Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new Start Printed Page 34534animal drug applications (NADAs) from Anthony Products Co. to Cross Vetpharm Group Ltd.
This rule is effective June 10, 2003.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, 301-827-6967; e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Anthony Products Co., 5600 Peck Rd., Arcadia, CA 91006, has informed FDA that it has transferred ownership of, and all rights and interest in, the following two approved NADAs to Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
|NADA Number||Trade Name|
|065-505||MICROCILLIN Injectable Suspension|
|065-506||COMBICILLIN Injectable Suspension|
Accordingly, the agency is amending the regulations in 21 CFR 522.1696a and 522.1696b 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 522End 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 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Section 522.1696aEnd Amendment Part
3. Section 522.1696bEnd Amendment Part Start Signature
Dated: May 19, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-14547 Filed 6-9-03; 8:45 am]
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