New Animal Drugs for Use in Animal Feeds; Lasalocid and Chlortetracycline, 24814-24817 [06-3953]
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Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Rules and Regulations
Authority: Secs. 202, 203(a) and (b), 205(a),
216, 223, 225, 228(a)–(e), and 702(a)(5) of the
Social Security Act (42 U.S.C. 402, 403(a)
and (b), 405(a), 416, 423, 425, 428(a)–(e), and
902(a)(5)).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
2. Section 404.336(e)(3) introductory
text is revised to read as follows:
21 CFR Part 558
I
§ 404.336 How do I become entitled to
widow’s or widower’s benefits as a
surviving divorced spouse?
Subpart G—[Amended]
3. The authority citation for subpart G
of part 404 continues to read as follows:
I
Authority: Secs. 202(i), (j), (o), (p), and (r),
205(a), 216(i)(2), 223(b), 228(a), and 702(a)(5)
of the Social Security Act (42 U.S.C. 402(i),
(j), (o), (p), and (r), 405(a), 416(i)(2), 423(b),
428(a), and 902(a)(5)).
4. Amend § 404.630(b) by revising the
second sentence of paragraph (b) and
adding a third sentence to paragraph (b)
to read as follows:
I
§ 404.630 Use of date of written statement
as filing date.
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(b) * * * If the claimant, the
claimant’s spouse, or a person described
in § 404.612 telephones us and advises
us of his or her intent to file a claim but
cannot file an application before the end
of the month, we will prepare and sign
a written statement if it is necessary to
prevent the loss of benefits. If the
claimant, the claimant’s spouse, or a
person described in § 404.612 contacts
us through the Internet by completing
and transmitting the Personal
Identification Information data on the
Internet Social Security Benefit
Application to us, we will use the date
of the transmission as the filing date if
it is necessary to prevent the loss of
benefits.
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Food and Drug Administration,
HHS.
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(e) * * *
(3) You are now at least age 50 but not
yet age 60 and you meet both of the
conditions in paragraphs (e)(3)(i) and
(ii) of this section:
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[FR Doc. 06–3983 Filed 4–26–06; 8:45 am]
New Animal Drugs for Use in Animal
Feeds; Lasalocid and Chlortetracycline
AGENCY:
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Food and Drug Administration
Final rule, technical
amendment.
ACTION:
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 twoway, 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.
Eric
S. Dubbin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0232, email: 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 twoway, 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 §§ 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, § 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
FOR FURTHER INFORMATION CONTACT:
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§ 558.311 to correct this error.
Furthermore, § 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.
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:
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PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
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Authority: 21 U.S.C. 360b, 371.
2. Amend § 558.128 as follows:
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);
I b. In the table in paragraph (e)(4), add
new paragraph (e)(4)(v) to read as
follows;
I c. Redesignate paragraphs (e)(6)(viii)
through (e)(6)(xiii) as paragraphs
(e)(6)(ix) through (e)(6)(xiv); and
I d. Add new paragraph (e)(6)(viii).
The additions read as follows:
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§ 558.128
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Chlortetracycline.
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(e) * * *
(4) * * *
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Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Rules and Regulations
Chlortetracycline
amount
Indications for use
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(v) 500 to 4,000
g/ton
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(6) * * *
(viii) Lasalocid in accordance with
§ 558.311.
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I 3. In § 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:
Lasalocid.
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(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
Lasalocid sodium
activity in grams
per ton
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046573.
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(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
§ 510.455 of this chapter.
(e)(1) * * *
Indications for use
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Chlortetracycline
25 to 100.
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Sponsor
Hand feed continuously for not more
than 5 days to provide 10 mg/lb body
weight per day.
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.
Combination in
grams per ton
(xx) 10 to 30.
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Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P.
multocida organisms susceptible to chlortetracycline.
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§ 558.311
Limitations
Limitations
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Sponsor
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1. Cattle fed in confinement for slaughter: For
improved feed efficiency; and for control of
bacterial pneumonia associated with shipping fever complex caused by Pasteurella
spp. susceptible to chlortetracycline.
2. Cattle under 700 pounds fed in confinement for slaughter: For improved feed efficiency; and for control of active infection of
anaplasmosis caused by Anaplasma
marginale susceptible to chlortetracycline.
