[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Rules and Regulations]
[Page 9828]
[FR Doc No: C1-2012-22975]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2009-0648; FRL-9728-7]

Approval and Promulgation of Implementation Plans; New Mexico;
Albuquerque/Bernalillo County: Infrastructure and Interstate Transport
Requirements for the 1997 and 2008 Ozone and the 1997 and 2006
PM2.5 NAAQS

Correction

0
In rule document 2012-22975 beginning on page 58032 in the issue of
Wednesday, September 19, 2012, make the following corrections:

Sec.  52.1620  [Corrected]

    Due to an error in the EPA approval date, the table entitled ``EPA-
APPROVED ALBUQUERQUE/BERNALILLO COUNTY, NM REGULATIONS'' on pages 58034
and 58035 is being reprinted in its entirety to read as follows:

                           EPA-Approved Albuquerque/Bernalillo County, NM Regulations
----------------------------------------------------------------------------------------------------------------
                                                             State
          State citation              Title/subject        approval/     EPA approval date       Explanation
                                                        effective date
----------------------------------------------------------------------------------------------------------------
   New Mexico Administrative Code (NMAC) Title 20--Environment Protection, Chapter 11--Albuquerque/Bernalillo
                                        County Air Quality Control Board
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Part 8 (20.11.8 NMAC)............  Ambient Air Quality       8/12/2009  September 19, 2012,  ...................
                                    Standards.                           [Insert FR page
                                                                         number where
                                                                         document begins].

                                                  * * * * * * *
Part 61 (20.11.61 NMAC)..........  Prevention of             1/10/2011  September 19, 2012,  ...................
                                    Significant                          [Insert FR page
                                    Deterioration.                       number where
                                                                         document begins].

                                                  * * * * * * *
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[FR Doc. C1-2012-22975 Filed 2-11-13; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Proposed Rules]
[Pages 29705-29712]
[FR Doc No: 2014-11511]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2013-0823; FRL-9911-04-Region 9]

Approval of Air Quality Implementation Plan Revisions; State of
California; South Coast VMT Emissions Offset Demonstrations

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submitted by the
State of California to meet the vehicle miles traveled emissions offset
requirement under the Clean Air Act for the 1-hour ozone and 1997 8-
hour ozone national ambient air quality standards (NAAQS) in the Los
Angeles-South Coast Air Basin. The EPA is proposing to approve this
revision because it demonstrates that California has put in place
specific enforceable transportation control strategies and
transportation control measures to offset the growth in emissions from
the growth in vehicle miles traveled and vehicle trips in the South
Coast, and thereby meets the applicable requirements of the Clean Air
Act. The EPA is taking comments on this proposal and plans to follow
with a final action.

DATES: Any comments must be submitted by June 23, 2014.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2013-0823, by one of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow
the on-line instructions.
     Email<EMAIL_ADDRESS>     Mail or Deliver: John Ungvarsky, Air Planning Office (AIR-
2), U.S. Environmental Protection Agency Region IX, 75 Hawthorne
Street, San Francisco, CA 94105.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
The www.regulations.gov Web site is an ``anonymous access'' system, and
the EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send email directly to
the EPA, your email address will be automatically captured and included
as part of the public comment. If the EPA cannot read your comments due
to technical difficulties and cannot contact you for clarification, the
EPA may not be able to consider your comment.
    Docket: The index to the docket for this action is available
electronically on the www.regulations.gov Web site and in hard copy at
EPA Region IX, 75 Hawthorne Street, San Francisco, California, 94105.
While all documents in the docket are listed in the index, some
information may be publicly available only at the hard copy location
(e.g., copyrighted material), and some may not be publicly available at
either location (e.g., CBI). To inspect the hard copy materials, please
schedule an appointment during normal business hours with the contact
listed in the FOR FURTHER INFORMATION CONTACT section below.

FOR FURTHER INFORMATION CONTACT: John Ungvarsky, Air Planning Office
(AIR-2), U.S. Environmental Protection Agency, Region IX, (415) 972-
3963<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Regulatory Background
    A. Ozone National Ambient Air Quality Standards
    B. South Coast Ozone Designations and Classifications
    C. Previous South Coast VMT Emissions Offset Demonstrations
II. Submittal of Revised South Coast VMT Emissions Offset
Demonstrations
    A. 2012 South Coast AQMP and CARB's Technical Supplement
    B. CAA Procedural Requirements for Submittals of SIPs and SIP
Revisions
III. Evaluation of Revised South Coast VMT Emissions Offset
Demonstrations
    A. Section 182(d)(1)(A) and the EPA's August 2012 VMT Emissions
Offset Demonstration Guidance
    B. Revised South Coast VMT Emissions Offset Demonstrations
IV. EPA's Proposed Action and Request for Public Comment
V. Statutory and Executive Order Reviews

I. Regulatory Background

A. Ozone National Ambient Air Quality Standards

    Ground-level ozone is formed when oxides of nitrogen
(NOX) and volatile organic compounds (VOC) react in the
presence of sunlight. These two pollutants, referred to as ozone
precursors, are emitted by many types of pollution sources, including
on- and off-road motor vehicles and engines, power plants and
industrial facilities, and smaller area sources such as lawn and garden
equipment and paints.
    Scientific evidence indicates that adverse public health effects
occur following exposure to ozone, particularly in children and adults
with lung disease. Breathing air containing ozone can reduce lung
function and inflame airways, which can increase respiratory symptoms
and aggravate asthma or other lung diseases. Ozone exposure also has
been associated with increased susceptibility to respiratory
infections, medication use, doctor visits, and emergency department
visits and hospital admissions for individuals with lung disease. Ozone
exposure also increases the risk of premature death from heart or lung
disease. Children are at increased risk from exposure to ozone because
their lungs are still developing and they are more likely to be active
outdoors, which increases their exposure.
    In 1979, under section 109 of the Clean Air Act (CAA or Act), the
EPA established primary and secondary national ambient air quality
standards (NAAQS, standards, or standard) for ozone at 0.12 parts per
million (ppm) averaged over a 1-hour period (referred to herein as the
``1-hour ozone standard'' or ``1-hour ozone NAAQS''). See 44 FR 8202
(February 8, 1979).
    In 1997, the EPA revised the ozone NAAQS to set the acceptable
level of ozone in the ambient air at 0.08 ppm, averaged over an 8-hour
period (referred to herein as the ``1997 8-hour ozone standard'' or
``1997 8-hour ozone NAAQS''). See 62 FR 38856 (July 18, 1997). The EPA
set the 8-hour ozone standard based on scientific evidence
demonstrating that ozone causes adverse health effects at lower
concentrations and over longer periods of time than was understood when
the previous 1-hour ozone standard was set. The EPA determined that the
8-hour ozone standard would be more protective of human health,
especially children and adults who are active outdoors, and individuals
with a pre-

existing respiratory disease, such as asthma.
    In 2008 (73 FR 16436, March 27, 2008), the EPA revised and further
strengthened the primary and secondary NAAQS for ozone by setting the
acceptable level of ozone in the ambient air at 0.075 ppm, averaged
over an 8-hour period (``2008 8-hour ozone standard''). Today's
proposed action relates only to the 1-hour and 1997 8-hour ozone
standards and does not relate to the 2008 8-hour ozone standard.

