[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Rules and Regulations]
[Pages 49967-49975]
[FR Doc No: 2020-16044]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0700; FRL-10012-09-Region 5]

Air Plan Approval; Indiana; Attainment Plan for the Southwest
Indiana Sulfur Dioxide Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving as a
State Implementation Plan (SIP) revision to the Southwest Indiana-
related elements of an Indiana submission to EPA dated October 2, 2015,
as supplemented on November 15, 2017 and September 18, 2019. EPA
concludes that Indiana has appropriately demonstrated that the plan
provides for attainment of the 2010 sulfur dioxide (SO2)
primary National Ambient Air Quality Standard (NAAQS) in the Southwest
Indiana area by the applicable attainment date and that the plan meets
the other applicable requirements under the Clean Air Act.

DATES: This final rule is effective on September 16, 2020.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2015-0700. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available through
www.regulations.gov, or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: John Summerhays at EPA Region 5,
Attainment Planning and Maintenance

Section, Air Programs Branch (AR-18J), Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312)
886-6067<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Summary of EPA's Notices of Proposed Rulemaking

    Following the promulgation in 2010 of a 1-hour primary
SO2 NAAQS, on August 5, 2013, at 78 FR 47191, EPA designated
an area in Southwest Indiana that included a township in each of
Daviess and Pike Counties, Indiana as nonattainment for this NAAQS, in
conjunction with designating three other areas in Indiana and multiple
areas in other states as nonattainment. On October 2, 2015, the Indiana
Department of Environmental Management (``Indiana'') submitted plans
addressing all four of its SO2 nonattainment areas. EPA has
taken separate action on Indiana's plans for its other nonattainment
areas: EPA published final action on plans for the Indianapolis and
Terre Haute areas on March 22, 2019, at 84 FR 10692, and published
final action on the plan for the Morgan County area on September 23,
2019, at 84 FR 49659.
    In addition to its October 2, 2015 submittal, Indiana made a
supplemental submittal on November 15, 2017, providing clarifications
on its inventory procedures and other elements of its four
nonattainment plans. EPA published a proposed rule proposing to approve
three of these plans (for the Southwest Indiana, Indianapolis, and
Terre Haute areas) on August 15, 2018, at 83 FR 40487.
    In response to that proposed rule, EPA received comments objecting
to, among other things, the manner in which Indiana calculated an
adjustment to the level of the 30-day average limit for Indianapolis
Power and Light's Petersburg power plant (IP&L-Petersburg or ``the
facility''). These comments prompted Indiana to recalculate the
adjustment factor used to determine the appropriate limits for this
facility, resulting in the adoption of revised limits and submittal of
these revised limits on September 18, 2019. Indiana also provided an
email on November 19, 2019 clarifying the interrelationship between the
commissioner's order containing the revised limits and the provisions
in Indiana regulations, both of which Indiana requested be incorporated
into the Indiana SIP.
    On February 24, 2020, at 85 FR 10350, EPA published a supplementary
proposed rule addressing Indiana's revised plan. This action evaluated
Indiana's revised 30-day average limits and the recalculated adjustment
factor used to determine those limits. The original submittal relied on
modeling to determine 1-hour emission limits that would provide for
attainment (expressed in pounds per million British Thermal Units
(MMBTU), known as critical emission rates), and imposed 30-day average
limits determined by multiplying these 1-hour rates by 80 percent.
Indiana's reevaluation concluded that a more appropriate adjustment
factor was 68 percent. Indiana made no change to its modeling; its
revised 30-day average limits reflect only this change in adjustment
factor. Therefore, the supplemental proposed rule solicited comments
only on this change to Indiana's plan.

II. Comments

    In response to its proposed rule of August 15, 2018, EPA received
relevant comments from Sierra Club addressing the reliance on 30-day
average emission limits for Indianapolis Power and Light's Petersburg
power plant (IP&L-Petersburg). EPA also received two anonymous comments
that address subjects outside the scope of our proposed action, do not
explain (or provide a legal basis for) how the proposed action should
differ in any way, and make no specific mention of the substantive
aspects of the proposed action. Consequently, these comments are not
germane to this rulemaking and require no further response. EPA
received no comments on its supplemental proposed rule of February 24,
2020.
    As noted above, Sierra Club had numerous comments on the
calculation of the adjustment factor used to determine the original 30-
day average limits, which resulted in Indiana recalculating the
adjustment factor and adopting revised limits, and which EPA then
discussed in a supplemental notice of proposed rulemaking (NPRM).
Consequently, some of Sierra Club's comments on the original Indiana
submittal are either moot or have been subject to an additional
solicitation of comments in light of the additional relevant available
information. EPA received no comments on this supplemental NPRM. The
following responses to Sierra Club's comments will identify the extent
to which comments on specific aspects of Indiana's calculations of 30-
day average limits for IP&L-Petersburg are still germane.
    Comment: Sierra Club notes the health effects from exposure to
SO2 ``in even very short time periods--such as five
minutes.'' Sierra Club expresses concern that IP&L-Petersburg's 30-day
average limit will allow spikes in emissions that cause spikes in
concentrations sufficient to yield violations of the 1-hour air quality
standard.
    Response: EPA believes that Indiana's establishment of a 30-day
average limit at a lower level than the 1-hour limit indicated to be
necessary by modeling will avoid some of the exceedances that would be
expected with emissions constantly at the modeled level, such that the
net effect of Indiana's lower, longer term average limit is to have
similar air quality as would be expected with a 1-hour limit. Further
discussion of this topic is provided below in response to more detailed
comments. Sierra Club properly focuses on whether Indiana's plan
provides for attainment of the 1-hour standard, and not on the shorter
term (e.g., five minutes) exposures that the standard is designed in
part to address. Nevertheless, EPA notes that suitably adjusted long
term limits can be expected to provide adequate mitigation of even the
shorter (sub-hour) exposures to SO2, for the same reasons
that such limits suitably address the 1-hour standard.
    Comment: Sierra Club observes that EPA's April 2014 guidance \1\
acknowledges that EPA historically has required averaging times
consistent with the averaging time of the standard, and specifically
stated that EPA would not approve plans relying solely on 30-day
average limits. Sierra Club cites other EPA statements that short term
standards must be addressed with short term average limits. Sierra Club
equates a 30-day average limit to a 720-hour average limit, and states
that a 720-hour limit would not sufficiently limit hourly emissions to
protect against violations of the air quality standard ``unless it was
shown through air dispersion modeling that the maximum uncontrolled
hourly emissions from a source'' would not result in violation of the
standard. Sierra Club notes that Table 8-1 of EPA's modeling guideline
``requires modeling for short term [standards] be based on the
allowable emissions over the averaging time of the [standard].'' Sierra
Club asserts that ``the maximum allowable hourly emission rate is
difficult to predict from a 30-day average limit.''
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    \1\ See ``Guidance for 1-Hour SO2 Nonattainment Area
SIP Submissions,'' available at https://www.epa.gov/sites/production/files/2016-06/documents/20140423guidance_nonattainment_sip.pdf.
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    Response: The EPA statements that Sierra Club cites predate the
2014 guidance, and thus reflect a time when EPA had not yet conducted
the analyses and completed evaluation of methods

