CAIR Replacement Rule

Discussions between the Electric Power Generation Industry and EPA

April 17, 2009

I.  Introduction

	On Friday, April 17, 2009, EPA met with the Edison Electric Institute
(EEI) and other electric power generation associations and companies to
discuss the CAIR replacement rule.  The following summary covers the key
issues discussed during the call.  Appendix A is a list of participants
that attended the meeting at EEI’s office.  Additional individuals
participated by Webinar and conference call.  Copies of several
presentations and other handouts distributed at the meeting can be found
at the end of these notes.

II.  EEI Opening Remarks

	John Kinsman, EEI, began the session by thanking EPA for meeting with
the power generation interests, and indicated that EEI was pleased to
serve as host and to have planned the meeting with the assistance of the
American Public Power Association (APPA), Electric Power Supply
Association (EPSA), Large Public Power Council (LPPC), Midwest Ozone
Group (MOG), National Mining Association (NMA), National Rural Electric
Cooperative Association (NRECA), Utility Air Regulatory Group (UARG),
and United Mine Workers of America (UMWA).   Kinsman asked that
in-person attendees use the microphones for all discussion and include
their name and affiliation before each remark.  Dan Chartier, EEI,
explained the workings of the webinar portion of the meeting.

	Kinsman noted the importance of the CAIR rule and said that EPA did an
excellent job in the original CAIR proceeding by recognizing real world
circumstances, setting aggressive but attainable emission reduction
requirements, and allowing flexibility and thus cost-effectiveness.
There will be a greater challenge with the remand rule given potential
constraints levied by the D.C. Circuit Court of Appeals.  EPA should
attempt to mesh the schedule for new SO2 and NOx emission reduction
requirements with the policy-making schedule for other crucial national
decisions regarding greenhouse gases, renewable energy strategies, and
energy efficiency standards.  Large amounts of SO2 and NOx emission
controls forced on a very aggressive timeline may become stranded as the
nation moves to a new electric power future.

	EPA should allow flexibility to the extent possible, including
emissions trading.  The Agency should not force command-and-control
reductions on small peaking or load-following units.  EPA should
consider cost and cost-effectiveness; limits on emissions trading will
in effect increase the cost of compliance.  Current economic conditions
are especially challenging for electricity generators, given the large
expenditures needed for transmission, distribution, new generation, new
efficiency efforts, smart grid, plug-in hybrid infrastructure, and
environmental controls.

III.  EPA Opening Remarks

	Sam Napolitano, CAMD, and Bill Harnett, OAQPS, spoke on behalf of EPA.
Napolitano m noted that EPA would produce a written account of the
meeting, as it is doing for other stakeholder meetings.  Harnett
emphasized that one key goal of the rulemaking will be to finalize a
rule that will not be overturned in court.  Napolitano presented slides
showing preliminary 2008 national Title IV SO2 emissions and eastern
U.S. NOx Budget Control Program ozone season NOx emissions.  The
preliminary 2008 SO2 emissions of 7.7 million tons are substantially
below emissions of 8.9 million tons of SO2 in 2007.

	Kinsman asked EPA to discuss highlights of its other stakeholder
meetings.  Harnett responded that states have asked EPA to keep the
remand rule schedule in synch with the schedules for meeting ozone and
particulate matter NAAQS.  Environmental groups suggested that EPA
should consider new ozone and particulate matter NAAQS.  They also
stressed that EPA should jointly look at SO2, NOx, hazardous air
pollutants, and carbon for the power industry, and provide an integrated
approach with significant emission reductions across the industry.

	John Quinn, Constellation Energy, asked whether EPA will ask Congress
to codify the CAIR trading system.  Napolitano responded that at this
time EPA staff are collecting information and analyzing options to
present to the new Assistant Administrator for Air and Radiation, who
should start soon.  EPA management, working with others in the
Administration, can then decide how the Agency will proceed.  At this
stage, EPA will provide Congress with technical assistance as requested,
but it is not asking for Congress to take any specific course of action.

IV.  Presentations in the Morning Session

A.	Bill Bumpers, Baker Botts L.L.P., representing Entergy Corporation

1.	Presentation Overview

●	Entergy supports emissions trading;

●	Entergy believes the D.C. Circuit Court of Appeals decision does not
allow EPA much latitude in responding on the NOx fuel factor adjustment;

●	EPA should produce a direct final rule and resolve this particular
issue because the computational response is straightforward and does not
affect other decisions; and

●	EPA should act quickly to avoid lawsuits.

2.	Discussion

	Napolitano noted that the Agency is sensitive to the NOx fuel factor
situation. CAMD has released a letter to Designated Representatives
indicating that it is unclear what will happen with the annual NOx
allowance market after 2009/2010.  EPA is working to resolve this
matter.

