Document ID: FDA-2011-N-0003-0068
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Monensin
Posted Date: 2012-01-27T05:00Z

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Page 4228]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1755]

[[Page 4228]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2011-N-0003]

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, A Division of Eli 
Lilly & Co. The supplemental NADA provides for approval of free-choice 
feeds for growing cattle on pasture or in dry lot (stocker and feeder 
cattle and dairy and beef replacement heifers).

DATES: This rule is effective January 27, 2012.

FOR FURTHER INFORMATION CONTACT: Suzanne Sechen, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, (240) 276-8105, email: suzanne.sechen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 95-735 that provides for use of RUMENSIN 90 
(monensin) Type A medicated article in free-choice feeds for growing 
cattle on pasture or in dry lot (stocker and feeder cattle and dairy 
and beef replacement heifers) for increased rate of weight gain and for 
prevention and control of coccidiosis. The supplemental NADA is 
approved as of November 18, 2011, and the regulations in 21 CFR 558.355 
are amended to reflect the approval.
    A summary of safety and effectiveness data and information 
submitted to support approval of this application may be seen in the 
Division of Dockets Management (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 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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority:  21 U.S.C. 360b, 371.

0
2. In Sec.  558.355, add paragraph (f)(3)(iv); and in paragraph 
(f)(3)(x)(c), remove the last sentence.
    The addition reads as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (iv) Amount. Monensin at concentrations in free-choice Type C 
medicated feeds to provide 50 to 200 mg per head per day.
    (a) Indications for use. Growing cattle on pasture or in dry lot 
(stocker and feeder cattle and dairy and beef replacement heifers): For 
increased rate of weight gain; for prevention and control of 
coccidiosis due to Eimeria bovis and E. zuernii.
    (b) Limitations. 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 supplement before using the monensin 
medicated supplement. The product's effectiveness in cull cows and 
bulls has not been established. See paragraph (d) of this section for 
other required label warnings.
* * * * *

    Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1755 Filed 1-26-12; 8:45 am]
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