for formulating longer term average limits that would provide for
attainment of a 1-hour air quality standard. Now that EPA has completed
this work, the 2014 guidance, for purposes of implementing the 2010
SO2 NAAQS, supersedes prior guidance on the topic.
    Sierra Club cites the requirement in EPA's modeling guideline \2\
to model the allowable emission rate based on a short term limitation,
but does not address the guidance in appendix A of EPA's 2014 guidance
(entitled ``Modeling Guidance for Nonattainment Areas''), which states
that notwithstanding the orientation of Table 8-1 toward short term
emission limits, ``current guidance . . . provides that after the state
determines the 1-hour limit that would be necessary to provide for
attainment, any longer term limit should be established at a level that
is sufficiently lower to provide comparable stringency. Thus, in cases
where a state wishes to apply a longer term average limit, the
attainment analysis would be based not on the level of the longer term
limit but rather on the level of the corresponding 1-hour emission
limit.'' See page A-79 of EPA's 2014 guidance. This recommended
approach avoids the unnecessary burden of defining an ensemble of
variable emissions that may be considered to reflect allowable
emissions and the burden of conducting a modeling analysis with such an
inventory. Instead, EPA recommends relying on standard modeling
approaches, as if a short-term limit were to be established. For
reasons described in the guidance and described in more detail in the
August 15, 2018 NPRM, EPA believes that a longer term limit that is
determined to have comparable stringency to the corresponding 1-hour
limit (generally, by applying an adjustment factor computed according
to recommended methods) will yield comparable air quality (i.e.,
comparable assurance that the standard will not be violated) as the 1-
hour limit. For that reason, and for ease of implementation, EPA does
not believe that an assessment of the range of emissions expected upon
compliance with a long-term limit or an assessment of the associated
air quality is warranted or necessary.
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    \2\ Title 40 Code of Federal Regulations part 51 appendix W,
entitled ``Guideline on Air Quality Models.''
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    Comment: Sierra Club asserts that ``ambient air quality conditions
can be rendered unsafe by as few as four hours of elevated emissions
over the course of a year.''
    Response: Indiana, by imposing a 30-day average limit on IP&L-
Petersburg's emissions determined in accordance with EPA's guidance,
allows a small number of occasions to have emissions above the critical
emissions value but requires most occasions to have emissions well
below this level, indeed requiring emissions on average to be 32
percent below the critical emissions value. In modeling constant
emissions, as in routine modeling to assess whether a particular set of
1-hour emissions limits would provide for attainment, one makes no
assessment of the impact of emissions sometimes being higher and other
times being lower than the constant emission level. Sierra Club
addresses only the occasions with higher emissions, noting their
potential to result in exceedances beyond those expected with emissions
always at the critical emissions value, thereby yielding a violation of
the standard. However, Sierra Club does not address the impact of
emissions generally being well below the critical emissions value.
Thus, Sierra Club does not consider the likelihood that the more
numerous occasions of emissions well below the critical emissions
value, mandated by the downward adjusted longer term average emissions
limit, would result in avoiding some of the exceedances that would be
expected with emissions always at the critical emissions value. EPA
does not dispute Sierra Club's contention that occasions with emissions
above the critical emissions value create added risk of exceedances of
the air quality standard (if these occasions occur when the meteorology
is conducive toward high concentrations at locations where violations
might occur), but Sierra Club does not dispute or otherwise address
EPA's contention that other occasions with emissions well below the
critical emissions value, which the downward adjusted 30-day average
limit requires to occur often, can be expected to yield a compensating
reduction in the frequency of concentrations above the level of the
standard. As explained in the NPRM, EPA believes that the net effect of
a properly downward adjusted longer-term limit is comparable to the
effect of a corresponding 1-hour emission limit and provides equally
for attainment.
    Comment: Sierra Club asserts that Indiana's modeling analysis,
which does not directly assess emissions allowed by a long-term average
emission limit, is contrary to the regulatory requirements in 40 CFR
51.112(a). Separately, Sierra Club objects to EPA's assertion that the
plan need not provide ``absolute certainty that attainment will in fact
occur'' and that the plan need only provide ``an adequate level of
confidence of prospective [attainment of the standard].'' Sierra Club
quotes from Clean Air Act section 172(c)(1), that attainment plans
``shall provide for attainment of the national primary ambient air
quality standards.'' [Emphasis in comments.] Sierra Club concludes that
``EPA has much more responsibility than just ensuring a plan provides
`an adequate level of confidence' '' of attainment.
    Response: The requirement in 40 CFR 51.112(a) is that ``[e]ach plan
must demonstrate that the measures, rules, and regulations contained in
it are adequate to provide for the timely attainment and maintenance of
the national standard that it implements.'' In this case, Indiana has
conducted modeling to identify 1-hour emission limits that would
provide for attainment. Indiana then provided an analysis of the degree
of adjustment needed for 30-day average limits to be comparably
stringent to those 1-hour limits, and Indiana adopted these 30-day
average limits. Because Indiana has conducted a suitable analysis of
appropriate 1-hour limits and suitably analyzed and adopted the 30-day
average limits that are comparably stringent, EPA believes that Indiana
has suitably demonstrated that the 30-day average limits in its plan
are adequate to provide for timely attainment of the SO2
standard, thereby satisfying the requirement of 40 CFR 51.112(a).
    Sierra Club has accurately quoted the requirement in the Clean Air
Act for attainment plans to provide for attainment. Evidently Sierra
Club believes that this requirement would have been met with 1-hour
limits, despite the possibility that future violations might occur if,
for example, future meteorology differs in unforeseeable ways from the
historic meteorology analyzed in planning. EPA believes that the 30-day
average limits adopted by Indiana provide comparable assurance of
attainment as would have been provided by the 1-hour limits that
Indiana would otherwise have relied on, and thus equally as well
satisfy the requirement that, in all reasonably foreseeable
circumstances, the plan provides for attainment.
    Comment: Sierra Club believes that the modeling analysis in
appendix B of EPA's 2014 guidance does not suffice to demonstrate that
30-day average limits at IP&L-Petersburg or elsewhere can protect
against violations of the SO2 standard as well as 1-hour
limits. Sierra Club believes that the appendix B analysis, by assuming
a fixed distribution among stacks at the facility and assuming no
changes in stack parameters pursuant to the addition of

