[Federal Register Volume 67, Number 95 (Thursday, May 16, 2002)]
[Rules and Regulations]
[Pages 34829-34831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10963]


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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

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, bacitracin methylene 
disalicylate, and roxarsone Type A medicated articles to make three-way 
combination drug Type C medicated feeds for broiler chickens.

DATES: This rule is effective May 16, 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 141-190 that 
provides for use of CLINACOX (0.2 percent diclazuril), BMD (10, 25, 30, 
40, 50, 60, or 75 grams per pound (g/lb) bacitracin methylene 
disalicylate), and 3-NITRO (45.4, 90, 227, or 360 g/lb roxarsone) Type 
A medicated articles to make combination drug Type C medicated feeds 
for broiler chickens. The Type C feeds contain 0.91 g/ton diclazuril, 
50 or 100 to 200 g/ton bacitracin methylene disalicylate, and 22.7 to 
45.4 g/ton roxarsone and are used for the prevention of coccidiosis 
caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. 
mitis (mivati), and E. maxima; as an aid in the prevention (at 50 g/ton 
bacitracin) or control (at 100 to 200 g/ton bacitracin) of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin; and for increased rate of weight gain, 
improved feed efficiency, and improved pigmentation. The NADA is 
approved as of December 14, 2001, and the regulations are amended in 21 
CFR 558.198 to reflect the approval.
    The regulations in 21 CFR 558.76 and 558.530 are also being amended 
to cross-reference approved combinations. 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

[[Page 34830]]

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 558.76 is amended by redesignating paragraphs (d)(3)(v) 
through (d)(3)(xvii) as paragraphs (d)(3)(vi) through (d)(3)(xviii), 
respectively, and by adding new paragraph (d)(3)(v) to read as follows:


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * * 
    (3) * * * 
    (v) Diclazuril alone and with roxarsone as in Sec. 558.198.
* * * * *

    3. Section 558.198 is amended by:
    a. Revising paragraph (a);
    b. Redesignating paragraph (b) as paragraph (c);
    c. Adding new paragraph (b);
    d. Redesignating paragraphs (d)(1)(iii) through (d)(1)(v) as 
paragraphs (d)(1)(v) through (d)(1)(vii), respectively; and
    e. Adding new paragraphs (d)(1)(iii) and (d)(1)(iv).
    The revisions and additions are to read as follows:


Sec. 558.198  Diclazuril.

    (a) Specifications. Type A medicated article containing 0.2 percent 
diclazuril.
    (b) Approvals. See No. 000061 in Sec. 510.600(c) of this chapter.
* * * * *
    (d) * * * 
    (1) * * * 

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 Diclazuril grams/
        ton                 Combination grams/ton                  Indications for use                         Limitations                   Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   *                  *                  *                  *                  *                  *                  *
(iii) 0.91 (1 ppm).  Bacitracin methylene disalicylate   Broiler chickens: As in item (i) of     Feed continuously as the sole ration    000061
                      50 plus roxarsone 22.7 to 45.4      this table; as an aid in the            throughout growing period. Use as
                                                          prevention of necrotic enteritis        sole source of organic arsenic; drug
                                                          caused or complicated by Clostridium    overdose or lack of water may result
                                                          spp. or other organisms susceptible     in leg weakness. Not for use in hens
                                                          to bacitracin; for increased rate of    producing eggs for human consumption.
                                                          weight gain, improved feed              Withdraw 5 days before slaughter.
                                                          efficiency, and improved                Bacitracin methylene disalicylate and
                                                          pigmentation.                           roxarsone provided by No. 046573 in
                                                                                                  Sec.  510.600(c) of this chapter.
(iv) 0.91 (1 ppm).   Bacitracin methylene disalicylate   Broiler chickens: As in item (i) of     Feed continuously as the sole ration    000061
                      100 to 200 plus roxarsone 22.7 to   this table; as an aid in the control    throughout growing period. Start at
                      45.4                                of necrotic enteritis caused or         first clinical signs of disease; vary
                                                          complicated by Clostridium spp. or      dosage of bacitracin based on
                                                          other organisms susceptible to          severity of infection; administer
                                                          bacitracin; for increased rate of       continuously for 5 to 7 days or as
                                                          weight gain, improved feed              long as clinical signs persist, then
                                                          efficiency, and improved                reduce bacitracin to prevention level
                                                          pigmentation.                           (50 grams per ton (g/ton). Use as
                                                                                                  sole source of organic arsenic; drug
                                                                                                  overdose or lack of water may result
                                                                                                  in leg weakness. Not for use in hens
                                                                                                  producing eggs for human consumption.
                                                                                                  Withdraw 5 days before slaughter.
                                                                                                  Bacitracin methylene disalicylate and
                                                                                                  roxarsone provided by No. 046573 in
                                                                                                  Sec.  510.600(c) of this chapter.
                   *                  *                  *                  *                  *                  *                  *
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[[Page 34831]]

* * * * *

    4. Section 558.530 is amended by revising paragraph (d)(5)(x) to 
read as follows:


Sec. 558.530  Roxarsone.

* * * * *
    (d) * * * 
    (5) * * * 
    (x) Diclazuril alone or in combination as in Sec. 558.198.
* * * * *

    Dated: March 15, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-10963 Filed 5-15-02; 8:45 am]
BILLING CODE 4160-01-S