Feed continuously in complete feed at a
rate of 350 mg chlortetracycline and not
less than 100 mg nor more than 360 mg
of lasalocid sodium activity per head per
day.
Feed continuously in complete feed at a
rate of 350 mg chlortetracycline and not
less than 100 mg nor more than 360 mg
of lasalocid sodium activity per head per
day.
046573
046573
Chlortetracycline
500 to 2000.
Cattle fed in confinement for slaughter: For
improved feed efficiency; and for treatment
of bacterial enteritis caused by E. coli and
bacterial pneumonia caused by P.
multocida organisms susceptible to chlortetracycline.
Feed continuously in complete feed for not
more than 5 days to provide 10 mg
chlortetracycline per lb body weight per
day and not less than 100 mg nor more
than 360 mg of lasalocid sodium activity
per head per day.
046573
(xxii) 25 to 30.
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(xxi) 10 to 30.
Chlortetracycline
25 to 42.2.
1. Cattle fed in confinement for slaughter: For
increased rate of weight gain and improved
feed efficiency; and for control of bacterial
pneumonia associated with shipping fever
complex caused by Pasteurella spp. susceptible to chlortetracycline.
2. Cattle under 700 pounds fed in confinement for slaughter: For increased rate of
weight gain and improved feed efficiency;
and for control of active infection of
anaplasmosis caused by Anaplasma
marginale susceptible to chlortetracycline.
Feed continuously in complete feed at a
rate of 350 mg chlortetracycline and not
less than 250 mg nor more than 360 mg
of lasalocid sodium activity per head per
day.
046573
Feed continuously in complete feed at a
rate of 350 mg chlortetracycline and not
less than 250 mg nor more than 360 mg
of lasalocid sodium activity per head per
day.
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Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Rules and Regulations
Lasalocid sodium
activity in grams
per ton
Combination in
grams per ton
Indications for use
Limitations
Sponsor
(xxiii) 25 to 30.
Chlortetracycline
500 to 1200.
Cattle fed in confinement for slaughter: For increased rate of weight gain and improved
feed efficiency; and for treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.
Feed continuously in complete feed for not
more than 5 days to provide 10 mg
chlortetracycline per lb body weight per
day and not less than 250 mg nor more
than 360 mg of lasalocid sodium activity
per head per day.
046573
(xxiv) 30 to 181.8.
Chlortetracycline
25 to 2800.
1. Beef cattle under 700 pounds: For control
of coccidiosis caused by Eimeria bovis and
E. zuernii; and for control of active infection
of anaplasmosis caused by Anaplasma
marginale susceptible to chlortetracycline.
2. Beef cattle up to 800 pounds: For control of
coccidiosis caused by Eimeria bovis and E.
zuernii; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible
to chlortetracycline.
Hand feed continuously at a rate of 350 mg
chlortetracycline per head per day and 1
mg lasalocid per 2.2 lb body weight per
day with a maximum of 360 mg lasalocid
per head per day.
Hand feed continuously at a rate of 350 mg
chlortetracycline per head per day and 1
mg lasalocid per 2.2 lb body weight per
day with a maximum of 360 mg lasalocid
per head per day.
046573
046573
(xxv) 30 to 181.8.
Chlortetracycline
500 to 4000.
Cattle up to 800 pounds: For control of coccidiosis caused by Eimeria bovis and E.
zuernii; and for treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms
susceptible to chlortetracycline.
Hand feed continuously for not more than 5
days to provide 10 mg chlortetracycline
per lb body weight per day and 1 mg
lasalocid per 2.2 lb body weight per day
with a maximum of 360 mg lasalocid per
head per day.
046573
(xxvi) 30 to 600.
Chlortetracycline
25 to 700.
1. Pasture cattle (slaughter, stocker, feeder
cattle, and beef replacement heifers): for increased rate of weight gain; and for control
of bacterial pneumonia associated with
shipping fever complex caused by
Pasteurella spp. susceptible to chlortetracycline.
2. Pasture cattle under 700 pounds (slaughter, stocker, feeder cattle, and beef replacement heifers): for increased rate of weight
gain; and for control of active infection of
anaplasmosis caused by Anaplasma
marginale susceptible to chlortetracycline.
