Document ID: FDA-2011-N-0003-0054
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Monensin
Posted Date: 2011-12-21T05:00Z

[Federal Register Volume 76, Number 245 (Wednesday, December 21, 2011)]
[Rules and Regulations]
[Pages 79064-79065]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32427]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2011-N-0003]

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, A Division of Eli 
Lilly & Co. The supplemental NADA revises a manufacturing specification 
for monensin free-choice Type C medicated feed for growing cattle on 
pasture or in dry lot.

DATES: This rule is effective December 21, 2011.

FOR FURTHER INFORMATION CONTACT: Matthew A. Lucia, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8116, email: 
matthew.lucia@fda.hhs.gov.

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 90 
(monensin, USP) Type A medicated article in a free-choice Type C 
medicated feed for growing cattle on pasture or in dry lot (stocker and 
feeder cattle and dairy and beef replacement heifers). The supplement 
revises the percent monensin Type A medicated article in the codified 
free-choice feed specifications to reflect use of a product containing 
90.7 grams of monensin per pound. The supplemental NADA is approved as 
of May 24, 2011, and the regulations in 21 CFR 558.355 are amended to 
reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The Agency has determined under 21 CFR 25.33 that this action is of 
a type

[[Page 79065]]

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.

    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. In Sec.  558.355, revise paragraph (f)(3)(x) introductory text and 
paragraph (f)(3)(x)(b) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (x) Amount per ton. 1,620 grams monensin, USP.
* * * * *
    (b) Specifications. Use as free-choice Type C medicated feed 
formulated as mineral granules as follows:

------------------------------------------------------------------------
                                                      International feed
           Ingredient                   Percent               No.
------------------------------------------------------------------------
Monocalcium phosphate (21%                     29.49            6-01-082
 phosphorus, 15% calcium).......
Sodium chloride (salt)..........               24.37            6-04-152
Dried cane molasses.............               20.0             4-04-695
Ground limestone (33% calcium)                 13.75            6-02-632
 or calcium carbonate (38%
 calcium).......................
Cane molasses...................                3.0             4-04-696
Processed grain by-products (as                 5.0   ..................
 approved by AAFCO).............
Vitamin/trace mineral premix \1\                2.5   ..................
Monensin Type A article, 90.7                   0.89  ..................
 grams per pound................
Antidusting oil.................                1.0   ..................
------------------------------------------------------------------------
\1\ Content of the vitamin/trace mineral premix may be varied. However,
  they should be comparable to those used for other free-choice feeds.
  Formulation modifications require FDA approval prior to marketing. The
  amount of selenium and ethylenediamine dihydroiodide (EDDI) must
  comply with the published requirements. (For selenium see 21 CFR
  573.920; for EDDI see 51 FR 11483 (April 3, 1986).)

* * * * *

    Dated: December 9, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-32427 Filed 12-20-11; 8:45 am]
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