[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Rules and Regulations]
[Pages 59490-59499]
[FR Doc No: 2016-20662]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2016-0096; FRL-9951-48-Region 9]

Air Plan Approval; Reno, Nevada; Second 10-Year Carbon Monoxide
Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a State Implementation Plan (SIP) revision
submitted by the State of Nevada. On July 3, 2008, the EPA redesignated
the Truckee Meadows area, consisting largely of the cities of Reno and
Sparks in Washoe County, Nevada, from nonattainment to attainment for
the carbon monoxide (CO) National Ambient Air Quality Standards (NAAQS)
and approved the State's plan addressing the area's maintenance of the
NAAQS for ten years. On November 7, 2014, the State of Nevada submitted
to the EPA a second maintenance plan for the Truckee Meadows area that
addressed maintenance of the NAAQS through 2030. The EPA is now
approving this second maintenance plan. The EPA is also finding
adequate and approving transportation conformity motor vehicle
emissions budgets (MVEBs) for the years 2015, 2020, 2025 and 2030. We
are taking these actions under the Clean Air Act (CAA or ``the Act'').

DATES: This rule is effective on October 31, 2016 without further
notice, unless the EPA receives adverse comments by September 29, 2016.
If we receive such comments, we will publish a timely withdrawal in the
Federal Register to notify the public that this direct final rule will
not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-

OAR-2016-0096 at http://www.regulations.gov, or via email to John
Kelly, Air Planning Office at<EMAIL_ADDRESS>For comments
submitted at Regulations.gov, follow the online instructions for
submitting comments. Once submitted, comments cannot be removed or
edited from Regulations.gov. For either manner of submission, the EPA
may publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud, or other file sharing system). For additional submission
methods, please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section. For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: John Kelly, EPA Region IX, (415) 947-
4151<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. Background
    A. Truckee Meadows Attainment Status
    B. 2014 Maintenance Plan
    C. Transportation Conformity
II. The EPA's Evaluation of Nevada's Submittal
    A. Ambient Air Quality Monitoring Data
    B. Attainment Inventory
    C. Maintenance Demonstration
    D. Transportation Conformity
    E. Ambient Air Quality Monitoring Network
    F. Verification of Continued Attainment
    G. Contingency Plan
III. Public Comment and Final Action
IV. Statutory and Executive Order Reviews

I. Background

A. Truckee Meadows Attainment Status

    Under the CAA Amendments of 1990, the Truckee Meadows area
(hereinafter referred to as Truckee Meadows, the Truckee Meadows area
or the area), which includes the Reno-Sparks metropolitan area in
Washoe County, Nevada, was designated and classified as a moderate CO
nonattainment area.\1\
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    \1\ For a detailed description of air quality planning in the
area, see the EPA's proposal to approve the first 10-year
maintenance plan, published in the Federal Register on January 7,
2008, 73 FR 1175 at 1177. The CO attainment table in 40 CFR 81.329
lists the area as ``Reno Area: Washoe County (part) Truckee Meadows
Hydrographic Area 87.''
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    The primary CO NAAQS are attained when ambient concentration design
values do not exceed either the 1-hour 35 parts per million (ppm) (or
10 milligrams per cubic meter) standard or the 8-hour 9 ppm (or 40
milligrams per cubic meter) standard more than once per year. See 40
CFR 50.8(a). According to monitoring data going back to 1980 in the
EPA's \2\ Air Quality System (AQS), Truckee Meadows has not had a
violation of the 1-hour CO standard.\3\ Regarding the 8-hour standard,
the area has not had a violation since 1991.\4\ The EPA determined in
2005 that the area had attained the CO NAAQS by the area's December 31,
1995 attainment deadline. See 70 FR 22803 (May 3, 2005). This
determination did not affect the designation of the area as
nonattainment or its classification as a moderate area.
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    \2\ The initials EPA, and the words ``we,'' ``us,'' or ``our''
mean or refer to the United States Environmental Protection Agency.
    \3\ See Truckee Meadows 1980-2016 1-Hour CO Violation Day Count
Report, data pulled from AQS on August 1, 2016.
    \4\ 2014 Maintenance Plan, page 1. See also, Truckee Meadows
1991-2016 8-Hour CO Violation Day Count Report, data pulled from AQS
on August 1, 2016, which verifies the District's assertion in the
2014 Maintenance Plan that there have been no 8-hour CO violations
in the Truckee Meadows area since 1991. This report also includes
more recent monitoring data (up through the first quarter of 2016)
than the 2014 Maintenance Plan.
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    On November 4, 2005, the State of Nevada (``State'' or ``Nevada'')
submitted a request to the EPA to redesignate Truckee Meadows from
nonattainment to attainment for the CO NAAQS. Along with this request,
the State submitted a CAA section 175A(a) maintenance plan, which
demonstrated that the area would maintain the CO NAAQS for the first 10
years following our approval of the redesignation request (``2005
Maintenance Plan''). We approved the State's redesignation request and
10-year maintenance plan on April 2, 2008. See 73 FR 38124 (July 3,
2008). For a detailed history of the CO planning efforts in the area up
to 2005, please see the EPA's proposal to approve the 2005 Maintenance
Plan. See 73 FR 1175 at 1177 (January 7, 2008).

B. 2014 Maintenance Plan

    Eight years after an area is redesignated to attainment, CAA
section 175A(b) requires the State to submit a subsequent maintenance
plan to the EPA, covering a second 10-year period.\5\ The second
maintenance plan must demonstrate continued compliance with the NAAQS
during this second 10-year period. To fulfill this requirement of the
CAA, Nevada submitted the second 10-year update of the Truckee Meadows
area CO maintenance plan to the EPA on November 7, 2014. The plan was
developed by the Washoe County Health District's (District) Air Quality
Management Division (AQMD) and is titled ``Second 10-Year Maintenance
Plan for the Truckee Meadows 8-Hour Carbon Monoxide Attainment Area,
August 28, 2014'' (hereinafter, ``2014 Maintenance Plan'' or ``Plan'').
The 2014 Maintenance Plan was adopted by the District's Board of Health
on August 28, 2014. See Washoe County Board of Health Certificate of
Adoption, August 28, 2014. Air quality planning and monitoring in
Truckee Meadows is the responsibility of the District, which
administers air quality programs in Washoe County through the AQMD. The
State Environmental Commission and the Nevada Department of Motor
Vehicles are responsible for the motor vehicle inspection and
maintenance program in Truckee Meadows.
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    \5\ In this case, the initial maintenance period extends through
2018. Thus, the second 10-year period must extend at least through
2028. The District's demonstration is for maintenance through 2030.
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C. Transportation Conformity

    Section 176(c) of the Act defines conformity as meeting the SIP's
purpose of eliminating or reducing the severity and number of
violations of the NAAQS and achieving expeditious attainment of such
standards. The Act further defines transportation conformity to mean
that no Federal transportation activity will: (1) Cause or contribute
to any new violation of any standard in any area; (2) increase the
frequency or severity of any existing violation of any standard in any
area; or (3) delay timely attainment of any standard or any required
interim emission reductions or other milestones in any area. The
federal transportation conformity rule, 40 CFR part 93 subpart A, sets
forth the criteria and procedures for demonstrating and assuring
conformity of transportation plans, programs and projects which are
developed, funded or approved by the U.S. Department of Transportation,
and by metropolitan planning organizations or other recipients of
Federal funds under Title 23 U.S.C. or the Federal Transit Laws.
    The transportation conformity rule applies within all nonattainment
and maintenance areas. As prescribed by the transportation conformity
rule, once an

area has an applicable SIP with MVEBs, the expected emissions from
planned transportation activities must be consistent with such
established budgets for that area.

