[Federal Register Volume 72, Number 4 (Monday, January 8, 2007)]
[Rules and Regulations]
[Page 653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4]


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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; Monensin

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 
revises the concentration of monensin in Type C medicated feeds used 
for improved feed efficiency, and for the prevention and control of 
coccidiosis in cattle fed in confinement for slaughter.

DATES: This rule is effective January 8, 2007.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, 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 95-735 that provides for use of RUMENSIN 80 
(monensin) Type A medicated articles. The supplement revises the 
concentration of monensin in Type C medicated feeds used for improved 
feed efficiency, and for the prevention and control of coccidiosis in 
cattle fed in confinement for slaughter. The supplemental NADA is 
approved as of December 1, 2006, and the regulations in 21 CFR 558.355 
are amended to reflect the approval. The basis of approval is discussed 
in the freedom of information summary.
    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.
    FDA has carefully considered the potential environmental impact of 
this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Division of Dockets 
Management (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.
    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 
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. Section 558.355 is amended as follows:
    a. Revise paragraph (d)(2);
    b. Revise the introductory text of paragraphs (f)(3)(i) and 
(f)(3)(vii);
    c. Revise paragraph (f)(3)(vii)(b);
    d. Amend paragraph (f)(3)(i)(b)(1) by revising the second sentence 
and adding a new third sentence.
    The revisions read as follows:


Sec.  558.355  Monensin.

* * * * *
    (d) * * *
    (2) Type C cattle feeds containing 40 grams or less monensin per 
ton shall bear an expiration date of 30 days after its date of 
manufacture.
    (f) * * *
    (3) * * *
    (i) [Amount per ton]. Monensin, 5 to 40 grams.
    (b) * * *
    (1) Limitations. * * * Feed continuously in complete feed at a rate 
of 50 to 480 milligrams of monensin per head per day. No additional 
improvement in feed efficiency has been shown from feeding monensin at 
levels greater than 30 grams per ton (360 milligrams per head per day). 
* * *
* * * * *
    (vii) Amount per ton. Monensin, 10 to 40 grams.
* * * * *
    (b) Limitations. For cattle fed in confinement for slaughter, feed 
at a rate of 0.14 to 0.42 milligram per pound of body weight per day, 
depending upon the severity of challenge, up to maximum of 480 
milligrams per head per day.
* * * * *

    Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E7-4 Filed 1-5-07; 8:45 am]
BILLING CODE 4160-01-S