[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Rules and Regulations]
[Pages 24814-24817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3953]


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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; Lasalocid and 
Chlortetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Alpharma Inc. The NADA provides for use of approved 
single-ingredient Type A medicated articles containing lasalocid and 
chlortetracycline to formulate two-way, combination drug Type B and 
Type C medicated feeds for pasture cattle and cattle fed in confinement 
for slaughter.

DATES: This rule is effective April 27, 2006.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Drive, Fort 
Lee, NJ 07024, filed NADA 141-250 for use of BOVATEC (lasalocid sodium) 
and AUREOMYCIN (chlortetracycline) Type A medicated articles to 
formulate two-way, combination drug Type B and Type C medicated feeds 
for pasture cattle and cattle fed in confinement for slaughter. The 
NADA is approved as of March 31, 2006, and the regulations are amended 
in Sec. Sec.  558.128 and 558.311 (21 CFR 558.128 and 558.311) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In addition, Sec.  558.128 is amended to reflect an approved 
concentration for single-ingredient chlortetracycline Type C medicated 
cattle feed which, in error, was omitted from the final rule announcing 
its approval (67 FR 43248, June 27, 2002). Also, FDA has found that the 
April 1, 2005, edition of parts 500 to 599 of title 21 of the Code of 
Federal Regulations (CFR) does not accurately reflect several special 
considerations regarding use for lasalocid. These special 
considerations were inadvertently deleted as a publication error. At 
this time, the regulations are being amended in Sec.  558.311 to 
correct this error. Furthermore, Sec.  558.311 is amended to codify an 
approved label statement warning against the use of medicated feeds 
containing lasalocid in calves to be processed for veal. These actions 
are being taken to improve the accuracy of the regulations.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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.
    The agency has determined under 21 CFR 25.33(a)(2) 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.

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. Amend Sec.  558.128 as follows:
0
a. In the table in paragraph (e)(4), redesignate paragraphs (e)(4)(v) 
through (e)(4)(viii) as paragraphs (e)(4)(vi) through (e)(4)(ix);
0
b. In the table in paragraph (e)(4), add new paragraph (e)(4)(v) to 
read as follows;
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c. Redesignate paragraphs (e)(6)(viii) through (e)(6)(xiii) as 
paragraphs (e)(6)(ix) through (e)(6)(xiv); and
0
d. Add new paragraph (e)(6)(viii).
    The additions read as follows:


Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

[[Page 24815]]



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   Chlortetracycline amount                Indications for use                     Limitations           Sponsor
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                                                  * * * * * * *
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(v) 500 to 4,000 g/ton          Calves, beef and nonlactating dairy       Hand feed continuously for     046573.
                                 cattle; treatment of bacterial            not more than 5 days to
                                 enteritis caused by E. coli and           provide 10 mg/lb body
                                 bacterial pneumonia caused by P.          weight per day.
                                 multocida organisms susceptible to
                                 chlortetracycline.
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                                                  * * * * * * *
 
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* * * * *
    (6) * * *
    (viii) Lasalocid in accordance with Sec.  558.311.
* * * * *

0
3. In Sec.  558.311, add paragraphs (d)(5), (d)(6), and (d)(7); and in 
the table in paragraph (e)(1) add paragraphs (xx) through (xxiii) to 
read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (d) * * *
    (5) Required label statements:
    (i) For liquid Type B feed (cattle and sheep): Mix thoroughly with 
grain and/or roughage prior to feeding. Feeding undiluted, mixing 
errors, or inadequate mixing (recirculation or agitation) may result in 
an excess lasalocid concentration which could be fatal to cattle and 
sheep. Do not allow horses or other equines access to Type A articles 
or Type B feeds containing lasalocid as ingestion may be fatal. Safety 
of lasalocid for use in unapproved species has not been established.
    (ii) For Type A articles or Type B feeds (cattle and sheep): 
Feeding undiluted or mixing errors may result in an excess lasalocid 
concentration which could be fatal to cattle and sheep. Do not allow 
horses or other equines access to Type A articles or Type B feeds 
containing lasalocid as ingestion may be fatal. Safety of lasalocid for 
use in unapproved species has not been established.
    (iii) For Type A articles, Type B or Type C feeds (cattle): A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (6) Lasalocid Type A medicated articles containing lasalocid dried 
fermentation residue are for use in cattle and sheep feed only.
    (7) Each use in a free-choice Type C cattle feed as in paragraphs 
(e)(1)(xii) and (e)(1)(xviii) of this section must be the subject of an 
approved NADA or supplemental NADA as provided in Sec.  510.455 of this 
chapter.
    (e)(1) * * *