Hand feed continuously at a rate of 350 mg
chlortetracycline and not less than 60 mg
or more than 300 mg lasalocid per head
daily in at least 1 lb of feed. Intakes of
lasalocid in excess of 200 mg/head/day
have not been shown to be more effective than 200 mg/head/day.
Hand feed continuously at a rate of 350 mg
chlortetracycline and not less than 60 mg
or more than 300 mg lasalocid per head
daily in at least 1 lb of feed. Intakes of
lasalocid in excess of 200 mg/head/day
have not been shown to be more effective than 200 mg/head/day.
046573
046573
(xxvii) 30 to 600.
Chlortetracycline
25 to 1100.
Pasture cattle over 700 pounds (slaughter,
stocker, feeder cattle, and beef replacement
heifers): For increased rate of weight gain;
and for control of control of active infection
of anaplasmosis caused by Anaplasma
marginale susceptible to chlortetracycline.
Hand feed continuously at a rate of 0.5 mg
chlortetracycline per lb body weight per
day and not less than 60 mg or more
than 300 mg lasalocid per head daily in
at least 1 lb of feed. Intakes of lasalocid
in excess of 200 mg/head/day have not
been shown to be more effective than
200 mg/head/day.
046573
(xxiii) 30 to 600.
Chlortetracycline
500 to 4000.
Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain; and
for treatment of bacterial enteritis caused by
E. coli and bacterial pneumonia caused by
P. multocida organisms susceptible to chlortetracycline.
Hand feed continuously for not more than 5
days to provide 10 mg chlortetracycline
per lb body weight per day and not less
than 60 mg or more than 300 mg
lasalocid per head daily in at least 1 lb of
feed. Intakes of lasalocid in excess of
200 mg/head/day have not been shown
to be more effective than 200 mg/head/
day.
046573
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Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Rules and Regulations
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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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9, 86 and 600
[FRL–8161–7]
OMB Approvals Under the Paperwork
Reduction Act; Technical Amendment
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: In compliance with the
Paperwork Reduction Act (PRA), this
technical amendment amends the table
that lists the Office of Management and
Budget (OMB) control numbers issued
under the PRA for Motor Vehicle
Emission and Fuel Economy
Compliance; Light Duty Vehicles, Light
Duty Trucks, and Highway Motorcycles.
DATES: Effective Date: This final rule is
effective April 27, 2006.
The information collection
requirements for part 86 published in
the Federal Register at 59 FR 16262,
April 6, 1994, which apply to 1998 and
later model year vehicles, have been
approved by the Office of Management
and Budget and are effective April 27,
2006.
40 CFR 600.206–93, 600.207–93,
600.209–95, 600.307–95, and 600.510–
93, published at 59 FR 39638, August 3,
1994, containing information
requirements which have been
approved by the Office of Management
and Budget, are effective April 27, 2006.
FOR FURTHER INFORMATION CONTACT:
Lynn Sohacki, Certification and
Compliance Division, 2000 Traverwood
Drive, Ann Arbor, MI 48103; (734) 214–
4851; sohacki.lynn@epa.gov.
SUPPLEMENTARY INFORMATION: This rule
does two things. First, EPA is amending
the table in 40 CFR part 9 of currently
approved information collection request
(ICR) control numbers issued by OMB
for various regulations. The amendment
updates the table to list those
information collection requirements
approved by OMB on November 1,
2005, under control number 2060–0104.
The regulations affected by the
amendments are codified at 40 CFR
parts 85 and 86. EPA will continue to
present OMB control numbers in a
consolidated table format to be codified
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in 40 CFR part 9 of the Agency’s
regulations, and in each CFR volume
containing relevant EPA regulations.
The table lists CFR citations with
reporting, recordkeeping, or other
information collection requirements,
and the current OMB control numbers.
This listing of the OMB control numbers
and their subsequent codification in the
CFR satisfies the requirements of the
Paperwork Reduction Act (44 U.S.C.
3501 et seq.) and OMB’s implementing
regulations at 5 CFR part 1320.
Second, the rule also makes
conforming amendments to the affected
regulations by removing three sets of
provisions in the Code of Federal
Regulations on related information
collections that are no longer applicable.
