[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Rules and Regulations]
[Page 40010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11073]


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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 Paste

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 Med-Pharmex, Inc. The ANADA provides for 
oral use of ivermectin paste in horses for treatment and control of 
various internal parasites or parasitic conditions.

DATES:  This rule is effective July 14, 2006.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, filed ANADA 200-390 for oral use of Ivermectin 
Paste 1.87% in horses for the treatment and control of various species 
of internal parasites or parasitic conditions. Med-Pharmex's Ivermectin 
Paste 1.87% is approved as a generic copy of Merial Ltd.'s EQVALAN 
Paste, approved under NADA 134-314. ANADA 200-390 is approved as of 
June 20, 2006, and 21 CFR 520.1192 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.
    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 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.

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2. In Sec.  520.1192, add paragraph (b)(4) to read as follows:


Sec.  520.1192   Ivermectin paste.

* * * * *
    (b) * * *
    (4) No. 054925 for use of a 1.87 percent paste as in paragraphs 
(e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
* * * * *

    Dated: June 30, 2006.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E6-11073 Filed 7-13-06; 8:45 am]
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