emission controls, does not properly address the multi-stack situation
at IP&L-Petersburg. Sierra Club objects further that the analysis in
appendix B, by using an inventory of how the source would actually emit
under a 30-day average limit, is not comparable to an analysis using
the maximum permissible emissions under a 1-hour emission limit.
    Response: The differences between the plant modeled for appendix B
(Canadys) and IP&L-Petersburg are not persuasive reasons to believe
that the results found for Canadys would not also apply to IP&L-
Petersburg. There is no question that modeling to identify suitable 1-
hour emission limits must be done on a source-specific basis,
considering the site-specific configurations of stacks, stack
parameters (reflecting any influence of controls on those stack
parameters), and other source-specific factors such as meteorology,
terrain, and dimensions of nearby buildings. However, appendix B
reflects a premise that a source-specific critical emission value
(i.e., a candidate value for a 1-hour emission limit) has been
identified. Appendix B addresses instead whether a 30-day average limit
that reflects an adjustment in accordance with appendix C of EPA's
guidance can be expected to result in attainment as well as imposition
of a 1-hour limit at the critical emission value. The two scenarios
addressed in appendix B (with and without a scrubber) reflect
adjustment factors of 68 percent and 69 percent, respectively. Thus,
the issue being addressed by appendix B is whether a 30-day average
limit reflecting such adjustments (determined based on a source-
specific measure of variability) can be expected to ensure attainment
as well as the corresponding 1-hour limit. EPA believes that this
comparison between air quality with an adjusted 30-day average limit
and air quality with the corresponding 1-hour limit applies to a broad
range of circumstances. In particular, EPA believes that longer term
limits established in accordance with EPA's guidance can provide for
comparable air quality as the analogous 1-hour limits for a broad range
of plants with various numbers of stacks, with various stack
parameters, and with a broad range in the absolute magnitude of the 1-
hour limits that are necessary to assure attainment.
    Sierra Club is correct that the modeling described in appendix B
for emissions in compliance with 30-day average limits is not directly
comparable to the modeling that was done in establishing a suitable 1-
hour limit. As Sierra Club notes, modeling for the 30-day average limit
scenarios reflected the expected distribution of emissions in
compliance with such a limit, inherently reflecting a margin of
compliance that sources routinely have at most times, whereas the
modeling for the 1-hour limit scenarios reflected no such margin of
compliance (i.e., these runs reflected emissions always at the 1-hour
limit).
    To address this comment, EPA performed additional analyses designed
to identify emission profiles with average emissions equal to the
presumptive 30-day average limit and to estimate the air quality that
would result. These analyses are described in detail in a document
entitled ``Supplemental Assessment of the Air Quality Consequences of
Applying Adjusted Long Term Average Emission Limits,'' which is
included in the docket for this action.
    The emission profiles used in this supplemental assessment were
generally based on the actual emissions variations found in the 30-day
periods having 99th percentile level average emissions. Profiles were
developed for two plants with limits established in recent attainment
plans for 2010 SO2 nonattainment areas: IP&L-Petersburg
(Unit 3) and Cardinal (Unit 1), a comparably large power plant in
Jefferson County, Ohio. In each case, the analyses used data for a
suitable period (3 years for IP&L-Petersburg and 5 years for Cardinal)
during which the sources were complying with the attainment-level
emission limit adopted by the state. Calculations were performed in
accordance with appendix C of the 2014 guidance to determine the 99th
percentile 30-day average emission rates and to determine appropriate
adjustment factors to be applied in determining 30-day average emission
limits. These calculations were performed separately on a pound per
hour basis and on a pound per MMBTU basis, supporting identification of
two actual emission profiles for each plant, one reflecting emission
variations in the 30-day period with approximately the 99th percentile
pound per hour value and one reflecting emission variations in the 30-
day period with approximately the 99th percentile pound per MMBTU
value. Since the analysis used the modeling information for a separate
plant (Canadys), the analyses used the critical emission value
identified in that modeling. Allowable emissions (as a 30-day average)
were calculated by multiplying this critical emission value by the
applicable adjustment factor. Allowable emission profiles were then
developed by scaling the actual emission profiles to the allowable
level, i.e., multiplying the emissions for each hour times the ratio of
the allowable emissions against the average emissions in the actual
profile, as well as by substituting the allowable emission value for
any time the plant was not operating in the actual profile period.
These allowable emission profiles were applied repeatedly, in the first
30 days and every successive 30 days, with the result that every 30-day
period in the 5-year analysis had average emissions equal to the
allowable emissions level.
    One of these profiles, namely for the 99th percentile pound per
MMBTU profile at IP&L-Petersburg, included a brief period with
exceptionally high emissions, reflecting minimal if any flue gas
desulfurization. Based on the uniqueness of these emissions during this
timeframe, EPA does not believe that such a profile, recurring every 30
days, is a realistic representation of emission variations that
routinely occur. The supplemental assessment document identified above
provides further rationale for treating this as an unrepresentative
profile, including evidence that such exceptional emissions are much
more rare in practice, engineering reasons that such operation is prone
to be damaging to the plant, and policy reasons that recurring
occasions of exceptionally high emissions would be contrary to guidance
to minimize the frequency and magnitude of occasions with emissions
above the critical emissions value. Therefore, for this assessment, EPA
replaced that profile with a profile based on emissions for the 30-day
period with approximately the 98th percentile 30-day average pound per
MMBTU value.
    The results of this assessment are shown in Table 1. For each of
the four profiles, the resulting air quality is somewhat below the air
quality standard. Since these profiles reflect allowable emissions at
all times, these results may be compared to the results of modeling
allowable emissions under the corresponding 1-hour limit (i.e.,
modeling emissions constantly at the critical emission value). Thus,
this assessment supports a conclusion similar to the conclusion from
appendix B, that establishment of a long term average emissions limit
estimated to have comparable stringency to the corresponding 1-hour
emission limit (calculated in accordance with the guidance in A C) can
be expected to result in comparable air quality, and that such a limit
provides comparable assurance of attainment.

       Table 1--Design Values Estimated for Each Emission Profile
------------------------------------------------------------------------
                                                           Design value
                         Profile                            ([micro]g/m
                                                            \3\ (ppb))
------------------------------------------------------------------------
Cardinal #/hour.........................................    181.2 (69.2)
Cardinal #/MMBTU........................................    190.6 (72.8)
Petersburg #/hour.......................................    156.3 (59.7)
Petersburg 98th %-ile #/MMBTU...........................    190.5 (72.7)
------------------------------------------------------------------------