The first of these provisions appears as
a note at the end of the table of contents
to part 86 of the Code and states that
information collections in regulations
appearing in the Federal Register on
April 6, 1994, have not been approved
by OMB. The referenced regulations
implemented new onboard refueling
vapor recovery (ORVR) requirements.
They are covered by OMB 2060–0104
and have been in approved Information
Collection Requests of EPA’s 0783 series
since 1995. The note has long been out
of date and this amendment removes it.
Similarly, the second set of provisions
is five notices appearing in part 600
regarding information collections
contained in regulations appearing in
the Federal Register on August 3, 1994.
That rule modified the fuel economy
regulations to include alternative-fueled
vehicles. These regulations are covered
by OMB 2060–0104 and have also been
in approved Information Collection
Requests of EPA’s 0783 series since
1995. Today’s rule removes these
notices as well. The removal of these
first two sets of provisions is
accomplished by the language under the
Effective Date heading of today’s rule.
The effective date given under that
heading is the date of publication of
today’s rule. The information
collections themselves have long been
approved by OMB, as discussed above,
are currently covered by OMB 2060–
0104, and are listed with the relevant
CFR citations in part 9. The third
provision is 40 CFR part 86, subpart AA.
Section 86.2500 in subpart AA states
that ‘‘All reporting and recordkeeping
requirements contained in part 86,
except for those requirements contained
in subparts G and K, have been
approved by the Office of Management
and Budget under control number 2060–
0104.’’ This provision was promulgated
at 50 FR 10648 on March 15, 1985.
Subparts G and K deal with Selective
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Enforcement Auditing of light-duty
vehicles and of heavy-duty engines,
heavy-duty vehicles, and light-duty
trucks. The ICR for the March 15, 1985,
rulemaking, ICR 0783.29, was approved
without restrictions in August, 1985.
Both the light and heavy duty Selective
Enforcement Audit information
collections were covered by OMB 2060–
0064, until the heavy-duty portion was
incorporated into 2060–0287 with IRC
1684.06 and the light-duty portion was
incorporated into 2060–0104. Both of
these control numbers have current
approvals and the list in part 9 is
updated to reflect this coverage of
Selective Enforcement Audit
collections. Today’s rule removes
Subpart AA.
The ICRs covered by this rule were
previously subject to public notice and
comment prior to OMB approval. Due to
the technical nature of the table and
conforming amendments, EPA finds that
further notice and comment is
unnecessary. As a result, EPA finds that
there is ‘‘good cause’’ under section
553(b)(B) of the Administrative
Procedure Act, 5 U.S.C. 553(b)(B), to
amend this table without prior notice
and comment.
I. Administrative Requirements
Under Executive Order 12866 (58 FR
51735, October 4, 1993), this action is
not a ‘‘significant regulatory action’’ and
is therefore not subject to review by the
Office of Management and Budget. In
addition, this action does not impose
any enforceable duty, contain any
unfunded mandate, or impose any
significant or unique impact on small
governments as described in the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4). This rule also does not
require prior consultation with State,
local, and tribal government officials as
specified by Executive Order 12875 (58
FR 58093, October 28, 1993) or
Executive Order 13084 (63 FR 27655
(May 10, 1998), or involve special
consideration of environmental justice
related issues as required by Executive
Order 12898 (59 FR 7629, February 16,
1994). Because this action is not subject
to notice-and-comment requirements
under the Administrative Procedure Act
or any other statute, it is not subject to
the regulatory flexibility provisions of
the Regulatory Flexibility Act (5 U.S.C.
601 et seq.). This rule also is not subject
to Executive Order 13045 (62 FR 19885,
April 23, 1997) because EPA interprets
E.O. 13045 as applying only to those
regulatory actions that are based on
health or safety risks, such that the
analysis required under section 5–501 of
the Order has the potential to influence
the regulation. This rule is not subject
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]]>Agencies
[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Rules and Regulations]
[Pages 24814-24817]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
(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) * * *
----------------------------------------------------------------------------------------------------------------
Lasalocid sodium
activity in Combination in Indications for use Limitations Sponsor
grams per ton grams per ton
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
[[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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[[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
