Document ID: FDA-2011-N-0003-0037
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Melengestrol; Monensin; Tylosin
Posted Date: 2011-10-20T04:00Z

[Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)]
[Rules and Regulations]
[Pages 65109-65110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27139]

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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; Melengestrol; 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 abbreviated new 
animal drug application (ANADA) filed by Ivy Laboratories, Division of 
Ivy Animal Health, Inc. The supplemental ANADA provides for use of 
increased dose levels of monensin in three-way, combination drug Type C 
medicated feeds for heifers fed in confinement for slaughter containing 
melengestrol acetate, monensin, and tylosin.

DATES: This rule is effective October 20, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a 
supplement to ANADA 200-375 for use of HEIFERMAX 500 (melengestrol 
acetate), RUMENSIN (monensin, USP), and TYLAN (tylosin phosphate) 
single-ingredient Type A medicated articles to make three-way, 
combination drug Type C medicated feeds for heifers fed in confinement 
for slaughter. The supplemental ANADA provides for use of increased 
dose levels of monensin. The supplemental application is approved as of 
September 1, 2011, and the regulations in 21 CFR 558.342 are amended to 
reflect the approval.
    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 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.

[[Page 65110]]

Sec.  558.342  [Amended]

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2. In Sec.  558.342, in the table in paragraph (e)(1), remove and 
reserve paragraph (e)(1)(vii); and in paragraph (e)(1)(xi), in the 
``Sponsor'' column, add ``021641''.

    Dated: October 14, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-27139 Filed 10-19-11; 8:45 am]
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