[Federal Register Volume 70, Number 242 (Monday, December 19, 2005)]
[Rules and Regulations]
[Pages 75017-75018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558


New Animal Drugs; Change of Sponsor; 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 a change of sponsor for four approved new 
animal drug applications (NADAs) for oral dosage forms and feed uses of 
tiamulin from Boehringer Ingelheim Vetmedica, Inc., to Novartis Animal 
Health US, Inc.

DATES: This rule is effective December 19, 2005.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, has informed FDA that it 
has transferred ownership of, and all rights and interest in, the 
following four approved NADAs, to Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408:

------------------------------------------------------------------------
          NADA Number                           Trade Name
------------------------------------------------------------------------
134-644                          DENAGARD (tiamulin) Soluble Antibiotic
------------------------------------------------------------------------
139-472                          DENAGARD (tiamulin) 25% Premixes
------------------------------------------------------------------------
140-916                          DENAGARD (tiamulin) Liquid Concentrate
------------------------------------------------------------------------
141-011                          DENAGARD (tiamulin)/chlortetracycline
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.2455, 520.2456, and 558.600 to reflect the transfer of ownership 
and a current format.
    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

21 CFR Part 520

    Animal drugs.

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 parts 520 and 
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  520.2455 to read as follows:


Sec.  520.2455  Tiamulin.

    (a) Specifications. (1) Each ounce of concentrate solution contains 
3.64 grams (12.3 percent) tiamulin hydrogen fumarate.
    (2) Each gram of soluble powder contains 450 milligrams (mg) 
tiamulin hydrogen fumarate.
    (b) Sponsors. See Nos. 058198 and 059130 in Sec.  510.600(c) of 
this chapter.
    (c) Related tolerances. See Sec.  556.738 of this chapter.
    (d) Special considerations. (1) Swine being treated with tiamulin 
should not have access to feeds containing polyether ionophores (e.g., 
lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse 
reactions may occur.
    (2) Do not use in swine weighing over 250 pounds (lb).
    (e) Conditions of use in swine--(1) Amounts and indications for 
use. Administer in drinking water for 5 consecutive days:
    (i) 3.5 mg per (/) lb of body weight daily for treatment of swine 
dysentery associated with Brachyspira hyodysenteriae susceptible to 
tiamulin.
    (ii) 10.5 mg/lb of body weight daily for treatment of swine 
pneumonia due to Actinobacillus pleuropneumoniae susceptible to 
tiamulin.
    (2) Limitations. Withdraw medication 3 days before slaughter 
following treatment at 3.5 mg/lb and 7 days before slaughter following 
treatment at 10.5 mg/lb of body weight. Prepare fresh medicated water 
daily. Use as only source of drinking water.

[[Page 75018]]

Sec.  520.2456  [Removed]

0
3. Remove Sec.  520.2456.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
4. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.600  [Amended]

0
5. Amend Sec.  558.600 in paragraph (b) and in the table in paragraphs 
(e)(1)(i) through (e)(1)(iv) in the ``Sponsor'' column by removing 
``000010'' and by adding in its place ``058198''.

    Dated: December 6, 2005.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 05-24165 Filed 12-16-05; 8:45 am]
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