Skip to Content

Rule

Intramammary Dosage Forms; Change of Sponsor

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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

DATES:

This rule is effective April 27, 2009.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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.

Start List of Subjects

List of Subjects in 21 CFR Part 526

End List of Subjects Start Amendment Part

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,

End Amendment Part Start Part

PART 526—INTRAMAMMARY DOSAGE FORMS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

2. In paragraph (c) of § 526.1696a, remove “050604” and add in its place “061623”.

End Amendment Part Start Signature

Dated: April 17, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. E9-9527 Filed 4-24-09; 8:45 am]

BILLING CODE 4160-01-S