[Federal Register: March 22, 2006 (Volume 71, Number 55)]
[Rules and Regulations]
[Page 14399-14406]
[DOCID:fr22mr06-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R10-OAR-2006-0010; FRL-8041-9]

Approval and Promulgation of Air Quality Implementation Plans;
Lakeview PM10 Maintenance Plan and Redesignation Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve a PM10
State Implementation Plan (SIP) maintenance plan revision for the
Lakeview, Oregon nonattainment area and to redesignate the area from
nonattattainment to attainment for PM10. PM10 air
pollution is suspended particulate matter with a nominal diameter less
than or equal to a nominal ten micrometers. EPA is approving the SIP
revision and redesignation request because the State adequately
demonstrates that the control measures being implemented in the
Lakeview area result in maintenance of the PM10 National
Ambient Air Quality Standards and all other requirements of the Clean
Air Act for redesignation to attainment are met.

DATES: This direct final rule will be effective May 22, 2006, without
further notice, unless EPA receives adverse comments by April 21, 2006.
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-R10-
OAR-2006-0010, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Donna Deneen, Office of Air, Waste and Toxics, AWT-
107, EPA, Region 10, 1200 Sixth Ave., Seattle, Washington 98101.
     Hand Delivery: EPA, Region 10 Mail Room, 9th Floor, 1200
Sixth Ave., Seattle, Washington 98101. Attention: Donna Deneen, Office
of Air, Waste and Toxics, AWT-107. Such deliveries are only accepted
during normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2006-0010. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov The http://www.regulations.gov. Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, such as CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov
 or in hard copy at EPA Region 10, Office of Air,

Waste and Toxics, 1200 Sixth Avenue, Seattle, Washington. EPA requests
that, if possible, you contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection.

FOR FURTHER INFORMATION CONTACT: Donna Deneen at telephone number:
(206) 553-6706, e-mail address<EMAIL_ADDRESS>fax number: (206)
553-0110, or the above EPA, Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'',
``us'' or ``our'' are used, we mean EPA.

Table of Contents

I. General Overview
    A. What Action Are We Taking?
    B. What Is the Background for This Action?
    1. Description of the Area
    2. Nonattainment History of the Lakeview Area
    3. Description of the Air Quality Problem
II. Review of Maintenance Plan
    A. What Criteria Did EPA Use To Review the Maintenance Plan?
    1. Attainment Emissions Inventory (and Future Year Inventory)
    2. Maintenance Demonstration
    3. Monitoring Network
    4. Verification of Continued Attainment
    5. Contingency Plan
    B. What Do We Conclude About the Maintenance Plan?
III. Review of Redesignation Request
    A. What Criteria Did EPA Use To Review the Request for
Redesignation?
    1. Attainment of the NAAQS
    2. SIP Nonattainment Area Plan Approval Under Section 110(k)
    3. Permanent and Enforceable Improvements in Air Quality
    4. Section 110 and Part D Requirements
    a. Section 110 Requirements
    b. Part D Requirements
    i. Section 172(c) Plan Provisions
    ii. Subpart 4 Requirements
    5. Transportation Conformity
    6. Maintenance Plans
    B. What Do We Conclude About the Request for Redesignation?
IV. Statutory and Executive Order Reviews

I. General Overview

A. What Action Are We Taking?

    We are taking direct final action to approve the SIP revision and
redesignation request submitted by the State of Oregon Department of
Environmental Quality (DEQ or State) on October 25, 2005, for the
Lakeview, Oregon PM10 nonattainment area (Lakeview
nonattainment area). We are approving the State's SIP revision and
request for redesignation because the State adequately demonstrates
that the control measures being implemented in the Lakeview area result
in maintenance of the PM10 National Ambient Air Quality
Standards (NAAQS) and all other requirements of the Clean Air Act (the
Act) for redesignation to attainment are met. See the Technical Support
Document (TSD) accompanying this notice for further supporting
documentation.

B. What Is the Background for This Action?

1. Description of the Area
    Lakeview is located in southern Oregon about 96 miles east of
Klamath Falls at an elevation of about 4800 feet. The area is typified
by semi-arid climate where annual rainfall is 13 inches. The Lakeview
Urban Growth Boundary (UGB), which defines the nonattainment area
boundaries, had an estimated population of 3,656 in 2000. The
population is projected to grow to just over 4,500 by 2025.
    Lakeview can experience very strong nighttime inversions that break
up with daytime solar heating. In the wintertime, arctic air masses
frequently move over the Goose Lake Basin. Temperatures can remain well
below freezing for several weeks at a time. Winter nights are commonly
clear and cool in the basin.
2. Nonattainment History of the Lakeview Area
    On July 1, 1987 (52 FR 24634), the Environmental Protection Agency
(EPA) revised the National Ambient Air Quality Standards (NAAQS) for
particulate matter with a new indicator that includes only those
particles with an aerodynamic diameter less than or equal to a nominal
10 micrometers (PM10). See 40 CFR 50.6. The 24-hour primary
PM10 standard is 150 micrograms per cubic meter ([mu]g/
m\3\), with no more than one expected exceedance per year over a three
year period. The annual primary PM10

standard is 50 [mu]g/m\3\ expected annual arithmetic mean over a three
year period. The secondary PM10 standards are identical to
the primary standards.
    By operation of law upon enactment of the 1990 Clean Air Act
Amendments, Lakeview, Oregon was designated ``unclassifiable'' for
PM10 due to a lack of air quality monitoring data (see Clean
Air Act section 107(d)(4)(B)(iii)). The State of Oregon subsequently
conducted monitoring in the Lakeview area to verify PM10
concentrations and determine if its designation status should be
revised.
    Based on monitoring data showing violation of the PM10
standard, on December 29, 1992, the Governor of Oregon requested that
Lakeview be redesignated to nonattainment for PM10.
Additionally, Oregon requested that the nonattainment area be defined
as the Lakeview Urban Growth Boundary. EPA approved these requests and
redesignated Lakeview as nonattainment for PM10 and
classified it as moderate effective December 25, 1993 (58 FR 49931).
    The State developed a nonattainment area SIP revision designed to
bring about attainment of the PM10 NAAQS. Oregon's Clean Air
Act Part D initial PM10 plan (nonattainment area plan) for
the Lakeview PM10 nonattainment area was submitted on June
1, 1995. EPA approved the Lakeview PM10 nonattainment area
plan on September 21, 1999. 64 FR 51051.
    In order for the Lakeview nonattainment area to be redesignated to
attainment for PM10, a 10-year maintenance plan and
redesignation request is required for the area. A SIP revision
containing these elements was submitted to EPA on October 25, 2005. We
are approving both these elements in this action.
3. Description of the Air Quality Problem
    The Lakeview area violated the Federal 24-hour PM10
standard of 150 [mu]g/m\3\ on multiple dates in 1991, 1992, 1993, and
1994. The highest 24-hour average PM10 concentration of 256
[mu]g/m\3\ was recorded on January 27, 1993. The last 24-hour
exceedance of 184 [mu]g/m\3\ was recorded on January 19, 1994.
    Higher levels of PM10 are typically a wintertime problem
in Lakeview due to temperature inversions that trap particulate matter
emissions in the area. Wintertime emissions sources include area
sources (wood stoves/fireplace emissions and fugitive dust) and
industrial sources.
    There have been no PM10 exceedances in Lakeview since
1994. Based on data measured after 1994, the Lakeview area attained the
24-hour PM10 NAAQS by the Clean Air Act deadline of December
31, 1999.
    The area has never exceeded the annual NAAQS of 50 [mu]g/m\3\. The
highest annual average PM10 concentration for Lakeview was
31.7 [mu]g/m\3\ in 1992. The area meets the annual PM10
NAAQS.

