New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin, 76862-76864 [2012-31397]
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76862
Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations
On August 7, 1998, Congress passed
WIA. Under WIA, which superseded the
JTPA, Congress required the Secretary of
Labor to develop and publish interim
final regulations (IFR) to implement this
transition no later than 180 days after
WIA’s enactment date. See 20 U.S.C.
9276(c)(1). The Department published
the WIA IFR on April 15, 1999. See 64
FR 18662. In that IFR, the Department
explicitly provided for the phased
transition of the JTPA programs to WIA,
to be fully completed by July 1, 2000.
See 64 FR 18662, 18663 (Apr. 15, 1999).
The final rule implementing WIA was
published on August 11, 2000. See 65
FR 49293 (Aug. 11, 2000).
Initially, although the JTPA
authorizing legislation was repealed, the
Department retained the JTPA
regulations in the Code of Federal
Regulations for grant closeout and
auditing purposes. However, now that
the JTPA programs have been
transitioned to WIA for over a decade,
the Department finds no reason to retain
the JTPA regulations. Furthermore, the
Department has previously removed
several other JTPA regulatory
provisions. Parts 629 and 630 were
removed at 57 FR 62004 (Dec. 29, 1992).
Part 635 was re-designated as 20 CFR
part 1005 at 54 FR 39352 (Sept. 26,
1989), and the Department later
removed part 1005 at 59 FR 26601 (May
23, 1994). Finally, the Department notes
that it re-designated part 684 as part 638
at 55 FR 12992 (Apr. 6, 1990). Those
JTPA regulatory provisions that remain
are subject to this removal notice.
List of Subjects
20 CFR Parts 626, 627, 628, 631 and 637
Accounting, Administrative practice
and procedure, Disaster assistance,
Grant programs—Labor, Manpower
training programs, Reporting and
recordkeeping requirements, Youth.
20 CFR Part 632
Administrative practice and
procedure, Fraud, Grant programs—
Indians, Grant programs—labor,
Hawaiian Natives, Manpower training
programs, Reporting and recordkeeping
requirements Youth.
ebenthall on DSK5TPTVN1PROD with
20 CFR Part 633
Grant programs—labor, Manpower
training programs, Migrant labor,
Recording and record keeping
requirements.
20 CFR Part 634
Grant Programs—labor, Manpower
training programs, Statistics.
VerDate Mar<15>2010
01:38 Dec 29, 2012
Jkt 229001
20 CFR Part 636
Administrative practice and
procedure, Grant programs—labor,
Manpower training programs.
20 CFR Part 638
Grant programs—labor, Job Corps,
Lobbying, Manpower training programs,
Recording and record keeping
requirements, Youth.
Accordingly, under the authority of
the Workforce Investment Act of 1998
(WIA), 29 U.S.C. 9276(a), and for the
reasons discussed in the preamble, the
Department amends 20 CFR Chapter V
by removing Parts 626, 627, 628, 631,
632, 633, 634, 636, 637, and 638 as
follows:
1. Remove and reserve part 626,
consisting of §§ 626.1 through 626.5.
■
2. Remove and reserve part 627,
consisting of §§ 627.100 through
627.906.
PART 628—[REMOVED AND
RESERVED]
3. Remove and reserve part 628,
consisting of §§ 628.100 through
628.804.
PART 631—[REMOVED AND
RESERVED]
4. Remove and reserve part 631,
consisting of §§ 631.1 through 631.87.
■
PART 632—[REMOVED AND
RESERVED]
5. Remove and reserve part 632,
consisting of §§ 632.1 through 632.263.
■
PART 633—[REMOVED AND
RESERVED]
6. Remove and reserve part 633,
consisting of §§ 633.102 through
633.322.
■
PART 634—[REMOVED AND
RESERVED]
7. Remove and reserve part 634,
consisting of §§ 634.1 through 634.5.
■
PART 636—[REMOVED AND
RESERVED]
8. Remove and reserve part 636,
consisting of §§ 636.1 through 636.11.
Sfmt 4700
Signed at Washington, DC, this 18th day of
December, 2012.
Jane Oates
Assistant Secretary, Employment and
Training Administration.
[FR Doc. 2012–31029 Filed 12–28–12; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Enrofloxacin;
Melengestrol; Meloxicam;
Pradofloxacin; Tylosin
AGENCY:
■
Fmt 4700
10. Remove and reserve part 638,
consisting of §§ 638.100 through
638.815.
