[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Rules and Regulations]
[Pages 41618-41625]
[FR Doc No: 2022-14733]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA-2022-0061]
RIN 2127-AL93

Federal Motor Vehicle Safety Standards; Minimum Sound
Requirements for Hybrid and Electric Vehicles

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Final rule.

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SUMMARY: This final rule amends the test procedure in section S6.7.3 of
Federal Motor Vehicle Safety Standard (FMVSS) No. 141, Minimum Sound
Requirements for Hybrid and Electric Vehicles, as proposed in the
September 17, 2019, notice of proposed rulemaking (NPRM), to specify
the single point in time that should be used when determining one-third
octave band levels of ambient noise measurements used in compliance
tests. The agency has chosen not to adopt the remaining portions of the
NPRM, including a proposal which would have allowed manufactures of
hybrid and electric vehicles (HEVs) to install a number of driver-
selectable pedestrian alert sounds in each HEV they manufacture. The
driver-selectable alert sounds proposal is not being adopted because of
a lack of supporting data. In addition, this final rule acknowledges
that a proposed technical change included in the September 17, 2019,
NPRM to correct two dates in NHTSA's phase-in reporting requirements
for FMVSS No. 141 is no longer needed. That change was addressed
previously by the agency's September 1, 2020, interim final rule that
extended the FMVSS No. 141 compliance deadline and phase-in dates by
six months. The interim final rule included adjustments to NHTSA's
reporting dates, superseding the need for the proposed corrections.

DATES: This final rule is effective on August 12, 2022.

ADDRESSES: All correspondence, comments and other information relating
to this document should refer to the docket number shown in the heading
and should be submitted to: Administrator, National Highway Traffic
Safety Administration, U.S. Department of Transportation, 1200 New
Jersey Avenue SE, West Building, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Mr. Michael Pyne, NHTSA Office of
Crash Avoidance Standards, by email to [email protected] or at 202-366-
4171, or Mr. Paul Connet, NHTSA Office of the Chief Counsel, by email
to [email protected] or at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On September 17, 2019, NHTSA issued an NPRM
to amend FMVSS No. 141, Minimum Sound Requirements for Hybrid and
Electric Vehicles (the ``quiet vehicles'' rule) to remove the numerical
limit on compliant sounds that a manufacturer may choose to install in
a vehicle.\1\ Under the proposal, a manufacturer would be allowed to
install any number of compliant sounds on each HEV make/model/body
style/trim they produce for sale in the United States. NHTSA requested
comment on that proposal and on whether the safety standard should
allow more than one compliant sound and if so, what the allowable
number should be.
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    \1\ 84 FR 48866.
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    The NPRM included two other proposed changes, one to amend the
FMVSS No. 141 test procedure for measuring ambient sound levels during
compliance tests, and the other to correct phase-in reporting dates.

Background

    To protect pedestrians and other road users, FMVSS No. 141 requires
HEVs to emit a pedestrian alert sound while operating in certain
conditions.\2\ The alert sound on a given vehicle is allowed to change
with vehicle operating speed or direction--the standard defines five
different operating conditions: stationary in neutral or forward gear
and with constant forward speed less than 10 km/h; reverse; and moving
at constant forward speed from 10 km/h up to but not including 20 km/

h, from 20 km/h up to 30 km/h, and at or just above 30 km/h. Beyond
that speed, alert sounds are no longer required by FMVSS No. 141 as
other sounds such as tires and airflow produce enough sound to make the
vehicle detectable.
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    \2\ Final Rule, Federal Motor Vehicle Safety Standards; Minimum
Sound Requirements for Hybrid and Electric Vehicles 81 FR 90416,
effective September 5, 2017; docket No. NHTSA-2016-0125.
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    Section 5.5 of the standard, titled ``Sameness requirement'',
requires any two vehicles of the same make, model, model year, body
type, and trim level to have the same pedestrian alert sound per
operating condition.\3\ The sameness requirement prevents manufacturers
from equipping multiple sounds for the same operating condition.
Additional details of NHTSA's implementation of the sameness
requirement are discussed in the preamble of the FMVSS No. 141 final
rule.\4\
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    \3\ Section S5.5.1 of FMVSS No. 141, as published in December
2016, allowed the alert sound to vary by model year as well as make
and model (see 81 FR 90472). This was further amended on February
26, 2018, to allow alert sounds to vary by trim level and body style
within a make/model/model year (see 83 FR 8189).
    \4\ See 81 FR 90416, 90472.
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    The sameness requirement in FMVSS No. 141 originates from section
3(a)(2) of the Pedestrian Safety Enhancement Act (PSEA) of 2010 which
states that the Federal regulation ``shall allow manufacturers to
provide each vehicle with one or more sounds that comply with the motor
vehicle safety standard at the time of manufacture.'' \5\ Section
3(a)(2) further states that the regulation ``shall require
manufacturers to provide, within reasonable manufacturing tolerances,
the same sound or set of sounds for all vehicles of the same make and
model and shall prohibit manufacturers from providing any mechanism for
anyone other than the manufacturer or the dealer to disable, alter,
replace, or modify the sound or set of sounds.'' \6\ The PSEA did not
provide any further specifics about the number of sounds that hybrid
and electric vehicles may have or how sounds may vary among vehicles of
the same make and model.
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    \5\ Public Law 111-373, 124 Stat. 4086 (January 4, 2011).
    \6\ Id.
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    In the original proposal for FMVSS No. 141, NHTSA interpreted this
section of the PSEA to mean that a manufacturer may choose to equip
different sounds for the different operating modes described above.\7\
In a joint comment to the proposal, several commenters stated that the
PSEA permitted the regulation to allow for multiple sounds to be
equipped for each operating conditions from which drivers could choose
from, and requested the agency to adopt driver-selectable sounds.\8\ As
discussed in the final rule establishing FMVSS No. 141, NHTSA
reaffirmed its understanding that the PSEA language restricted the
agency from promulgating a rule that would permit vehicles to be
equipped with more than one alert sound for a given operating
condition, hence foreclosing the possibility of driver-selectable
sounds.\9\
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    \7\ See 78 FR 2798, 2804.
    \8\ See 81 FR 90416, 90475.
    \9\ In the 2016 final rule, NHTSA stated: ``Given our
understanding of the PSEA, we are not including provisions requested
by these commenters that would allow for driver-selectable
pedestrian alert sounds. . . . We believe that this approach is
necessary to satisfy the requirements contained in the PSEA language
and that allowing a means for owners to select or modify alert
sounds . . . would be in conflict with the language of the PSEA.
Furthermore, by not allowing driver-selectable sounds, the final
rule adheres more closely to the PSEA requirement that vehicles of a
given make and model must have the same alert sound.'' 81 FR 90416,
90475.
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Alliance/Global Petition on Driver-Selectable Sounds

    The issue of permitting driver-selectable sounds was raised as one
aspect of a multi-part petition for reconsideration that was jointly
submitted to NHTSA in 2017 by the Alliance of Automobile Manufacturers
(Alliance) and Global Automakers (Global).\10\ Their petition requested
several amendments, one of which was that NHTSA modify the sameness
requirement in section S5.5 of FMVSS No. 141 to allow each HEV to be
equipped with multiple compliant pedestrian alert sounds from which a
vehicle owner/operator could select according to their preference.\11\
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    \10\ Docket No. NHTSA-2016-0125-0012. At the time of their
petition, Alliance and Global were separate entities. Subsequently,
they joined to form a single entity called the Alliance for
Automotive Innovation with member companies.
    \11\ NHTSA issued a final rule on February 26, 2018, to address
the other requested actions in the Alliance/Global petition for
reconsideration (83 FR 8182). In that petition response, the agency
announced that it was planning to publish a notice of proposed
rulemaking to allow driver-selectable sounds.
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    As the agency weighed the petition for reconsideration, the agency
concluded that amending the standard to permit driver-selectable sounds
would represent a significant--and likely unforeseeable--change in the
agency's position. The agency determined that it was in the public's
best interest to publish a new proposal on the issue to facilitate
comment. The agency published an NPRM in September 2019 soliciting
public comment on a proposal to allow unlimited sounds on HEVs,
provided the manufacturer certified that each sound complies with the
requirements of FMVSS No. 141, as well as related questions including
whether the safety standard should be amended to allow only a limited
number of sounds.
    In their petition, Alliance/Global stated that NHTSA's
implementation of FMVSS No. 141 adopted an inflexible approach to
ensuring sameness and did not account for specific statutory language
in the PSEA that permits multiple alert sounds per vehicle. Alliance/
Global stated that the words ``one or more sounds'' in Section 3(a)(2)
of the PSEA provide this flexibility. Alliance/Global said that
providing a selection of sounds is essential for customer acceptance of
HEVs, stating:

    Satisfying our customers is a primary concern for OEMs [Original
Equipment Manufacturers]. Since `one size does not fit all' neither
will one alert sound for a given make, model, trim level and model
year satisfy all those consumers purchasing all these same vehicles.

