[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70015-70016]
[FR Doc No: 2010-28763]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

External Defibrillators; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing the following
public workshop: FDA Public Workshop on External Defibrillators. The
purpose of the public workshop is to share FDA's understanding of the
risks and benefits of external defibrillators, to clarify FDA's current
expectations for how industry should identify, report, and take action
on problems observed with these devices, and to promote innovation for
next-generation devices that will bring safer, more effective external
defibrillators to market.
    Dates and Time: The public workshop will be held on December 15,
2010, from 8 a.m. to 5:30 p.m., and on December 16, 2010, from 8 a.m.
to 2 p.m. Persons interested in attending this public workshop must
register by 5 p.m. on December 8, 2010.
    Location: The public workshop will be held in the Great Room at the
Food and Drug Administration, White Oak Campus, Bldg. 31, 10903 New
Hampshire Ave., Silver Spring, MD 20903.
    Contact: Megan Moynahan, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5404, Silver Spring, MD 20903, 301-796-
5435, FAX:<PHONE_NUMBER>, or e-mail<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: Registration is
free and will be on a first-come, first-served basis. To register for
the public workshop, please visit the following Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm232062.htm (or go the FDA Medical Devices New & Events--Workshops &
Conferences calendar and select this public workshop from the posted
events list). Please provide complete contact information for each
attendee, including name, title, affiliation, address, e-mail, and
telephone number. For those without Internet access, please call the
contact person to register. Registration requests should be received by
5 p.m. on December 8, 2010. Early registration is recommended because
seating is limited and, therefore, FDA may limit the number of
participants from each organization. If time and space permit, onsite
registration on the day of the public workshop will be provided
beginning at 7:30 a.m.
    Registrants requesting to present written material or to make oral
presentations at the public workshop, please call the contact person by
November 29, 2010.
    If you need special accommodations due to a disability, please
contact Susan Monahan (e-mail<EMAIL_ADDRESS>at least 7
days in advance.

SUPPLEMENTARY INFORMATION:

I. Background

    External defibrillators (including automated external
defibrillators (AEDs)) are life-saving devices designed to restore
normal heart rhythms following sudden cardiac arrest. Each year, nearly
300,000 Americans collapse from sudden cardiac arrest. In sudden
cardiac arrest, the heart unexpectedly stops pumping blood to the body.
When normal heart rhythms are not restored quickly, sudden cardiac
arrest can cause death.
    External defibrillators are important, life-saving devices.
However, over the past 5 years we have seen persistent safety problems
with all types of external defibrillators, across all manufacturers of
these devices. From January 1, 2005, to July 10, 2010, there were a
total of 68 recalls, of which 9 occurred in 2005 increasing to 17 in
2009 (the last complete year for which data are available). During this
period, FDA received over 28,000 medical device reports (MDRs), of
which 4,210 occurred in 2005 increasing to 7,807 in 2009 (the last
complete year for which data are available). FDA conducted multiple
inspections of all external defibrillator manufacturers throughout this
time period.
    Many of the types of problems we have identified are preventable,
correctable, and impact patient safety. As part of a comprehensive
review, FDA identified several industry practices that have contributed
to these persistent safety risks including industry practices for
designing and manufacturing defibrillators, handling user complaints,
conducting recalls, and communicating with users. In some cases, these
practices can contribute to device performance problems, place undue
burden on users, and put patients at risk.
    To date, FDA has addressed individual device problems on a case-by-
case basis. However, our analysis of MDRs, recalls, and inspections
confirms that common problems persist across all types of external
defibrillators and all manufacturers. One purpose of the public
workshop is to share FDA's understanding of the risks and benefits of
external defibrillators and to clarify FDA's current expectations for
how industry should identify, report, and take action on problems
observed with these devices.
    In addition, to promote innovation and to better understand patient
outcomes, FDA is collaborating with the University of Colorado's
Department of Emergency Medicine and the Centers for Disease Control
and Prevention (CDC) to develop a multi-city AED registry that will
link with the CDC-funded Cardiac Arrest Registry to Enhance Survival
(CARES). The registry will provide the infrastructure to foster the
development of innovative AED features such as automated integration
into local 9-1-1 systems. FDA will work with multiple stakeholders to
facilitate the development of next-generation defibrillators, enhance
surveillance of defibrillators in community settings, and improve the
rapid delivery of treatment for sudden cardiac arrest patients. One
purpose of the public workshop on December 15 and 16, 2010, is to
advance these efforts by bringing together government, industry,
academia, and users, including clinicians and consumers, to share
perspectives.

II. Topics for Discussion at the Public Workshop

    The public workshop will be organized to allow facilitated
discussion by industry, academia, clinicians, users, and regulators on
the following broad topic areas:
    1. What are the nature, scope, and impact of external defibrillator
problems that have been observed? What are the root causes of these
problems?
    2. How should problems with external defibrillators be identified,
reported, and acted upon by industry and users?
    3. What factors or criteria should be considered when designing
external defibrillators for use in different environments (hospital,
community, home)?
    4. What features of next generation devices can be defined that
will increase the diffusion of new technologies, enhance device
interoperability, and improve ease of use?

    5. How might device registries improve our ability to identify
early device performance signals, or enhance the use of external
defibrillators?

III. Transcripts

    Please be advised that as soon as a transcript is available, it can
be obtained in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857. A link to the transcripts will also be available
on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the
posted events list), approximately 45 days after the public workshop.

    Dated: November 9, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28763 Filed 11-15-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Rules and Regulations]
[Pages 38834-38838]
[FR Doc No: 2017-17247]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2016-0626; FRL-9966-37-Region 1]

Air Plan Approval; Vermont; Regional Haze Five-Year Progress
Report

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
Vermont's regional haze progress report, submitted on February 29, 2016
as a revision to its State Implementation Plan (SIP). Vermont's SIP
revision addresses requirements of the Clean Air Act (CAA) and EPA's
rules that require states to submit periodic reports describing the
progress toward reasonable progress goals (RPGs) established for
regional haze and a determination of adequacy of the State's existing
regional haze SIP. EPA is approving Vermont's progress report on the
basis that it addresses the progress report and adequacy determination
requirements for the first implementation period covering through 2018.