Sonja Rodman, OGC, explained that EPA cannot say that it will respond to
the NOx fuel factor issue in the manner Bill Bumpers proposes.  She
added that EPA is concerned about its ability to use cost in determining
significant contribution and, thus, state budgets.

Peter Glaser, NMA, indicated that not everyone endorses the approach
suggested by Bill Bumpers.

Theresa Pugh, APPA, asked for clarification regarding to whom EPA sent
the letter regarding annual NOx allowances.  Napolitano replied that the
letter was sent to Designated Representatives and is posted on the EPA
CAMD website.

Norm Fichthorn, Hunton & Williams L.L.P., representing UARG, asked
Rodman to discuss further EPA's views regarding consideration of costs.
Rodman stated that the court decision is very complicated and more a
minefield than a roadmap.  The NOx SIP Call decision (Michigan v. EPA)
holds that EPA can consider cost but one underlying theme in the CAIR
decision (North Carolina v. EPA) is the Court’s discomfort with the
way EPA relied on cost in the CAIR analyses.

Ray Butts, Florida Power & Light, expressed support for Bumper's
suggestion for a direct final rule on the NOx fuel factor issue.  He
also urged EPA to provide guidance to states that had adopted
regulations on this part of the rule.

Brian Trower, Ames (IA) Electric Department, asked if the current CAIR
would be in place in 2010.  Sonja said that it would and explained that
EPA has indicated it will take approximately two years to finalize a
replacement rule.  Thus, it is unlikely a final replacement rule would
be issued in 2010.

B.	Stephen Fotis, Van Ness Feldman, representing LPPC

1.	Presentation Overview

●	Move as quickly as possible to craft a simple resolution;

●	Many aspects of the original rule are "salvageable";

●	Do not prohibit emissions trading; and

●	Conduct modeling relating trading to significant contribution.

2.	Discussion

	Gene Trisko, UMWA, stated that Michigan v. EPA supports consideration
of cost-effectiveness and withstood the court's scrutiny in North
Carolina v. EPA.  In terms of developing a rule that will withstand
legal challenges, it is more likely that consensus can be reached on
cost effectiveness than on environmental effectiveness.

Rodman replied that parts of the cost effectiveness analysis were
challenged in oral argument by counsel for petitioners that challenged
EPA's use of the NOx fuel factor adjustment (Entergy and FPL).  Bumpers
said that he supports Trisko's statement and that the NOx fuel factor
petitioners (Entergy and FPL) did not oppose the cost-effectiveness
test, but rather addressed EPA's method of applying the
cost-effectiveness test in the context of the NOx fuel factor issue.

Farzie Shelton, Lakeland Electric, asked about new modeling given the
now lower emissions of SO2 and NOx compared to the original rule.
Harnett replied that numerous factors such as baseline year and controls
in place require a new look.

C.	Mike Cashin, Minnesota Power

1.	Presentation Overview

Minnesota Status

●	October 31, 2008 administrative agreement granting stay of CAIR;

●	EPA will determine through rulemaking whether Minnesota should be in
CAIR;

●	EPA has not yet published the Minnesota stay in the Federal
Register; and

●	Minnesota sources should not be compelled to make further CAIR
compliance expenditures until EPA resolves this issue.

Baseline

●	Using 2015 as air quality modeled reference year for revised rule
allows for consideration of utility control retrofit measures under
construction;

●	Possible to retain 2010 reference year for non-attainment modeling;

●	However, a 2010 baseline would likely overstate emissions relative
to 2015;

●	Inventory and modeling should reflect most recently available,
quality-controlled resources; and

●	Use 2015 as first compliance year in CAIR replacement rule.

Significant Contribution

●	Correlation between air quality models and ground level air quality
monitor results should limit significance level used to include a state
in CAIR replacement rule;

●	CAIR TSD NOx model results vs. monitors demonstrated variability at
over +/- 10 percent of the annual PM2.5 NAAQS standard;

●	EPA already established CAIR significance levels much more stringent
than supported by EPA's correlation analysis; and

●	Retain current CAIR significance levels for revised CAIR replacement
rule until correlation analysis can justify a change.

Significant Contribution Remedies

●	Court concerned that sources near nonattainment areas could buy
allowances, leaving significant contribution issues unresolved;

●	Independent of CAIR replacement rule, continue to require local
source reductions in nonattainment areas in accordance with the Clean
Air Act (CAA);

●	Allow intrastate trading; and

●	States able to demonstrate elimination of significant contribution
should be able to leave program upon filing an accepted emission control
maintenance plan.

