Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone, 69992-69995 [2013-27917]
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69992
Federal Register / Vol. 78, No. 226 / Friday, November 22, 2013 / Rules and Regulations
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 14 is
amended as follows:
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE:
1. The authority citation for 21 CFR
part 14 continues to read as follows:
■
Authority: 5 U.S.C. App. 2; 15 U.S.C.
1451–1461, 21 U.S.C. 41–50, 141–149, 321–
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Pub. L. 108–155.
§ 14.100
[Amended]
2. Section 14.100 is amended by
removing paragraph (f) and
redesignating paragraph (g) as paragraph
(f).
■
Dated: November 14, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 123
[Docket No. FDA–2013–D–0269]
Guidance for Industry on Purchasing
Reef Fish Species Associated With the
Hazard of Ciguatera Fish Poisoning;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry entitled
‘‘Guidance for Industry: Purchasing Reef
Fish Species Associated with the
Hazard of Ciguatera Fish Poisoning.’’
The document provides guidance to
primary seafood processors who
purchase reef fish on how to minimize
the risk of ciguatera fish poisoning
(CFP) from fish that they distribute. The
guidance intends to help protect the
public health by reducing the risk of
CFP.
ehiers on DSK2VPTVN1PROD with RULES
SUMMARY:
Submit either electronic or
written comments on FDA guidances at
any time.
ADDRESSES: Submit written requests for
single copies of the guidance to Division
of Seafood Safety/Office of Food Safety,
DATES:
VerDate Mar<15>2010
14:00 Nov 21, 2013
Jkt 232001
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/FoodGuidances or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27913 Filed 11–21–13; 8:45 am]
BILLING CODE 4160–01–P
I. Background
[FR Doc. 2013–27854 Filed 11–21–13; 8:45 am]
AGENCY:
Center for Food Safety and Applied
Nutrition, (HFS–325), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Karen Swajian, Division of Seafood
Safety, Center for Food Safety and
Applied Nutrition (HFS–325), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2300.
SUPPLEMENTARY INFORMATION:
We are announcing the availability of
a guidance for industry entitled
‘‘Guidance for Industry: Purchasing Reef
Fish Species Associated with the
Hazard of Ciguatera Fish Poisoning.’’
This guidance is being issued consistent
with our good guidance practices
regulation (21 CFR 10.115). The
guidance represents our current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
In the Federal Register of March 26,
2013 (78 FR 18273), FDA made
available a draft guidance entitled
‘‘Guidance for Industry: Purchasing Reef
Fish Species Associated with the
Hazard of Ciguatera Fish Poisoning’’
and gave interested parties an
opportunity to submit comments by
May 28, 2013, for us to consider before
beginning work on the final version of
the guidance. We received three
comments on the draft guidance, but the
comments did not prompt us to revise
the guidance. Therefore, we are issuing
the guidance with minor changes
(revising dates mentioned in the
guidance to reflect the most current
information). The guidance announced
in this notice finalizes the draft
guidance dated March 2013.
II. Comments
Interested persons may submit either
electronic comments regarding the
guidance to https://www.regulations.gov
or written comments to the Division of
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2013–N–0002]
Withdrawal of Approval of New Animal
Drug Applications; Carbarsone;
Roxarsone
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal approval of three new
animal drug applications (NADAs) for
roxarsone or carbarsone Type A
medicated articles at the sponsor’s
request because the products are no
longer manufactured or marketed.
DATES: This rule is effective December 2,
2013.
FOR FURTHER INFORMATION CONTACT: John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079,
john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis
Inc., 333 Portage St., Kalamazoo, MI
49007, has requested that FDA
withdraw approval of the following
three NADAs because the products,
used to manufacture Type B and Type
C medicated feeds, are no longer
manufactured or marketed: NADA 007–
891 for 3–NITRO (roxarsone) Type A
SUMMARY:
E:\FR\FM\22NOR1.SGM
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Federal Register / Vol. 78, No. 226 / Friday, November 22, 2013 / Rules and Regulations
medicated articles, NADA 092–953 for
Roxarsone Type A Medicated Articles,
and NADA 010–285 for CARB–O–SEP
(carbarsone) Type A medicated article.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADAs 007–891, 010–285, and 092–
953, and all supplements and
amendments thereto, is withdrawn,
effective December 2, 2013. As provided
in the regulatory text of this document,
the animal drug regulations are
amended to reflect these voluntary
withdrawals of approval.
