[Federal Register Volume 69, Number 140 (Thursday, July 22, 2004)]
[Rules and Regulations]
[Page 43735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16627]



[[Page 43735]]

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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 Tablets and 
Chewables

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 veterinary prescription use of chewable ivermectin tablets 
in dogs to prevent canine heartworm disease by eliminating the tissue 
stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) 
after infection.

DATES: This rule is effective July 22, 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: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed ANADA 200-297 that provides 
for veterinary prescription use of Ivermectin Chewable Tablets for Dogs 
to prevent canine heartworm disease by eliminating the tissue stage of 
heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after 
infection. Phoenix Scientific, Inc.'s Ivermectin Chewable Tablets for 
Dogs are approved as a generic copy of Merial Ltd.'s HEARTGARD 
Chewables, approved under NADA 140-886. The ANADA is approved as of 
June 18, 2004, and the regulations are amended in 21 CFR 520.1193 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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.1193  [Amended]

0
2. Section 520.1193 is amended in paragraph (b)(2) by removing ``No. 
051311'' and by adding in its place ``Nos. 051311 and 059130''.

    Dated: July 13, 2004.
Stephen Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-16627 Filed 7-21-04; 8:45 am]
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