Coverage and Timing Issues

●	Eliminate significant contribution to nonattainment from upwind
states;

●	CAA provisions for addressing local nonattainment should dominate
local emission reduction requirements;

●	Significance level rather than NAAQS stringency is key to
determining whether state should be in program;

●	Determination of significant contributions will drive control
requirements more than relative stringency of NAAQS; and

●	Revisions of NAAQS should primarily impact local control measures
imposed under CAA nonattainment requirements.

Allowance Allocation Equity

●	Sources should be allocated allowances at no cost;

●	Remedy allocation equity concerns raised by the court;

●	Attainment state sources that are "well controlled" should at
minimum receive allowances sufficient to support operations without
requiring allowance purchases;

●	Nonattainment area sources should receive allowances needed to
support compliance from residual emissions, post control retrofits that
meet "highly cost-effective" control criteria; and

●	Consider diminishing returns (cost-effectiveness) of emission
control retrofits on units in attainment area states when establishing
allowance allocations.

B.	Discussion

	Fotis asked about the geographic scope of CAIR and whether it could
change.  Harnett replied that there could be changes, but that whatever
criteria EPA uses to decide scope would be applied even-handedly among
states.  Rodman added that significant contribution and interference
with maintenance both must be addressed.

	Reid Clemmer, PPL, suggested that just as Title IV ratcheted down SO2
based on 2.5 and 1.2 lb/mmBtu emission rates, CAIR could continue with
something like 0.6 lb/mmBtu for allocating allowances.

V.  Presentations in the Afternoon Session

A.	David Flannery, Jackson Kelly PLLC, representing MOG
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●	Regional, limited to addressing regional transport, which states
cannot do alone;

●	Use state SIP process to resolve any residual non-attainment issues;

●	Preserve as much of original CAIR as possible, consistent with court
decision; and

●	Addressing newer NAAQS is important for states, but MOG reluctant to
suggest that replacement CAIR rule do so.

	(b)  Relationship to other Programs

●	Allow covered sources to satisfy BART and RACT requirements by
participating; and

●	Eliminate any possible basis for section 126 petitions.

	(c)  Cost-Effectiveness

●	Highly cost-effective and account for adverse economic impacts on
sources; and

●	Consider cost and availability of capital required to install
controls.

	(d)  Trading

●	Use IPM and other models to assess viability of different types of
trading programs – intrastate trading, ISO trading, and CAIR regional
trading;

●	Compare modeled results with those from a no-trading scenario; and

●	Select broadest trading program that can satisfy the court.

 Allowance Allocations

●	Need to develop new system for allocations given rejection of Title
IV;

●	Unsure exactly how to develop new allocation methodology, but should
seek public comments on how to develop alternative allocation
methodology; and

●	Allocations should not be auctioned.

Modeling

●	Must validate state emission inventories; EPA should indicate types
of controls that can be assumed;

●	Assess both 2007 and 2008 and establish base year.  2005 used in
recent modeling and questions being raised about meteorological
relevance of 2008.  May need to combine 2007 and 2008 data;

●	Take advantage of recent scientific development in biogenics;

●	Stakeholder group should agree on MET data;

●	Domain size should be consistent among modelers;

●	MOG has a modeling contractor; other RPOs also modeling.  Given
expense and difficulty, results should be shared and coordinated under
EPA's leadership;

●	Review and revise boundary conditions as necessary;

●	Pick nonattainment deadline years.  2012 and 2015 suggested, also
2018;

●	Pick maintenance year.  2025 suggested; and

●	Use stakeholder process to explain which dates should be used and
why.

2.	Discussion

	Napolitano asked how many members MOG represents.  Flannery replied
that MOG represents over 90,000 megawatts of generating capacity, with
members including First Energy, EON, Duke, City of Springfield,
Illinois, and others.  Napolitano sought and received clarification that
MOG represents both municipal and investor-owned utilities.

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●	Develop CAIR replacement/transport rule that achieves significant
progress towards the most “rule-concurrent” defined NAAQS,
facilitates cost effective compliance, and will survive legal scrutiny;

●	Make every effort to create market-based cap and trade program;

●	Trading program alone might not satisfy court, but leveraging market
will drive deeper, far more cost-effective, reductions;

●	Once caps have been established, EPA can work with states to address
any residual nonattainment issues;

●	Develop a CAIR replacement rule, based on existing Acid Rain
Program, to include EGUs and other industrial sources. Consider
obtaining a targeted amendment to the Clean Air Act that would allow EPA
to change the retirement ratio for the purpose of reducing the cap഻

●	Court-imposed limitations may be an issue and legislative amendment
may be required to allow for changes in retirement ratios;

●	Building program from scratch would disrupt marketplace; and

●	Use of distant, future year baseline will create legal uncertainty.