II. The EPA's Evaluation of Nevada's Submittal

    The 2014 Maintenance Plan contains the following major sections:
(1) An introductory section containing a general discussion of plan
approvals and the area's redesignation to attainment; and (2) a
maintenance plan section including subsections on the attainment
emissions inventory, a maintenance demonstration, MVEBs, the area's
monitoring network, verification of continued attainment, and a
contingency plan. See 2014 Maintenance Plan, Chapters 1 and 2.
    Following is the EPA's evaluation of the 2014 Maintenance Plan
under the CAA, the EPA's implementing regulations and relevant
guidance.

A. Ambient Air Quality Monitoring Data

    As noted above, the primary NAAQS for CO are: 9 ppm (or 10
milligrams per cubic meter) for an 8-hour average concentration not to
be exceeded more than once per year and 35 ppm (or 40 milligrams per
cubic meter) for a 1-hour average concentration not to be exceeded more
than once per year. See 40 CFR 50.8(a).
    The 2014 Maintenance Plan includes a summary of 8-hour CO design
values for the years 2008 to 2013. See 2014 Maintenance Plan, Table 1-
1, page 2. In addition, the EPA examined monitoring data for Truckee
Meadows for the last ten years, including a large portion of the period
covered by the first maintenance plan. Table 1 shows the complete,
quality assured and certified ambient air monitoring design values for
CO in the area for the years 2006 to 2015 and preliminary data for
2016. The first maintenance plan covers the years 2008-2018. The year
2015 is the last year for which we have complete, quality assured and
certified ambient air monitoring design values for CO in the area. The
monitoring data show that CO design values in the Truckee Meadows area
have been well below the level of the NAAQS throughout the last decade.
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    \6\ Design values were derived from AQS. The EPA notes that the
8-hour CO design value given in the 2014 Maintenance Plan for the
year 2011 (i.e., 2.9 ppm) appears to be in error and should actually
be as shown (i.e., 2.6 ppm). For 1-hour CO design values, see the
Truckee Meadows 1-Hour CO 2006-2016 Maximum Values Report, dated
August 1, 2016. For 8-hour CO design values, see the Truckee Meadows
8-Hour CO 2006-2016 Maximum Values Report, dated August 1, 2016.
    \7\ Preliminary design values for 2016 through March 31, 2016.
See Truckee Meadows 2016 1-hour Completeness Report, dated August 1,
2016.

   Table 1--CO Design Values for Truckee Meadows, NV, Years 2006-2015
------------------------------------------------------------------------
                  Design Values (ppm) \6\
------------------------------------------------------------    Years
                    1-Hour                         8-Hour
------------------------------------------------------------------------
4.8...........................................          3.3         2006
4.7...........................................          3.3         2007
3.9...........................................          2.9         2008
4.2...........................................          2.6         2009
3.1...........................................          2.6         2010
3.4...........................................          2.6         2011
2.8...........................................          2.3         2012
2.8...........................................          2.4         2013
3.2...........................................          2.4         2014
2.7...........................................          2.0         2015
2.2...........................................          1.5     \7\ 2016
------------------------------------------------------------------------

B. Attainment Inventory

    Due to the area's status at the time as moderate nonattainment for
the CO standards, the District developed a 1990 baseline emissions
inventory and has continued to update the inventory pursuant to CAA
requirements every three years. The most recent inventory at the time
the state submitted the 2014 Maintenance Plan was for the year 2011.
The District is using the 2011 emissions inventory, adjusted down due
to unusually high wildfire emissions that occurred that year, as the
attainment inventory. The District refers to this attainment inventory
as the Truckee Meadows maintenance emissions limit. With the level of
emissions that occurred in 2011, the area still attained the CO
standards. Levels at or below the downward-adjusted 2011 emissions
(that is, the Truckee Meadows maintenance emissions limit) are
therefore expected to maintain the standards. The unadjusted emissions
levels are presented in Table 2. The District then adjusts the nonpoint
source category to reflect more representative wildfire emissions, and
then uses the adjusted total emissions for the area as the maintenance
emissions limit, as explained in section III.C below.

                       Table 2--2011 CO Inventory
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                                                          2011 Inventory
                     Source category                        (pounds per
                                                               day)
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Point...................................................           3,361
Nonpoint................................................         154,956
Non-road................................................          50,706
On-road.................................................         163,500
                                                         ---------------
  Total *...............................................         372,522
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* Totals may not add up due to rounding.

    The EPA finds that the 2011 inventory information presented by the
District is acceptable and consistent with the source category amounts
and totals for the 2011 National Emissions Inventory for Washoe County,
with one exception. The District's information does not account for
railroad (locomotive) emissions. Locomotive emissions would add 3.6
tons per year of CO emissions to the area, or 19.7 pounds per day (lbs/
day). Compared to a total inventory of 372,522 lbs/day, however, the
omission of railroad emissions amounts to less than 0.01% of the total
CO emissions for the area, and the EPA therefore does not believe the
omission to be significant.

C. Maintenance Demonstration

    In general, a state may demonstrate that an area will maintain the
NAAQS by showing that future emissions will not exceed the level of the
attainment inventory.\8\ Attainment must be demonstrated for the 10-
year period following the first ten years covered by the initial
maintenance plan. For the Truckee Meadows area, the first maintenance
period ranges from 2008, when the EPA approved the area's redesignation
request and maintenance plan, through the year 2018. In the 2014
Maintenance Plan, the District must also demonstrate attainment for the
10-year period following the first ten years. The 2014 Maintenance Plan
covers a portion of the first 10-year period (through 2018), as well as
the second ten years, 2018 through 2028. In addition, a state may go
beyond the minimum requirements of the CAA. The District has elected to
make the horizon year for this Plan 2030 for the convenience of
transportation planning.
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    \8\ See the EPA's September 4, 1992 John Calcagni memorandum
entitled ``Procedures for Processing Requests to Redesignate Areas
to Attainment,'' at page 9, available online at: https://www.epa.gov/sites/production/files/2016-03/documents/calcagni_memo_-_procedures_for_processing_requests_to_redesignate_areas_to_attainment_090492.pdf.
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    Although the 2005 Maintenance Plan addresses maintenance through
the year 2018, the emissions projections of the 2014 Maintenance Plan
replace those from the previous plan. The District's rationale is that
there are now better

