Document ID: FDA-2010-N-0002-0052
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feed: Ractopamine
Posted Date: 2010-09-03T04:00Z

[Federal Register: September 3, 2010 (Volume 75, Number 171)]
[Rules and Regulations]               
[Page 54019-54020]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se10-6]                         

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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 Feed; 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 two supplemental new animal 
drug applications (NADAs) filed by Elanco Animal Health, A Division of 
Eli Lilly & Co. The supplemental NADAs provide for administering a Type 
C medicated feed containing ractopamine hydrochloride as a top dress on 
Type C medicated feeds containing monensin, USP, or monensin, USP, and 
tylosin phosphate to cattle fed in confinement for slaughter.

DATES: This rule is effective September 3, 2010.

FOR FURTHER INFORMATION CONTACT:  Suzanne J. Sechen, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail: 
suzanne.sechen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 141-225 that provides for use of OPTAFLEXX 
(ractopamine hydrochloride) and RUMENSIN (monensin, USP) Type A 
medicated articles to formulate two-way combination drug Type C 
medicated feeds for cattle fed in confinement for slaughter. Elanco 
Animal Health also filed a supplement to NADA 141-224 that provides for 
use of OPTAFLEXX (ractopamine hydrochloride), RUMENSIN (monensin, USP), 
and TYLAN (tylosin phosphate) Type A medicated articles to formulate 
three-way combination drug Type C medicated feeds for cattle fed in 
confinement for slaughter.
    The supplemental NADAs provide for administering ractopamine 
hydrochloride Type C medicated feeds as a top dress on Type C medicated 
feeds containing monensin, USP, or monensin, USP, and tylosin phosphate 
to cattle fed in confinement for slaughter as the means by which the 
two-way or three-way combinations will be created. Supplemental NADA 
141-224 is approved as of June 7, 2010; supplemental NADA 141-225 is 
approved as of June 17, 2010; and the regulations in 21 CFR 558.500 are 
amended to reflect the approvals.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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 these actions are 
of a type that do 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

    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)(2)(xii) and (e)(2)(xiii) to 
read as follows:

Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
    (2) * * *

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                                  Combination in
   Ractopamine in  grams/ton         grams/ton       Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(xii) Not to exceed 800; to      Monensin 10 to    Cattle fed in            Top dress ractopamine         000986
 provide 70 to 400 mg/head/day.   40 to provide     confinement for          in a minimum of 1.0 lb
                                  0.14 to 0.42 mg   slaughter: As in         of medicated feed
                                  monensin/lb of    paragraph (e)(2)(i) of   during the last 28 to
                                  body weight,      this section; for        42 days on feed. Not
                                  depending on      prevention and control   for animals intended
                                  severity of       of coccidiosis due to    for breeding. See Sec.
                                  coccidiosis       Eimeria bovis and E.       558.355(d).
                                  challenge, up     zuernii.
                                  to 480 mg/head/
                                  day.
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[[Page 54020]]

(xiii) Not to exceed 800; to     Monensin 10 to    Cattle fed in            Top dress ractopamine         000986
 provide 70 to 400 mg/head/day.   40 to provide     confinement for          in a minimum of 1.0 lb
                                  0.14 to 0.42 mg   slaughter: As in         of medicated feed
                                  monensin/lb of    paragraph (e)(2)(i) of   during the last 28 to
                                  body weight,      this section; for        42 days on feed. Not
                                  depending on      prevention and control   for animals intended
                                  severity of       of coccidiosis due to    for breeding. See Sec.
                                  coccidiosis       Eimeria bovis and E.      Sec.   558.355(d) and
                                  challenge, up     zuernii; and for         558.625(c).
                                  to 480 mg/head/   reduction of incidence
                                  day, plus         of liver abscesses
                                  tylosin 8 to      caused by
                                  10.               Fusobacterium
                                                    necrophorum and
                                                    Arcanobacterium
                                                    (Actinomyces)
                                                    pyogenes.
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* * * * *

    Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-22071 Filed 9-2-10; 8:45 am]
BILLING CODE 4160-01-S