B. South Coast Ozone Designations and Classifications

    Section 107 of the CAA requires the EPA to designate all areas of
the country as nonattainment, attainment, or unclassifiable for each of
the NAAQS, depending upon whether such areas experience violations of
the NAAQS or contribute to violations in a nearby area. In the late
1970s, the EPA designated the Los Angeles-South Coast Air Basin Area
(South Coast) \1\ as nonattainment for the 1-hour ozone NAAQS. Under
the 1990 CAA Amendments, ozone nonattainment areas were further
classified, based on the severity of their nonattainment problem, as
``Marginal'', ``Moderate,'' ``Serious,'' ``Severe,'' \2\ or
``Extreme,'' and the South Coast was classified as ``Extreme''
nonattainment for the 1-hour ozone standard. See 56 FR 56694 (November
6, 1991).
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    \1\ The South Coast includes Orange County, the southwestern
two-thirds of Los Angeles County, southwestern San Bernardino
County, and western Riverside County. The South Coast is home to
approximately 17 million people, has a diverse economic base, and
contains one of the highest-volume port areas in the world. For a
precise description of the geographic boundaries of the South Coast,
please see 40 CFR 81.305.
    \2\ In EPA's final rule to classify nonattainment areas for the
1-hour ozone standard, Severe areas were classified as either
Severe-15 or Severe-17 based on their design value. See 56 FR 56694
(November 6, 1991).
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    In 2004, the EPA designated areas of the country with respect to
the 1997 8-hour ozone standard, 69 FR 23858 (April 30, 2004), and the
EPA designated the South Coast as ``Severe-17'' \3\ for the 1997 ozone
standard, but later granted the State of California's request to
reclassify the South Coast to ``Extreme'' for that standard. See 75 FR
24409 (May 5, 2010).
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    \3\ In EPA's final rule to classify nonattainment areas for the
1997 8-hour ozone standard, Severe areas were classified as either
Severe-15 or Severe-17 based on their design value. See 69 FR 23858
(April 30, 2004).
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C. Previous South Coast VMT Emissions Offset Demonstrations

    Once the EPA has promulgated a NAAQS, states are required to
develop and submit plans that provide for the implementation,
maintenance, and enforcement of the NAAQS under CAA section 110(a)(1).
The content requirements for such plans, which are referred to as state
implementation plans (SIPs) are found in CAA section 110(a)(2). The CAA
further requires states with nonattainment areas to submit revisions to
their SIPs that provide for, among other things, attainment of the
relevant standard within certain prescribed periods.
    In California, as a general matter, the California Air Resources
Board (CARB) is responsible for adoption and submittal to the EPA of
California SIPs and California SIP revisions and is the primary State
agency responsible for regulation of mobile sources. Local and regional
air pollution control districts are responsible for developing regional
air quality plans and for regulation of stationary sources. For the
South Coast, the South Coast Air Quality Management District (SCAQMD or
District) develops and adopts air quality management plans (AQMPs) to
address CAA SIP planning requirements applicable to that region.
Generally, such AQMPs are then submitted to CARB for adoption and
submittal to the EPA as revisions to the California SIP.
    Under the CAA, as amended in 1990, the control requirements and
date by which attainment of the 1-hour ozone standard was to be
achieved varied with an area's classification. ``Extreme'' areas, such
as the South Coast, were subject to the most stringent planning
requirements but were provided the most time to attain the standard
(i.e., until 2010). The various ozone planning requirements to which
``Extreme'' ozone nonattainment areas were subject are set forth in
section 172(c) and section 182(a)-(e) of the CAA.
    The specific ozone planning requirement that is relevant for the
purposes of this action is CAA section 182(d)(1)(A), which, in relevant
part, requires the state, if subject to its requirements, to ``submit a
revision that identifies and adopts specific enforceable transportation
control strategies and transportation control measures to offset any
growth in emissions from growth in vehicle miles traveled or numbers of
vehicle trips in such area.'' \4\ Herein, we use ``VMT'' to refer to
vehicle miles traveled and refer to the related SIP requirement as the
``VMT emissions offset requirement.'' In addition, we refer to the SIP
revision intended to demonstrate compliance with the VMT emissions
offset requirement as the ``VMT emissions offset demonstration.''
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    \4\ CAA section 182(d)(1)(A) includes three separate elements.
Please see the related discussion in our proposed rule withdrawing
our previous approvals of the South Coast VMT emissions offset
demonstrations and disapproving the same at 77 FR 58067, at 58068
(September 19, 2012). This proposed action relates only to the first
element of CAA section 182(d)(1)(A) (i.e., the VMT emissions offset
requirement).
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    As described above, in 1997, the EPA revised the ozone NAAQS and
established the 1997 8-hour ozone NAAQS. Under the EPA's Phase I rules
governing the transition from the 1-hour ozone standard to the 1997 8-
hour ozone standard, the EPA revoked the 1-hour ozone standard
effective June 2005 but also established ``anti-backsliding''
provisions that, in effect, carried forward most of the SIP
requirements that had applied to an area by virtue of its 1-hour ozone
classification to areas designated as nonattainment for the 1997 8-hour
ozone standard. See 69 FR 23951 (April 30, 2004); 40 CFR 51.905(a)(1);
and 40 CFR 51.900(f). The VMT emission offset requirement is one of the
requirements carried forward; thus, the South Coast, which is
designated nonattainment for the 1997 8-hour ozone standard, remains
subject to the VMT emissions offset requirement for the 1-hour ozone
standard, notwithstanding the revocation of that standard in 2005.
Moreover, the South Coast is also subject to the VMT emissions offset
requirement for the 1997 8-hour ozone standard by virtue of its
classification, initially as ``Severe-17'' and later as ``Extreme,''
for the 1997 ozone standard. See 69 FR 23858 (April 30, 2004); 70 FR
71612 (November 29, 2005); 75 FR 24409 (May 5, 2010); and 40 CFR
51.902(a).
    In 2008, to comply with the VMT emissions offset requirement for
the 1-hour ozone standard, the SCAQMD submitted a demonstration showing
decreases in aggregate year-over-year motor vehicle emissions in the
South Coast from a base year (1990) through the applicable attainment
year (2010).\5\ The following year, the EPA approved the South Coast 1-
hour ozone VMT emissions offset demonstration as meeting the VMT
emissions offset requirement of CAA section 182(d)(1)(A). See 74 FR
10176 (March 10, 2009). The EPA also approved the South Coast VMT
emissions offset demonstration submitted in connection with the area's
``Extreme'' classification for the 1997 8-hour ozone standard. See 77
FR 12674 (March 1, 2012). Once again, the approved demonstration showed
decreases in aggregate year-