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.’’
Roxarsone in grams
per ton
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:
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.
§ 558.120
[Amended]
2. In § 558.120, remove and reserve
paragraphs (a)(1) and (d)(1)(i).
■
3. In § 558.530, remove and reserve
paragraphs (a) and (b); and revise the
tables in paragraphs (d)(1) through (3) to
read as follows:
■
§ 558.530
*
Roxarsone.
*
*
(d) * * *
(1) * * *
*
*
Combinations in
grams per ton
Indications for use
Limitations
Chlortetracycline 10
to 50.
Growing chickens: For increased rate of
weight gain, improved feed efficiency,
and improved pigmentation.
(iii) 22.7 to 45.4 ..........
Chlortetracycline
100 to 200.
Growing chickens: For increased rate of
weight gain, improved feed efficiency,
and improved pigmentation; and for
control of infectious synovitis caused
by Mycoplasma synoviae susceptible
to chlortetracycline.
(iv) 22.7 to 45.4 ..........
Chlortetracycline
200 to 400.
(v) 22.7 to 45.4 ..........
Chlortetracycline
500.
Growing chickens: For increased rate of
weight gain, improved feed efficiency,
and improved pigmentation; and for
control of chronic respiratory disease
(CRD) and air sac infection caused
by M. gallisepticum and Escherichia
coli susceptible to chlortetracycline.
Growing chickens: For increased rate of
weight gain, improved feed efficiency,
and improved pigmentation; and for
reduction of mortality due to E. coli
infections susceptible to chlortetracycline.
Feed continuously throughout growing
period; withdraw 5 days before
slaughter; as sole source of organic
arsenic; drug overdose or lack of
water may result in weakness or paralysis of the legs.
Chlortetracycline as provided by No.
054771 in § 510.600(c) of this chapter.
Feed continuously for 7 to 14 days;
withdraw 5 days before slaughter; as
sole source of organic arsenic; drug
overdose or lack of water may result
in weakness or paralysis of the legs.
Chlortetracycline as provided by No.
054771 in § 510.600(c) of this chapter.
Feed continuously for 7 to 14 days;
withdraw 5 days before slaughter; as
sole source of organic arsenic; drug
overdose or lack of water may result
in weakness or paralysis of the legs.
Chlortetracycline as provided by No.
054771 in § 510.600(c) of this chapter.
Feed continuously for 5 days; withdraw
5 days before slaughter; as sole
source of organic arsenic; drug overdose or lack of water may result in
weakness or paralysis of the legs.
Chlortetracycline as provided by No.
054771 in § 510.600(c) of this chapter.
(i) [Reserved] .............
(ii) 22.7 to 45.4 ...........
69993
Sponsor
054771
054771
054771
054771
(2) * * *
Roxarsone in grams
per ton
ehiers on DSK2VPTVN1PROD with RULES
(i) [Reserved] .............
(ii) 22.7 to 45.4 ...........
VerDate Mar<15>2010
Combinations in
grams per ton
Indications for use
Limitations
Chlortetracycline 10
to 50.
Growing turkeys: For increased rate of
weight gain, improved feed efficiency,
and improved pigmentation.
Feed continuously throughout growing
period; withdraw 5 days before
slaughter; as sole source of organic
arsenic; drug overdose or lack of
water may result in weakness or paralysis of the legs.
Chlortetracycline as provided by No.
054771 in § 510.600(c) of this chapter.
14:00 Nov 21, 2013
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Sponsor
054771
69994
Federal Register / Vol. 78, No. 226 / Friday, November 22, 2013 / Rules and Regulations
Roxarsone in grams
per ton
Combinations in
grams per ton
Indications for use
Limitations
Feed continuously for 7 to 14 days;
withdraw 5 days before slaughter; as
sole source of organic arsenic; drug
overdose or lack of water may result
in weakness or paralysis of the legs.
