[Federal Register Volume 68, Number 192 (Friday, October 3, 2003)]
[Rules and Regulations]
[Pages 57351-57352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25090]


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

DATES: This rule is effective October 3, 2003.

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. Terr., St. Joseph, MO 64503, filed ANADA 200-265 that provides for 
the use of Praziquantel Tablets for the removal and control of certain 
cestode parasites in dogs. Phoenix Scientific, Inc.'s Praziquantel 
Tablets are approved as a generic copy of Bayer HealthCare LLC's 
DRONCIT (praziquantel) Canine Tablets approved under NADA 111-798. The 
ANADA is approved as of August 28, 2003, 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.

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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

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

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

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2. Section 520.1870 is amended by revising paragraphs (a), (b), and 
(c)(1) to read as follows:


Sec.  520.1870  Praziquantel tablets.

    (a) Specifications. Each tablet contains:
    (1) 34 milligrams (mg) praziquantel.
    (2) 11.5 or 23 mg praziquantel.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 000859 for use of the product described in paragraph (a)(1) 
of this section, as in paragraph (c)(1) of this section; and for use of 
the product described in paragraph (a)(2) of this section, as in 
paragraph (c)(2) of this section.
    (2) No. 059130 for use of the product described in paragraph (a)(1) 
of this section, as in paragraphs (c)(1)(i), (c)(1)(ii), and 
(c)(1)(iii)(B) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 pounds (lb) and 
under, 1/2 tablet (17 mg); 6 to 10 lb, 1 tablet (34 mg); 11 to 15 lb, 1 
1/2 tablets (51 mg); 16 to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 
tablets (102 mg); 46 to 60 lb, 4 tablets (136 mg); over 60 lb, 5 
tablets maximum (170 mg). Administer directly by mouth or crumbled and 
in feed.

[[Page 57352]]

    (ii) Indications for use--(A) For removal of canine cestodes 
Dipylidium caninum and Taenia pisiformis.
    (B) For removal of the canine cestode Echinococcus granulosus, and 
for removal and control of the canine cestode Echinococcus 
multilocularis.
    (iii) Limitations--(A) If labeled only for use as in paragraph 
(c)(1)(ii)(A) of this section: Not intended for use in puppies less 
than 4 weeks of age. Consult your veterinarian before administering 
tablets to weak or debilitated animals and for assistance in the 
diagnosis, treatment, and control of parasitism.
    (B) If labeled for use as in paragraph (c)(1)(ii)(B) of this 
section: Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
* * * * *

    Dated: September 15, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 03-25090 Filed 10-2-03; 8:45 am]
BILLING CODE 4160-01-S