[Federal Register Volume 66, Number 95 (Wednesday, May 16, 2001)]
[Rules and Regulations]
[Pages 27022-27023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12229]


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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, Nicarbazin, 
and Bambermycins

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. The NADA provides for use of 
approved narasin/nicarbazin and bambermycins Type A medicated articles 
to make three-way combination Type C medicated feeds used for 
prevention of coccidiosis, increased rate of weight gain, and improved 
feed efficiency in broiler chickens.

DATES: This rule is effective May 16, 2001.

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 
140-942 that provides for use of Maxiban<Register> (36 grams per pound 
(g/lb) each of narasin and nicarbazin) and Flavomycin<Register> (2, 4, 
or 10 g/lb of bambermycins activity) Type A medicated articles to make 
three-way combination Type C medicated feeds for use in broiler 
chickens. The combination Type C medicated feeds contain 27 to 45 g/ton 
narasin and 27 to 45 g/ton nicarbazin (in a fixed 1:1 ratio) and 1 to 2 
g/ton bambermycins, and are used for prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, and E. 
mivati, and for increased rate of weight gain and improved feed 
efficiency. The NADA is approved as of March 8, 2001, and the 
regulations are amended in 21 CFR 558.95 and 558.363 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 
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.


Sec. 558.95  [Amended]

    2. Section 558.95 Bambermycins is amended in paragraph (d)(5)(iv) 
by adding ``nicarbazin or'' following ``with'', and in paragraph 
(d)(5)(v) by removing ``Nicarbazine'' and adding in its place 
``Nicarbazin''.
    3. Section 558.363 is amended by adding paragraph (d)(1)(xii) to 
read as follows:


Sec.  558.363  Narasin.

* * * * *

[[Page 27023]]

    (d)  *  *  *
    (1)  *  *  *
    (xii) Amount per ton. Narasin, 27 to 45 grams; nicarbazin, 27 to 45 
grams; and bambermycins, 1 to 2 grams.
    (A) Indications for use. 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.
    (B) Limitations. Feed continuously as the sole ration. Do not allow 
adult turkeys, horses, or other equines access to formulations 
containing narasin. Ingestion of narasin by these animals has been 
fatal. Do not feed to laying hens. Withdraw 5 days before slaughter. 
Narasin and nicarbazin as provided by 000986, bambermycins by 012799 in 
Sec. 510.600(c) of this chapter.
* * * * *

    Dated: April 23, 2001.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 01-12229 Filed 5-15-01; 8:45 am]
BILLING CODE 4160-01-S