[Federal Register Volume 77, Number 219 (Tuesday, November 13, 2012)]
[Proposed Rules]
[Pages 67582-67583]
[FR Doc No: 2012-27454]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 77, No. 219 / Tuesday, November 13, 2012 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1031; Directorate Identifier 2012-NE-31-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Rolls-Royce Deutschland Ltd & Co KG (RRD) Tay 611-8 turbofan
engines. This proposed AD was prompted by a recent quality review
determination that bolts with reduced material properties may have been
installed in some engines. This proposed AD would require inspection
and replacement if necessary, of affected bolts. We are proposing this
AD to prevent uncontained turbine disc fracture and damage to the
airplane.

DATES: We must receive comments on this proposed AD by January 14,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this proposed AD, contact
Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827
Blankenfelde-Mahlow, Germany; phone: 49 0 33-7086-1883; fax: 49 0 33-
7086-3276. 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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (phone:<PHONE_NUMBER>) is the
same as the Mail address provided in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Frederick Zink, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-1031;
Directorate Identifier 2012-NE-31-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2012-0163, dated August 28, 2012 (referred to hereinafter as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    The results of a recent quality review of low pressure turbine
(LPT) stage 1 static air seal and high pressure turbine (HPT) stage
1 air seal support bolts identified that, before installation, those
bolts may have not been inspected. As a consequence, bolts with
reduced material properties may have been installed in some engines.
    This condition, if not detected and corrected, could lead to
failure of a bolt, potentially causing turbine disc fracture and
release of high-energy debris, possibly resulting in damage to the
aeroplane and/or injury to the occupants.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    RRD has issued Alert Service Bulletin TAY-72-A1696, Revision 1,
dated June 11, 2012. The actions described in this service information
are intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are proposing this AD because we evaluated all information
provided by EASA and determined the unsafe condition exists and is
likely to exist or develop on other products of the same type design.
This proposed AD would require inspection and replacement if necessary,
of affected bolts.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 20 engines installed on

airplanes of U.S. registry. We also estimate that it would take about 4
hours per engine to comply with this proposed AD. The average labor
rate is $85 per hour. Required parts would cost about $1,848. Based on
these figures, we estimate the cost of the proposed AD on U.S.
operators to be $43,760.

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.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. 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 proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Rolls-Royce Deutschland Ltd & Co KG (Formerly Rolls-Royce
Deutschland GmbH, Formerly Rolls-Royce plc): Docket No. FAA-2012-
1031; Directorate Identifier 2012-NE-31-AD.

(a) Comments Due Date

    We must receive comments by January 14, 2013.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to Rolls-Royce Deutschland Ltd & Co KG (RRD) Tay
611-8 turbofan engines, serial numbers 16245, 16256, 16417, 16418,
16584, 16585, 16639, 16640, 16701, 16702, 16813, 16814, 16853,
16854, 16879, 16880, 16898, 16905, 16906, 16911, 16923, 16935, and
16936, with a date of the last shop visit before December 8, 2006.

(d) Reason

    This AD was prompted by a recent quality review determination
that bolts with reduced material properties may have been installed
in some engines. We are issuing this AD to prevent uncontained
turbine disc fracture and damage to the airplane.

(e) Actions and Compliance

    Unless already done, for engines with a date of the last shop
visit before December 8, 2006, do the following actions:
    (1) If engine cycles accumulated since the last engine shop
visit is 5,400 cycles or more on the effective date of this AD,
inspect the bolts installed in the low-pressure turbine (LPT) stage
1 static seal and high-pressure turbine (HPT) stage 1 air seal
support within 100 engine cycles-in-service.
    (2) If engine cycles accumulated since the last engine shop
visit is fewer than 5,400 cycles on the effective date of this AD,
inspect the bolts installed in the LPT stage 1 static seal and HPT
stage 1 air seal support before accumulating 5,500 engine cycles
since the last engine shop visit.
    (3) If any broken bolt, brown bolt, or bolt with a rough
oxidized surface is identified, then replace all bolts with new
bolts before further flight.
    (4) Within 30 days after the inspection, report the inspection
findings to RRD service engineering. Guidance on reporting can be
found in Alert Service Bulletin TAY-72-A1696, Revision 1, dated June
11, 2012.

(f) Installation Prohibition

    After the effective date of this AD, do not install any HPT
module and/or LPT module into any engine, or any engine onto an
airplane, unless the bolts have been inspected and replaced if
necessary, as specified in paragraph (e) of this AD.

(g) Paperwork Reduction Act Burden Statement

    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.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
to this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(i) Related Information

    (1) For more information about this AD, contact Frederick Zink,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Aviation Safety Agency AD 2012-0163, dated
August 28, 2012, and RRD Alert Service Bulletin TAY-72-A1696,
Revision 1, dated June 11, 2012, for related information.
    (3) For service information identified in this AD, contact
Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827
Blankenfelde-Mahlow, Germany; phone: 49 0 33-7086-1883; fax: 49 0
33-7086-3276. 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<PHONE_NUMBER>.