    The petition also discussed comments submitted to the agency in
February 2014 jointly by the Alliance, Global, the American Council of
the Blind (ACB), and the National Federation of the Blind (NFB), in
which the commenters, including the two advocate organizations,
recognized the need to provide consumers with a reasonable number of
driver-selectable sound choices for customer acceptance reasons.\12\
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    \12\ Docket No. NHTSA-2011-0148-0322.
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    In a March 2017 follow-up letter, Alliance/Global supplemented
their petition with additional information and included a
recommendation that not more than five sounds should be allowed per
vehicle. The letter included the following explanation: \13\
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    \13\ Docket No. NHTSA-2016-0125-0016.

    Because every additional driver-selectable choice of sound
requires a separate certification test as well as a compliance test,
the number of driver-selectable choices provided by manufacturers
would naturally be limited for practical reasons. However, to
address potential concerns that manufacturers might provide too many
optional sounds, we recommend that the number of permitted driver-
selectable sounds be limited to no more than five driver-selectable
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alert sounds for any make, model, trim level, model year vehicle.

    Alliance/Global did not provide data in the form of consumer
surveys, research, or economic impact analysis to support the request
to allow multiple sounds in their petition. Similarly, besides the
qualitative explanation mentioned above, the specific recommendation of
not-more-than-five sounds per HEV was not accompanied by supporting
research or analysis.

Proposed Rule on Driver-Selectable Sounds

    In response to the Alliance/Global petition, NHTSA proposed
amending FMVSS No. 141 to allow an unlimited number of pedestrian alert
sounds per vehicle for any operating condition. In the proposal, NHTSA
acknowledged that the PSEA language regarding the sameness of sounds
was subject to more than one interpretation, and that alternative
readings of the statute could accommodate an amendment to allow
vehicles to be equipped with multiple FMVSS No. 141-compliant sounds
for the same operating conditions. The proposal reasoned that consumer
preferences depend on subjective factors, such as how a vehicle sounds.
The NPRM also suggested that the proposal to allow multiple alert
sounds in theory should not impair safety as all additional sounds
would still have to comply with FMVSS No. 141.
    NHTSA requested comment and supporting information on any safety
implications, compliance issues, consumer-acceptance factors, cost
issues, or other possible alternatives that were relevant to allowing
an unlimited number of compliant driver-selectable sounds in FMVSS No.
141. In particular, the NPRM asked for comments on the potential safety
issues related to HEV recognition by pedestrians if a multitude of new
compliant driver-selectable sounds are available, and the extent to
which having an unlimited number of sounds would lead to the potential
for a pedestrian to be unable to identify the sounds as coming from a
motor vehicle.\14\
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    \14\ The NPRM also noted that an international regulation,
United Nations Economic Commission for Europe (ECE) Regulation No.
138 on Audible Vehicle Alerting Systems, allows vehicle
manufacturers to define alternative sounds which can be selected by
the driver and does not specify a particular limit on the number of
alternative sounds that may be provided.
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Summary of Comments on the NPRM

    NHTSA received comments from a variety of sources, including some
in favor of the proposal, some opposing it, and other comments offering
additional information, not all of it directly related to the
proposal.\15\ Fifty-two commenters responded to the NPRM: four were
from advocacy groups representing people who are blind, have low vision
or other disabilities, including the National Federation of the Blind
(NFB), the American Council of the Blind (ACB), the Consortium for
Citizens with Disabilities (CCD), and The Seeing Eye; two were from
organizations representing the automotive industry, including a joint
comment from the Alliance and Global Automakers and a comment from SAE
International; one submittal was from an educational institution, the
Perkins School for the Blind; and 45 were from individual members of
the public.
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    \15\ Docket No. NHTSA-2019-0085.
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    The NFB commented that a ``reasonable number'' of sounds that meet
the requirements should be allowed so that HEVs with alert sounds are
more palatable to consumers but did not recommend any specific limit on
the number of allowable sounds. The NFB stated that it fully supports
the Alliance/Global petition, including the assertion that the number
of sounds per HEV will be effectively limited by the cost to certify.
    Other advocacy groups including the ACB, The Seeing Eye, and the
CCD expressed safety concerns about allowing an unlimited number of
sounds. The ACB comment diverged from the position it had supported
previously in the joint comment letter of February 2014, discussed
above. In response to the NPRM, the ACB urged NHTSA to limit the number
of sounds from which car owners can select and stated that uniformity
is imperative for safety. The ACB stated, ``a distinguishable and
uniform sound is necessary to assist the blind community in quickly
identifying hybrid or electric cars.'' ACB said that sounds need to be
recognizable as a vehicle, ideally that of a car engine, and said that
car owners should not be involved in selecting sounds. The CCD
reiterated these same comments.
    The Seeing Eye commented, ``For recognition purposes, it is
important that all vehicles emit the same standardized sound regardless
of manufacturer.'' Furthermore, it said that restricting the number of
sounds is not enough, and that clear specifications for the types of
sounds are needed.
    The Perkins School for the Blind submitted a spreadsheet containing
554 individual comments from students, staff members, and others
associated with the school.\16\ Of these, more than half (282)
consisted of nearly identical responses that included the following
statement or a very similar one:
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    \16\ As a general note, some of NHTSA's earliest research on
quiet vehicle human factors during the 2011 timeframe utilized
volunteers from the Perkins School for the Blind located in
Cambridge, MA, to evaluate detectability of different vehicle
sounds.

    I believe silent cars should be required to emit a set of clear,
consistent and recognizable sounds. These sounds should be
researched and set by a national governing body. I feel strongly
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that owners should not be allowed to select from a menu of sounds.

