[Federal Register Volume 67, Number 143 (Thursday, July 25, 2002)]
[Rules and Regulations]
[Pages 48549-48550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18877]


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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 
Bambermycins

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 bambermycins Type 
A medicated articles to make two-way combination drug Type C medicated 
feeds for growing turkeys.

DATES: This rule is effective July 25, 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 141-195 that 
provides for use of CLINACOX (0.2 percent diclazuril) and FLAVOMYCIN 
(2, 4, or 10 grams per pound (g/lb) of bambermycins activity) Type A 
medicated articles to make two-way combination drug Type C medicated 
feeds containing 0.91 g/ton diclazuril and 1 to 2 or 2 g/ton 
bambermycins for growing turkeys. The Type C feeds containing 0.91 g/
ton diclazuril and 1 to 2 g/ton bambermycins are used for the 
prevention of coccidiosis caused by E. adenoeides, E. gallopavonis, and 
E. meleagrimitis and improved feed efficiency. The Type C feeds 
containing 0.91 g/ton diclazuril and 2 g/ton bambermycins are used for 
the prevention of coccidiosis caused by E. 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 being 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 paragraphs (d)(2)(iii) and 
(d)(2)(iv) to read as follows:


Sec. 558.198  Diclazuril.

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

------------------------------------------------------------------------
  Diclazuril     Combination     Indications
  grams/ton       grams/ton        for use       Limitations    Sponsor
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*                  *                  *                  *
                  *                  *                  *
(iii) 0.91 (1  Bambermycins 1  Growing         As in           000061
 ppm).          to 2            turkeys: As     paragraph
                                in paragraph    (d)(2)(i) of
                                (d)(2)(i) of    this section.
                                this section;   Bambermycins
                                for improved    provided by
                                feed            No. 057926 in
                                efficiency.     Sec.  510.600
                                                (c) of this
                                                chapter.
(iv) 0.91 (1   Bambermycins 2  Growing         As in           000061
 ppm).                          turkeys: As     paragraph
                                in paragraph    (d)(2)(i) of
                                (d)(2)(i) of    this section.
                                this section;   Bambermycins
                                for increased   provided by
                                rate of         No. 057926 in
                                weight gain     Sec.
                                and improved    510.600(c) of
                                feed            this chapter.
                                efficiency.
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[[Page 48550]]

    Dated: July 8, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-18877 Filed 7-24-02; 8:45 am]
BILLING CODE 4160-01-S