[Federal Register Volume 67, Number 88 (Tuesday, May 7, 2002)]
[Rules and Regulations]
[Pages 30545-30546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11207]


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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 Robenidine Hydrochloride

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 bacitracin methylene disalicylate (BMD) and 
robenidine hydrochloride Type A medicated articles to make two-way 
combination Type C medicated broiler and fryer chicken feeds used for 
prevention of coccidiosis, and as an aid in the prevention or control 
of necrotic enteritis.

DATES:  This rule is effective May 7, 2002.

FOR FURTHER INFORMATION CONTACT:  Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7584, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-154 that provides for use of 
BMD (10, 25, 30, 40, 50, 60, or 75 grams per pound (g/lb) BMD) and 
ROBENZ (30 g/lb robenidine hydrochloride) Type A medicated articles to 
make two-way combination Type C medicated feeds containing 30 g/ton 
robenidine hydrochloride and 50 or 100 to 200 g/ton BMD for use in 
broiler and fryer chickens.
    The combination Type C medicated feeds containing 50 g/ton BMD are 
used for prevention of coccidiosis caused by Eimeria tenella, E. 
necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and as 
an aid in the prevention of necrotic enteritis caused or complicated by 
Clostridium spp. or other organisms susceptible to bacitracin. The 
combination Type C medicated feeds containing 100 to 200 g/ton BMD are 
used for prevention of coccidiosis caused E. tenella, E. necatrix, E. 
acervulina, E. brunetti, E. mivati, and E. maxima, and as an aid in the 
control of necrotic enteritis caused or complicated by Clostridium spp. 
or other organisms susceptible to bacitracin. NADA 141-154 is approved 
as of February 11, 2002, and the regulations are amended in 21 CFR 
558.515 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.
    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 
the 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.

[[Page 30546]]

    2. Section 558.515 is amended in the table in paragraph (d) by 
adding new entries after the entry for ``Bacitracin (as bacitracin 
methylene disalicylate) 27 to 50'' under the ``Combination in grams/
ton'' column to read as follows:


Sec. 558.515  Robenidine hydrochloride.

* * * * *
    (d) * * *

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     Robenidine
  hydrochloride in      Combination in        Indications for use             Limitations             Sponsor
     grams/ton            grams/ton
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*                *                  *                  *                  *                  *
                                                        *
                     Bacitracin (as       *    *    *                 *    *    *                 *    *    *
                      bacitracin
                      methylene
                      disalicylate) 27
                      to 50
                     Bacitracin (as       For broiler and fryer       Feed continuously as sole   046573
                      bacitracin           chickens: As an aid in      ration. Do not feed to
                      methylene            the prevention of           laying hens. Withdraw 5
                      disalicylate) 50     necrotic enteritis caused   days before slaughter.
                                           or complicated by
                                           Clostridium spp. or other
                                           organisms susceptible to
                                           bacitracin.
                     Bacitracin (as       For broiler and fryer       To control a necrotic       046573
                      bacitracin           chickens: As an aid in      enteritis outbreak, start
                      methylene            the control of necrotic     medication at first
                      disalicylate) 100    enteritis caused or         clinical signs of
                      to 200               complicated by              disease; administer
                                           Clostridium spp. or other   continuously for 5 to 7
                                           organisms susceptible to    days or as long as
                                           bacitracin.                 clinical signs persist,
                                                                       then reduce bacitracin
                                                                       methylene disalicylate to
                                                                       prevention level (50 g/
                                                                       ton). Do not feed to
                                                                       laying hens. Withdraw 5
                                                                       days before slaughter.
*                  *                  *                  *                  *                  *
                                                        *
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    Dated: April 18, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-11207 Filed 5-6-02; 8:45 am]
BILLING CODE 4160-01-S