planning assumptions and improved emissions calculation methodologies
that were not available in developing the previous plan. Updated
methodologies include the change from using MOBILE6 mobile source
modeling software, used for the 2005 Maintenance Plan, to the MOVES
model used for the 2014 Maintenance Plan.
    As noted above, the District used its 2011 periodic emissions
inventory \9\ to develop the baseline 2011 ``maintenance emissions
limit'' for the Truckee Meadows area, which is then used to compare
future emissions inventories for the purpose of verifying continued
attainment of the CO NAAQS as long as those future emissions are lower
than the maintenance emissions limit.
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    \9\ See Washoe County, Nevada: 2011 Periodic Emissions Inventory
and Appendices A, B, and C.
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    As shown in Table 3, for most emissions categories, the District
simply used emission levels from the 2011 periodic emissions inventory
to develop its 2011 maintenance emissions limit. However, for
wildfires, the District noted that 2011 was an unusually active year
for wildfires, with corresponding CO emissions of 105,092 lbs/day. To
approximate more typical wildfire emissions for purposes of producing
the 2011 Truckee Meadows maintenance emissions limit, the District used
the average of wildfire emissions for the four previous inventory years
(1999, 2002, 2005, and 2008). That average is 217 lbs/day, which the
District used to adjust the nonpoint source category. Due to this
adjustment, total nonpoint emissions for the nonpoint source category
are 50,081 lbs/day for the maintenance emissions limit, as compared
with 154,956 lbs/day in the 2011 emissions inventory, as shown in Table
3. See 2014 Maintenance Plan, Table 2-3.

  Table 3--Truckee Meadows CO Emissions Inventories, in Pounds per Day
------------------------------------------------------------------------
                                                   2011         2011
                                               -------------------------
                                                             Maintenance
                Source category                  Periodic     emissions
                                                 inventory   limit (lbs/
                                                 (lbs/day)      day)
------------------------------------------------------------------------
Point.........................................       3,361         3,361
Nonpoint......................................     154,956        50,081
Non-Road Mobile...............................      50,706        50,706
On-Road Mobile................................     163,500       163,500
                                               -------------------------
  Total *.....................................     372,522       267,648
------------------------------------------------------------------------
* Totals may not add up due to rounding.

    The District supports its use of 267,648 lbs/day maintenance
emissions limit as the attainment inventory because it uses the most
accurate emissions inventory methodologies, is a current and
comprehensive emissions inventory, identifies the level of emissions in
the Truckee Meadows area sufficient to maintain the CO standards, and
will be the emissions inventory most consistent with the 2030 projected
inventory required for demonstrating maintenance of the CO standards.
See 2014 CO Maintenance Plan, page 6.
    The District used the following methodologies or models, as
described in EPA guidance,\11\ to project the 2011 maintenance
emissions limit (i.e. the 2011 periodic emissions inventory adjusted to
exclude unusually high wildfire emissions) out to future milestone
years 2015, 2020, 2025 and 2030 for each of the emissions source
categories, in order to demonstrate continued maintenance with the CO
NAAQS.
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    \10\ See ``Procedures for Preparing Emissions Projections,''
EPA-450/4-91-019, July 1991, available online at https://www.epa.gov/nscep.
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    1. Baseline Emissions Projections. Washoe County's 2030 population,
employment and vehicle miles travelled (VMT) forecasts (2014
Maintenance Plan, Appendix A) were used as surrogates to project the
2030 emissions, and were consistent with those used by the local
metropolitan planning organization.
    2. EPA Models. Non-road and on-road motor vehicle categories
accounted for approximately 59% of the 2011 emissions inventory. To
ensure consistency throughout the maintenance demonstration period, the
same non-road and on-road models were used to estimate the 2030
projected emissions inventory.
    3. Emissions Category Surveys. The District uses surveys to
estimate emissions from residential wood combustion (RWC). The District
applied an adjustment factor based on heating degree days to the most
recent survey (conducted in 2012-2013) to project RWC emissions from
2015 through 2030. See 2014 Maintenance Plan, Appendix A.1
    Table 4 lists the 2011 Truckee Meadows maintenance emissions limit
and projected emissions for 2015, 2020, 2025 and 2030 for the four
major CO emissions source categories in the area. See 2014 Maintenance
Plan, Table 2-4. The District provides a more detailed inventory for
2011 and projected future years in the 2014 Maintenance Plan, Appendix
B.

                     Table 4--Truckee Meadows CO Maintenance Emissions Inventories (lbs/day)
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         Source category              2011 *           2015            2020            2025            2030
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Point...........................           3,361           3,768           4,357           4,974           5,678
Nonpoint........................          50,081          47,820          45,236          42,845          40,355
Non-Road........................          50,706          43,725          45,385          48,320          51,656
On-Road.........................         163,500         150,330         140,129         138,938         142,686
                                 -------------------------------------------------------------------------------
    Total **....................         267,648         245,642         235,107         235,077         240,375
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* Truckee Meadows maintenance emissions limit.
** Totals may not add up due to rounding.

    The District projects that population, number of households,
employment and VMT will increase through 2030 and beyond, but that
federally enforceable CO control programs targeting gasoline-powered
motor vehicles, RWC and diesel-powered motor vehicles will help offset
this growth. Because future emissions are not projected to exceed the
level of the 2011 Truckee Meadows maintenance emissions limit of
267,648 lbs/day, the District asserts that the CO NAAQS will be
maintained through the maintenance demonstration period.\11\
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    \11\ Although the summary paragraph following Table 2-4 in the
plan compares future year projections shown in the table to the
``2011 Truckee Meadows maintenance emissions inventory,'' EPA
believes that the District clearly intended to make the comparison
to the ``Truckee Meadows Maintenance Emissions Limit,'' as the
District stated in this single-asterisk (*) note to the table. See
2014 Maintenance Plan, page 7.
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    The EPA agrees with the District's conclusion. Even with the growth
expected in the area in the future, overall emissions of CO in the area
are declining and provide assurance that the area will not violate the
CO standard in the future. With respect to wildfire emissions, we find
that the District's approach of adjusting both the attainment inventory
(i.e., the maintenance emissions limit) and the projected future year
emissions inventories to exclude unusually high 2011 wildfire emissions
is reasonable.

