[Federal Register Volume 67, Number 138 (Thursday, July 18, 2002)]
[Rules and Regulations]
[Pages 47257-47258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18119]


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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; Diclazuril and 
Bacitracin Methylene Disalicylate

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 use of approved single-ingredient diclazuril and bacitracin 
methylene disalicylate Type A medicated articles to make two-way 
combination drug Type C medicated feeds for growing turkeys.

DATES: This rule is effective July 18, 2002.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., P.O. Box 3182, Union, NJ 07083, filed NADA 141-194 that 
provides for use of CLINACOX (0.2 percent diclazuril) and BMD (10, 25, 
30, 40, 50, 60, or 75 grams per pound (g/lb) bacitracin methylene 
disalicylate) Type A medicated articles to make two-way combination 
drug Type C medicated feeds for growing turkeys. The Type C feeds 
contain 0.91 g/ton diclazuril and 4 to 50 g/ton bacitracin methylene 
disalicylate, and they are used for the prevention of coccidiosis 
caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, 
and for increased rate of weight gain and improved feed efficiency. The 
NADA is approved as of April 2, 2002, and the regulations are amended 
in 21 CFR 558.198 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 each 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)(2) 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.

    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 558.198 is amended by adding paragraph (d)(2)(ii) to 
read as follows:

[[Page 47258]]

Sec. 558.198   Diclazuril.

* * * * *
    (d) * * * 
    (2) * * * 
      

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Diclazuril grams/   Combination grams/
       ton                  ton              Indications for use              Limitations             Sponsor
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*                  *                  *                  *                  *                  *
                                                        *
(ii) 0.91 (1       Bacitracin methylene  Growing turkeys: As in       As in paragraph (d)(2)(i)    000061
 ppm).              disalicylate 4 to     paragraph (d)(2)(i) of       of this section.
                    50.                   this section; for            Bacitracin methylene
                                          increased rate of weight     disalicylate provided by
                                          gain and improved feed       No. 046573 in Sec.
                                          efficiency.                  510.600(c) of this
                                                                       chapter.
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    Dated: July 8, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-18119 Filed 7-17-02; 8:45 am]
BILLING CODE 4160-01-S