Document ID: FDA-2009-N-0665-0014
Agency: fda
Document Type: Rule
Title: Intramammary Dosage Forms:  Change of Sponsor,
Posted Date: 2009-04-27T04:00Z

[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Rules and Regulations]
[Page 18990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9527]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526

[Docket No. FDA-2009-N-0665]

Intramammary Dosage Forms; 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 an approved new 
animal drug application (NADA) from Merial Ltd. to Cross Vetpharm Group 
Ltd.

DATES: This rule is effective April 27, 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: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, has informed FDA that it has transferred 
ownership of, and all rights and interest in, NADA 065-383 for Formula 
A-34 (procaine penicillin G) mastitis infusion tube to Cross Vetpharm 
Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.
    Accordingly, the agency is amending the regulations in 21 CFR 
526.1696a 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 526

    Animal drugs.

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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 526 is 
amended as follows:

PART 526--INTRAMAMMARY DOSAGE FORMS

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1. The authority citation for 21 CFR part 526 continues to read as 
follows:

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

Sec.  526.1696a   [Amended]

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2. In paragraph (c) of Sec.  526.1696a, remove ``050604'' and add in 
its place ``061623''.

    Dated: April 17, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-9527 Filed 4-24-09; 8:45 am]
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