[Federal Register Volume 68, Number 81 (Monday, April 28, 2003)]
[Rules and Regulations]
[Pages 22293-22294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10416]



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  Federal Register / Vol. 68, No. 81 / Monday, April 28, 2003 / Rules 
and Regulations  

[[Page 22293]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Praziquantel, Pyrantel 
Pamoate, and Febantel Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Bayer Corp., Agriculture Division, Animal 
Health. The supplemental NADA provides for use of a larger size of 
praziquantel/pyrantel pamoate/febantel tablet for the removal of 
several species of internal parasites in dogs.

DATES: This rule is effective April 28, 2003.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Division, Animal 
Health, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement to 
NADA 141-007 that provides for use of a larger size of DRONTAL PLUS 
(praziquantel/pyrantel pamoate/febantel) Tablets for the removal of 
several species of internal parasites in dogs. The supplemental NADA is 
approved as of February 10, 2003, and the regulations are amended in 21 
CFR 520.1872 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(d)(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 520.1872 is amended by adding new paragraph (a)(3), and by 
revising the table in paragraph (c)(1)(i) to read as follows:


Sec.  520.1872  Praziquantel, pyrantel pamoate, and febantel tablets.

    (a) * * *
    (3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel 
base, and 680.4 mg febantel.
* * * * *
    (c) * * *
    (1) * * *
    (i) * * *

----------------------------------------------------------------------------------------------------------------
                  Weight of animal                                    Number of tablets per dose
----------------------------------------------------------------------------------------------------------------
            Kilograms                   Pounds           Tablet no. 1        Tablet no. 2        Tablet no. 3
----------------------------------------------------------------------------------------------------------------
0.9 to 1.8                           2 to 4                 1/2           ..................  ..................
2.3 to 3.2                           5 to 7                   1           ..................  ..................
3.6 to 5.4                          8 to 12               1 1/2           ..................  ..................
5.9 to 8.2                         13 to 18                   2           ..................  ..................
8.6 to 11.4                        19 to 25               2 1/2           ..................  ..................
11.8 to 13.6                       26 to 30           ..................          1           ..................
14.1 to 20.0                       31 to 44           ..................      1 1/2           ..................
20.4 to 27.2                       45 to 60           ..................          2                   1
27.7 to 40.9                       61 to 90           ..................  ..................      1 1/2
41.3 to 54.5                      91 to 120           ..................  ..................          2
----------------------------------------------------------------------------------------------------------------


[[Page 22294]]

* * * * *

    Dated: April 4, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-10416 Filed 4-25-03; 8:45 am]
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