II. Review of Maintenance Plan

A. What Criteria Did EPA Use To Review the Maintenance Plan?

    Section 107(d)(3)(E) of the Act stipulates that for an area to be
redesignated to attainment, EPA must fully approve a maintenance plan
which meets the requirements of Section 175A. Section 175A defines the
general framework of a maintenance plan, which must provide for
maintenance (i.e., continued attainment) of the relevant NAAQS in the
area for at least ten years after redesignation. The following is a
list of core provisions required in an approvable maintenance plan.
    1. The State must develop an attainment emissions inventory to
identify the level of emissions in the area which is sufficient to
attain the NAAQS.
    2. The State must demonstrate maintenance of the NAAQS.
    3. The State must verify continued attainment through operation of
an appropriate air quality monitoring network.
    4. The maintenance plan must include contingency provisions to
promptly correct any violation of the NAAQS that occurs after
redesignation of the area.
    As explained below, the PM10 maintenance plan for the
Lakeview nonattainment area complies with each of these requirements.
1. Attainment Emissions Inventory (and Future Year Inventory)
    The State submitted a PM10 attainment emissions
inventory for 2001, a year in which no PM10 exceedances
occurred and one of the five years used to determine the area's
PM10 design value for the maintenance plan. Based on the
2001 worst case day emissions inventory, area sources (mainly wood
stoves/fireplace emissions and fugitive dust) account for 59 percent of
the emissions. The rest are attributed to industrial sources, onroad
sources, nonroad sources and natural sources. These account for 28
percent, 11 percent, 1 percent, and 1 percent, respectively. Annually,
area sources accounted for 40 percent of the emissions, with
industrial, onroad, nonroad, and natural sources accounting for 30
percent, 21 percent, 8 percent, and 1 percent, respectively.
    The state also submitted a 2017 emissions inventory to correspond
with the end of the 10 year period covered by the Lakeview maintenance
plan. The total emissions projected for 2017 are about 12 percent
higher than those of the 2001 attainment inventory on a worst case day
and 31 percent higher annually. The increase is primarily due to the
use of allowable emissions from the existing point sources, and not
primarily due to a projected increase in actual emissions. The
projected growth in population, households, and industrial employment
is expected to be about 1 percent per year and vehicle miles traveled
(VMT) are projected to increase at 1.7 percent per year. In addition to
the VMT projection of 1.7 percent per year, an additional ten percent
was added to VMT to address future unanticipated transportation
projects.
    Based on review of the emissions inventories, EPA concludes that
the methods used to develop the emissions inventories are consistent
with EPA guidelines. The assumptions and calculations were checked and
found to be thorough and comprehensive. In sum, the State has
adequately developed an attainment emissions inventory for 2001 that
identifies the levels of emissions of PM10 in the area that
is sufficient to attain the NAAQS. Further, the State has adequately
developed a future year (2017) inventory for use in demonstrating
maintenance with the NAAQS at least ten years after redesignation.
2. Maintenance Demonstration
    A State may generally demonstrate maintenance of the NAAQS by
either showing that future emissions of a pollutant or its precursors
will not exceed the level of the attainment inventory, or by modeling
to show that the future mix of sources and emission rates will not
cause a violation of the NAAQS. Under the Act, PM10 areas
are required to submit modeled attainment demonstrations to show that
proposed reductions in emissions will be sufficient to attain the
applicable NAAQS. For these areas, the maintenance demonstration should
be based upon the same level of modeling. The demonstration should be
for a period of 10 years following the redesignation.
    EPA approved the use of proportional roll-back with receptor
analysis for the Lakeview attainment demonstration. 64 FR 51051
(September 21, 1999). The proportional rollback approach assumes