DATES: This direct final rule will be effective October 16, 2017,
unless EPA receives adverse comments by September 15, 2017. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2016-0626 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Anne K. McWilliams, Air Quality
Planning Unit, U.S. Environmental Protection Agency, New England
Regional Office, 5 Post Office Square--Suite 100, (Mail code OEP05-2),
Boston, MA 02109-3912, telephone<PHONE_NUMBER>, facsimile (617) 918-
0697, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Throughout this document whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA.

Table of Contents

I. Background
II. EPA's Evaluation of Vermont's SIP Revision
    A. Regional Haze Progress Report
    B. Determination of Adequacy of Existing Regional Haze Plan
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    States are required to submit a progress report in the form of a
SIP revision that evaluates progress towards the RPGs for each
mandatory Class I Federal area (Class I area) \1\ within the state and
each Class I area outside of the state which may be affected by
emissions from within the state. See 40 CFR 51.308(g). States are also
required to submit, at the same time as the progress report, a
determination of the adequacy of the State's existing SIP. See 40 CFR
51.308(h). The first progress report is due five years after submittal
of the initial regional haze SIP. On August 26, 2009, the Vermont
Department of Environmental Conservation (VT DEC) submitted the State's
first regional haze SIP in accordance with the requirements of 40 CFR
51.308.\2\
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    \1\ Areas designated as mandatory Class I Federal areas consist
of national parks exceeding 6000 acres, wilderness areas and
national memorial parks exceeding 5000 acres, and all international
parks that were in existence on August 7, 1977 (42 U.S.C. 7472(a)).
Listed at 40 CFR part 81, subpart D.
    \2\ On May 22, 2012, EPA approved Vermont's August 26, 2009
regional haze SIP to address the first implementation period for
regional haze. See 77 FR 30212.
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    On February 29, 2016, VT DEC submitted a revision to the Vermont
SIP detailing the progress made in the first planning period toward
implementation of the Long Term Strategy (LTS) outlined in the
Vermont's 2009 regional haze SIP submittal, the visibility improvement
measured at the State's one Class I area, and a determination of the
adequacy of the State's existing regional haze SIP. EPA is approving
Vermont's February 29, 2016 SIP revision on the basis that it satisfies
the requirements of 40 CFR 51.308(g) and (h).

II. EPA's Evaluation of Vermont's SIP Revision

    On February 29, 2016, Vermont submitted its ``Regional Haze Five-
Year Progress Report'' (Progress Report) to EPA as a SIP revision.
    Vermont is home to one Class I area, the Lye Brook Wilderness Area
(Lye Brook). During the regional haze planning process, an area-of-
influence modeling analysis based on back trajectories was used to
assess Vermont's contribution to visibility impairment at Lye Brook and
other Class I areas in other states.\3\ Based on

this analysis, it was determined that Vermont does not influence
visibility impairment at any Class I area, including Lye Brook. In the
2009 Vermont regional haze SIP, however, the State agreed to pursue the
coordinated course of action agreed to by the Mid-Atlantic/Northeast
Visibility Union (MANE-VU) \4\ to assure reasonable progress toward
preventing any future, and remedying any existing, impairment of
visibility in the Class I areas within the MANE-VU region. These
strategies are commonly referred to as the MANE-VU ``Ask.'' The MANE-VU
``Ask'' includes: a timely implementation of best available retrofit
technology (BART) requirements; a 90 percent or more reduction in
sulfur dioxide (SO2) emissions at 167 electrical generating
units (EGUs) ``stacks'' identified by MANE-VU (or comparable
alternative measures); a lower sulfur fuel oil strategy (with limits
specified for each State); and continued evaluation of other control
measures.\5\ Vermont is not home to any BART sources or targeted EGUs.
However, Vermont has adopted a lower sulfur fuel oil strategy which is
discussed in greater detail below.
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    \3\ Contributions to Regional Haze in the Northeast and Mid-
Atlantic United States, August 2006 http://www.nescaum.org/documents/contributions-to-regional-haze-in-the-northeast-and-mid-atlantic-united-states/mane-vu_haze_contribution_asessment-2006-0831.pdf/.
    \4\ MANE-VU is a collaborative effort of State governments,
Tribal governments, and various federal agencies established to
initiate and coordinate activities associated with the management of
regional haze, visibility and other air quality issues in the
Northeastern United States. Member State and Tribal governments
include: Connecticut, Delaware, the District of Columbia, Maine,
Maryland, Massachusetts, New Hampshire, New Jersey, New York,
Pennsylvania, Penobscot Indian Nation, Rhode Island, and Vermont.
    \5\ The MANE-VU ``Ask'' was structured around the finding that
SO2 emissions were the dominate visibility impairing
pollutant at the Northeastern Class I areas and electrical
generating units comprised the largest SO2 emission
sector. See ``Regional Haze and Visibility in the Northeast and Mid-
Atlantic States,'' January 31, 2001.
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A. Regional Haze Progress Report

