Document ID: FDA-2012-N-0002-0003
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Tiamulin
Posted Date: 2012-04-17T04:00Z

[Federal Register Volume 77, Number 74 (Tuesday, April 17, 2012)]
[Rules and Regulations]
[Pages 22667-22668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9196]

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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 the withdrawal of approval of those parts 
of a new animal drug application (NADA) for a tiamulin Type A medicated 
article that pertain to the production indications for use of increased 
rate of weight gain and improved feed efficiency in swine.

DATES: This rule is effective April 17, 2012.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish

[[Page 22668]]

Pl., Rockville, MD 20855, 240-276-8341, email: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novartis Animal Health U.S., Inc. 
(Novartis), 3200 Northline Ave., suite 300, Greensboro, NC 27408, has 
requested that FDA withdraw approval of those parts of NADA 139-472 for 
DENAGARD (tiamulin) Type A medicated article pertaining to the 
production indications for use of increased rate of weight gain and 
improved feed efficiency in swine. Novartis requested voluntary 
withdrawal of approval of these indications for use because the product 
is no longer marketed for these uses. Revised product labeling 
reflecting the withdrawal of these indications has been approved in a 
supplement to NADA 139-472.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that the approval of those parts of NADA 139-472 pertaining to the 
production indications for use of increased rate of weight gain and 
improved feed efficiency in swine is withdrawn, effective April 17, 
2012. As provided for in the regulatory text of this document, the 
animal drug regulations are amended to reflect this withdrawal of 
approval.
    With the withdrawal of approval of the production indications for 
tiamulin, the lowest concentration of the drug in feed now has a 
preslaughter withdrawal period. In accordance with 21 CFR 
558.3(b)(1)(ii), tiamulin is now a Category II drug, and the table in 
21 CFR 558.4(d) is revised to reflect that change. However, the maximum 
concentration of tiamulin in Type B feeds is not being increased from 
the current 3.5 grams per pound (g/lb) because there is an approved 5-
g/lb Type A medicated article.
    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 Director of 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 I'' table, remove 
the entry for ``Tiamulin''; and in the ``Category II'' table, 
alphabetically add a new entry for ``Tiamulin'' to read as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                                                                   Assay limits
                  Drug                     Assay limits percent \1\     Type B maximum  (100x)      percent \1\
                                                    Type A                                         Type B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Tiamulin................................  113.4 g/lb, 100-108.......  3.5 g/lb (0.8%)...........          90-115
                                          5 and 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 limits, 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 Type C medicated feed.

* * * * *

Sec.  558.600  [Amended]

0
3. In Sec.  558.600, in the table, remove and reserve paragraph 
(e)(1)(i).

    Dated: March 21, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-9196 Filed 4-16-12; 8:45 am]
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