[Federal Register: April 28, 2003 (Volume 68, Number 81)]
[Rules and Regulations]
[Page 22293-22294]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap03-1]
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Rules and Regulations
Federal Register
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[[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.
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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:
mberson@cvm.fda.gov.
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) * * *
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Weight of animal Number of tablets per dose
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Kilograms Pounds Tablet no. 1 Tablet no. 2 Tablet no. 3
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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
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[[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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