[Federal Register Volume 69, Number 205 (Monday, October 25, 2004)]
[Rules and Regulations]
[Page 62181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin 
Topical Solution

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 an abbreviated new animal drug 
application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA 
provides for topical use of ivermectin on cattle for treatment and 
control of various species of external and internal parasites.

DATES: This rule is effective October 25, 2004.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed ANADA 200-272 for NOROMECTIN 
(ivermectin) Pour On for Cattle. The application provides for topical 
use of 0.5 percent ivermectin solution on cattle for the treatment and 
control of various species of gastrointestinal nematodes, lungworms, 
grubs, horn flies, lice, and mites. Norbrook Laboratories, Ltd.'s 
NOROMECTIN Pour-On for Cattle is approved as a generic copy of Merial 
Ltd.'s IVOMEC Pour-On for Cattle, approved under NADA 140-841. The 
application is approved as of September 13, 2004, and the regulations 
are amended in 21 CFR 524.1193 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.
    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 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec.  524.1193  [Amended]

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2. Section 524.1193 is amended in paragraph (b)(2) by adding in 
numerical order ``055529''.

    Dated: October 8, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-23760 Filed 10-22-04; 8:45 am]
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