    This section includes EPA's analysis of Vermont's Progress Report
SIP submittal, and an explanation of the basis of our approval.
    In its Progress Report, Vermont describes its implementation of the
MANE-VU ``Ask'' for the sulfur content of fuel oil. Vermont adopted the
low-sulfur fuel oil strategy on September 28, 2011 in Vermont's Air
Pollution Control Regulations (VT APCR) Section 5-221(1) to take effect
in two phases. The first phase began on July 1, 2014, lowering the
allowable concentration of sulfur in No. 2 and lighter distillate fuels
to 0.05% (500 parts per million (ppm)) by weight. The second phase, to
take effect on July 1, 2018, further lowers the sulfur limit for No. 2
and lighter distillate oils to 0.0015% (15 ppm) by weight, the sulfur
limit for No. 4 residual oil to 0.25% (2,500 ppm) by weight, and the
sulfur limit for No. 5 and No. 6 residual oils, heavier residual oils,
and used oils to 0.5% (5,000 ppm) by weight. EPA has approved Vermont's
Section 5-221(1) into the Vermont SIP. See 77 FR 30213 (May 22, 2012).
    Vermont's Progress Report also includes the status of
SO2 emission reductions from states that affect Class I
areas in MANE-VU relative to the MANE-VU ``Ask.'' \6\ Vermont consulted
with states in the eastern United States that affect visibility at the
Lye Brook Class I area, outlining how the states could meet the MANE-VU
``Ask'' and help achieve reasonable progress for the Class I area in
Vermont and other MANE-VU States. These emission reductions were
included in the modeling that predicted progress toward meeting the
RPGs for Lye Brook. EPA finds that Vermont's summary of the status of
the implementation of measures in its Progress Report adequately
addresses the applicable provisions under 40 CFR 51.308(g).
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    \6\ Memorandum from NESCAUM to MANE-VU ``Overview of State and
Federal Actions Relative to MANE-VU Asks'' dated March 28, 2013
http://www.nescaum.org/documents/summary-memo-mane-vu-asks-20130328-final.pdf/.
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    During the development of the regional haze SIP for the first
planning period, MANE-VU and Vermont determined that SO2 was
the greatest contributor to anthropogenic visibility impairment at the
State's Class I area. Therefore, the bulk of visibility improvement
achieved in the first planning period was expected to result from
reductions in SO2 emissions from sources inside and outside
of the State. In its Progress Report SIP Table 7.3, Vermont presents
data from statewide emissions inventories developed for the years 2002,
2008, 2011, and projected inventories for 2018 for SO2,
Oxides of Nitrogen (NOX), Fine Particulate Matter
(PM2.5) and Volatile Organic Compounds
(VOC).7 8 Vermont's emissions inventories include the
following source sectors: point, area/nonpoint, on-road, and non-road.
The Progress Report highlights that the total SO2 emissions
from all sectors decreased from 7,293 tons per year (tpy) in 2002 to
3,450 tpy in 2011, i.e., approximately a 53% reduction. The annual
SO2 emissions projection for 2018 is 3,493 tpy. VT DEC
demonstrated that by 2011, Vermont had already achieved the
SO2 emission reductions expected during the first regional
haze planning period.
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    \7\ The 2002, 2008, and 2011 inventories are all based on the
respective EPA's National Emission Inventory (NEI). https://www.epa.gov/air-emissions-inventories/national-emissions-inventory-nei.
    \8\ The 2018 projected inventory is taken directly from Table
6.4 in Vermont's 2009 regional haze SIP revision. See 77 FR 30212.
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    EPA finds that Vermont has adequately addressed the provision under
40 CFR 51.308(g). Vermont has detailed the SO2 reductions
from the 2002 regional haze baseline by using the most recently
available year of data at the time of the development of Vermont's
Progress Report, which is 2011.
    The provisions under 40 CFR 51.308(g) also require that states with
Class I areas within their borders provide information on current
visibility conditions and the difference between current visibility
conditions and baseline visibility conditions expressed in terms of
five-year averages of these annual values.
    Vermont is home to one Class I area, the Lye Brook Wilderness Area.
From 1992 to 2012, VT DEC operated an Interagency Monitoring of
Protected Visual Environments (IMPROVE) program monitor on Mt. Equinox
(LYBR1), near the Lye Brook Wilderness Area. In 2012, a second IMPROVE
site was established on Mt. Snow in Dover, Vermont (LYEB1) due to the
planned discontinuation of the Mt. Equinox site. Monitors at both sites
collected data concurrently for a period of nine months. On the 20%
best and worst days, the two sites were found to have a nearly one-to-
one relationship. In the Progress Report, VT DEC provides the data in
deciviews (dv) \9\ for the baseline 2000-2004 five-year average
visibility, the most recent 2010-2014 five-year average visibility, the
2018 RPG from Vermont's 2009 regional haze SIP, and the calculated
visibility improvement.\10\ See Table 1.
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    \9\ The deciview is a measure for tracking progress in improving
visibility. Each deciview change is an incremental change in
visibility perceived by the human eye. The preamble to the Regional
Haze Rule provides additional details about the deciview (64 FR
35714 (July 1, 1999)).
    \10\ 2000-2011 data from LYBR1 site and 2012-2014 data from
LYEB1 site.