D. Transportation Conformity

    Transportation conformity is required by section 176(c) of the CAA.
Conformity to a SIP means that transportation activities will not
produce new air quality violations, worsen existing violations, or
delay timely attainment of the NAAQS. See CAA section 176(c)(1)(B). The
EPA's conformity rule at 40 CFR part 93, subpart A requires that
transportation plans, programs and projects conform to SIPs and
establishes the criteria and procedures for determining whether or not
they conform. To effectuate its purpose, the conformity rule generally
requires a demonstration that emissions from the Regional
Transportation Plan and the Transportation Improvement Program are
consistent with the MVEBs contained in the applicable control strategy
SIP revision or maintenance plan. See 40 CFR 93.101, 93.118, and
93.124. An MVEB is defined as the level of mobile source emissions of a
pollutant relied upon in the attainment or maintenance demonstration to
show compliance with the NAAQS in the nonattainment or maintenance
area.\12\
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    \12\ Further information concerning the EPA's interpretations
regarding MVEBs can be found in the preamble to the EPA's November
24, 1993, transportation conformity rule (see 58 FR 62193-62196).
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    The EPA's process for determining adequacy of a MVEB consists of
three basic steps: (1) Notifying the public of a SIP submission; (2)
providing the public the opportunity to comment on the MVEB during a
public comment period; and, (3) making a finding of adequacy or
inadequacy. See 40 CR 93.118(f). In order for us to find an MVEB
adequate and approvable, the submittal must meet the conformity
adequacy provisions of 40 CFR 93.118(e)(4) and (5). The 2005
Maintenance Plan established CO MVEBs (in terms of pounds per typical
CO season day) of 330,678 pounds per typical CO season day in year 2010
and 321,319 pounds per typical CO season day in year 2016. The EPA
found the CO MVEBs adequate for transportation conformity purposes
effective March 30, 2006 (March 15, 2006, 71 FR 13386) \13\ and
approved the MVEBs on July 3, 2008 (73 FR 38124).
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    \13\ See also letter from Deborah Jordan, Director, U.S. EPA
Region 9 Air Division, to Leo M. Drozdoff, P.E., Director, Nevada
Division of Environmental Protection, dated February 14, 2006,
available online at: https://www3.epa.gov/otaq/stateresources/transconf/adequacy/ltrs/truckee033006.pdf.
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    The 2014 Maintenance Plan establishes new MVEBs for CO, as shown in
Table 5.

 Table 5--Transportation Conformity Motor Vehicle Emissions Budgets for the Truckee Meadows CO Maintenance Area
                                                    [lbs/day]
----------------------------------------------------------------------------------------------------------------
                      Year                             2015            2020            2025            2030
----------------------------------------------------------------------------------------------------------------
CO MVEB.........................................         172,336         172,670         171,509         169,959
----------------------------------------------------------------------------------------------------------------

    The District developed these MVEBs using emissions inventory
projections for the years 2015 through 2030. The MVEBs include on-road
vehicles, heavy duty diesel vehicle idling, and a safety margin. The
latter is the excess emissions between the total projected emissions
for a specific year and the 2011 maintenance emissions limit. We note
that the MVEBs in the 2014 Maintenance Plan differ from those contained
for similar years in the 2005 Maintenance Plan. These differences are
due to the use of the latest planning assumptions for the
transportation network, including VMT, vehicle speeds and vehicle
population for passenger cars and trucks, in the development of the
Washoe County 2011 periodic emissions inventory. As in previous
periodic emissions inventories, these planning assumptions were
consistent with those used by the local metropolitan planning
organization for their transportation plans.
    We are not announcing the availability of these MVEBs through the
EPA's Adequacy Web site and providing a separate comment period on the
adequacy of the MVEBs. Instead, we are reviewing the adequacy of the
MVEBs simultaneously with our review of the 2014 Maintenance Plan
itself. See 40 CFR 93.118(f)(2). In order to determine whether these
MVEBs are adequate and approvable, we have evaluated whether the MVEBs
meet the conformity adequacy provisions of 40 CFR 93.118(e)(4) and (5)
and have determined that the MVEBs meet the applicable criteria. These
criteria include, for example, that the MVEBs are clearly identified
and precisely quantified, that the Plan shows a clear relationship
among the emissions budgets, control measures and the total emissions
inventory, among other criteria. The details of the EPA's evaluation of
the MVEBs are provided in a memo to file for this rulemaking.\14\
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    \14\ See memo from John J. Kelly, Air Planning Office, EPA
Region 9, to Docket EPA-R09-OAR-2016-0096, dated August 5, 2016.
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    In accordance with the State's request and the EPA's evaluation,
with this action the EPA finds adequate and approves CO MVEBs for the
years 2015, 2020, 2025 and 2030. Upon the effective date of this
action, the Washoe County Regional Transportation Commission and the
U.S. Department of Transportation must use these budgets in future
conformity analyses. Any and all comments on the adequacy and
approvability of the 2015, 2020, 2025 or 2030 MVEBs should be submitted

during the comment period stated in the DATES section of this document.

E. Ambient Air Quality Monitoring Network

    The District has maintained an ambient air quality monitoring
network in Washoe County, including the Truckee Meadows area, in
accordance with the EPA's ambient air quality monitoring network
regulations in 40 CFR part 58. Monitors are operated by the District,
and they submit an Annual Network Plans (ANPs) for the County to the
EPA.
    The EPA is currently reviewing the 2016 ANP submitted by the
District.\15\ The EPA approved the District's previous ANPs, the most
recent three of which were submitted to the EPA by the District in
2013,\16\ 2014 \17\ and 2015.\18\ The docket to this action includes
these approvals and the associated ANPs, as well as the ANP currently
under review.
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    \15\ ``Washoe County Health District Air Quality Management
Division 2016 Ambient Air Monitoring Network Plan,'' dated July 1,
2016.
    \16\ ``Washoe County Health District Air Quality Management
Division 2013 Ambient Air Monitoring Network Plan,'' dated July 1,
2013 and our approval, letter from Meredith Kurpius, Manager, Air
Quality Analysis Office, U.S. EPA Region 9 to Daniel Inouye, Chief,
Monitoring and Planning Branch, Air Quality Management Division,
Washoe County Health District, dated December 11, 2013.
    \17\ ``Washoe County Health District Air Quality Management
Division 2014 Ambient Air Monitoring Network Plan,'' dated July 1,
2014 and our approval, letter from Meredith Kurpius, Manager, Air
Quality Analysis Office, U.S. EPA Region 9 to Daniel Inouye, Chief,
Monitoring and Planning, Air Quality Management Division, Washoe
County Health District, dated October 29, 2014.
    \18\ ``Washoe County Health District Air Quality Management
Division 2015 Ambient Air Monitoring Network Plan,'' dated July 1,
2015 and our approval, letter from Meredith Kurpius, Manager, Air
Quality Analysis Office, U.S. EPA Region 9 to Daniel Inouye, Chief,
Monitoring and Planning, Air Quality Management Division, Washoe
County Health District, dated October 21, 2015.
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    In addition to reviewing the District's ANPs, the EPA performs
Technical Systems Audits (TSAs) of ambient air monitoring programs in
accordance with 40 CFR part 58, appendix A, section 2.5, which requires
that the EPA conduct a TSA of each primary quality assurance
organization (PQAO) every three years. A PQAO is an organization that
is responsible for a set of stations that monitor the same pollutant
and for which data quality assessments can be pooled. The District is
the PQAO for CO monitoring in Washoe County, which includes the Truckee
Meadows area. See 40 CFR 58.1.
    The most recent TSA for the District was conducted by the EPA in
2016, but the report for that TSA has not yet been finalized. The most
recent TSA for which the final report is available was conducted in
2013. The EPA found that the District's air monitoring program was
robust and met the EPA's requirements. There were no findings that were
cause for data invalidation.\19\
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    \19\ See letter from Deborah Jordan, Director, U.S. EPA Region 9
Air Division, to Charlene Albee, Director, Air Quality Management
Division, Washoe County Health District, dated August 19, 2014,
transmitting a report titled ``Technical System Audit Report, Washoe
County Health District Air Quality Management Division Ambient Air
Monitoring Program (September 4-6, 2013).''
---------------------------------------------------------------------------

