[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.198]

[Page 398-400]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
 
      Subpart B--Specific New Animal Drugs for Use in Animal Feeds
 
Sec. 558.198  Diclazuril.

    (a) Approvals. Type A medicated article: 0.2 percent of diclazuril 
to 000061 in Sec. 510.600(c) of this chapter.
    (b) Related tolerances. See Sec. 556.175 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. (1) It is used in Type C feed as follows:

[[Page 399]]



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       Diclazuril grams/ton             Combination grams/ton                            Indications for use                                   Limitations                        Sponsor
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(i) 0.91 (1 part per million                                         Broiler chickens: For the prevention of coccidiosis caused  Feed continuously. Not for use in hens   000061
 (ppm))                                                               by Eimeria tenella, E. necatrix, E. acervulina, E.          producing eggs for human food.
                                                                      brunetti, E. mitis (mivati), and E. maxima. Because
                                                                      diclazuril is effective against E. maxima later in its
                                                                      life cycle, subclinical intestinal lesions may be present
                                                                      for a short time after infection. Diclazuril was shown in
                                                                      studies to reduce lesion scores and improve performance
                                                                      and health of birds challenged with E. maxima.
(ii) 0.91 (1 ppm)                 Bacitracin methylene disalicylate  Broiler chickens: As in item (i) of this table; for         As in item (i) of this table.            000061
                                   4 to 50                            increased rate of weight gain and improved feed             Bacitracin methylene disalicylate
                                                                      efficiency.                                                 provided by 046573.
(iii) 0.91 (1 ppm)                Bambermycins 1 to 2                Broiler chickens: As in item (i) of this table); for        As in item (i) of this table.            000061
                                                                      increased rate of weight gain and improved feed             Bambermycins provided by 012799.
                                                                      efficiency.
(iv) 0.91 (1 ppm)                 Virginiamycin 5                    Broiler chickens: As in item (i) of this table; for         As in item (i) of this table;            000061
                                                                      increased rate of weight gain and improved feed             Virginiamycin provided by 000069.
                                                                      efficiency.
(v) 0.91 (1 ppm)                  Virginiamycin 5 to 15              Broiler chickens: As in item (i) of this table; for         As in item (i) of this table.            000061
                                                                      increased rate of weight gain.                              Virginiamycin provided by 000069.
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[[Page 400]]

    (2) [Reserved]

[64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000]