[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Rules and Regulations]
[Page 24958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin Liquid

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 Veterinary Laboratories, Inc. The ANADA 
provides for oral use of ivermectin solution in horses for the 
treatment and control of various species of internal and cutaneous 
parasites.

DATES: This rule is effective May 5, 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: Veterinary Laboratories, Inc., 12340 Santa 
Fe Dr., Lenexa, KS 66215, filed ANADA 200-341 that provides for oral 
use of SPARMECTIN-E (ivermectin) Liquid for Horses for the treatment 
and control of various species of internal and cutaneous parasites. 
Veterinary Laboratories' SPARMECTIN-E Liquid for Horses is approved as 
a generic copy of Merial Ltd.'s EQVALAN (ivermectin) Oral Liquid for 
Horses, approved under NADA 140-439. The ANADA is approved as of March 
8, 2004, and the regulations are amended in 21 CFR 520.1195 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 Subject 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

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

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


Sec.  520.1195   [Amended]

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2. Section 520.1195 is amended in paragraph (b)(1) by adding ``000857'' 
in numerical sequence.

    Dated: April 23, 2004.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-10193 Filed 5-4-04; 8:45 am]
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