[Federal Register Volume 71, Number 120 (Thursday, June 22, 2006)]
[Rules and Regulations]
[Pages 35792-35794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-55520]


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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

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 500 to 599, 
revised as of April 1, 2006, on page 391, in Sec.  558.76, paragraphs 
(a), (b), and (d)(1) are corrected to read as follows:


Sec.  558.76  Bacitracin methylene disalicylate.

    (a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, 
or 75 grams per pound to 046573 in Sec.  510.600(c) of this chapter.
    (b) Special considerations. The quantities of antibiotics are 
expressed in terms of the equivalent amount of antibiotic standard.
* * * * *
    (d) Conditions of use. (1) It is used as follows:

[[Page 35793]]



----------------------------------------------------------------------------------------------------------------
    Bacitracin methylene
  disalicylate in grams per     Combination in grams     Indications for use         Limitations        Sponsor
             ton                      per ton
----------------------------------------------------------------------------------------------------------------
(i) 4 to 50.................  .......................  Chickens, turkeys, and  ......................     046573
                                                        pheasants; increased
                                                        rate of weight gain
                                                        and improved feed
                                                        efficiency \1\.
(ii) 5 to 20................  .......................  Quail not over 5 weeks  ......................     046573
                                                        of age; increased
                                                        rate of weight gain
                                                        and improved feed
                                                        efficiency \1\.
(iii) 10 to 25..............  .......................  Chickens; for           For first 7 months of      046573
                                                        increased egg           production.
                                                        production and
                                                        improved feed
                                                        efficiency for egg
                                                        production.
(iv) 10 to 30...............  .......................  Swine: for increased    For growing and            046573
                                                        rate of weight gain     finishing swine.
                                                        and improved feed
                                                        efficiency.
                              Chlortetracycline        Swine; for increased    Feed for not more than     046573
                               approximately 400,       rate of weight gain     14 days; bacitracin       048164
                               varying with body        and improved feed       methylene
                               weight and food          efficiency; for         disalicylate provided
                               consumption to provide   treatment of            by No. 046573;
                               10 milligrams per        bacterial enteritis     chlortetracycline
                               pound of body weight     caused by Escherichia   provided by Nos.
                               per day.                 coli and Salmonella     046573 and 048164 in
                                                        choleraesuis and        Sec.   510.600(c) of
                                                        bacterial pneumonia     this chapter.
                                                        caused by Pasteurella
                                                        multocida susceptible
                                                        to chlortetracycline.
                                                       Swine; for control of   Feed for not more than     046573
                                                        porcine proliferative   14 days;
                                                        enteropathies           chlortetracycline and
                                                        (ileitis) caused by     BMD as provided by
                                                        Lawsonia                046573 in Sec.
                                                        intracellularis         510.600(c) of this
                                                        susceptible to          chapter.
                                                        chlortetracycline.
(v) [Reserved]
(vi) 50.....................  .......................  Broiler chickens; as    ......................     046573
                                                        an aid in the
                                                        prevention of
                                                        necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other organisms
                                                        susceptible to
                                                        bacitracin.
                                                       Replacement chickens;   Feed continuously as       046573
                                                        as an aid in the        sole ration.
                                                        prevention of
                                                        necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other organisms
                                                        susceptible to
                                                        bacitracin.
(vii)-(viii) [Reserved]
(ix) 100 to 200.............  .......................  Broiler chickens; as    ......................     046573
                                                        an aid in the control
                                                        of necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other organisms
                                                        susceptible to
                                                        bacitracin.
                                                       Replacement chickens;    Feed continuously as      046573
                                                        as an aid in the        sole ration. Start at
                                                        control of necrotic     first clinical signs
                                                        enteritis caused or     of disease, vary
                                                        complicated by          dosage based on
                                                        Clostridium spp. or     severity of
                                                        other organisms         infection, administer
                                                        susceptible to          continuously for 5 to
                                                        bacitracin.             7 days or as long as
                                                                                clinical signs
                                                                                persist, then reduce
                                                                                medication to
                                                                                prevention level (50
                                                                                g/t).
(x) 200.....................  .......................  Turkeys; as an aid in   ......................     046573
                                                        the control of
                                                        transmissible
                                                        enteritis in growing
                                                        turkeys complicated
                                                        by organisms
                                                        susceptible to
                                                        bacitracin methylene
                                                        disalicylate.
                                                       Quail; for the          From Type A medicated      046573
                                                        prevention of           articles containing
                                                        ulcerative enteritis    25, 40, or 50 grams
                                                        in growing quail due    of bacitracin
                                                        to Clostridium          methylene
                                                        colinum susceptible     disalicylate. Feed
                                                        to bacitracin           continuously as the
                                                        methylene               sole ration.
                                                        disalicylate.
(xi) 250....................  .......................  1. Growing/Finishing    As the sole ration.        046573
                                                        Swine: For control of   Not for use in swine
                                                        swine dysentery         weighing more than
                                                        associated with         250 pounds. Diagnosis
                                                        Treponema               should be confirmed
                                                        hyodysenteriae on       by a veterinarian
                                                        premises with a         when results are not
                                                        history of swine        satisfactory.
                                                        dysentery but where
                                                        signs of the disease
                                                        have not yet
                                                        occurred; or
                                                        following an approved
                                                        treatment of the
                                                        disease condition.
                                                       2. Pregnant sows: For   As the sole ration.     .........
                                                        control of              Feed to sows from 14
                                                        clostridial enteritis   days before through
                                                        caused by C.            21 days after
                                                        perfringens in          farrowing on premises
                                                        suckling piglets.       with a history of
                                                                                clostridial scours.
                                                                                Diagnosis should be
                                                                                confirmed by a
                                                                                veterinarian when
                                                                                results are not
                                                                                satisfactory.
----------------------------------------------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require
  effectiveness data as specified by Sec.   514.111 of this chapter, but may require bioequivalency and safety
  information.


[[Page 35794]]

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[FR Doc. 06-55520 Filed 6-21-06; 8:45 am]
BILLING CODE 1505-01-D