36112 [E9-17356]

Download as PDF Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Rules and Regulations industry of the business concern combined with its affiliates. * * * * * DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dated: July 16, 2009. Karen Gordon Mills, Administrator. [FR Doc. E9–17323 Filed 7–17–09; 11:15 am] 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 BILLING CODE 8025–01–P 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 36111 (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) NADA 141–178 NAVIGATOR Paste (nitazoxanide) 520.1498 (065274) ANADA 200–279 KETAFLO Injection (ketamine HCl, USP) 522.1222a (000074) IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 Abbott Laboratories, North Chicago, IL 60064 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notice that approval of NADAs 141–162 and 141–178, and ANADA 200–279, and all supplements and amendments thereto, are withdrawn, effective August 3, 2009.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: jlentini on DSKJ8SOYB1PROD with RULES ■ Authority: 21 U.S.C. 360b. § 520.1390 ■ [Removed] 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 1. The authority citation for 21 CFR part 520 continues to read as follows: Jkt 217001 [Docket No. FDA–2009–N–0665] 3. Remove § 520.1498. ■ 18:20 Jul 21, 2009 21 CFR Parts 520 and 524 [Removed] PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS VerDate Nov<24>2008 Food and Drug Administration 2. Remove § 520.1390. § 520.1498 ■ DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 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. E:\FR\FM\22JYR1.SGM 22JYR1 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 Application No. (NADA/ANADA) 007–076 008–244 049–729 200–318 21 CFR Section 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. [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’’. jlentini on DSKJ8SOYB1PROD with RULES ■ 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 VerDate Nov<24>2008 Product Name 520.2325a 520.2325a 520.2261a 524.1193 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. § 520.2261a 18:20 Jul 21, 2009 Jkt 217001 Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland: Sulfa-Nox (sulfaquinoxaline) Liquid Sulfa-Nox (sulfaquinoxaline) Concentrate PURINA Sulfa (sulfamethazine) VIRBAMEC (ivermectin) Pour-On DEPARTMENT OF STATE 22 CFR Part 41 [Public Notice: 6676] Foreign Officials: Definition of Immediate Family Members, as Amended State Department. Final rule. AGENCY: ACTION: 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 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 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. E:\FR\FM\22JYR1.SGM 22JYR1

Agencies

[Federal Register Volume 74, Number 139 (Wednesday, July 22, 2009)]
[Rules and Regulations]
[Pages 36111-36112]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17356]


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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, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft.

[[Page 36112]]

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.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.2261a  [Amended]

0
2. In paragraph (a) of Sec.  520.2261a, remove ``051311 and 053501'' 
and in its place add ``053501 and 061623''.


Sec.  520.2325a  [Amended]

0
3. In paragraph (a)(2) of Sec.  520.2325a, remove ``051311'' and in its 
place add ``061623''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
4. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec.  524.1193  [Amended]

0
5. In paragraph (b) of Sec.  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

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