    A few commenters in this group elaborated on that core statement,
providing statements of fact, opinions, or personal experiences with
quiet vehicles in traffic. The large collection of comments from the
Perkins School also included the following:
     In addition to the 282 pro forma comments, 57 comments
conveyed a similar message in the commenters' own words; many of these
elaborated on the general need for `silent' vehicles to emit a sound or
sounds for pedestrian safety.
     Another 117 comments called for a consistent, recognizable
sound or sounds in vehicles so blind persons can detect that a vehicle
is nearby. Of these, 109 called for a single, uniform sound.
     Eighty comments were generally supportive of finding a
solution to quiet car dangers but did not address the question of
allowing multiple sounds.
     Fourteen addressed miscellaneous issues outside the scope
of the proposal, and four comments focused on opposing the idea of a
menu of sound options (though these seem to have mistakenly assumed
that drivers could create their own sounds).
    There were 45 comments submitted to the docket by individual
members of the public, some of which did not directly address the
proposal in the NPRM to allow unlimited driver-selectable alert sounds.
Among those that did address the proposal, almost all did not support
it. These comments did not provide additional data or research, though
some offered anecdotal evidence. Many comments from individuals focused
on other issues that were out of scope, including one or more of the
following:
     expressing a general like or dislike for the concept of
adding noise to HEVs;
     pointing out the beneficial reduction in traffic noise
that electric vehicles make possible;
     suggesting that quiet gas-engine vehicles should be
subject to the same requirements as HEVs.
    Based on statements in some of these comments, it seems likely
there was some misunderstanding of either the proposal or NHTSA's
existing minimum sound requirements. For example, it was apparent that
one or more of the commenters believed that vehicle owners would be
allowed to create their own sounds or use random recorded sounds, or
that the existing NHTSA regulation specifies a single, universal alert
sound for all HEVs. Others did not acknowledge that every additional
driver-selectable alert sound allowed under the proposal would have to
meet the minimum safety requirements.
    The Alliance/Global comment fully supported the proposal for an
unlimited number of driver selectable sounds and

reiterated their position that ``offering drivers a selection of
pedestrian alert sounds . . . facilitates an increase in consumer
choice and promotes consumer satisfaction and acceptance.'' The comment
stated that compliance costs will be prohibitive enough to limit the
number of sounds that automakers install in a vehicle and will thus
prevent them from offering more than a reasonable number.\17\ The
Alliance/Global comment did not recommend any specific limit on the
allowable number of sounds or mention their previous recommendation of
not more than five allowable sounds. They maintained their position
that a ``reasonable number of choices should be permitted as long as
each selectable choice meets the minimum sound requirements.''
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    \17\ The agency notes that, under the self-certification statute
in the Motor Vehicle Safety Act, manufacturers have some discretion
in how they certify, and there is no explicit requirement for a
manufacturer to test each sound. However, in certifying compliance,
the manufacturer must exercise reasonable care, and NHTSA would find
a vehicle noncompliant if an alert sound failed to meet the standard
when tested by NHTSA.
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    Prior to issuing the NPRM, NHTSA considered alternatives to the
proposal to allow an unlimited number of alert sounds. One alternative
entailed proposing to allow a limited number of driver-selectable alert
sounds. The NPRM did not include that specific proposal, but it sought
comment on allowing a limited number and, in that case, how many alert
sounds should be allowed. NHTSA did not receive any comments in
response to the alternative of allowing a limited number of sounds.
    The SAE International provided a comment that did not pertain to
the proposed rulemaking on selectable sounds but focused exclusively on
the test procedure issue raised in the NPRM concerning ambient noise
measurement, as discussed later in this document.

Comment Analysis

    The great majority of the comments on the NPRM, including those
submitted by organizations and people who are blind or who have low
vision, did not favor the proposal to allow HEVs to have an unlimited
number of different pedestrian alert sounds. To the contrary, most of
those comments were in favor of more uniformity, rather than less, in
the number and types of alert sounds allowed on HEVs. In fact, while
out-of-scope of the NPRM, at least one organization expressed a
preference for permitting only a single, uniform sound for all HEVs
regardless of vehicle make or model. These commenters stated that
having greater uniformity makes it easier for sight-impaired
pedestrians to recognize vehicles, and thus safer for them to navigate
in traffic. Several comments from individuals included descriptions of
unsafe encounters with quiet vehicles.
    The joint comment from the Alliance/Global supported the proposal
to amend FMVSS No. 141 to allow HEVs to have an unlimited number of
pedestrian alert sounds. Similarly, the comment from the NFB favored
providing drivers with a ``reasonable number'' of sounds per vehicle
from which drivers could choose a preferred sound.
    However, these comments were not accompanied by any data or
analysis to show that unlimited sounds would have no impact on
pedestrian safety. The Alliance/Global and the NFB did not provide
information such as data from research or analyses, like consumer
surveys for example, or other information to support an amendment to
allow either multiple alert sounds or an unlimited number of sounds.
They also did not provide any economic or market analysis to support
their contention that allowing multiple alert sounds is likely to
increase acceptance of HEVs in the U.S. new-vehicle market.
Furthermore, the agency has no specific information of its own that
addresses these questions of safety and consumer acceptance.
    In addition, the Alliance and the NFB submitted a late comment in
the form of a letter to the agency on March 17, 2022. The organizations
stated that material, including tutorials, guides, and videos, is
currently available online to assist individuals that would like to
disable the pedestrian alert sound, a mandated vehicle safety system,
required under FMVSS No. 141. The organizations asserted that
individuals that dislike the alert sound provided by a vehicle
manufacturer may seek to disable the sound but that, if provided the
option to choose from alternative sounds, such individuals would be
more likely to select one than to disable the system. The organizations
suggested that NHTSA should therefore allow up to five driver-
selectable sounds as a means to ensure that the benefits associated
with the requirements contained FMVSS No. 141 are not eliminated.
    The agency notes that these commenters did not provide any data or
analysis as part of the late comment to support their claims. FMVSS No.
141 sets requirements that apply to manufacturers, modifiers, repair
shops, and others, but does not set requirements for end-users.
Furthermore, the use and treatment of vehicles by individual end-users
generally is not subject to NHTSA's vehicle safety regulations.
However, States may choose to require individuals to maintain vehicles
after first sale in such a way that they comply with Federal motor
vehicle safety standards. In addition, states regulate insurance
companies, which may impose deterrents on individuals to dissuade them
from disabling important vehicle safety systems such as the one
required by FMVSS No. 141. The organizations did not provide any data
or analysis about the potential actions of individuals to intentionally
make inoperative a required vehicle safety system, nor did they provide
any data or analysis to quantify how their requested action to allow
multiple driver-selectable sounds would cause individuals determined to
silence their vehicle alert sound required by FMVSS No. 141 to instead
just select a different sound from among those that could be installed
on their vehicle. The agency finds it speculative to suggest that
allowing multiple driver-selectable sounds might dissuade vehicle
owners from disabling a safety system required by FMVSS No. 141,
especially given that a vocal minority of commenters over the course of
several rulemakings have argued that HEVs should not be required to
have any alert sound because they prefer quiet vehicles, not that there
is a lack of preferrable alternative sounds.
    Although the commenters that opposed the proposal also did not
provide substantial information in the form of research or analyses to
support their position, NHTSA believes it prudent to err on the side of
caution and safety in the absence of data or other evidence.
    While the current standard does not require a uniform sound across
manufacturers or even carlines, by restricting the variation of sounds
among make/model/trim groups there is an incentive to manufacturers to
apply sounds that appeal to a broader range of tastes. Removing this
restriction would allow manufacturers to make more obscure sounds that
only appeal to a small minority of HEV owners.
    After reviewing the comments, NHTSA also is concerned about the
potential compliance and safety impacts of the proposal. There are
unanswered questions relating to the cost/benefit impact of unlimited
driver-selectable sounds including:
     How can the costs and benefits be accurately determined?
     Is it reasonable to expect costs of certification to be
the primary factor in limiting the number of driver-selectable sounds?

     What is the safety impact? Will HEV recognition be
compromised as the number of allowable sounds increases, and can that
be quantified?
     Will selectable sounds increase consumer acceptance?
     Will there be unintended consequences, e.g., incentives
for manufacturers to develop a larger number of customized sounds that
appeal to narrow driver populations?
    Considering the comments and all other factors, NHTSA has concluded
that there is insufficient data or other compelling information to
support amending FMVSS No. 141 to allow more than one pedestrian alert
sound per HEV, and there is significant opposition from many commenters
to the proposal to allow unlimited driver-selectable sounds.
    As a result, the agency has concluded that the existing
requirement--that HEVs of the same make, model, model year, body style,
and trim level, must have the same alert sound--should remain in
effect, and the provisions in S5.5 of FMVSS No. 141 should not be
amended at this time.
    Accordingly, NHTSA is not adopting the proposal from the September
17, 2019, NPRM relating to driver-selectable alert sounds.

