[Federal Register Volume 71, Number 1 (Tuesday, January 3, 2006)]
[Rules and Regulations]
[Pages 5-6]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs; 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

[[Page 6]]

drug application (NADA) filed by Elanco Animal Health. The supplemental 
NADA revises the description of growing cattle fed monensin Type C 
medicated feeds for increased rate of weight gain and for prevention 
and control of coccidiosis.

DATES: This rule is effective January 3, 2006.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

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 the use of RUMENSIN 80 
(monensin sodium) Type A medicated article. The supplemental NADA 
revises the description of growing cattle fed monensin Type C medicated 
feeds for increased rate of weight gain and for prevention and control 
of coccidiosis. The supplemental NADA is approved as of November 18, 
2005, and the regulations in 21 CFR 558.355 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 21 CFR 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 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(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.

0
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, in paragraph (f)(3)(iii)(b), remove ``Feed to 
pasture cattle (slaughter, stocker, feeder, and dairy and beef 
replacement heifers).''; and revise paragraphs (f)(3)(iii)(a), 
(f)(3)(x)(a), and (f)(3)(x)(c) to read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (iii) * * *
    (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.
* * * * *
    (x) * * *
    (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.
* * * * *
    (c) Limitations. Feed 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. The product's effectiveness in cull cows and bulls has not 
been established. Consumption by unapproved species may result in toxic 
reactions.
* * * * *

    Dated: December 14, 2005.
Stephen D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-24671 Filed 12-30-05; 8:45 am]
BILLING CODE 4160-01-S