■
21 CFR Parts 520, 522, 529, and 558
■
Frm 00054
PART 638—[REMOVED AND
RESERVED]
Food and Drug Administration
PART 627—[REMOVED AND
RESERVED]
PO 00000
9. Remove and reserve part 637,
consisting of §§ 637.100 through
637.310.
■
BILLING CODE 4510–FN–P
PART 626—[REMOVED AND
RESERVED]
■
PART 637—[REMOVED AND
RESERVED]
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during November 2012. FDA
is also informing the public of the
availability of summaries the basis of
approval and of environmental review
documents, where applicable.
DATES: This rule is effective December
31, 2012.
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,
email: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations to
reflect original and supplemental
approval actions during November
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
SUMMARY:
E:\FR\FM\31DER1.SGM
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Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations
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.
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.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER 2012
NADA/
ANADA
Sponsor
New animal drug
product name
Action
141–344 ..................
Bayer HealthCare
LLC, Animal
Health Division,
P.O. Box 390,
Shawnee Mission, KS 66201.
Abbott Laboratories, Inc., North
Chicago, IL
60064.
Bayer HealthCare
LLC, Animal
Health Division,
P.O. Box 390,
Shawnee Mission, KS 66201.
Huvepharma AD,
5th Floor, 3A
Nikolay Haitov
St., 1113 Sophia,
Bulgaria.
VERAFLOX
(pradofloxacin)
Oral Suspension
for Cats.
Original approval for the treatment of
skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida,
Streptococcus canis, S. aureus, S.
felis, and S. pseudintermedius.
Original approval for the control of pain
and inflammation associated with osteoarthritis in dogs.
141–346 ..................
141–068 ..................
200–534 ..................
OROCAM
(meloxicam)
Transmucosal
Oral Spray.
BAYTRIL 100
(enrofloxacin)
Injectable Solution.
TYLOVET 100
(tylosin phosphate) and
RUMENSIN
(monensin) and
MGA
(melengestrone
acetate) liquid
and dry, combination drug
Type C medicated feeds.
21 CFR Section
FOIA
summary
NEPA
review
520.1860
Yes
CE 1
529.1350
Yes
CE 1
Supplemental approval adding treatment and control of swine respiratory
disease associated with Bordetella
bronchiseptica
and
Mycoplasma
hyopneumoniae.
522.812
Yes
CE 1
Original approval as a generic copy of
NADA 138–870.
558.342
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.
List of Subjects
21 CFR Parts 520, 522, and 529
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, 522, 529, and 558 are
amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
(c) Special considerations. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
Federal law prohibits the extralabel use
of this drug in food-producing animals.
(d) Conditions of use in cats—(1)
Amount. Administer 3.4 mg/lb (7.5 mg/
kg) body weight once daily for 7
consecutive days.
(2) Indications for use. For the
treatment of skin infections (wounds
and abscesses) in cats caused by
susceptible strains of Pasteurella
multocida, Streptococcus canis,
Staphylococcus aureus, Staphylococcus
felis, and Staphylococcus
pseudintermedius.
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
ebenthall on DSK5TPTVN1PROD with
■
2. Add § 520.1860 to read as follows:
§ 520.1860
01:38 Dec 29, 2012
Enrofloxacin.
*
*
*
*
*
(e) * * *
(3) * * *
(ii) Indications for use. For the
treatment and control of swine
respiratory disease (SRD) associated
with Actinobacillus pleuropneumoniae,
Pasteurella multocida, Haemophilus
parasuis, Streptococcus suis, Bordetella
bronchiseptica, and Mycoplasma
hyopneumoniae.
*
*
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
5. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
6. Add § 529.1350 to read as follows:
■
Pradofloxacin.
(a) Specifications. Each milliliter of
suspension contains 25 milligrams (mg)
pradofloxacin.
(b) Sponsor. See No. 000859 in
§ 510.600(c) of this chapter.
VerDate Mar<15>2010
3. The authority citation for 21 CFR
part 522 continues to read as follows:
§ 522.812
Jkt 229001
§ 529.1350
4. In § 522.812, revise paragraph
(e)(3)(ii) to read as follows:
(a) Specifications. Each milliliter of
solution contains 5 milligrams (mg)
meloxicam.
(b) Sponsor. See No. 000074 in
§ 510.600(c) of this chapter.
Authority: 21 U.S.C. 360b.
■
PO 00000
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Fmt 4700
Sfmt 4700
E:\FR\FM\31DER1.SGM
Meloxicam.