Amendment To Clarify Ambient Noise Measurement Procedure

    The NPRM proposed modifying the text of section 6.7.3 in FMVSS No.
141 to remove ambiguity in the procedure for evaluating ambient
(background) noise during compliance tests. This issue was raised by
the Alliance and Global in an April 2018 letter.\18\
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    \18\ See Docket No. NHTSA-2018-0018-0004.
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    Evaluation of ambient sounds during vehicle compliance tests as
required in section S6.7 of FMVSS No. 141 is necessary to ensure
ambient noise remains acceptably low and to apply ambient corrections
to vehicle measurements. Ambient sound is any background noise that is
present at the test site during a vehicle compliance evaluation that is
not emitted by the test vehicle itself. Table 8 and Table 9 of FMVSS
No. 141 specify ambient noise limits for overall sound level and one-
third octave band level, respectively, relative to the sound level of
the test vehicle.
    In prescribing how ambient one-third octave band levels are to be
evaluated for correction of vehicle measurements, section S6.7.3
indicates that the ambient levels used are the minimum levels at any
point in time over the required 60 seconds of recorded ambient noise.
The wording used in S6.7.3 implies that the levels of different one-
third octave bands may be evaluated at different times. This was not
NHTSA's intention. The correct method intended by the agency is to
evaluate ambient levels of all 13 one-third octave bands at the same
point in time for an individual microphone. For each microphone, the
point in time used is the unique point during the 60 seconds (or more)
of recorded ambient noise when the overall sound pressure level of the
ambient is at a minimum for that same microphone, as identified in the
preceding step, S6.7.2, in the test procedure. Consequently, the point
used for computing the 13 one-third octave bands may vary across
microphones but, for a single microphone, all 13 one-third octave bands
are computed at the same point in time.
    To resolve this, NHTSA proposed amending S6.7.3 to state the
intended method of evaluating ambient one-third octave bands more
clearly for the purpose of applying corrections to measurements of
vehicle sound.
    There was one comment submitted on this topic in response to the
NPRM, from SAE International (SAE). SAE did not comment on the details
of the proposed amendment of S6.7.3, but rather expressed a broader
concern with NHTSA's approach to ambient noise measurement more
generally. This is something SAE has written to the agency about on a
previous occasion.\19\ SAE's present comment maintained that FMVSS No.
141 compliance test procedures should not use the minimum ambient sound
level. SAE stated the correct method is to ascertain and apply the
maximum ambient sound level. However, NHTSA considered that approach in
the past and was not persuaded to change the ambient correction
methodology in FMVSS No. 141.
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    \19\ See SAE comment, Docket No. NHTSA-2016-0125-0021, at p. 1.
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    Because the SAE comment did not specifically address the proposal
to reword S6.7.3 and instead focused on a broader test procedure
concern that NHTSA has previously considered but chose not to adopt,
the agency is proceeding with a final rule to adopt the amended test
procedure as proposed.
    An amended S6.7.3 is included below. This amendment is scheduled to
take effect 30 days after the date of publication in the Federal
Register.

Proposed Correction of Phase-In Reporting Dates

    The NPRM included a proposal to correct two dates in the part 585
phase-in reporting requirements associated with FMVSS No. 141. However,
those changes are no longer necessary.
    The FMVSS No. 141 final rule published in December 2016 required
vehicle manufacturers to report on their production of compliant HEVs
during a one-year phase-in period from September 1, 2018, to August 31,
2019.\20\ NHTSA later acknowledged that part 585, subpart N,
incorrectly refers to this one-year period in two places as ``the
production year ending August 31, 2018'' instead of ``the production
year ending August 31, 2019.'' When NHTSA granted a petition for
reconsideration in February 2018 to extend the FMVSS No. 141 phase-in
and compliance deadlines by one year, the reporting dates in part 585,
subpart N, were all adjusted by adding one year.\21\ However, because
those two dates were off by one year, the adjusted dates also were off
by one year. In the NPRM, NHTSA proposed correcting this discrepancy.
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    \20\ The reporting requirements and associated due dates for
phase-in of compliance with FMVSS No. 141 are contained in 49 CFR
part 585, subpart N.
    \21\ 85 FR 8182.
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    On September 1, 2020, NHTSA published an interim final rule (IFR)
to extend the FMVSS No. 141 phase-in and compliance deadlines by an
additional six months to provide relief to automakers experiencing
vehicle manufacturing disruptions resulting from the Covid-19 national
health emergency.\22\ The IFR included six-month adjustments to the due
dates for FMVSS No. 141 phase-in reporting contained in part 585,
subpart N.\23\ Those newly adjusted reporting dates supersede the
corrections NHTSA proposed in September 2019 and obviate the need for
any further changes. In addition, the agency did not receive any
comments on the proposed date change. Therefore, in this document,
NHTSA is making no changes to the phase-in reporting dates.\24\
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    \22\ 85 FR 54273.
    \23\ As per normal procedure, the interim final rule allowed for
public comment. In response to the IFR, there were no comments
submitted on the topic of phase-in reporting dates for FMVSS No.
141.
    \24\ As stipulated in the IFR, the phase-in period for FMVSS No.
141, covering 50 percent of a manufacturer's HEV production, ran
from March 1, 2020, through February 28, 2021. Full compliance with
FMVSS No. 141, covering 100 percent of each manufacturer's HEV
production, began on March 1, 2021.
---------------------------------------------------------------------------

Rulemaking Analyses and Notices

A. Executive Order 12866, Executive Order 13563, and DOT Regulatory
Policies and Procedures

    NHTSA has considered the impact of this rulemaking action under
Executive Order 12866, Executive Order 13563,

and the Department of Transportation Order 2100.6, ``Policies and
Procedures for Rulemakings.'' This rulemaking is not considered
significant and was not reviewed by the Office of Management and Budget
under E.O. 12866, ``Regulatory Planning and Review.'' Given the minimal
impact of the rule, in accordance with the Department's regulatory
policies and procedures, we have not prepared a full regulatory
evaluation.\25\ The agency has further determined that the impact of
this rule is so minimal that the preparation of a full regulatory
evaluation is not required.
---------------------------------------------------------------------------

    \25\ Department of Transportation, Adoption of Regulatory
Policies and Procedures, 44 FR 11034 (Feb. 26, 1979).
---------------------------------------------------------------------------

    This final rule does not add any cost, as it does not change the
scope or applicability of FMVSS No. 141 and does not add new
requirements or increase design or production burden for vehicle
manufacturers.
    This final rule does not have any effect on safety, as the
modification of a step in the test procedures related to ambient noise
correction does not change the safety requirements in the standard that
apply to all pedestrian alert sounds.

B. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.,
as amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA) of 1996), whenever an agency is required to publish a notice
of rulemaking for any proposed or final rule, it must prepare and make
available for public comment a regulatory flexibility analysis that
describes the effect of the rule on small entities (i.e., small
businesses, small organizations, and small governmental jurisdictions).
The Small Business Administration's regulations at 13 CFR part 121
define a small business, in part, as a business entity ``which operates
primarily within the United States'' (13 CFR 121.105(a)). No regulatory
flexibility analysis is required if the head of an agency certifies the
rule would not have a significant economic impact on a substantial
number of small entities.
    SBREFA amended the Regulatory Flexibility Act to require Federal
agencies to provide a statement of the factual basis for certifying
that a rule would not have a significant economic impact on a
substantial number of small entities.
    NHTSA has considered the effects of this final rule under the
Regulatory Flexibility Act. This final rule would directly impact
manufacturers of hybrid and electric vehicles. Most manufacturers
affected by this final rule are not small businesses. To the extent any
manufacturers of hybrid or electric vehicles are small businesses, we
do not believe this final rule would have a significant economic impact
on any small businesses as this final rule would not impose any
additional costs on manufacturers.

