[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Pages 261-262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Clomipramine Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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.

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: 
[email protected].

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

[[Page 262]]

that 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.

List of Subjects in 21 CFR Part 520

    Animal drugs.

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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, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

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2. In Sec.  520.455, revise the section heading and paragraph (a) to 
read as follows:


Sec.  520.455  Clomipramine tablets.

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

    Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-22509 Filed 1-3-07; 8:45 am]
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