[Federal Register Volume 62, Number 170 (Wednesday, September 3, 1997)]
[Rules and Regulations]
[Pages 46443-46444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23245]


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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 
applications (ANADA) filed by Equi Aid Products, Inc. The ANADA 
provides for using pyrantel tartrate Type A medicated articles to make 
Type B medicated feeds used as equine anthelmintics.

EFFECTIVE DATE: September 3, 1997.

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: Equi Aid Products, Inc., 1517 West Knudsen 
Dr., Phoenix, AZ 85027, filed ANADA 200-168, which provides for using 
pyrantel tartrate Type A medicated articles to make Type B medicated 
feeds for horses for prevention of Strongylus vulgaris larval 
infections and control of the following parasites in horses: (1) Large 
strongyles (adults) S. vulgaris, S. edentatus, Triodontophorus spp.; 
(2) small strongyles (adults and fourth-stage larvae) Cyathostomum 
spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., 
Poteriostomum spp.; (3) pinworm (adults and fourth-stage larvae) 
Oxyuris equi; and (4) ascarids (adults and fourth-stage larvae) 
Parascaris equorum.
    Equi Aid's ANADA 200-168 is approved as a generic copy of Pfizer's 
NADA 140-819. The ANADA is approved as of September 3, 1997 and 21 CFR 
558.485(a) 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the 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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).
    2. Section 558.485 is amended by adding new paragraph (a)(28) to 
read as follows:


[[Page 46444]]




Sec. 558.485   Pyrantel tartrate.

    (a) * * *
    (28) To 062240: 48 grams per pound, paragraph (e)(2) of this 
section.
* * * * *

    Dated: August 22, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-23245 Filed 9-2-97; 8:45 am]
BILLING CODE 4160-01-F