[Federal Register Volume 74, Number 198 (Thursday, October 15, 2009)]
[Rules and Regulations]
[Page 52885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24716]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]


New Animal Drugs for Use in Animal Feeds; Monensin; Tylosin

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 revises limitations for liquid Type B 
medicated cattle feeds containing tylosin phosphate.

DATES: This rule is effective October 15, 2009.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, 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 12-491 for use of TYLAN (tylosin phosphate) Type A 
medicated article. For liquid Type B medicated cattle feeds containing 
tylosin phosphate, the supplement removes the presolubilization 
instructions previously required for manufacture and reduces the expiry 
from 8 weeks to 31 days. The supplemental NADA is approved as of 
September 8, 2009, and the regulations in 21 CFR 558.625 are amended to 
reflect the approval. In addition, the limitations for two-way 
combination drug medicated liquid feeds containing tylosin and monensin 
in 21 CFR 558.355 are amended to reflect the revised limitations for 
tylosin liquid feeds.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    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.

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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. In Sec.  558.355, revise paragraph (f)(3)(ii)(b) to read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (ii) * * *
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously as sole ration at the rate of 50 to 480 
milligrams of monensin and 60 to 90 milligrams of tylosin per head per 
day. Combination drug liquid Type B medicated feeds may be used to 
manufacture dry Type C medicated feeds as in Sec.  558.625(c) of this 
chapter.
* * * * *


Sec.  558.625  [Amended]

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3. In Sec.  558.625, remove and reserve paragraph (c)(2)(i); and in 
paragraph (c)(3), remove ``8 weeks'' and in its place add ``31 days''.

    Dated: September 25, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-24716 Filed 10-14-09; 8:45 am]
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