New Animal Drugs; Cefpodoxime; Meloxicam, 5713-5715 [2013-01647]
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Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Rules and Regulations
economic, environmental, and energy
aspects of this AD. We will consider all
comments received by the closing date
and may amend this AD because of
those comments.
We will post all comments we
receive, without change, to https://
www.regulations.gov, including any
personal information you provide. We
will also post a report summarizing each
substantive verbal contact we receive
about this AD.
Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. ‘‘Subtitle VII:
Aviation Programs’’ describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701:
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
pmangrum on DSK3VPTVN1PROD with
Regulatory Findings
This AD will not have federalism
implications under Executive Order
13132. This AD will not have a
substantial direct effect 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.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
(2) Is not a ‘‘significant rule’’ under
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation
in Alaska to the extent that it justifies
making a regulatory distinction, and
(4) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared a regulatory evaluation
of the estimated costs to comply with
this AD and placed it in the AD docket.
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List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
2013–02–02 CFM International, S.A.:
Amendment 39–17323; Docket No.
FAA–2012–1289; Directorate Identifier
2012–NE–43–AD.
(a) Effective Date
This AD is effective January 28, 2013.
(b) Affected ADs
None.
(c) Applicability
This AD applies to CFM International, S.A.
CFM56–3, CFM56–3B, and CFM56–3C
turbofan engines, modified by Supplemental
Type Certificate SE00034EN, with a highpressure turbine (HPT) disk, part number (P/
N) 880026, serial number (S/N)
GLKBAA9307, GLKBAA9335, GLKBAA9404,
GLKBAA9407, or GLKBAA9409, installed.
(d) Unsafe Condition
This AD was prompted by a report of a
forging process error during manufacture of
these HPT disks. We are issuing this AD to
prevent uncontained release of multiple
turbine blades, damage to the engine, and
damage to the airplane.
(e) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(1) For CFM56–3, CFM56–3B, and CFM56–
3C turbofan engines operating to 20,100 lbs
maximum takeoff (MTO) thrust, remove the
HPT disk from service on or before
accumulating 8,000 cycles-since-new (CSN).
(2) For CFM56–3B and CFM56–3C turbofan
engines operating to 22,100 lbs MTO thrust,
remove the HPT disk from service on or
before accumulating 8,000 CSN.
(3) For CFM56–3C turbofan engines
operating to 23,500 lbs MTO thrust, remove
the HPT disk from service on or before
accumulating 4,000 CSN.
(4) For HPT disks that have been used in
multiple models or thrust installations, the
formula in the ADDED DATA section of Pratt
& Whitney Special Instruction 6F–12 dated
December 21, 2012 must be used to calculate
the remaining life on the disk.
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5713
(f) Alternative Methods of Compliance
(AMOCs)
The Manager, Engine Certification Office,
FAA, may approve AMOCs for this AD. Use
the procedures found in 14 CFR 39.19 to
make your request.
(g) Related Information
For more information about this AD,
contact Kenneth Steeves, Aerospace
Engineer, Engine Certification Office, FAA,
12 New England Executive Park, Burlington,
MA 01803; phone: 781–238–7765; fax: 781–
238–7199; email: kenneth.steeves@faa.gov.
(h) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Pratt & Whitney Corp. Special
Instruction No. 6F–12, dated December 21,
2012.
(ii) Reserved.
(3) For service information identified in
this AD, contact Pratt & Whitney, 400 Main
St., East Hartford, CT 06108; phone: 860–
565–7700; fax: 860–565–1605.
(4) You may view this service information
at the FAA, Engine & Propeller Directorate,
12 New England Executive Park, Burlington,
MA. For information on the availability of
this material at the FAA, call 781–238–7125.
(5) You may view this service information
at the National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Burlington, Massachusetts, on
January 14, 2013.
Thomas Boudreau,
Acting Manager, Engine & Propeller
Directorate, Aircraft Certification Service.