(j) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on November 1, 2012.
Colleen M. D'Alessandro,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2012-27454 Filed 11-9-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Notices]
[Pages 5816-5817]
[FR Doc No: 2012-2548]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2012-0016]

Information Collection Requests to Office of Management and
Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit Information Collection Requests
(ICRs) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collections of information: 1625-0035,
Title 46 CFR Subchapter Q: Lifesaving, Electrical, Engineering and
Navigation Equipment, Construction and Materials & Marine Sanitation
Devices (33 CFR part 159); and 1625-0079, Standards of Training,
Certification and Watchkeeping for Seafarers (STCW), 1995 and 1997
Amendments to the International Convention. Our ICRs describe the
information we seek to collect from the public. Before submitting these
ICRs to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before April 6, 2012.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2012-0016] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT). To avoid duplicate
submissions, please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: DMF (M-30), DOT, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
    (3) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, to attention Desk Officer for the Coast
Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-611), Attn Paperwork Reduction Act Manager, U.S. Coast
Guard, 2100 2nd St. SW., STOP 7101, Washington, DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Ms. Kenlinishia Tyler, Office of
Information Management, telephone<PHONE_NUMBER>, or fax (202) 475-
3929, for questions on these documents. Contact Ms. Renee V. Wright,
Program Manager, Docket Operations,<PHONE_NUMBER>, for questions on
the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collections; (2) the accuracy of the estimated burden of the
Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of information
technology. In response to your comments, we may revise these ICRs or
decide not to seek approval for the Collections. We will consider all
comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this

request, [USCG-2012-0016], and must be received by April 6, 2012. We
will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2012-0016], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit your comments and material by electronic means,
mail, fax, or delivery to the DMF at the address under ADDRESSES; but
please submit them by only one means. To submit your comment online, go
to http://www.regulations.gov, and type ``USCG-2012-0016'' in the
``Keyword'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.
    Viewing comments and documents: To view comments, as well as
documents mentioned in this Notice as being available in the docket, go
to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Keyword'' box
insert ``USCG-2012-0016'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. You may also visit the DMF in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Requests

    1. Title: Title 46 CFR Subchapter Q: Lifesaving, Electrical,
Engineering and Navigation Equipment, Construction and Materials &
Marine Sanitation Devices (33 CFR part 159).
    OMB Control Number: 1625-0035.
    Summary: This information is used by the Coast Guard to ensure that
regulations governing specific types of safety equipment, material and
Marine Sanitation Devices (MSDs) installed on commercial vessels and
pleasure craft are met. Manufacturers are required to submit drawings,
specifications, and laboratory test reports to the CG before any
approval is given.
    Need: Title 46 U.S.C. 2103, 3306, 3703, and 4302 authorize the
Coast Guard to establish safety equipment and material regulations.
Title 46 CFR parts 159 to 164 prescribe these requirements. Title 33
U.S.C. 1322 authorizes the Coast Guard to establish MSD regulations.
Title 33 CFR part 159 prescribes these rules. NVIC 8-01 (Chg 2)
prescribes the standards for navigation equipment. This information
will be used to determine whether manufacturers are in compliance with
Coast Guard regulations. When the Coast Guard approves any safety
equipment, material or MSD for use on a commercial vessel or pleasure
craft, the manufacturer is issued a Certificate of Approval.
    Forms: CGHQ-10030.
    Respondents: Manufacturers of safety equipment, materials and
marine sanitation devices.
    Frequency: On occasion.
    Burden Estimate: The estimated burden has decreased from 103,289
hours to 58,414 hours a year.
    2. Title: Standards of Training, Certification and Watchkeeping for
Seafarers (STCW), 1995 and 1997 Amendments to the International
Convention
    OMB Control Number: 1625-0079.
    Summary: This information is necessary to ensure compliance with
the international requirements of the STCW Convention, and to maintain
an acceptable level of quality in activities associated with training
and assessment of merchant mariners.
    Need: Chapter 71 of 46 U.S.C. authorizes the Coast Guard to issue
regulations related to licensing of merchant mariners. These
regulations are contained in 46 CFR chapter I, subchapter B.
    Type of Request: Extension of currently approved collection for the
existing STCW requirements. NOTE--The Coast Guard has an ongoing
rulemaking related to STCW [USCG-2004-17914; RIN 1625-AA16]. Comments
related to that rulemaking are outside the scope of this extension
request.
    Forms: None.
    Respondents: Owners and operators of vessels, training
institutions, and mariners.
    Frequency: On occasion.
    Burden Estimate: The estimated burden remains 17,927 hours a year.

