[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Pages 45879-45880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18821]


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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

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 supplemental new animal drug 
application (NADA) filed by Elanco Animal Health. The supplemental NADA 
provides for use of monensin Type A medicated article to make Type C 
medicated feed formulated as mineral granules for free-choice feeding 
for the prevention and control of coccidiosis, and increased rate of 
weight gain in pasture cattle (slaughter, stocker, feeder, and dairy 
and beef replacement heifers). A technical correction is also being 
made.

DATES: This rule is effective July 26, 2000.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
supplemental NADA 95-735 that provides for use of RUMENSIN 80 
(80 grams per pound (g/lb) of monensin as monensin sodium) Type A 
medicated article to make Type C medicated feed formulated as mineral 
granules for free-choice feeding to pasture cattle. The free-choice 
medicated mineral granules contain 1,620 g/ton monensin and are used 
for prevention and control of coccidiosis caused by Eimeria bovis and 
E. zuernii, and for increased rate of weight gain in pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers). 
The supplemental NADA is approved as of July 7, 2000, and the 
regulations are amended in Sec. 558.355(f)(3)(x) (21 CFR 
558.355(f)(3)(x)) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, Sec. 558.355(d)(6) is revised to reflect current 
precautionary statements regarding the ingestion of monensin-containing 
formulations by unapproved species.

[[Page 45880]]

    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)(1) 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 558.355 is amended by revising paragraphs (d)(6), 
(f)(3)(x)(a), and (f)(3)(x)(c) to read as follows:


Sec. 558.355  Monensin.

* * * * *
    (d) * * *
    (6) The labeling of all formulations containing monensin shall bear 
the following caution statement: Do not allow horses, other equines, 
mature turkeys, or guinea fowl access to feed containing monensin. 
Ingestion of monensin by horses and guinea fowl has been fatal.
* * * * *
    (f) * * *
    (3) * * *
    (x) * * *
    (a) Indications for use. For increased rate of weight gain; and for 
prevention and control of coccidiosis caused by Eimeria bovis and E. 
zuernii in pasture cattle (slaughter, stocker, feeder, and dairy and 
beef replacement heifers).
* * * * *
    (c) Limitations. For free-choice feeding to pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers) at 
a rate of 50 to 200 milligrams per head per day. During the first 5 
days of feeding, cattle should receive no more than 100 milligrams per 
day. Do not feed additional salt or minerals. Do not mix with grain or 
other feeds. Monensin is toxic to cattle when consumed at higher than 
approved levels. Stressed and/or feed- and/or water-deprived cattle 
should be adapted to the pasture and to unmedicated mineral supplement 
before using the monensin mineral supplement. Do not feed to lactating 
dairy cattle. The product's effectiveness in cull cows and bulls has 
not been established. Consumption by unapproved species may result in 
toxic reactions. A feed manufacturing facility must possess a medicated 
feed mill license issued under Sec. 515.20 of this chapter in order to 
manufacture this free-choice Type C feed.
* * * * *

    Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-18821 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F