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Rule

Oral Dosage Form New Animal Drugs; Clomipramine Tablets

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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 approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA adds a 5-milligram tablet size of clomipramine hydrochloride, used in dogs for treatment of separation anxiety.

DATES:

This rule is effective January 4, 2007.

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FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: melanie.berson@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to NADA 141-120 that provides for the veterinary prescription use of CLOMICALM (clomipramine hydrochloride) Tablets for treatment of separation anxiety in dogs. The supplement provides for a 5-milligram tablet size of clomipramine hydrochloride. The supplemental NADA is approved as of November 22, 2006, and 21 CFR 520.455 is amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type Start Printed Page 262that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 520

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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 520—ORAL 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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2. In § 520.455, revise the section heading and paragraph (a) to read as follows:

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Clomipramine tablets.

(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.

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Dated: December 19, 2006.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. E6-22509 Filed 1-3-07; 8:45 am]

BILLING CODE 4160-01-S