2.	Discussion

Power sector attendees also expressed concern about using predicted data
to create the baseline and recommended that EPA create a baseline using
monitored data.  They suggested that EPA might use other data to help
inform the Agency during the creation of the baseline.

Responding to Napolitano’s question about the year that should be
used, Cunningham suggested 2012.

Flannery noted that MOG has been looking at 2012 and 2015, which are
clearly within the range of years that need to be examined.  However, it
is unclear by which year sources would need to be controlled.

Napolitano asked Flannery to discuss capital considerations further.
Flannery noted that it is difficult for utilities to get the necessary
capital because the money supply is tighter.  Thus, it is a lot harder
for projects to go forward.  Harnett asked whether capital concerns were
driven more by a lack of availability or by the higher cost of capital.

	Robbie Laborde, Cleco, asked what other source categories had been
suggested to EPA for inclusion in the replacement CAIR program.  Harnett
replied that industrial boilers and cement kilns had been suggested, and
that EPA had considered these sources during the original CAIR
rulemaking process but had decided not to include them.

	William Slade, Con Edison Co. of New York, indicated that not all agree
that industrial boilers should be included, and he urged EPA to take a
careful look at the cost and difficulty of installing controls on
industrial boilers.

C.	Norm Fichthorn, Hunton & Williams L.L.P., representing UARG

1.	Presentation Overview

	(a)  Procedural Issues

●	Issue ANPR so stakeholders and other interested parties can submit
comments earlier; and

●	Allow stakeholders and public to review modeling plans and analyses.

	(b)  Framework for Analysis

●	Use established two-step analysis for significant contribution to
nonattainment:

1.	Determine air quality contributions to identify states to be covered;
and

2.	Apply "highly cost-effective" test to determine state emissions
budgets.  As part of the highly cost-effective test, evaluate
feasibility and availability of controls and cost of finance.  May have
to apply the cost-effectiveness analysis on a state-by-state rather than
region wide basis, or
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●	Analyze interference with maintenance using same two-step framework.
 Perhaps consider modeling years that are further out than those used
for significant contribution to nonattainment.

	(c)  Principles for Air Quality Analysis

●	Use established "current-monitored-plus-future-modeled" test for
nonattainment;

●	Use most current and accurate emissions inventory.  Both before and
after EPA’s issuance of proposed rule, states and sources should be
able to review, comment on, and provide corrections to emissions data
and modeling results, including any results from IPM if that model is
used;

●	Modeling must meet model performance criteria, and compliance with
those criteria should be documented in transparent model studies; and

●	Do not attempt to address possible future NAAQS that have not been
promulgated.

	(d)  Principles for Highly Cost-Effective Analysis and Remedy

●	Emissions budgets should reflect trade-off between tons and trading.
 Program that allows less scope for trading should also require smaller
reductions because lack of or restrictions on trading drive up cost of
reductions, meaning that fewer reductions can be deemed highly
cost-effective;

●	Emissions budgets should reflect trade-off between tons and timing.
More ambitious compliance dates must be coupled with smaller emissions
reduction targets because a faster compliance schedule means that fewer
emissions can be deemed highly cost-effective;

●	Flexibility is necessary in addressing whether and how to align a
CAIR replacement rule’s compliance dates with NAAQS attainment dates.
For example, compliance years cannot possibly match all conceivable
attainment dates for NAAQS, especially if EPA addresses 2006 and 2008
NAAQS.  As with original CAIR rule, more than one phase of compliance
may be required;

●	States must retain discretion in deciding how to achieve emission
budgets.  States should, for example, be able to allow, at a minimum,
intrastate trading;

●	EPA should propose for public comment back-up federal implementation
plan (FIP), which states that do not want to adopt, or fail to adopt, a
SIP could use to satisfy program requirements; and

●	Sufficient time is required for transition to new program.  UARG
does not believe compliance before 2015 would be possible.

2.	Discussion

	EPA clarified that the current CAIR rule would probably be in effect in
the period between when the replacement rule is promulgated (probably in
2011) and the first compliance date for the replacement rule.

	Jim Ketcham-Colwill, OAR, noted that the court seemed to question the
use of one analytical method for determining inclusion in the CAIR
region and a second, different method for determining the required
reductions.  The court seems to be concerned that the actual remedy was
not directly connected to the determination of whether a state was in
the program.

	Fotis agreed that additional time would be needed for a transition
especially before a more stringent phase of controls came into effect.
He also clarified that there could be a process allowing for earlier
transition to the new program without having to wait until the first
compliance date.  Fichthorn noted that his comments were focused on
implementation of additional control requirements, i.e., the timing for
sources to achieve compliance with any more stringent emissions
reduction requirements that may be imposed by a replacement rule.