that future air quality levels are directly proportional to increases
or decreases in total emissions for the area. Receptor analysis
(chemical mass balance (CMB) in this case) determines the amount and
kind of emission reductions that are required to attain the NAAQS.
Using this combined approach, DEQ concluded that a significant
reduction in woodsmoke would bring the total 24-hour PM10
concentration below the NAAQS. The State subsequently implemented
control measures to reduce woodsmoke, and soon after, the area's
PM10 levels dropped. As of December 31, 1997 (which was
prior to the area's Clean Air Act deadline), air quality data showed
the Lakeview area attained the PM10 NAAQS.
    To demonstrate the area will continue to maintain the
PM10 NAAQS, DEQ relied on the same level of modeling as was
used for the attainment demonstration. DEQ used actual 24-hour
emissions for 2001, the area's 2001 design value, and the projected 24-
hour emissions for the maintenance year of 2017 to estimate 24-hour
PM10 levels in 2017. To predict worst case 2017 annual
PM10 concentrations, DEQ used the increase in emissions from
2001(actual emissions) to 2017 (projected emissions). Based on these
assumptions, DEQ's modeling results show the estimated 24-hour
PM10 concentration for Lakeview on a worst case day in 2017
is 122 [mu]g/m\3\. The estimated annual concentration for Lakeview in
2017 is 26 [mu]g/m\3\.
    In sum, the modeling results show that the Lakeview area will meet
both the 24-hour and annual PM10 NAAQS at least until 2017.
We therefore conclude that the State meets the requirements under
section 175A of the Act to demonstrate maintenance of the NAAQS for
PM10.
3. Monitoring Network
    DEQ has operated an ambient air quality monitoring network for
PM10 in Oregon since the mid 1980s. The State network
includes one monitoring site in Lakeview and utilizes EPA reference or
equivalent method monitors and routine precision and accuracy checks of
the monitoring equipment and makes necessary maintenance performed when
warranted. EPA routinely reviews the State monitoring program and it
meets Federal requirements.
4. Verification of Continued Attainment
    Once an area has been redesignated, the State must continue to
operate an appropriate air quality monitoring network, in accordance
with 40 CFR Part 58, to verify the attainment status of the area. The
maintenance plan should contain provisions for continued operation of
air quality monitors that will provide such verification. The Lakeview
maintenance plan provides for continued ambient monitoring in the area.
5. Contingency Plan
    Section 175A of the Act also requires that a maintenance plan
include contingency provisions, as necessary, to correct promptly any
violation of the NAAQS that occurs after redesignation. These
contingency measures are distinguished from those generally required
for nonattainment areas under Section 172(c)(9). For the purposes of
section 175A, a State is not required to have fully adopted contingency
measures that will take effect without further action by the State in
order for the maintenance plan to be approved. At a minimum, a
contingency plan must require that the State will implement all
measures contained in the Part D nonattainment plan for the area prior
to redesignation.
    Under the maintenance plan, the State will continue to implement
the measures contained in its Part D nonattainment plan. The measures
carried over address the following sources: residential woodstoves,
outdoor burning activities, winter road sanding, forest burning, an
existing industrial source, and fugitive dust. With regard to new
industrial sources, once Lakeview is redesignated to attainment and
becomes a maintenance area, the PSD and maintenance NSR programs apply
instead of the nonattainment NSR program. This means that Best
Achievable Control Technology (BACT) will apply instead of Lowest
Achievable Emission Rate (LAER) technology and the requirement to
demonstrate compliance with a growth allowance cap (a provision
specific to Oregon that is not required by PSD) and PSD increment will
apply instead of the requirement to obtain offsets. By having
maintenance NSR requirements in addition to PSD requirements, the
Lakeview PM10 maintenance plan goes beyond what is required
by the Clean Air Act.
    In addition to continuing to implement the measures contained in
the Part D nonattainment area plan, the State provides for additional
contingency measures under a ``phased'' approach. Phase One is
triggered if PM10 concentrations equal or exceed 93 percent
(140 [mu]g/m\3\) of the 24-hour or 90 percent (45 [mu]g/m\3\) of the
annual NAAQS. If Phase One is triggered, the air quality committee and
DEQ will evaluate the cause of the exceedance and recommend strategies
to be considered for implementation. Within six months of the trigger,
the committee will evaluate the cause of the near exceedance and if
necessary, identify and recommend an action plan with a schedule for
implementation of additional strategies as necessary to prevent an
exceedance or violation of the PM10 standards. The schedule
will include automatic implementation of more stringent requirements
should Phase Two need to be implemented.
    Phase Two is triggered if a violation of the PM10
standard occurs and is validated by DEQ. If Phase Two is triggered,
reinstatement of nonattainment Part D New Source Review requirements
for major sources of PM10 will automatically be implemented.
In addition, strategies developed under Phase One, or re-evaluated
under Phase Two, will be implemented on a schedule in an action plan,
with all actions permanent and enforceable. The contingencies
strategies to be considered include alternative heating systems,
industrial strategies, a mandatory woodstove curtailment program,
forest slash burning strategies, an uncertified woodstove ordinance,
and outdoor burning restrictions.
    In carrying over all the control and contingency measures from the
moderate area plan and providing for additional contingency measures
under its phased approach, the Lakeview maintenance plan meets the
contingency plan requirements under Section 175A of the Act.

B. What Do We Conclude About the Maintenance Plan?

    Based on our review of the Lakeview PM10 maintenance
plan and for the reasons discussed above, we conclude that the
requirements for an approvable maintenance plan under the Act have been
met. Therefore, we are approving the maintenance plan for
PM10 submitted for the Lakeview nonattainment area.

III. Review of Redesignation Request

A. What Criteria Did EPA Use To Review the Request for Redesignation?

    The criteria used to review the redesignation request are derived
from the Act, the General Preamble, and a policy and guidance
memorandum from John Calcagni, dated September 4, 1992, entitled
Procedures for Processing Requests to Redesignate Areas to Attainment.
Section 107(d)(3)(E) of the Act states that the EPA can redesignate an
area to attainment if the following conditions are met:

    1. The Administrator has determined the area has attained the
NAAQS.
    2. The Administrator has fully approved the applicable
implementation plan under Section 110(k).
    3. The Administrator has determined that the improvement in air
quality is due to permanent and enforceable reductions in emissions.
    4. The State has met all applicable requirements for the area under
Section 110 and Part D.
    5. The Administrator has fully approved a maintenance plan,
including a contingency plan, for the area under Section 175A.
1. Attainment of the NAAQS
    According to the Calcagni memorandum, the demonstration that the
area has attained the PM10 NAAQS involves submitting ambient
air quality data from an ambient air monitoring network representing
peak PM10 concentrations. The data also should be recorded
in the EPA's Air Quality System (AQS) database. The 24-hour
PM10 NAAQS is 150 [mu]g/m\3\. An area has attained the 24-
hour standard when the average number of expected exceedances per year
is less than or equal to one, when averaged over a three year period.
40 CFR 50.6. To make this determination, three consecutive years of
complete ambient air quality monitoring data must be collected in
accordance with federal requirements (40 CFR Part 58, including
appendices).
    Oregon's redesignation request for the Lakeview PM10
nonattainment area is based on valid ambient air quality data for 1991
through 2003. These data were collected and analyzed according to 40
CFR 50.6 and 40 CFR Part 50, Appendix J and stored in EPA's Air Quality
System (AQS). These data meet minimum quality assurance requirements
and have been certified by the State as being valid.
    EPA reviewed the 1991-2004 PM10 data reported to EPA's
Air Quality System (AQS) for the Lakeview nonattainment area. There
have been no exceedences of the 24-hour PM10 standard since
1994, and the area has attained the standard (the average number of
expected exceedances averaged over a three year period has been less
than or equal to one) since the three year period ending on December
31, 1997.
    The annual PM10 NAAQS is 50 [mu]g/m\3\. To determine
attainment, the expected annual mean PM10 concentration,
which is the average of the weighted annual mean for three consecutive
years, is compared to the annual standard. The weighted annual mean for
each year, 1991 through 2004 for Lakeview, is below 50 [mu]g/m\3\
Because these values are below the 50 [mu]g/m\3\ standard, the
nonattainment area is in attainment with the annual PM10
NAAQS.
    The Lakeview nonattainment area in Oregon attained the 24-hour and
annual PM10 NAAQS as of December 31, 1999, as required by
the Clean Air Act. The area continues to be in attainment with both the
24-hour and annual PM10 NAAQS.
2. SIP Nonattainment Area Plan Approval Under Section 110(k)
    In order for an area to qualify for redesignation, the SIP for the
area must be fully approved under section 110(k) of the Act.
    Oregon's Clean Air Act Part D initial PM10 plan for the
Lakeview PM10 nonattainment area was submitted on June 1,
1995. EPA approved the Lakeview PM10 nonattainment area plan
on September 21, 1999. 64 FR 51051. Thus, the area has a fully approved
nonattainment area SIP.
3. Permanent and Enforceable Improvement in Air Quality
    The State must be able to reasonably attribute the improvement in
air quality to permanent and enforceable emissions reductions. In
making this showing, the State must demonstrate that air quality
improvements are the result of actual enforceable emissions reductions.
This showing should consider emission rates, production capacities, and
other related information. The analysis should assume that sources are
operating at permitted levels (or historic peak levels) unless evidence
is presented that such an assumption is unrealistic.
    Improvements in air quality in the Lakeview nonattainment area are
reasonably attributed to permanent and enforceable emissions
reductions. A significant drop in peak PM10 concentrations
occurred in the 1994-1995 timeframe, coinciding with implementation of
the area's voluntary woodstove curtailment program and a mandatory
woodstove change-out program. In addition to the voluntary woodstove
curtailment program and the mandatory woodstove change-out program,
Lakeview's permanent and enforceable control measures include a
mandatory woodstove certification program requiring all new woodstoves
sold in the State to be laboratory tested for emissions and efficiency
prior to sale. In addition, DEQ relied on its major new source review
program as a growth management strategy for industry.
    The State also has demonstrated that the improvement in air quality
was not due to either economic or meteorological conditions. Lakeview
has had a relatively steady population and unemployment rate since the
early 1990s through 2003. The area's PM10 reductions do not
appear to be the result of an economic recession.
    With regard to meteorology, DEQ compared the stagnation conditions
during the 1991-92 through 1993-94 exceedance period to meteorological
conditions in more recent years. In the past thirteen-year period
(1991-92 to 2003-04) the most stagnant PM10 season was the
1991-92 season when PM10 levels were high. The least
stagnant PM10 season was in 2002-03 when the PM10
concentrations were low. DEQ concluded that although it appears that
PM10 concentrations seem to follow weather patterns and
weather patterns show less poor ventilation recently, PM10
concentrations have declined at a greater rate than ventilation has
improved. We agree with DEQ's analysis and that it is reasonable to
conclude that the steady decrease in PM10 concentrations
from the early 1990s to the early 2000s is due to permanent and
enforceable control measures and not to a change in economic or
meteorological conditions.
4. Section 110 and Part D Requirements
    Before EPA may approve a redesignation request, the applicable
programs under section 110 and Part D that were due prior to the
submission of a redesignation request must be adopted by the State and
approved by EPA into the SIP.
a. Section 110 Requirements
    Section 110(a)(2) of the Act contains general requirements for
nonattainment area plans. These requirements include, but are not
limited to, submission of a SIP that has been adopted by the State
after reasonable notice and public hearing; provisions for
establishment and operation of appropriate apparatus, methods, systems
and procedures necessary to monitor ambient air quality; implementation
of a permit program; provisions for Part C--Prevention of Significant
Deterioration (PSD) and Part D--New Source Review (NSR) permit
programs; criteria for stationary source emission control measures,
monitoring, and reporting, provisions for modeling; and provisions for
public and local agency participation.
    The Administrator has fully approved the applicable implementation
plan under Section 110(k). In 40 CFR 52.1972, EPA has approved Oregon's
SIP for the attainment and maintenance of the national standards under
Section

