New Animal Drugs; Change of Sponsor's Name, 32897-32898 [2012-13409]
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Federal Register / Vol. 77, No. 107 / Monday, June 4, 2012 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
Eldon Taylor, Federal Aviation
Administration, Operations Support
Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057;
telephone (425) 203–4537.
SUPPLEMENTARY INFORMATION:
pmangrum on DSK3VPTVN1PROD with RULES
History
On April 6, 2012, the FAA published
in the Federal Register a notice of
proposed rulemaking to modify
controlled airspace at Billings, MT (77
FR 20747). Interested parties were
invited to participate in this rulemaking
effort by submitting written comments
on the proposal to the FAA. No
comments were received.
Class E airspace designations are
published in paragraph 6005, of FAA
Order 7400.9V dated August 9, 2011,
and effective September 15, 2011, which
is incorporated by reference in 14 CFR
part 71.1. The Class E airspace
designation listed in this document will
be published subsequently in that
Order.
The Rule
This action amends Title 14 Code of
Federal Regulations (14 CFR) part 71 by
modifying Class E airspace extending
upward from 700 feet above the surface,
at Billings Logan International Airport,
to accommodate aircraft using RNAV
(GPS) standard instrument approach
procedures at the airport. The
geographic coordinates of the airport are
updated to coincide with the FAA’s
aeronautical database. This action is
necessary for the safety and
management of IFR operations.
The FAA has determined this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this regulation: (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); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified this rule, when promulgated,
will not have a significant economic
impact on a substantial number of small
entities under the criteria of the
Regulatory Flexibility Act. The FAA’s
authority to issue rules regarding
aviation safety is found in Title 49 of the
U.S. Code. Subtitle 1, Section 106
discusses the authority of the FAA
Administrator. Subtitle VII, Aviation
Programs, describes in more detail the
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15:10 Jun 01, 2012
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scope of the agency’s authority. This
rulemaking is promulgated under the
authority described in Subtitle VII, Part
A, Subpart I, Section 40103. Under that
section, the FAA is charged with
prescribing regulations to assign the use
of airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it modifies
controlled airspace at Billings Logan
International Airport, Billings, MT.
Issued in Seattle, Washington, on May 24,
2012.
John Warner,
Manager, Operations Support Group, Western
Service Center.
Environmental Review
Food and Drug Administration
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1E, ‘‘Environmental
Impacts: Policies and Procedures,’’
paragraph 311a. This airspace action is
not expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment.
21 CFR Part 510
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR part 71.1 of the Federal Aviation
Administration Order 7400.9V, Airspace
Designations and Reporting Points,
dated August 9, 2011, and effective
September 15, 2011 is amended as
follows:
■
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
*
*
*
*
*
ANM MT E5 Billings, MT [Modified]
Billings Logan International Airport, MT
(Lat. 45°48′28″ N., long. 108°32′34″ W.)
That airspace extending upward from 700
feet above the surface within a 16-mile radius
of Billings Logan International Airport; that
airspace extending upward from 1,200 feet
above the surface within a 63-mile radius of
the Billings Logan International Airport.
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[FR Doc. 2012–13373 Filed 6–1–12; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Change of
Sponsor’s Name
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from
Novopharm Ltd. to Teva Canada Ltd.
DATES: This rule is effective June 4,
2012.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8300,
email: steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Novopharm Ltd., 30 Novopharm Ct.,
Toronto, Ontario, Canada M1B 2K9 has
informed FDA of a change of name to
Teva Canada Ltd. Accordingly, the
Agency is amending the regulations in
21 CFR 510.600(c) to reflect these
changes.
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 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
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 510 is amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
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04JNR1
32898
Federal Register / Vol. 77, No. 107 / Monday, June 4, 2012 / Rules and Regulations
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Novopharm Ltd.’’ and alphabetically
add a new entry for ‘‘Teva Canada Ltd.’’;
and in the table in paragraph (c)(2),
revise the entry for ‘‘043806’’ to read as
follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug
labeler
code
Firm name and address
*
*
*
*
Teva Canada Ltd., 30 Novopharm
Ct., Toronto, Ontario, Canada
M1B 2K9 ...................................
*
*
*
*
043806
*
*
(2) * * *
Firm name and
address
Drug labeler code
*
*
*
*
*
043806 ...................... Teva Canada Ltd., 30
Novopharm Ct., Toronto, Ontario,
Canada M1B 2K9.
*
*
*
*
*
Dated: May 29, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–13409 Filed 6–1–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2011–1029]
Connecticut (CT) activities. This action
is necessary to provide for the safety of
life and protection of naval vessels on
navigable waters during OPSAIL 2012
CT. This action will restrict vessel from
entering into, transiting through,
mooring or anchoring within the zones
unless authorized by the Captain of the
Port (COTP) Sector Long Island Sound
(SLIS).
DATES: This rule is effective from 7:30
a.m. on July 3, 2012 until 5 p.m. on July
9, 2012.
