[Federal Register Volume 65, Number 160 (Thursday, August 17, 2000)]
[Rules and Regulations]
[Pages 50133-50135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20936]


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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, Bacitracin 
Methylene Disalicylate, Bambermycins, and Virginiamycin

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 three new animal drug 
applications (NADA's) filed by Schering-Plough Animal Health Corp. The 
NADA's provide for use of the approved, single-ingredient diclazuril 
Type A medicated article together with approved, single-ingredient Type 
A medicated articles for either bacitracin methylene disalicylate 
(BMD), virginiamycin, or bambermycins to make two-way combination Type 
C medicated feeds used for prevention of coccidiosis, increased rate of 
weight gain, and improved feed efficiency in broiler chickens.

DATES: This rule is effective August 17, 2000.

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.

[[Page 50134]]


SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., P.O. Box 3182, Union, NJ 07083, filed three NADA's that 
provide for use of ClinacoxTM (0.91 grams per pound (g/lb) 
diclazuril activity) Type A medicated article together with other 
approved, single-ingredient Type A medicated articles to make two-way 
combination Type C medicated broiler chicken feeds used for the 
prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. 
acervulina, E. 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. The 
combination Type C medicated feeds are also used for increased rate of 
weight gain and for improved feed efficiency.
    NADA 141-153 provides for use of ClinacoxTM and 
BMD (10, 25, 30, 50, 60, or 75 g/lb bacitracin activity as 
BMD) Type A medicated articles to make combination Type C medicated 
broiler chicken feed containing 0.91 g/ton diclazuril and 4 to 50 g/ton 
BMD and is approved as of January 13, 2000.
    NADA 141-158 provides for use of ClinacoxTM and 
Flavomycin  (2, 4, or 10 g/lb of bambermycins activity) Type 
A medicated articles to make combination Type C medicated broiler 
chicken feed containing 0.91 g/ton diclazuril and 1 to 2 g/ton 
bambermycins and is approved as of July 3, 2000.
    NADA 141-090 provides for use of ClinacoxTM and 
Stafac (5, 10, 20, 50, or 227 g/lb virginiamycin activity) 
Type A medicated articles to make combination Type C medicated broiler 
chicken feed containing 0.91 g/ton diclazuril and 5 or 5 to 15 g/ton 
virginiamycin and is approved as of January 13, 2000. The combination 
Type C medicated feed containing 5 g/ton virginiamycin is used for 
prevention of coccidiosis, increased rate of weight gain, and improved 
feed efficiency. The combination Type C medicated feed containing 5 to 
15 g/ton virginiamycin is used for prevention of coccidiosis and 
increased rate of weight gain only.
    The regulations are amended in 21 CFR 558.76, Secs. 558.95, 558.198 
and 558.635 (21 CFR 558.95, 558.198 and 558.635) to reflect these 
approvals. The basis of approval for each application is discussed in 
separate freedom of information summaries.
    Sections 558.95 and 558.635 are also amended editorially to 
consolidate the cross-references for approved combinations in paragraph 
(d) and to list them in alphabetical order.
    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 these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither 
environmental assessments nor environmental impact statements are 
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 (d)(3)(vi) through (d)(3)(xviii) and by adding 
new paragraph (d)(3)(v) to read as follows:


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (v) Diclazuril as in Sec. 558.198.
* * * * *

    3. Section 558.95 is amended by revising paragraphs (d)(5)(i) 
through (d)(5)(iv) to read as follows:


Sec. 558.95  Bambermycins.

* * * * *
    (d) * * *
    (5) Bambermycins may be used in combination with:
    (i) Diclazuril as in Sec. 558.198.
    (ii) Halofuginone as in Sec. 558.265.
    (iii) Narasin alone or with roxarsone as in Sec. 558.363.
    (iv) Nicarbazine as in Sec. 558.366.

    4. Section 558.198 is amended by revising paragraph (d) to read as 
follows:


Sec. 558.198  Diclazuril.

* * * * *
    (d) Conditions of use. (1) It is used in Type C feed as follows:

 
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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.

[[Page 50135]]

 
(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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    (2) [Reserved]

    5. Section 558.635 is amended by revising paragraphs (d)(4)(i) 
through (d)(4)(vii) to read as follows:


Sec. 558.635  Virginiamycin.

* * * * *
    (d) * * *
    (4) Virginiamycin may be used in combination with:
    (i) Amprolium and ethopabate as in Sec. 558.58.
    (ii) Diclazuril as in Sec. 558.198.
    (iii) Halofuginone as in Sec. 558.265.
    (iv) Lasalocid as in Sec. 558.311.
    (v) Monensin alone or with roxarsone as in Sec. 558.355.
    (vi) Salinomycin alone or with roxarsone as in Sec. 558.550.
    (vii) Semduramicin as in Sec. 558.555.

    Dated: July 26, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-20936 Filed 8-16-00; 8:45 am]
BILLING CODE 4160-01-F