[FR Doc. 2013–01360 Filed 1–25–13; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 522
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Cefpodoxime;
Meloxicam
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
SUMMARY:
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Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Rules and Regulations
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during December 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 28,
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.
FDA is
amending the animal drug regulations to
reflect approval actions for several
original ANADAs during December
2012, as listed in table 1. 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
SUPPLEMENTARY INFORMATION:
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/CVMFOIA
ElectronicReadingRoom/default.htm.
TABLE 1—ORIGINAL ANADAS APPROVED DURING DECEMBER 2012
NADA/
ANADA
Sponsor
New animal drug product
name
Action
21 CFR
section
FOIA
summary
200–485 .......
Accord Healthcare, Inc.,
1009 Slater Rd., suite
210–B, Durham, NC
27703.
Norbrook Laboratories, Ltd.,
Station Works, Newry
BT35 6JP, Northern Ireland.
Putney, Inc., 400 Congress
St., suite 200, Portland,
ME 04101.
Meloxicam Injection ..............
Original approval as a generic copy of NADA 141–
219.
522.1367
yes .........
CE1
LOXICOM (meloxicam) Solution for Injection.
Original approval as a generic copy of NADA 141–
219.
522.1367
yes .........
CE1
Cefpodoxime Proxetil Tablets
Original approval as a generic copy of NADA 141–
232.
520.370
yes .........
CE1
200–491 .......
200–543 .......
NEPA
review
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 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘Accord Healthcare, Inc.’’ and
revise the entry for ‘‘Jurox Pty. Ltd.’’;
and in the table in paragraph (c)(2),
numerically add an entry for ‘‘016729’’
and revise the entry for ‘‘049480’’ to
read as follows:
(1) * * *
Animal drugs.
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 510, 520, and 522 are
amended as follows:
*
*
*
Accord Healthcare, Inc.,
1009 Slater Rd., suite
210–B, Durham, NC 27703
*
*
*
*
Jurox Pty. Ltd., 85 Gardiner
St., Rutherford, NSW
2320, Australia ..................
*
PART 510—NEW ANIMAL DRUGS
*
1. The authority citation for 21 CFR
part 510 continues to read as follows:
*
*
*
*
*
*
*
*
049480 ........ Jurox Pty. Ltd., 85 Gardiner
St., Rutherford, NSW 2320,
Australia
*
*
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.370
[Amended]
4. In paragraph (b) of § 520.370,
remove ‘‘No. 000009’’ and in its place
049480 add ‘‘Nos. 000009 and 026637’’.
*
(2) * * *
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
5. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Authority: 21 U.S.C. 360b.
16:47 Jan 25, 2013
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*
■
■
VerDate Mar<15>2010
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
016729
*
Firm name and address
*
*
*
*
*
016729 ........ Accord Healthcare, Inc., 1009
Slater Rd., suite 210–B,
Durham, NC 27703
*
Drug
labeler code
Firm name and address
21 CFR Parts 520 and 522
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Drug labeler
code
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Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Rules and Regulations
§ 522.1367
[Amended]
Background
6. In paragraph (b) of § 522.1367,
remove ‘‘No. 000010’’ and in its place
add ‘‘Nos. 000010, 016729, and
055529’’.
■
Dated: January 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–01647 Filed 1–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
23 CFR Part 635
[FHWA Docket No. FHWA–2012–0098]
RIN 2125–AF47
Regulatory History
Construction and Maintenance—
Culvert Pipe Selection
Federal Highway
Administration (FHWA), Department of
Transportation (DOT).
ACTION: Final rule.
AGENCY:
Section 1525 of the Moving
Ahead for Progress in the 21st Century
Act (MAP–21) requires the Secretary of
Transportation to modify FHWA
regulations to ensure that States shall
have the autonomy to determine culvert
and storm sewer material types to be
included in the construction of a project
on a Federal-aid highway. This final
rule is intended to implement this
legislative requirement.
DATES: This rule is effective February
27, 2013.
