[Federal Register Volume 64, Number 192 (Tuesday, October 5, 1999)]
[Rules and Regulations]
[Pages 53926-53927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25773]


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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 a supplemental new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides 
for revised feeding instructions for use of pyrantel tartrate Type A 
medicated articles to make Type C medicated horse feeds.

EFFECTIVE DATE: October 5, 1999.

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.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed supplemental NADA 140-819 that provides for revised 
feeding instructions for use of Pfizer's pyrantel tartrate Type A 
medicated articles (Strongid 48 (48 grams of pyrantel 
tartrate per pound (g/lb))) to make Type C medicated horse feeds 
(Strongid C (4.8 g/lb) and Strongid C2x (9.6 g/lb)) 
used for the prevention of Strongylus vulgaris larval infections, and 
control of several types of adult and 4th stage larval large and small 
strongyle, pinworm, and ascarid infections. The supplement provides for 
use of a top-dressed Type C feed containing up to 20,000 g of pyrantel 
tartrate per ton to be fed at the currently approved rate of 1.2 
milligrams per pound of body weight daily. The supplemental NADA is 
approved as of August 24, 1999, and Sec. 558.485 (21 CFR 558.485) is 
amended to reflect the approval.
    Also, Sec. 558.485(e)(2)(i)(A) is amended to reflect that the 
organism Triodontophorus is now classified as a small strongyle.
    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)(3) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on

[[Page 53927]]

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 revising paragraphs (e)(2)(i) 
introductory text, (e)(2)(i)(A), and the first sentence of paragraph 
(e)(2)(i)(B), and by adding and reserving paragraph (e)(2)(ii) to read 
as follows:


Sec. 558.485   Pyrantel tartrate.

 * * * * *
    (e) * * *
    (2) Horses--(i) Amount. Feed continuously at the rate of 1.2 
milligrams per pound (2.64 milligrams per kilogram) of body weight.
    (A) Indications for use. Prevention of Strongylus vulgaris larval 
infections; control of adult large strongyles (S. vulgaris, and S. 
edentatus), adult and 4th stage larvae small strongyles (Cyathostomum 
spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., 
Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage 
larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids 
(Parascaris equorum).
    (B) Limitations. Administer either as a top-dress (not to exceed 
20,000 grams per ton) or mixed in the horse's daily grain ration (not 
to exceed 1,200 grams per ton) during the time that the animal is at 
risk of exposure to internal parasites. * * *
    (ii) [Reserved]

    Dated: September 9, 1999.
Melanie R. Berson,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-25773 Filed 10-4-99; 8:45 am]
BILLING CODE 4160-01-F