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Lasalocid sodium
   activity in      Combination in          Indications for use                  Limitations             Sponsor
  grams per ton     grams per ton
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                                                  * * * * * * *
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(xx) 10 to 30.    Chlortetracycline  1. Cattle fed in confinement for  Feed continuously in complete      046573
                   25 to 100.         slaughter: For improved feed      feed at a rate of 350 mg
                                      efficiency; and for control of    chlortetracycline and not less
                                      bacterial pneumonia associated    than 100 mg nor more than 360
                                      with shipping fever complex       mg of lasalocid sodium
                                      caused by Pasteurella spp.        activity per head per day.
                                      susceptible to
                                      chlortetracycline.
                  .................  2. Cattle under 700 pounds fed    Feed continuously in complete      046573
                                      in confinement for slaughter:     feed at a rate of 350 mg
                                      For improved feed efficiency;     chlortetracycline and not less
                                      and for control of active         than 100 mg nor more than 360
                                      infection of anaplasmosis         mg of lasalocid sodium
                                      caused by Anaplasma marginale     activity per head per day.
                                      susceptible to
                                      chlortetracycline.
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(xxi) 10 to 30.   Chlortetracycline  Cattle fed in confinement for     Feed continuously in complete      046573
                   500 to 2000.       slaughter: For improved feed      feed for not more than 5 days
                                      efficiency; and for treatment     to provide 10 mg
                                      of bacterial enteritis caused     chlortetracycline per lb body
                                      by E. coli and bacterial          weight per day and not less
                                      pneumonia caused by P.            than 100 mg nor more than 360
                                      multocida organisms susceptible   mg of lasalocid sodium
                                      to chlortetracycline.             activity per head per day.
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(xxii) 25 to 30.  Chlortetracycline  1. Cattle fed in confinement for  Feed continuously in complete      046573
                   25 to 42.2.        slaughter: For increased rate     feed at a rate of 350 mg
                                      of weight gain and improved       chlortetracycline and not less
                                      feed efficiency; and for          than 250 mg nor more than 360
                                      control of bacterial pneumonia    mg of lasalocid sodium
                                      associated with shipping fever    activity per head per day.
                                      complex caused by Pasteurella
                                      spp. susceptible to
                                      chlortetracycline.
                  .................  2. Cattle under 700 pounds fed    Feed continuously in complete      046573
                                      in confinement for slaughter:     feed at a rate of 350 mg
                                      For increased rate of weight      chlortetracycline and not less
                                      gain and improved feed            than 250 mg nor more than 360
                                      efficiency; and for control of    mg of lasalocid sodium
                                      active infection of               activity per head per day.
                                      anaplasmosis caused by
                                      Anaplasma marginale susceptible
                                      to chlortetracycline.
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[[Page 24816]]

