New Animal Drugs; Meloxicam; Nicarbazin, 22-25 [2012-31234]
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22
Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Rules and Regulations
subpart F of part 23, the earliest that an
SD or MSP would be required to comply
with such requirements is December 31,
2012. The changes to compliance dates
for § 23.201 will extend the compliance
date for certain provisions of this rule
until May 1, 2013.
The changes to compliance dates
being adopted do not change the
substance of the rules; rather, they
merely provide additional time by
which parties can comply. As such, the
costs and benefits of the Commission’s
action relate only to the additional time
provided.
Commission expects that reduced
market liquidity would increase the
costs of hedging, which would then be
passed on the public in the form of
higher costs.
4. Section 15(a)
Section 15(a) of the CEA requires the
Commission to consider the effects of its
actions in light of the following five
factors:
such a decrease in swaps activity will
adversely impact the price discovery
process of the swaps markets.
d. Sound Risk Management
If counterparties refrain from
transacting in swaps, the ability of other
market participants to hedge their risks
using these instruments may suffer. By
mitigating the concerns of market
participants regarding compliance with
Commission rules, the changes to
compliance dates being adopted herein
help ensure that, while firms diligently
complete the compliance requirements,
they can continue entering into swap
transactions to hedge their business and
investment risks.
tkelley on DSK3SPTVN1PROD with
2. Costs
The Commission does not anticipate
there being any new, quantifiable costs
attributable to these changes to
compliance dates being adopted because
it is only extending the compliance
dates for certain requirements in part 23
of the Commission’s regulations. At the
same time, however, the Commission is
mindful that a delay in the protections
afforded by the regulations could result
in costs to the public, even if the same
is not amenable to quantification. The
Commission believes, however, that
these costs are mitigated by the
maintenance of various other provisions
relating to (i) prohibitions on fraud,
manipulation and abusive practices, (ii)
fair dealings in communications, and
(iii) reasonable diligence regarding
recommended swaps. These provisions
are unaffected by delayed compliance
from this extension. The Commission
invites comments from the public on
any costs, quantitative and qualitative,
arising from the delay granted by the
changes to compliance dates being
adopted.
3. Benefits
The additional time for compliance
provided for in this release will yield
substantial benefit for market
participants and the public alike.
Absent this extension, market
participants would be required to
implement temporary solutions while
the more permanent, industry wide
solutions described earlier are finalized.
The Commission believes that this
duplication of efforts to achieve
compliance would impose extensive
burdens and costs on parties without
any concomitant benefit to the public.
Moreover, the Commission is concerned
that based on the representations made
by market participants, absent the
changes to compliance dates being
adopted, market participants might exit
the market or curtail their swaps activity
due to a lack of legal certainty and
protection afforded by Commission
relief. If that were to occur, the
a. Protection of Market Participants and
the Public
The Commission believes that by
extending the compliance date for
certain regulations in part 23, market
participants will be able to continue to
participate in the swaps market without
concerns about potential consequences
of failure to comply with the specified
regulations. This will, in turn, protect
the public by ensuring that the economy
does not suffer as a result of any
unintended consequences that may have
arisen if market participants exited the
swaps market. The Commission
recognizes that any delay in compliance
with the aforementioned business
conduct and documentation
requirements continues to leave the
public without the protections and
attendant benefits of those
requirements. However, the
Commission believes that delaying
compliance for only certain business
conduct and documentation
requirements, while retaining the
original compliance dates for
fundamental counterparty protections
relating to (i) prohibitions on fraud,
manipulation and abusive practices, (ii)
fair dealings in communications, and
(iii) reasonable diligence regarding
recommended swaps, will mitigate
those effects while avoiding this risk
that market participants will exit the
market due to legal uncertainty.
b. Efficiency, Competitiveness, and
Financial Integrity of Markets
The Commission believes that
extending the compliance dates for the
aforementioned rules will help protect
the efficiency and competitiveness of
the markets by obviating the need to
stop transacting in swaps due to delay
in complying with specific Commission
regulations. It will also strengthen the
financial integrity of markets by
ensuring that market participants do not
transact in the swaps markets while not
being in full compliance with these
regulations.
BILLING CODE 6351–01–P
c. Price Discovery
If concerns regarding non-compliance
results in a reduction in participation by
a large number of market participants,
ACTION:
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e. Other Public Interest Considerations
The Commission has not identified an
impact on other public interest
considerations, other than those
mentioned above, as a result of the
changes to compliance dates being
adopted herein, but seeks comment as to
any potential impact on this and other
15(a) factors.
