[Federal Register Volume 65, Number 228 (Monday, November 27, 2000)]
[Rules and Regulations]
[Page 70661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30048]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 Phoenix Scientific, Inc. The ANADA 
provides for use of ivermectin oral paste for the treatment and control 
of various species of harmful gastrointestinal parasites in horses.

DATES: This rule is effective November 27, 2000.

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: Phoenix Scientific, Inc., 3915 South 48th 
Street Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 
200-286 that provides for use of PHOENECTIN<SUP>TM</SUP> (ivermectin) 
Paste 1.87%. The ANADA provides for oral use of ivermectin paste for 
the treatment and control of various species of harmful 
gastrointestinal parasites in horses. The ANADA is approved as a 
generic copy of Merial Ltd.'s NADA 134-314 for EQVALAN<Register> 
(ivermectin) Paste for Horses. ANADA 200-286 is approved as of 
September 20, 2000, and the regulations are amended in 21 CFR 520.1192 
to reflect the approval. The basis for 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.

    2. Section 520.1192 is amended by revising paragraphs (a) and (b), 
by redesignating paragraph (c) as paragraph (d), and by adding new 
paragraph (c) to read as follows.


Sec. 520.1192  Ivermectin paste.

    (a) Specifications. Each milligram of paste contains 0.0187 
milligram (1.87 percent) or 0.00153 milligram (0.153 percent) of 
ivermectin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter, as follows:
    (1) No. 050604 for use of a 1.87 percent paste as in paragraph 
(d)(1) of this section and a 0.153 percent paste as in paragraph (d)(2) 
of this section.
    (2) No. 059130 for use of a 1.87 percent paste as in paragraph 
(d)(1) of this section.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
* * * * *

    Dated: October 16, 2000.
Stephen S. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-30048 Filed 11-24-00; 8:45 am]
BILLING CODE 4160-01-F