[Federal Register Volume 72, Number 214 (Tuesday, November 6, 2007)]
[Rules and Regulations]
[Pages 62570-62571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21816]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs; 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 three-way combination 
Type C medicated feeds containing ractopamine, monensin, and tylosin 
for cattle fed in confinement for slaughter and a revision to bacterial 
pathogen nomenclature.

DATES: This rule is effective November 6, 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 141-224 that provides for use of OPTAFLEXX 
(ractopamine hydrochloride), RUMENSIN (monensin USP), and TYLAN 
(tylosin phosphate) Type A medicated articles to make dry and liquid 
three-way combination medicated feeds for cattle fed in confinement for 
slaughter. The supplemental NADA provides for an increased level of 
monensin in combination Type C medicated feeds and a revision to 
bacterial pathogen nomenclature. The supplemental NADA is approved as 
of October 12, 2007, and the regulations in 21 CFR 558.500 are amended 
to reflect the approval.

[[Page 62571]]

    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 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, in the table in paragraph (e)(2), revise 
paragraphs (e)(2)(iv) and (e)(2)(ix) to read as follows:


Sec.  558.500  Ractopamine.

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

----------------------------------------------------------------------------------------------------------------
  Ractopamine in
     grams/ton       Combination in grams/ton       Indications for use             Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(iv) 8.2 to 24.6    Monensin 10 to 40 to       Cattle fed in confinement     As in paragraph              000986
                     provide 0.14 to 0.42 mg    for slaughter: As in          (e)(2)(i) of this
                     monensin/lb of body        paragraph (e)(2)(i) of this   section; see Sec.  Sec.
                     weight, depending on       section; for prevention and     558.355(d) and
                     severity of coccidiosis    control of coccidiosis due    558.625(c) of this
                     challenge, up to 480 mg/   to Eimeria bovis and E.       chapter.
                     head/day, plus tylosin 8   zuernii; and for reduction
                     to 10                      of incidence of liver
                                                abscesses caused by
                                                Fusobacterium necrophorum
                                                and Arcanobacterium
                                                (Actinomyces) pyogenes.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(ix) 9.8 to 24.6    Monensin 10 to 40 to       Cattle fed in confinement     As in paragraph              000986
                     provide 0.14 to 0.42 mg    for slaughter: As in          (e)(2)(vi) of this
                     monensin/lb of body        paragraph (e)(2)(vi) of       section; see Sec.  Sec.
                     weight, depending on       this section; for               558.355(d) and
                     severity of coccidiosis    prevention and control of     558.625(c) of this
                     challenge, up to 480 mg/   coccidiosis due to Eimeria    chapter.
                     head/day, plus tylosin 8   bovis and E. zuernii; and
                     to 10                      for reduction of incidence
                                                of liver abscesses caused
                                                by Fusobacterium
                                                necrophorum and
                                                Arcanobacterium
                                                (Actinomyces) pyogenes.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


    Dated: October 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21816 Filed 11-5-07; 8:45 am]
BILLING CODE 4160-01-S