    Dated: January 27, 2012.
R.E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2012-2548 Filed 2-3-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Notices]
[Page 33511]
[DOCID:fr13jy09-147]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance with certain
requirements of its safety standards. The individual petition is
described below; including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Kenwood U.S.A. Corporation

[(Waiver Petition Docket Number FRA-2009-0059]

    Kenwood U.S.A. Corporation (Kenwood) seeks a waiver of compliance
from certain provisions of 49 CFR part 232, Brake System Safety
Standards for Freight and Other Non-Passenger Trains and Equipment.
Specifically, Sec.  232.409(d)--Inspection and Testing of end-of-train
devices, which requires the telemetry equipment to be tested for
accuracy and calibrated if necessary at least every 368 days. It also
requires that the date and location of the last calibration or test, as
well as the name of the person performing the calibration or test, be
legibly displayed on a weather-resistant sticker or other marking
device affixed to the outside of both the front and the rear unit.
    This waiver will cover all Kenwood model NX-800-K UHF digital
transceivers manufactured on or after August 24, 2007. This transceiver
is competitive with a digitally synthesized radio produced by Wabtec,
for which a similar waiver was granted (see Docket Number FRA-2004-
18895); and Kenwood requests that its product be treated in a similar
fashion.
    Kenwood states that its NX-800-K device is inherently stable,
reflecting the state of the art in digital synthesized transceivers.
Test results submitted by Kenwood as part of its Federal Communications
Commission (FCC) authorization process confirm the extreme frequency
stability of this digital synthesized device. This compliance meets the
(FCC) TIA-603 standard and current FCC Part 90 service rule
specifications for railroad applications. Kenwood states that, as such,
annual re-certification is unnecessary and administratively burdensome.
Kenwood further states that the annual re-certification requirement was
developed at the time when such radios were crystal controlled and
stability was an issue, and that the rule has no application to
digitally synthesized modern transceivers. Kenwood believes that the
spirit of the rule is not violated by the requested waiver inasmuch as
the radio design obviates the need for the annual certification and
measurements.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0059) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received within 30 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC, on July 7, 2009.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E9-16506 Filed 7-13-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: August 24, 2007 (Volume 72, Number 164)]
[Notices]
[Page 48708-48709]
[DOCID:fr24au07-129]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56281; File No. SR-CHX-2007-16]

Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.;
Notice of Filing of Proposed Rule Change as Modified by Amendment No. 1
Thereto To Amend Its Bylaws To Prevent Exchange Director From
Participating in the Determination of Any Matter Involving an Issuer of
a Security Listed or To Be Listed on the Exchange if the Director Is a
Director, Officer, or Employee of the Issuer

August 17, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 27, 2007, the Chicago Stock Exchange, Inc. (``CHX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by CHX. On
August 10, 2007, CHX filed an amendment to the proposed rule change.\3\
The Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Partial Amendment No. 1 modified the last sentence of
footnote 6 below, to state that when a director recuses himself or
herself from a decision, the Exchange reflects that recusal in the
minutes of the meeting at which the recusal occurred, in accordance
with its internal written policies.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CHX proposes to amend its bylaws to bar a director from
participating in a matter relating to an issuer of a security, if the
director is a director, officer or employee of the issuer of that
security. The text of this proposed rule change is available on the
Exchange's Web site at http://www.chx.com/content/Participant_Information/Rules_Filings.html
, at the Office of the Secretary of the

Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, CHX included statements
concerning the purpose of and basis for the proposed rule changes and
discussed any comments it received regarding the proposal. The text of
these statements may be examined at the places specified in Item IV
below. CHX has prepared summaries, set forth in sections A, B and C
below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Changes

1. Purpose
    Under the Exchange's rules, if the Exchange proposes to delist a
security, the issuer of the security has the right to avail itself of a
hearing before a hearing officer and to appeal the decision of the
hearing officer to the Exchange's Executive Committee.\4\ The
Exchange's Executive Committee is composed entirely of Exchange
directors.\5\
---------------------------------------------------------------------------

    \4\ See Article 25, Rule 4 of CHX's bylaws.
    \5\ See Article 2, Rule 2 of CHX's bylaws. The committee must
consist of not less than five members, plus the chairman of the
Board. A majority of the committee members must be public directors.
Id.
---------------------------------------------------------------------------

    Although the Exchange's bylaws generally prevent a director from
participating in the determination of any matter in which the director
is personally interested, no provision of

the bylaws specifically confirms that a director should not participate
in a decision involving the issuer of a security if he or she is a
director, officer or employee of the issuer. This proposed change would
add a clarification to the Exchange's bylaws to confirm that, in a
matter involving the issuer of a security listed or to be listed on the
Exchange, a director shall be deemed to be personally interested in the
matter if he or she is a director, officer or employee of the issuer of
the security.\6\ The Exchange believes that this new provision
appropriately limits a director's ability to participate in proceedings
involving a company for which he or she serves as a director, officer
or employee.\7\
---------------------------------------------------------------------------