FOR FURTHER INFORMATION CONTACT: Mr.
Gerald Yakowenko, Office of Program
Administration, (202) 366–1562, or Mr.
Michael Harkins, Office of the Chief
Counsel, (202) 366–4928, Federal
Highway Administration, 1200 New
Jersey Avenue SE., Washington, DC
20590. Office hours are from 8 a.m. to
4:30 p.m., e.t., Monday through Friday,
except Federal holidays.
SUPPLEMENTARY INFORMATION:
SUMMARY:
pmangrum on DSK3VPTVN1PROD with
Electronic Access and Filing
This document may be viewed online
through the Federal eRulemaking portal
at https://www.regulations.gov. Retrieval
help and guidelines are available on the
Web site. It is available 24 hours each
day, 365 days a year. An electronic copy
of this document may also be
downloaded from the Office of the
Federal Register’s home page at: https://
www.archives.gov/federal-register and
the Government Printing Office’s Web
page at: https://www.gpo.gov/fdsys.
VerDate Mar<15>2010
15:13 Jan 25, 2013
Jkt 229001
Under the ‘‘Administrative Procedure
Act’’ (5 U.S.C. 553(b)), an agency may
waive the normal notice and comment
procedure if it finds, for good cause, that
it would be impracticable, unnecessary,
or contrary to the public interest. The
FHWA finds that notice and comment
for this rule is unnecessary because it
implements a congressional mandate to
amend 23 CFR 635.411 to allow States
to choose culvert and storm sewer
material type. The regulatory
amendments in this final rule are based
upon the statutory language and FHWA
does not anticipate receiving
meaningful comments to alter the
regulation given the explicit mandate.
Accordingly, FHWA finds good cause
under 5 U.S.C. 553(b)(3)(B) to waive
notice and opportunity for comment.
The ‘‘General Material
Requirements,’’ found in 23 CFR part
635 subpart D, supports competitive
bidding principles in 23 U.S.C. 112 with
certain requirements and procedures
relating to product and material
selection and use on Federal-aid
highway projects.
Securing competition in the area of
culvert pipe material selection has been
a concern of FHWA since the 1960s. In
an internal Bureau of Public Roads (now
FHWA) Memorandum issued October 7,
1963, the Bureau of Public Roads
addressed the issue of culvert selection
and in general product selection in
writing:
* * * a State’s desire to select only one
type of pipe for bidding purposes on the
basis that such selection will favor State and
local public interests cannot be accepted by
Public Roads.
This Memorandum further states,
Except where otherwise dictated by
engineering evaluations of individual site
conditions, there is no basic disadvantage in
specifying all acceptable alternate types and
either calling for competitive bids on them or
permitting the successful bidder to name the
type he will furnish. Even when it is
indicated that one type might receive lower
bid prices, competitive bidding of the one
type with other acceptable types could result
in lower contract prices.
Through a revision to Policy &
Procedure Memorandum 21–6.3 dated
October 3, 1972, the FHWA included a
table entitled ‘‘Summary of Acceptable
Criteria for Specifying Types of Culvert
Pipes.’’ On September 30, 1974, the
table was included in the CFR as an
appendix to 23 CFR 635.117 (39 FR
35152). According to § 635.117(d), as in
effect in 1974, Appendix A
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5715
* * * sets forth the FHWA requirements
regarding the specification of alternate types
of culvert pipes, and the number and types
of such alternatives which must be set forth
in the specifications for various types of
drainage installations.
On September 10, 1976, this section was
redesignated as 23 CFR 635.411 (41 FR
36204) and remained unchanged until
2006, though the market had changed to
the extent that Appendix A no longer
adequately encompassed the universe of
available alternatives.
Section 5514 of the Safe,
Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for
Users (SAFETEA–LU, Pub. L. 109.59;
August 10, 2005), titled ‘‘Competition
for Specification of Alternative Types of
Culvert Pipes,’’ required the Secretary of
Transportation to ensure that States
provide for competition with respect to
the specification of alternative types of
culvert pipes through requirements that
are commensurate with competition for
other construction materials. To
implement this provision, the FHWA
issued a final rule on November 15,
2006 (71 FR 66450), that deleted
Appendix A from the CFR.
