Document ID: FDA-2009-N-0665-0041
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor
Posted Date: 2009-07-22T04:00Z

[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Rules and Regulations]               
[Page 36111-36112]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy09-5]                         

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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.

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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]

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