    \6\ This proposal is a slightly-amended version of the proposal
originally made in SR-CHX-2006-25, which has been withdrawn. In this
new version of the proposal, the Exchange, at the recommendation of
Commission staff, has expanded its original filing to cover all
proceedings involving an issuer of a security, instead of limiting
the proposal only to delisting proceedings. Importantly, however,
this proposal is not designed to affect other provisions of this
section of the bylaws; specifically, this proposal is not designed
to prevent a participant director who is an employee of an issuer
that is also a participant firm from participating in the
determination of matters that may affect participants as a whole or
certain groups of participants, as already expressly permitted by
the bylaws. See Article II, Section 7 of the CHX's bylaws.
    In this revised version of the original proposal, the Exchange
also has confirmed that, although it will typically deem a director
to be ``personally interested'' in a matter relating to an issuer if
the director is a director, officer or employee of that issuer
(subject to the exception described above), the Exchange will review
other relationships between a director and an issuer on a case-by-
case basis to determine whether inappropriate personal interest
exists. When a director recuses himself or herself from a decision,
the Exchange reflects that recusal in the minutes of the meeting at
which the recusal occurred, in accordance with its internal written
policies.
    \7\ This bylaws change is also consistent with a recommendation
made by the Commission's Office of Compliance Inspections and
Examinations.
---------------------------------------------------------------------------

2. Statutory Basis
    CHX believes the proposal is consistent with the requirements of
the Act and the rules and regulations thereunder that are applicable to
a national securities exchange, and, in particular, with the
requirements of Section 6(b) of the Act.\8\ The proposed rule change is
consistent with Section 6(b)(5) of the Act \9\ because it would promote
just and equitable principles of trade, remove impediments to, and
perfect the mechanism of, a free and open market and a national market
system, and, in general, protect investors and the public interest by
confirming that an Exchange director should not participate in
proceedings involving a company for which he or she serves as a
director, officer or employee.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78(f)(b).
    \9\ 15 U.S.C. 78(f)(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement of Burden on Competition

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Changes Received From Members, Participants or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Changes and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CHX-2007-16 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CHX-2007-16. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CHX-2007-16 and should be
submitted on or before September 14, 2007.
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-16756 Filed 8-23-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 174 (Friday, September 7, 2012)]
[Notices]
[Pages 55204-55205]
[FR Doc No: 2012-22053]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project No. 943-117]

 Pubic Utility District No. 1 of Chelan County; Notice of
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Application Type: Non-project use of project lands and waters:
water withdrawal.
    b. Project No.: 943-117.
    c. Date Filed: July 31, 2012.
    d. Applicant: Public Utility District No. 1 of Chelan County,
Washington.
    e. Name of Project: Rock Island Hydroelectric Project.
    f. Location: The proposed non-project use would be located on the
Wenatchee River, near the confluence with the Columbia River.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Ms. Michelle Smith, Public Utility District
No. 1 of Chelan County, Licensing and Compliance Manager, 327 N.
Wenatchee Ave., Wenatchee, WA 98801,<PHONE_NUMBER>.
    i. FERC Contact: Ms. Andrea Claros,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests, is September 17, 2012.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and
contact information at the end of your comments.
    Please include the project number (P-943-117) on any comments,
motions, or recommendations filed.
    k. Description of Request: The Public Utility District No. 1 of
Chelan County requests Commission approval to authorize Pioneer Water
Users Association (PWUA) to construct a new point of water diversion
within the Rock Island Hydroelectric Project boundary, on the Wenatchee
River, adjacent to the upstream side of the State Road 285 bridge. PWUA
proposes to construct a pump intake, fish screen and pipeline. The new
point of diversion would pump a maximum of 4.9 million gallons per day,
from May to September to upstream agricultural lands. The pipeline
would connect to a pump house and approximately 4 miles of pressurized
pipe, outside of the project boundary. This new system would replace an
existing 54-mile open ditch irrigation system. PWUA also proposes to
remove an in-river diversion structure located north of the town of
Monitor. The purpose of the new water diversion is to improve aquatic
habitat conditions and increase instream flows in the Wenatchee River.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/efiling.asp. Enter the docket number excluding the last three digits in
the docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the amendment. Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: August 31, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-22053 Filed 9-6-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1955-1957]
[FR Doc No: 2016-00540]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4809]

Patient and Medical Professional Perspectives on the Return of
Genetic Test Results and Interpretations; Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Patient and Medical Professional
Perspectives on the Return of Genetic Test Results.'' The purpose of
this public workshop is to understand patient and provider perspectives
on receiving potentially medically relevant genetic test results. The
topic(s) to be discussed will focus on better defining the specific
information patients and providers prefer to receive, with an emphasis
on the type(s) and amount of evidence available to interpret the
results for medical purposes, how those results should be returned, and
what information is needed to understand the results in the event that
they could effectively aid in medical decision making.