                       Table 1--Observed Visibility vs. Established Visibility Goals (in deciviews) for Lye Brook Wilderness Area
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Baseline 2000-    Most recent
                                                2004 5-year    2010-2014 5-     Visibility         2018
                                                  average      year  average    improvement     reasonable             Meets 2018 progress goal?
                                                visibility      visibility         (dv)        progress goal
                                                   (dv)            (dv)                            (dv)
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20% Most Impaired Days......................            24.4            18.5             5.9            20.9  Yes.
20% Least Impaired Days.....................             6.4             5.1             1.3             5.5  Yes.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The baseline visibility for Lye Brook was 24.4 dv on the 20% most
impaired days and 6.4 dv on the least impaired days. The most recent
five-year average visibility data (2010-2014) demonstrates that the
State has already achieved and surpassed the 2018 RPG for the 20% most
impaired days (18.5 dv vs. RPG of 20.9 dv) and ensured no visibility
degradation for the 20% least impaired days for the first planning
period (5.1 dv vs. RPG of 5.5 dv).
    EPA finds that Vermont provided the required information regarding
visibility conditions to meet the applicable requirements under 40 CFR
51.308(g), specifically providing baseline visibility conditions (2000-
2004), current conditions based on the most recently available IMPROVE
monitoring data (2010-2014), and a comparison with the RPGs.
    As discussed above, Vermont's Progress Report SIP Table 7.3
presents data from statewide emissions inventories developed for the
years 2002, 2008, 2011, and projected inventories for 2018 for
SO2, NOX, PM2.5 and VOC. From 2002
through 2011, Vermont's overall area/nonpoint (the largest
SO2 sector) emissions were reduced from 5,386 to 2,927 tons
of SO2, below the 2018 projection of 2,990 tons
SO2. For NOX, from 2002 to 2011, the State
achieved an overall 35% reduction from 30,231 tons to 19,644 tons. VT
DEC is estimating that the state will achieve an additional 8,000 tpy
NOX reduction, mostly from fleet turnover in the on-road
mobile sector, which would result in an emissions level on par with the
approximately 11,000 tons of NOx projected for 2018 in Vermont's
regional haze SIP. VT DEC indicates that based on the 2011 emissions
data, the State has already reduced VOC emissions below the level
projected for 2018 (42% reduction by 2011 vs. the projected 19%
reduction by 2018). Finally, VT DEC notes that PM2.5
emissions have increased from 2002 (11,446 tons) to 2008 (14,355 tons)
and then decreased in 2011 (13,406 tons). VT DEC notes that this
fluctuation is most likely attributable, in part, to increased
residential wood burning, as well as to changes in the emission
reporting methodology for estimating fugitive dust emissions. The
Vermont projection for PM2.5 emissions in 2018 is 7,932
tons.
    EPA finds that Vermont has adequately addressed the applicable
provisions under 40 CFR 51.308(g). VT DEC compared the most recently
updated emission inventory data available at the time of the
development of the Progress Report with the baseline emissions from its
regional haze SIP. The Progress Report appropriately details the 2011
SO2, NOX, PM2.5, and VOC reductions
achieved, by sector, thus far in the regional haze planning period.
    In its Progress Report, Vermont states that sulfates continue to be
the biggest single contributor to regional haze at Lye Brook. Vermont's
emissions were not found to be impacting any Class I area. VT DEC
focused its analysis on addressing large SO2 emissions from
point sources outside of the state. The State did not find any
significant changes in NOX and PM2.5 which might
impede or limit progress during the first planning period. In addition,
VT DEC cited the 2013 Northeast States for Coordinated Air Use
Management (NESCAUM) report, discussed below, which indicates that all
of the MANE-VU Class I areas are on track to meet the 2018 visibility
goals established by the states in their regional haze SIPs.\11\
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    \11\ NESCAUM for MANE-VU, ``Tracking Visibility Progress 2004-
2011,'' revised May 24, 2013. http://www.nescaum.org/documents/manevu-trends-2004-2011-report-final-20130430.pdf/view.
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    EPA finds that VT DEC has adequately addressed the applicable
provisions under 40 CFR 51.308(g). The emissions from Vermont were not
found to impact any Class I area. The State also adequately
demonstrated that there are no significant changes in emissions of
SO2, PM2.5, or NOX from contributing
states which have impeded progress in reducing emissions and improving
visibility in Vermont's Class I area, Lye Brook.
    In its Progress Report, VT DEC states that it believes that the
elements and strategies relied on in its original 2009 regional haze
SIP are sufficient to enable Vermont to meet all established RPGs. To
support this conclusion, VT DEC notes that 2013 SO2
emissions from all EGUs in the entire MANE-VU region are already less
than the 2018 projection (315,675 tons vs. 365,024 tons).\12\ In
addition, Vermont discusses visibility data from Tracking Visibility
Progress, 2004-2011, prepared by NESCAUM, which updated the progress at
MANE-VU Class I areas during the five-year period ending in 2014. The
data included information for the Vermont Class I area, between 2000
and 2014, in the context of short- and long-term visibility goals. The
report indicates that visibility impairment on the best and worst days
from 2000 to 2014 has improved at Lye Brook. Vermont notes the NESCAUM
report indicates that all the MANE-VU Class I states continue to be on
track to meet their 2018 RPGs for improved visibility and that further
progress may occur through recently adopted or proposed regulatory
programs. Based upon the NESCAUM report and visibility data, Vermont
states in its Progress Report that visibility improvement at Lye Brook
has occurred for the most impaired days and no degradation of
visibility has occurred for the least impaired days. Therefore, Vermont
finds that Lye Brook is on track to meet the RPGs for 2018 based on
observed visibility improvement.
---------------------------------------------------------------------------

    \12\ Mid-Atlantic Air Management Association (MARAMA) Regional
Emission Trends Analysis for MANE-VU States: Technical Support
Document, Revision 3, March 22, 2013. See the docket for this
rulemaking.
---------------------------------------------------------------------------

    EPA finds that Vermont has adequately addressed the applicable
provisions under 40 CFR 51.308(g). EPA views this requirement as an
assessment that should evaluate emissions and visibility trends and
other readily available information. In its Progress Report, Vermont
described the improving visibility trends using data from the IMPROVE
network and the downward emissions trends in key pollutants in the
State and the MANE-VU region. With a focus on SO2 emissions
from upwind EGUs, Vermont determined that the State's regional

haze SIP is sufficient for the Class I area within the state to meet
its RPGs.
    Vermont's visibility monitoring strategy relies upon participation
in the IMPROVE network. As discussed above, the Mt. Equinox (LYBR1)
IMPROVE monitor near Lye Brook was replaced by a second IMPROVE site
established on Mt. Snow in Dover, Vermont (LYEB1). On the 20% best and
worst days, the two sites were found to have a nearly one-to-one
relationship. VT DEC finds that the Mt. Snow IMPROVE monitor is an
appropriate replacement for the discontinued Mt. Equinox monitor and
that there is no indication of a need for additional monitoring sites
or equipment.
    EPA finds that Vermont has adequately addressed the applicable
provisions under 40 CFR 51.308(g) by reviewing and detailing any
changes to the state's visibility monitoring strategy.