Issued in Washington, DC on December 18,
2012, by the Commission.
Sauntia S. Warfield,
Assistant Secretary of the Commission.
Appendix to Business Conduct and
Documentation Requirements for Swap
Dealers and Major Swap Participants—
Commission Voting Summary
Note: The following appendices will not
appear in the Code of Federal Regulations.
Appendix 1—Commission Voting
Summary
On this matter, Chairman Gensler and
Commissioners Sommers, Chilton, O’Malia
and Wetjen voted in the affirmative; no
Commissioner voted in the negative.
[FR Doc. 2012–30885 Filed 12–31–12; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 558
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Meloxicam;
Nicarbazin
AGENCY:
Food and Drug Administration,
HHS.
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
SUMMARY:
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Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Rules and Regulations
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during October 2012. FDA is
also informing the public of the
availability of summaries of the basis of
approval and of environmental review
documents, where applicable.
DATES:
This rule is effective January 2,
2013.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations to
reflect original and supplemental
approval actions during October 2012,
as listed in table 1 of this document. In
addition, FDA is informing the public of
the availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act (NEPA) and,
for actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOI Summaries)
under the Freedom of Information Act
(FOIA). These public documents 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. Persons with access to the
Internet may obtain these documents at
the Center for Veterinary Medicine
FOIA Electronic Reading Room: https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER 2012
New animal drug
product name
NADA/ANADA
Sponsor
009–476 ..........................................
Phibro Animal
Health Corp.,
GlenPointe
Centre East,
Third floor, 300
Frank W. Burr
Blvd., suite 21,
Teaneck, NJ
07666.
Phibro Animal
Health Corp.,
GlenPointe
Centre East,
Third floor, 300
Frank W. Burr
Blvd., suite 21,
Teaneck, NJ
07666.
Cross Vetpharm
Group Ltd.,
Broomhill Rd.,
Tallaght, Dublin 24, Ireland.
098–378 ..........................................
200–496 ..........................................
21 CFR
section
Action
FOIA
summary
NEPA
review
NICARB 25%
(nicarbazin)
Type A medicated article.
Supplement revising nicarbazin
dosage to a range consistent
with dosage approved for use in
combination feeds.
558.366
No ......
CE 1
NICARB 25%
(nicarbazin)
and bacitracin
methylene disalicylate Type
A medicated
articles.
Supplement revising nicarbazin
dosage to a range consistent
with dosage approved for use in
combination feeds.
558.366
No ......
CE 1
AMPROMED P
for Poultry
(amprolium)
9.6% Oral Solution.
Original approval as a generic
copy of NADA 13–149.
520.100
Yes ....
CE 1
1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
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.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
List of Subjects
2. In § 520.100, revise paragraph (b)(4)
and the introductory text in paragraph
(d)(1) to read as follows:
■
21 CFR Part 520
Animal drugs.
21 CFR Part 558
§ 520.100
*
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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 parts 520 and 558 are amended as
follows:
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Amprolium.
*
*
*
*
(b) * * *
(4) No. 061623 for use of products
described in paragraphs (a)(1) and (a)(2)
of this section as in paragraph (d) of this
section.
*
*
*
*
*
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
(d) * * * (1) Growing chickens,
turkeys, and laying hens. It is used in
drinking water as follows:
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
4. In § 558.366, in paragraph (d),
amend the table as follows:
■ a. Revise the entries for ‘‘90.8 to 181.6
(0.01 to 0.02 pct)’’.
■ b. In the entry for ‘‘113.5 (0.0125
pct)’’, in the entry for ‘‘Chickens; aid in
preventing outbreaks of cecal (Eimeria
tenella) and intestinal (E. acervulina, E.
maxima, E. necatrix, and E. brunetti)
■
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Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Rules and Regulations
coccidiosis’’, remove ‘‘066104’’ from the
‘‘Sponsor’’ column.
■ c. In the entry for ‘‘113.5 (0.0125
pct)’’, in the entry for ‘‘Bacitracin
Nicarbazin in
grams per ton
methylene disalicylate 30’’, remove
‘‘066104’’ from the ‘‘Sponsor’’ column.
The revisions read as follows:
Broiler chickens: As an aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; and for increased rate of
weight gain and improved feed efficiency.
