[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Rules and Regulations]
[Pages 65666-65667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22882]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 two-way combination Type 
B and Type C medicated feeds containing ractopamine hydrochloride and 
monensin for cattle fed in confinement for slaughter.

DATES: This rule is effective November 23, 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 141 225 that provides for use of OPTAFLEXX 
(ractopamine hydrochloride) and RUMENSIN (monensin USP) Type A 
medicated articles to make dry and liquid two-way combination medicated 
feeds for cattle fed in confinement for slaughter. The supplemental 
NADA provides for an increased level of monensin in combination Type B 
and Type C medicated feeds. The supplemental NADA is approved as of 
October 30, 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:

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 65667]]


0
2. In Sec.  558.500, in the table in paragraph (e)(2), revise 
paragraphs (e)(2)(ii) and (e)(2)(vii) to read as follows:


Sec.  558.500  Ractopamine.

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

------------------------------------------------------------------------
 Ractopamine     Combination     Indications for
  grams/ton       grams/ton            use         Limitations   Sponsor
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
(ii) 8.2 to   Monensin 10 to    Cattle fed in     As in         000986
 24.6          40 to provide     confinement for   paragraph
               0.14 to 0.42 mg   slaughter: As     (e)(2)(i)
               monensin/lb of    in paragraph      of this
               body weight,      (e)(2)(i) of      section;
               depending on      this section;     see
               severity of       for prevention    paragraph
               coccidiosis       and control of    Sec.  Sec.
               challenge, up     coccidiosis due
               to 480 mg/head/   to Eimeria        558.355(d)
               day               bovis and E       of this
                                 zuernii.          chapter.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
(vii) 9.8 to  Monensin 10 to    Cattle fed in     As in         000986
 24.6          40 to provide     confinement for   paragraph
               0.14 to 0.42 mg   slaughter: As     (e)(2)(vi)
               monensin/lb of    in paragraph      of this
               body weight,      (e)(2)(vi) of     section;
               depending on      this section;     see
               severity of       for prevention    paragraph
               coccidiosis       and control of    Sec.  Sec.
               challenge, up     coccidiosis due
               to 480 mg/head/   to Eimeria        558.355(d)
               day               bovis and E       of this
                                 zuernii.          chapter.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------


    Dated: November 8, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-22882 Filed 11-21-07; 8:45 am]
BILLING CODE 4160-01-S