Document ID: FDA-2010-N-0002-0030
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Melengestrol, Monensin, and Ractopamine
Posted Date: 2010-04-22T04:00Z

[Federal Register: April 22, 2010 (Volume 75, Number 77)]
[Rules and Regulations]               
[Page 20917]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap10-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0002]

 
New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, 
and Ractopamine

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, Div. of Ivy 
Animal Health, Inc. The supplemental NADA provides for an increased 
level of monensin in three-way combination Type C medicated feeds 
containing ractopamine, melengestrol, and monensin for heifers fed in 
confinement for slaughter.

DATES: This rule is effective April 22, 2010.

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, Div. of Ivy Animal Health, 
Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to 
ANADA 200-448 that provides for use of HEIFERMAX 500 (melengestrol 
acetate) Liquid Premix, OPTAFLEXX (ractopamine hydrochloride), and 
RUMENSIN (monensin, USP) single-ingredient Type A medicated articles to 
make dry and liquid, three-way combination drug Type C medicated feeds 
for heifers fed in confinement for slaughter. The supplemental ANADA 
provides for an increased level of monensin. The supplemental ANADA is 
approved as of February 16, 2010, and the regulations are amended in 21 
CFR 558.500 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.

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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

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.500  [Amended]

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2. In Sec.  558.500, in paragraph (e)(2)(viii), in the ``Limitations'' 
column, remove ``000009''and add in its place ``000009 or 021641'', and 
in the ``Sponsor'' column, remove ``No. 000986''and add in its place 
``000986, 021641''; and remove paragraph (e)(2)(xii).

    Dated: April 19, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-9304 Filed 4-21-10; 8:45 am]
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