110. We also fully-approved Oregon's nonattainment NSR program, most
recently on January 22, 2003. 68 FR 29530. In addition, Oregon has a
fully approved Prevention of Significant Deterioration (PSD) program,
also approved on January 22, 2003. 68 FR 29530. See Oregon
Administrative Rules Chapter 340, Divisions 200, 202, 209, 212, 216,
222, 224, 225 and 268.
b. Part D Requirements
    Part D consists of general requirements applicable to all areas
which are designated nonattainment based on a violation of the NAAQS.
The general requirements are followed by a series of subparts specific
to each pollutant. All PM10 nonattainment areas must meet
the applicable general provisions of subpart 1 and the specific
PM10 provisions in subpart 4, ``Additional Provisions for
Particulate Matter Nonattainment Areas.'' The following paragraphs
discuss these requirements as they apply to the Lakeview nonattainment
area.
i. Section 172(c) Plan Provisions
    This section contains general requirements for nonattainment area
plans. A thorough discussion of these requirements may be found in the
general preamble to Title I (57 FR 13498 (April 16, 1992)). The
requirements for reasonable further progress, identification of certain
emissions increases, emissions inventory, and other measures needed for
attainment are satisfied by the nonattainment area plan submitted for
the Lakeview nonattainment area and approved on September 21, 1999. 64
FR 51051.
ii. Subpart 4 Requirements
    As a moderate PM10 nonattainment area, the Lakeview,
Oregon area must meet Part D, subpart 4, sections 189(a), (c), and (e)
requirements before the area can be redesignated to attainment. These
requirements must be fully approved into the SIP:
    (a) Provisions to assure that RACM was implemented by December 10,
1993;
    (b) Either a demonstration that the plan provided for attainment as
expeditiously as practicable but not later than December 31, 1994, or a
demonstration that attainment by that date was impracticable;
    (c) Quantitative milestones which were achieved every 3 years and
which demonstrate reasonable further progress (RFP) toward attainment
by December 31, 1994;
    (d) Provisions to assure that the control requirements applicable
to major stationary sources of PM10 also apply to major
stationary sources of PM10 precursors, except where the
Administrator determined that such sources do not contribute
significantly to PM10 levels which exceed the NAAQS in the
area.
    (e) Permit program under section 173 for the construction and
operation of new and modified major stationary sources of
PM10.
    EPA approved the nonattainment area plan for the Lakeview
nonattainment area, which met the initial requirements of the 1990
Clean Air Act for moderate PM10 nonattainment areas on
September 21, 1999. 64 FR 51051. This plan met requirements for RACM/
BACM, demonstrating attainment, quantitative milestones,
PM10 precursors, contingency measures, and quantitative
milestones for demonstrating RFP. As mentioned above, the provisions
related to NSR were most recently approved in the Oregon SIP most
recently approved on January 22, 2003. 68 FR 29530. Oregon also has a
fully approved PSD program, also approved on January 22, 2003. 68 FR
29530. See Oregon Administrative Rules Chapter 340, Divisions 200, 202,
209, 212, 216, 222, 224, 225 and 268.
5. Transportation Conformity
    Under section 176(c) of the Act, transportation plans, programs and
projects in nonattainment or maintenance areas that are funded or
approved under Title 23 U.S.C. or the Federal Transit Laws must conform
to the applicable SIP. In short, a transportation plan is deemed to
conform to the applicable SIP if the emissions resulting from the
implementation of that transportation plan are less than or equal to
the motor vehicle emissions level or ``budget'' established in the SIP
for the maintenance year and other analysis years.
    DEQ has developed a PM10 MVEB for Lakeview through 2017
that meets the transportation conformity criteria in 40 CFR
93.118(e)(4). The motor vehicle emissions budget is established for all
years. The budget is as follows:

        Lakeview PM10 Motor Vehicle Emissions Budget Through 2017
                    [Pounds PM10/24-hour winter day]
------------------------------------------------------------------------
                             Year                              All years
------------------------------------------------------------------------
Motor Vehicle Emissions Budget...............................        311
------------------------------------------------------------------------

    The TSD summarizes how the PM10 motor vehicle emissions
budget meets the criteria contained in the conformity rule at 40 CFR
93.118(e)(4).
6. Maintenance Plans
    Section 107(d)(3)(E) of the Act stipulates that for an area to be
redesignated, EPA must fully approve a maintenance plan which meets the
requirements of section 175A. A State may submit both the redesignation
request and the maintenance plan at the same time and rulemaking on
both may proceed on a parallel track.
    On October 25, 2005, DEQ submitted a PM10 maintenance
plan and redesignation request for the Lakeview nonattainment area. In
Section II above, we evaluated the plan and concluded that the
requirements for an approvable maintenance plan under the Act have been
met.