31DER1
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Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations
(c) Conditions of use in dogs—(1)
Amount. Administer 0.1 mg per
kilogram of body weight once daily
using the metered dose pump.
(2) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
7. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.342
Regulatory Analysis and Notices
[Amended]
8. In § 558.342, in the table, in
paragraph (e)(1)(xi), in the
‘‘Limitations’’ column, revise the last
sentence to read ‘‘Monensin provided
by No. 000986 and tylosin provided by
Nos. 000986 and 016592 in § 510.600(c)
of this chapter.’’; and in the ‘‘Sponsor’’
column, add ‘‘016592’’.
■
Dated: December 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–31397 Filed 12–28–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF STATE
22 CFR Parts 120 and 126
[Public Notice 8135]
RIN 1400–AD26
Amendment to the International Traffic
in Arms Regulations: Afghanistan and
Change to Policy on Prohibited
Exports
Department of State.
ACTION: Final rule.
AGENCY:
The Department of State is
amending the International Traffic in
Arms Regulations (ITAR) to list
Afghanistan as a major non-NATO ally,
and to make available the use of two
additional defense export license
exemptions for proscribed destinations.
DATES: Effective Date: This rule is
effective December 31, 2012.
FOR FURTHER INFORMATION CONTACT: Ms.
Candace M. J. Goforth, Director, Office
of Defense Trade Controls Policy, U.S.
Department of State, telephone (202)
663–2792, or email
DDTCResponseTeam@state.gov. ATTN:
Regulatory Change, Afghanistan and
126.1.
SUPPLEMENTARY INFORMATION: On July 6,
2012, President Obama exercised his
ebenthall on DSK5TPTVN1PROD with
SUMMARY:
VerDate Mar<15>2010
01:38 Dec 29, 2012
authority under section 517 of the
Foreign Assistance Act of 1961 (FAA) to
designate the Islamic Republic of
Afghanistan as a major non-NATO ally
(MNNA) for purposes of the FAA and
the Arms Export Control Act. This final
rule amends ITAR § 120.32, which lists
major non-NATO allies, to account for
this designation. Section 126.1 is
amended to except the exemptions at
ITAR §§ 126.4 and 126.6 from the
prohibitions therein and the text is
further amended to clarify the
requirements therein. Additionally,
§ 126.1(g) is amended to clarify
references to United Nations Security
Council resolutions.
Jkt 229001
Administrative Procedure Act
The Department of State is of the
opinion that controlling the import and
export of defense articles and services is
a foreign affairs function of the United
States Government and that rules
implementing this function are exempt
from sections 553 (rulemaking) and 554
(adjudications) of the Administrative
Procedure Act. Since the Department is
of the opinion that this rule is exempt
from 5 U.S.C. 553, it is the view of the
Department that the provisions of
section 553(d) do not apply to this
rulemaking. Therefore, this rule is
effective upon publication. The
Department also finds that, given the
national security issues surrounding
U.S. policy towards Afghanistan, notice
and public procedure on this rule would
be impracticable, unnecessary, or
contrary to the public interest; for the
same reason, the rule will be effective
immediately.
Regulatory Flexibility Act
Since the Department is of the
opinion that this rule is exempt from the
rulemaking provisions of 5 U.S.C. 553,
it does not require analysis under the
Regulatory Flexibility Act.
Unfunded Mandates Act of 1995
This rulemaking does not involve a
mandate that will result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
in any year and it will not significantly
or uniquely affect small governments.
Therefore, no actions were deemed
necessary under the provisions of the
Unfunded Mandates Reform Act of
1995.
Small Business Regulatory Enforcement
Fairness Act of 1996
This rulemaking has been found not
to be a major rule within the meaning
PO 00000
Frm 00056
Fmt 4700
Sfmt 4700
of the Small Business Regulatory
Enforcement Fairness Act of 1996.
Executive Orders 12372 and 13132
This rulemaking will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with Executive Order 13132,
it is determined that this rulemaking
does not have sufficient federalism
implications to require consultations or
warrant the preparation of a federalism
summary impact statement. The
regulations implementing Executive
Order 12372 regarding
intergovernmental consultation on
Federal programs and activities do not
apply to this rulemaking.
Executive Orders 12866 and 13563
Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributed impacts, and equity).
These Executive Orders stress the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This rule has been
designated ‘‘significant regulatory
actions,’’ although not economically
significant, under section 3(f) of
Executive Order 12866. Accordingly,
this rule has been reviewed by the
Office of Management and Budget
(OMB).
