[Federal Register Volume 66, Number 28 (Friday, February 9, 2001)]
[Rules and Regulations]
[Page 9650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3415]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Chewable 
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 an abbreviated new animal drug 
application (ANADA) filed by Blue Ridge Pharmaceuticals, Inc. The ANADA 
provides for use of pyrantel pamoate chewable tablets for the removal 
of certain gastrointestinal parasites and prevention of reinfection in 
puppies and dogs.

DATES: This rule is effective February 9, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Blue Ridge Pharmaceuticals, Inc., 4249-105 
Piedmont Pkwy., Greensboro, NC 27410, filed ANADA 200-281 that provides 
for use of WORMEXX<Register> (pyrantel pamoate) Chewable Tablets for 
the removal of certain gastrointestinal parasites and prevention of 
reinfection in puppies and dogs. Blue Ridge's WORMEXX<Register> 
Chewable Tablets is approved as a generic copy of Farnam Co.'s D-
WORM<Register> (pyrantel pamoate) Dog Wormer Chewable Tablets, approved 
under NADA 139-191. ANADA 200-281 is approved as of January 3, 2001, 
and 21 CFR 520.2041 is amended to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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.
    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

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

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


Sec. 520.2041  [Amended]

    2. Section 520.2041 Pyrantel pamoate chewable tablets is amended in 
paragraph (b) by removing ``No. 017135'' and adding in its place ``Nos. 
017135 and 065274''.

    Dated: January 31, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-3415 Filed 2-8-01; 8:45 am]
BILLING CODE 4160-01-F