    Comment: Sierra Club asserts that ``[n]either Indiana nor EPA
evaluated the reasonably available control measures that could be
utilized'' at IP&L-Petersburg. Sierra Club highlights a consultant's
evaluation of such measures at this plant, as reported to the Indiana
Utility Regulatory Commission. Sierra Club identifies several of the
measures identified in this consultant's evaluation, and states that
``EPA cannot justify allowing a 30-day average limit . . . without
considering all reasonably available control measures.''
    Response: EPA guidance for implementing the SO2 NAAQS
advises that a plan that provides for attainment may be considered to
have implemented all reasonably available control measures. EPA
believes that the 30-day average limits in Indiana's plan provide for
attainment as well as would have been provided by 1-hour limits.
Therefore, EPA believes that use of these 30-day average limits does
not create a need for requirements for specific control measures
(beyond the requirements inherent in the emission limit) that would not
apply with the use of 1-hour limits. While the measures evaluated in
the consultant's report may be useful approaches for the company to
comply with Indiana's emission limits, EPA does not believe that
approval of Indiana's plan should be contingent on Indiana adopting
requirements for any of these specific measures.
    Comment: Sierra Club objects that Indiana ``did not conduct a unit-
specific analysis in determining emissions variability.'' Sierra Club
believes that Indiana is not justified in evaluating emissions
variability only for the FGD stack \3\ for Unit 2, rather than
examining variability of emissions for all four units at IP&L-
Petersburg and including emissions from the bypass stacks (as
applicable at Units 1 and 2). Sierra Club notes, in particular, that
neither the 30-day average limits nor any other requirement will ensure
that emissions from the bypass stacks will not occur. Sierra Club notes
that the units differ significantly, as they use scrubbers of different
vintages and these scrubbers have been upgraded recently, so that
Indiana may not assume that the variability of the FGD stack emissions
at Unit 2 in the period from 2006 to 2010 is representative of either
the variability of emissions of the other three units at that time or
of the variability of emissions that can be expected for any of the
four units once the units meet the proposed SIP limits. Sierra Club
thus implies that the data Indiana used are not appropriate for
determining the degree of adjustment warranted for all four units for
an attainment plan for this area.
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    \3\ The ``FGD stack'' refers to the stack that vents emissions
from the unit's control device, and thus represents controlled
emissions. The bypass stack vents the emissions from the unit when
the control device is not controlling emissions properly.
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    Response: In response to this comment, Indiana provided further
explanation of its reliance on data from the Unit 2 FGD stack, namely
that these data, by exclusively reflecting controlled emissions and
reflecting more stable control equipment operation than Unit 1, provide
the best data set for representing the distribution of emissions for
all four units once Indiana's limits take effect. An extensive
discussion of Indiana's rationale is provided in the February 24, 2020
supplemental NPRM, on which Sierra Club did not comment. Furthermore,
additional analyses of variability at all four units at IP&L-Petersburg
that were described in the supplemental NPRM provide additional support
for EPA's belief that the 2006 to 2010 data for the Unit 2 FGD stack
provide an appropriate data base for anticipating the variability that
has in fact occurred in the time after Indiana's limits took effect. In
absence of comments on this additional explanation, EPA maintains that
Indiana's adjustment factor, based on 2006 to 2010 data for the FGD
stack at Unit 2, is appropriate.
    Comment: Sierra Club notes that EPA's guidance recommends that
variability analyses be based on ```an adequately robust data' with at
least `3 to 5 years of stable data (without changes that significantly
altered emissions variability)'.'' Sierra Club believes that the data
set for IP&L-Petersburg's Unit 2 FGD stack does not meet these
criteria. Sierra Club notes significant variability from year to year
in the maximum 30-day average emissions (in pounds per hour) and
emission rate (in pounds per MMBTU), which was permissible given the
absence of a constraining emission limit. Sierra Club further notes
that the emissions from the Unit 2 FGD stack were below Indiana's
proposed 30-day average proposed SIP limit for two of the five years
included in Indiana's analysis, yet even in those years those emissions
(not including bypass stack emissions) exceeded the critical mass
emissions value in 82 and 99 hours (in 2007 and 2008, respectively).
    Response: The February 24, 2020 supplemental NPRM addresses most of
these comments. In particular, the supplemental action provided
additional rationale for the use of historic data from the Unit 2 FGD
stack for assessing the expected variability of emissions at all four
units at IP&L-Petersburg, and the supplemental action described EPA's
analysis of more recent data that help confirm Indiana's forecast of
variability and that indicate that the three units that are complying
with the revised limits are emitting above the critical emissions value
less than one percent of the time. Because EPA received no comments on
this supplemental action, EPA considers the supplemental information to
address these comments on the initial NPRM.
    The supplemental NPRM did not address the portion of this comment
that argued that year-to-year variability in emissions, expressed in
terms of year-to-year variations in the maximum 30-day average pound
per hour and pound per MMBTU, is too great to consider the 2006 to 2010
period to be a period of stable operation with respect to emissions
from the Unit 2 FGD stack. That portion of the comment is addressed
here.
    The purpose of the relevant portion of EPA's guidance is to
determine variability based on a data set that best reflects the degree
of variability that can be expected once the facility complies with the
limits in the plan. A data set with significant changes in control
levels (e.g., two years of uncontrolled emissions and two years of well
controlled emissions) would either (at the 99th percentile level) be
dominated by the two years of uncontrolled emissions data or give a
distorted picture of variability, thus giving results that are either
insufficiently robust or misleading.
    However, Sierra Club has made no argument that the control regime
for the Unit 2 emissions that are vented through the FGD stack changed
during the 2006 to 2010 period. Instead, Sierra Club is effectively
arguing that routine operation of the control equipment during that
period results in significant variations in emissions from year to
year. EPA expects year-to-year differences in plant operations, and
indeed EPA seeks to include that variability in its recommended
approach to assessing the appropriate degree of adjustment of longer-
term limits. Indeed, EPA's analysis of post-control data described in
the supplemental NPRM suggests that the multi-year variability of
current

emissions is similar to the multi-year variability of Unit 2 FGD stack
emissions in 2006 to 2010. ``Stable operation'' cannot be defined as
operation without year-to-year variations; such a definition would
defeat the purpose of forecasting the variability in emissions that can
be expected into the future once the SIP control strategy is
implemented. If anything, Sierra Club's comment highlights the
importance of using the entirety of a multi-year data base (EPA
recommends at least three to five years) for determining the relative
stringency of a long term average limit as compared to a 1-hour limit,
for a period with a stable control regime such as was the case here.
    Comment: Sierra Club objects that Indiana did not evaluate whether
limits with an intermediate averaging period (e.g., 24 hours) might be
more appropriate or whether supplemental limitations on peak hourly
emissions might be warranted. Sierra Club provided statistics for each
of the four units on the number of days since the limits took effect
(using data from January 1, 2017 to June 30, 2018) during which at
least one hour exceeded the critical emission rate, despite the four
units all complying with Indiana's 30-day average emission limits. For
Units 1 through 4 during that one and one half year period, Sierra Club
noted 63 days, 138 days, 9 days, and 22 days, respectively, with at
least one hour having more emissions than the unit's critical emissions
value, representing respectively 11.5 percent, 25.3 percent, 1.7
percent, and 4.0 percent of the days in that period. Sierra Club
further notes eight hours during which total SO2 emissions
exceeded the sum of the four units' critical emissions values (in
approximate terms, a plant-wide critical emissions value). Sierra Club
concludes that Indiana's 30-day average limits cannot be considered
comparably stringent to 1-hour limits at the critical emissions value,
that modeling of the critical emissions value does not suffice to
demonstrate that the 30-day average limits provide for attainment, and
that supplemental limits must be imposed to assure that ``actual
occurrences of hourly emission rates above the critical emissions
values will only occur on `rare' occasions.''
    Response: EPA's initial NPRM concluded that Indiana's 30-day
average limits appeared to be sufficiently stringent to constrain
hourly emissions to be only rarely above the critical emissions values,
without the need for supplemental limits. The same logic would suggest
that the use of limits with an intermediate averaging time such as 24
hours is also not necessary to assure that hours with emissions above
the critical emissions value will be rare.
    EPA's initial NPRM reported the results of an examination of five
years of data from Unit 2 from before Indiana's limits took effect,
noting that the unit exceeded the 30-day average limit for about seven
percent of the averages and that the unit exceeded the critical
emissions value for about six percent of the hours. Sierra Club uses a
data set for 18 months starting when Indiana's limits took effect,
which is a data set that is more indicative of operation in accordance
with the limits in Indiana's plan. Sierra Club also examined data for
all four units. Finally, EPA's supplemental NPRM, on which Sierra Club
did not comment, reviewed the data for a 30-month period starting when
Indiana's limits took effect. Specifically, for this 30-month period,
Units 1, 3, and 4 complied with their revised 30-day average limits and
had hourly emissions above the critical emissions value (i.e., the
modeled mass emissions in pounds per hour) for 0.9 percent, 0.1
percent, and 0.4 percent of the hours, respectively. Unit 2 exceeded
its revised limit 17 percent of the 30-day averages, while exceeding
the critical emission value 3 percent of the time. This suggests that
the necessary improvements in scrubber efficiency at Unit 2 would
likely yield a percentage of hours with emissions above the critical
emission value that is similar to the percentages found for the three
units that are already complying with limits. In absence of comments on
this information, EPA continues to believe that Indiana's 30-day
average limits are sufficient to constrain emissions to be only rarely
above the critical emissions value, even without supplemental limits or
limits set with a shorter averaging time.
    Comment: Sierra Club noted that Indiana determined its 30-day
average limits on emission levels (in pounds per hour) on the basis of
an adjustment factor calculated to reflect variability of emission
rates (in pounds per MMBTU), to which Sierra Club objected as being
inappropriate and contrary to EPA guidance.
    Response: EPA agrees that the variability of emission levels is
prone to be different from the variability of emission rates, and
Sierra Club is correct that EPA guidance recommends determining and
applying separate adjustment factors for these two types of limits.
Indiana's amended plan, including revised emission rate limits, no
longer includes 30-day average mass emission level limits.\4\ EPA's
supplemental NPRM provided EPA's review of this and other revisions
Indiana made, and EPA received no comments on the revisions or on the
review provided in its supplemental action. Thus, this comment is now
moot.
---------------------------------------------------------------------------

