[Federal Register Volume 72, Number 193 (Friday, October 5, 2007)]
[Rules and Regulations]
[Pages 56896-56898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19732]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs; 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 four-way combination 
Type C medicated feeds containing ractopamine, melengestrol, monensin, 
and tylosin for heifers fed in confinement for slaughter, a revision to 
bacterial pathogen nomenclature, and an increase in liver tolerance.

DATES: This rule is effective October 5, 2007.

FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0221, 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 141-233 that provides for use of OPTAFLEXX 
(ractopamine hydrochloride), MGA (melengestrol acetate), RUMENSIN 
(monensin), and TYLAN (tylosin phosphate) Type A medicated articles to

[[Page 56897]]

make dry and liquid four-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; for suppression of estrus (heat); 
and for reduction of incidence of liver abscesses caused by 
Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes 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 in four-way combination Type C medicated feeds containing 
ractopamine, melengestrol, monensin, and tylosin for heifers fed in 
confinement for slaughter, a revision to bacterial pathogen 
nomenclature, and an increase in the cattle liver tolerance. The 
supplemental NADA is approved as of September 11, 2007, and the 
regulations in 21 CFR 556.420 and 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 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

21 CFR Part 556

    Animal drugs, Foods.

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 parts 556 and 
558 are amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
1. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
2. In Sec.  556.420, revise paragraph (b)(1) to read as follows:


Sec.  556.420  Monensin.

* * * * *
    (b) * * *
    (1) Cattle--(i) Liver. 0.10 part per million (ppm).
    (ii) Muscle, kidney, and fat. 0.05 ppm.
    (iii) Milk. Not required.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
4. In Sec.  558.500, in the table in paragraph (e)(2), revise paragraph 
(e)(2)(x) and add paragraph (e)(2)(xi) to read as follows:


Sec.  558.500  Ractopamine.

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

----------------------------------------------------------------------------------------------------------------
  Ractopamine in    Combination in grams/
     grams/ton               ton                Indications for use               Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(x) 9.8 to 24.6     Monensin 10 to 40 to  Heifers fed in confinement for  As in paragraph (e)(2)(vi)      000986
                     provide 0.14 to       slaughter: As in paragraph      of this section; see
                     0.42 mg monensin/lb   (e)(2)(vi) of this section;     paragraphs Sec.  Sec.
                     of body weight,       for prevention and control of   558.342(d), 558.355(d) and
                     depending on          coccidiosis due to Eimeria      558.625(c) of this
                     severity of           bovis and E. zuernii; for       chapter. Melengestrol
                     coccidiosis           reduction of incidence of       acetate as provided by No.
                     challenge, up to      liver abscesses caused by       000009 in Sec.
                     480 mg/head/day,      Fusobacterium necrophorum and   510.600(c) of this
                     plus tylosin 8 to     Arcanobacterium (Actinomyces)   chapter.
                     10, plus              pyogenes; and for suppression
                     melengestrol          of estrus (heat).
                     acetate to provide
                     0.25 to 0.5 mg/head/
                     day
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(xi) 9.8 to 24.6    Monensin 10 to 30,    Heifers fed in confinement for  As in paragraph (e)(2)(vi)      021641
                     plus tylosin 8 to     slaughter: As in paragraph      of this section; see
                     10, plus              (e)(2)(vi) of this section;     paragraphs Sec.  Sec.
                     melengestrol          for prevention and control of   558.342(d), 558.355(d) and
                     acetate to provide    coccidiosis due to Eimeria      558.625(c) of this
                     0.25 to 0.5 mg/       bovis and E. zuernii; for       chapter. Melengestrol
                     head/day              reduction of incidence of       acetate as provided by No.
                                           liver abscesses caused by       021641 in Sec.
                                           Fusobacterium necrophorum and   510.600(c) of this
                                           Actinomyces (Corynebacterium)   chapter.
                                           pyogenes; and for suppression
                                           of estrus (heat).
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[[Page 56898]]

    Dated: September 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-19732 Filed 10-4-07; 8:45 am]
BILLING CODE 4160-01-S