over-year motor vehicle emissions in the South Coast from a base year
through the applicable attainment year.\6\
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    \5\ Letter from Elaine Chang, Deputy Executive Officer, SCAQMD,
dated September 10, 2008.
    \6\ See the SCAQMD's Final 2007 Air Quality Management Plan
(June 2007) for the South Coast Air Basin, chapter 6, table 6-12.
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    In approving the South Coast VMT emissions offset demonstrations in
2009 and 2012, the EPA applied its then-longstanding interpretation of
the VMT emissions offset requirement, first explained in guidance in
the General Preamble to Title I of the Clean Air Act (see 57 FR 13498,
at 13521-13523, April 16, 1992), that no transportation control
measures are necessary if aggregate motor vehicle emissions are
projected to decline each year from the base year of the plan to the
attainment year. See 74 FR 10176, at 10179-10180 (March 10, 2009); 76
FR 57872, at 57889 (September 16, 2011). However, in response to a
legal challenge brought in the U.S. Court of Appeals for the Ninth
Circuit, the Court ruled against the EPA's approval of the South Coast
VMT emissions offset demonstration for the 1-hour ozone standard,
determining that the EPA incorrectly interpreted the statutory phrase
``growth in emissions'' in section 182(d)(1)(A) as meaning a growth in
``aggregate motor vehicle emissions'' versus a growth solely from VMT.
Essentially, the Court ruled that additional transportation control
measures are required whenever vehicle emissions are projected to be
higher than they would have been had VMT not increased, even when
aggregate vehicle emissions are actually decreasing. However, the Court
acknowledged that ``clean car technology'' advances could result in
there being no increase in emissions even in the face of VMT growth,
which would then allow VMT to increase without triggering the
requirement to adopt offsetting transportation control measures.
Association of Irritated Residents v. EPA, 632 F.3d. 584, at 596-597
(9th cir. 2011), reprinted as amended on January 27, 2012, 686 F.3d
668, further amended February 13, 2012.
    Based on this reasoning, the Court remanded the approval of the
South Coast VMT emissions offset demonstration for the 1-hour ozone
standard back to the EPA for further proceedings consistent with the
opinion. In response, we withdrew our approval of the South Coast VMT
emissions offset demonstration for the 1-hour ozone standard and
disapproved it. See 78 FR 18849 (March 28, 2013). Furthermore, because
our approval of the South Coast VMT emissions offset demonstration for
the 1997 8-hour ozone standard was predicated on the same rationale as
the corresponding South Coast demonstration for the 1-hour ozone
standard that was rejected by the Ninth Circuit, we withdrew our
approval of the South Coast VMT emissions offset demonstration for the
1997 8-hour ozone standard and disapproved it as well. Id.
    Specifically, we withdrew our previous approvals of the VMT
emissions offset demonstrations and disapproved the same because we
found that the submitted VMT emissions offset demonstrations were not
consistent with the Court's ruling on the requirements of section
182(d)(1)(A) because they failed to identify, compared to a baseline
assuming no VMT growth, the level of ``increased'' emissions, within
the overall set of declining aggregate motor vehicle emissions,
resulting solely from VMT growth and to show how such relatively higher
emissions, compared to what they would have been had VMT held constant,
have been offset through adoption and implementation of transportation
control strategies and transportation control measures. See 77 FR
58067, at 58070 (September 19, 2012).\7\
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    \7\ For a more detailed discussion of the regulatory and SIP
submittal history of the South Coast Air Basin 1-hour and 8-hour
nonattainment areas with respect to the VMT emissions offset
requirement under CAA section 182(d)(1)(A), the South Coast VMT
emissions offset demonstrations, the related EPA actions, and the
ensuing litigation and Court decision, please see our rule proposing
to disapprove our previous approvals of the South Coast emissions
offset demonstrations and disapproval of the same at 77 FR 58067, at
58068-58070 (September 19, 2012).
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II. Submittal of Revised South Coast VMT Emissions Offset
Demonstrations

A. 2012 South Coast AQMP and CARB's Technical Supplement

    As described above, in March 2013, the EPA finalized the withdrawal
of its previous approvals of SIP revisions submitted by the State of
California to meet the VMT emissions offset requirement under the CAA
for the South Coast 1-hour and 1997 8-hour ozone nonattainment areas.
See 78 FR 18849 (March 28, 2013). In response, CARB and the SCAQMD
(``State'') prepared and adopted revised South Coast VMT emissions
offset demonstrations to show compliance with the VMT emissions offset
requirement under section 182(d)(1)(A) for the 1-hour and 1997 8-hour
ozone standards consistent with the Court's opinion in the Association
of Irritated Residents case discussed above.
    On February 13, 2013, CARB submitted, as a revision to the
California SIP, the Final 2012 Air Quality Management Plan (December
2012) (``2012 South Coast AQMP'') for the South Coast Air Basin (``2012
South Coast AQMP''), adopted by SCAQMD on December 21, 2012 and by CARB
on January 25, 2013.\8\ The revised South Coast VMT emissions offset
demonstrations, which are the subject of today's proposed action, are
included in the February 13, 2013 SIP revision submittal as appendix
VIII, titled ``Vehicle Miles Traveled Emissions Offset Demonstration''
(February 2013), to the 2012 South Coast AQMP. In this document, we are
proposing action only on the revised South Coast VMT emissions offset
demonstrations contained in appendix VIII of the 2012 South Coast AQMP.
The EPA will take action on the other portions of the 2012 South Coast
AQMP, including the revised South Coast 1-hour ozone attainment
demonstration found in appendix VII to 2012 South Coast AQMP, in
separate rulemakings.
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    \8\ See CARB Resolution 13-3 (January 25, 2013) and letter from
James N. Goldstene, Executive Officer, CARB, to Jared Blumenfeld,
Regional Administrator, EPA Region 9, letter with enclosures
(February 13, 2013).
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    The revised South Coast VMT emissions offset demonstrations address
the requirement under CAA section 182(d)(1)(A) for a state with ozone
nonattainment areas classified as ``Severe'' or ``Extreme'' to identify
and adopt specific enforceable transportation control strategies and
transportation control measures to offset any growth in emissions from
growth in VMT or the numbers of vehicle trips. The demonstrations
include analyses for the 1-hour ozone and 1997 8-hour ozone standards.
    On April 3, 2014, CARB submitted a technical supplement to the
revised South Coast VMT emissions offset demonstration submitted on
February 13, 2013 (``technical supplement''). See letter and enclosures
from Lynn Terry, Deputy Executive Officer, CARB, to Deborah Jordan,
Director, Air Division, EPA Region 9. CARB's technical supplement
includes a revised set of motor vehicle emissions estimates reflecting
technical changes to the inputs used to develop the original set of
calculations.\9\ While the vehicle

emissions estimates in CARB's technical supplement differ from those
contained in the demonstration as submitted on February 13, 2013, the
conclusions of the analysis remain the same.
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    \9\ The principal difference between the two sets of
calculations is that CARB's technical supplement includes running
exhaust, start exhaust, hot soak, and running loss emissions of VOCs
in all of the emissions scenarios. These processes are directly
related to VMT and vehicle trips. The revised calculation excludes
diurnal and resting loss emissions of VOCs from all of the emissions
scenarios because such evaporative emissions are related to vehicle
population rather than to VMT or vehicle trips.
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B. CAA Procedural Requirements for Submittals of SIPs and SIP Revisions

