[Federal Register Volume 72, Number 239 (Thursday, December 13, 2007)]
[Rules and Regulations]
[Pages 70776-70777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; 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 new animal drug 
application (NADA) filed by Elanco Animal Health. 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 December 13, 2007.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, 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 141-234 that provides for use of OPTAFLEXX 
(ractopamine hydrochloride), MGA (melengestrol acetate), and RUMENSIN 
(monensin USP) Type A medicated articles to make dry and liquid three-
way combination Type C medicated feeds used for increased rate of 
weight gain, improved feed efficiency, and increased carcass leanness; 
for prevention and control of coccidiosis due to Eimeria bovis and E. 
zuernii; and for suppression of estrus (heat) in heifers fed in 
confinement for slaughter during the last 28 to 42 days on feed. The 
supplemental NADA provides for an increased level of monensin. The 
supplemental NADA is approved as of November 20, 2007, 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(a)(2) 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 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:

[[Page 70777]]

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.

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2. In Sec.  558.500, in the table in paragraph (e)(2), revise paragraph 
(e)(2)(viii) and add paragraph (e)(2)(xii) to read as follows:


Sec.  558.500  Ractopamine.

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

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  Ractopamine     Combination     Indications
   grams/ton       grams/ton        for use      Limitations    Sponsor
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                              * * * * * * *
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(viii) 9.8 to   Monensin 10 to  Heifers fed in  As in             000986
 24.6            40 to provide   confinement     paragraph
                 0.14 to 0.42    for             (e)(2)(vi)
                 mg monensin/    slaughter: As   of this
                 lb of body      in paragraph    section; see
                 weight,         (e)(2)(vi) of   Sec.  Sec.
                 depending on    this section;   558.342(d)
                 severity of     for             and
                 coccidiosis     prevention      558.355(d)
                 challenge, up   and control     of this
                 to 480 mg/      of              chapter.
                 head/day,       coccidiosis     Melengestrol
                 plus            due to          acetate as
                 melengestrol    Eimeria bovis   provided by
                 acetate to      and E.          No. 000009
                 provide 0.25    zuernii; and    in Sec.
                 to 0.5 mg/      for             510.600(c)
                 head/day        suppression     of this
                                 of estrus       chapter.
                                 (heat).
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                              * * * * * * *
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(xii) 9.8 to    Monensin 10 to  Heifers fed in  As in             021641
 24.6            30, plus        confinement     paragraph
                 melengestrol    for             (e)(2)(vi)
                 acetate to      slaughter: As   of this
                 provide 0.25    in paragraph    section; see
                 to 0.5 mg/      (e)(2)(vi) of   Sec.  Sec.
                 head/day        this section;   558.342(d)
                                 for             and
                                 prevention      558.355(d)
                                 and control     of this
                                 of              chapter.
                                 coccidiosis     Melengestrol
                                 due to          acetate as
                                 Eimeria bovis   provided by
                                 and E.          No. 021641
                                 zuernii; and    in Sec.
                                 for             510.600(c)
                                 suppression     of this
                                 of estrus       chapter.
                                 (heat).
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    Dated: December 5, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-24145 Filed 12-12-07; 8:45 am]
BILLING CODE 4160-01-S