Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.
This rule is effective July 22, 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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Start Printed Page 36112Worth, TX 76137, has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs and one approved ANADA to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
|Application No. (NADA/ANADA)||21 CFR Section||Product Name|
|007-076||520.2325a||Sulfa-Nox (sulfaquinoxaline) Liquid|
|008-244||520.2325a||Sulfa-Nox (sulfaquinoxaline) Concentrate|
|049-729||520.2261a||PURINA Sulfa (sulfamethazine)|
|200-318||524.1193||VIRBAMEC (ivermectin) Pour-On|
Accordingly, the agency is amending the regulations in 21 CFR 520.2261a, 520.2325a, and 524.1193 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 Parts 520 and 524End 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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In paragraph (a) of § 520.2261a, remove “051311 and 053501” and in its place add “053501 and 061623”.End Amendment Part
3. In paragraph (a)(2) of § 520.2325a, remove “051311” and in its place add “061623”.End Amendment Part Start Part
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
4. The authority citation forEnd Amendment Part
5. In paragraph (b) of § 524.1193 remove “051311” and in numerical sequence add “061623”.End Amendment Part Start Signature
Dated: July 14, 2009.
Director, Center for Veterinary Medicine.
[FR Doc. E9-17356 Filed 7-21-09; 8:45 am]
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