Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for diclofenac sodium cream and ivermectin otic suspension from IDEXX Pharmaceuticals, Inc., to Boehringer Ingelheim Vetmedica, Inc.
This rule is effective June 4, 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
IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-186 for SURPASS (diclofenac sodium) topical cream and NADA 141-174 for ACAREXX (ivermectin) otic suspension to Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002. Accordingly, the regulations are amended in 21 CFR 524.590 and 524.1195 to reflect the change of sponsorship.
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 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
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSStart Amendment Part
1. The authority citation forEnd Amendment Part
2. In paragraph (b) of § 524.590, remove “065274” and in its place add “000010”.End Amendment Part
3. In paragraph (b) of § 524.1195, remove “065274” and in its place add “000010”.End Amendment Part Start Signature
Dated: May 27, 2009.
Director, Center for Veterinary Medicine.
[FR Doc. E9-13015 Filed 6-3-09; 8:45 am]
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