B. Determination of Adequacy of Existing Regional Haze Plan

    In its Progress Report SIP, Vermont submitted a negative
declaration to EPA regarding the need for additional actions or
emission reductions in Vermont beyond those already in place and those
to be implemented by 2018 according to Vermont's regional haze SIP.
    In its Progress Report SIP, Vermont determined that the existing
regional haze SIP requires no further substantive revision at this time
to achieve the RPGs for the Class I area within the state. The basis
for the State's negative declaration is the finding that visibility has
improved at all Class I areas in the MANE-VU region. In addition, even
though Vermont sources were not found to impact visibility in any Class
I area, the SO2 emissions from the state's sources have
decreased. While NOX emissions are still greater than the
level previously projected for 2018, additional substantial
NOX emission reductions are expected from the mobile sector
over the next several years. Finally, Vermont expects the downward
trend in SO2 emissions from EGUs in the other MANE-VU states
to continue through 2018.
    EPA concludes that Vermont has adequately addressed the provisions
under 40 CFR 51.308(h) because the visibility and emission trends
indicate that the Lye Brook Wilderness Area has met its RPGs for 2018.

III. Final Action

    EPA is approving Vermont's regional haze Five-Year Progress Report
SIP revision, submitted by VT DEC on February 29, 2016, as meeting the
applicable regional haze requirements set forth in 40 CFR 51.308(g) and
(h).
    The EPA is publishing this action without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision should
relevant adverse comments be filed. This rule will be effective October
16, 2017 without further notice unless the Agency receives relevant
adverse comments by September 15, 2017.
    If the EPA receives such comments, then EPA will publish a notice
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on the proposed rule. All parties
interested in commenting on the proposed rule should do so at this
time. If no such comments are received, the public is advised that this
rule will be effective on October 16, 2017 and no further action will
be taken on the proposed rule. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 16, 2017. Filing a
petition for reconsideration by

the Administrator of this final rule does not affect the finality of
this action for the purposes of judicial review nor does it extend the
time within which a petition for judicial review may be filed, and
shall not postpone the effectiveness of such rule or action. Parties
with objections to this direct final rule are encouraged to file a
comment in response to the parallel notice of proposed rulemaking for
this action published in the proposed rules section of today's Federal
Register, rather than file an immediate petition for judicial review of
this direct final rule, so that EPA can withdraw this direct final rule
and address the comment in the proposed rulemaking. This action may not
be challenged later in proceedings to enforce its requirements. (See
section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Regional haze, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: July 24, 2017.
Deborah A. Szaro,
Acting Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart UU--Vermont

0
2. In Sec.  52.2370, the table in paragraph (e) is amended by adding
the entry ``Vermont Regional Haze Five-Year Progress Report'' at the
end of the table to read as follows:

Sec.  52.2370   Identification of plan.

* * * * *
    (e) * * *

                                             Vermont Non-Regulatory
----------------------------------------------------------------------------------------------------------------
                                      Applicable        State submittal
   Name of non-regulatory SIP        geographic or      date/ effective    EPA approval date      Explanation
            provision             nonattainment area         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Vermont Regional Haze Five-Year   Statewide.........  Submitted 2/29/     8/16/2017, [insert  ..................
 Progress Report.                                      2016.               Federal Register
                                                                           citation].
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-17247 Filed 8-15-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 148 (Thursday, August 1, 2013)]
[Proposed Rules]
[Pages 46540-46543]
[FR Doc No: 2013-18564]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0667; Directorate Identifier 2013-NM-062-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 747-400 airplanes. This proposed AD
was prompted by reports of fasteners missing on an airplane undergoing
a passenger-to-freighter conversion. This proposed AD would require
doing a general visual inspection of the station 1920 splice clip for
correct fastener installation, and related investigative and corrective
actions if necessary. We are proposing this AD to detect and correct
missing or incorrect fasteners, which can lead to cracking and loss of
load carrying capacity, resulting in a possible decompression event.

DATES: We must receive comments on this proposed AD by September 16,
2013.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
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 Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Bill Ashforth, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:
425-917-6590; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2013-0667;
Directorate Identifier 2013-NM-062-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 because of 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 we
receive about this proposed AD.

Discussion

    We have received a report of an airplane, while undergoing a
passenger-to-freighter conversion, missing fasteners on the station
1920 splice clip. The possibility of this discrepancy exists on
airplanes already delivered. This condition, if not corrected, could
result in cracking and loss of load carrying capacity, resulting in a
possible decompression event.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin 747-53A2844, Revision 1,
dated July 30, 2012. For information on the procedures and compliance
times, see this service information at http://www.regulations.gov by
searching for Docket No. FAA-2013-0667.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between the Proposed AD and the Service
Information.''
    The phrase ``related investigative actions'' might be used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that: (1) Are related to the primary actions, and (2) further
investigate the nature of any condition found. Related investigative
actions in an AD could include, for example, inspections.
    In addition, the phrase ``corrective actions'' might be used in
this proposed AD. ``Corrective actions'' are actions that correct or
address any condition found. Corrective actions in an AD could include,
for example, repairs.

Differences Between the Proposed AD and the Service Information

    Although the service bulletin specifies that operators may contact
the manufacturer for disposition of certain repair conditions, this
proposed AD would require operators to repair those conditions in
accordance with a method approved by the FAA.

Costs of Compliance

    We estimate that this proposed AD affects 3 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on
                 Action                              Labor cost             Parts cost    Cost per       U.S.
                                                                                product     operators
----------------------------------------------------------------------------------------------------------------
Inspection for correct fastener           2 work-hours x $85 per hour =             $0         $170         $510
 installation.                             $170.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs that
would be required based on the results of the proposed inspection. We
have no way of determining the number of aircraft that might need these
repairs:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                    Labor cost                 Parts cost    product
----------------------------------------------------------------------------------------------------------------
Inspections for cracking......................  3 work-hours x $85 per hour = $255....           $0         $255
Fastener installation.........................  2 work-hours x $85 per hour = $170....            0          170
Repair........................................  2 work-hours x $85 per hour = $170....            0          170
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2013-0667; Directorate Identifier
2013-NM-062-AD.