    In the 2014 Maintenance Plan, the District commits to continued
operation of its CO monitoring network, in accordance with 40 CFR part
58, to verify the attainment status of the Truckee Meadows area. See
2014 Maintenance Plan, page 8. In addition, the District will continue
to review the Washoe County CO monitoring network pursuant to 40 CFR
58.10 to ensure the network meets the monitoring objectives defined in
40 CFR part 58, appendix D. Funding for the monitoring network to meet
its objectives has been derived in the past primarily from CAA section
105 grants and the State's Department of Motor Vehicles. The District
commits to maintaining these funding sources. See 2014 Maintenance
Plan, page 8.
    The District commits to the continuation of collecting and quality-
assuring ambient CO monitoring data in accordance with 40 CFR part 58
and to providing the data to the EPA's AQS. The data will therefore be
available for public review. See 2014 Maintenance Plan, page 9.
    Table 6 lists the active Washoe County CO monitoring sites
identified in the Plan. See 2014 Maintenance Plan, page 9, Table 2-7.
As noted in the footnotes to the table, two of the monitoring sites
have since discontinued CO monitoring (i.e., South Reno and Galletti),
and the District has indicated that it intends to submit to the EPA a
request to shut down two more sites (i.e., Toll and Lemmon Valley). The
EPA notes that the Lemmon Valley monitoring site is within Washoe
County but is not located in the Truckee Meadows area.

            Table 6--Active Washoe County CO Monitoring Sites
------------------------------------------------------------------------
      Site ID             Site name         Site address        City
------------------------------------------------------------------------
32-031-0016........  Reno3.............  301A State Street  Reno.
32-031-0020........  South Reno *......  4110 DeLucchi      Reno.
                                          Lane.
32-031-0022........  Galletti *........  305 Galletti Way.  Reno.
32-031-0025........  Toll **...........  684A State Route   Reno.
                                          341.
32-031-1005........  Sparks............  750 4th Street...  Sparks.
32-031-2009........  Lemmon Valley **..  325 W. Patrician   Reno.
                                          Drive.
------------------------------------------------------------------------
* The District discontinued CO monitoring at the South Reno and Galletti
  monitoring sites in 2014. Details of these network modifications, as
  well as copies of the EPA's approval letters, can be found in the
  District's 2015 ANP (Appendices A and B).
** In its 2016 ANP, the District indicates it will seek EPA approval to
  discontinue CO monitoring at the Toll and Lemmon Valley monitoring
  sites, but will not discontinue monitoring at these locations without
  such approval. See the District's 2016 ANP.

    The District is required to maintain a CO monitor at the Reno3
site. See 40 CFR part 58, appendix D, section 3. Other CO monitoring
sites are not required for Washoe County by the EPA's minimum
monitoring requirements. See 40 CFR part 58, appendix D, section 4.2.
    Based on the information in the 2014 Maintenance Plan, as well as
recent ANPs and the 2013 TSA report, the EPA has determined that the
area's air quality monitoring network meets the requirements of the CAA
and implementing regulations in 40 CFR part 58.

F. Verification of Continued Attainment

    To support the District's continued operation and maintenance of
the Washoe County ambient CO monitoring network, the District also
commits to tracking actual CO emissions, in order to identify potential
increases in ambient CO concentration. The District has three existing
mechanisms to track CO emissions.
    1. Periodic Emissions Inventories. The District commits to
continuing to prepare and submit to the EPA a

comprehensive periodic CO emissions inventory on a triennial schedule.
Prior to submittal of the 2014 Maintenance Plan, the last periodic
emissions inventory prepared was for the year 2011. See 2014
Maintenance Plan, page 9. In addition, the District has prepared and
submitted to the EPA a periodic emissions inventory for the area for
2014.
    2. Consolidated Emissions Reporting Rule (CERR) and Air Emissions
Reporting Rule (AERR). The EPA's AERR (40 CFR part 51 subpart A), which
incorporates the former CERR, requires regular updates of point and
area emissions sources within Washoe County. The District commits to
continued compliance with the CERR and AERR. See 2014 Maintenance Plan,
page 10.
    3. Residential Wood Use Survey. RWC is a significant source of CO
emissions during the winter in Truckee Meadows. Between 1993 and 2013,
the District completed nine residential wood use surveys. These surveys
estimated the device (i.e., fireplace, woodstove and pellet stove)
population, the amount of wood burned, and CO emissions from RWC in
Washoe County. As part of the 2014 Maintenance Plan, the District
renews the commitment it made in the 2005 Maintenance Plan to conduct a
residential wood use survey at least once every three years. See 2014
Maintenance Plan, page 10.
    The EPA agrees with the District that continued ambient air
monitoring and emissions tracking will ensure verification of continued
attainment and maintenance of the 8-hour CO NAAQS within the Truckee
Meadows area.

G. Contingency Plan

    Section 175A of the CAA requires that a maintenance plan include
contingency provisions, as necessary, to promptly correct any violation
of a NAAQS that occurs after the redesignation to attainment of an area
for that NAAQS. As a maintenance area for CO, this requirement applies
to Truckee Meadows. According to the EPA's guidance,\20\ the
contingency plan for a maintenance area should clearly identify the
following:
---------------------------------------------------------------------------

    \20\ EPA's September 4, 1992 memorandum entitled ``Procedures
for Processing Requests to Redesignate Areas to Attainment,'' at
page 12, available online at: https://www.epa.gov/sites/production/files/2016-03/documents/calcagni_memo_-_procedures_for_processing_requests_to_redesignate_areas_to_attainment_090492.pdf.
---------------------------------------------------------------------------

 Specific indicators or triggers that will be used to determine
when contingency measures need to be implemented;
 contingency measures to be adopted;
 schedule and procedures for adoption and implementation; and
 specific time limit for action.