C. Executive Order 13132 (Federalism)

    NHTSA has examined this final rule pursuant to Executive Order
13132 (64 FR 43255, August 10, 1999) and concluded that no additional
consultation with States, local governments or their representatives is
mandated beyond the rulemaking process. The agency has concluded that
the rulemaking would not have sufficient federalism implications to
warrant consultation with State and local officials or the preparation
of a federalism summary impact statement. The final rule would not have
``substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.''
    NHTSA rules can preempt in two ways. First, the National Traffic
and Motor Vehicle Safety Act contains an express preemption provision:
When a motor vehicle safety standard is in effect under chapter 301, a
State or a political subdivision of a State may prescribe or continue
in effect a standard applicable to the same aspect of performance of a
motor vehicle or motor vehicle equipment only if the standard is
identical to the standard prescribed under chapter 301. 49 U.S.C.
30103(b)(1). It is this statutory command by Congress that preempts any
non- identical State legislative and administrative law addressing the
same aspect of performance.
    The express preemption provision described above is subject to a
savings clause under which ``[c]ompliance with a motor vehicle safety
standard prescribed under this chapter does not exempt a person from
liability at common law.'' 49 U.S.C. 30103(e).
    Pursuant to this provision, State common law tort causes of action
against motor vehicle manufacturers that might otherwise be preempted
by the express preemption provision are generally preserved. However,
the Supreme Court has recognized the possibility, in some instances, of
implied preemption of such State common law tort causes of action by
virtue of NHTSA's rules, even if not expressly preempted. This second
way that NHTSA rules can preempt is dependent upon there being an
actual conflict between an FMVSS and the higher standard that would
effectively be imposed on motor vehicle manufacturers if someone
obtained a State common law tort judgment against the manufacturer,
notwithstanding the manufacturer's compliance with the NHTSA standard.
Because most NHTSA standards established by an FMVSS are minimum
standards, a State common law tort cause of action that seeks to impose
a higher standard on motor vehicle manufacturers will generally not be
preempted. However, if and when such a conflict does exist--for
example, when the standard at issue is both a minimum and a maximum
standard--the State common law tort cause of action is impliedly
preempted. See Geier v. American Honda Motor Co., 529 U.S. 861 (2000).
    Pursuant to Executive Order 13132 and 12988, NHTSA has considered
whether this rulemaking action could or should preempt State common law
causes of action. The agency's ability to announce its conclusion
regarding the preemptive effect of one of its rules reduces the
likelihood that preemption will be an issue in any subsequent tort
litigation.
    To this end, the agency has examined the nature (e.g., the language
and structure of the regulatory text) and objectives of this final rule
and finds that this rule prescribes only a minimum safety standard. As
such, NHTSA does not intend that this rule preempt State tort law that
would effectively impose a higher standard on motor vehicle
manufacturers than that established by this rule. Establishment of a
higher standard by means of State tort law would not conflict with the
minimum standard announced here. Without any conflict, there could not
be any implied preemption of a State common law tort cause of action.

D. Executive Order 12988 (Civil Justice Reform)

    With respect to the review of the promulgation of a new regulation,
section 3(b) of Executive Order 12988, ``Civil Justice Reform'' (61 FR
4729; Feb. 7, 1996), requires that Executive agencies make every
reasonable effort to ensure that the regulation: (1) Clearly specifies
the preemptive effect; (2) clearly specifies the effect on existing
Federal law or regulation; (3) provides a clear legal standard for
affected conduct, while promoting simplification and burden reduction;
(4) clearly specifies the retroactive effect, if any; (5) specifies
whether administrative proceedings are to be required before

parties file suit in court; (6) adequately defines key terms; and (7)
addresses other important issues affecting clarity and general
draftsmanship under any guidelines issued by the Attorney General. This
document is consistent with that requirement.
    Pursuant to E.O. 12988, NHTSA notes that the issue of preemption is
discussed separately in this final rule. NHTSA notes further that there
is no requirement that individuals submit a petition for
reconsideration or pursue other administrative proceedings before they
may file suit in court.

E. Protection of Children From Environmental Health and Safety Risks

    Executive Order 13045, ``Protection of Children from Environmental
Health and Safety Risks'' (62 FR 19855, April 23, 1997), applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental,
health, or safety risk that the agency has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the agency must evaluate the environmental health or
safety effects of the planned rule on children and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the agency.
    This final rule is not expected to have a disproportionate health
or safety impact on children. Consequently, no further analysis is
required under Executive Order 13045.

F. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA), a person is not
required to respond to a collection of information by a Federal agency
unless the collection displays a valid Office of Management and Budget
(OMB) control number. There is not any new information collection
requirement associated with this final rule.

G. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) requires NHTSA to evaluate and use existing voluntary
consensus standards in its regulatory activities unless doing so would
be inconsistent with applicable law (e.g., the statutory provisions
regarding NHTSA's vehicle safety authority) or otherwise impractical.
Voluntary consensus standards are technical standards developed or
adopted by voluntary consensus standards bodies. Technical standards
are defined by the NTTAA as ``performance-based or design-specific
technical specification and related management systems practices.''
They pertain to ``products and processes, such as size, strength, or
technical performance of a product, process or material.'' Examples of
organizations generally regarded as voluntary consensus standards
bodies include ASTM International, the SAE International, and the
American National Standards Institute. If NHTSA does not use available
and potentially applicable voluntary consensus standards, we are
required by the Act to provide Congress, through OMB, an explanation of
the reasons for not using such standards.
    NHTSA considered and utilized voluntary consensus standards in the
development of the FMVSS No. 141 standard. NHTSA utilized SAE J2889 as
a basis for the test procedures in FMVSS No. 141, as discussed in the
preamble to the original final rule establishing the safety standard in
2016.\26\ NHTSA's test procedures include a specific deviation from the
J2889 procedures for reasons discussed in the original final rule
preamble. That deviation was raised in a comment and is addressed in
this final rule document in the discussion of comments pertaining to
the amended test procedure.
---------------------------------------------------------------------------

    \26\ 81 FR 90416.
---------------------------------------------------------------------------

    There are no other voluntary consensus standards developed by
voluntary consensus standards bodies pertaining to this final rule.

H. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires Federal agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of more
than $100 million annually (adjusted for inflation with base year of
1995). Before promulgating a rule for which a written statement is
needed, section 205 of the UMRA generally requires the agency to
identify and consider a reasonable number of regulatory alternatives
and adopt the least costly, most cost-effective, or least burdensome
alternative that achieves the objectives of the rule. The provisions of
section 205 do not apply when they are inconsistent with applicable
law. Moreover, section 205 allows the agency to adopt an alternative
other than the least costly, most cost-effective, or least burdensome
alternative if the agency publishes with the final rule an explanation
of why that alternative was not adopted.
    This final rule will not result in any expenditure by State, local,
or tribal governments or the private sector of more than $100 million,
adjusted for inflation.

I. National Environmental Policy Act

    NHTSA analyzed the original FMVSS No. 141 final rule for the
purposes of the National Environmental Policy Act. The agency
determined that implementation of that rule would not have any
significant impact on the quality of the human environment.\27\
---------------------------------------------------------------------------

    \27\ Docket no. NHTSA-2016-0125, https://www.regulations.gov/document?D=NHTSA-2016-0125-0009.
---------------------------------------------------------------------------

    The final rule amends FMVSS No. 141 in a way that would not change
the impact for the purposes of the National Environmental Policy Act.
Therefore, the agency has determined that implementation of this action
will not have any significant impact on the quality of the human
environment.

J. Regulation Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN contained in the heading at the beginning of this document
to find this action in the Unified Agenda.

K. Privacy Act

    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).

List of Subjects in 49 CFR Part 571

    Imports, Motor vehicle safety, Motor vehicles, Reporting and
recordkeeping requirements, Rubber and rubber products.

