Document ID: FDA-2011-N-0003-0021
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Change of Sponsor
Posted Date: 2011-07-08T04:00Z

[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Rules and Regulations]
[Page 40229]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17151]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form 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 a new animal drug 
application (NADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.

DATES: This rule is effective July 8, 2011.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, has informed FDA that it has transferred ownership of, 
and all rights and interest in, NADA 092-150 for Purina Horse & Colt 
Wormer (pyrantel tartrate) to Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland. Accordingly, the regulations are amended 
in 21 CFR 520.2045 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 Part 520

    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 part 520 is 
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.  520.2045  [Amended]

0
2. In paragraph (b)(2) of Sec.  520.2045, remove ``051311'' and in its 
place add ``061623''.

    Dated: July 1, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2011-17151 Filed 7-7-11; 8:45 am]
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