Broiler chickens: As an aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; and for increased rate of
weight gain and improved feed efficiency.
Penicillin 2.4 to 50 ..
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*
*
Broiler chickens: As an aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis.
Bacitracin methylene
disalicylate 30.
VerDate Mar<15>2010
*
.................................
Broiler chickens: As an aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of
weight gain and improved feed efficiency.
*
16:06 Dec 31, 2012
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Fmt 4700
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Nicarbazin.
*
*
(d) * * *
Indications for use
Bacitracin methylene
disalicylate 4 to 50
and roxarsone
22.7 to 45.4.
*
90.8 to 181.6 (0.01
to 0.02 pct).
Combination in
grams per ton
§ 558.366
Limitations
*
*
Sponsor
*
*
*
Feed continuously as sole ration from
066104
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to
laying hens. Withdraw 4 days before
slaughter for use levels at or below
113.5 g/ton. Withdraw 5 days before
slaughter for use levels above 113.5 g/
ton.
Feed continuously as sole ration from
066104
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis. Discontinue medication 5 days before
marketing the birds for human consumption to allow for elimination of the
drug from edible tissue. Do not feed to
laying hens in production. Nicarbazin
as provided by No. 066104; bacitracin
methylene disalicylate and roxarsone
by No. 046573 in § 510.600(c) of this
chapter.
Feed continuously as sole ration from
066104
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to
laying hens. Withdraw 4 days before
slaughter for use levels at or below
113.5 g/ton. Withdraw 5 days before
slaughter for use levels above 113.5 g/
ton.
Feed continuously as sole ration from
066104
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis. Do
not use in flushing mashes. Do not
feed to chickens producing eggs for
human consumption. Discontinue medication 5 days before marketing the
birds for human consumption to allow
for elimination of the drug from edible
tissue. Penicillin as procaine penicillin
G. Nicarbazin and penicillin as provided by No. 066104 in § 510.600(c) of
this chapter.
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Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Rules and Regulations
Nicarbazin in
grams per ton
Combination in
grams per ton
Indications for use
Broiler chickens: As an aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of
weight gain and improved feed efficiency, and improved pigmentation.
Penicillin 2.4 to 50
and roxarsone
22.7 to 45.4.
*
*
Limitations
Feed continuously as sole ration from
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis. Feed
as the sole source of organic arsenic;
drug overdose or lack of water may result in leg weakness; do not use in
flushing mashes. Discontinue medication 5 days before marketing the birds
for human consumption to allow for
elimination of the drug from edible tissue. Do not feed to laying hens in production. Penicillin as procaine penicillin
G. Nicarbazin and penicillin as provided by No. 066104; roxarsone by No.
046573 in § 510.600(c) of this chapter.
*
Dated: December 21, 2012
Bernadette Dunham,
Director, Center for Veterinary Medicine.
*
*
CDC barges in the RNA from their
dangerous cargo or vessel arrival and
movement reporting obligations
currently in effect under other
regulations or placed into effect under
appropriate Coast Guard authority.
[FR Doc. 2012–31234 Filed 12–31–12; 8:45 am]
BILLING CODE 4160–01–P
Effective midnight January 15,
2013, 33 CFR 165.830(d), (e), (f), (g), and
(h) are stayed until midnight September
30, 2013.
DATES:
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2012–
1074. To view documents mentioned in
this preamble as being available in the
docket, go to 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
rulemaking. 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.
ADDRESSES:
33 CFR Part 165
[USCG–2012–1074]
RIN 1625–AA11
Regulated Navigation Area; Reporting
Requirements for Barges Loaded With
Certain Dangerous Cargoes, Inland
Rivers, Eighth Coast Guard District;
Extension of Stay (Suspension)
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Commander, Eighth
Coast Guard District is extending the
previously published stay (suspension)
of reporting requirements under the
Regulated Navigation Area (RNA)
established by 33 CFR 165.830 for
barges loaded with certain dangerous
cargoes (CDC barges) in the inland rivers
of the Eighth Coast Guard District. A
two year stay was previously published
at 76 Federal Register (FR) 1360
(January 10, 2011), which expires
January 15, 2013. This extension is
necessary because the Coast Guard
continues to analyze future reporting
needs and evaluate possible changes in
CDC reporting requirements. This
extension of the suspension of the CDC
reporting requirements in no way
relieves towing vessel operators and
fleeting area managers responsible for
tkelley on DSK3SPTVN1PROD with
SUMMARY:
VerDate Mar<15>2010
16:06 Dec 31, 2012
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If
you have questions about this temporary
rule, call or email LT Jason Doherty,
Coast Guard; telephone 504–671–2266,
email: Jason.C.Doherty@uscg.mil. If you
have questions on viewing the docket,
call Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Table of Acronyms
CDC Certain Dangerous Cargo
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
PO 00000
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*
Sponsor
066104
*
A. Regulatory History and Information
The Coast Guard is issuing this
temporary final rule without prior
notice and opportunity to comment
pursuant to authority under section 4(a)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(3)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because it
would be impracticable, unnecessary,
and contrary to the public interest.
