[Federal Register Volume 66, Number 16 (Wednesday, January 24, 2001)]
[Rules and Regulations]
[Page 7579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1865]



[[Page 7579]]

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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 Med-Pharmex, 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 January 24, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, filed ANADA 200-292 for IVERSOL (ivermectin) 
Liquid for Horses. The application provides for oral use of 1.0 percent 
ivermectin solution in horses for the treatment and control of various 
species of gastrointestinal nematodes, lungworms, stomach bots, and 
cutaneous larvae and microfilariae. MedPharmex's IVERSOL Liquid for 
Horses is approved as a generic copy of Merial Ltd.'s EQVALAN 
(ivermectin) Oral Liquid for Horses, approved under NADA 140-439. ANADA 
200-292 is approved as of December 7, 2000, and 21 CFR 520.1195 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 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 Dockets Management Branch (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.

    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

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

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


Sec. 520.1195  [Amended]

    2. Section 520.1195 Ivermectin liquid is amended in paragraph (b) 
by adding ``, 051259,'' after ``050604''.

    Dated: January 8, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-1865 Filed 1-23-01; 8:45 am]
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