B. What Do We Conclude About the Request for Redesignation?

    Based on our evaluation of DEQ's October 25, 2005 SIP submittal, we
conclude that all the requirements for redesignation in Section
107(d)(3)(E) have been met. Therefore, we are redesignating of the
Lakeview PM10 nonattainment area to attainment.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it 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).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes,

as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action also does not have Federalism implications because it does
not have substantial direct effects 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,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This action merely approves a state rule implementing a Federal
standard, and does not alter the relationship or the distribution of
power and responsibilities established in the Clean Air Act. This rule
also is not subject to Executive Order 13045 ``Protection of Children
from Environmental Health Risks and Safety Risks'' (62 FR 19885, April
23, 1997), because it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    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 rule 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 May 22, 2006. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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. This action may not be challenged later in proceedings
to enforce its requirements. See section 307(b)(2).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: February 24, 2006.
Julie M. Hagensen,
Acting Regional Administrator, Region 10.

0
Chapter I, title 40 of the Code of Federal Regulations is amended as
follows:

PART 52--[AMENDED]

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

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

Subpart MM--Oregon

0
2. Section 52.1970 is amended by adding paragraph (c)(147) to read as
follows:

Sec.  52.1970  Identification of plan.

* * * * *
    (c) * * *
    (147) On October 25, 2005, the Oregon Department of Environmental
Quality submitted a PM10 maintenance plan and requested
redesignation of the Lakeview PM10 nonattainment area to
attainment for PM10. The State's maintenance plan and the
redesignation request meet the requirements of the Clean Air Act.
    (i) Incorporation by reference.
    (A) The following sections of Oregon Administrative Rule 340: 204-
0030, 204-0040, 224-0060 (2)(d) and 225-0020(8), as effective September
9, 2005.

0
3. Section 52.1973 is amended by adding paragraph (e)(4) to read as
follows:
* * * * *

Sec.  52.1973  Approval of plans.

    (e) * * *
    (4) EPA approves as a revision to the Oregon State Implementation
Plan, the Lakeview PM10 maintenance plan adopted by the
Oregon Environmental Quality Commission on August 11, 2005 and
submitted to EPA on October 25, 2005.
* * * * *

PART 81--[AMENDED]

0
4. The authority citation for part 81 continues to read as follows:

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

0
5. In Sec.  81.338, the table entitled ``Oregon PM-10'' is amended by
revising the entry for ``Lakeview (the Urban Growth Boundary Area)'' to
read as follows:

Sec.  81.338  Oregon.

* * * * *

                                                 Oregon.--PM-10
----------------------------------------------------------------------------------------------------------------
                                                     Designation                          Classification
          Designated area           ----------------------------------------------------------------------------
                                          Date                   Type                  Date            Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Lakeview (the Urban Growth Boundary         5/22/06  Attainment.................
 area).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 06-2701 Filed 3-21-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: February 8, 2008 (Volume 73, Number 27)]
[Notices]
[Page 7627-7628]
[DOCID:fr08fe08-113]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Recordkeeping Requirements; Agency Information
Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration, DOT

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment period was
published on November 28, 2007 (72 FR 67346-67347).

DATES: Comments must be submitted on or before March 10, 2008.

FOR FURTHER INFORMATION CONTACT: George Stevens, NHTSA, NVS-223,
Washington, DC 20590, phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: 49 CFR part 556, Exemption for Inconsequential Defect or
Noncompliance.
    OMB Number: 2127--0045.
    Type of Request: Reinstatement, without change, of a previously
approved collection which has expired.
    Abstract: The National Highway Traffic Safety Administration's
statute at 49 U.S.C. 30118, Notification of Defects and Noncompliance,
and 49 U.S.C. 30120, Remedies for Defects and Noncompliance, generally
requires manufacturers of motor vehicles and items of replacement
equipment to conduct a notification and remedy campaign (recall) when
their products are determined to contain a safety-related defect or a
noncompliance with a Federal motor vehicle safety standard (FMVSS).
Those sections require a manufacturer of motor vehicles or motor
vehicle equipment to notify distributors, dealers, and purchasers if
any of the manufacturer's products are determined to either contain a
safety-related defect or fail to comply with an applicable FMVSS. The
manufacturer is under a concomitant obligation to remedy such defect or
noncompliance. Pursuant to 49 U.S.C. 30118(d) and 30120(h), Exemptions,
a manufacturer may seek an exemption from these notification and remedy
requirements on the basis that the defect or noncompliance is
inconsequential as it relates to motor vehicle safety. NHTSA exercised
this statutory authority to excuse inconsequential defects or
noncompliances when it promulgated 49 CFR part 566, Exemption for
Inconsequential Defect or Noncompliance. This regulation establishes
the procedures for manufacturers to submit exemption petitions to the
agency and the procedures the agency will use in evaluating those
petitions. Part 556 allows the agency to ensure that inconsequentiality
petitions are both properly substantiated and efficiently processed.
    Affected Public: Businesses or other for-profit entities.
    Estimated Total Annual Burden: 200.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th
Street, NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments Are Invited On: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; the accuracy of the Agency's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication.

    Issued on: February 5, 2008.
Daniel C. Smith,
Associate Administrator for Enforcement.
 [FR Doc. E8-2374 Filed 2-7-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Pages 9566-9568]
[FR Doc No: 2016-03942]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77181; File No. SR-EDGX-2016-03]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Rules
8.15, Imposition of Fines for Minor Violation(s) of Rules, and 25.3,
Penalty for Minor Rule Violations, Amending the Exchange's Minor Rule
Violation Plan

February 19, 2016.
    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 February 10, 2016, EDGX Exchange, Inc. (``EDGX'' or the
``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 prepared by the Exchange. 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 is proposing to amend Rules 8.15 and 25.3 to amend the
Exchange's Minor Rule Violation Plan.
    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 Exchange 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 these 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 8.15 applicable to the
Exchange's equity platform (``EDGX Equities'') to remove the $2,500
penalty limitation contained in Rule 8.15(a) in order to modify the
permissible penalties for minor rule violations with respect to Rule
25.3 applicable to the EDGX options platform (``EDGX Options'') and to
allow the Exchange the discretion to impose penalties in excess of
$2,500 under both the EDGX Equities and EDGX Options Minor Rule
Violation Plans. The proposal further provides that only fines that do
not exceed $2,500 will not be reported. Fines that exceed $2,500 will
continue to be publicly reported by the Exchange \3\ and reported as
final in compliance with SEC Rule 19d-1(c).\4\
---------------------------------------------------------------------------

    \3\ As set forth in Interpretation and Policy .01 to Rule 8.11,
except as provided in Rule 8.15(a), the staff shall cause details
regarding all formal disciplinary actions where a final decision has
been issued to be published on a Web site maintained by the
Exchange.
    \4\ 17 CFR 240.19d-1(c).
---------------------------------------------------------------------------

