[Federal Register Volume 72, Number 233 (Wednesday, December 5, 2007)]
[Rules and Regulations]
[Pages 68478-68479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23519]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; Monensin

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 
revises the concentration of monensin in two-way Type B and Type C 
medicated feeds containing monensin and tylosin to cattle fed in 
confinement for slaughter and a revision to bacterial pathogen 
nomenclature.

DATES: This rule is effective December 5, 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 104-646 that provides for use of RUMENSIN (monensin 
USP) and TYLAN (tylosin phosphate) 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 and a revision to bacterial pathogen nomenclature. The 
supplemental NADA is approved as of October 30, 2007, and the 
regulations in 21 CFR 558.355 are amended to reflect the approval.

[[Page 68479]]

    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.

0
2. In Sec.  558.355, revise paragraphs (f)(3)(ii) and (f)(3)(xii) to 
read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (ii) Amount per ton. Monensin, 5 to 40 grams; plus tylosin, 8 to 10 
grams.
    (a) Indications for use. Cattle fed in confinement for slaughter: 
For improved feed efficiency; and reduction of incidence of liver 
abscesses caused by Fusobacterium necrophorum and Arcanobacterium 
(Actinomyces) pyogenes.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously as sole ration at the rate of 50 to 480 
milligrams of monensin and 60 to 90 milligrams of tylosin per head per 
day. Combination drug liquid Type B medicated feeds may be used to 
manufacture dry Type C medicated feeds and shall conform to mixing 
instructions as in Sec.  558.625(c) of this chapter.
* * * * *
    (xii) Amount per ton. Monensin, 10 to 40 grams; plus tylosin, 8 to 
10 grams.
    (a) Indications for use. Cattle fed in confinement for slaughter: 
For prevention and control of coccidiosis due to E. bovis and E. 
zuernii; and reduction of incidence of liver abscesses caused by 
Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. For prevention and control of coccidiosis, feed at a rate of 
0.14 to 0.42 milligrams monensin per pound of body weight per day, 
depending upon the severity of challenge, up to maximum of 480 
milligrams per head per day; and 60 to 90 milligrams of tylosin per 
head per day.
* * * * *

    Dated: November 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-23519 Filed 12-4-07; 8:45 am]
BILLING CODE 4160-01-S