	Tim Smith, OAQPS, asked what trading restrictions could be used to
ensure that the replacement program satisfied the court decision.
Fichthorn replied that UARG did not have any specific proposals at this
time, but he suggested that EPA keep the issue open.  Other parties have
made a number of different proposals, and UARG hopes that EPA will look
at all the potential options.  In addition, he noted, it is clear that
the court decision in no way limited states' ability to have trading
programs on an intrastate basis.

	Napolitano asked why 2015 had been suggested as the earliest possible
compliance date.  Fichthorn replied that CAIR was finalized in 2005 and
that compliance was required about three-and-a-half years later,
beginning in January 2009 for NOx.  The same timeframe built upon an
early-2011 final CAIR replacement rule (EPA’s projected date for final
rulemaking action) does not permit an emission-control compliance date
for sources that is earlier than 2015.  Fichthorn clarified that 2015
was not a proposed effective date for a new rule but rather the earliest
possible compliance date that could be considered.

John McManus, American Electric Power, agreed with Norm and mentioned
that EGUs were already planning to get reductions for 2015.  He also
mentioned concerns with the availability of capital and with future
regulatory changes.  Regulations dealing with fly ash and carbon are
being looked at along with other issues like renewable portfolio
requirements.  With all the new regulations in the pipeline it is
important that EPA keep capital requirements in mind and the Agency
should be cautious in approach and timing.

Bumpers suggested that the court was more concerned that the modeling
did not show clearly enough that reductions would happen than it was
with trading as a concept.  He suggested that EPA try implementing a
rule based on modeling and then require each state to subsequently
demonstrate that the reductions were happening as the modeling had
predicted.  If the reductions were not close enough to the modeled
results a state could be required to implement further SIP reductions.
This would allow EPA to avoid imposing state budgets that specifically
reflect levels of reductions that would eliminate significant
contribution.

In response to questions, Napolitano explained that EPA had started some
preliminary analytical work but did not have any of it to share.  No
major decisions have been made on technical details and nothing is firm.
 Rather staff is trying to set up analyses and get the groundwork laid
for when the new Assistant Administrator arrives.

Napolitano was then asked about how the response to section 126
petitions would work in conjunction with the anticipated two-year CAIR
revision rulemaking schedule.  He replied that, although the court did
not impose a specific time limit for EPA’s response to North
Carolina’s section 126 petition, EPA is working to determine how to
move forward and understands the time-sensitive nature of the issue.

Delaware's more recent petition is a different situation, and EPA will
be engaging in conversations with Delaware to attempt to resolve the
issues raised in the petition.

Lou Pocalujka, Consumers Energy, suggested that EPA should pay close
attention to the baseline year for the emissions inventory.  He
suggested that technical discussions on which emissions inventory to use
have included arguments that the 2008 emissions inventory might be
unrepresentative, due to a temporary economic downturn.  In Michigan,
these emission reductions are not temporary.  They are looking at
reductions due to permanent shutdowns of major sources, which are not
coming back.  Calendar year 2009 is likely to be worse.  A 2007
emissions inventory would be unrepresentative.  EPA is urged to use an
emissions inventory that is representative of current emissions.

VI. Concluding Remarks

Harnett explained that coordinating with the Assistant Administrator for
Air and Radiation is important.  However, the D.C. Circuit Court's
mandate and remand are premised, at least in part, on EPA's
representations to the court that a CAIR replacement rule would take
about two years to finish.  Depending on timing considerations, EPA
staff might turn, as necessary, to EPA Administrator Lisa Jackson for
decisions.

Napolitano thanked everyone for their suggestions and participation.

PRESENTATIONS  AND  HANDOUTS

PSEG Services Corporation

80 Park Plaza,

Newark, NJ

07102

Edison Electric Institute (EEI) April 17, 2009, Discussion Meeting with
EPA

Subject: CAIR Replacement Rule:  PSEG discussion points

As EPA considers it options in responding to the court’s decision in
NC v. EPA, PSEG would encourage the Agency to establish a
“transport” rule that will (1) achieve substantial progress toward
the national air quality standards for PM and ozone, (2) stand up to
legal scrutiny, and (3) facilitate cost-effective compliance.

EPA should make every effort to rely on a market-based, cap-and-trade
approach to minimize the contributions from transported air pollution.
It may not be appropriate to rely on a trading program alone to address
all incidents of significant contribution, but given the economic
advantages, it should certainly play a central role.