    Further, the Exchange proposes to amend the EDGX Options Minor Rule
Violation Plan penalty schedule contained in Rule 25.3(d)--for
violations of Rule 22.6(d) regarding Market Makers maintaining
continuous bids and offers--to aggregate violations of Rule 22.6(d)
that occur in a single month of a rolling 24-month period and sanction
such aggregated violations as a single offense. The proposed amended
penalty schedule is substantially similar to International Securities
Exchange (``ISE'') Rule 1614(d)(11) Minor Rule Violation Plan penalties
for continuous options quotation violations. In addition to these
changes, the Exchange proposes to make minor non-substantive changes to
conform to the Rules of BATS Exchange, Inc., specifically by
capitalizing the term ``rule'' in Rule 8.15 and by adding the words
``and Policy'' to Interpretation and Policy .01.
Removal of Penalty Limitation
    Rule 25.3 states that the Exchange may proceed under the Minor Rule
Violation Plan pursuant to the procedures set forth in Rule 8.15
applicable to EDGX Equities. Currently, Rule 8.15(a) states that the
Exchange may impose a fine ``not to exceed $2,500'' for a minor rule
violation. Because existing Rule 25.3 recommends the imposition of
penalties in excess of $2,500 in certain circumstances, the

Exchange believes the penalty limitation in 8.15(a) is obsolete,
inappropriate, and unnecessarily confusing. Moreover, abiding by the
terms of the penalty limitation contained in 8.15(a) for purposes of
the EDGX Options Minor Rule Violation Plan deprives Rule 25.3 of much
of its meaning and effectiveness. Further, it is the Exchange's
position that the penalty limitation currently contained in Rule
8.15(a) is also unnecessary because the Exchange must exercise its
discretion to opt to proceed under the Minor Rule Violation Plan rather
than under its default process, the formal disciplinary process. As a
practical matter, if an individual or entity exceeds the prescribed
Minor Rule Violation Plan fine threshold of $2,500, it will oftentimes
be appropriate for the Exchange to decline to exercise its discretion
to proceed under the Minor Rule Violation Plan and to instead proceed
under the formal disciplinary process. The Exchange, however, believes
it should have the discretion to elect to proceed under the Minor Rule
Violation Plan for a minor rule violation that would otherwise
cumulatively exceed $2,500. Accordingly, the Exchange proposes to
eliminate the penalty limitation in Rule 8.15(a).
    The Exchange recognizes, however, a fine exceeding $2,500 must be
reported as final in accordance with SEC Rule 19d-1(c),\5\ regardless
of whether or not it is imposed under the Minor Rule Violation Plan.
The Exchange provides, therefore, that only fines that do not exceed
$2,500 will not be reported. Fines that exceed $2,500 will continue to
be reported as final in compliance with SEC Rule 19d-1(c).\6\
---------------------------------------------------------------------------

    \5\ 17 CFR 240.19d-1(c).
    \6\ Id.
---------------------------------------------------------------------------

Amendment to MRVP for Continuous Quoting Violations
    The Exchange proposes to amend Rule 25.3(d) to impose fines for
violations of Rule 22.6(d)--regarding a Market Maker's failure to
maintain continuous bids and offers--under the Minor Rule Violation
Plan by aggregating the violations that occur in a month and
sanctioning the violations as a single offense. The Exchange proposes
to continue its current recommendation of issuing a letter of caution
for the first offense in a rolling 24-month period. For the second
violation in the period, the Exchange proposes to issue a $1,000
penalty; for the third a $2,500 penalty; for the fourth a $5,000
penalty. Finally, if there occurs a fifth violation within a rolling
24-month period, the Exchange believes that such a violation is
inappropriate for disposition under the Minor Rule Violation Plan, and
the proposed amendment to Rule 25.3(d) directs that the violation be
enforced in a formal disciplinary action. The Exchange believes it is
appropriate to recommend higher penalties than recommended in current
Rule 25.3(d) because the Exchange is aggregating violations that occur
in a month and sanctioning the violations as a single offense.
    As with other violations covered under the Exchange's Minor Rule
Violation Plan, the Exchange may elect to forgo the Minor Rule
Violation Plan and enforce any egregious violations of its rules under
the Exchange's formal disciplinary process.
2. Statutory Basis
    The Exchange believes that its 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.\7\ Specifically, the
proposal is consistent with Section 6(b)(5) of the Act,\8\ which
requires exchange rules to 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. The Exchange also believes the
proposed rule change is consistent with Section 6(b)(1) of the Act,\9\
which requires that the Exchange be organized and have the capacity to
be able to carry out the purposes of the Act such that it can enforce
compliance with the Act by persons registered with the Exchange. The
Exchange also believes the proposed rule change furthers the objectives
of Section 6(b)(6) \10\ of the Act, which requires that the rules of an
exchange provide that its members and persons associated with its
members be appropriately disciplined for violation of the provisions of
the Act, the rules and regulations thereunder, or the rules of the
exchange, by expulsion, suspension, limitation of activities,
functions, and operations, fine, censure, being suspended or barred
from being associated with a member, or any other fitting sanction.
Finally, the Exchange believes that the proposed rule change furthers
the objectives of Section 6(b)(7) of the Act,\11\ in particular, in
that it provides fair procedures for the disciplining of members and
persons associated with members.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ 15 U.S.C. 78f(b)(1).
    \10\ 15 U.S.C. 78f(b)(6).
    \11\ 15 U.S.C. 78f(b)(7).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change for Rule 8.15(a)
fulfills the requirements set forth above because it modifies the
procedures for the Exchange to discipline minor EDGX Options rule
violations by removing the $2,500 penalty limitation from the EDGX
Equities and EDGX Options Minor Rule Violation Plan and makes other
minor stylistic and conforming changes. The proposed rule change
further provides that the Exchange will not report fines that do not
exceed $2,500 under the Minor Rule Violation Plan except as required
under SEC Rule 19d-1(c).\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19d-1(c).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change for Rule 25.3(d)
fulfills the requirements set forth above because it permits the
Exchange to levy progressively larger fines against a repeat-offender
and prescribes that after five violations in a rolling 24-month period,
the conduct is outside the purview of the Minor Rule Violation Plan,
and formal disciplinary action is appropriate. Further, the Exchange
believes the proposed rule change for Rule 25.3(d) fulfills the
requirements set forth above because it clearly defines when and how a
Market Maker may be disciplined under the Minor Rule Violation Plan.
The Exchange also notes that the proposed rule change for Rule 25.3(d)
is based on and substantially similar to ISE Rule 1614(d)(11).

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

    The Exchange believes the proposal is consistent with Section
6(b)(8) of the Act \13\ in that it does not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposed change merely amends the procedures
the Exchange intends to follow with regard to minor EDGX Options Rule
22.6(d) violations and removes an obsolete and unnecessary penalty
limitation. Thus, the Exchange does not believe the proposed rule
change will have any effect on competition.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any

unsolicited written comments from Members or other interested parties.

