[Federal Register Volume 67, Number 33 (Tuesday, February 19, 2002)]
[Rules and Regulations]
[Pages 7268-7269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3831]



[[Page 7268]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


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 Boehringer Ingelheim Vetmedica, Inc. The 
supplemental NADA provides for use of approved tiamulin Type A 
medicated articles to make Type B and Type C medicated feeds used for 
the control of porcine proliferative enteropathies (ileitis) in swine.

DATES: This rule is effective February 19, 2002.

FOR FURTHER INFORMATION CONTACT: Diane D. Jeang, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7574, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, filed a supplement to 
approved NADA 139-472 that provides for use of DENAGARD (5, 10, or 
113.4 grams (g) per pound of tiamulin) Type A medicated articles to 
make Type B and Type C medicated feeds for use in growing and finishing 
swine. The Type C medicated feeds contain 35 g per ton tiamulin and are 
used for the control of porcine proliferative enteropathies (ileitis) 
associated with Lawsonia intracellularis. The NADA is approved as of 
November 26, 2001, and Sec. 558.600 (21 CFR 558.600) is amended to 
reflect the approval. Section 558.600 is also being revised to a 
tabular format. The basis for approval is discussed in the freedom of 
information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning on November 26, 2001, because the application contains 
substantial evidence of the effectiveness of the drug involved, any 
studies of animal safety, or in the case of food-producing animals, 
human food safety studies (other than bioequivalence or residue 
studies) required for the approval of the application and conducted or 
sponsored by the applicant. The 3 years of marketing exclusivity 
applies only to the new claim for which the supplemental application 
was approved.
    The agency has determined under 21 CFR 25.33(a)(1) 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 
the 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

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

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

    2. Section 558.600 is revised to read as follows:


Sec. 558.600  Tiamulin.

    (a) Specifications. Type A article containing 5, 10, or 113.4 grams 
of tiamulin (as tiamulin hydrogen fumarate) per pound.
    (b) Approvals. See No. 000010 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. If signs of toxicity occur, discontinue use.
    (2) Not for use in swine weighing over 250 pounds.
    (3) Use as sole source of tiamulin.
    (e) Conditions of use--(1) Swine. It is used as follows:

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                                   Combination in
   Tiamulin in grams per ton       grams per ton     Indications for use      Limitations           Sponsor
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(i) 10........................   ..................  For increased rate   Feed continuously    000010
                                                      of weight gain and   as the sole ration.
                                                      improved feed
                                                      efficiency.
(ii) 35.......................  ...................  1. For control of    Feed continuously    000010
                                                      swine dysentery      as sole ration on
                                                      associated           premises with a
                                                      withBrachyspira      history of swine
                                                      (formerly            dysentery but
                                                      Serpulina or         where signs of
                                                      Treponema)           disease have not
                                                      hyodysenteriae       yet occurred or
                                                      susceptible to       following approved
                                                      tiamulin.            treatment of
                                                                           disease. Withdraw
                                                                           2 days before
                                                                           slaughter.
                                ...................  2. For control of    Feed continuously    000010
                                                      porcine              as the sole ration
                                                      proliferative        for not less than
                                                      enteropathies        10 days. Withdraw
                                                      (ileitis)            2 days before
                                                      associated           slaughter.
                                                      withLawsonia
                                                      intracellularis.

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(iii) 35......................  Chlortetracycline,   For treatment of     Feed continuously    000010
                                 approximately 400    swine bacterial      as sole ration for
                                 (varying with body   enteritis caused     14 days. Use as
                                 weight and feed      byEscherichia coli   only source of
                                 consumption to       and Salmonella       chlortetracycline.
                                 provide 10           choleraesuis and     Withdraw 2 days
                                 milligrams of        bacterial            before slaughter.
                                 chlortetracycline    pneumonia caused    As
                                 per pound of body    by Pasteurella       chlortetracycline
                                 weight daily).       multocida            calcium complex,
                                                      susceptible to       Type A medicated
                                                      chlortetracycline,   articles
                                                      and control of       containing the
                                                      swine dysentery      equivalent of 50
                                                      associated with      to 100 grams per
                                                      Brachyspira          pound of
                                                      (formerly            chlortetracycline
                                                      Serpulina or         hydrochloride
                                                      Treponema)           provided by 046573
                                                      hyodysenteriae       and 053389 in Sec.
                                                      susceptible to        510.600(c) of
                                                      tiamulin.            this chapter.
(iv) 200......................  ...................  For treatment of     Feed continuously    000010
                                                      swine dysentery      as the sole feed
                                                      associated with      for 14 consecutive
                                                      Brachyspira          days. Withdraw
                                                      (formerly            feed 7 days before
                                                      Serpulina or         slaughter.
                                                      Treponema)
                                                      hyodysenteriae
                                                      susceptible to
                                                      tiamulin.
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    (2) [Reserved]

    Dated: January 31, 2002.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-3831 Filed 2-15-02; 8:45 am]
BILLING CODE 4160-01-S