[Federal Register Volume 71, Number 172 (Wednesday, September 6, 2006)]
[Rules and Regulations]
[Pages 52429-52430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14673]


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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; Amprolium

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 Merial Ltd. The supplemental NADA provides 
for formulation of Type C medicated calf feeds containing amprolium 
used for the prevention and treatment of coccidiosis at a broader range 
of concentrations.

DATES: This rule is effective September 6, 2006.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed a supplement to NADA 12-350 for CORID 
(amprolium) Type A Medicated Article 25%. The supplemental NADA 
provides for formulation of Type C medicated calf feeds used for the 
prevention and treatment of coccidiosis at a broader range of 
concentrations. The supplemental NADA is approved as of July 19, 2006, 
and 21 CFR 558.55 is amended 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 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.
    FDA has determined under 21 CFR 25.33(a)(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 558

    Animal drugs, Animal feeds.

0
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

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
0
2. Revise paragraph (d)(1) of Sec.  558.55 to read as follows:


Sec.  558.55  Amprolium.

* * * * *
    (d) * * *
    (1) Cattle. It is used as follows:

[[Page 52430]]



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    Amprolium in Grams per Ton           Indications for Use                                    Limitations                                   Sponsor
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(i) 113.5 to 11, 350; to provide 5      Calves: As an aid in the       Top-dress on or mix in the daily ration. Feed for 21 days during    050604
 milligrams (mg) per kilogram of       prevention of coccidiosis   periods of exposure or when experience indicates that coccidiosis is
 body weight per day.                caused by Eimeria bovis and   likely to be a hazard; as sole source of amprolium. Withdraw 24 hours
                                                       E. zurnii     before slaughter. A withdrawal period has not been established for
                                                                       this product in preruminating calves. Do not use in calves to be
                                                                                                                     processed for veal
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(ii) 113.5 to 11, 350; to provide       Calves: As an aid in the      Top-dress on or mix in the daily ration. Feed for 5 days; as sole    050604
 10 mg per kilogram of body weight      treatment of coccidiosis   source of amprolium. Withdraw 24 hours before slaughter. A withdrawal
 per day.                            caused by Eimeria bovis and      period has not been established for this product in preruminating
                                                       E. zurnii           calves. Do not use in calves to be processed for veal. For a
                                                                   satisfactory diagnosis, a microscopic examination of the feces should
                                                                   be done by a veterinarian or diagnostic laboratory before treatment;
                                                                      when treating outbreaks, the drug should be administered promptly
                                                                                                          after diagnosis is determined
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    Dated: August 22, 2006.
Steven D. Vaughn,
Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E6-14673 Filed 9-5-06; 8:45 am]
BILLING CODE 4160-01-S