Document ID: FDA-2009-N-0665-0006
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin - Final Rule
Posted Date: 2009-03-02T05:00Z

[Federal Register: March 2, 2009 (Volume 74, Number 39)]
[Rules and Regulations]               
[Page 9049]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02mr09-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin

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 abbreviated new 
animal drug application (ANADA) filed by IVX Animal Health, Inc. The 
supplemental ANADA adds claims for persistent effectiveness against 
various species of external and internal parasites when cattle are 
treated with a 1-percent ivermectin solution by subcutaneous injection.

DATES:  This rule is effective March 2, 2009.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-228 
that provides for use of PHOENECTIN (ivermectin) Injection 1% for the 
treatment and control of parasites in cattle. The supplemental ANADA 
adds claims for persistent effectiveness against various species of 
external and internal parasites of cattle. The supplemental ANADA is 
approved as of January 23, 2009, and the regulations are amended in 21 
CFR 522.1192 to reflect the approval.
    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.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type 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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec.  522.1192  [Amended]

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2. In Sec.  522.1192, in paragraph (b)(2), remove ``No. 055529'' and in 
its place add ``Nos. 055529 and 059130''; and remove paragraph (b)(3).

    Dated: February 18, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-4304 Filed 2-27-09; 8:45 am]

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