[Federal Register Volume 65, Number 212 (Wednesday, November 1, 2000)]
[Rules and Regulations]
[Pages 65270-65271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27967]


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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 Tylosin 
Phosphate

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, single-ingredient narasin and tylosin phosphate Type A 
medicated articles to make two-way combination Type C medicated feeds 
used as an aid in the prevention of coccidiosis, for increased rate of 
weight gain, and improved feed efficiency in broiler chickens.

DATES: This rule is effective November 1, 2000.

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 
141-170 that provides for use of MONTEBAN<Register> (36, 45, 54, 72, or 
90 grams per pound (g/lb) narasin activity) and TYLAN<Register> (10 g/
lb of tylosin phosphate) Type A medicated articles to make combination 
Type C medicated broiler chicken feeds. The combination Type C 
medicated feeds contain 54 to 72 g/ton narasin and 4 to 50 g/ton 
tylosin phosphate and are used for the prevention of coccidiosis caused 
by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, 
and E. maxima, increased rate of weight gain, and improved feed 
efficiency in broiler chickens. The NADA is approved as of September 
20, 2000, and the regulations in Secs. 558.363 and 558.625 (21 CFR 
558.363 and 558.625) are amended 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.


[[Page 65271]]



    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 558.363 is amended in paragraph (d)(1) by adding 
paragraph (d)(1)(xi) to read as follows:


Sec. 558.363  Narasin.

* * * * *
    (d) * * *
    (1) * * *
    (xi) Amount per ton. Narasin, 54 to 72 grams, plus tylosin, 4 to 50 
grams.
    (A) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima, for increased rate of weight gain, and improved 
feed efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or other equines 
access to formulations containing narasin. Ingestion of narasin by 
these species has been fatal. Narasin sodium and tylosin phosphate as 
provided by 000986 in Sec. 510.600(c) of this chapter.
* * * * *

    3. Section 558.625 is amended by revising paragraph (f)(2) to read 
as follows:


Sec. 558.625  Tylosin.

* * * * *
    (f) * * *
    (2) Tylosin may also be used in combination with:
    (i) Hygromycin B as in Sec. 558.274.
    (ii) Melengestrol acetate alone or in combination with certain 
ionophores as in Sec. 558.342.
    (iii) Monensin as in Sec. 558.355.
    (iv) Narasin as in Sec. 558.363.
    (v) Pyrantel tartrate as in Sec. 558.485.

    Dated: October 16, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-27967 Filed 10-31-00; 8:45 am]
BILLING CODE 4160-01-F