[Federal Register Volume 69, Number 205 (Monday, October 25, 2004)]
[Rules and Regulations]
[Pages 62180-62181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Praziquantel Tablets

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 a supplemental abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for use of oral praziquantel tablets for 
the removal of certain tapeworm parasites in dogs.

DATES: This rule is effective October 25, 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].

[[Page 62181]]


SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-265 
that provides for use of PRAZI-C (praziquantel) Tablets for the removal 
of certain tapeworm parasites in dogs. Phoenix Scientific, Inc.'s 
PRAZI-C Tablets are approved as a generic copy of Bayer HealthCare 
LLC's Tape Worm Tabs approved under NADA 111-798. The supplemental 
ANADA is approved as of September 15, 2004, and the regulations are 
amended in 21 CFR 520.1870 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 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.

0
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.

0
2. Section 520.1870 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  520.1870  Praziquantel tablets.

* * * * *
    (b) * * *
    (2) No. 059130 for use of the product described in paragraph (a)(1) 
of this section, as in paragraph (c)(1) of this section.
* * * * *

    Dated: October 14, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-23761 Filed 10-22-04; 8:45 am]
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