    CAA section 110(a)(1) and (2) and CAA section 110(l) require a
state to provide reasonable public notice and opportunity for public
hearing prior to the adoption and submission of a SIP or SIP revision.
To meet this requirement, every SIP submittal should include evidence
that adequate public notice was given and an opportunity for a public
hearing was provided consistent with the EPA's implementing regulations
in 40 CFR 51.102.
    CARB and the District have satisfied applicable statutory and
regulatory requirements for reasonable public notice and hearing prior
to adoption and submittal of the 2012 South Coast AQMP, which as noted
above, included the revised South Coast VMT emissions offset
demonstrations as appendix VIII to the plan. The District provided a
public comment period and held a public hearing prior to the adoption
of the 2012 South Coast AQMP on December 7, 2012.\10\ CARB provided the
required public notice and opportunity for public comment prior to its
January 25, 2013 public hearing on the plan.\11\
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    \10\ See SCAQMD Governing Board Resolution No. 12-19.
    \11\ See CARB Board Resolution No. 13-3.
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    The SIP submittal includes notices of the District and CARB public
hearings as evidence that all hearings were properly noticed. We
therefore find that the submittals meet the procedural requirements of
CAA sections 110(a) and 110(l).

III. Evaluation of Revised South Coast VMT Emissions Offset
Demonstrations

A. Section 182(d)(1)(A) and the EPA's August 2012 VMT Emissions Offset
Demonstration Guidance

    As noted previously, the first element of CAA section 182(d)(1)(A)
requires that areas classified as ``Severe'' or ``Extreme'' submit a
SIP revision that identifies and adopts transportation control
strategies and transportation control measures sufficient to offset any
growth in emissions from growth in VMT or the number of vehicle trips.
In response to the Court's decision in Association of Irritated
Residents v. EPA, also discussed above, the EPA issued a memorandum
titled Guidance on Implementing Clean Air Act Section 182(d)(1)(A):
Transportation Control Measures and Transportation Control Strategies
to Offset Growth in Emissions Due to Growth in Vehicle Miles Travelled
(herein referred to as the ``August 2012 guidance'').\12\
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    \12\ Memorandum from Karl Simon, Director, Transportation and
Climate Division, Office of Transportation and Air Quality, to Carl
Edland, Director, Multimedia Planning and Permitting Division, EPA
Region 6, and Deborah Jordan, Director, Air Division, EPA Region 9,
August 30, 2012.
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    The August 2012 Guidance discusses the meaning of the terms,
``transportation control strategies'' (TCSs) and ``transportation
control measures'' (TCMs), and recommends that both TCSs and TCMs be
included in the calculations made for the purpose of determining the
degree to which any hypothetical growth in emissions due to growth in
VMT should be offset. Generally, TCSs is a broad term that encompasses
many types of controls including, for example, motor vehicle emission
limitations, inspection and maintenance (I/M) programs, alternative
fuel programs, other technology-based measures, and TCMs, that would
fit within the regulatory definition of ``control strategy.'' See,
e.g., 40 CFR 51.100(n). TCMs are defined at 40 CFR 51.100(r) as meaning
``any measure that is directed toward reducing emissions of air
pollutants from transportation sources. Such measures include, but are
not limited to those listed in section 108(f) of the Clean Air Act[,]''
and generally refer to programs intended to reduce the VMT, the number
of vehicle trips, or traffic congestion, such as programs for improved
public transit, designation of certain lanes for passenger buses and
high-occupancy vehicles (HOVs), trip reduction ordinances, and the
like.
    The August 2012 guidance explains how states may demonstrate that
the VMT emissions offset requirement is satisfied in conformance with
the Court's ruling. States are recommended to estimate emissions for
the nonattainment area's base year and the attainment year. One
emission inventory is developed for the base year, and three different
emissions inventory scenarios are developed for the attainment year.
For the attainment year, the state would present three emissions
estimates, two of which would represent hypothetical emissions
scenarios that would provide the basis to identify the ``growth in
emissions'' due solely to the growth in VMT, and one that would
represent projected actual motor vehicle emissions after fully
accounting for projected VMT growth and offsetting emissions reductions
obtained by all creditable TCSs and TCMs. See the August 2012 guidance
for specific details on how states might conduct the calculations.
    The base year on-road VOC emissions should be based on VMT in that
year and it should reflect all enforceable TCSs and TCMs in place in
the base year. This would include vehicle emissions standards, state
and local control programs such as I/M programs or fuel rules, and any
additional implemented TCSs and TCMs that were already required by or
credited in the SIP as of that base year.
    The first of the emissions calculations for the attainment year
would be based on the projected VMT and trips for that year, and assume
that no new TCSs or TCMs beyond those already credited in the base year
inventory have been put in place since the base year. This calculation
demonstrates how emissions would hypothetically change if no new TCSs
or TCMs were implemented, and VMT and trips were allowed to grow at the
projected rate from the base year. This estimate would show the
potential for an increase in emissions due solely to growth in VMT and
trips. This represents a ``no action'' taken scenario. Emissions in the
attainment year in this scenario may be lower than those in the base
year due to the fleet that was on the road in the base year gradually
being replaced through fleet turnover; however, provided VMT and/or
numbers of vehicle trips will in fact increase by the attainment year,
they would still likely be higher than they would have been assuming
VMT had held constant.
    The second of the attainment year's emissions calculations would
also assume that no new TCSs or TCMs beyond those already credited have
been put in place since the base year, but would also assume that there
was no growth in VMT and trips between the base year and attainment
year. This estimate reflects the hypothetical emissions level that
would have occurred if no further TCMs or TCSs had been put in place
and if VMT and trip levels had held constant since the base year. Like
the ``no action'' attainment year estimate described above, emissions
in the attainment year may be lower than those in the base year due to
the fleet that was on the road in the base year gradually being
replaced by cleaner vehicles through fleet turnover, but in this case
they would not be influenced by any growth in VMT or trips. This
emissions estimate would reflect a ceiling on the attainment emissions
that should be allowed to occur under the statute as interpreted by the
Court because it shows what would happen under a scenario in which no
offsetting TCSs or TCMs have yet been

put in place and VMT and trips are held constant during the period from
the area's base year to its attainment year. This represents a ``VMT
offset ceiling'' scenario. These two hypothetical status quo estimates
are necessary steps in identifying the target level of emissions from
which states would determine whether further TCMs or TCSs, beyond those
that have been adopted and implemented in reality, would need to be
adopted and implemented in order to fully offset any increase in
emissions due solely to VMT and trips identified in the ``no action''
scenario.
    Finally, the state would present the emissions that are actually
expected to occur in the area's attainment year after taking into
account reductions from all enforceable TCSs and TCMs that in reality
were put in place after the baseline year. This estimate would be based
on the VMT and trip levels expected to occur in the attainment year
(i.e., the VMT and trip levels from the first estimate) and all of the
TCSs and TCMs expected to be in place and for which the SIP will take
credit in the area's attainment year, including any TCMs and TCSs put
in place since the base year. This represents the ``projected actual''
attainment year scenario. If this emissions estimate is less than or
equal to the emissions ceiling that was established in the second of
the attainment year calculations, the TCSs or TCMs for the attainment
year would be sufficient to fully offset the identified hypothetical
growth in emissions.
    If, instead, the estimated projected actual attainment year
emissions are still greater than the ceiling which was established in
the second of the attainment year emissions calculations, even after
accounting for post-baseline year TCSs and TCMs, the state would need
to adopt and implement additional TCSs or TCMs to further offset the
growth in emissions and bring the actual emissions down to at least the
``had VMT and trips held constant'' ceiling estimated in the second of
the attainment year calculations, in order to meet the VMT offset
requirement of section 182(d)(1)(A) as interpreted by the Court.