MAP–21 Legislative Provision
On July 6, 2012, President Obama
signed the Moving Ahead for Progress in
the 21st Century Act (MAP–21), Public
Law 112–141, 126 Stat. 405. Section
1525 of MAP–21, ‘‘State Autonomy for
Culvert Pipe Selection,’’ requires the
Secretary of Transportation, within 180
days of the date of enactment of MAP–
21 (October 1, 2012) to modify section
635.411 of title 23 CFR, to ensure that
States shall have the autonomy to
determine culvert and storm sewer
material types to be included in the
construction of a project on a Federalaid highway. The use of the word
‘‘autonomy’’ in this section gives the
State transportation departments (State
DOTs) and other direct recipients the
sole authority and discretion to make a
decision regarding culvert and storm
sewer material types without any input
or approval from the FHWA. As a result,
a State DOT may choose to exercise its
autonomy regarding culvert and storm
sewer type selection to either:
(a) Include all material types deemed
acceptable as a result of engineering and
economic analysis, or
(b) Restrict the pool of available
culvert and storm sewer material types
to those which the State DOT would
select.
Although section 1525 gives the
States the autonomy to determine
culvert and storm sewer material types,
section 1525 does not relieve the States
of compliance with other applicable
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]]>Agencies
[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Rules and Regulations]
[Pages 5713-5715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01647]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 522
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Cefpodoxime; Meloxicam
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 actions for new animal drug
[[Page 5714]]
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during December 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 28, 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 approval actions for several original ANADAs during December
2012, as listed in table 1. 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 ANADAs Approved During December 2012
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action section FOIA summary NEPA review
----------------------------------------------------------------------------------------------------------------
200-485........... Accord Meloxicam Original 522.1367 yes......... CE\1\
Healthcare, Injection. approval as a
Inc., 1009 generic copy of
Slater Rd., NADA 141-219.
suite 210-B,
Durham, NC 27703.
200-491........... Norbrook LOXICOM Original 522.1367 yes......... CE\1\
Laboratories, (meloxicam) approval as a
Ltd., Station Solution for generic copy of
Works, Newry Injection. NADA 141-219.
BT35 6JP,
Northern Ireland.
200-543........... Putney, Inc., 400 Cefpodoxime Original 520.370 yes......... CE\1\
Congress St., Proxetil Tablets. approval as a
suite 200, generic copy of
Portland, ME NADA 141-232.
04101.
----------------------------------------------------------------------------------------------------------------
\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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 522
Animal drugs.
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 510,
520, and 522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
2. In Sec. 510.600, in the table in paragraph (c)(1),
alphabetically add an entry for ``Accord Healthcare, Inc.'' and revise
the entry for ``Jurox Pty. Ltd.''; and in the table in paragraph
(c)(2), numerically add an entry for ``016729'' and revise the entry
for ``049480'' to read as follows:
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, 016729
Durham, NC 27703.......................................
* * * * *
Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, 049480
Australia..............................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
016729.............................. Accord Healthcare, Inc., 1009
Slater Rd., suite 210-B, Durham,
NC 27703
* * * * *
049480.............................. Jurox Pty. Ltd., 85 Gardiner St.,
Rutherford, NSW 2320, Australia
* * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.370 [Amended]
0
4. In paragraph (b) of Sec. 520.370, remove ``No. 000009'' and in its
place add ``Nos. 000009 and 026637''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
[[Page 5715]]
Sec. 522.1367 [Amended]
0
6. In paragraph (b) of Sec. 522.1367, remove ``No. 000010'' and in its
place add ``Nos. 000010, 016729, and 055529''.
Dated: January 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-01647 Filed 1-25-13; 8:45 am]
BILLING CODE 4160-01-P