(a) Comments Due Date

    We must receive comments by September 16, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 747-400 series
airplanes, certificated in any category, as identified in Boeing
Alert Service Bulletin 747-53A2844, Revision 1, dated July 30, 2012.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of fasteners missing on an
airplane undergoing a passenger-to-freighter conversion. We are
issuing this AD to detect and correct missing or incorrect
fasteners, which can lead to cracking and loss of load carrying
capacity, resulting in a possible decompression event.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection

    Except as required by paragraph (h)(1) of this AD, at the times
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 747-53A2844, Revision 1, dated July 30, 2012: Do a general
visual inspection for correct installation of the station 1920
splice clip common to the auxiliary sill web and the tie clip, and
do all applicable related investigative and corrective actions in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 747-53A2844, Revision 1, dated July 30, 2012,
except as required by paragraph (h)(2) of this AD. Do all applicable
related investigative and corrective actions before further flight.

(h) Exceptions to the Service Information

    (1) Where Boeing Alert Service Bulletin 747-53A2844, Revision 1,
dated July 30, 2012, specifies a compliance time ``after the
original issue date of the service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) If any cracking is found during any inspection required by
this AD, and Boeing Alert Service Bulletin 747-53A2844, Revision 1,
dated July 30, 2012, specifies contacting Boeing for appropriate
action: Before further flight, repair using a method approved in
accordance with the procedures specified in paragraph (j) of this
AD.

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Boeing Alert Service Bulletin 747-53A2844,
dated September 15, 2011, except the detailed inspection for
cracking of the auxiliary sill outer chord tee and attached parts
and all applicable related investigative and corrective actions must
be done in accordance with Boeing Alert Service Bulletin 747-
53A2844, Revision 1, dated July 30, 2012, at the times specified in
paragraph (g) of this AD. Boeing Alert Service Bulletin 747-53A2844,
dated September 15, 2011, is not incorporated by reference in this
AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(k) Related Information

    (1) For more information about this AD, contact Bill Ashforth,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced
service information at the FAA, Transport Airplane

Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on July 21, 2013.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-18564 Filed 7-31-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47891-47893]
[FR Doc No: 2012-19614]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67603; File No. SR-NYSE-2012-35]

 Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Reducing From 10 Days to Five Days the Shareholder Notification Period
That Is a Condition to a Waiver of the NYSE's Shareholder Approval
Requirements Pursuant to Section 312.05 of the Exchange's Listed
Company Manual

August 6, 2012.
    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 August 6, 2012, the New York Stock Exchange LLC (``NYSE'' or
``Exchange'') 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 the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to reduce from 10 days to five days the
shareholder notification period that is a condition to a waiver of the
NYSE's shareholder approval requirements pursuant to Section 312.05 of
the Exchange's Listed Company Manual (the ``Manual''). The Exchange
also proposes to permit the shareholder notification to be effectuated
by a broadly disseminated press release in addition to a letter to
shareholders, and the date of such press release shall serve as the
commencement date of the shareholder notification period, subject to a
minimum notification period of at least two days from the date of
mailing of the shareholder letter. The text of the proposed rule change
is available on the Exchange's Web site at www.nyse.com, at the
principal office 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, the self-regulatory organization
included

statements concerning the purpose of, and basis for, the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of those statements may be examined at the places
specified in Item IV below. The Exchange has prepared summaries, set
forth in sections A, B, and C below, of the most significant parts of
such statements.

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

1. Purpose
    In connection with an emergency capital raising transaction by
Knight Capital Group, Inc. (``KCG''), the Exchange proposes to reduce
from 10 days to five days the shareholder notification period that is a
condition to a waiver of the NYSE's shareholder approval requirements
pursuant to Section 312.05 of the Manual. The Exchange also proposes to
permit the shareholder notification to be effectuated by a broadly
disseminated press release in addition to a letter to shareholders, and
the date of such press release shall serve as the commencement date of
the shareholder notification period, subject to a minimum notification
period of at least two days from the date of mailing of the shareholder
letter. The Exchange does not intend to amend the text of Section
312.05.
    Section 312.03(c) of the Manual requires a listed company to obtain
shareholder approval prior to the issuance of shares of common stock
representing 20% or more of the voting power or number of shares
outstanding of the company's then outstanding common stock or the
issuance of securities convertible into, exchangeable for or
exercisable for 20% or more of the voting power or number of shares
outstanding of the company's then outstanding shares of common
stock.\3\
---------------------------------------------------------------------------

    \3\ There are exceptions to the shareholder approval
requirements of Section 312.03(c) for public offerings for cash and
for a transaction that qualifies as a ``Bona Fide Private
Financing'' as defined in Section 312.04(g).
---------------------------------------------------------------------------

    Subject to approval by the Exchange of an application made by the
company, Section 312.05 provides an exception to the shareholder
approval requirements of Section 312.03 when (1) the delay in securing
shareholder approval would seriously jeopardize the financial viability
of the enterprise and (2) reliance by the company on that exception is
expressly approved by the audit committee of the listed company's board
of directors (the ``financial distress exception''). A company relying
on this exception must mail to all shareholders not later than 10 days
before issuance of the securities a letter alerting them to its
omission to seek the shareholder approval that would otherwise be
required under the policy of the Exchange and indicating that the audit
committee of the board has expressly approved the exception.
    KCG has made an application to the Exchange for a waiver of the
Exchange's shareholder approval requirements pursuant to Section 312.05
in relation to a proposed emergency capital raise. KCG has obtained the
approval of its audit committee as required by Section 312.05. After
extensive discussion with KCG, the Exchange has concluded that KCG's
use of the financial viability exception is warranted and has approved
KCG's application. However, KCG has informed the Exchange that it does
not believe that it will be able to obtain the necessary funding on an
immediate basis unless the investors are able to convert the securities
they purchase into common stock more quickly than would be possible if
the Exchange required the full 10 days notice to shareholders provided
for in Section 312.05 of the Manual.
    KCG has informed the Exchange that there is grave doubt as to its
ability to continue its operations in the immediate future if it is
unable to obtain significant funding immediately. Given the company's
belief that it will be unable to raise this capital if it is unable to
issue common stock to its potential investors until the end of the full
10-day notification period required under Section 312.05 of the Manual,
KCG has informed the Exchange that it will likely be unable to continue
its operations with immediate effect unless the Exchange shortens that
notification period.
    Accordingly, the Exchange proposes to reduce from 10 to five days
the shareholder notification requirement of Section 312.05 in relation
to KCG's financial distress application. In addition, the Exchange
proposes to permit the shareholder notification to be effectuated
through KCG's issuance of a broadly disseminated press release, in
addition to a shareholder letter, disclosing the information required
by Section 312.05 of the Manual as well as that it obtained additional
exemptive relief to reduce the shareholder notification requirement
from 10 to five days, and the date of such press release shall serve as
the commencement date of the shareholder notification period, subject
to a minimum notification period of at least two days from the date of
mailing of the shareholder letter. The press release must also disclose
the earliest date at which the convertible securities will be converted
or become convertible into common stock.\4\
---------------------------------------------------------------------------