This rule will be enforced during the
following dates and times:
1. Naval Vessel Security Zones will be
enforced from 7:30 a.m. on July 3, 2012
until 5 p.m. on July 9, 2012.
2. Admiral Shear State Pier Security
Zone will be enforced from 7:30 a.m. on
July 3, 2012 until 5 p.m. on July 9, 2012.
3. Fireworks Safety Zone will be
enforced from 8:30 p.m. until 10 p.m. on
July 7, 2012. If the fireworks display is
postponed, it will be enforced from 8:30
p.m. until 10 p.m. on July 8, 2012.
ADDRESSES: Documents mentioned in
this preamble are part of docket [USCG–
2011–1029]. 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.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Petty Officer Joseph Graun,
Prevention Department, U.S. Coast
Guard Sector Long Island Sound, (203)
468–4544, Joseph.L.Graun@uscg.mil. If
you have questions on viewing or
submitting material to the docket, call
Renee V. Wright, Program Manager,
Docket Operations, telephone (202)
366–9826.
SUPPLEMENTARY INFORMATION:
Table of Acronyms
Safety & Security Zones; OPSAIL 2012
Connecticut, Thames River, New
London, CT
pmangrum on DSK3VPTVN1PROD with RULES
RIN 1625–AA00; AA87
COTP Captain of the Port
CT Connecticut
DHS Department of Homeland Security
FR Federal Register
SLIS Sector Long Island Sound
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
A. Regulatory History and Information
The Coast Guard is
establishing temporary safety and
security zones on the Thames River near
New London, CT for OPSAIL 2012
SUMMARY:
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15:10 Jun 01, 2012
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On March 20, 2012 the Coast Guard
published a notice of proposed
rulemaking entitled Safety & Security
Zones; OPSAIL 2012 Connecticut,
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Fmt 4700
Sfmt 4700
Thames River, New London, CT in the
Federal Register (77 FR 16198). We
received no comments on the proposed
rule. No public meeting was requested
and none were held.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Due to the need for immediate
action, the restriction of vessel traffic is
necessary to protect life, property and
the environment; therefore, a 30-day
notice is impracticable. Delaying the
effective date would be contrary to the
regulation’s intended objectives of
protecting persons and vessels, and
enhancing public and maritime safety.
B. Basis and Purpose
The legal basis for the temporary rule
is 33 U.S.C. 1231, 46 U.S.C. Chapter
701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub.
L. 107–295, 116 Stat. 2064; and
Department of Homeland Security
Delegation No. 0170.1, which
collectively authorize the Coast Guard
to define safety and security zones.
OPSAIL 2012 CT is a multi-day
marine event involving a gathering of
naval vessels, and a fireworks display.
This rule is necessary to; (1) protect
participating naval vessels from security
threats. (2) Protect waterway users from
the dangers inherent to fireworks
displays.
C. Discussion of Comments, Changes
and the Final Rule
No comments were received and no
changes were made to the final rule.
D. Regulatory Analyses
We developed this rule after
considering numerous statutes and
executive orders related to rulemaking.
Below we summarize our analyses
based on these statutes or executive
orders.
1. Regulatory Planning and Review
This rule is not a significant
regulatory action under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, as supplemented
by Executive Order 13563, Improving
Regulation and Regulatory Review, and
does not require an assessment of
potential costs and benefits under
section 6(a)(3) of Executive Order 12866
or under section 1 of Executive Order
13563. The Office of Management and
Budget has not reviewed it under those
Orders.
The Coast Guard has determined this
rule is not a significant regulatory action
for the following reasons: (1) The
regulated areas will be of limited
E:\FR\FM\04JNR1.SGM
04JNR1
]]>Agencies
[Federal Register Volume 77, Number 107 (Monday, June 4, 2012)]
[Rules and Regulations]
[Pages 32897-32898]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13409]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Change of Sponsor's Name
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's name from Novopharm
Ltd. to Teva Canada Ltd.
DATES: This rule is effective June 4, 2012.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8300, email:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Novopharm Ltd., 30 Novopharm Ct., Toronto,
Ontario, Canada M1B 2K9 has informed FDA of a change of name to Teva
Canada Ltd. Accordingly, the Agency is amending the regulations in 21
CFR 510.600(c) to reflect these changes.
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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 is
amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
[[Page 32898]]
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Novopharm Ltd.'' and alphabetically add a new entry for ``Teva
Canada Ltd.''; and in the table in paragraph (c)(2), revise the entry
for ``043806'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug
Firm name and address labeler
code
------------------------------------------------------------------------
* * * * *
Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, Canada 043806
M1B 2K9.....................................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
043806.................................... Teva Canada Ltd., 30
Novopharm Ct., Toronto,
Ontario, Canada M1B 2K9.
* * * * *
------------------------------------------------------------------------
Dated: May 29, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-13409 Filed 6-1-12; 8:45 am]
BILLING CODE 4160-01-P
