[Federal Register Volume 71, Number 7 (Wednesday, January 11, 2006)]
[Rules and Regulations]
[Pages 1689-1690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-228]


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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 C medicated feeds in component 
feeding systems (including top dress) for increased milk production 
efficiency in dairy cows.

DATES: This rule is effective January 11, 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 in Type C medicated feeds 
fed in component feeding systems (including top dress) used for 
increased milk production efficiency (production of marketable solids-
corrected milk per unit of feed intake) in dairy cows. The supplemental 
NADA is approved as of December 15, 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.

[[Page 1690]]

1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through 
Friday.
    FDA 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.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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.

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2. Section 558.355 is amended in the last sentence in paragraph 
(f)(3)(xiii)(B) by removing ``(d)(12)'' and adding in its place 
``(d)(13)''; and by adding paragraph (f)(3)(xiv) to read as follows:


Sec.  558.355   Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (xiv) Amount per ton. Monensin, 11 to 400 grams.
    (A) Indications for use. For increased milk production efficiency 
(production of marketable solids-corrected milk per unit of feed 
intake) in dairy cows.
    (B) Limitations. Feed continuously to dry and lactating dairy cows 
in a component feeding system (including top dress). The Type C 
medicated feed must be fed in a minimum of 1 lb of feed to provide 185 
to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day 
monensin to dry cows. See paragraphs (d)(2), (d)(5), (d)(6), (d)(7)(i), 
(d)(7)(ii), (d)(7)(iii), (d)(7)(vi), (d)(8), and (d)(13) of this 
section.
* * * * *

    Dated: January 4, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-228 Filed 1-10-06; 8:45 am]
BILLING CODE 4160-01-S