B. Revised South Coast VMT Emissions Offset Demonstrations

    For the revised South Coast VMT emissions offset demonstrations,
the State used EMFAC2011, the latest EPA-approved motor vehicle
emissions model for California.\13\ The EMFAC2011 model estimates the
on-road emissions from two combustion processes (i.e., running exhaust
and start exhaust) and four evaporative processes (i.e., hot soak,
running losses, diurnal losses, and resting losses). The EMFAC2011
model combines trip-based VMT data from the regional transportation
planning agencies (i.e., Southern California Association of
Governments), starts data based on household travel surveys, and
vehicle population data from the California Department of Motor
Vehicles. These sets of data are combined with corresponding emission
rates to calculate emissions.
---------------------------------------------------------------------------

    \13\ See 78 FR 14533 (March 6, 2013) regarding the EPA's
approval of the 2011 version of the California EMFAC model (short
for EMissionFACtor) and announcement of its availability. The
software and detailed information on the EMFAC vehicle emission
model can be found on the following CARB Web site: http://www.arb.ca.gov/msei/msei.htm.
---------------------------------------------------------------------------

    Emissions from running exhaust, start exhaust, hot soak, and
running losses are a function of how much a vehicle is driven. As such,
emissions from these processes are directly related to VMT and vehicle
trips, and the State included emissions from them in the calculations
that provide the basis for the revised South Coast VMT emissions offset
demonstrations. The State did not include emissions from resting loss
and diurnal loss processes in the analysis because such emissions are
related to vehicle population, not to VMT or vehicle trips, and thus
are not part of ``any growth in emissions from growth in vehicle miles
traveled or numbers of vehicle trips in such area'' (emphasis added)
under CAA section 182(d)(1)(A).
    The revised South Coast VMT emissions offset demonstrations address
both the 1-hour ozone standard and the 1997 8-hour ozone standard and
include two different ``base year'' scenarios: 1990, for the purposes
of the VMT emissions offset demonstration for the 1-hour ozone
standard, and 2002, for the purposes of the VMT emissions offset
demonstration for the 1997 8-hour ozone standard. The ``base year'' for
VMT emissions offset demonstration purposes should generally be the
same ``base year'' used for nonattainment planning purposes. In 2012,
the EPA approved the 2002 base year inventory for the South Coast for
the purposes of the 1997 8-hour ozone standard, 77 FR 12674, at 12693
(March 1, 2012), and thus, the State's selection of 2002 as the base
year for the revised South Coast VMT emissions offset demonstration for
the 1997 8-hour ozone standard is appropriate. With respect to the 1-
hour ozone standard, the revised South Coast attainment demonstration,
submitted to the EPA on February 13, 2013, relies on a base year of
2008, rather than 1990; however, the State's selection of 1990 as the
base year for the VMT offset demonstration is appropriate because 1990
was used as the base year for 1-hour ozone SIP planning purposes under
the CAA Amendments of 1990, which established, among other
requirements, the VMT emissions offset requirement in section
182(d)(1)(A).
    The demonstrations also include the previously described three
different attainment year scenarios (i.e., no action, VMT offset
ceiling, and projected actual) but the attainment year differs between
the two demonstrations. Year 2022 was selected as the attainment year
for the revised VMT emissions offset demonstration for the 1-hour ozone
standard, and year 2023 was selected as the attainment year for the
revised demonstration for the 1997 8-hour ozone standard. For the 1997
8-hour ozone standard, the State's selection of 2023 is appropriate
given that the approved South Coast 1997 8-hour ozone plan demonstrates
attainment by the applicable attainment date of June 15, 2024 based on
the 2023 controlled emissions inventory. See 76 FR 57872, at 57885
(September 16, 2011) and 77 FR 12674, at 12693 (March 1, 2012).
    For the 1-hour ozone standard, in 2013, the EPA found the
California SIP for the South Coast to be substantially inadequate to
comply with the obligation to adopt and implement a plan providing for
attainment of the 1-hour ozone standard. 78 FR 889 (January 7, 2013).
Under this ``SIP call,'' effective February 6, 2013, the State was
required to develop a revised South Coast plan demonstrating attainment
of the 1-hour ozone standard as expeditiously as practicable, but no
later than five years from the effective date of the SIP call, or, in
this case, no later than February 6, 2018, unless the State can
demonstrate that it needs up to an additional five years, i.e., up to
February 6, 2023, to attain the standard in light of the severity of
the nonattainment problem and the availability and feasibility of
control measures.
    The revised South Coast 1-hour ozone attainment demonstration,
which was submitted along with the revised VMT emissions offset
demonstrations and the rest of the 2012 South Coast AQMP on February
13, 2013, provides a justification for the full five years beyond the
statutory five-year attainment date. The revised South Coast 1-hour
ozone attainment demonstration thus provides a demonstration of
attainment of the 1-hour ozone standard in the South Coast by 2023
based on the controlled 2022 emissions inventory. In a separate
rulemaking action published elsewhere

in today's Federal Register, EPA is proposing to approve 2022 as the
attainment year for the 1-hour ozone standard in the South Coast.\14\
Based on the proposed approval of 2022 as the attainment year for the
South Coast for the 1-hour ozone standard, we find CARB's selection of
Year 2022 as the attainment year for the revised VMT emissions offset
demonstration for the 1-hour ozone standard to be acceptable. For
additional background and justification regarding the 2022 attainment
year, please see the separate rulemaking action published elsewhere in
today's Federal Register.
---------------------------------------------------------------------------

    \14\ In this context, ``attainment year'' refers to the ozone
season immediately preceding a nonattainment area's attainment date.
In the case of the South Coast for the 1-hour ozone standard, the
proposed applicable attainment date is February 6, 2023, and the
ozone season immediately preceding that date will occur in year
2022.
---------------------------------------------------------------------------

    Tables 1 and 2 summarize the relevant distinguishing parameters for
each of the emissions scenarios and show the State's corresponding VOC
emissions estimates. Table 1 provides the parameters and emissions
estimates for the revised VMT emissions offset demonstration for the 1-
hour ozone standard, and table 2 provides the corresponding values for
the revised demonstration for the 1997 8-hour ozone standard.