Once the overall NOx and SO2 emissions caps have been established, EPA
and the states can work to address any residual emissions that might be
contributing to nonattainment.

In implementing a NOx cap-and-trade program, EPA should include power
plants and other major industrial sources to facilitate cost-effective
compliance.  We suggest it was a mistake to exclude industrial boilers
from the CAIR rule, given that they were included in the NOx SIP call.

Building off the existing SO2 trading program would be the most
efficient method for reducing future SO2 emissions.  However,
recognizing the limitations imposed by the court decision, consider the
possibility to obtain a targeted amendment to the Clean Air Act that
would allow EPA to change the retirement ratio for the purpose of
reducing the cap.  Companies have purchased or sold future vintage
allowances.  Starting a program from scratch would be very disruptive to
the market.

In terms of establishing a baseline for determining a state’s
contribution to nonattainment, we would be concerned with the Agency
using a distant future year baseline because the assumptions would
become more-and-more speculative leaving the rule vulnerable to legal
challenge.  For example, predicting the SO2 reductions that might result
from a future MACT standard for mercury would place the Agency on shaky
legal ground.

We recognize the challenges that the Agency faces in trying to navigate
the court the decision.  We don’t envy your task, but we look to be
helpful and responsive to the Agency as you develop your response.

If you have any questions on these discussion points, please call me

Daniel Cunningham

(973) 430-6307

<EMAIL_ADDRESS>

EPA Public Input about CAIR Replacement Rule

Minnesota Power (ALLETE) Key Points

April 17, 2009

Contact:  Michael Cashin,<PHONE_NUMBER>

Minnesota Status.  On October 31, 2008 the Environmental Protection
Agency (EPA) issued a letter to Minnesota Power indicating its intention
to publish in the Federal Register a rule amending the Clean Air
Interstate Rule (CAIR) to stay the effectiveness of the rule with
respect to sources located in the State of Minnesota. The administrative
stay was to remain in effect until such time as EPA determines through a
rulemaking under the Clean Air Act whether Minnesota should be included
in the CAIR region for fine particulate matter. The stay has not yet
been issued, creating great uncertainty for sources within Minnesota.
Minnesota sources should not be compelled to make further expenditures
to address CAIR compliance until EPA has resolved the Minnesota issues
as directed by the U.S. Court of Appeals for the District of Columbia.
Minnesota Power encourages EPA to expeditiously publish the rule staying
CAIR as to Minnesota sources.

Baseline.  Minnesota Power (MP) suggests that EPA assess significant
contributions to nonattainment referencing modeling projected for 2015.
The original CAIR initiated utility actions for control retrofits that
targeted a more stringent emission cap in 2015.  Utilities that
subsequently provided for emission controls in anticipation of CAIR
requirements should have the benefit of such controls given
consideration in significant contribution to nonattainment modeling
assessments.   Nonattainment contribution modeling could retain the
previous 2010 reference year, but much is in transition, likely
resulting in a 2010 baseline overstating the impacts of utility
emissions relative to a 2015 outlook.

Significant Contribution Issues.  On several occasions Minnesota Power
submitted comments to EPA that there appeared to be modeling
deficiencies in CAIR. MP noted how both the CMAQ and REMSAD models
overstated the impact of NOx on PM2.5 compared to IMPROVE Monitor and
STN Particulate Monitor Observations, as was indicated in EPA’s
technical support documentation.  For higher NOx concentrations modeling
results and monitor results deviated by +/- 2 ug/m3, which is over ten
percent of the annual PM2.5 standard.  Similar deviations were evident
for ozone modeling results vs. monitor measurements.  MP does not
consider it reasonable that a State’s significant contribution to
nonattainment be based on modeled contributions any less than the 90th
percentile correlation between computer models and monitor results.
However, EPA has already established CAIR significance values at lower
levels than would be supported by EPA’s correlation analysis.
Consequently, MP suggests that EPA retain the current CAIR analysis,
State significant contribution levels of 2 ppb ozone and 0.20 ug/m3
annual PM2.5 until which time EPA can demonstrate through correlation
analysis justification for different significant contribution values.
MP also notes that electric utility emissions are the primary target for
control by the CAIR replacement rule, so it is suggested that EPA
consider establishing significant contributions from a state assigning
EPA’s significant contribution levels to modeled, CAIR controlled
source emissions only.  Air quality models and emission inventories used
by EPA for significant contribution modeling should reflect the most
recent, quality controlled resources available to EPA to help assure EPA
methods are best suited to accurately and equitably support achievement
of air quality improvement goals.