    \4\ Indiana has provided modeling demonstrating that attainment
is assured by a limit corresponding to the ``critical emission
rate'' (which may be defined as the pound per MMBTU rate that at
maximum load suffices to provide for attainment), and so Indiana's
plan provides for attainment without need for an additional limit on
pounds of emissions per hour.
---------------------------------------------------------------------------

III. EPA's Final Action

    EPA is approving Indiana's SIP submission for the Southwest Indiana
SO2 nonattainment area, which Indiana submitted to EPA on
October 2, 2015 and supplemented on June 7, 2017, November 15, 2017,
and September 18, 2019, and clarified on November 19, 2019. This
SO2 nonattainment plan included Indiana's attainment
demonstration for this area. The nonattainment plan also addressed
requirements for emission inventories, reasonably available control
technology/reasonably available control measures, reasonable further
progress, and contingency measures. Indiana has previously addressed
requirements regarding nonattainment area new source review.\5\ EPA has
determined that Indiana's SO2 nonattainment plan for
Southwest Indiana meets the applicable requirements of Clean Air Act
sections 110, 172, 191, and 192.
---------------------------------------------------------------------------

    \5\ As noted in the NPRM, EPA approved Indiana's nonattainment
new source review rules on October 7, 1994 (94 FR 24838).
---------------------------------------------------------------------------

    Underpinning Indiana's attainment plan for Southwest Indiana are
three rules and a Commissioner's Order. The rule that is most pertinent
to this action is Indiana Administrative Code, Title 326, Rule 7-4-15
(326 IAC 7-4-15), entitled ``Pike County sulfur dioxide emission
limitations'', effective January 1, 2017, which provides 1-hour
emission limits for IP&L-Petersburg and the Frank E. Ratts facility and
provide the terms under which IP&L may switch between being subject to
the 1-hour limits in the rule and the 30-day average limits in the
Commissioner's order. Two other rules, namely 326 IAC 7-1.1-3
(``Compliance date'') and 326 IAC 7-2-1 (``Reporting requirements;
methods to determine compliance''), are also pertinent to the Marion,
Morgan, and Vigo County nonattainment plans and were approved in the
context of action on the Marion and Vigo County action (See 84 FR
10692, published March 22, 2019.) As a result of this action, the SIP
will include Pike County limits (in

addition to previously approved limits for Marion, Morgan and Vigo
Counties) as well as the implementing provisions in 326 IAC 7-1.1-3 and
326 IAC 7-2-1, and no reapproval of these implementing provisions and
indeed no SIP revision is needed for these implementing provisions to
govern the implementation of the Pike County limits, as Indiana
intended.\6\ In accordance with Indiana's request, EPA is approving
paragraphs a, b, d, and e of 326 IAC 7-4-15. EPA is also approving
Commissioner's Order Number 2019-2, issued on July 31, 2019 and
effective on August 18, 2019. Indiana did not request approval of 326
IAC 7-4-15(c), because these 30-day average limits have been superseded
by the 30-day average limits in Commissioner's Order. As discussed in
the supplemental NPRM, EPA is following Indiana's interpretation that
compliance with the limits in the Commissioner's Order substitute for
and supersede the limits in 326 IAC 7-4-15(c), and accordingly that the
provisions of 326 IAC 7-4-15(d) describe how 30-day average emission
rates are to be calculated to determine compliance with the limits in
the Commissioner's Order, and that the provisions of 326 IAC 7-4-15(e)
set the terms under which IP&L may elect to switch whether they must
meet the 1-hour emission limits in 326 IAC 7-4-15(a) or the 30-day
average limits in the Commissioner's Order.
---------------------------------------------------------------------------

    \6\ To avoid any potential for confusion, EPA wishes to note
that the compliance deadline for the limits in the commissioner's
order is specified in the commissioner's order and not in 326 IAC 7-
1.1-3.
---------------------------------------------------------------------------

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of an Indiana
regulation described in the amendments to 40 CFR part 52 set forth
below. EPA has made, and will continue to make, these documents
generally available through www.regulations.gov, and at the EPA Region
5 Office (please contact the applicable person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the SIP, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the Clean Air Act as of the effective date of the final rulemaking
of EPA's approval, and will be incorporated by reference in the next
update to the SIP compilation.\7\
---------------------------------------------------------------------------

    \7\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 16, 2020. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
Reference, Reporting and recordkeeping requirements, Sulfur oxides.

