[Federal Register Volume 64, Number 21 (Tuesday, February 2, 1999)]
[Rules and Regulations]
[Pages 4965-4966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2411]


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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

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 Elanco Animal Health, a Division of Eli Lilly & Co. The 
NADA provides for combining approved narasin/nicarbazin (1:1 fixed 
ratio) and bacitracin methylene disalicylate (BMD) Type A medicated 
articles to make combination drug Type C medicated broiler chicken 
feeds for prevention of certain forms of coccidiosis and for increased 
rate of weight gain and improved feed efficiency.

EFFECTIVE DATE: February 2, 1999.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, a Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 
140-926 that provides for combining approved narasin/nicarbazin (1:1 
fixed ratio) Maxiban and BMD Type A medicated articles to 
make combination drug Type C medicated broiler chicken feeds. The feeds 
contain 27 to 45 grams per ton (g/t) each of narasin and nicarbazin and 
4 to 50 g/t BMD. The feeds are used for the prevention of coccidiosis 
caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. 
brunetti, and E. mivati, and for increased rate of weight gain and 
improved feed efficiency. The NADA is approved as of January 4, 1999, 
and the regulations are amended in 21 CFR 558.76, 558.363, and 558.366 
to reflect the approval.

[[Page 4966]]

    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.
    This approval is for use of approved Type A medicated articles to 
make combination drug Type C medicated feeds. One ingredient, 
nicarbazin, is a Category II drug 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 
for making a Type B or C medicated feed as in this application. 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 manufacture in a licensed feed mill. Therefore, 
use of narasin/nicarbazin and BMD Type A medicated articles to make 
Type C medicated feeds as in NADA 140-926 requires manufacture in a 
licensed feed mill.
    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)(xix) to 
read as follows:

Sec. 558.76  Bacitracin methylene disalicylate.

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

Sec. 558.363  Narasin.

* * * * *
    (d) * * *
    (2) * * *
    (ii) Nicarbazin and bacitracin methylene disalicylate 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 ``Narasin 27 
to 45 and bacitracin methylene disalicylate 4 to 50'' to read as 
follows:

Sec. 558.366  Nicarbazin.

* * * * *
    (c) * * *

 
----------------------------------------------------------------------------------------------------------------
 Nicarbazin in grams    Combination in grams
       per ton                per ton          Indications for use        Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
27 to 45
                       Narasin 27 to 45 and   Broiler chickens;      Feed continuously as   000986
                        bacitracin methylene   prevention of          sole ration.
                        disalicylate 4 to 50   coccidiosis caused     Withdraw 5 days
                                               by Eimeria tenella,    before slaughter. Do
                                               E. necatrix, E.        not allow turkeys,
                                               acervulina, E.         horses, or other
                                               maxima, E. brunetti,   equines access to
                                               E. mivati; for         formulations
                                               increased rate of      containing narasin.
                                               weight gain and        Ingestion of narasin
                                               improved feed          by these species has
                                               efficiency.            been fatal. Do not
                                                                      feed to laying hens.
                                                                      Narasin and
                                                                      nicarbazin as
                                                                      provided by 000986,
                                                                      bacitracin methylene
                                                                      disalicylate by
                                                                      046573.
  *                    *                    *                    *                    *                    *
                                                             *
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    Dated: January 22, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-2411 Filed 2-1-99; 8:45 am]
BILLING CODE 4160-01-F