    \4\ KCG has advised that it will also send a letter to
shareholders contemporaneously with or shortly after issuance of the
press release, but in any event at least two days prior to
conversion by the investors of the securities they purchase into
common stock.
---------------------------------------------------------------------------

    The Exchange believes that this relief is appropriate in light of
the uniqueness of the circumstances giving rise to KCG's urgent need
for capital. In particular, KCG operates a broker-dealer with
significant operations and there could be some disruption to KCG's
customers should KCG's operations cease abruptly. Moreover, KCG has
advised that if the notice period is not shortened it will not be able
to raise the capital needed to continue operations in the immediate
future. With respect to the use of a press release in addition to a
shareholder letter, the Exchange believes that the extremely high
volume of trading in KCG' stock during the last few days has likely
resulted in significant changes to its shareholder base and that a
press release is therefore an effective means of communication with
such shareholders. In addition, the Exchange believes that the
reduction in the notification period is in the best interests of KCG's
existing shareholders, since KCG will otherwise likely be unable to
raise necessary capital to avoid insolvency, and likely significant
erosion or elimination of shareholder value, absent such reduction.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \5\ of the Securities Exchange Act of 1934 (the
``Act''), in general, and furthers the objectives of Section 6(b)(5) of
the Act,\6\ in particular in that it is designed to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. The Exchange believes that
the proposed amendment is consistent with the investor protection
objectives of Section 6(b)(5) of the Act in that KCG will likely become
insolvent if the Exchange does not reduce the required notification
period and the existing shareholders of KCG therefore have a compelling

interest in the company's ability to raise capital as quickly as
possible. The Exchange also believes that use of a broadly disseminated
press release is an effective means of communication with KCG's
shareholders, in view of the extremely high trading volume in its stock
during the last few days. The Exchange also notes that shareholders
would still have a reasonable period of at least five days notice of
the issuance, including at least a two day notice period after mailing
of the shareholder letter. The Exchange also believes that the proposed
waiver would facilitate transactions in securities, as there could be
disruption to KCG's customers if KCG ceased operations abruptly.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\ Because
the Exchange states that the foregoing proposed rule change: (1) Does
not significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). The Exchange has requested that the
Commission waive the requirement that the Exchange provide the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date on which the
Exchange filed the proposed rule change pursuant to Rule 19b-
4(f)(6)(iii). The Commission hereby grants this request.
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange requested that the Commission waive
the 30-day operative delay so that the proposed rule change may take
effect upon filing with the Commission pursuant to Section 19(b)(3)(A)
\11\ and Rule 19b-4(f)(6) \12\ thereunder, and also become operative on
that same date. The Commission believes that waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest.\13\ The Exchange has represented, among other things,
that (i) the waiver would allow KCG to obtain on an immediate basis the
capital it needs to enable it to continue operations and avoid
insolvency; (ii) KCG's existing shareholders, whom this notification is
designed to inform, have a compelling interest in KCG's ability to
raise capital as quickly as possible; and (iii) under these
circumstances, by issuing a broadly disseminated press release, in
addition to mailing a shareholder letter, KCG will provide effective
notice of the issuance to its shareholders and its shareholders will
still have a reasonable notice period of the issuance of at least five
days. The Commission hereby waives the 30-day operative delay and
designates the proposal operative upon filing.\14\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \14\ In connection with this release, the Commission is not
making any findings as to the accuracy of the representations made
by the Exchange or expressing any view regarding the merits of any
transaction, or its terms, entered into by KCG.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2012-35 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2012-35. This file
number should be included on the subject line if email 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 Web site viewing and
printing 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 the 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-NYSE-2012-35 and should be
submitted on or before August 31, 2012.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-19614 Filed 8-9-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Notices]
[Pages 58849-58851]
[FR Doc No: 2012-23454]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0967]

Prescription Drug User Fee Act Patient-Focused Drug Development;
Public Meeting and Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment related to FDA's patient-
focused drug development initiative. This initiative is being conducted
to fulfill FDA performance commitments made as part of the fifth
authorization of the Prescription Drug User Fee Act (PDUFA V). This
effort provides for a more systematic approach under PDUFA V for
obtaining patient perspective on the disease severity and the currently
available treatments for a set of disease areas. FDA is publishing a
preliminary list of nominated disease areas for the patient-focused
drug development initiative and the criteria used for nomination. The
public is invited to comment on this preliminary list through a public
docket and at a public meeting where FDA will provide an overview of
the patient-focused drug development initiative with discussion of the
nominated disease areas.