DATES: The public workshop will be held on March 2, 2016, from 8 a.m.
to 4 p.m. Submit either electronic or written comments on the public
workshop by March 31, 2016.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-4809 for ``Patient and Medical Professional Perspectives on
the Return of Genetic Test Results; Public Workshop; Request for
Comments.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including

the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on http://www.regulations.gov. Submit both copies to the Division of
Dockets Management. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, 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: Cara Tenenbaum, Center for Devices and
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 5563,
10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In his State of the Union address on January 20, 2015, President
Obama launched the Precision Medicine Initiative (PMI),\1\ in order to
empower health care providers to tailor treatment and prevention
strategies to an individual's unique characteristics. This may include
analysis of genetic information, including information gathered through
Next Generation Sequencing (NGS). As part of PMI, FDA is considering
new approaches in its regulation of NGS. FDA is interested in promoting
innovation while ensuring that patients have access to cutting edge
technologies that are accurate and provide meaningful information to
inform their health care decisions.
---------------------------------------------------------------------------

    \1\ The Precision Medicine Initiative found on the White House's
Web site at: https://www.whitehouse.gov/precision-medicine.
---------------------------------------------------------------------------

    NGS produces significant amounts of information, including some
that may be difficult for patients and health care professionals to
interpret with presently available scientific knowledge. In some cases,
the evidence for association of many genetic variants with particular
diseases is limited because of the rarity of the variant or because it
partially contributes to a disease in combination with other factors.
In other cases, the evidence may be contradictory or not be available
currently, but may be clearer in the future. Additionally, some
findings may be unexpected or incidental to what a physician is looking
for. FDA seeks to learn, when results are generated in a CLIA-compliant
laboratory, which results are of importance to patients and providers,
how those results should be returned, and how much and what types of
evidence supporting interpretation of those results is necessary. Thus,
FDA is seeking public input from patients and health care professionals
to inform its approach regarding the return of results of genetic
tests.

II. Topics for Discussion at the Public Workshop

    In response to President Obama's PMI, the public workshop will
consider the different uses of genetic testing. For example, tests that
determine the risk of developing a condition, tests that diagnose
hereditary genetic disorders, and tests that can guide treatment or
therapeutic interventions. Additionally, the workshop and invited
speakers will cover various topics, including which results (e.g.,
variants or mutations) and interpretations are useful to patients when
undergoing genetic testing; what types of results patients would want
to receive when there is no medical action that can be taken; how best
can results of genetic test be presented; patients' preference in
receiving results that are supported by limited or conflicting evidence
and how best such results should be presented; how information can be
best presented to ease integration into clinical care and health care
provider workflow; what providers want to know about results that are
supported by limited or conflicting evidence; what information should
be included in test reports and how it should be presented; and what
specific information providers can do without.
    FDA will present case studies as a starting point for discussion,
which will be available on the meeting Web page in advance of the
public meeting. Furthermore, the following will be considered in the
context of different uses of genetic testing: Health literacy/numeracy
of patients; genetics/genomics literacy of health care practitioners;
the personal utility of knowing about the presence of a mutation or
variant whether it is actionable or not; that a mutation or variant may
have limited evidence at the time the test is initially run but
evidence may be gathered that changes the interpretation of the
mutation or variant; privacy concerns; demographic information and
subpopulations; undiagnosed patients; and underserved populations.
    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by February 24, 2016, 4 p.m. Early
registration is recommended because space is limited and, therefore,
FDA may limit the number of participants from each organization. If
time and space permits, onsite registration on the day of the public
workshop will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan, email<EMAIL_ADDRESS>phone: 301-
796-5661, no later than February 20, 2016.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting/public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, email, and telephone number. Those
without Internet access should contact Susan Monahan to register (see
contact for special accommodations). Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. If you have never attended a Connect Pro event before,
test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro
program, visit http://www.adobe.com/go/connectpro_overview. FDA has
verified the Web site addresses in this document, as of the date this
document publishes in the Federal Register, but Web sites are subject
to change over time.
    Requests for Oral Presentations: This public workshop includes
public comment and topic-focused sessions. During online registration
you may indicate if you wish to present during a public comment
session. FDA has

included general topics for discussion in this document. If you do
request to present public comments, please list which topics you wish
to address. FDA will do its best to accommodate requests to make public
comment. Following the close of registration, FDA will determine the
amount of time allotted to each presenter and the approximate time each
oral presentation is to begin, and will select and notify participants
by February 24, 2016. All requests to make oral presentations must be
received by the close of registration on February 24, 2016, at 4 p.m.
If selected for presentation, any presentation materials must be
emailed to Cara Tenenbaum (see FURTHER INFORMATION CONTACT) no later
than February 26, 2016. No commercial promotional material will be
permitted to be presented or distributed at the public workshop.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

    Dated: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00540 Filed 1-13-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 249 (Thursday, December 29, 2022)]
[Notices]
[Pages 80211-80212]
[FR Doc No: 2022-28338]

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SECURITIES AND EXCHANGE COMMISSION

[Securities Act of 1933 Release No. 11142/December 23, 2022; Securities
Exchange Act of 1934 Release No. 96577/December 23, 2022]

Order Approving Public Company Accounting Oversight Board Budget
and Annual Accounting Support Fee for Calendar Year 2023

