[Federal Register Volume 72, Number 81 (Friday, April 27, 2007)]
[Rules and Regulations]
[Pages 20942-20943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Diclazuril

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 Schering-Plough Animal Health Corp. The NADA provides 
for the veterinary prescription use of diclazuril oral pellets in 
horses for the treatment of equine protozoal myeloencephalitis.

DATES: This rule is effective April 27, 2007.

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, filed NADA 141-268 for the veterinary 
prescription use of PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets 
in horses for the treatment of equine protozoal myeloencephalitis (EPM) 
caused by Sarcocystis neurona. The NADA is approved as of March 29, 
2007, and the regulations in 21 CFR part 520 are amended by adding new 
Sec.  520.606 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning March 29, 2007.
    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.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to

[[Page 20943]]

the Center for Veterinary Medicine, 21 CFR part 520 is amended as 
follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

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2. Add Sec.  520.606 to read as follows:


Sec.  520.606  Diclazuril.

    (a) Specifications. Each 100 grams (g) of pellets contain 1.56 g 
diclazuril.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 milligram 
(mg) per kilogram (0.45 mg per pound) of body weight in the daily grain 
ration for 28 days.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis (EPM) caused by Sarcocystis neurona.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: April 13, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-8041 Filed 4-26-07; 8:45 am]
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