Executive Order 12988
The Department of State has reviewed
this rulemaking in light of sections 3(a)
and 3(b)(2) of Executive Order 12988 to
eliminate ambiguity, minimize
litigation, establish clear legal
standards, and reduce burden.
Executive Order 13175
The Department of State has
determined that this rulemaking will
not have tribal implications, will not
impose substantial direct compliance
costs on Indian tribal governments, and
will not pre-empt tribal law.
Accordingly, the requirement of
Executive Order 13175 does not apply
to this rulemaking.
Paperwork Reduction Act
This rule does not impose any new
reporting or recordkeeping requirements
E:\FR\FM\31DER1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Rules and Regulations]
[Pages 76862-76864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31397]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 529, and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam;
Pradofloxacin; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during November 2012. FDA is also informing the public of the
availability of summaries the basis of approval and of environmental
review documents, where applicable.
DATES: This rule is effective December 31, 2012.
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, email:
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect original and supplemental approval actions during November
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
[[Page 76863]]
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.
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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During November 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug FOIA
NADA/ ANADA Sponsor product name Action 21 CFR Section summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-344........................ Bayer HealthCare VERAFLOX Original approval for 520.1860 Yes CE \1\
LLC, Animal (pradofloxacin) the treatment of skin
Health Division, Oral Suspension infections (wounds and
P.O. Box 390, for Cats. abscesses) in cats
Shawnee Mission, caused by susceptible
KS 66201. strains of Pasteurella
multocida,
Streptococcus canis,
S. aureus, S. felis,
and S.
pseudintermedius.
141-346........................ Abbott OROCAM (meloxicam) Original approval for 529.1350 Yes CE \1\
Laboratories, Transmucosal Oral the control of pain
Inc., North Spray. and inflammation
Chicago, IL 60064. associated with
osteoarthritis in dogs.
141-068........................ Bayer HealthCare BAYTRIL 100 Supplemental approval 522.812 Yes CE \1\
LLC, Animal (enrofloxacin) adding treatment and
Health Division, Injectable control of swine
P.O. Box 390, Solution. respiratory disease
Shawnee Mission, associated with
KS 66201. Bordetella
bronchiseptica and
Mycoplasma
hyopneumoniae.
200-534........................ Huvepharma AD, 5th TYLOVET 100 Original approval as a 558.342 Yes CE \1\
Floor, 3A Nikolay (tylosin generic copy of NADA
Haitov St., 1113 phosphate) and 138-870.
Sophia, Bulgaria. RUMENSIN
(monensin) and
MGA
(melengestrone
acetate) liquid
and dry,
combination drug
Type C medicated
feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
List of Subjects
21 CFR Parts 520, 522, and 529
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,
522, 529, 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. Add Sec. 520.1860 to read as follows:
Sec. 520.1860 Pradofloxacin.
(a) Specifications. Each milliliter of suspension contains 25
milligrams (mg) pradofloxacin.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian. Federal law prohibits
the extralabel use of this drug in food-producing animals.
(d) Conditions of use in cats--(1) Amount. Administer 3.4 mg/lb
(7.5 mg/kg) body weight once daily for 7 consecutive days.
(2) Indications for use. For the treatment of skin infections
(wounds and abscesses) in cats caused by susceptible strains of
Pasteurella multocida, Streptococcus canis, Staphylococcus aureus,
Staphylococcus felis, and Staphylococcus pseudintermedius.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 522.812, revise paragraph (e)(3)(ii) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(e) * * *
(3) * * *
(ii) Indications for use. For the treatment and control of swine
respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis,
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma
hyopneumoniae.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
6. Add Sec. 529.1350 to read as follows:
Sec. 529.1350 Meloxicam.
(a) Specifications. Each milliliter of solution contains 5
milligrams (mg) meloxicam.
(b) Sponsor. See No. 000074 in Sec. 510.600(c) of this chapter.
[[Page 76864]]
(c) Conditions of use in dogs--(1) Amount. Administer 0.1 mg per
kilogram of body weight once daily using the metered dose pump.
(2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
7. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.342 [Amended]
0
8. In Sec. 558.342, in the table, in paragraph (e)(1)(xi), in the
``Limitations'' column, revise the last sentence to read ``Monensin
provided by No. 000986 and tylosin provided by Nos. 000986 and 016592
in Sec. 510.600(c) of this chapter.''; and in the ``Sponsor'' column,
add ``016592''.
Dated: December 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-31397 Filed 12-28-12; 8:45 am]
BILLING CODE 4160-01-P