Significant Contribution Remedies.  The DC Circuit Court of Appeals
identified how sources near a nonattainment state might continue to make
a significant contribution to nonattainment if such sources were allowed
to buy emission allowances allocated to distant sources.  EPA modeling
also established that close proximity sources both within the
nonattainment state and in nearby states, including sources not subject
to CAIR controls (e.g. transportation emissions) dominated local
nonattainment contributions.  In some cases, emissions within the
nonattainment state were of sufficient magnitude to interfere with local
attainment, regardless of out of state source reductions.  MP suggests
that EPA allow states the option to implement in-state trading to meet
CAIR replacement rule state emission reduction targets while continuing
to require local source reductions in nonattainment areas in accordance
with the Clean Air Act.

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8lacement rule controls should be dominated by their significant
contribution to nonattainment analysis and related significant
contribution levels.  Consequently, the determination of a state’s
significant contribution to nonattainment will drive control
requirements more so than the relative stringency of the NAAQS being
applied.  In turn, Clean Air Act provisions that require local source
emission reductions in nonattainment areas should adequately address
coverage and timing issues, leaving the CAIR replacement rule to focus
on elimination of a state’s significant contribution to a neighboring
state’s nonattainment with the NAAQS.

Other.  MP notes that equitable allocation of SO2 and NOx allowances was
a key issue that was brought before the Court and that helped lead to
the need for EPA to establish a CAIR replacement rule. MP emphasizes
that EPA should continue to provide for a free allocation of allowances
to emission sources based on their historic emissions, but also notes
that facilities that have provided for lower emissions through controls
operation, control retrofits or fuel switching should have assurance
that they are not disadvantaged in allowance allocations relative to
sources that have historically high emission rates.  Consequently, EPA
should establish allowance allocations that give consideration to local
nonattainment status within a state as well as the emissions performance
for sources determined to be significantly contributing to nonattainment
in other states.  At a minimum, sources in upwind states that are
“well controlled” should receive an emission allowance allocation
sufficient to assure that they are not compelled to buy allowances
released from local nonattainment area sources that are retrofitting
controls as required under the Clean Air Act.

Minnesota Power (ALLETE)

Key Points

EPA CAIR Replacement Rule

April 17, 2009

Mike Cashin,<PHONE_NUMBER>

Minnesota Status, CAIR RR

Oct. 31 Administrative Agreement, EPA and MP

Stay of CAIR in effect until EPA determines through rulemaking under the
CAA whether Minnesota should be included in CAIR

EPA has not yet published the Minnesota stay in the Federal Register

MN sources should not be compelled to make further CAIR compliance
expenditures until EPA has resolved MN issues as directed by the US
Court of Appeals for District of Columbia

Baseline, CAIR RR

2015 air quality modeled reference year for the CAIR RR allows original
CAIR initiated utility control retrofit measures under construction to
receive consideration for significant contribution to nonattainment
analysis.

2010 reference year is crossed over during the CAIR Phase 1
implementation under the stay. “Outdated”

Inventory and modeling should reflect most recently available, quality
controlled resources.

EPA should also establish 2015 as the target year for the next phase of
new controls under the CAIR Replacement Rule

Significant Contribution, CAIR RR

Correlation between air quality models and ground level air quality
monitor results should limit the significance level used to subject a
State to the CAIR RR.

CAIR TSD NOx model results vs. monitors demonstrated variability at over
+/- 10% of the annual PM2.5 NAAQS standard.

EPA already established CAIR significance levels much more stringent
than supported by EPA’s correlation analysis.

EPA should retain the current CAIR significance levels for the CAIR RR
until which time correlation analysis can justify a change.

Significant Contribution Remedies, CAIR RR

The DC Circuit Court of Appeals identified concerns where sources near
nonattainment areas could buy allowances from distant sources, not
resolving their significant contribution to nonattainment.

EPA should continue to require local source reductions in nonattainment
areas in accordance with the Clean Air Act independent of the CAIR RR

EPA should allow States subject to the CAIR RR the option for intrastate
trading of allowances to meet their CAIR RR state target.

States determined to be significant contributors to nonattainment under
the CAIR RR analysis that later demonstrate they have eliminated their
significant contribution to nonattainment should be able to petition out
of the CAIR RR upon filing of an accepted emission control maintenance
plan.

Coverage and Timing Issues,

CAIR RR

The focus of the CAIR RR should be to eliminate the significant
contribution to nonattainment from upwind states.

The CAA provisions for addressing local nonattainment should dominate
local emission reduction requirements, not the CAIR RR.

The significance level dominates determination of states subject to CAIR
RR controls, not the NAAQS stringency.

EPA revision of NAAQS standards should primarily impact local control
measures imposed under the CAA nonattainment area requirements.

