Proposed Modification of Class B Airspace; Las Vegas, NV, 2646-2647 [2013-00646]
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Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Proposed Rules
(h) Repetitive Inspections
Repeat the inspection required in
paragraph (g)(3) of this AD before 10,000
hours since last overhaul if after last overhaul
the HMU is exposed to TS–1 fuel.
[FR Doc. 2013–00529 Filed 1–11–13; 8:45 am]
(i) Paperwork Reduction Act Burden
Statement
BILLING CODE 4910–13–P
A federal agency may not conduct or
sponsor, and a person is not required to
respond to, nor shall a person be subject to
a penalty for failure to comply with a
collection of information subject to the
requirements of the Paperwork Reduction
Act unless that collection of information
displays a current valid OMB Control
Number. The OMB Control Number for this
information collection is 2120–0056. Public
reporting for this collection of information is
estimated to be approximately 5 minutes per
response, including the time for reviewing
instructions, completing and reviewing the
collection of information. All responses to
this collection of information are mandatory.
Comments concerning the accuracy of this
burden and suggestions for reducing the
burden should be directed to the FAA at: 800
Independence Ave. SW., Washington, DC
20591, Attn: Information Collection
Clearance Officer, AES–200.
(j) Alternative Methods of Compliance
(AMOCs)
The Manager, Engine Certification Office,
may approve AMOCs for this AD. Use the
procedures found in 14 CFR 39.19 to make
your request.
srobinson on DSK4SPTVN1PROD with
(k) Related Information
(1) For more information about this AD,
contact Martin Adler, Aerospace Engineer,
Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803;
phone: 781–238–7157; fax: 781–238–7199;
email: martin.adler@faa.gov.
(2) Refer to EASA Airworthiness Directive
No. 2012–0123, dated July 9, 2012, and CFM
SBs CFM56–5 S/B 73–0182, Revision 7,
dated September 25, 2012, and CFM56–5B S/
B 73–0122, Revision 9, dated September 25,
2012, for related information.
(3) For service information identified in
this AD, contact CFM International Inc.,
Aviation Operations Center, 1 Neumann
Way, M/D Room 285, Cincinnati, OH 45125;
International phone: 1–513–552–3272; USA
phone: 877–432–3272; International fax: 1–
513–552–3329; USA fax: 877–432–3329;
email: geae.aoc@ge.com; or CFM
International SA, Customer Support Center,
International phone: 33 1 64 14 88 66; fax:
33 1 64 79 85 55; email:
snecma.csc@snecma.fr.
(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.
VerDate Mar<15>2010
16:19 Jan 11, 2013
Jkt 229001
Issued in Burlington, Massachusetts, on
January 4, 2013.
Robert J. Ganley,
Acting Manager, Engine & Propeller
Directorate, Aircraft Certification Service.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2012–0966; Airspace
Docket No. 12–AWA–5]
RIN 2120–AA66
Proposed Modification of Class B
Airspace; Las Vegas, NV
Federal Aviation
Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking
(NPRM); Reopening of comment period.
AGENCY:
This action reopens the
comment period for an NPRM that was
published on October 26, 2012. In that
document, the FAA proposed to modify
the Las Vegas, NV, Class B airspace area
to ensure the containment of large
turbine-powered aircraft within Class B
airspace.
DATES: The comment period for the
NPRM published in the Federal
Register on October 26, 2012 (77 FR
65332) closed on December 26, 2012, is
reopened until February 13, 2013.
ADDRESSES: Send comments on this
proposal to the U.S. Department of
Transportation, Docket Operations, M–
30, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12–140,
Washington, DC 20590–0001; telephone:
(202) 366–9826. You must identify FAA
Docket No. FAA–2012–0966 and
Airspace Docket No. 12–AWA–5, at the
beginning of your comments. You may
also submit comments through the
Internet at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Paul
Gallant, Airspace Policy and ATC
Procedures Group, Office of Airspace
Services, Federal Aviation
Administration, 800 Independence
Avenue SW., Washington, DC 20591;
telephone: (202) 267–8783.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Comments Invited
Interested parties are invited to
participate in this proposed rulemaking
by submitting such written data, views,
or arguments as they may desire.