             Table 1--VMT Emissions Offset Inventory Scenarios and Results for 1-Hour Ozone Standard
----------------------------------------------------------------------------------------------------------------
                                                       VMT                 Starts          Controls      VOC
                                             -------------------------------------------------------  emissions
                  Scenario                                                                          ------------
                                                 Year     1000/day     Year     1000/day     Year        tpd
----------------------------------------------------------------------------------------------------------------
Base Year...................................       1990    257,490       1990     46,060       1990          873
No Action...................................       2022    394,838       2022     72,531       1990          488
VMT Offset Ceiling..........................       1990    257,490       1990     46,060       1990          312
Projected Actual............................       2022    394,838       2022     72,531       2022           65
----------------------------------------------------------------------------------------------------------------
Source: CARB's Technical Supplement, April 3, 2014.

          Table 2--VMT Emissions Offset Inventory Scenarios and Results for 1997 8-Hour Ozone Standard
----------------------------------------------------------------------------------------------------------------
                                                       VMT                 Starts          Controls      VOC
                                             -------------------------------------------------------  emissions
                  Scenario                                                                          ------------
                                                 Year     1000/day     Year     1000/day     Year        tpd
----------------------------------------------------------------------------------------------------------------
Base Year...................................       2002    330,268       2002     58,039       2002          280
No Action...................................       2023    395,750       2023     72,730       2002          115
VMT Offset Ceiling..........................       2002    330,268       2002     58,039       2002           89
Projected Actual............................       2023    395,750       2023     72,730       2023           62
----------------------------------------------------------------------------------------------------------------
Source: CARB's Technical Supplement, April 3, 2014.

    For the two ``base year'' scenarios, the State ran the EMFAC2011
model for the applicable base year (i.e., 1990 for the 1-hour ozone
standard and 2002 for the 1997 8-hour ozone standard) using VMT and
starts data corresponding to those years. As shown in tables 1 and 2,
the State estimates South Coast VOC emissions at 873 tons per day (tpd)
in 1990 and 280 tpd in 2002.
    For the two ``no action'' scenarios, the State first identified the
on-road motor vehicle control programs (i.e., TCSs or TCMs) put in
place since the base years and incorporated into EMFAC2011 and then ran
EMFAC2011 with the VMT and starts data corresponding to the applicable
attainment year (i.e., 2022 for the 1-hour ozone standard and 2023 for
the 1997 8-hour ozone standard) without the emissions reductions from
the on-road motor vehicle control programs put in place after the base
year. Thus, the ``no action'' scenarios reflect the hypothetical VOC
emissions that would occur in the attainment years in the South Coast
if the State had not put in place any additional TCSs or TCMs after
1990 (for the 1-hour ozone VMT emissions offset demonstration) or after
2002 (for the 8-hour ozone demonstration). As shown in tables 1 and 2,
the State estimates ``no action'' South Coast VOC emissions at 488 tons
per day (tpd) in 2022 and 115 tpd in 2023. The principal difference
between the two estimates is that the latter value (used for the
revised VMT emissions offset demonstration for the 8-hour ozone
standard) reflects the emissions reductions from TCSs and TCMs put in
place by the end of 2002 whereas the former value (used for the revised
demonstration for the 1-hour ozone standard) reflects only the
emissions reductions from TCSs and TCMs put in place by the end of
1990. The most significant of the measures adopted since 1990 and
relied upon for the 1-hour ozone VMT emissions offset demonstration
include tiered (series of increasingly stringent limits) emissions
standards for new motor vehicles (i.e., Low Emissions Vehicles I, II,
and III standards), content specifications for gasoline (i.e.,
California Reformulated Gasoline Phases 1, 2, and 3), and enhancements
to the State's I/M program (i.e., Smog Check II). See attachments 1 and
2 of Appendix VIII to the 2012 South Coast AQMP (i.e., the revised
South Coast VMT emissions offset demonstrations) for the entire list of
TCSs and TCMs adopted by the State since 1990.\15\
---------------------------------------------------------------------------

    \15\ The docket for today's action includes an updated list of
the post-1990 transportation control strategies in attachment 1 of
Appendix VIII to the South Coast AQMP.
---------------------------------------------------------------------------

    For the ``VMT offset ceiling'' scenarios, the State ran the
EMFAC2011 model for the attainment years but with VMT and starts data
corresponding to base year values. Like the ``no action'' scenarios,
the EMFAC2011 model was adjusted to reflect the VOC emissions levels in
the attainment years without the benefits of the post-base-year on-road
motor vehicle control programs. Thus, the ``VMT offset ceiling''
scenarios reflect hypothetical VOC emissions in the South Coast if the
State had not put in place any TCSs or TCMs after the base years and if
there had been no growth in VMT or vehicle trips between the base years
and the attainment years.

    The hypothetical growth in emissions due to growth in VMT and trips
can be determined from the difference between the VOC emissions
estimates under the ``no action'' scenarios and the corresponding
estimates under the ``VMT offset ceiling'' scenarios. Based on the
values in tables 1 and 2, the hypothetical growth in emissions due to
growth in VMT and trips in the South Coast would have been 176 tpd
(i.e., 488 tpd minus 312 tpd) for the purposes of the revised VMT
emissions offset demonstration for the 1-hour ozone standard, and 26
tpd (i.e., 115 tpd minus 89 tpd) for the purposes of the corresponding
demonstration for the 8-hour ozone standard. These hypothetical
differences establish the levels of VMT growth-caused emissions that
need to be offset by the combination of post-baseline year TCMs and
TCSs and any necessary additional TCMs and TCSs.
    For the ``projected actual'' scenario calculations, the State ran
the EMFAC2011 model for the attainment years with VMT and starts data
at attainment year values and with the full benefits of the relevant
post-baseline year motor vehicle control programs. For this scenario,
the State included the emissions benefits from TCSs and TCMs put in
place since the base year. The most significant measures put in place
during the 2002 to 2023 time frame, relied upon for the 8-hour ozone
demonstration, include Low Emission Vehicles II and III standards, Zero
Emissions Vehicle standards, and California Reformulated Gasoline Phase
3. Again, see attachments 1 and 2 of the Appendix VIII to the 2012
South Coast AQMP. These measures are also relied upon in the approved
South Coast 8-hour ozone attainment demonstration and the revised South
Coast 1-hour ozone attainment demonstration.\16\
---------------------------------------------------------------------------

    \16\ See 77 FR 12674 (March 1, 2012) for the EPA's approval or
waiver/authorization of the TCSs and TCMs relied upon for the 1997
8-hour ozone attainment demonstration in the 2007 South Coast AQMP.
Also see Technical Support Document for the Final Rulemaking Action
on the South Coast 2007 8-Hour Ozone Plan and the South Coast
Portions of the Revised 2007 State Strategy, USEPA Region 9,
December 2011. Also see footnote 15. Per section 209 of the CAA, the
EPA has previously waived (for control of emissions from new motor
vehicles of new motor vehicle engines prior to March 30, 1966) or
authorized (for control emissions of nonroad engines or vehicles)
all such TCSs and TCMs.
---------------------------------------------------------------------------

