Food and Drug Administration, HHS.
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.
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: email@example.com.End Further Info End Preamble Start Supplemental 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 526End 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 FORMSEnd Part Start Amendment Part
1. The authority citation forEnd 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.
Director, Center for Veterinary Medicine.
[FR Doc. E9-9527 Filed 4-24-09; 8:45 am]
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