[Federal Register Volume 74, Number 1 (Friday, January 2, 2009)]
[Rules and Regulations]
[Page 6]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31128]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2008-N-0039]


New Animal Drugs for Use in Animal Feeds; Tiamulin

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 two supplemental new animal 
drug applications (NADAs) filed by Novartis Animal Health US, Inc. The 
supplemental NADAs provide for removal of a 250-pound weight 
restriction and the addition of a reproductive caution statement to 
labeling of tiamulin medicated feeds used for the treatment or control 
of certain bacterial enteric diseases in swine.

DATES:  This rule is effective January 2, 2009.

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to 
NADA 139-472 for DENAGARD (tiamulin) Medicated Premixes used for the 
treatment or control of certain bacterial enteric diseases in swine. 
Novartis Animal Health US, Inc., also filed a supplement to NADA 141-
011 for the use of DENAGARD (tiamulin) Medicated Premixes and 
Chlortetracycline Type A medicated articles to manufacture 2-way 
combination drug medicated swine feeds used for the treatment or 
control of certain bacterial enteric diseases. The supplemental NADAs 
provide for removal of a 250-pound weight restriction and the addition 
of a reproductive caution statement to labeling. The supplemental NADAs 
are approved as of December 9, 2008, and 21 CFR 558.600 is amended to 
reflect the approval.
    Approval of these supplemental NADAs 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 these actions are 
of a type that do 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.

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. In Sec.  558.600, revise paragraphs (d)(2) and (e)(1)(i) to read as 
follows:


Sec.  558.600  Tiamulin.

* * * * *
    (d) * * *
    (2) The effects of tiamulin on swine reproductive performance, 
pregnancy, and lactation have not been determined.
* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
    Tiamulin grams per ton         grams per ton     Indications for use      Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10........................  ...................  For increased rate   Feed continuously    058198
                                                      of weight gain and   as the sole
                                                      improved feed        ration. Not for
                                                      efficiency.          use in swine
                                                                           weighing over 250
                                                                           pounds.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: December 22, 2008.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E8-31128 Filed 12-31-08; 8:45 am]
BILLING CODE 4160-01-S