 
(xxiii) 25 to     Chlortetracycline  Cattle fed in confinement for     Feed continuously in complete      046573
 30.               500 to 1200.       slaughter: For increased rate     feed for not more than 5 days
                                      of weight gain and improved       to provide 10 mg
                                      feed efficiency; and for          chlortetracycline per lb body
                                      treatment of bacterial            weight per day and not less
                                      enteritis caused by E. coli and   than 250 mg nor more than 360
                                      bacterial pneumonia caused by     mg of lasalocid sodium
                                      P. multocida organisms            activity per head per day.
                                      susceptible to
                                      chlortetracycline.
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(xxiv) 30 to      Chlortetracycline  1. Beef cattle under 700 pounds:  Hand feed continuously at a        046573
 181.8.            25 to 2800.        For control of coccidiosis        rate of 350 mg
                                      caused by Eimeria bovis and E.    chlortetracycline per head per
                                      zuernii; and for control of       day and 1 mg lasalocid per 2.2
                                      active infection of               lb body weight per day with a
                                      anaplasmosis caused by            maximum of 360 mg lasalocid
                                      Anaplasma marginale susceptible   per head per day.
                                      to chlortetracycline.
                  .................  2. Beef cattle up to 800 pounds:  Hand feed continuously at a        046573
                                      For control of coccidiosis        rate of 350 mg
                                      caused by Eimeria bovis and E.    chlortetracycline per head per
                                      zuernii; and for control of       day and 1 mg lasalocid per 2.2
                                      bacterial pneumonia associated    lb body weight per day with a
                                      with shipping fever complex       maximum of 360 mg lasalocid
                                      caused by Pasteurella spp.        per head per day.
                                      susceptible to
                                      chlortetracycline.
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(xxv) 30 to       Chlortetracycline  Cattle up to 800 pounds: For      Hand feed continuously for not     046573
 181.8.            500 to 4000.       control of coccidiosis caused     more than 5 days to provide 10
                                      by Eimeria bovis and E.           mg chlortetracycline per lb
                                      zuernii; and for treatment of     body weight per day and 1 mg
                                      bacterial enteritis caused by     lasalocid per 2.2 lb body
                                      E. coli and bacterial pneumonia   weight per day with a maximum
                                      caused by P. multocida            of 360 mg lasalocid per head
                                      organisms susceptible to          per day.
                                      chlortetracycline.
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(xxvi) 30 to      Chlortetracycline  1. Pasture cattle (slaughter,     Hand feed continuously at a        046573
 600.              25 to 700.         stocker, feeder cattle, and       rate of 350 mg
                                      beef replacement heifers): for    chlortetracycline and not less
                                      increased rate of weight gain;    than 60 mg or more than 300 mg
                                      and for control of bacterial      lasalocid per head daily in at
                                      pneumonia associated with         least 1 lb of feed. Intakes of
                                      shipping fever complex caused     lasalocid in excess of 200 mg/
                                      by Pasteurella spp. susceptible   head/day have not been shown
                                      to chlortetracycline.             to be more effective than 200
                                                                        mg/head/day.
                  .................  2. Pasture cattle under 700       Hand feed continuously at a        046573
                                      pounds (slaughter, stocker,       rate of 350 mg
                                      feeder cattle, and beef           chlortetracycline and not less
                                      replacement heifers): for         than 60 mg or more than 300 mg
                                      increased rate of weight gain;    lasalocid per head daily in at
                                      and for control of active         least 1 lb of feed. Intakes of
                                      infection of anaplasmosis         lasalocid in excess of 200 mg/
                                      caused by Anaplasma marginale     head/day have not been shown
                                      susceptible to                    to be more effective than 200
                                      chlortetracycline.                mg/head/day.
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(xxvii) 30 to     Chlortetracycline  Pasture cattle over 700 pounds    Hand feed continuously at a        046573
 600.              25 to 1100.        (slaughter, stocker, feeder       rate of 0.5 mg
                                      cattle, and beef replacement      chlortetracycline per lb body
                                      heifers): For increased rate of   weight per day and not less
                                      weight gain; and for control of   than 60 mg or more than 300 mg
                                      control of active infection of    lasalocid per head daily in at
                                      anaplasmosis caused by            least 1 lb of feed. Intakes of
                                      Anaplasma marginale susceptible   lasalocid in excess of 200 mg/
                                      to chlortetracycline.             head/day have not been shown
                                                                        to be more effective than 200
                                                                        mg/head/day.
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(xxiii) 30 to     Chlortetracycline  Pasture cattle (slaughter,        Hand feed continuously for not     046573
 600.              500 to 4000.       stocker, feeder cattle, and       more than 5 days to provide 10
                                      dairy and beef replacement        mg chlortetracycline per lb
                                      heifers): For increased rate of   body weight per day and not
                                      weight gain; and for treatment    less than 60 mg or more than
                                      of bacterial enteritis caused     300 mg lasalocid per head
                                      by E. coli and bacterial          daily in at least 1 lb of
                                      pneumonia caused by P.            feed. Intakes of lasalocid in
                                      multocida organisms susceptible   excess of 200 mg/head/day have
                                      to chlortetracycline.             not been shown to be more
                                                                        effective than 200 mg/head/
                                                                        day.
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[[Page 24817]]

* * * * *

    Dated: April 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3953 Filed 4-26-06; 8:45 am]
BILLING CODE 4160-01-S