[Federal Register Volume 67, Number 31 (Thursday, February 14, 2002)]
[Rules and Regulations]
[Pages 6867-6869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3614]


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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 Zoalene

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 6868]]

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Alpharma, Inc. The supplemental NADA 
provides for using approved single-ingredient bacitracin methylene 
disalicylate and zoalene Type A medicated articles to make two-way 
combination drug Type C medicated feeds used for the management of 
necrotic enteritis and coccidiosis in replacement and broiler chickens.

DATES: This rule is effective February 14, 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, filed supplemental NADA 141-085 that provides 
for combining approved BMD (10, 25, 30, 40, 50, 60, or 75 grams per 
pound (g/lb) bacitracin methylene disalicylate) and ZOAMIX (113.5 g/lb 
zoalene) Type A medicated articles to make two-way combination drug 
Type C medicated chicken feeds containing 50 or 100 to 200 g/ton 
bacitracin methylene disalicylate and 36.3 to 113.5 or 113.5 g/ton 
zoalene. The combination Type C feeds containing 50 g/ton bacitracin 
methylene disalicylate and 36.3 to 113.5 g/ton zoalene are used as an 
aid in the prevention of necrotic enteritis caused or complicated by 
Clostridium spp. or other organisms susceptible to bacitracin and for 
the development of active immunity to coccidiosis in replacement 
chickens. The combination Type C feeds containing 100 to 200 g/ton 
bacitracin methylene disalicylate and 36.3 to 113.5 g/ton zoalene are 
used as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin and for the development of active immunity to coccidiosis in 
replacement chickens. The combination Type C feeds containing 50 g/ton 
bacitracin methylene disalicylate and 113.5 g/ton zoalene are used as 
an aid in the prevention of necrotic enteritis caused or complicated by 
Clostridium spp. or other organisms susceptible to bacitracin and for 
the prevention and control of coccidiosis in broiler chickens. The 
combination Type C feeds containing 100 to 200 g/ton bacitracin 
methylene disalicylate and 113.5 g/ton zoalene are used as an aid in 
the control of necrotic enteritis caused or complicated by Clostridium 
spp. or other organisms susceptible to bacitracin and for the 
prevention and control of coccidiosis in broiler chickens. The 
supplemental NADA is approved as of November 30, 2001, and the 
regulations are amended in 21 CFR 558.680 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.
    2. Section 558.680 is amended by redesignating paragraphs (a), (b), 
and (c) as paragraphs (b), (c), and (d), respectively; by adding new 
paragraph (a); by revising newly redesignated paragraph (b); and in the 
table in paragraph (d)(1) by adding in item (i) after the entry for 
``Arsanilic acid 90 (0.01%) plus penicillin 2.4 to 50'' the entries for 
``Bacitracin methylene disalicylate 50'' and ``Bacitracin methylene 
disalicylate 100 to 200'', and by adding in item (ii) after the entry 
for ``Bacitracin 4 to 50 plus roxarsone 22.7 to 45.4 (0.0025% to 
0.005%)'' the entries for ``Bacitracin methylene disalicylate 50'' and 
``Bacitracin methylene disalicylate 100 to 200'' to read as follows:


Sec. 558.680  Zoalene.

    (a) Specifications. Type A medicated article containing 25 percent 
zoalene.
    (b) Approvals. See No. 046573 in Sec. 510.600(c) of this chapter.
* * * * *
    (d) * * * 
    (1) * * * 

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                                  Combination in grams/
      Zoalene in grams/ton                 ton             Indications for use             Limitations
----------------------------------------------------------------------------------------------------------------
          *          *            *          *           *          *                      *
(i) 36.3-113.5 (0.004-0.0125%)            * * *                   * * *                       * * *
                                  Bacitracin methylene   Replacement chickens;   Feed continuously as sole
                                    disalicylate 50       development of active   ration as in subtable in this
                                                          immunity to             item (i); grower ration not to
                                                          coccidiosis; as an      be fed to birds over 14 weeks
                                                          aid in the prevention   of age. Bacitracin methylene
                                                          of necrotic enteritis   disalicylate as provided by
                                                          caused or complicated   046573 in Sec.  510.600(c) of
                                                          by Clostridium spp.     this chapter.
                                                          or other organisms
                                                          susceptible to
                                                          bacitracin.

[[Page 6869]]

 
                                  Bacitracin methylene   Replacement chickens;   Feed continuously as sole
                                   disalicylate 100 to    development of active   ration as in subtable in this
                                   200                    immunity to             item (i). To control necrotic
                                                          coccidiosis; as an      enteritis, start medication at
                                                          aid in the control of   first clinical signs of
                                                          necrotic enteritis      disease; vary bacitracin
                                                          caused or complicated   dosage based on the severity
                                                          by Clostridium spp.     of infection; administer
                                                          or other organisms      continuously for 5 to 7 days
                                                          susceptible to          or as long as clinical signs
                                                          bacitracin.             persist, then reduce
                                                                                  bacitracin to prevention level
                                                                                  (50 grams/ton). Bacitracin
                                                                                  methylene disalicylate as
                                                                                  provided by 046573 in Sec.
                                                                                  510.600(c) of this chapter.
          *          *            *          *           *          *                      *
(ii) 113.5 (0.0125%)                      * * *                   * * *                       * * *
                                  Bacitracin methylene   Broiler chickens;       Feed continuously as sole
                                   disalicylate 50        prevention and          ration. Bacitracin methylene
                                                          control of              disalicylate as provided by
                                                          coccidiosis; as an      046573 in Sec.  510.600(c) of
                                                          aid in the prevention   this chapter.
                                                          of necrotic enteritis
                                                          caused or complicated
                                                          by Clostridium spp.
                                                          or other organisms
                                                          susceptible to
                                                          bacitracin.
                                  Bacitracin methylene   Broiler chickens;       Feed continuously as sole
                                   disalicylate 100 to    prevention and          ration. To control necrotic
                                   200                    control of              enteritis, start medication at
                                                          coccidiosis; as an      first clinical signs of
                                                          aid in the control of   disease; vary bacitracin
                                                          necrotic enteritis      dosage based on the severity
                                                          caused or complicated   of infection; administer
                                                          by Clostridium spp.     continuously for 5 to 7 days
                                                          or other organisms      or as long as clinical signs
                                                          susceptible to          persist, then reduce
                                                          bacitracin.             bacitracin to prevention level
                                                                                  (50 grams/ton). Bacitracin
                                                                                  methylene disalicylate as
                                                                                  provided by 046573 in Sec.
                                                                                  510.600(c) of this chapter.
          *          *            *          *           *          *                      *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 1, 2002.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-3614 Filed 2-13-02; 8:45 am]
BILLING CODE 4160-01-S