    For the reasons set forth in the preamble, the National Highway
Traffic Safety Administration amends 49 CFR part 571 as follows:

PART 571--FEDERAL MOTOR VEHICLE SAFETY STANDARDS

0
1. The authority citation for part 571 continues to read as follows:

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166;
delegation of authority at 49 CFR 1.95.

0
2. Amend Sec.  571.141 by revising paragraph S6.7.3 to read as follows:

Sec.  571.141   Standard No. 141; Minimum Sound Requirements for Hybrid
and Electric Vehicles.

* * * * *
    S6.7.3 For each microphone, compute an ambient level for each of
the 13 one-third octave bands using the time that is associated with
the minimum A-weighted overall ambient identified in S6.7.2 of this
section.
* * * * *

    Issued in Washington, DC, under authority delegated in 49 CFR
1.95 and 501.8.
Steven S. Cliff,
Administrator.
[FR Doc. 2022-14733 Filed 7-12-22; 8:45 am]
BILLING CODE 4910-59-P


	SUPPORTING STATEMENT FOR STANDARD FORM 83-I

	PART A OF THE SUPPORTING STATEMENT

1.  IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) TITLE AND NUMBER OF THE INFORMATION COLLECTION

Regulation of Fuel and Fuel Additives: Gasoline Benzene Program.
Current OMB control number is 2060-0277.  The EPA number for this
proposed ICR is 1591.20.  The docket number is EPA-HQ-OAR-2005-0036.

(b) SHORT CHARACTERIZATION/ABSTRACT

Section 211(k) of the Clean Air Act (“Act”) mandates that
reformulated gasoline (RFG) which meets various requirements be
exclusively sold in nine statutory control areas and in other ozone
nonattainment areas that “opt-in” to the reformulated gasoline
program.  The Act also requires EPA to regulate the production and sale
of conventional gasoline (non-RFG) throughout the rest of the country.
Refiners and importers of gasoline are required to demonstrate
compliance by conducting sampling and testing of the gasoline and
reporting the results to EPA’s Office of Transportation and Air
Quality.  See 40 CFR Part 80, subparts D through F.  Previous ICRs in
this 1591 series have covered start up costs and other record keeping,
reporting, and testing requirements associated with the final rule.
This proposed ICR covers burdens and costs associated with the proposed
gasoline benzene program, which includes an averaging, banking and
trading credit program.  The program will not be fully implemented until
2011, but there are several information collection items related to
registration, establishment of benzene baselines and early credit
generation, and pre-compliance reporting that will apply from 2007-2009,
and these are the subject of this proposed ICR.  For convenience, we
have included rough estimates for future reporting beyond that timeframe
as well.  Future reporting will be the subject of a future proposed ICR.

2.  NEED FOR AND USE OF THE COLLECTION

(a) NEED/AUTHORITY FOR THE COLLECTION

The basic need and authority for the collection of information have
been established in the ICR for the RFG and anti-dumping final rule.
The Act specifically provides that recordkeeping and reporting
requirements are among the tools EPA may use in enforcement of the
provisions of § 211(k) and also provides that EPA must develop an
enforceable scheme.  Sections 114 and 208 of the Act authorize EPA to
require recordkeeping and reporting regarding enforcement of the
provisions of Title II of the Act.

(b) PRACTICAL UTILITY/USERS OF THE DATA

The practical utility and use of the collection of information related
to the RFG and conventional gasoline have been established in the ICR
for the RFG and anti-dumping  final rule.

The EPA’s Office of Enforcement and Compliance Assurance and EPA’s
Office of Air and Radiation, Office of Transportation and Air Quality,
will be the governmental users of the information contained in this
proposed information collection.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

(a) NONDUPLICATION

This proposed ICR is not unnecessarily duplicative of information
otherwise reasonably accessible to the Agency.  Wherever possible, we
have designed the proposed regulation to make sure that there is no
unnecessary duplication.  For example, parties who have already
registered under the RFG and anti-dumping program do not have to
re-register and recordkeeping and reporting related to sampling and
testing activities are not proposed to be altered, since existing
provisions adequately meet program needs.

(b) PUBLIC NOTICE REQUIRED PRIOR TO ICR SUBMISSION TO OMB

The proposed ICR changes are included in the proposed rule.  A copy of
the proposed rule is available in this docket and it will be submitted
for publication in the Federal Register.

(c) CONSULTATIONS

No representatives from the affected industry participated in the
development process regarding the specific modification, included in
this proposed ICR; however, industry was consulted in making the
assumptions related to the original information collection burden and in
developing the proposed rule that this proposed ICR is based on. We are
seeking industry comment via this draft supporting statement and
encourage all interest parties to submit comments to us.

(d) EFFECTS OF LESS FREQUENT COLLECTION

Less frequent reporting would make discovery and correction of
violations take too long to discover from the date of violation, and
would give non-complying parties a competitive advantage for long
periods of time.  A lesser recordkeeping burden would make verification
of compliance extremely difficult.

(e) GENERAL GUIDELINES

The general guidelines for the collection of information pursuant to the
RFG and anti-dumping rule are approved in the ICR for the final RFG and
anti-dumping rule.

(f) CONFIDENTIALITY AND SENSITIVE QUESTIONS

 (i) Confidentiality

Any information submitted to EPA for which a claim of confidentiality is
made will be safeguarded according to EPA regulations at 40 C.F.R. 2.201
et. seq.

(ii) Sensitive Questions

This section is not applicable as this proposed ICR does not involve
matters of a sensitive nature.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

(a) RESPONDENTS/NAICS and SIC CODES

Respondents are gasoline refiners and importers (324110 / 2911) of RFG
and conventional gasoline.

(b) INFORMATION REQUESTED

(i) Data Items, Including Recordkeeping Requirements

Knowledge of the following definitions at 40 CFR 80.2 is important for a
thorough understanding of the reporting and recordkeeping requirements:

“Gasoline” means any fuel sold in any State (State means a State,
the District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands, Guam,  American Samoa, and the Northern Mariana Islands) for
use in motor vehicles and motor vehicle engines, and commonly or
commercially known or sold as gasoline.

“Refiner” means any person who owns, leases, operates, controls, or
supervises a refinery.

“Importer” means a person who imports gasoline, gasoline blending
stocks or components, or diesel fuel from a foreign country into the
United States (including the Commonwealth of Puerto Rico, the Virgin
Islands, Guam, American Samoa, and the Northern Mariana Islands).

“Reformulated Gasoline” means any gasoline whose formulation has
been certified under 40 CFR 80.40 and which meets each of the standards
and requirements prescribed under 40 CFR 80.41.

“Conventional Gasoline” means any gasoline which has not been
certified under 40 CFR 80.40.

REPORTING REQUIREMENTS

	The following reporting requirements may be applicable to a party
between January 1, 2007 and December 31, 2009:

Company Registration - Registration is required under this proposed
regulation for refiners and importers and will use existing forms.
Refiners and importers who have already registered with us will not be
required to register again. EPA issues a four-digit identification
number for each company.

Facility Registration - Refiners and importers must register all their
facilities.  Facilities already registered with us will not be required
to be registered again.  Application will be via existing EPA forms.
EPA issues a five-digit identification number for each facility.

Attest Engagement “Audit” Report - Refiners and importers who meet
compliance on average will have to expand the existing attest engagement
to include benzene content and credit generation.  An attest engagement
is performed by an independent auditor.  There is no EPA form, but the
attest engagement must follow requirements specified in the regulation
and which are based upon American Institute of Certified Public
Accountants (AICPA) standards.

Benzene Baseline Application – Those refiners intending to generate
early credits must establish a benzene baseline 60 days prior to the end
of the first period during which credits will be generated.  This is a
one time application.  There is no standard EPA form.

Hardship Applications:  Refiners may apply for temporary hardship relief
or for small refiner status.  Refiners or importers may apply for relief
under extraordinary circumstances.  These are one time applications.
There is no standard EPA form.