Chlortetracycline as provided by No.
054771 in § 510.600(c) of this chapter.
Feed continuously for 7 to 14 days;
withdraw 5 days before slaughter; as
sole source of organic arsenic; drug
overdose or lack of water may result
in weakness or paralysis of the legs.
Chlortetracycline as provided by No.
054771 in § 510.600(c) of this chapter.
054771
Feed continuously for 7 to 14 days;
withdraw 5 days before slaughter; as
sole source of organic arsenic; drug
overdose or lack of water may result
in weakness or paralysis of the legs.
Chlortetracycline as provided by No.
054771 in § 510.600(c) of this chapter.
054771
(iii) 22.7 to 45.4 ..........
Chlortetracycline
200.
Growing turkeys: For increased rate of
weight gain, improved feed efficiency,
and improved pigmentation; and for
control of infectious synovitis caused
by Mycoplasma synoviae susceptible
to chlortetracycline.
(iv) 22.7 to 45.4 ..........
Chlortetracycline
400.
(v) 22.7 to 45.4 ..........
Chlortetracycline,
25 mg/lb body
weight daily.
1. Growing turkeys: For increased rate
of weight gain, improved feed efficiency, and improved pigmentation;
and for control of hexamitiasis caused
by Hexamita meleagrides susceptible
to chlortetracycline.
2. Turkey poults not over 4 weeks of
age: Reduction of mortality due to
paratyphoid caused by Salmonella
typhimurium susceptible to chlortetracycline.
Growing turkeys: For increased rate of
weight gain, improved feed efficiency,
and improved pigmentation; and for
control of complicating bacterial organisms associated with bluecomb
(transmissible enteritis, coronaviral
enteritis) susceptible to chlortetracycline.
Sponsor
054771
(3) * * *
Roxarsone in grams
per ton
(i) [Reserved] .............
(ii) 22.7 to 34.1 ...........
(iii) [Reserved] ............
(iv) 181.5 ....................
ehiers on DSK2VPTVN1PROD with RULES
(v) 181.5 .....................
VerDate Mar<15>2010
Combinations in
grams per ton
Indications for use
Limitations
Chlortetracycline
400 (to administer 10 mg/lb
body weight).
Growing and finishing swine: For increased rate of weight gain and improved feed efficiency; and for treatment of bacterial enteritis caused by
E. coli and S. choleraesuis and bacterial
pneumonia
caused
by
Pasteurella multocida susceptible to
chlortetracycline.
Feed for not more than 14 days; withdraw 5 days before slaughter; as sole
source of organic arsenic.
054771
Chlortetracycline 10
to 50.
Growing and finishing swine: For increased rate of weight gain and improved feed efficiency; and for treatment of swine dysentery.
054771
Chlortetracycline
400 (to administer 10 mg/lb
body weight).
Growing and finishing swine: For the
treatment of swine dysentery; and for
treatment of bacterial enteritis caused
by E. coli and S. choleraesuis and
bacterial pneumonia caused by P.
multocida susceptible to chlortetracycline.
Feed for not more than 6 consecutive
days; if improvement is not observed,
consult a veterinarian; withdraw 5
days before slaughter; as a sole
source of organic arsenic; animals
must consume enough medicated
feed to provide a therapeutic dose.
Feed for not more than 6 consecutive
days; if improvement is not observed,
consult a veterinarian; withdraw 5
days before slaughter; as a sole
source of organic arsenic; animals
must consume enough medicated
feed to provide a therapeutic dose.
14:00 Nov 21, 2013
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Sponsor
054771
Federal Register / Vol. 78, No. 226 / Friday, November 22, 2013 / Rules and Regulations
*
*
*
*
viewing the docket, call Cheryl F.
Collins, Program Manager, Docket
Operations, telephone (202)366–9826.