Comments that provide the factual basis
supporting the views and suggestions
presented are particularly helpful in
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Frm 00020
Fmt 4702
Sfmt 4702
developing reasoned regulatory
decisions on the proposal. Comments
are specifically invited on the overall
regulatory, aeronautical, economic,
environmental, and energy-related
aspects of the proposal.
Communications should identify both
docket numbers (FAA Docket No. FAA–
2012–0966 and Airspace Docket No. 12–
AWA–5) and be submitted in triplicate
to the Docket Management Facility (see
ADDRESSES section for address and
phone number). You may also submit
comments through the Internet at
https://www.regulations.gov.
Commenters wishing the FAA to
acknowledge receipt of their comments
on this action must submit with those
comments a self-addressed, stamped
postcard on which the following
statement is made: ‘‘Comments to
Docket Nos. FAA–2012–0966 and
Airspace Docket No. 12–AWA–5.’’ The
postcard will be date/time stamped and
returned to the commenter.
All communications received on or
before the specified closing date for
comments will be considered before
taking action on the proposed rule. The
proposal contained in this action may
be changed in light of comments
received. All comments submitted will
be available for examination in the
public docket both before and after the
closing date for comments. A report
summarizing each substantive public
contact with FAA personnel concerned
with this rulemaking will be filed in the
docket.
Availability of NPRM’s
An electronic copy of this document
may be downloaded through the
Internet at https://www.regulations.gov.
You may review the public docket
containing the proposal, any comments
received, and any final disposition in
person in the Dockets Office (see
ADDRESSES section for address and
phone number) between 9:00 a.m. and
5.00 p.m., Monday through Friday,
except Federal holidays. An informal
docket may also be examined during
normal business hours at the office of
the Western Service Center, Operations
Support Group, Federal Aviation
Administration, 1601 Lind Ave. SW.,
Renton, WA 98057.
Persons interested in being placed on
a mailing list for future NPRMs should
contact the FAA’s Office of Rulemaking,
(202) 267–9677, for a copy of Advisory
Circular No. 11–2A, Notice of Proposed
Rulemaking Distribution System, which
describes the application procedure.
Background
In the Federal Register of October 26,
2012, the FAA issued a NPRM entitled
E:\FR\FM\14JAP1.SGM
14JAP1
Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Proposed Rules
‘‘Proposed Modification of Class B
Airspace; Las Vegas, NV’’ (77 FR 65332).
The FAA requested that comments on
that proposal be received on or before
December 26, 2012. By letter dated
December 7, 2012, the Aircraft Owners
and Pilots Association (AOPA)
requested that the FAA extend the
comment period for at least 30 days.
AOPA stated that the original comment
period encompassed two Federal
holidays and that no comments had
been posted to the docket as of the date
of their letter. AOPA added that an
extension would provide additional
time for the public to review the NPRM
and submit substantive comments on
the proposal.
Reopening of Comment Period
The FAA has reviewed AOPA’s
request for additional time to comment
on the NPRM and has determined that
reopening of the comment period is
consistent with the public interest and
that good cause exists for taking this
action.
Accordingly, the comment period for
Docket No. FAA–2012–0966; Airspace
Docket No. 12–AWA–5, is reopened as
indicated in the DATES section, above.
Issued in Washington, DC, on January 8,
2013.
Gary A. Norek,
Manager, Airspace Policy and ATC
Procedures Group.
[FR Doc. 2013–00646 Filed 1–10–13; 4:15 pm]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. FDA–2012–N–0677]
Dental Devices; Reclassification of
Blade-Form Endosseous Dental
Implant
AGENCY:
Food and Drug Administration,
Proposed order.
The Food and Drug
Administration (FDA) is proposing to
reclassify the blade- form endosseous
dental implant, a preamendments class
III device, into class II (special controls).
On its own initiative, based on new
information, FDA is proposing to revise
the classification of blade-form
endosseous dental implants.
DATES: Submit either electronic or
written comments on this proposed
order by April 15, 2013. See section XI
srobinson on DSK4SPTVN1PROD with
SUMMARY:
VerDate Mar<15>2010
16:19 Jan 11, 2013
Jkt 229001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2012–N–0677 for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert Docket
No. FDA–2012–N–0677 into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Melissa Burns, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring,
MD 20993, 301–796–5616,
melissa.burns@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
HHS.