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

    Because the foregoing proposed rule change does not: (A)
Significantly affect the protection of investors or the public
interest; (B) impose any significant burden on competition; and (C) by
its terms, become operative for 30 days from the date on which it was
filed or such shorter time as the Commission may designate it has
become effective pursuant to Section 19(b)(3)(A) of the Act \14\ and
paragraph (f)(6) of Rule 19b-4 thereunder,\15\ the Exchange has
designated this rule filing as non-controversial. The Exchange has
given 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 of filing of
the proposed rule change, or such shorter time as designated by the
Commission.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b 4.
---------------------------------------------------------------------------

    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: (1)
Necessary or appropriate in the public interest; (2) for the protection
of investors; or (3) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or 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 email to<EMAIL_ADDRESS>Please include
File Number SR-EDGX-2016-03 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-EDGX-2016-03. 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
10:00 a.m. and 3:00 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-EDGX-2016-03, and should be
submitted on or before March 17, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-03942 Filed 2-24-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 10, 2009 (Volume 74, Number 216)]
[Rules and Regulations]
[Page 57886-57888]
[DOCID:fr10no09-4]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0085]
RIN 1625-AA11

Regulated Navigation Area; East Rockaway Inlet to Atlantic Beach
Bridge, Nassau County, Long Island, NY

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is establishing a regulated navigation area
extending from the entrance of East Rockaway Inlet to the Atlantic
Beach Bridge, Nassau County, New York. This regulated navigation area
will affect commercial vessels carrying petroleum products in excess of
250 barrels by requiring them to plan all transits of the regulated
navigation area so that they maintain a minimum of two feet under keel
clearance at all times. Additionally, they may not transit the
regulated navigation area if a small craft advisory, or more severe
weather warning, has been issued, unless authorized by the Captain of
the Port Long Island Sound. This action is necessary because
significant shoaling in this area has reduced the depths of the
navigable channel and has increased the risk of vessels grounding in
the channel and the potential for a significant oil spill.

DATES: This rule is effective December 10, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0085 and are available online by going to
http://www.regulations.gov, inserting USCG-2008-0085 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail: Chief Petty Officer Christie Dixon, Prevention
Department, USCG Sector Long Island Sound at<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On June 15, 2009, we published a notice of proposed rulemaking
(NPRM) entitled ``Regulated Navigation Area; East Rockaway Inlet to
Atlantic Beach Bridge, Nassau County, Long Island, NY'' in the Federal
Register (74 FR 28199). We did not receive any comments or requests for
meetings on the proposed rule.

Background and Purpose

    East Rockaway Inlet is on the South Shore of Long Island, in Nassau
County. Water depths in the federal navigation channel change
constantly and have been reduced in some areas to as low as five feet
at times. This channel was last dredged by the Army Corps of Engineers
during the winter of 2008-2009 and is on a 2 year cycle for dredge
work. The channel buoys require regular relocation to mark best water
as the channel shoals in between dredge cycles. East Rockaway Inlet is
frequented by small coastal tankers and tugs towing oil barges
supplying two facilities: Sprague Energy Oceanside, located in
Oceanside, Long Island, New York, a supplier of home heating oil for
Long Island, and Keyspan E.F. Barrett, an electrical power generation
facility, located in Island Park, Long Island, New York. For vessels
carrying 250 or more barrels of petroleum, approximately 60 transits
occur in that area each year. The shoaling in this area has reduced
depths to a point where there is an increased risk of vessels grounding
and the potential for a significant oil spill. Similar shoaling led to
the grounding in late 2003 of a small coastal tanker carrying home
heating oil.
    This rule will provide for the safety of vessel traffic and
protection of the maritime environment in and around East Rockaway
Inlet, Long Island, New York.

Discussion of Comments and Changes

    There were not any comments or changes to the regulatory text.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities, some of which
may be small entities: The owners or operators of vessels carrying
petroleum products intending to transit or anchor in those portions of
the East Rockaway Inlet covered by the regulated navigation area; and
Sprague Energy Oceanside and Keyspan E.S. Barrett which receive the
vessels affected by this regulated

navigation area. Recreational and other maritime traffic is not
otherwise restricted or prohibited from transiting this area. In the
NPRM the Coast Guard invited small entities who thought their business
would be affected by this rule to submit a comment explaining why the
entity qualifies and how and to what degree this rule would
economically affect it. No comments were received and no changes were
made to the regulation.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule which involves the establishment
of a regulated navigation area was published as a Notice of Proposed
Rulemaking with an invitation to comment on June 15, 2009. No comments
were received that would affect the assessment of environmental impacts
from this action. An environmental analysis checklist and a categorical
exclusion determination are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Public Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.156 to read as follows:

Sec.  165.156  Regulated Navigation Area, East Rockaway Inlet to
Atlantic Beach Bridge, Nassau County, Long Island, New York.

    (a) Location. The following area is a Regulated Navigation Area:
All waters of East Rockaway Inlet in an area bounded by lines drawn
from position 40[deg]34'56'' N, 073[deg]45'19'' W, (approximate
position of Silver Point breakwater buoy, LLNR 31500) running north to
a point of land on the northwest side of the inlet at position
40[deg]35'28'' N, 073[deg]46'12'' W, thence easterly along the shore to
the east side of the Atlantic Beach Bridge, State Route 878, over East
Rockaway Inlet, thence across the bridge to the south side of East
Rockaway Inlet, thence westerly along the shore and across the water to
the beginning.
    (b) Regulations. (1) The general regulations contained in 33 CFR
165.10, 165.11, and 165.13 apply.
    (2) In accordance with the general regulations, the following
regulations apply to vessels carrying petroleum products in excess of
250 barrels:
    (i) The vessel must have plans in place to maintain a minimum of
two feet under keel clearance at all times.
    (ii) A vessel requiring a nighttime transit through East Rockaway
Inlet may only do so only after receiving approval from the Captain of
the Port Long Island Sound.
    (iii) Vessels are prohibited from transiting East Rockaway Inlet if
a small craft advisory or greater has been issued for the area unless
specific approval is received from the Captain of the Port Long Island
Sound.
    (iv) In an emergency, any vessel may deviate from the regulations
in this section to the extent necessary to avoid endangering the safety
of persons, the environment, and or property. If deviation from the
regulations is necessary, the master or their designee shall inform the
Coast Guard as soon as it is practicable to do so.
    (c) Waivers. (1) The Captain of the Port Long Island Sound may,
upon request, waive any regulation in this section.
    (2) An application for a waiver must state the need for the waiver
and describe the proposed vessel operations through the Regulated
Navigation Area.

    Dated: October 22, 2009.
Joseph L. Nimmich,
Rear Admiral, U.S. Coast Guard Commander, First Coast Guard District.
[FR Doc. E9-26991 Filed 11-9-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63782-63783]
[FR Doc No: 2022-22744]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Animal Generic Drug User Fee Act; Public Meeting; Request for
Comments; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments; extension of
comment period.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
extending the comment period for the notice announcing a public meeting
and requesting comments that appeared in the Federal Register of
September 30, 2022. In that notice, FDA announced a public meeting to
discuss the proposed recommendations for the reauthorization of the
Animal Generic Drug User Fee Act (AGDUFA IV) for fiscal years 2024
through 2028 and that the comment period would be open until November
9, 2022. FDA is taking this action due to a delay in the posting of the
AGDUFA IV Performance Goals and Procedures Letter. This extension will
provide the public 30 days to comment as required.