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

    Dated: July 16, 2020.
Kurt Thiede,
Regional Administrator, Region 5.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

0
2. In Sec.  52.770:
0
a. In paragraph (c) amend the table by adding an entry for ``7-4-15''
under ``Article 7. Sulfur Dioxide Rules,'' ``Rule 4. Emission
Limitations and Requirements by County'';
0
b. In paragraph (d) amend the table by adding an entry at the end with
a CO date of ``7/31/2019'' for ``IP&L-Petersburg''; and
0
c. In paragraph (e) amend the table by adding an entry for ``Southwest
Indiana 2010 Sulfur Dioxide (SO2) Attainment Plan'' after
the entry for ``Ozone (8-Hour, 1997): South Bend-Elkhart, IN (Elkhart
and St. Joseph Counties)''.
    The additions read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                        EPA--Approved Indiana Regulations
----------------------------------------------------------------------------------------------------------------
                                                        Indiana
      Indiana citation              Subject         effective date    EPA approval date            Notes
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                         Article 7. Sulfur Dioxide Rules
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                             Rule 4. Emission Limitations and Requirements by County
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
7-4-15.....................  Pike County sulfur          10/5/2015  8/17/2020, [insert     Only (a), (b), (d),
                              dioxide emission                       Federal Register       and (e). EPA is
                              limitations.                           citation].             approving a
                                                                                commissioner's order
                                                                                in place of (c).

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

* * * * *
    (d) * * *

                       EPA--Approved Indiana Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
          CO date                    Title             SIP rule          EPA approval           Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
7/31/2019..................  IP&L-Petersburg......          7-4-15  8/17/2020, [insert     30-day average
                                                                     Federal Register       limits.
                                                                     citation].
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                       EPA--Approved Indiana Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                Title                  Indiana date           EPA approval                   Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Southwest Indiana 2010 Sulfur                10/2/15  8/17/2020, [insert Federal
 Dioxide (SO2) Attainment Plan.                        Register citation].

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

* * * * *
[FR Doc. 2020-16044 Filed 8-14-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 195 (Wednesday, October 11, 2017)]
[Rules and Regulations]
[Pages 47084-47091]
[FR Doc No: 2017-21224]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0624; Product Identifier 2016-NM-135-AD; Amendment
39-19067; AD 2017-20-10]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A319 series airplanes, Model A320-211, -212, -214, -231, -
232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -
213, -231, and -232 airplanes. This AD was prompted by a runway
excursion due to an unexpected thrust increase leading to an unstable
approach performed using the current flight management and guidance
computer (FMGC) standard. This AD requires identification of
potentially affected FMGCs, replacement of any affected FMGC, and
applicable concurrent actions. We are issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective November 15, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 15,
2017.

ADDRESSES: For service information identified in this final rule,
contact Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email<EMAIL_ADDRESS>Internet
http://www.airbus.com. You may view this referenced service information
at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0624.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0624; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
800-647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 1601 Lind
Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>; fax 425-227-
1149.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Airbus Model A319
series airplanes, Model A320-211, -212, -214, -231, -232, and -233
airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and
-232 airplanes. The NPRM published in the Federal Register on June 29,
2017 (82 FR 29440) (``the NPRM''). The NPRM was prompted by a runway
excursion due to an unexpected thrust increase leading to an unstable
approach performed using the current FMGC standard. The NPRM proposed
to require identification of potentially affected FMGCs, replacement of
any affected FMGC, and applicable concurrent actions. We are issuing
this AD to prevent unstable approaches due to an unexpected thrust
increase, which could result in reduced

controllability of the airplane and runway excursions.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2016-0122, dated June 21, 2016 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model A319
series airplanes, Model A320-211, -212, -214, -231, -232, and -233
airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and
232 airplanes. The MCAI states:

    Following an instrument landing system (ILS) approach, during
night, in rainy condition, an A321 aeroplane experienced a
longitudinal runway excursion. Investigation revealed that the
approach was not stabilized with an overspeed of 19 knots (kts) over
the runway threshold, followed by a long flare (18 seconds) with
touchdown far behind the touchdown zone. The aeroplane exited the
runway at 75 kts and came to rest around 300 meters beyond the end
of the runway. During the final approach, at 150 feet Radio
Altimeter (RA) altitude, the corrected airspeed of the aeroplane was
165 kts (24 kts overspeed). Auto thrust (ATHR) commanded a transient
N1 increase up to 70% due to the ATHR speed Mach control law.
    The ATHR system on A320 family aeroplane was designed to
maintain accurately the aircraft speed/Mach to speed/Mach target by
commanding the thrust, featuring also a trade-off at low altitude
between thrust corrections to maintain speed equal to speed target
and too large thrust corrections destabilizing the aircraft
trajectory near the ground. The conclusions of the investigations
were that the main contributor to this runway excursion was a non-
stabilized approach not followed by a go-around. ATHR misbehaviour
in case of large overspeed led to an unexpected thrust increase,
which is considered as a contributor to the long flare.
    This ATHR characteristic, reported as ``Spurious thrust increase
during approach,'' was initially found in 1996 and a modification
was developed and introduced in Flight Guidance (FG) 2G standard
``C8 or I8'' (C for CFM engines and I for IAE engines) in 2001.
    Prompted by these findings, Airbus introduced a programme to
encourage operators to replace the FMGC Legacy with the FMGC
equipped with Flight Management System type 2 (FMS2) and FG
standard, which introduces additional operational capabilities,
including Runway Overrun Protection System/Runway Overrun Warning
(ROPS/ROW) and Autopilot/Traffic Collision Avoidance System (AP/
TCAS). It was determined that the ROPS, in a scenario similar to the
one described above, would have triggered a <>
aural alert before touchdown. Information was made available through
Airbus Service Information Letter (SIL) 22-039 (later superseded by
Word In Service Experience (WISE) In Service Information
22.83.00003), and EASA published Safety Information Bulletin (SIB)
2013-19, recommending the FMGC upgrade.
    Since EASA SIB was published, it was determined that many
operators have chosen not to implement the optional upgrade that
improves the ATHR behaviour.
    More recently, prompted by a recommendation from the BEA (Bureau
d'Enqu[ecirc]tes et d'Analyses pour la s[eacute]curit[eacute] de
l'aviation civile) of France, to reduce the risk of further runway
excursions due to uninterrupted unstable approaches performed with
the legacy FMGC standard, EASA decided to require installation of at
least the first version of the FMS2 and associated FG for legacy
aeroplanes.
    DGAC [Direction G[eacute]n[eacute]rale de l'Aviation Civile]
France issued AD 1999-411-140(B)R1 [which corresponds to FAA AD
2000-12-13, Amendment 39-11791 (65 FR 37845, June 19, 2000) (``AD
2000-12-13'')] and AD 1998-226-119(B)R1 [which corresponds to FAA AD
98-19-08, Amendment 39-10750 (63 FR 50503, September 22, 1998)] to
address different unsafe conditions, requiring to install a certain
previous FMGC standard that may be susceptible to the ``Spurious
thrust increase during approach''.
    For the reasons described above, this [EASA] AD * * * requires
replacement of the affected FMGC units with upgraded units [and
applicable concurrent actions].

