[Federal Register Volume 66, Number 162 (Tuesday, August 21, 2001)]
[Rules and Regulations]
[Pages 43773-43774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20983]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ponazuril

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 new animal drug application 
(NADA) filed by Bayer Corp., Agriculture Division, Animal Health. The 
NADA provides for veterinary prescription use of ponazuril

[[Page 43774]]

paste for the treatment of protozoal myeloencephalitis in horses.

DATES: This rule is effective August 21, 2001.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Division, Animal 
Health, P.O. Box 390, Shawnee Mission, KS 66201, filed NADA 141-188 
that provides for veterinary prescription use of MarquisTM 
(ponazuril) EPM Paste for the treatment of equine protozoal 
myeloencephalitis caused by Sarcocystis neurona. The NADA is approved 
as of July 19, 2001, and the regulations are amended in 21 CFR part 520 
by adding Sec. 520.1855 to reflect the approval. The basis of 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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning July 19, 2001, 
because no active ingredient (including any ester or salt of the drug) 
has been previously approved in any other application filed under 
section 512(b)(1) of the act.
    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.

    2. Section 520.1855 is added to read as follows:


Sec. 520.1855  Ponazuril.

    (a) Specifications. Each gram of paste contains 150 milligrams (mg) 
ponazuril.
    (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 5 mg per kilogram body 
weight, daily for 28 days.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis caused by Sarcocystis neurona.
    (3) Limitations. Not for use in horses intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: August 1, 2001.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 01-20983 Filed 8-20-01; 8:45 am]
BILLING CODE 4160-01-S