*
Dated: November 18, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–27917 Filed 11–21–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2013–0936]
Drawbridge Operation Regulation;
Upper Mississippi River, Rock Island,
IL
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the Rock Island
Railroad and Highway Drawbridge
across the Upper Mississippi River, mile
482.9, at Rock Island, Illinois. The
deviation is necessary to allow the
bridge owner time to perform preventive
maintenance and critical repairs that are
essential to the continued safe operation
of the drawbridge. The work is
scheduled in the winter, when the
impact on navigation is minimal,
instead of scheduling the work at other
times in the year, when river traffic is
prevalent. This deviation allows the
bridge to be maintained in the closedto-navigation position for 77 days.
DATES: This deviation is effective from
7:30 a.m., December 18, 2013 to 7:30
a.m. March 4, 2014.
ADDRESSES: The docket for this
deviation, USCG–2013–0936, is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this deviation. You may
also visit the Docket Management
Facility in Room W12–140 on the
ground floor of the Department of
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Eric A.
Washburn, Bridge Administrator,
Western Rivers, Coast Guard; telephone
(314) 269–2378, email Eric.Washburn@
uscg.mil. If you have questions on
ehiers on DSK2VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
14:00 Nov 21, 2013
Jkt 232001
The U.S.
Army Rock Island Arsenal requested a
temporary deviation for the Rock Island
Railroad and Highway Drawbridge, mile
482.9, at Rock Island, Illinois across the
Upper Mississippi River. It has a
vertical clearance of 23.8 feet above
normal pool in the closed position. The
Rock Island Railroad and Highway
Drawbridge currently operates in
accordance with 33 CFR 117.5, which
states the general requirement that
drawbridges shall open promptly and
fully for the passage of vessels when a
request to open is given in accordance
with the subpart.
The deviation period is from 7:30
a.m., December 18, 2013 to 7:30 a.m.,
March 4, 2014 when the draw span will
remain in the closed-to-navigation
position. During this time the bridge
owner will replace critical control
components that are essential to the
continued safe operation of the
drawbridge. The bridge will not be able
to open for emergencies and there is no
immediate alternate route for vessels to
pass this section of the Upper
Mississippi River. The Coast Guard will
also inform the users of the waterway
through our Local and Broadcast
Notices to Mariners of the change in
operating schedule for the bridge so that
vessels can arrange their transits to
minimize any impact caused by the
temporary deviation.
Winter conditions on the Upper
Mississippi River coupled with the
closure of Army Corps of Engineer’s
Lock No. 18 (Mile 410.5 UMR) and Lock
No. 22 (Mile 301.2 UMR) till 11 a.m.,
March 4, 2014 will preclude any
significant navigation demands for the
drawspan opening.
There are no alternate routes for
vessels transiting this section of the
Upper Mississippi River.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
SUPPLEMENTARY INFORMATION:
Dated: November 5, 2013.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2013–28039 Filed 11–21–13; 8:45 am]
BILLING CODE 9110–04–P
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69995
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R07–OAR–2013–0585; FRL–9903–14–
Region 7]
Approval and Promulgation of
Implementation Plans; State of
Missouri; Restriction of Emission of
Sulfur Compounds and Emissions
Banking and Trading
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
EPA is approving two
revisions to the State Implementation
Plan (SIP) for Missouri that were
submitted on September 5, 2012. The
revision to the Missouri rule
‘‘Restriction of Emission of Sulfur
Compounds’’ removes redundant sulfur
dioxide standards and outdated
compliance dates. Due to these
revisions, several within-rule references
are amended. Revisions to the Missouri
rule ‘‘Emissions Banking and Trading’’
removes all definitions, as they are now
included in the general definitions rule.
The reference to the state’s Ambient Air
Quality Standards rule that is included
in the definition of National Ambient
Air Quality Standards is also removed.
The revisions to Missouri’s rules do not
have an adverse affect on air quality.
EPA’s approval of this SIP revision is
being done in accordance with the
requirements of the Clean Air Act
(CAA).
SUMMARY:
This direct final rule will be
effective January 21, 2014, without
further notice, unless EPA receives
adverse comment by December 23,
2013. If EPA receives adverse comment,
we will publish a timely withdrawal of
the direct final rule in the Federal
Register informing the public that the
rule will not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R07–
OAR–2013–0585, by one of the
following methods:
1. www.regulations.gov. Follow the
on-line instructions for submitting
comments.