    Concurrent actions include the installation of certain FMGCs,
wiring, display management computers, wiring associated with pin
programming, and applicable operational program configuration disks.
You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0624.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received. Air Line Pilots
Association, International supported the NPRM.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information, which
describes procedures for replacement of any affected FMGC with a
serviceable FMGC. These documents are distinct since they apply to
different airplane configurations.
     Airbus Service Bulletin A320-22-1090, Revision 11, dated
July 20, 2004.
     Airbus Service Bulletin A320-22-1103, Revision 04, dated
March 12, 2004.
     Airbus Service Bulletin A320-22-1116, Revision 04, dated
March 29, 2004.
     Airbus Service Bulletin A320-22-1152, Revision 03, dated
February 18, 2005.
     Airbus Service Bulletin A320-22-1243, Revision 05, dated
May 31, 2010.
     Airbus Service Bulletin A320-22-1519, Revision 02, dated
December 21, 2015.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 1,032 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection............................  1 work-hour x $85 per                 $0             $85         $87,720
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

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

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement................................  9 work-hours x $85 per hour = $765.         $30,000         $30,765
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2017-20-10 Airbus: Amendment 39-19067; Docket No. FAA-2017-0624;
Product Identifier 2016-NM-135-AD.

(a) Effective Date

    This AD is effective November 15, 2017.

(b) Affected ADs

    This AD affects AD 2000-12-13, Amendment 39-11791 (65 FR 37845,
June 19, 2000) (``AD 2000-12-13'').

(c) Applicability

    This AD applies to the Airbus airplanes, certificated in any
category, identified in paragraphs (c)(1) through (c)(3) of this AD,
all manufacturer serial numbers.
    (1) Airbus Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes.
    (2) Airbus Model A320-211, -212, -214, -231, -232, and -233
airplanes.
    (3) Airbus Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 22, Auto Flight.

(e) Reason

    This AD was prompted by a report of a runway excursion due to an
unexpected thrust increase leading to an unstable approach performed
using the current flight management and guidance computer (FMGC)
standard. We are issuing this AD to prevent unstable approaches due
to an unexpected thrust increase, which could result in reduced
controllability of the airplane and runway excursions.

(f) Compliance

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

(g) Inspection and Replacement of Affected FMGC

    (1) Within 36 months after the effective date of this AD:
Inspect the FMGC to determine if any FMGC with an affected part
number identified in Figure 1 to paragraphs (g)(1), (g)(2), (h)(1),
(h)(2), and (j) of this AD is installed. A review of airplane
maintenance records is acceptable in lieu of inspecting the FMGC,
provided those records can be relied upon for that purpose and the
part number of the FMGC can be conclusively identified from that
review.
    (2) If any affected FMGC with an affected part number identified
in Figure 1 to paragraphs (g)(1), (g)(2), (h)(1), (h)(2), and (j) of
this AD is found during any inspection or review required by
paragraph (g)(1) of this AD: Within 36 months after the effective
date of this AD, replace the FMGC with a serviceable FMGC having a
part number that is not identified in Figure 1 to paragraphs (g)(1),
(g)(2), (h)(1), (h)(2), and (j) of this AD, in accordance with the
Accomplishment Instructions and paragraph 1.B. (concurrent actions)
of the applicable service information specified in paragraphs
(g)(2)(i) through (g)(2)(vi) of this AD, or using a method approved
by the Manager, International Section, Transport Standards Branch,
FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA
Design Organization Approval (DOA). Refer to Figure 2 to paragraph
(g)(2) of this AD and Figure 3 to paragraph (g)(2) of this AD for
the lists of approved eligible FMGCs certified as of the effective
date of this AD.
    (i) Airbus Service Bulletin A320-22-1090, Revision 11, dated
July 20, 2004 (installation of FMGC part number (P/N) C13042BA01).
    (ii) Airbus Service Bulletin A320-22-1103, Revision 04, dated
March 12, 2004 (installation of FMGC P/N C13043AA01).
    (iii) Airbus Service Bulletin A320-22-1116, Revision 04, dated
March 29, 2004 (installation of FMGC P/N C13043BA01).
    (iv) Airbus Service Bulletin A320-22-1152, Revision 03, dated
February 18, 2005 (installation of FMGC P/N C13043AA02).
    (v) Airbus Service Bulletin A320-22-1243, Revision 05, dated May
31, 2010 (installation of FMGC P/N C13043BA04).
    (vi) Airbus Service Bulletin A320-22-1519, Revision 02, dated
December 21, 2015 (installation of FMGC P/N C13207CA00).

BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TR11OC17.000

[GRAPHIC] [TIFF OMITTED] TR11OC17.001

[GRAPHIC] [TIFF OMITTED] TR11OC17.002

(h) Unaffected Airplanes

    (1) An airplane on which Airbus Modification 31896 or Airbus
Modification 31897 has been embodied in production is not affected
by the requirements of paragraph (g) of this AD, provided it is
conclusively determined that no FMGC with an affected part number
identified in Figure 1 to paragraphs (g)(1), (g)(2), (h)(1), (h)(2),
and (j) of this AD has been installed on that airplane since the
date of issuance of the original certificate of airworthiness or the
original export certificate of airworthiness. A review of airplane
maintenance records is acceptable to make this determination
provided those records can be relied upon for that purpose and the
part number of the FMGC can be conclusively identified from that
review.
    (2) An airplane on which the actions specified in paragraph
(g)(2) have been done before the effective date of this AD is not
affected by the requirements in paragraph (g) of this AD, provided
it is conclusively determined that no FMGC with an affected part
number identified in Figure 1 to paragraphs (g)(1), (g)(2), (h)(1),
(h)(2), and (j) of this AD has been installed on that airplane since
accomplishing the actions specified in paragraph (g)(2) of this AD.
A review of airplane maintenance records is acceptable to make this
determination provided those records can be relied upon for that
purpose and the part number of the FMGC can be conclusively
identified from that review.

(i) Parts Installation Limitation

    Installation of an FMGC standard approved after the effective
date of this AD on any airplane, is acceptable for compliance with
the actions required by paragraph (g)(2) of this AD, provided the
conditions specified in paragraphs (i)(1) and (i)(2) of this AD are
accomplished.
    (1) The software and hardware standard, as applicable, must be
approved by the

Manager, International Section, Transport Standards Branch, FAA; or
EASA; or Airbus's EASA DOA.
    (2) The installation must be accomplished using airplane
modification instructions approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus's EASA
DOA.

(j) Parts Installation Prohibition

    As of the effective date of this AD, no person may install on
any airplane an FMGC with an affected part number identified in
Figure 1 to paragraphs (g)(1), (g)(2), (h)(1), (h)(2), and (j) of
this AD.