DATES: FDA is extending the comment period announced in the notice of
public meeting and request for comments published September 30, 2022
(87 FR 59441). Either electronic or written comments on the notice must
be submitted by November 14, 2022, to ensure that the Agency considers
your comments regarding this public meeting and request for comments.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 14, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-

2011-N-0655 for ``Animal Generic Drug User Fee Act.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 30,
2022, FDA published a notice announcing a public meeting and requesting
comments on the proposed recommendations for the reauthorization of the
AGDUFA IV for fiscal years 2024 through 2028.
    Interested persons were originally given until November 9, 2022, to
comment on the public meeting and request for comments. Due to a delay
in the posting of the AGDUFA IV Performance Goals and Procedures Letter
to our website at https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings, we are extending the comment
period until November 14, 2022, to allow for a 30-day comment period.

    Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22744 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P


1 0 20 40 60 80 0 2 4 6 8 10 F T P M a s s E m i s s i o n mg/ mile mg/ mile 0 100 200 300 400 0 1 2 3 0 50 100 F T P M a s s E m i s s i o n mg/ mile mg/ mile g/ mile CO CO NOx NOx NMHC NMHC Toluene Benzene Xylene n Hexane 1.3 Butadiene Formaldehyde Acetaldehyde Sthylene Ethylbenzene Regulated Compounds MSAT Compounds Ratio 10 75

20

F F 75

20

F F Test Temperature Test Temperature MSAT increasing rate is as same as NMHC increasing rate.

(= 10)

Vehicle 1 ( BIN5) 20' F Emission 2 0 200 400 600 800 0 2 4 0 100 200 300 0 50 100 150 0 3 6 9 12 15 18 F T P M a s s E m i s s i o n mg/ mile mg/ mile g/ mile CO CO NOx NOx NMH C NMH C Toluene 1.3 Butadiene Formaldehyde Acetaldehyde Sthylene Ethylbenzene Xylene n Hexane Benzene F T P M a s s E m i s s i o n mg/ mile mg/ mile Test Temperature Test Temperature Regulated Compounds MSAT Compounds Ratio 10 75

20

F F 75

20

F F MSAT increasing rate is as same as NMHC increasing rate.

(= 10)

Vehicle 2 ( BIN5) 20' F Emission 3 0 3 6 9 12 15 0 200 400 600 800 18 0 50 100 150 M S A T M a s s E m i s s i o n mg/ mile NMOG Mass Emission mg/ mile Toluene   Vehicle 1   Vehicle 2 Toluene   Vehicle 1   Vehicle 2 Benzene   Vehicle 1   Vehicle 2 Xylene   Vehicle 1   Vehicle 2 Benzene   Vehicle 1   Vehicle 2 Xylene   Vehicle 1   Vehicle 2 n Hexane

Vehicle 1   Vehicle 2 n Hexane

Vehicle 1   Vehicle 2 mg/ mile Toluene : Y = 0.184X + 0.549 ( R 2 : 0.989)

Benzene : Y = 0.0214X + 0.950 ( R 2 : 0.980)

Xylene : Y = 0.0206X + 1.076 ( R 2 : 0.989)

n Hexane: Y = 0.0210X   0.395 ( R 2 : 0.997)

20

NMOG 90m g/ mile  6.7

Point Estimate ( mg/ mile) Measured Value mg/ mile Vehicle 1 NMOG 90.0 347 3.86 Toluene 17.1 68.0 3.98 Benzene 2.88 8.91 3.10 Xylene 2.93 7.59 2.59 n Hexane 1.50 6.24 4.17 Vehicle 2 NMOG 90.0 678 7.53 Toluene 17.1 120 7.03 Benzene 2.88 14.9 5.16 Xylene 2.93 15.0 5.12 n Hexane 1.50 13.8 9.22 Ratio ( 6.7

/ 20

)

Ratio of 20

and   6.7

Emission Value for MSAT Compounds Correlation between NMHC and MSAT Component


[Federal Register Volume 85, Number 155 (Tuesday, August 11, 2020)]
[Notices]
[Pages 48539-48541]
[FR Doc No: 2020-17533]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0626]

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pulmonary-Allergy Drugs
Advisory Committee. The general function of the committee is to provide
advice and recommendations to FDA on regulatory issues. The meeting
will be open to the public. FDA is establishing a docket for public
comment on this document.

DATES: The meeting will take place virtually on August 31, 2020, from
10 a.m. Eastern Time to 4 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2020-N-0626. The docket will close on August
28, 2020. Submit either electronic or written comments on this public
meeting by August 28, 2020. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before August 28, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 28, 2020. Comments received by mail/hand
delivery/courier (for written/

paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
    Comments received on or before August 17, 2020, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2020-N-0626 for ``Pulmonary-Allergy Drugs Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
Eastern Time and 4 p.m. Eastern Time, Monday through Friday, 240-402-
7500.
     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.'' FDA 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 https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information 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 the 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Philip Bautista, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting will be heard, viewed, captioned, and recorded
through an online teleconferencing platform. On August 31, 2020, the
committee will discuss supplemental new drug application 209482/S-008,
for TRELEGY ELLIPTA, a fixed-dose combination (fluticasone furoate,
umeclidinium, and vilanterol inhalation powder oral inhalation),
submitted by GlaxoSmithKline, for the following proposed labeling
claim: Reduction in all-cause mortality in patients with chronic
obstructive pulmonary disease (COPD). The focus of the discussion will
be on the efficacy data submitted to support the proposed labeling
claim, including the results from the Informing the Pathway of COPD
Treatment trial and the influence of inhaled corticosteroids withdrawal
on the results.
    FDA intends to make the meeting's background material and pre-
recorded presentations available to the public no later than 2 business
days before the meeting. The pre-recorded presentations will be viewed
by the committee prior to the meeting and will not be replayed on
meeting day. If FDA is unable to post the background material and/or
pre-recorded presentations on its website prior to the meeting, the
background material and/or pre-recorded presentations will be made
publicly available on FDA's website at the time of the advisory
committee meeting. The meeting will include brief summaries of the pre-
recorded presentations. Background material and the link to the online
teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate
advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before August 17, 2020, will be provided to the

committee. Oral presentations from the public will be scheduled on
August 31, 2020, between approximately 12:50 p.m. Eastern Time and 1:50
p.m. Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person (see FOR FURTHER
INFORMATION CONTACT). The notification should include a brief statement
of the general nature of the evidence or arguments they wish to
present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their
presentation, on or before August 14, 2020. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by August 17, 2020.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Philip Bautista (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 5, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17533 Filed 8-10-20; 8:45 am]
BILLING CODE 4164-01-P