Pre-Compliance Reports:  Refiners and importers will submit this report,
which will typically take the form of a letter.  There is no standard
EPA form.

Annual Reports:  Annual reports will be submitted by refiners and
importers using established EPA forms.  It will be necessary for EPA to
develop a new benzene credit report, but this form has not yet been
developed.

	During the initial three years of the program (the period covered by
this ICR), most  recordkeeping and reporting activities will be
performed only by parties who choose to generate early benzene credits.
In future years, it will be necessary to develop product transfer
documents (PTDs) and pump labels for aircraft and certain racing fuels
that would be exempt under the proposed benzene requirements.  Future
reporting items are roughly estimated in this ICR for informational
purposes, although they are not part of the burden calculations.

(ii) 	Respondent Activities

The following are required:

Read and comprehend the regulations and instructions on completing the
forms.

Train personnel to meet the requirements, employing new technologies if
warranted.

Develop the information that is not already available.

Gather and organize the information.

Review the information, perform quality assurance, and take corrective
action, if necessary, to meet the regulatory requirements.

Report the information to EPA, on forms as appropriate, and/or retain
the information, as specified in the regulations.

5.  	THE INFORMATION COLLECTED--AGENCY ACTIVITIES, COLLECTION
METHODOLOGY AND INFORMATION MANAGEMENT

(a) AGENCY ACTIVITIES

The following are required:

Develop a thorough understanding of the regulatory requirements.
Prepare guidance documents and forms.

Convey the requirements in a manner that is understandable.  Emphasize
the benefits of submitting data electronically.

Respond to inquiries.

Provide access to the regulations, guidance documents, and forms.

Review the submitted information prior to data entry for compliance with
submission requirements.

Contact the respondent when the information has not been submitted
properly and provide guidance on correction of the problem.

Maintain and refine hardware and software systems for handling
confidential data via hard copy and electronically.

Administer a contract for data entry.

Input information into databases and store the information.

Perform data analysis and identify violations.

 (b) COLLECTION METHODOLOGY AND MANAGEMENT

The information collection has been developed by EPA offices that have
planned and allocated resources for the efficient and effective
management and use of the information to be collected, including the
processing of the information in a manner which will enhance the utility
of the information for the Agency and the public.  The information
collection, to the maximum extent practicable, uses appropriate
information technology to reduce burden and improve data quality, Agency
efficiency, and responsiveness to the public.

EPA has supplied, or will supply, forms and electronic formats for many
reporting requirements.  (For some of the proposed requirements, forms
or formats would be impractical.  The information may be submitted in a
manner chosen by the respondent.)  It is our goal to have nearly all
forms received electronically and in a simplified, flat file format by
the time this proposed rule is finalized and implemented.

The product transfer document information can be included on standard
transfer documentation customarily used.  EPA allows the information to
be encoded to facilitate reporting and save space.  Detailed production
documents are already used and maintained by refiners.

The information is carefully reviewed for compliance with the
requirements.  Most of the information submitted to the Agency under the
RFG and anti-dumping program is confidential.  It is stored in a secure
area and on secure databases.

No changes to the collection methodologies in the existing ICR for the
RFG and anti-dumping final rule are anticipated as a result of this
proposed ICR modification.

(c) SMALL BUSINESS FLEXIBILITY

The underlying proposed rule attempts to provide small businesses
maximum flexibility in meeting the benzene content standard.  For
example, small refiners may apply for flexibility in meeting regulatory
requirements.

(d) COLLECTION SCHEDULE

There is no change in collection schedules relative to the ICR for the
RFG and anti-dumping final rule as a result of this proposed ICR
modification.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

 	(a) ESTIMATING THE RESPONDENT BURDEN

We drew upon experience implementing similar regulations among the same
entities to develop estimates of the burden associated with this
modification.

(b) ESTIMATING THE RESPONDENT COST

Three labor categories are involved:  managerial (includes legal and
professional review), technical, and clerical. The estimates use Bureau
of Labor Statistics, "Employer Costs for Employee Compensation - Table
12 - Private Industry, Manufacturing, and Non-Manufacturing Industries
by Occupational Group (December 2003), with a 3% inflation factor
applied to bring the values to 2006.  Using this method, the following
wages and benefits apply by category:

Wages and Benefits

Managerial 	$53.87 per hour

Technical	$35.29 per hour

Clerical	$24.56 per hour

Doubling for company overhead beyond wages and benefits, and for
convenience, rounding up to the dollar, gives the following rates for
this ICR:

Total Employer Cost

Managerial	$108 per hour

Technical	$71 per hour

Clerical	$49 per hour

The labor mix for the activities estimated will be about the same for
each and is consistent with prior ICRs in this series.  It is assumed
that for each hour of activity the mix will be about 0.1 hour
managerial, 0.7 hour technical, and 0.2 hour clerical.  This gives an
average labor cost of $71 per hour, which will be used in this ICR
modification.

	(c) ESTIMATING AGENCY BURDEN AND COST

The annual Agency burden is determined using the 2006 OPM hourly pay
table applicable for the Washington DC area, with values multiplied by
1.6, the standard government benefits multiplier. The hourly wage rates
are as follows, rounded up to the nearest five dollars:

EPA Manager = $80

Technical Staff (GS-13) = $60

Clerical Staff (GS-5) = $25

We have assumed that each response will require 3.5 hours of technical
staff time to review and prepare the written response.  It is estimated
that manager will be required to expend 0.25 hour per response and that
the clerical staff will expend 0.25 hour per response.  Contractors will
not be used to handle these applications and are not included.  The
total number of responses is calculated for benzene baseline
applications (70), temporary hardship applications (20), applications
for relief under extraordinary circumstances (2), and small refiner
applications (25), which yields a total of 117 Agency responses.

The total annual Agency burden hours are estimated as follows:

Activity	No. of

Responses	Manager

Hours	Technical

Hours	Clerical

Hours	Total Agency Hours

Evaluate Data	117	0	2.5	0	292.5

Prepare

And Send

Response	117	0.25	1	0.0	146.25

Store Data	117	0	0	0.25	29.25

Total

0.25	3.5	0.25	478

The total cost per responses is estimated to be $6/clerical worker,
$210/technical staff, and $20/manager, which yields $236/response.  The
total cost burden to the Agency for 117 responses would be $27,612.

(d) ESTIMATING THE RESPONDENT UNIVERSE

We were able to estimate the number of regulated entities drawing upon
our experience regulating the same entities.  We have assumed 125
refiners and 60 importers, total.  We have assumed 70 refiners would
generate early credits.  (This number is based upon an estimate of 68 in
the proposed Regulatory Impact Analysis, rounded up to 70.)  Importers
cannot generate early credits.  "Purchased services" on the following
table relates to refiners who may hire an outside consultant to prepare
their benzene application; this has been a common practice in industry
with respect to similar applications.