2. Email: bhesania.amy@epa.gov.
3. Mail or Hand Delivery: Amy
Bhesania, Environmental Protection
Agency, Air Planning and Development
Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219.
Instructions: Direct your comments to
Docket ID No. EPA–R07–OAR–2013–
0585. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
DATES:
E:\FR\FM\22NOR1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Rules and Regulations]
[Pages 69992-69995]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27917]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2013-N-0002]
Withdrawal of Approval of New Animal Drug Applications;
Carbarsone; Roxarsone
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal approval of three new animal
drug applications (NADAs) for roxarsone or carbarsone Type A medicated
articles at the sponsor's request because the products are no longer
manufactured or marketed.
DATES: This rule is effective December 2, 2013.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007, has requested that FDA withdraw approval of the following three
NADAs because the products, used to manufacture Type B and Type C
medicated feeds, are no longer manufactured or marketed: NADA 007-891
for 3-NITRO (roxarsone) Type A
[[Page 69993]]
medicated articles, NADA 092-953 for Roxarsone Type A Medicated
Articles, and NADA 010-285 for CARB-O-SEP (carbarsone) Type A medicated
article.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 007-891, 010-285, and 092-953, and all
supplements and amendments thereto, is withdrawn, effective December 2,
2013. As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these voluntary withdrawals of
approval.
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:
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.
Sec. 558.120 [Amended]
0
2. In Sec. 558.120, remove and reserve paragraphs (a)(1) and
(d)(1)(i).
0
3. In Sec. 558.530, remove and reserve paragraphs (a) and (b); and
revise the tables in paragraphs (d)(1) through (3) to read as follows:
Sec. 558.530 Roxarsone.
* * * * *
(d) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combinations in
Roxarsone in grams per ton grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 45.4............ Chlortetracycline Growing chickens: For Feed continuously 054771
10 to 50. increased rate of throughout growing
weight gain, improved period; withdraw 5
feed efficiency, and days before slaughter;
improved pigmentation. as sole source of
organic arsenic; drug
overdose or lack of
water may result in
weakness or paralysis
of the legs.
Chlortetracycline as
provided by No. 054771
in Sec. 510.600(c)
of this chapter.
(iii) 22.7 to 45.4........... Chlortetracycline Growing chickens: For Feed continuously for 7 054771
100 to 200. increased rate of to 14 days; withdraw 5
weight gain, improved days before slaughter;
feed efficiency, and as sole source of
improved pigmentation; organic arsenic; drug
and for control of overdose or lack of
infectious synovitis water may result in
caused by Mycoplasma weakness or paralysis
synoviae susceptible of the legs.
to chlortetracycline. Chlortetracycline as
provided by No. 054771
in Sec. 510.600(c)
of this chapter.
(iv) 22.7 to 45.4............ Chlortetracycline Growing chickens: For Feed continuously for 7 054771
200 to 400. increased rate of to 14 days; withdraw 5
weight gain, improved days before slaughter;
feed efficiency, and as sole source of
improved pigmentation; organic arsenic; drug
and for control of overdose or lack of
chronic respiratory water may result in
disease (CRD) and air weakness or paralysis
sac infection caused of the legs.
by M. gallisepticum Chlortetracycline as
and Escherichia coli provided by No. 054771
susceptible to in Sec. 510.600(c)
chlortetracycline. of this chapter.
(v) 22.7 to 45.4............. Chlortetracycline Growing chickens: For Feed continuously for 5 054771
500. increased rate of days; withdraw 5 days
weight gain, improved before slaughter; as
feed efficiency, and sole source of organic
improved pigmentation; arsenic; drug overdose
and for reduction of or lack of water may
mortality due to E. result in weakness or
coli infections paralysis of the legs.
susceptible to Chlortetracycline as
chlortetracycline. provided by No. 054771
in Sec. 510.600(c)
of this chapter.
