[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]
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