The contract for the CDC barge
reporting system at the Inland River
Vessel Movement Center (IRVMC)
expired in January 2011. Due to the
expiration of this contract, the Coast
Guard would not be able to receive and
process reports, therefore, in late
December 2010, the Coast Guard
decided to suspend the IRVMC
reporting requirements for a two-year
period. This suspension was published
in the Federal Register at 76 FR 1360
(January 10, 2011), and expires on
January 15, 2013.
At this time, the contract for the CDC
barge reporting system has not been
renewed, and the Coast Guard is still
considering whether to enter into a new
contract and lift the suspension, modify
the reporting requirements in the RNA,
or repeal the RNA completely. An
extension of the stay is necessary while
the Coast Guard continues to consider
these options.
We believe prior notice and comment
is unnecessary because we expect the
affected public will have no objection to
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]]>Agencies
[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Rules and Regulations]
[Pages 22-25]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31234]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Meloxicam; Nicarbazin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect
[[Page 23]]
approval actions for new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs) during October 2012.
FDA is also informing the public of the availability of summaries of
the basis of approval and of environmental review documents, where
applicable.
DATES: This rule is effective January 2, 2013.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect original and supplemental approval actions during October
2012, as listed in table 1 of this document. In addition, FDA is
informing the public of the availability, where applicable, of
documentation of environmental review required under the National
Environmental Policy Act (NEPA) and, for actions requiring review of
safety or effectiveness data, summaries of the basis of approval (FOI
Summaries) under the Freedom of Information Act (FOIA). These public
documents 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. Persons
with access to the Internet may obtain these documents at the Center
for Veterinary Medicine FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During October 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action section FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
009-476.......................... Phibro Animal Health NICARB 25% Supplement revising 558.366 No................. CE \1\
Corp., GlenPointe (nicarbazin) Type A nicarbazin dosage
Centre East, Third medicated article. to a range
floor, 300 Frank W. consistent with
Burr Blvd., suite dosage approved for
21, Teaneck, NJ use in combination
07666. feeds.
098-378.......................... Phibro Animal Health NICARB 25% Supplement revising 558.366 No................. CE \1\
Corp., GlenPointe (nicarbazin) and nicarbazin dosage
Centre East, Third bacitracin to a range
floor, 300 Frank W. methylene consistent with
Burr Blvd., suite disalicylate Type A dosage approved for
21, Teaneck, NJ medicated articles. use in combination
07666. feeds.
200-496.......................... Cross Vetpharm Group AMPROMED P for Original approval as 520.100 Yes................ CE \1\
Ltd., Broomhill Poultry (amprolium) a generic copy of
Rd., Tallaght, 9.6% Oral Solution. NADA 13-149.
Dublin 24, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
human environment.
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
21 CFR Part 520
Animal drugs.
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 parts 520 and
558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.100, revise paragraph (b)(4) and the introductory text
in paragraph (d)(1) to read as follows:
Sec. 520.100 Amprolium.
* * * * *
(b) * * *
(4) No. 061623 for use of products described in paragraphs (a)(1)
and (a)(2) of this section as in paragraph (d) of this section.
* * * * *
(d) * * * (1) Growing chickens, turkeys, and laying hens. It is
used in drinking water as follows:
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In Sec. 558.366, in paragraph (d), amend the table as follows:
0
a. Revise the entries for ``90.8 to 181.6 (0.01 to 0.02 pct)''.
0
b. In the entry for ``113.5 (0.0125 pct)'', in the entry for
``Chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and
intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti)
[[Page 24]]
coccidiosis'', remove ``066104'' from the ``Sponsor'' column.
