[Federal Register Volume 67, Number 87 (Monday, May 6, 2002)]
[Rules and Regulations]
[Pages 30326-30328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10964]


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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; Nicarbazin, Narasin, 
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

[[Page 30327]]

application (NADA) filed by Alpharma, Inc. The NADA provides for using 
approved two-way narasin/nicarbazin and single-ingredient bacitracin 
methylene disalicylate (BMD) Type A medicated articles to make three-
way, combination drug Type C medicated feeds for broiler chickens.

DATES: This rule is effective May 6, 2002.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7580, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, has filed NADA 141-124 that provides for the 
combination use of approved MAXIBAN (36 grams per pound (g/lb) each of 
narasin and nicarbazin) and BMD (10, 25, 30, 40, 50, 60, or 75 g/lb 
bacitracin methylene disalicylate) Type A medicated articles in three-
way, combination drug Type C medicated feeds for broiler chickens. The 
Type C feeds containing 27 to 45 g/ton each narasin and nicarbazin and 
50 g/ton bacitracin methylene disalicylate are used for the prevention 
of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, 
E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention 
of necrotic enteritis caused or complicated by Clostridium spp. or 
other organisms susceptible to bacitracin. The Type C broiler feeds 
containing 27 to 45 g/ton each narasin and nicarbazin and 100 to 200 g/
ton BMD are used for the prevention of coccidiosis caused by E. 
tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. 
mivati as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin. The NADA is approved as of January 14, 2002, and the 
regulations in 21 CFR 558.76 and 558.366 are amended 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 this 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.
    FDA 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.


Sec. 558.76  [Amended]

    2. Section 558.76 Bacitracin methylene disalicylate is amended in 
paragraph (d)(3)(xii) by adding ``or narasin'' after ``narasin''.
    3. Section 558.366 is amended in the table in paragraph (d), in the 
column for ``Combination in grams per ton'' after the entry for 
``Narasin 27 to 45 and bacitracin methylene disalicylate 4 to 50'' by 
adding entries for ``Narasin 27 to 45 and bacitracin methylene 
disalicylate 50'' and ``Narasin 27 to 45 and bacitracin methylene 
disalicylate 100 to 200'' to read as follows:


Sec. 558.366  Nicarbazin.

* * * * *
    (d) * * * 

------------------------------------------------------------------------
Nicarbazin in  Combination in    Indications
grams per ton   grams per ton      for use       Limitations    Sponsor
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
27 to 45       Narasin 27 to   Broiler         Feed            046573
                45 and          chickens: For   continuously
                bacitracin      prevention of   as sole
                methylene       coccidiosis     ration. Do
                disalicylate    caused by       not feed to
                50.             Eimeria         laying hens.
                                tenella, E.     Withdraw 5
                                necatrix, E.    days before
                                acervulina,     slaughter. Do
                                E. maxima, E.   not allow
                                brunetti, and   turkeys,
                                E. mivati; as   horses or
                                an aid in the   other equines
                                prevention of   access to
                                necrotic        formulations
                                enteritis       containing
                                caused or       narasin.
                                complicated     Ingestion of
                                by              narasin by
                                Clostridium     these species
                                spp. or other   has been
                                organisms       fatal.
                                susceptible     Narasin and
                                to              nicarbazin as
                                bacitracin.     provided by
                                                No. 000986,
                                                bacitracin
                                                methylene
                                                disalicylate
                                                by No. 046573
                                                in Sec.
                                                510.600(c) of
                                                this chapter.

[[Page 30328]]

 
               Narasin 27 to   Broiler         To control      046573
                45 and          chickens: For   necrotic
                bacitracin      prevention of   enteritis,
                methylene       coccidiosis     start
                disalicylate    caused by       medication at
                100 to 200.     Eimeria         first
                                tenella, E.     clinical
                                necatrix, E.    signs of
                                acervulina,     disease; vary
                                E. maxima, E.   dosage based
                                brunetti, and   on the
                                E. mivati; as   severity of
                                an aid in the   infection;
                                control of      administer
                                necrotic        continuously
                                enteritis       for 5 to 7
                                caused or       days or as
                                complicated     long as
                                by              clinical
                                Clostridium     signs
                                spp. or other   persist, then
                                organisms       reduce
                                susceptible     bacitracin to
                                to              prevention
                                bacitracin.     level (50 g/
                                                ton). Do not
                                                feed to
                                                laying hens.
                                                Withdraw 5
                                                days before
                                                slaughter. Do
                                                not allow
                                                turkeys,
                                                horses or
                                                other equines
                                                access to
                                                formulations
                                                containing
                                                narasin.
                                                Ingestion of
                                                narasin by
                                                these species
                                                has been
                                                fatal.
                                                Narasin and
                                                nicarbazin as
                                                provided by
                                                No. 000986,
                                                bacitracin
                                                methylene
                                                disalicylate
                                                by No. 046573
                                                in Sec.
                                                510.600(c) of
                                                this chapter.
 
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------


    Dated: April 9, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-10964 Filed 5-3-02; 8:45 am]
BILLING CODE 4160-01-S