ACTION:
of this document for the proposed
effective date of a final order based on
this proposed order.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2012–N–
0677, by any of the following methods:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105–115), the
Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250), the Medical Devices Technical
Corrections Act (Public Law 108–214),
the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85), and the Food and Drug
PO 00000
Frm 00021
Fmt 4702
Sfmt 4702
2647
Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112–144),
establish a comprehensive system for
the regulation of medical devices
intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c)
established three categories (classes) of
devices, reflecting the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513 of the FD&C Act,
devices that were in commercial
distribution before the enactment of the
1976 amendments, May 28, 1976
(generally referred to as preamendments
devices), are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
FDA has classified most
preamendments devices under these
procedures.
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
postamendments devices), are
automatically classified by section
513(f) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless, and
until, the device is reclassified into class
I or II or FDA issues an order finding the
device to be substantially equivalent, in
accordance with section 513(i) of the
FD&C Act, to a predicate device that
does not require premarket approval.
The Agency determines whether new
devices are substantially equivalent to
predicate devices by means of
premarket notification procedures in
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and 21 CFR part 807.
A preamendments device that has
been classified into class III may be
marketed by means of premarket
notification procedures (510(k) process)
without submission of a premarket
approval application (PMA) until FDA
issues a final order under section 515(b)
of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval or until
the device is subsequently reclassified
into class I or class II.
On July 9, 2012, FDASIA was enacted.
Section 608(a) of FDASIA (126 Stat.
1056) amended section 513(e) of the
FD&C Act changing the process for
reclassifying a preamendments device
from rulemaking to an administrative
order.
E:\FR\FM\14JAP1.SGM
14JAP1
Agencies
[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Proposed Rules]
[Pages 2646-2647]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00646]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2012-0966; Airspace Docket No. 12-AWA-5]
RIN 2120-AA66
Proposed Modification of Class B Airspace; Las Vegas, NV
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking (NPRM); Reopening of comment
period.
-----------------------------------------------------------------------
SUMMARY: This action reopens the comment period for an NPRM that was
published on October 26, 2012. In that document, the FAA proposed to
modify the Las Vegas, NV, Class B airspace area to ensure the
containment of large turbine-powered aircraft within Class B airspace.
DATES: The comment period for the NPRM published in the Federal
Register on October 26, 2012 (77 FR 65332) closed on December 26, 2012,
is reopened until February 13, 2013.
ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone: (202) 366-9826. You must identify FAA Docket No. FAA-2012-
0966 and Airspace Docket No. 12-AWA-5, at the beginning of your
comments. You may also submit comments through the Internet at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy and ATC
Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone: (202) 267-8783.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No.
FAA-2012-0966 and Airspace Docket No. 12-AWA-5) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at https://www.regulations.gov.
Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Nos. FAA-2012-0966 and Airspace Docket No. 12-AWA-5.'' The
postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.
Availability of NPRM's
An electronic copy of this document may be downloaded through the
Internet at https://www.regulations.gov.
You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5.00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Operations
Support Group, Federal Aviation Administration, 1601 Lind Ave. SW.,
Renton, WA 98057.
Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.
Background
In the Federal Register of October 26, 2012, the FAA issued a NPRM
entitled
[[Page 2647]]
``Proposed Modification of Class B Airspace; Las Vegas, NV'' (77 FR
65332). The FAA requested that comments on that proposal be received on
or before December 26, 2012. By letter dated December 7, 2012, the
Aircraft Owners and Pilots Association (AOPA) requested that the FAA
extend the comment period for at least 30 days. AOPA stated that the
original comment period encompassed two Federal holidays and that no
comments had been posted to the docket as of the date of their letter.
AOPA added that an extension would provide additional time for the
public to review the NPRM and submit substantive comments on the
proposal.
Reopening of Comment Period
The FAA has reviewed AOPA's request for additional time to comment
on the NPRM and has determined that reopening of the comment period is
consistent with the public interest and that good cause exists for
taking this action.
Accordingly, the comment period for Docket No. FAA-2012-0966;
Airspace Docket No. 12-AWA-5, is reopened as indicated in the DATES
section, above.
Issued in Washington, DC, on January 8, 2013.
Gary A. Norek,
Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2013-00646 Filed 1-10-13; 4:15 pm]
BILLING CODE P