    The following is the EPA's analysis of the 2014 CO Maintenance
Plan's contingency plan regarding the above four criteria:
    The 2014 Maintenance Plan identifies significant sources that
contribute to the highest CO concentrations during the winter CO season
months, November through January. The 2014 Maintenance Plan includes a
two-tiered contingency plan based on ambient air monitoring data.
    As part of the EPA's approval into the SIP of the 2005 Maintenance
Plan, we approved a contingency plan for the area. Part of the
contingency plan (``Tier 1''), as discussed in greater detail below,
relies entirely on the area's emergency episode plan. Such plans are
required under CAA section 110(a)(2)(G). We approved the District's
emergency episode plan on June 18, 2007 (72 FR 33397).
1. Contingency Plan Tier 1
a. Specific Indicators or Triggers Which Will Be Used To Determine When
Contingency Measures Need To Be Implemented
    The Tier 1 trigger mechanism is a single exceedance of the 8-hour
CO standard, that is, a monitored concentration greater than or equal
to 9 ppm (9.5 ppm to adjust for rounding), at any State and Local Air
Monitoring Station (SLAMS), Special Purpose Monitoring (SPM) or
national Core Multi-Pollutant Monitoring Station (NCore) site operated
within Washoe County. The EPA notes that this trigger is protective of
the 8-hour CO NAAQS in three respects.
    First, it takes two non-overlapping CO exceedances to violate the
standard. The CAA requires that, at a minimum, contingency measures be
triggered when the standard is violated. In the 2014 Maintenance Plan,
the District is committing to triggering this Tier 1 portion of its
contingency plan with a single exceedance. This entails implementation
of a contingency measure upon an exceedance of the CO NAAQS, before the
NAAQS is violated.
    Second, the trigger for Tier 1 can occur at any monitor in the
County. This is more protective of the CO NAAQS than would otherwise be
required by the Act in that the District is required to trigger Tier 1
using an exceedance of any monitor in Washoe County, rather than
relying only on the monitors within the Truckee Meadows maintenance
area within the County.
    Third, implementation of Tier 1 would occur in the entire
jurisdiction of the District, that is, County-wide. Controls related to
the Stage 1 Alert episode would be implemented in the entire County,
which could benefit the Truckee Meadows area within the County.
b. The Contingency Measures To Be Adopted
    As we noted above, the EPA has already approved the District's
emergency episode plan into the SIP. This emergency plan currently is
triggered, independent of any contingency plan, during any monitored or
predicted concentration at a level of 9.4 ppm or above. Once the
emergency plan is triggered, the duration of its implementation depends
on the circumstances of the episode, regarding monitored and predicted
levels of CO.
    In the Tier 1 contingency measure, the District will initiate a
rulemaking to permanently lower the County-wide Stage 1 Alert
activation level from 9.4 ppm down to 9.0 ppm. The District will
initiate this rulemaking if a monitored CO concentration is above 9.4
ppm (i.e., 9.5 ppm or above). Monitors that can activate Tier 1 include
any monitor in the entire County, that is, not just within the Truckee
Meadows area. For informational purposes, Table 7 lists the actions the
District takes once a Stage 1 Alert level is either recorded or
predicted for the County. See 2014 Maintenance Plan, page 11. When Tier
1 is triggered, the District will initiate a specific rulemaking change
for adoption by the District's Board of Health (WCDBOH). In the event
Tier 1 is triggered, the District would initiate revision of WCDBOH
Regulation 050.001, Emergency Episode Plan (adopted March 23, 2006).
The rule revision would revise the Stage 1 Alert level from the current
level of 9.4 ppm down to the lower level of 9.0 ppm.

                 Table 7--Stage 1 Alert Episode Actions
------------------------------------------------------------------------
    Stage 1 alert episode action description       WCDBOH regulation No.
------------------------------------------------------------------------
Terminate open burning..........................  040.035 and 050.001.
Terminate use of incinerators subject to          050.001.
 District operating permits.
Curtailment of unnecessary motor vehicle use      050.001.
 through the District's public outreach program.
Prohibition of the burning of solid fuel in any   040.051 and 050.001.
 commercial or residential stoves and/or
 fireplaces with the Truckee Meadows area.
Curtailment of all District permitted sources     050.001.
 that have the potential to emit 50 tons or more
 of CO per year with the Truckee Meadows area.
------------------------------------------------------------------------

c. A Schedule and Procedures for Adoption and Implementation
    The implementation schedule the District identifies in the 2014
Maintenance Plan is meant to begin the rulemaking process promptly. The
rule revision must be adopted by the WCDBOH and implemented before the
next CO season (i.e., November, December and January).
    The District also commits to notify the EPA Region 9 office within
45 days of the triggering of tier 1. See 2014 Maintenance Plan, page
11.
d. A Specific Time Limit for Action
    The schedule discussed above provides a specific time limit for
action by the Board in that the rule revision is to be adopted and
implemented before the next CO season.
2. Contingency Plan Tier 2
a. Specific Indicators or Triggers Which Will Be Used To Determine When
Contingency Measures Need To Be Implemented
    The Tier 2 trigger mechanism is a second, non-overlapping
exceedance of the 8-hour CO standard (i.e., greater than or equal to
9.5 ppm to adjust for rounding) at any SLAMS, SPM or NCore site
operated within Washoe County. The EPA notes that only a second non-
overlapping exceedance at the same monitor would constitute a violation
of the 8-hour CO NAAQS, so this approach is more protective of the
standard than is required by the form of the standard itself. Also, the
EPA notes that this trigger is also more protective of the CO NAAQS
than is required because it goes beyond the boundary of the Truckee
Meadows area and encompasses the entire Washoe County District.
b. The Contingency Measures To Be Adopted
    For Tier 2, the District will maintain a list of potential
contingency measures and provide recommendations to the WCDBOH. The
District's recommendations to the Board will include a timeline for
adoption and implementation to promptly correct any violation of the CO
NAAQS. The list of Tier 2 potential contingency measures are shown in
Table 8. See 2014 CO Maintenance Plan, Table 2-8.

             Table 8--Tier 2 Potential Contingency Measures
------------------------------------------------------------------------
           Emission category              Potential contingency measure
------------------------------------------------------------------------
Residential Wood Combustion............   Increase one-acre lot
                                          size exemption.
                                          Mandatory curtailment
                                          at lower CO concentrations.
                                          Change-out program to
                                          cleaner-burning devices.
Mobile Sources.........................   Strengthen inspection
                                          and maintenance smog check
                                          program.
                                          Reinstate oxygenated
                                          fuels program.
                                          Non-road and on-road
                                          diesel engine repowers and
                                          rebuilds.
                                          Truck Stop
                                          Electrification systems.
                                          Fleet modernization.
                                          Strengthen maximum
                                          idling time for diesel
                                          vehicles.
------------------------------------------------------------------------

c. A Schedule and Procedures for Adoption and Implementation
    The implementation schedule the District identifies in the 2014
Maintenance Plan is meant to begin the rulemaking process promptly. No
later than 45 days after Tier 2 is triggered, recommendations shall be
presented to the Board at its next regularly scheduled meeting. The
District commits to review and update as necessary the list of
potential Tier 2 contingency measures at least once every three years.
See 2014 Maintenance Plan, page 12. The District also commits to notify
the EPA Region 9 office within 45 days of the triggering of Tier 2. See
2014 CO Maintenance Plan, page 12.
d. A Specific Time Limit for Action
    The schedule discussed above for Tier 2 implementation provides a
specific time limit for action by the Board. Rule revision
recommendations are to be presented to the Board within a set time
frame, and the Board will review and update the recommendations, as
necessary, but not less than once every three years. Further, the time
frame for the District to provide recommendations to the Board requires
the District to present at the Board's next scheduled meeting, but no
later than 45 days after triggering Tier 2. The Board typically meets
every month.
    Tier 2 also involves a regular review of CO control measures by the
District and the Board. This review occurs at least once every three
years regardless of whether there is an exceedance of the CO NAAQS.
3. Contingency Plan Conclusion
    The EPA agrees with the District that prompt action and
implementation of Tier 1 and Tier 2 contingency measures may prevent
future exceedances and violations of the 8-hour CO NAAQS. The EPA
believes the District's two-tiered contingency plan will promptly
address violations if they do occur. Triggering contingency measures at
monitored concentration levels that exceed, but do not violate the
standard, is an important component of this approach.

III. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, the EPA is fully
approving the State of Nevada's second 10-year

maintenance plan, titled ``Second 10-Year Maintenance Plan for the
Truckee Meadows 8-Hour Carbon Monoxide Attainment Area, August 28,
2014.'' We are also approving MVEBs for the years 2015, 2020, 2025 and
2030.
    We do not think anyone will object to these approvals, so we are
finalizing them without proposing them in advance. However, in the
Proposed Rules section of this Federal Register, we are simultaneously
proposing approval of the same submitted Plan and MVEBs. If we receive
adverse comments by September 29, 2016, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on October 31, 2016. This will incorporate this
plan into the federally enforceable SIP and require use of the new
MVEBs in all future CO conformity analyses.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:

 Is not a significant regulatory action subject to review by
the Office of Management and Budget under Executive Orders 12866 (58 FR
51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
 does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
 is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);
 does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
 does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
 is not an economically significant regulatory action based on
health or safety risks subject to Executive Order 13045 (62 FR 19885,
April 23, 1997);
 is not a significant regulatory action subject to Executive
Order 13211 (66 FR 28355, May 22, 2001);
 is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
 does not provide the EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 31, 2016. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the Proposed
Rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that the EPA can withdraw this direct final rule and address the
comment in the proposed rulemaking. This action may not be challenged
later in proceedings to enforce its requirements (see section
307(b)(2)).

List of Subjects in 40 CFR Part 52

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

    Dated: August 15, 2016.
Alexis Strauss,
Acting Regional Administrator, Region IX.

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

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart DD--Nevada

0
2. Section 52.1470, paragraph (e) is amended by adding, under the table
heading ``Air Quality Implementation Plan for the State of Nevada'' a
new entry after the entry ``Redesignation Request and Maintenance Plan
for the Truckee Meadows Carbon Monoxide Non-Attainment Area (September
2005), excluding appendices B, C, and D'' to read as follows:

Sec.  52.1470   Identification of plan.

* * * * *
    (e) * * *

                   EPA-Approved Nevada Nonregulatory Provisions and Quasi-Regulatory Measures
----------------------------------------------------------------------------------------------------------------
                                       Applicable         State
      Name of SIP provision          geographic or      submittal    EPA approval date         Explanation
                                   nonattainment area      date
----------------------------------------------------------------------------------------------------------------
                           Air Quality Implementation Plan for the State of Nevada \1\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Second 10-Year Maintenance Plan   Truckee Meadows,         11/7/14  [INSERT Federal      Fulfills requirement
 for the Truckee Meadows 8-Hour    Washoe County.                    Register CITATION]   for second ten-year
 Carbon Monoxide Attainment                                          (8/30/16).           maintenance plan.
 Area, August 28, 2014.                                                                   Includes motor vehicle
                                                                                emissions budgets for
                                                                                2015, 2020, 2025 and
                                                                                2030.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ The organization of this table generally follows from the organization of the State of Nevada's original
  1972 SIP, which was divided into 12 sections. Nonattainment and maintenance plans, among other types of plans,
  are listed under Section 5 (Control Strategy). Lead SIPs and Small Business Stationary Source Technical and
  Environmental Compliance Assistance SIPs are listed after Section 12 followed by nonregulatory or quasi-
  regulatory statutory provisions approved into the SIP. Regulatory statutory provisions are listed in 40 CFR
  52.1470(c).

* * * * *
[FR Doc. 2016-20662 Filed 8-29-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Rules and Regulations]
[Pages 1489-1492]
[FR Doc No: 2016-00011]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-1984; Directorate Identifier 2015-NM-022-AD;
Amendment 39-18363; AD 2016-01-04]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2005-01-09,
which applied to certain The Boeing Company Model 747-100, 747-100B,
747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D,
747-400F, and 747SR series airplanes. AD 2005-01-09 required a one-time
detailed inspection for discrepancies of the frame web and inner chords
on the forward edge frame of the number 5 main entry door cutout, and
corrective action if necessary. This new AD adds repetitive high
frequency eddy current (HFEC) inspections for cracking of the frame
inner chords (forward and aft), and corrective action if necessary.
This AD was prompted by additional cracking found in the same area
after completion of the one-time detailed inspection. We are issuing
this AD to detect and correct discrepancies of the frame web and inner
chords, which could result in cracking, subsequent severing of the
frame, and consequent rapid depressurization of the airplane.

DATES: This AD is effective February 17, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 17,
2016.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-1984.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1984; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

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

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2005-01-09, Amendment 39-13933 (70 FR 1340,
January 7, 2005). AD 2005-01-09 applied to certain The Boeing Company
Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F,
747-300, 747-400, 747-400D, 747-400F, and 747SR series airplanes. The
NPRM published in the Federal Register on June 24, 2015 (80 FR 36255)
(``the NPRM''). The NPRM was prompted by additional cracking found in
the same area after completion of the one-time detailed inspection. The
NPRM proposed to continue to require a one-time detailed inspection for
discrepancies of the frame web and inner chords on the forward edge
frame of the number 5 main entry door cutout, and corrective action if
necessary. The NPRM also proposed to require repetitive HFEC
inspections for cracking of the frame inner chords (forward and aft),
and corrective action if necessary. We are issuing this AD to detect
and correct discrepancies of the frame web and inner chords, which
could result in cracking, subsequent severing of the frame, and
consequent rapid depressurization of the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment. United Airlines concurred with the
NPRM.

Request for Credit for Accomplishing Certain Inspections Required by AD
2013-17-08, Amendment 39-17572 (78 FR 57053, September 17, 2013) (``AD
2013-17-08'')

    UPS asked that credit be included in the proposed AD (80 FR 36255,
June 24, 2015) for accomplishing the inspections required by AD 2013-
17-08. UPS stated that paragraph (g) of the proposed AD would require
accomplishing the same inspections that are required by AD 2013-17-08.
UPS added that the proposed AD has a lower threshold for accomplishing
the inspections than that in AD 2013-17-08. UPS noted that Boeing
confirmed that these inspections are duplicated and stated that a
revision of the service information may be forthcoming to provide
clarification.
    We agree with the commenter that accomplishing the inspections
required by AD 2013-17-08 before the effective date of this AD is
acceptable for compliance with the inspections required by this AD. We
had already included credit for accomplishing the inspections required
by AD 2013-17-08 in paragraph (i)(2) of the proposed AD.
    However, since the compliance time in AD 2013-17-08 is later than
the compliance time required by this AD, we have not given credit for
inspections that will be done for AD 2013-17-08 on or after the
effective date of this AD. Operators may apply for approval of an AMOC
in accordance with the provisions specified in paragraph (j) of this
AD, by submitting data substantiating that the request would provide an
acceptable level of safety. Therefore, we have made no further change
to this AD.