DATES: Submit either electronic or written comments by November 1,
2012. The public meeting will be held on October 25, 2012, from 9 a.m.
to 12:30 p.m. Registration to attend the meeting must be received by
October 18, 2012. See the SUPPLEMENTARY INFORMATION

section for information on how to register for the meeting.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993-0002. 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.
    Submit electronic comments to www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Andrea Tan, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1168, Silver
Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>or

Robert Yetter, Center for Biologics Evaluation and Research (HFM-25),
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-
0373.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act of 2012 (FDASIA). Title I of
FDASIA reauthorizes the Prescription Drug User Fee Act (PDUFA) that
provides FDA with the necessary user fee resources to maintain an
efficient review process for human drug and biologic products. The
reauthorization of PDUFA includes performance goals and procedures that
represent FDA's commitments during fiscal years (FY) 2013-2017. These
commitments are referred to in section 101 of FDASIA and are available
on the FDA Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    Section X of these commitments relates to enhancing benefit-risk
assessment in regulatory decisionmaking. A key part of regulatory
decisionmaking is establishing the context in which the particular
decision is made. In drug regulation, this context includes a thorough
understanding of the severity of the treated condition and the adequacy
of the existing treatment options. Patients who live with a disease
have a direct stake in the outcome of the review process and are in a
unique position to contribute to weighing benefit-risk considerations
that can occur throughout the medical product development process.
Though several programs exist to facilitate patient representation,
there are currently few venues in which the patient perspective is
discussed outside of a specific product's marketing application review.
The human drug and biologic review process could benefit from a more
systematic and expansive approach to obtaining input from patients who
experience a particular disease or condition.
    FDA is committed to obtaining input from patients and, as set out
in the commitment letter, will conduct public meetings to consider 20
different disease areas over the 5-year authorization of the program.
For each disease area, FDA will conduct a public meeting to discuss
such topics as the impact of the disease on patients, the spectrum of
severity for those who have the disease, the measures of benefit that
matter most to patients, and the adequacy of the existing treatment
options for patients. These meetings will include participation of FDA
review divisions, the relevant patient advocacy community, and other
interested stakeholders. FDA seeks public comment on the set of disease
areas that will be discussed at these meetings throughout PDUFA V. A
preliminary list of possible disease areas and the criteria used to
identify these disease areas are published in this notice for public
comment.
    FDA recognizes that there is significant interest in patient-
focused drug development within the patient community. To ensure that
patient stakeholders have an opportunity to contribute as this
initiative moves forward in PDUFA V, FDA also is convening an
additional series of patient consultation meetings with patient
stakeholders to discuss key process questions for patient-focused drug
development. These consultation meetings will be separate from the
disease-specific meetings that are part of FDA's commitments in PDUFA
V. FDA has published a separate notice elsewhere in this issue of the
Federal Register requesting that patient stakeholders notify FDA if
they intend to participate in the patient consultation meetings.

II. Disease Area Nomination

    FDA is nominating the following disease areas as potential
candidates for the focus of one of the 20 future public meetings and
invites public comment on this preliminary list. In your comments,
please identify the disease areas that you consider to be of greatest
priority and explain the rationale for your recommendation.
     Pulmonary arterial hypertension.
     Heart failure.
     Primary glomerular diseases.
     Narcolepsy.
     Huntington's Disease.
     Depression.
     Autism.
     Peripheral neuropathy.
     Fibromyalgia.
     Obesity.
     Nocturia.
     Chronic fatigue syndrome.
     Irritable bowel syndrome.
     Inflammatory bowel disease.
     Alopecia areata.
     Diabetic ulcers.
     Female sexual dysfunction.
     Interstitial cystitis/painful bladder syndrome.
     Fracture healing.
     Diabetic foot infections.
     Hepatitis C.
     HIV.
     Patients who have experienced an organ transplant.
     Sickle cell disease.
     Chronic graft versus host disease.
     Amyloidosis.
     Aplastic anemia.
     Melanoma.
     Lung cancer.
     Cancer and young patients.
     Cancer treatment in pregnancy.
     Cancer and sexual dysfunction.
     Cancer and depression.
     Clotting disorders (e.g., hemophilia A (factor VIII
deficiency) and von Willebrand disease).
     Thrombotic disorders (e.g., antithrombin deficiency and
protein C deficiency).
     Primary humoral immune deficiencies (e.g., common variable
immune deficiency).
     Neurologic disorders treated with immune globulins (e.g.,
chronic inflammatory demyelinating polyneuropathy).
     Hereditary angioedema.
     Alpha-1 antitrypsin deficiency.
    FDA is also interested in public comment on disease areas that are
not represented on this preliminary list. The Agency used several
criteria to develop the preliminary list of potential disease areas.
FDA requests that when proposing additional disease areas for
consideration, please describe how you

applied the identified criteria in making recommendations for
additional disease areas to consider.
    FDA also welcomes public comment on the criteria for disease area
selection. These criteria include the following:
     Disease areas that are chronic, symptomatic, or affect
functioning and activities of daily living;
     Disease areas that reflect a range of severity;
     Disease areas for which aspects of the disease are not
formally captured in clinical trials;
     Disease areas that have a severe impact on identifiable
subpopulations (such as children or the elderly);
     Disease areas that represent a broad range in terms of
size of the affected population; or
     Disease areas for which there are currently no therapies
or very few therapies, or the available therapies do not directly
affect how a patient feels, functions, or survives.
    FDA will consider the public comments received at the public
meeting and through the docket and post the set of disease areas for FY
2013-2015 on the FDA Web site. By the end of FY 2015, FDA will initiate
a public process for determining the list of disease areas for FY 2016-
2017.

III. Public Meeting

    FDA is holding a public meeting that will begin FDA's patient-
focused drug development initiative in PDUFA V. The purpose of this
meeting will be to obtain public comment on the preliminary list of
potential disease areas and the criteria used to develop the list. In
addition, recognizing that there are many more disease areas than can
be addressed in the 20 planned FDA meetings for PDUFA V, FDA will also
discuss strategies that have already been pursued by patient and other
public stakeholder collaborations outside of FDA to address the types
of questions being considered under the PDUFA patient-focused drug
development effort, to review lessons learned and identify a roadmap
that could be used by patient-focused private collaborations going
forward.
    If you wish to attend this meeting, please register by email to
<EMAIL_ADDRESS>by October 18, 2012. Your email should
contain complete contact information, including name, title,
affiliation, address, email address, and phone number. Seating will be
limited, so early registration is recommended. Registration is free and
will be on a first-come, first-served basis. However, FDA may limit the
number of participants from each organization based on space
limitations. Registrants will receive confirmation once they have been
accepted. Onsite registration on the day of the meeting will be based
on space availability. If you need special accommodations because of
disability, please contact Andrea Tan (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the meeting.

    Dated: September 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23454 Filed 9-21-12; 8:45 am]
BILLING CODE 4160-01-P