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Ophthalmic and Topical Dosage Form New Animal Drugs; Change of Sponsor; Diclofenac; Ivermectin Otic Suspension

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Information about this document as published in the Federal Register.

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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 diclofenac sodium cream and ivermectin otic suspension from IDEXX Pharmaceuticals, Inc., to Boehringer Ingelheim Vetmedica, Inc.

DATES:

This rule is effective June 4, 2009.

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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.

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SUPPLEMENTARY 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.

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List of Subjects in 21 CFR Part 524

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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,

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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

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[Amended]
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2. In paragraph (b) of § 524.590, remove “065274” and in its place add “000010”.

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[Amended]
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3. In paragraph (b) of § 524.1195, remove “065274” and in its place add “000010”.

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Dated: May 27, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. E9-13015 Filed 6-3-09; 8:45 am]

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