Request To Include Terminating Action

    UPS also recommended adding a sentence to paragraph (h) of the
proposed AD to terminate the repetitive inspections required by AD
2013-17-08, after accomplishment of the initial inspections required by
the proposed AD.
    We do not agree to specify that the actions required by paragraph
(h) of this AD terminate the repetitive inspections required by AD
2013-17-08, because those inspections are more extensive than the
inspections in this AD. However, affected operators who wish to
terminate the repetitive inspections required by AD 2013-17-08 may
apply for approval of an AMOC in accordance with the provisions
specified in paragraph (j) of this AD, by submitting data
substantiating that the request would provide an acceptable level of
safety. We have not changed this AD in this regard.

Request To Correct Typographical Error

    Boeing asked that a typographical error in the ``Related AD''
section of the proposed AD be corrected. Boeing stated that the
description of the inspection area in AD 2013-17-08 of the frame
segment should be changed from ``between 16 and 31'' to ``between 15
and 31.'' Boeing noted that this is a typographical error.
    We agree that there is a typographical error in the ``Related AD''
section of the proposed AD, as noted by the commenter. That section
should specify ``the frame segment between 15 and 31''; however, since
that section of the preamble does not reappear in the final rule, no
change to this AD is necessary in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed, with minor editorial changes. We have determined
that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed and approved Boeing Alert Service Bulletin 747-53A2494,
Revision 1, dated January 9, 2015. The service information describes
procedures for a one-time detailed inspection and repetitive surface
HFEC inspections of the Station 2231 frame inner chords (forward and
aft), and repair of discrepancies. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 174 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost    Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Detailed inspection..............  2 work-hours x $85             $0  $170................  $29,580.
                                    per hour = $170.
HFEC inspections.................  4 work-hours x $85              0  $340 per inspection   $59,160 per
                                    per hour = $340.                   cycle.                inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that will enable us to provide
a cost estimate for the on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2005-01-09, Amendment 39-13933 (70 FR 1340, January 7, 2005), and
adding the following new AD:

2016-01-04 The Boeing Company: Amendment 39-18363; Docket No. FAA-
2015-1984; Directorate Identifier 2015-NM-022-AD.

(a) Effective Date

    This AD is effective February 17, 2016.

(b) Affected ADs

    This AD replaces AD 2005-01-09, Amendment 39-13933 (70 FR 1340,
January 7, 2005) (``AD 2005-01-09'').

(c) Applicability

    This AD applies to The Boeing Company Model 747-100, -100B, 747-
100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D,
747-400F, and 747SR series airplanes; certificated in any category;
as identified in Boeing Alert Service Bulletin 747-53A2494, Revision
1, dated January 9, 2015.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of additional cracking found in
the same area after completion of the one-time detailed inspection.
We are issuing this AD to detect and correct discrepancies of the
frame web and inner chords, which could result in cracking,
subsequent severing of the frame, and consequent rapid
depressurization of the airplane.

(f) Compliance

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

(g) Inspections

    Do the applicable actions specified in paragraphs (g)(1),
(g)(2), (g)(3), and (g)(4) of this AD, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
53A2494, Revision 1, dated January 9, 2015, except as required by
paragraph (h)(2) of this AD.
    (1) At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 747-53A2494,
Revision 1, dated January 9, 2015, except as required by paragraph
(h)(1) of this AD: Do a detailed inspection for nicks, scratches, or
gouges of the Station 2231 frame inner chords, forward and aft, at
stringer 26 at the edge and side of the inner chords.
    (2) At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 747-53A2494,
Revision 1, dated January 9, 2015, except as required by paragraph
(h)(1) of this AD: Do a surface high frequency eddy current (HFEC)
inspection for cracks of the frame inner chords, forward and aft.
    (3) Based on the findings from the inspections specified in
paragraphs (g)(1) and (g)(2) of this AD, do all applicable
corrective actions, before further flight.
    (4) Repeat the HFEC inspection specified in paragraph (g)(2) of
this AD at the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 747-53A2494,
Revision 1, dated January 9, 2015.

(h) Exceptions to Service Bulletin Specifications

    (1) Where Boeing Alert Service Bulletin 747-53A2494, Revision 1,
dated January 9, 2015, specifies a compliance time ``after the
release of Revision 1 of this service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) Where Boeing Alert Service Bulletin 747-53A2494, Revision 1,
dated January 9, 2015, specifies to contact Boeing for repair
instructions: Before further flight, repair using a method approved
in accordance with the procedures specified in paragraph (j) of this
AD.

(i) Credit for Previous Actions

    (1) This paragraph provides credit for inspections required by
paragraph (g)(1) of this AD, if those inspections were performed
before the effective date of this AD using Boeing Alert Service
Bulletin 747-53A2494, dated September 18, 2003, which was
incorporated by reference in AD 2005-01-09.
    (2) This paragraph provides credit for inspections required by
paragraphs (g)(1) and (g)(2) of this AD, if those inspections were
performed before the effective date of this AD using Boeing Alert
Service Bulletin 747-53A2450, Revision 7, dated November 2, 2011,
which was incorporated by reference in AD 2013-17-08, Amendment 39-
17572 (78 FR 57053, September 17, 2013).

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization

Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane and the approval must
specifically refer to this AD.
    (4) AMOCs approved for AD 2005-01-09 are approved as AMOCs for
the corresponding provisions of paragraph (g)(1) of this AD.

(k) Related Information

    For more information about this AD, contact Nathan Weigand,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 747-53A2494, Revision 1, dated
January 9, 2015.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 28, 2015.
Philip Forde,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-00011 Filed 1-12-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
[Notices]
[Pages 53383-53384]
[FR Doc No: 2020-18951]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1767]

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee
and the Drug Safety and Risk Management 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 Joint Meeting of the
Psychopharmacologic Drugs Advisory Committee and the Drug Safety and
Risk Management 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 be held on October 9, 2020, from 8 a.m. to 5
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-1767. The docket will close on October
8, 2020. Submit either electronic or written comments on this public
meeting by October 8, 2020. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before October 8, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of October 8, 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 September 25, 2020, will be provided
to the committees. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is canceled, 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-1767 for ``Joint Meeting of the Psychopharmacologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
the ADDRESSES section), 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.'' 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: LaToya Bonner, 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 presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The
committees will discuss the efficacy, safety, and benefit-risk profile
of new drug application (NDA) 213378, olanzapine and samidorphan oral
tablets, submitted by Alkermes, Inc., for the proposed indications of
schizophrenia and bipolar disorder.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. 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. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before September 25, 2020, will be provided to
the committees. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit 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 September 16, 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 September 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 LaToya Bonner (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 24, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-18951 Filed 8-27-20; 8:45 am]
BILLING CODE 4164-01-P