    As shown in tables 1 and 2, the results from these calculations
establish projected actual attainment-year VOC emissions of 65 tpd for
the 1-hour standard demonstration and 62 tpd for the 1997 8-hour
standard demonstration. The State then compared these values against
the corresponding VMT offset ceiling values to determine whether
additional TCMs or TCSs would need to be adopted and implemented in
order to offset any increase in emissions due solely to VMT and trips.
Because the ``projected actual'' emissions are less than the
corresponding ``VMT Offset Ceiling'' emissions, the State concluded
that the demonstration shows compliance with the VMT emissions offset
requirement and that there are sufficient adopted TCSs and TCMs to
offset the growth in emissions from the growth in VMT and vehicle trips
in the South Coast for both the 1-hour and 1997 8-hour standards. In
fact, taking into account of the creditable post-baseline year TCMs and
TCSs, the State showed that they offset the hypothetical differences by
423 tpd for the 1-hour standard and by 53 tpd for the 1997 8-hour
standards, rather than merely the required 176 tpd and 26 tpd,
respectively.\17\
---------------------------------------------------------------------------

    \17\ The offsetting VOC emissions reductions from the TCSs and
TCMs put in place after the respective base year can be determined
by subtracting the ``projected actual'' emissions estimates from the
``no action'' emissions estimates in tables 1 and 2. For the
purposes of the 1-hour ozone demonstration, the offsetting emissions
reductions, 423 tpd (488 tpd minus 65 tpd), exceed the growth in
emissions from growth in VMT and vehicle trips (176 tpd). For the
purposes of the 8-hour ozone demonstration, the offsetting emissions
reductions, 53 tpd (115 tpd minus 62 tpd), exceed the growth in
emissions from growth in VMT and vehicle trips (26 tpd).
---------------------------------------------------------------------------

    Based on our review of the State's submittal, including the
technical supplement, we find the State's analysis to be acceptable and
agree that the State has adopted sufficient TCSs and TCMs to offset the
growth in emissions from growth in VMT and vehicle trips in the South
Coast for the purposes of the 1-hour ozone and 1997 8-hour ozone
standard. As such, we find that the revised South Coast VMT emissions
offset demonstrations, comply with the VMT emissions offset requirement
in CAA section 182(d)(1)(A), and therefore, we propose approval of the
revised South Coast VMT emissions offset demonstrations for the 1-hour
ozone and 1997 8-hour ozone standards as a revision to the California
SIP.

IV. EPA's Proposed Action and Request for Public Comment

    Under CAA section 110(k)(3), and for the reasons set forth above,
EPA is proposing to approve CARB's submittal dated February 13, 2013 of
the revised South Coast VMT emissions offset demonstrations for the 1-
hour ozone and 1997 8-hour ozone standards, as supplemented by CARB on
April 3, 2014, as a revision to the California SIP. We are proposing to
approve this SIP revision because we believe that it demonstrates that
California has put in place specific enforceable transportation control
strategies and transportation control measures to offset the growth in
emissions from the growth in VMT and vehicle trips in the South Coast
for both the 1-hour ozone and 1997 8-hour ozone standards, and thereby
meets the applicable requirements in section 182(d)(1)(A) of the Clean
Air Act.
    EPA is soliciting public comments on the issues discussed in this
document or on other relevant matters. We will accept comments from the
public on this proposal for the next 30 days. We will consider these
comments before taking final action.

V. Statutory and Executive Order Reviews

    The Administrator is required to approve a SIP submission that
complies with the provisions of the Act and applicable Federal
regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP
submissions, EPA's role is to approve State choices, provided that they
meet the criteria of the Clean Air Act. Accordingly, this action merely
proposes to approve a State plan revision as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For these reasons, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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 CAA; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental regulations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: May 5, 2014.
Jared Blumenfeld,
Regional Administrator, EPA Region 9.
[FR Doc. 2014-11511 Filed 5-22-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62093-62094]
[FR Doc No: 2023-19404]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4848]

Application of Human Factors Engineering Principles for
Combination Products: Questions and Answers; Guidance for Industry and
FDA Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry and FDA staff
entitled ``Application of Human Factors Engineering Principles for
Combination Products: Questions and Answers.'' This document provides
questions and answers for industry and FDA staff on the application of
human factors engineering (HFE) principles to the development of
combination products as defined under the regulations. The guidance
clarifies how the unique aspects of a combination product influence the
considerations within the HFE process. This guidance is intended to
facilitate the development of combination products. This guidance
finalizes the draft guidance entitled ``Human Factors Studies and
Related Clinical Study Considerations in Combination Product Design and
Development'' issued on February 3, 2016.

DATES: The announcement of the guidance is published in the Federal
Register on September 8, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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-2015-D-4848 for ``Application of Human Factors Engineering
Principles for Combination Products: Questions and Answers.'' Received
comments 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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Office of

Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Patricia Love, Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Avenue,
Bldg. 32, Rm. 5129, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected] or [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Application of Human Factors Engineering
Principles for Combination Products: Questions and Answers.'' This
guidance provides questions and answers for industry and FDA staff on
the application of HFE principles to the development of combination
products as defined under 21 CFR part 3. This guidance should be used
in conjunction with the guidance for industry and FDA staff ``Applying
Human Factors and Usability Engineering to Medical Devices'' (available
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices) and with the guidance for industry ``Safety Considerations for
Product Design to Minimize Medication Errors'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-product-design-minimize-medication-errors-guidance-industry).
    This guidance focuses on considerations for the application of HFE
principles to combination products comprised of a medical device
combined with a drug or a biological product submitted for review in
the Center for Biologics Evaluation and Research, the Center for
Devices and Radiological Health, or the Center for Drug Evaluation and
Research. This guidance discusses, among other things, the definition
of a combination product critical task, considerations for combination
products due to the use of a drug or biological product constituent
part together with a device constituent part, training as part of the
user interface, and human factors (HF) validation data to support the
combination product user interface that may be included in a premarket
submission.
    This guidance finalizes the draft guidance entitled ``Human Factors
Studies and Related Clinical Study Considerations in Combination
Product Design and Development'' issued on February 3, 2016 (81 FR
5764). FDA considered comments received on the draft guidance as the
guidance was finalized. Changes from the draft to the final guidance
include: change in format to a questions and answers format, deletion
of HF information that is redundant with other FDA guidance documents
and focusing the guidance on combination product specific issues,
providing additional information in response to comments, clarification
of the combination product critical task definition, further
explanation of considerations to help identify combination product
critical tasks, and replacement of an appendix of examples of user task
failures with examples that provide a contextual discussion of
combination product critical task considerations. In addition,
editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Application of Human Factors Engineering
Principles for Combination Products: Questions and Answers.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for 21 CFR part 312 for investigational new drug
applications have been approved under OMB control number 0910-0014 and
the collections of information for 21 CFR part 812 for investigational
device exemptions have been approved under OMB control number 0910-
0078. The collections of information in 21 CFR part 314 for new drug
applications have been approved under OMB control number 0910-0001 and
the collections of information in 21 CFR part 601 for biologics license
applications have been approved under OMB control number 0910-0338. The
collections of information in 21 CFR part 814, subparts A through E for
premarket approval applications have been approved under OMB control
number 0910-0231. The collections of information in 21 CFR part 807,
subpart E for premarket notifications have been approved under OMB
control number 0910-0120 and the collections of information in 21 CFR
860, subpart D for De Novo classifications have been approved under OMB
control number 0910-0844.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19404 Filed 9-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 6, 2008 (Volume 73, Number 88)]
[Proposed Rules]
[Page 24901-24904]
[DOCID:fr06my08-27]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0328]
RIN 1625-AA11

Safety Zone; Thunder on Niagara, Niagara River, North Tonawanda,
NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes establishment of a safety zone for a
powerboat race in the Captain of the Port Buffalo zone. This proposed
rule is intended to restrict vessels from areas of water during events
that pose a hazard to public safety. The safety zone established by
this proposed rule is necessary to protect spectators, participants,
and vessels from the hazards associated with a powerboat race.