    The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley
Act''),\1\ established the Public Company Accounting Oversight Board
(``PCAOB'') to oversee the audits of companies that are subject to the
securities laws, and related matters, in order to protect the interests
of investors and further the public interest in the preparation of
informative, accurate, and independent audit reports. Section 982 of
the Dodd-Frank Wall Street Reform and Consumer Protection Act \2\
amended the Sarbanes-Oxley Act to provide the PCAOB with explicit
authority to oversee auditors of broker-dealers registered with the
Securities and Exchange Commission (the ``Commission''). The PCAOB is
to accomplish these investor protection and public interest goals
through the registration of public accounting firms, standard setting,
inspections, and investigation and disciplinary programs. The PCAOB is
subject to the

comprehensive oversight of the Commission.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 7201 et seq.
    \2\ Public Law 111-203, 124 Stat. 1376 (2010).
---------------------------------------------------------------------------

    Section 109 of the Sarbanes-Oxley Act provides that the PCAOB shall
estblish a reasonable annual accounting support fee, as may be
necessary or appropriate to establish and maintain the PCAOB. Under
Section 109(f) of the Sarbanes-Oxley Act, the aggregate annual
accounting support fee shall not exceed the PCAOB's aggregate
``recoverable budget expenses,'' which may include operating, capital,
and accrued items. The PCAOB's annual budget and accounting support fee
are subject to approval by the Commission. In addition, the PCAOB must
allocate the annual accounting support fee among issuers and among
registered brokers and dealers.
    Section 109(b) of the Sarbanes-Oxley Act directs the PCAOB to
establish a budget for each fiscal year in accordance with the PCAOB's
internal procedures, subject to approval by the Commission. Rule 190 of
Regulation P (the ``Budget Rule'') governs the Commission's review and
approval of PCAOB budgets and annual accounting support fees.\3\ The
Budget Rule provides, among other things, a timetable for the
preparation and submission of the PCAOB budget and for Commission
actions related to each budget, a description of the information that
should be included in each budget submission, limits on the PCAOB's
ability to incur expenses and obligations except as provided in the
approved budget, procedures relating to supplemental budget requests,
requirements for the PCAOB to provide on a quarterly basis certain
budget-related information, and a list of definitions that apply to the
rule and to general discussions of PCAOB budget matters.
---------------------------------------------------------------------------

    \3\ 17 CFR 202.190.
---------------------------------------------------------------------------

    In accordance with the Budget Rule, in March 2022 the PCAOB
provided the Commission with a narrative description of its program
issues and outlook for the 2023 budget year. In response, the
Commission provided the PCAOB with economic assumptions and general
budgetary guidance for the 2023 budget year. The PCAOB subsequently
delivered a preliminary budget and budget justification to the
Commission. Staff from the Commission's Office of the Chief Accountant
and Office of Financial Management dedicated a substantial amount of
time to the review and analysis of the PCAOB's programs, projects, and
budget estimates and participated in several meetings with staff of the
PCAOB to further develop the understanding of the PCAOB's budget and
operations. During the course of this review, Commission staff relied
upon representations and supporting documentation from the PCAOB. Based
on this review, the Commission issued a ``passback'' letter to the
PCAOB on October 27, 2022. On November 18, 2022, the PCAOB adopted its
2023 budget and accounting support fee during an open meeting, and
subsequently submitted that budget to the Commission for approval.
    After considering the above, the Commission did not identify any
proposed disbursements in the 2023 budget adopted by the PCAOB that are
not properly recoverable through the annual accounting support fee, and
the Commission believes that the aggregate proposed 2023 annual
accounting support fee does not exceed the PCAOB's aggregate
recoverable budget expenses for 2023.
    The Commission continues to emphasize the importance of the PCAOB's
identification of efficiencies and process improvements. Accordingly,
the Commission requests that the PCAOB evaluate its operational
efficiency, improvements, and budgetary needs and submit such
assessments to the Commission in connection with the 2024 budget cycle.
    Coordination between the SEC and PCAOB continues to be important.
The Commission directs the PCAOB during 2023 to continue to hold
monthly meetings, as necessary, with the Commission's staff to discuss
important policy initiatives, changes related to program areas, and
significant impacts to the PCAOB's 2023 budget, including significant
differences between actual and budgeted amounts and anticipated cost-
savings. Separately, the Commission directs the PCAOB to continue its
written quarterly updates on recent activities, including strategic
initiatives, for the PCAOB's Office of Economic and Risk Analysis;
Office of Data, Security, and Technology; and Division of Registration
and Inspections. The Commission expects the PCAOB to make itself
available to meet with individual Commissioners on these and other
topics. Further, the Commission requests that the PCAOB submit its 2022
annual report to the Commission by March 31, 2023.
    The Commission understands that the Office of Management and Budget
(``OMB'') has determined that the 2023 budget of the PCAOB is subject
to sequestration under the Budget Control Act of 2011.\4\ For 2022, the
PCAOB sequestered $17.7 million. That amount will become available in
2023. For 2023, the sequestration amount will be 5.7% or $19.9 million.
Consequently, we expect the PCAOB will have approximately $2.2 million
less funds available from the 2022 sequestration for spending in 2023.
Accordingly, the PCAOB should submit a revised spending plan for 2023
reflecting a $2.2 million reduction to budgeted expenditures as a
result of the increase in sequestration amount from 2022 to 2023.
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    \4\ OMB Report to the Congress on the BBEDCA 251A Sequestration
for Fiscal Year 2023 (Mar. 28, 2022), available at https://www.whitehouse.gov/wp-content/uploads/2022/03/BBEDCA_251A_Sequestration_Report_FY2023.pdf.
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    The Commission has determined that the PCAOB's 2023 budget and
annual accounting support fee are consistent with Section 109 of the
Sarbanes-Oxley Act. Accordingly,
    It is ordered, pursuant to Section 109 of the Sarbanes-Oxley Act,
that the PCAOB budget and annual accounting support fee for calendar
year 2023 are approved.