(k) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g)(2) of this AD, if those actions were performed before the
effective date of this AD using the applicable service information
identified in Figure 4 to paragraph (k) of this AD.
[GRAPHIC] [TIFF OMITTED] TR11OC17.003

BILLING CODE 4910-13-C

(l) Terminating Action for Other ADs

    Accomplishing the actions required by paragraph (g)(1) of this
AD, and, as applicable, paragraph (g)(2) of this AD, terminates all
requirements of AD 2000-12-13.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Section, send it to the
attention of the person identified in paragraph (n)(2) of this AD.
Information may be emailed to<EMAIL_ADDRESS>
Before using

any approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus's EASA
DOA. If approved by the DOA, the approval must include the DOA-
authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2016-0122, dated June 21, 2016,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0624.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone
425-227-1405; fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(3) and (o)(4) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Service Bulletin A320-22-1090, Revision 11, dated
July 20, 2004.
    (ii) Airbus Service Bulletin A320-22-1103, Revision 04, dated
March 12, 2004.
    (iii) Airbus Service Bulletin A320-22-1116, Revision 04, dated
March 29, 2004.
    (iv) Airbus Service Bulletin A320-22-1152, Revision 03, dated
February 18, 2005.
    (v) Airbus Service Bulletin A320-22-1243, Revision 05, dated May
31, 2010.
    (vi) Airbus Service Bulletin A320-22-1519, Revision 02, dated
December 21, 2015.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 20, 2017.
Dionne Palermo,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2017-21224 Filed 10-10-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Notices]
[Pages 79687-79688]
[FR Doc No: 2013-31252]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-29-000]

Texas Eastern Transmission, LP; Notice of Application

    Take notice that on December 10, 2013 Texas Eastern Transmission,
LP (Texas Eastern), at 5400 Westheimer Court, Houston, Texas 77056,
filed an application in Docket No. CP14-29-000 pursuant to section 7(b)
of the Natural Gas Act (NGA) and Part 157 of the Commission's
regulations to abandon in place and by sale certain pipeline facilities
located in offshore Gulf of Mexico. Specifically, Texas Eastern
proposes to abandon 29.82 miles of 20-inch diameter offshore lateral
pipeline, designated as Line 41-A-6, consisting of 14.39 miles proposed
for abandonment in place and 15.43 miles proposed for abandonment by
sale. Texas Eastern states that there will be no termination or
reduction in firm service to any existing customers after the proposed
abandonment, all as more fully set forth in the application, which is
on file with the Commission and open to public inspection.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Any questions regarding this application should be directed to Berk
Donaldson, Director, Rates & Certificates, Texas Eastern Transmission,
LP, P.O. Box 1642, Houston, Texas 77251, or by calling (713) 627- 4488
(telephone), or fax (713) 627- 5947, or email
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be

required to serve copies of filed documents on all other parties.
However, the non-party commentors will not receive copies of all
documents filed by other parties or issued by the Commission (except
for the mailing of environmental documents issued by the Commission)
and will not have the right to seek court review of the Commission's
final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: January 13, 2014.

    Dated: December 23, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-31252 Filed 12-30-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Pages 67175-67176]
[FR Doc No: 2014-26694]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0258]

Combined Functionality for Molecular Diagnostic Instruments;
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Molecular Diagnostic
Instruments with Combined Functions.'' This guidance document provides
industry and Agency staff with FDA's current thinking on regulation of
molecular diagnostic instruments that combine in a single instrument
both approved/cleared device functions and device functions for which
approval/clearance is not required, and on the type of information that
FDA recommends that applicants include in a submission for a molecular
diagnostic instrument that measures or characterizes nucleic acid
analytes and has combined functions.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Molecular Diagnostic Instruments With Combined Functions'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002; or Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Andrew Grove, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document provides industry and Agency staff with
FDA's current thinking on regulation of molecular diagnostic
instruments that combine in a single instrument both approved/cleared
device functions and device functions for which approval/clearance is
not required, and on the type of information that FDA recommends that
applicants include in a submission for a molecular diagnostic
instrument that measures or characterizes nucleic acid analytes and has
combined functions. Molecular diagnostic instruments, for example,
real-time thermocyclers, are critical components of certain in vitro
diagnostic devices. They are often used to perform multiple unrelated
assays, such as those that detect methicillin resistant Staphylococcus
aureus, hepatitis C virus, and genetic markers of cystic fibrosis.
These types of instruments cannot generally be approved/cleared alone,
i.e., without an accompanying assay, because their safety and
effectiveness cannot be evaluated without reference to the assays that
they run and their defined performance parameters. However, the same
instruments may also be used for additional purposes that do not
require FDA approval or clearance, such as for basic scientific
research. In the past, FDA has provided informal advice in response to
individual inquiries regarding the permissibility of having functions
for which approval/clearance is not required on an instrument intended
to be used with approved/cleared in vitro diagnostic assays. This
guidance is meant to communicate FDA's policy regarding molecular
diagnostic instruments with combined functions.
    This guidance applies to molecular diagnostic instruments that are
medical devices used with assays that measure or characterize nucleic
acid analytes, human or microbial, and that combine both approved/
cleared and non-approved/non-cleared functions in a single instrument.
This guidance applies to the instrument itself (hardware) as well as to
any firmware or software intended to operate on or to control the
instrument. This guidance also addresses software that is distributed
as a stand alone device for use with an approved/cleared molecular
diagnostic assay.
    The guidance does not apply to instruments approved/cleared for use
with assays that are intended to screen donors of blood and blood
components, human cells, tissues, and cellular and tissue-based
products, for communicable diseases. The document also does not apply
to instruments approved/cleared for blood grouping. We encourage
manufacturers wishing to market such instruments with combined
functionality to contact the appropriate office in the Center for
Biologics Evaluation and Research (CBER).
    The recommendations in this guidance do not apply to assays and
reagents. They are also not intended to change FDA's position regarding
the marketing of Research Use Only and Investigational Use Only assays
for clinical use.
    The draft guidance was announced in the Federal Register of April
9, 2013 (78 FR 21128), and the comment period closed on July 8, 2013.
Several comments were received during the comment period. We took the
suggestions into consideration in revising and finalizing this
guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on molecular diagnostic instruments with
combined functions. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from

CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Molecular Diagnostic Instruments With
Combined Functions'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1763 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 803 have been approved under OMB control
number 0910-0437; and the collections of information in 21 CFR part 801
and 21 CFR 809.10 have been approved under OMB control number 0910-
0485.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26694 Filed 11-10-14; 8:45 am]
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[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Rules and Regulations]
[Page 11386]
[FR Doc No: 2023-03586]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0922; Airspace Docket No. 22-ASO-15]
RIN 2120-AA66

Establishment of Class D Airspace and Amendment of Class E
Airspace; Selma, AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; delay of the effective date.

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SUMMARY: This action changes the effective date of a final rule
published in the Federal Register on January 12, 2023 for Airspace
Docket No. 22-ASO-15. In that rule, the effective date was
inadvertently published as February 23, 2023. This action delays the
effective date to April 20, 2023.

DATES: The effective date of the final rule published January 12, 2023
(88 FR 1987), is delayed to April 20, 2023.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register (88 FR 1987,
January 12, 2023) for Docket No. FAA-2022-0922 to establish Class D
airspace and amend Class E airspace extending upward from 700 feet
above the surface at Craig Field Airport, Selma, AL. In that rule, the
effective date was inadvertently published as February 23, 2023. This
action delays the effective date to April 20, 2023.

Delay of Effective Date

    Accordingly, pursuant to the authority delegated to me, the
effective date for Airspace Docket No. 22-ASO-15, as published in the
Federal Register on January 12, 2023 (88 FR 1987), Airspace Docket No.
22-ASO-15, is hereby delayed from February 23, 2023, to April 20, 2023.

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389

    Issued in College Park, Georgia, on February 15, 2023.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2023-03586 Filed 2-22-23; 8:45 am]
BILLING CODE 4910-13-P