DATES: Comments and related materials must reach the Coast Guard on or
before May 21, 2008.

ADDRESSES: You may mail comments and related material to Commander,
U.S. Coast Guard Sector Buffalo, 1 Fuhrmann Boulevard, Buffalo, NY
14203. Sector Buffalo Prevention Department maintains the public docket
for this rulemaking. Comments and material received from the public, as
well as documents indicated in this preamble as being available in the
docket, will become part of this docket and will be available for
inspection or copying at U.S. Coast Guard Sector Buffalo between 8 a.m.
and 3 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have further questions on this
rule, contact Lieutenant Tracy Wirth, U.S. Coast Guard Sector Buffalo,
at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related material. If you do so, please include your name
and address, identify the docket number for this rulemaking [USCG-2008-
0328], indicate the specific section of this document to which each
comment applies, and give the reason for each comment. Please submit
all comments and related material in an unbound format, no larger than
8\1/2\ by 11 inches, suitable for copying. If you would like to know
they reached us, please enclose a stamped, self-addressed postcard or
envelope. We will consider all comments and material received during
the comment period. We may change this proposed rule in view of them.

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for a meeting by writing to Commander, Coast Guard Sector
Buffalo at the address under ADDRESSES explaining why one would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Background and Purpose

    Temporary safety zones are necessary to ensure the safety of
vessels and spectators from the hazards associated with powerboat
races. Based on recent accidents that have occurred in other Captain of
the Port zones, the Captain of the Port Buffalo, has determined
powerboat races pose significant risks to public safety and property.
The likely combination of large numbers of recreational vessels,
congested waterways, and alcohol use, could easily result in serious
injuries or fatalities.

Discussion of Proposed Rule

    The proposed rule and associated safety zones are necessary to
ensure the safety of vessels and people during events in the Captain of
the Port Buffalo area of responsibility that may pose a hazard to the
public. The proposed safety zone is described in subparagraph (1) of
this regulation. The proposed safety zone will be enforced only
immediately before and during the event which poses hazard to the
public and only upon notice by the Captain of the Port. The Captain of
the Port Buffalo will cause notice of enforcement of the safety zone
established by this section to be made by all appropriate means to the
affected segments of the public including publication in the Federal
Register in accordance with 33 CFR 165.7(a). Such means of notification
may also include, but are not limited to, Broadcast Notice to Mariners
or Local Notice to Mariners. The Captain of the Port will issue a
Broadcast Notice to Mariners notifying the public when enforcement of
the safety zone established by this section is suspended.

Regulatory Evaluation

    This proposed 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.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary.
    The Coast Guard's use of this safety zone will be periodic in
nature, of short duration, and designed to minimize the impact on
navigable waters. This safety zone will only be enforced immediately
before and during the time the event occurs. Furthermore, this safety
zone has been designed to allow vessels to transit unrestricted to
portions of the waterway not affected by the safety zone. The Coast
Guard expects insignificant adverse impact to mariners from the
activation of this safety zone.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed 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 proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    This proposed rule would affect the following entities, some of
which might be small entities: The owners or operators of vessels
intending to transit or anchor in the area designated as the safety
zone in subparagraph (1) during the date and time the safety zone is
being enforced. This safety zone would not have a significant economic
impact on a substantial number of small entities for the following
reasons. The safety zone in this proposed rule would be in effect for
short periods of time and only once per year. The safety zone has been
designed to allow traffic to pass safely around the zone whenever
possible and vessels will be allowed to pass through the zone with the
permission of the Captain of the Port.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
proposed rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact LT Tracy Wirth,
Prevention Department, Coast Guard Sector Buffalo, Buffalo, NY

at<PHONE_NUMBER>. 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 proposed 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 proposed rule will not result in such
expenditure, we do discuss the effects of this proposed rule elsewhere
in this preamble.

Taking of Private Property

    This proposed rule will not effect the 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 proposed 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 proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This proposed 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

    The Coast Guard recognizes the treaty rights of Native American
Tribes. Moreover, the Coast Guard is committed to working with Tribal
Governments to implement local policies and to mitigate tribal
concerns. We have determined that these special local regulations and
fishing rights protection need not be incompatible. We have also
determined that this Proposed 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.
Nevertheless, Indian Tribes that have questions concerning the
provisions of this Proposed Rule or options for compliance are
encouraged to contact the point of contact listed under FOR FURTHER
INFORMATION CONTACT.

Energy Effects

    We have analyzed this proposed 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 proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is not likely to
leave a significant impact on the human environment. A preliminary
``Environmental Analysis Check List'' is available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    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; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

    2. Add Sec.  165.T09-002 to read as follows:

Sec.  165.T09-002  Safety Zone; Thunder on Niagara, Niagara River,
North Tonawanda, NY.

    (a) Location. The following area is a temporary safety zone: all
waters of the Upper Niagara River, North Tonawanda, NY within two miles
of the Grand Island Bridge located at 42[deg]03'36'' N, 078[deg]54'45''
W to 43[deg]03'09'' N, 078[deg]55'21'' W to 43[deg]03'00'' N,
078[deg]53'42'' W to 43[deg]02'42'' N, 078[deg]54'09'' W. All
Geographic coordinates are North American Datum of 1983 (NAD 83).
    (b) Effective Period. This regulation is effective from 11 a.m. May
31, 2008 to 6 p.m. June 1, 2008. This zone will be enforced from 11
a.m. to 6 p.m. on May 31, 2008 and June 1, 2008.
    (c) Regulations.
    (1) The general regulations contained in 33 CFR 165.23 apply.
    (2) All persons and vessels must comply with the instructions of
the Coast Guard Captain of the Port or the designated on scene patrol
personnel. Coast Guard patrol personnel include commissioned, warrant,
and petty officers of the U.S. Coast Guard. Upon

being hailed by a U.S. Coast Guard vessel via siren, radio, flashing
light, or other means, the operator shall proceed as directed.
    (3) Commercial vessels may request permission from the Captain of
the Port Buffalo to transit the safety zone. Approval will be made on a
case-by-case basis. Requests must be made in advance and approved by
the Captain of the Port before transits will be authorized. The Captain
of the Port may be contacted via U.S. Coast Guard Sector Buffalo on
Channel 16, VHF-FM.

    Dated: April 14, 2008.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
 [FR Doc. E8-10005 Filed 5-5-08; 8:45 am]

BILLING CODE 4910-15-P