[Federal Register Volume 64, Number 72 (Thursday, April 15, 1999)]
[Rules and Regulations]
[Pages 18574-18575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9454]


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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; Narasin and Nicarbazin 
With Bacitracin Methylene Disalicylate and Roxarsone

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 using approved 
narasin and nicarbazin, bacitracin methylene disalicylate (BMD), and 
roxarsone Type A medicated articles to make Type C medicated broiler 
chicken feeds.

EFFECTIVE DATE: April 15, 1999.
FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-112 that provides for 
combining approved MaxibanTM (27 grams per pound (g/lb) each 
of narasin and nicarbazin), BMD (10, 25, 30, 40, 50, 60, or 
75 g/lb BMD), and 3-Nitro (45.4, 90, or 227 g/lb roxarsone) 
Type A medicated articles to make Type C medicated broiler chicken 
feeds. The Type C feed contains 27 to 45 g/ton (t) each of narasin and 
nicarbazin, 50 g/t BMD, and 22.7 to 45.4 g/t roxarsone. The Type C feed 
is used for prevention of coccidiosis caused by Eimeria tenella, E. 
necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, as an 
aid in the prevention of necrotic enteritis caused or complicated by 
Clostridium spp. or other organisms susceptible to bacitracin, for 
increased rate of weight gain, improved feed efficiency, and improved 
pigmentation.
    The NADA is approved as of March 4, 1999, and the regulations are 
amended by adding 21 CFR 558.76(d)(3)(xxi), 558.363(d)(2)(iii), and 
558.530(d)(5)(xxv), and by amending 21 CFR 558.366(c) to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
    This approval is for use of Type A medicated articles to make 
combination drug Type C medicated feeds. Narasin with nicarbazin and 
roxarsone are Category II drugs as defined in 21 CFR 558.3(b)(1)(ii). 
As provided in 21 CFR 558.4(b), an approved form FDA 1900 is required 
to make a Type C medicated feed from a Category II drug. Under 21 
U.S.C. 360b(m), as amended by the Animal Drug Availability Act of 1996 
(Pub. L. 104-250), medicated feed applications have been replaced by a 
requirement for feed mill licenses. Therefore, use of Type A medicated 
articles to make Type C medicated feeds as provided in NADA 141-112 is 
limited to manufacture in a licensed feed mill.
    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.

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 adding paragraph (d)(3)(xxi) to 
read as follows:


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (xxi) Narasin with nicarbazin and roxarsone as in Sec. 558.366.
    3. Section 558.363 is amended by adding paragraph (d)(2)(iii) to 
read as follows:


Sec. 558.363  Narasin.

* * * * *
    (d) * * *
    (2) * * *
    (iii) Bacitracin methylene disalicylate, nicarbazin, and roxarsone 
as in Sec. 558.366.
    4. Section 558.366 is amended in the table in paragraph (c) under 
entry ``27 to 45'' by alphabetically adding an entry for ``Naracin 27 
to 45, bacitracin methylene disalicylate 50, and roxarsone 22.7 to 
45.4'' to read as follows:


Sec. 558.366  Nicarbazin.

* * * * *
    (c) * * *

 
----------------------------------------------------------------------------------------------------------------
Nicarbazin in grams   Combination in grams
      per ton                per ton            Indications for use            Limitations            Sponsor
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27 to 45

[[Page 18575]]

 
  *                                       *                    *                    *                    *
                     Narasin 27 to 45,       Broiler chickens;          Feed continuously as       046573
                      bacitracin methylene    prevention of              sole ration. Withdraw 5
                      disalicylate 50, and    coccidiosis caused by      days before slaughter.
                      roxarsone 22.7 to       Eimeria tenella, E.        Do not allow turkeys,
                      45.4.                   necatrix, E. acervulina,   horses or other equines
                                              E. maxima, E. brunetti,    access to formulations
                                              and E. mivati, as an aid   containing narasin.
                                              in the prevention of       Ingestion of narasin by
                                              necrotic enteritis         these species has been
                                              caused or complicated by   fatal. Do not feed to
                                              Clostridium spp. or        laying hens. Use as
                                              other organisms            sole source of organic
                                              susceptible to             arsenic. Narasin and
                                              bacitracin, for            nicarbazin as provided
                                              increased rate of weight   by 000986, bacitracin
                                              gain, improved feed        methylene disalicylate
                                              efficiency, and improved   and roxarsone by
                                              pigmentation.              046573.
  *                   *                   *                    *                    *                    *
                                                            *
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    5. Section 558.530 is amended by adding paragraph (d)(5)(xxv) to 
read as follows:


Sec. 558.530  Roxarsone.

* * * * *
    (d) * * *
    (5) * * *
    (xxv) Bacitracin methylene disalicylate, narasin, and nicarbazin as 
in Sec. 558.366.

    Dated: April 1, 1999.
George A. Mitchell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 99-9454 Filed 4-15-99; 8:45 am]
BILLING CODE 4160-01-F