Document ID: FDA-2008-N-0039-0022
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Nicarbazin
Posted Date: 2008-03-26T04:00Z

[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Rules and Regulations]               
[Page 15884-15885]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr08-14]                         

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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; Bacitracin Methylene 
Disalicylate and Nicarbazin

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 Alpharma, Inc. The NADA provides for use of approved, 
single-ingredient Type A medicated articles containing bacitracin 
methylene disalicylate and nicarbazin to formulate two-way combination 
drug Type C medicated feeds for broiler chickens.

DATES: This rule is effective March 26, 2008.

FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary 
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rt. 22, Bridgewater, NJ 
08807, filed NADA 141-279 that provides for use of BMD (bacitracin 
methylene disalicylate) and NICARB (nicarbazin) Type A medicated 
articles to formulate two-way combination drug Type C medicated feeds 
for broiler chickens. The NADA is approved as of February 21, 2008, and 
the regulations are amended in 21 CFR 558.366 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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.

0
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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In the table in paragraph (d) of Sec.  558.366, alphabetically add 
new entries for ``Bacitracin methylene disalicylate 4 to 50'' and 
``Bacitracin methylene disalicylate 50'' to read as follows:

Sec.  558.366  Nicarbazin.

* * * * *
    (d) * * *

------------------------------------------------------------------------
 Nicarbazin    Combination
in grams per   in grams per    Indications     Limitations     Sponsor
     ton           ton           for use
------------------------------------------------------------------------
113.5          *              * *             * *                      *
 (0.0125
 pct)
------------------------------------------------------------------------
              Bacitracin     Broiler         Feed                 046573
               methylene      chickens; aid   continuously
               disalicylate   in preventing   as sole
               4 to 50.       outbreaks of    ration from
                              cecal           time chicks
                              (Eimeria        are placed on
                              tenella) and    litter until
                              intestinal      past the time
                              (E.             when
                              acervulina,     coccidiosis
                              E. maxima, E.   is ordinarily
                              necatrix, and   a hazard; do
                              E. brunetti)    not use as a
                              coccidiosis;    treatment for
                              for increased   outbreaks of
                              rate of         coccidiosis;
                              weight gain     do not use in
                              and improved    flushing
                              feed            mashes; do
                              efficiency.     not feed to
                                              laying hens;
                                              withdraw 4
                                              days before
                                              slaughter.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
              Bacitracin     Broiler         Feed                 046573
               methylene      chickens; aid   continuously
               disalicylate   in preventing   as sole
               50.            outbreaks of    ration from
                              cecal           time chicks
                              (Eimeria        are placed on
                              tenella) and    litter until
                              intestinal      past the time
                              (E.             when
                              acervulina,     coccidiosis
                              E. maxima, E.   is ordinarily
                              necatrix, and   a hazard; do
                              E. brunetti)    not use as a
                              coccidiosis;    treatment for
                              as an aid in    outbreaks of
                              the             coccidiosis;
                              prevention of   do not use in
                              necrotic        flushing
                              enteritis       mashes; do
                              caused or       not feed to
                              complicated     laying hens;
                              by              withdraw 4
                              Clostridium     days before
                              spp. or other   slaughter.
                              organisms
                              susceptible
                              to
                              bacitracin.
------------------------------------------------------------------------
                              * * * * * * *
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[[Page 15885]]

    Dated: March 12, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6063 Filed 3-25-08; 8:45 am]

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