0
c. In the entry for ``113.5 (0.0125 pct)'', in the entry for
``Bacitracin methylene disalicylate 30'', remove ``066104'' from the
``Sponsor'' column.
The revisions read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(d) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams
Nicarbazin in grams per ton per ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
90.8 to 181.6 (0.01 to 0.02 pct)... ...................... Broiler chickens: As an aid in Feed continuously as sole ration from 066104
preventing outbreaks of cecal (Eimeria time chicks are placed on litter until
tenella) and intestinal (E. past the time when coccidiosis is
acervulina, E. maxima, E. necatrix, ordinarily a hazard. Do not use as a
and E. brunetti) coccidiosis. treatment for coccidiosis. Do not feed
to laying hens. Withdraw 4 days before
slaughter for use levels at or below
113.5 g/ton. Withdraw 5 days before
slaughter for use levels above 113.5 g/
ton.
Bacitracin methylene Broiler chickens: As an aid in Feed continuously as sole ration from 066104
disalicylate 4 to 50 preventing outbreaks of cecal (Eimeria time chicks are placed on litter until
and roxarsone 22.7 to tenella) and intestinal (E. past the time when coccidiosis is
45.4. acervulina, E. maxima, E. necatrix, ordinarily a hazard; do not use as a
and E. brunetti) coccidiosis; and for treatment for outbreaks of
increased rate of weight gain and coccidiosis. Discontinue medication 5
improved feed efficiency. days before marketing the birds for
human consumption to allow for
elimination of the drug from edible
tissue. Do not feed to laying hens in
production. Nicarbazin as provided by
No. 066104; bacitracin methylene
disalicylate and roxarsone by No.
046573 in Sec. 510.600(c) of this
chapter.
Bacitracin methylene Broiler chickens: As an aid in Feed continuously as sole ration from 066104
disalicylate 30. preventing outbreaks of cecal (Eimeria time chicks are placed on litter until
tenella) and intestinal (E. past the time when coccidiosis is
acervulina, E. maxima, E. necatrix, ordinarily a hazard. Do not use as a
and E. brunetti) coccidiosis; and for treatment for coccidiosis. Do not feed
increased rate of weight gain and to laying hens. Withdraw 4 days before
improved feed efficiency. slaughter for use levels at or below
113.5 g/ton. Withdraw 5 days before
slaughter for use levels above 113.5 g/
ton.
Penicillin 2.4 to 50.. Broiler chickens: As an aid in Feed continuously as sole ration from 066104
preventing outbreaks of cecal (Eimeria time chicks are placed on litter until
tenella) and intestinal (E. past the time when coccidiosis is
acervulina, E. maxima, E. necatrix, ordinarily a hazard; do not use as a
and E. brunetti) coccidiosis, and for treatment for outbreaks of
increased rate of weight gain and coccidiosis. Do not use in flushing
improved feed efficiency. mashes. Do not feed to chickens
producing eggs for human consumption.
Discontinue medication 5 days before
marketing the birds for human
consumption to allow for elimination
of the drug from edible tissue.
Penicillin as procaine penicillin G.
Nicarbazin and penicillin as provided
by No. 066104 in Sec. 510.600(c) of
this chapter.
[[Page 25]]
Penicillin 2.4 to 50 Broiler chickens: As an aid in Feed continuously as sole ration from 066104
and roxarsone 22.7 to preventing outbreaks of cecal (Eimeria time chicks are placed on litter until
45.4. tenella) and intestinal (E. past the time when coccidiosis is
acervulina, E. maxima, E. necatrix, ordinarily a hazard; do not use as a
and E. brunetti) coccidiosis, and for treatment for outbreaks of
increased rate of weight gain and coccidiosis. Feed as the sole source
improved feed efficiency, and improved of organic arsenic; drug overdose or
pigmentation. lack of water may result in leg
weakness; do not use in flushing
mashes. Discontinue medication 5 days
before marketing the birds for human
consumption to allow for elimination
of the drug from edible tissue. Do not
feed to laying hens in production.
Penicillin as procaine penicillin G.
Nicarbazin and penicillin as provided
by No. 066104; roxarsone by No. 046573
in Sec. 510.600(c) of this chapter.
* * * * * * *
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Dated: December 21, 2012
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-31234 Filed 12-31-12; 8:45 am]
BILLING CODE 4160-01-P
