[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Rules and Regulations]
[Pages 13235-13236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin

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 Phoenix Scientific, Inc. The ANADA 
provides for use of ivermectin injection for the treatment and control 
of various species of external and internal parasites in cattle, swine, 
reindeer, and American bison.

DATES: This rule is effective March 5, 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: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
228 that provides for use of PhoenectinTM (ivermectin) 
Injection for cattle and swine. The ANADA provides for use of a 1 
percent solution of ivermectin, by subcutaneous injection, in cattle 
for the treatment and control of various species of gastrointestinal 
nematodes, lungworms, grubs, lice, and mites; in swine for the 
treatment and control of various species of gastrointestinal nematodes, 
lungworms, lice, and mites; in reindeer for the treatment and control 
of warbles; and in American bison for the treatment and control of 
grubs. The ANADA is approved as a generic copy of Merial Ltd.'s NADA 
128-409 for Ivomec (ivermectin) Injection.
    ANADA 200-228 is approved as of December 27, 2000, and the 
regulations are amended in 21 CFR 522.1192 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 522

    Animal drugs.


[[Page 13236]]


    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

    2. Section 522.1192 is amended by revising paragraph (b) to read as 
follows:


Sec. 522.1192  Ivermectin  injection.

* * * * *
    (b) Sponsors. See No. 050604 in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section. See No. 059130 in 
Sec. 510.600(c) of this chapter for use as in paragraphs (d)(2), 
(d)(3), (d)(4), and (d)(6) of this section.
* * * * *

    Dated: February 12, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-5222 Filed 3-2-01; 8:45 am]
BILLING CODE 4160-01-U