----------------------------------------------------------------------------------------------------------------
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combinations in
Roxarsone in grams per ton grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 45.4............ Chlortetracycline Growing turkeys: For Feed continuously 054771
10 to 50. increased rate of throughout growing
weight gain, improved period; withdraw 5
feed efficiency, and days before slaughter;
improved pigmentation. as sole source of
organic arsenic; drug
overdose or lack of
water may result in
weakness or paralysis
of the legs.
Chlortetracycline as
provided by No. 054771
in Sec. 510.600(c)
of this chapter.
[[Page 69994]]
(iii) 22.7 to 45.4........... Chlortetracycline Growing turkeys: For Feed continuously for 7 054771
200. increased rate of to 14 days; withdraw 5
weight gain, improved days before slaughter;
feed efficiency, and as sole source of
improved pigmentation; organic arsenic; drug
and for control of overdose or lack of
infectious synovitis water may result in
caused by Mycoplasma weakness or paralysis
synoviae susceptible of the legs.
to chlortetracycline. Chlortetracycline as
provided by No. 054771
in Sec. 510.600(c)
of this chapter.
(iv) 22.7 to 45.4............ Chlortetracycline 1. Growing turkeys: For Feed continuously for 7 054771
400. increased rate of to 14 days; withdraw 5
weight gain, improved days before slaughter;
feed efficiency, and as sole source of
improved pigmentation; organic arsenic; drug
and for control of overdose or lack of
hexamitiasis caused by water may result in
Hexamita meleagrides weakness or paralysis
susceptible to of the legs.
chlortetracycline. Chlortetracycline as
2. Turkey poults not provided by No. 054771
over 4 weeks of age: in Sec. 510.600(c)
Reduction of mortality of this chapter.
due to paratyphoid
caused by Salmonella
typhimurium
susceptible to
chlortetracycline.
(v) 22.7 to 45.4............. Chlortetracycline, Growing turkeys: For Feed continuously for 7 054771
25 mg/lb body increased rate of to 14 days; withdraw 5
weight daily. weight gain, improved days before slaughter;
feed efficiency, and as sole source of
improved pigmentation; organic arsenic; drug
and for control of overdose or lack of
complicating bacterial water may result in
organisms associated weakness or paralysis
with bluecomb of the legs.
(transmissible Chlortetracycline as
enteritis, coronaviral provided by No. 054771
enteritis) susceptible in Sec. 510.600(c)
to chlortetracycline. of this chapter.
----------------------------------------------------------------------------------------------------------------
(3) * * *
----------------------------------------------------------------------------------------------------------------
Combinations in
Roxarsone in grams per ton grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 34.1............ Chlortetracycline Growing and finishing Feed for not more than 054771
400 (to swine: For increased 14 days; withdraw 5
administer 10 mg/ rate of weight gain days before slaughter;
lb body weight). and improved feed as sole source of
efficiency; and for organic arsenic.
treatment of bacterial
enteritis caused by E.
coli and S.
choleraesuis and
bacterial pneumonia
caused by Pasteurella
multocida susceptible
to chlortetracycline.
(iii) [Reserved].............
(iv) 181.5................... Chlortetracycline Growing and finishing Feed for not more than 054771
10 to 50. swine: For increased 6 consecutive days; if
rate of weight gain improvement is not
and improved feed observed, consult a
efficiency; and for veterinarian; withdraw
treatment of swine 5 days before
dysentery. slaughter; as a sole
source of organic
arsenic; animals must
consume enough
medicated feed to
provide a therapeutic
dose.
(v) 181.5.................... Chlortetracycline Growing and finishing Feed for not more than 054771
400 (to swine: For the 6 consecutive days; if
administer 10 mg/ treatment of swine improvement is not
lb body weight). dysentery; and for observed, consult a
treatment of bacterial veterinarian; withdraw
enteritis caused by E. 5 days before
coli and S. slaughter; as a sole
choleraesuis and source of organic
bacterial pneumonia arsenic; animals must
caused by P. multocida consume enough
susceptible to medicated feed to
chlortetracycline. provide a therapeutic
dose.
----------------------------------------------------------------------------------------------------------------
[[Page 69995]]
* * * * *
Dated: November 18, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-27917 Filed 11-21-13; 8:45 am]
BILLING CODE 4160-01-P
