[Federal Register Volume 65, Number 216 (Tuesday, November 7, 2000)]
[Rules and Regulations]
[Page 66621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Pyrantel Tartrate

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 Farnam Companies, Inc. The ANADA provides 
for use of pyrantel tartrate in horse feed for the prevention and 
control of various species of internal parasites.

DATES: This rule is effective November 7, 2000.

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: Farnam Companies, Inc., 301 West Osborn, 
Phoenix, AZ 85013-3928, is sponsor of ANADA 200-282 that provides for 
use of CONTINUEX<SUP>TM</SUP> (pyrantel tartrate) Daily Dewormer. The 
ANADA provides for use of pyrantel tartrate in horse feed for the 
prevention and control of various species of internal parasites. The 
ANADA is approved as a generic copy of Pfizer Inc.'s NADA 140-819 for 
STRONGID<Register> 48. ANADA 200-282 is approved as of September 26, 
2000, and the regulations are amended in 21 CFR 558.485 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(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 558

    Animal drugs, Animal feeds.
    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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

    2. Section 558.485 is amended by adding paragraph (a)(29) to read 
as follows:


Sec. 558.485  Pyrantel tartrate.

    (a) * * *
    (29) To 017135: 48 grams per pound, paragraph (e)(2) of this 
section.
* * * * *

    Dated: October 26, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-28523 Filed 11-6-00; 8:45 am]
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