[Federal Register Volume 65, Number 172 (Tuesday, September 5, 2000)]
[Rules and Regulations]
[Pages 53582-53583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22570]


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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; Monensin 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, single ingredient monensin and bambermycins Type A medicated 
articles to make two-way combination Type C medicated feeds used for 
prevention of coccidiosis, increased rate of weight gain, and improved 
feed efficiency in growing turkeys.

DATES: This rule is effective September 5, 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 
140-955 that provides for use of Coban (45 or 60 grams per 
pound (g/lb) of monensin as monensin sodium) and Flavomycin 
(2, 4, or 10 g/lb of bambermycins activity) Type A medicated articles 
to make combination Type C medicated feeds. The combination Type C 
medicated feeds containing 54 to 90 g/ton monensin and 1 to 2 g/ton 
bambermycins and are used for prevention of coccidiosis caused by 
Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis; and for 
improved feed efficiency in growing turkeys. The combination Type C 
medicated feeds containing 54 to 90 g/ton monensin and 2 g/ton 
bambermycins and are used for prevention of coccidiosis caused by E. 
adenoeides, E. meleagrimitis, and E. gallopavonis; and for increased 
rate of weight gain and improved feed efficiency in growing turkeys. 
The NADA is approved as of June 28, 2000, and the regulations in 21 CFR 
558.95 and 558.355 are amended to reflect the approval.
    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.


    2. Section 558.95 is amended by redesignating paragraphs 
(d)(5)(iii) and (d)(5)(iv) as (d)(5)(iv) and (d)(5)(v), and by adding 
new paragraph (d)(5)(iii) to read as follows:


Sec. 558.95  Bambermycins.

* * * * *
    (d) * * *
    (5) * * *
    (iii) Monensin as in Sec. 558.355.
* * * * *

    3. Section 558.355 is amended by adding paragraphs (f)(2)(v) and 
(f)(2)(vi) to read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (2) * * *
    (v) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 1 
to 2 grams.
    (a) Indications for use. For the prevention of coccidiosis in 
turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, 
and for improved feed efficiency in growing turkeys.
    (b) Limitations. For growing turkeys only. Feed continuously as 
sole ration. Some strains of turkey coccidia may be monensin tolerant 
or resistant. Monensin may interfere with development of immunity to 
turkey coccidiosis. Bambermycins as provided by No. 012799 in 
Sec. 510.600(c) of this chapter.
    (vi) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 2 
grams.
    (a) Indications for use. For the prevention of coccidiosis in 
turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, 
and

[[Page 53583]]

for increased rate of weight gain and improved feed efficiency in 
growing turkeys.
    (b) Limitations. For growing turkeys only. Feed continuously as 
sole ration. Some strains of turkey coccidia may be monensin tolerant 
or resistant. Monensin may interfere with development of immunity to 
turkey coccidiosis. Bambermycins as provided by No. 012799 in 
Sec. 510.600(c) of this chapter.
* * * * *

    Dated: August 23, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-22570 Filed 9-1-00; 8:45 am]
BILLING CODE 4160-01-F