[Federal Register: April 27, 2006 (Volume 71, Number 81)]
[Rules and Regulations]
[Page 24814-24817]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap06-7]
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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: eric.dubbin@fda.hhs.gov.
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;
0
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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(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]]
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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