
[Federal Register Volume 77, Number 78 (Monday, April 23, 2012)]
[Rules and Regulations]
[Pages 24138-24139]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2012-N-0002]


New Animal Drugs for Use in Animal Feeds; Tiamulin

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 Novartis Animal Health US, Inc. The 
supplemental NADA provides for approval of a new concentration of a 
Type A medicated article.

DATES: This rule is effective April 23, 2012.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, email: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc. (Novartis), 
3200 Northline Ave., Suite 300, Greensboro, NC 27408, filed a 
supplement to NADA 139-472 for DENAGARD (tiamulin hydrogen fumarate) 
Type A medicated articles for use of a new product formulation in 
medicated swine feed. The supplemental NADA is approved as of January 
6, 2012, and the regulations in 21 CFR 558.4 and 558.600 are amended to 
reflect the approval.
    The Agency has determined under 21 CFR 25.33 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.

    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 paragraph (d) of Sec.  558.4, in the ``Category II'' table, 
revise the entries for ``Tiamulin'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                            Assay limits                          Assay limits
                          Drug                            percent \1\ Type    Type B maximum    percent \1\ Type
                                                                 A                (100x)            B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Tiamulin hydrogen fumarate.............................            90-115            10 g/lb      90-115/70-130
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make a Type C medicated feed.


[[Page 24139]]

* * * * *

0
3. In Sec.  558.600, revise paragraph (a) and the heading of the first 
column in the table in paragraph (e)(1) to read as follows:


Sec.  558.600  Tiamulin.

    (a) Specifications. Type A article containing 363.2 grams of 
tiamulin hydrogen fumarate per pound.
* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Tiamulin hydrogen fumarate in
          grams per ton                  * * *               * * *               * * *               * * *
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
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* * * * *

    Dated: April 17, 2012.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2012-9708 Filed 4-20-12; 8:45 am]
BILLING CODE 4160-01-P


