Document ID: FDA-2010-N-0002-0007
Agency: fda
Document Type: Notice
Title: New Animal Drugs for Use in Animal Feeds: Ractopamine; Monensin
Posted Date: 2010-02-05T05:00Z

[Federal Register: February 5, 2010 (Volume 75, Number 24)]
[Rules and Regulations]               
[Page 5887-5888]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe10-5]                         

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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; Ractopamine; 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 an original new animal drug 
application (NADA) filed by Elanco Animal Health, A Division of Eli 
Lilly & Co. The NADA provides for use of single-ingredient Type A 
medicated articles containing ractopamine hydrochloride and monensin to 
formulate two-way combination Type C medicated feeds for finishing hen 
and tom turkeys.

DATES:  This rule is effective February 5, 2010.

FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary 
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8101, e-mail: linda.wilmot@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly

[[Page 5888]]

& Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141-
301 for use of TOPMAX (ractopamine hydrochloride) and COBAN (monensin, 
USP) single-ingredient Type A medicated articles to formulate two-way 
combination Type C medicated feeds for finishing hen and tom turkeys. 
The NADA is approved as of December 11, 2009, and the regulations in 21 
CFR 558.500 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.

0
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.

0
2. In Sec.  558.500, add paragraphs (e)(3)(iii) and (e)(3)(iv) to read 
as follows:

Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
   Ractopamine in       Combination in
     grams/ton            grams/ton            Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(iii) 4.6 to 11.8    Monensin 54 to 90    Finishing hen turkeys: As in  Feed continuously as sole         000986
 (5 to 13 ppm)                             paragraph (e)(3)(i) of this   ration during the last 7
                                           section; and for the          to 14 days prior to
                                           prevention of coccidiosis     slaughter. See Sec.
                                           in growing turkeys caused     558.355(d).
                                           by Eimeria adenoeides, E.
                                           meleagrimitis and E.
                                           gallopavonis.
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(iv) 4.6 to 11.8 (5  Monensin 54 to 90    Finishing tom turkeys: As in  Feed continuously as sole         000986
 to 13 ppm)                                paragraph (e)(3)(ii) of       ration during the last 14
                                           this section; and for the     days prior to slaughter.
                                           prevention of coccidiosis     Feeding ractopamine to tom
                                           in growing turkeys caused     turkeys during periods of
                                           by Eimeria adenoeides, E.     excessive heat can result
                                           meleagrimitis and E.          in increased mortality.
                                           gallopavonis.                 See Sec.   558.355(d).
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    Dated: February 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-2427 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S