[Federal Register Volume 67, Number 251 (Tuesday, December 31, 2002)]
[Rules and Regulations]
[Pages 79852-79853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32848]


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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; 
Praziquantel Injectable Solution

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 the veterinary prescription

[[Page 79853]]

use of an injectable praziquantel solution in dogs and cats for the 
removal of various species of cestodes (tapeworms).

DATES: This rule is effective December 31, 2002.

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, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
176 that provides for the veterinary prescription use of PRAZITECH 
(praziquantel) Injection in dogs and cats for the removal of various 
species of cestodes (tapeworms). Phoenix Scientific's PRAZITECH 
Injection is approved as a generic copy of Bayer Corp.'s DRONCIT 5.68% 
Injectable Solution, approved under NADA 111-607. The ANADA is approved 
as of October 16, 2002, and the regulations are amended in 21 CFR 
522.1870 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 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.

    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.


Sec.  522.1870  [Amended]

    2. Section 522.1870 Praziquantel injectable solution is amended in 
paragraph (b) by removing ``Sponsor. See 000859'' and by adding in its 
place ``Sponsors. See Nos. 000859 and 059130''.

    Dated: December 18, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-32848 Filed 12-30-02; 8:45 am]
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