    By the Commission.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-28338 Filed 12-28-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Pages 54229-54230]
[FR Doc No: 2022-19038]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4661-DR; Docket ID FEMA-2022-0001]

Alaska; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Alaska (FEMA-4661-DR), dated July 26, 2022,
and related determinations.

DATES: The declaration was issued July 26, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 26, 2022, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Alaska resulting from a landslide on May 7, 2022, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Alaska.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated area and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Yolanda J. Jackson, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.

    The following areas of the State of Alaska have been designated as
adversely affected by this major disaster:

    Kenai Peninsula Borough for Public Assistance.
    All areas within the State of Alaska are eligible for assistance
under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-19038 Filed 9-1-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: July 27, 2006 (Volume 71, Number 144)]
[Notices]
[Page 42694-42696]
[DOCID:fr27jy06-90]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54159; File No. SR-NASD-2006-058]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Order Granting Accelerated Approval
of a Proposed Rule Change and Amendment No. 1 Thereto Regarding Pricing
for Non-Members Using the Nasdaq Market Center and Nasdaq's Brut and
INET Facilities

July 17, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 1, 2006, the National Association of Securities Dealers, Inc.
(``NASD''), through its subsidiary, The Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by Nasdaq. On June 12, 2006,
Nasdaq filed Amendment No. 1 to the proposed rule change.\3\ The

Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons, and at the
same time is granting accelerated approval of the proposed rule change,
as amended.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, Nasdaq amended the description of the
proposed rule change to indicate that when a market participant
enters an order into Nasdaq's Brut or INET systems that is sent to a
Nasdaq Market Center market participant that charges an access fee
to Brut or INET, the market participant entering the order shall be
charged (i) the applicable execution fee of the Nasdaq Facilities,
or (ii) in the case of executions against Quotes/Orders at less than
$1.00 per share, a pass-through of the access fee charged to Brut or
INET.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    This filing relates to the pricing for non-members using the Nasdaq
Market Center and Nasdaq's Brut and INET Facilities. The filing will
apply to these non-members the same rule change that Nasdaq is
instituting for members.\4\ Nasdaq seeks approval to implement the
proposed rule change retroactively as of May 1, 2006. The text of the
proposed rule change is below. Proposed new language is in italics.\5\
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    \4\ See Securities Exchange Act Release No. 34-54160 (July 17,
2006). Notice of filing and immediate effectiveness of proposed rule
change regarding the pricing schedule for NASD members using the
Nasdaq Market Center and Nasdaq's Brut and INET Facilities.
    \5\ Changes are marked to the rule text that appears in the
electronic NASD Manual found at http://www.nasd.com, as amended by

SR-NASD-2006-013 (January 30, 2006). The NASDAQ Stock Market LLC
(``NASDAQ LLC'') will not file conforming changes to its rules with
regard to order execution and routing by non-members, since persons
that are not members of NASDAQ LLC will not be permitted to use its
order execution and routing systems.
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7010. System Services

