[Federal Register Volume 69, Number 28 (Wednesday, February 11, 2004)]
[Rules and Regulations]
[Pages 6557-6558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2893]


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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; technical amendment.

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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 revised labeling for the use of single-ingredient monensin 
Type A medicated articles to make Type C medicated feeds used for the 
prevention and control of coccidiosis in feedlot cattle. The 
regulations are being amended to remove a redundant entry for use of 
monensin in Type C medicated cattle feeds.

DATES:  This rule is effective February 11, 2004.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 95-735 for use of RUMENSIN 80 (monensin sodium) Type 
A medicated article. The supplemental NADA provides revised labeling 
for Type C medicated feeds containing 10 to 30 grams per ton (g/ton) of 
monensin used for the prevention and control of coccidiosis caused by 
Eimeria bovis and E. zuernii in feedlot cattle. This revised labeling 
replaces labeling approved in 1998 for this indication (64 FR 5158, 
February 3, 1999). The supplemental application is approved as of 
December 12, 2003, and the regulations are amended in 21 CFR 
558.355(f)(3)(vii) to remove indications for improved feed efficiency 
in cattle feeds containing 10 to 30 g/ton of monensin. This indication 
for use is already codified in 21 CFR 558.355(f)(3)(i) for cattle feeds 
containing 5 to 30 g of monensin per ton.
    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,

[[Page 6558]]

neither an environmental assessment nor 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.

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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.


Sec. 558.355  [Amended]

0
2. Section 558.355 Monensin is amended in paragraph (f)(3)(vii)(a) by 
removing ``improved feed efficiency; for''; and in paragraph 
(f)(3)(vii)(b) by removing ``feed continuously to provide 50 to 360 
milligrams monensin per head per day. For prevention and control of 
coccidiosis,''.

    Dated: January 30, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-2893 Filed 2-10-04; 8:45 am]
BILLING CODE 4160-01-S