(e) BOTTOM LINE BURDEN HOURS AND COSTS

The annual estimates in burden hours and costs associated with this
direct final rule are as follows:

Annual Respondent Burden Hours & Costs

(Including Non-Postage "Other Costs")

Collection

Activity 	# Respondents

By Activity	# Responses per Respondent 	Total # of Responses 	# Hours
per Response	Total Hours and Total Costs

@ $71/hour	Non-Postage Other Costs

(O&M)

Refiner and importer registration

(proposed §

80.1225)	10	1	10	1	10 hours

---

$710	0

Facility registration

(proposed § 80.1225)	10	2	20	1	20 hours

---

$1,420	0

Benzene baseline applications

(proposed § 80.1285)	70	1	70	200	14,000 hrs

---

$994,000	$994,000

Temporary hardship applications

(proposed § 80.1335)	20	1	20	40	800 hours

---

$56,800	0

Application for relief under extreme circum-stances

(proposed § 80.1336)	2	1	2	40	80 hours

---

$5,680	0

Application for small refiner status

(proposed § 80.1340)	25	1	25	40	1,000 hours

---

$71,000	0

Generate and retain calculations related to benzene content and credits

(proposed § 80.1350)	70	1	70	40	2,800 hours

---

$198,800	0

Pre-Compliance Reporting

(proposed §

80.1352)	125	1	125	40	5,000 hrs

---

$355,000	0

TOTALS	332	9	342	402	23,710 hours

===

$1,683,410

	$994,000

TOTALS:

TOTAL NO. OF REPORTS:   342

TOTAL BURDEN HOURS:   23,710

TOTAL LABOR COSTS:   $1,683,410

TOTAL NON-POSTAGE COSTS (for PURCHASED SERVICES):  $994,000

The following information is provided for informational purposes only,
as it relates to future recordkeeping and reporting activities
associated with this proposed rule that would not be covered by the
initial three-year period of the proposed ICR.  These will be the
subject of a future ICR modification, but are provided here in order to
aid interested parties in understanding the proposed rule.  Attest
engagements are required to be performed by an outside auditor and
therefore are all "purchased services."  Attest engagements are already
performed under the anti-dumping program, so the cost estimated is an
additional charge for adding the benzene item to the pre-existing attest
engagement.

Annual Respondent Burden Hours & Costs

(Including Non-Postage "Other Costs")

Applicable after December 31, 2009

---informational table only;   not included in burden estimates---

Collection

Activity 	# Respondents

By Activity	# Responses per Respondent 	Total # of Responses 	# Hours
per Response	Total Hours and Total Costs

@ $71/hour	Non-Postage Other Costs

(O&M)

Refiner and importer registration

(proposed §

80.1225)	10	1	10	1	10 hours

---

$710	0

Facility registration

(proposed § 80.1225)	10	2	20	1	20 hours

---

$1,420	0

Application for relief under extreme circum-stances

(proposed §80.1336)	2	1	2	40	80 hours

---

$5,680

	0

Generate and retain calculations related to benzene content and credits

(proposed § 80.1350)	185	1	185	40	7,400

---

$525,400	0

Developing in-house format / procedure for annual reporting and report

(year one)

(see proposed §§ 80.1295 and 80.1354)	185	1	185	100	18,500 hrs

---

$1,313,500	0

Pre-Compliance Reporting

(proposed §

80.1352)

For 2010	125	1	125	40	5,000 hours

---

$355,000	0

Annual reports

(after year one)

(see proposed §§ 80.1295 and 80.1354)	185	1	185	1	185 hours

---

$13,135	0

Attest engagement

(see proposed § 80.1375)	185	1	185	2	All purchased services.

	$26,270

Implement code for PTDs for aircraft / racing	50	1	50	4	200 hours

---

$14,200	0

Develop pump labels for aircraft / racing	50	1	50	4	200 hours

---

$14,200	0

TOTALS	987	11	997	233	31,595 hrs

===

$2,243,245	$26,270

(f) REASON FOR CHANGE IN BURDEN

	The proposed change in burden is due to issuance of a notice of
proposed rulemaking affecting benzene content of RFG and conventional
gasoline.

(g) BURDEN STATEMENT

 The average Agency burden in hours per response for this ICR is
estimated to be four (4) hours.  The average respondent burden in hours
per response for this ICR is estimated to be 70 hours.

 Burden means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency.  This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for the notice of proposed
rulemaking and for this ICR.  Comments may be submitted to the attention
of the following docket number: EPA-HQ-OAR-2005-0036.   You can also
send comments to the Office of Information and Regulatory Affairs,
Office of Management and Budget, 725 17th Street, NW, Washington, DC
20503, Attention: Desk Office for EPA.  Please include the docket number
in any correspondence.

B.	COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

This section is not applicable because statistical methods are not used
in the data collection associated with the reformulated and anti-dumping
regulations.

 Please note that costs are not expressed in thousands of dollars as is
the usual custom for supporting statements, but in actual dollars.
Because some amounts are relatively small, it is easier in this case to
use actual dollars.

 This is the total number of hours from the "Annual Respondent Burden
Hours & Costs" table on page 9, divided by the total number of reports,
rounded up for simplicity.

 PAGE  15


[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16597-16598]
[FR Doc No: 2017-06700]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0726]

Antibody Mediated Rejection in Kidney Transplantation; Public
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public workshop regarding new developments and scientific
issues related to antibody mediated rejection (AMR) in kidney
transplantation. This public workshop is intended to provide
information for and gain perspective from individuals, industry, health
care professionals, researchers, public health organizations, patients,
patient care providers, and other interested persons on various aspects
of clinical development of medical products for prophylaxis and/or
treatment of AMR in kidney transplant recipients, including clinical
trial design and endpoints. The input from this public workshop will
also help in developing topics for future discussion.

DATES: The public workshop will be held on April 12, 2017, from 8 a.m.
to 6 p.m. and April 13, 2017, from 8:30 a.m. to 1:30 p.m. Submit either
electronic or written comments on this public workshop by April 27,
2017. Late, untimely filed comments will not be considered. Electronic
comments must be submitted on or before April 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 27, 2017. 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. See the SUPPLEMENTARY
INFORMATION section for registration date and information. Workshop
updates and the workshop agenda will be made available at: http://www.fda.gov/Drugs/NewsEvents/ucm532070 prior to the workshop.

ADDRESSES: The public workshop will be held at the Tommy Douglas
Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903.
The conference center's phone number is<PHONE_NUMBER>.
    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): Division of Dockets Management (HFA-305), Food

and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-0726 for ``Antibody Mediated Rejection in Kidney
Transplantation.'' Received comments, those filed in a timely manner
(see DATES) will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop regarding AMR in kidney
transplantation. This public workshop will focus on scientific
considerations in the clinical development of medical products for
prophylaxis and/or treatment of AMR in kidney transplant recipients.
    Among the primary goals of this workshop are the discussion of the
role of immunosuppressive medication nonadherence in the development of
de novo donor specific antibody (DSA) formation and subsequent AMR, new
developments in transplantation and their impact on patient management
(such as pretransplant sensitization not manifested by DSA, donor/
recipient human leukocyte antigen (HLA) epitope matching, routine
posttransplant DSA monitoring), the natural course of the acute-chronic
AMR continuum and its temporal association with cellular rejection and
changes in glomerular filtration rate (GFR), unmet medical needs and
the potential implications of these factors on the design of clinical
trials for the prevention and management of AMR.
    The Agency encourages individuals, industry, health care
professionals, researchers, public health organizations, patients,
patient care providers, and other interested persons to attend this
public workshop.

II. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop
must register by April 6, 2017, midnight Eastern Time. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone to
<EMAIL_ADDRESS>    Registration is free and based on space availability, with priority
given to early registrants. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization. Registrants will receive confirmation when they
have been accepted. If time and space permit, onsite registration on
the day of the public workshop will be provided beginning at 7:30 a.m.
on April 12, 2017, and 8 a.m. on April 13, 2017. We will let
registrants know if registration closes before the day of the public
workshop.
    If you need special accommodations due to a disability, please
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION
CONTACT) no later than April 5, 2017.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments and requests to participate in the focused sessions.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation, or submit requests for designated representatives
to participate in the focused sessions. All requests to make oral
presentations must be received by the close of registration on April 6,
2017. Following the close of registration, we will determine the amount
of time allotted to each presenter and the approximate time each oral
presentation is to begin, and will select and notify participants by
April 7, 2017. If selected for presentation, any presentation materials
must be emailed to<EMAIL_ADDRESS>no
later than April 10, 2017. No commercial or promotional material will
be permitted to be presented or distributed at the public workshop.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A link to the transcript will also be
available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm532070.htm approximately 45 days after the workshop.

    Dated: March 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06700 Filed 4-4-17; 8:45 am]
 BILLING CODE 4164-01-P