    (a)-(h) No change.
    (i) Nasdaq Market Center and Brut Facility Order Execution.
    (1)-(7) No change.
    (8) The fees applicable to non-members using Nasdaq's Brut and Inet
Facilities shall be the fees established for members under Rule
7010(i), as amended by SR-NASD-2005-019, SR-NASD-2005-035, SR-NASD-
2005-048, SR-NASD-2005-071, SR-NASD-2005-125, SR-NASD-2005-137, SR-
NASD-2005-154, SR-NASD-2006-013, SR-NASD-2006-023, [and] SR-NASD-2006-
031,  and SR-NASD-2006-057, and as applied to non-members by SR-NASD-
2005-020, SR-NASD-2005-038, SR-NASD-2005-049, SR-NASD-2005-072, SR-
NASD-2005-126, SR-NASD-2005-138, SR-NASD-2005-155, SR-NASD-2006-014,
SR-NASD-2006-024, [and ]SR-NASD-2006-032, and SR-NASD-2006-058.
    (j)-(w) No change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change, as
amended, and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item III below. Nasdaq has prepared summaries, set forth
in Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Nasdaq is reducing its fees for market participants routing orders
from its three trading platforms--the Nasdaq Market Center, Brut, and
Inet--to the American Stock Exchange (``Amex''). Specifically, whereas
Nasdaq previously charged $0.01 per share executed for routing such
orders, the fee is be reduced to $0.003 per share executed. However, an
additional fee of $0.01 will be charged in cases where the Amex
specialist charges a fee to execute the order (which generally occurs
when the order remains on the specialist book for more than a certain
amount of time before being executed).
    Nasdaq is also broadening the conditions under which a market
participant may qualify for a reduced fee of $0.0028 per share executed
to access liquidity and route orders in Nasdaq-listed securities and
exchange-traded funds. Currently, market participants qualify for the
$0.0028 fee (a reduction from the otherwise applicable fee of $0.003
per share executed) if they (i) provide an daily average of more than
30 million shares of liquidity during a month and (ii) access and/or
route a daily average of more than 50 million shares of liquidity
during a month. With the proposed rule change, the reduced fee would
also be available to market participants that (i) provide a daily
average of more than 20 million shares of liquidity during a month and
(ii) access and/or route a daily average of more than 60 million shares
of liquidity during a month. Thus, the change will broaden the
availability of the reduced fee to market participants that provide
comparatively less liquidity but access and/or route comparatively more
liquidity.
    Nasdaq is also adding rule text to clarify the application of its
current fee schedule to orders that are entered into Brut or Inet,
routed to the Nasdaq Market Center for execution, and then delivered
for execution to an ECN that receives orders through the order delivery
functionality of the Nasdaq Market Center. Because the current fee
schedule is ambiguous as to the treatment of such orders, Nasdaq
believes that the rule text should be clarified to reflect Nasdaq's
interpretation of the fee schedule. Because the orders are transmitted
using Brut/Inet routing technology and then transmitted again for
execution through the systems of a third party, Nasdaq believes that it
is most appropriate to categorize these orders as routed orders.
Accordingly, routing fees, which range from $0.001 to $0.004 per share
executed, apply rather than order execution or delivery fees.
    SR-NASD-2006-057 \6\ applied these changes to NASD members on an
immediately effective basis. Nasdaq is submitting this filing to apply
these changes to non-members, who Nasdaq anticipates will be allowed to
continue to use the Brut and Inet facilities until NASDAQ LLC begins to
operate as a national securities exchange.
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    \6\ See supra note 4.
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2. Statutory Basis
    Nasdaq believes that the proposed rule change, as amended, is
consistent with the provisions of Section 15A of the Act,\7\ in
general, and with Section 15A(b)(5) of the Act,\8\ in particular, in
that it provides for the equitable allocation of reasonable dues, fees
and other charges among members and issuers and other persons using any
facility or system which the NASD operates or controls.
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    \7\ 15 U.S.C. 78o-3.
    \8\ 15 U.S.C. 78o-3(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change, as amended,
will result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing,

including whether the proposed rule change, as amended, is consistent
with the Act. Comments may be submitted by any of the following
methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-058 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASD-2006-058. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street, NE,
Washington, DC 20549. Copies of such filing also will be available for
inspection and copying at the principal office of the NASD. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASD-2006-058 and should be
submitted on or before August 17, 2006.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a self-regulatory organization.\9\
Specifically, the Commission believes that the proposed rule change, as
amended, is consistent with Section 15A(b)(5) of the Act,\10\ which
requires that the rules of the self-regulatory organization provide for
the equitable allocation of reasonable dues, fees, and other charges
among members and issuers and other persons using any facilities or
system which it operates or controls.
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    \9\ The Commission has considered the proposed rule's impact on
efficiency, competition and capital formation. 15 U.S.C. 78c(f).
    \10\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

    The Commission notes that this proposal would retroactively modify
pricing for non-NASD members using the Nasdaq Market Center and
Nasdaq's Brut and INET Facilities that would permit the schedule for
non-NASD members to mirror the schedule applicable to NASD members that
became effective May 1, 2006, pursuant to SR-NASD-2006-057.
    The Commission finds good cause for approving the proposed rule
change, as amended, prior to the 30th day of the date of publication of
the notice thereof in the Federal Register. The Commission notes that
the proposed fees for non-NASD members are identical to those in SR-
NASD-2006-057, which implemented those fees for NASD members and which
became effective as of May 1, 2006. The Commission notes that this
change will promote consistency in Nasdaq's fee schedule by applying
the same pricing schedule with the same date of effectiveness for both
NASD members and non-NASD members. Therefore, the Commission finds that
there is good cause, consistent with Section 19(b)(2) of the Act,\11\
to approve the proposed rule change, as amended, on an accelerated
basis.
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    \11\ 15 U.S.C. 78s(b)(2).
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change, as amended, (File No. SR-NASD-
2006-058) is approved on an accelerated basis.
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    \12\ Id.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
 [FR Doc. E6-11981 Filed 7-26-06; 8:45 am]

BILLING CODE 8010-01-P