Document ID: FDA-2011-N-0003-0056
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs: Ivermectin Topical Solution
Posted Date: 2011-12-29T05:00Z

[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Rules and Regulations]
[Pages 81806-81807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33382]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2011-N-0003]

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 Cross Vetpharm Group, Ltd. The 
supplemental ANADA adds claims for persistent effectiveness against 
various species of external and internal parasites when cattle are 
treated with a topical solution of ivermectin.

DATES: This rule is effective December 29, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8197, email: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group, Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed a supplement to ANADA 200-318 for

[[Page 81807]]

BIMECTIN (ivermectin) Pour-On, a topical solution used on cattle to 
control infestations of certain species of external and internal 
parasites. The supplemental ANADA adds claims for persistent 
effectiveness against various species of external and internal 
parasites that were approved for the pioneer product with 3 years of 
marketing exclusivity (69 FR 501, January 6, 2004). The supplemental 
ANADA is approved as of September 21, 2011, and 21 CFR 524.1193 is 
amended to reflect the approval.
    Approval of this supplemental ANADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The Agency has determined under 21 CFR 25.33 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.

    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

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.1193  [Amended]

0
2. In Sec.  524.1193, in paragraph (b)(1), in numerical sequence add 
``, and 061623''; and in paragraph (b)(2), remove ``061623,''.

    Dated: December 22, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-33382 Filed 12-28-11; 8:45 am]
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