Other: Allowance Allocation Equity

CAIR RR

All allowances should be allocated at no cost to the emission sources
subject to compliance with allowances.

The DC Circuit Court of Appeals identified allowance allocation equity
concerns for EPA action under the CAIR remand that EPA should remedy
with the CAIR RR.

Attainment state sources that are “well controlled” should at
minimum receive allowances sufficient to support operations without
requiring allowance purchases.

Nonattainment area sources should receive allowances needed to support
compliance from residual emissions, post control retrofits that meet
“highly cost effective” control criteria.

Diminishing returns (cost effectiveness) of emission control retrofits
on units in attainment area states should receive consideration when
establishing allowance allocations.

MIDWEST OZONE GROUP

Preliminary Comments on the CAIR Replacement Rule

April 17, 2009

David M. Flannery

Jackson Kelly PLLC

Charleston, West Virginia

Scope

Limit to regional transport

Use state SIP process to resolve residual non-attainment

Preserve as much of initial CAIR rule, as possible, consistent with
Court decision

Relationship to Other Programs

For covered sources, CAIR should be structured in a way that:

	-	allows BART and RACT to be satisfied through CAIR compliance and

	- 	eliminates any possible basis for §126 petitions

Cost Effectiveness

CAIR controls:

	-	should be “highly cost effective”

	-	account for adverse economic impact on sources

	-	account for the lack of availability of capital

Trading

Examination of various trading options

	-	intrastate trading

	-	ISO trading

	-	CAIR region trading

Comparison to no trading scenario

Evaluate IPM and alternative approaches to assessing policy alternatives

Select broadest possible trading program

Allowance Allocations

Develop a new system of allocations (given rejection of Title IV)

Seek public comment on alternative allocation methods

Allocations should not be auctioned

Modeling

Validate state emission inventories

Establish the base year (assess both 2007 and 2008)

A stakeholder group should agree on MET data

Domain size should be consistent among modelers

Modeling (continued)

Encourage use of best science in air quality and biogenics models

Review boundary conditions and revise as appropriate

Select representative future years most relevant to non-attainment
deadlines (2012, 2015, other?)

Select the year to be examined for maintenance (2025)

CAIR Remand Issues:  Principles that Should Guide EPA’s Upcoming
Rulemaking

The Perspective of

the Utility Air Regulatory Group

April 17, 2009

Norman W. Fichthorn

Hunton & Williams LLP

Procedural Issues

EPA should issue an Advance Notice of Proposed Rulemaking

EPA should allow stakeholder and public review of modeling plans and
analyses

Substantive Issues

Framework for Analysis

EPA should use the established two-step analysis for significant
contribution:

(1) Determine air quality contributions to identify states to be covered
by the rule; then

(2) Apply the “highly cost-effective” test to determine state
emission budgets

The “interference with maintenance” analysis should also follow the
basic two-step framework

Substantive Issues

Principles for the Air Quality Analysis

EPA should use the “current-monitored-plus-future-modeled” test for
nonattainment

EPA should use the most current, accurate emission inventory

Modeling must meet model performance criteria

EPA should not address possible future NAAQS

Substantive Issues

Principles for the “Highly Cost-Effective” Analysis and
Determination of the Remedy

Emission budgets should reflect the trade-off between tons and trading

Emission budgets should reflect the trade-off between tons and timing

Flexibility will be needed in aligning compliance dates with attainment
dates

Substantive Issues

Principles for the “Highly Cost-Effective” Analysis and
Determination of the Remedy (cont’d)

States must retain discretion in deciding how to achieve emission
budgets

EPA should propose a “back-up” federal implementation plan for
public comment

Adequate time for transition to a new program is needed

CAIR REPLACEMENT RULE DISCUSSION WITH EPA

ATTENDING IN PERSON

FIRST NAME	LAST NAME	COMPANY NAME

John	McManus	American Electric Power

David	Arthur	Calpine

William	Slade	Con Edison Co. of NY

John	Quinn	Constellation

Lou	Pocalujka	Consumers Energy

Lenny	Dupuis	Dominion

Heather	Eades	Dominion

Daniel	Chartier	Edison Electric Institute

John	Kinsman	Edison Electric Institute

Chuck	Barlow	Entergy

Bill	Bumpers	Entergy (Baker Botts)

Bruce	Alexander	Exelon

Michael	Krancer	Exelon

Ray	Butts	FPL

John	Hampf	FPL

Stephen	Fotis	Large Public Power Council (Van Ness Feldman)

Usha	Turner	Luminant

Sara	Orr	Midwest Generation (Latham & Watkins)

Michael	Cashin	Minnesota Power

William	Butler	Mirant

David 	Flannery	Midwest Ozone Group (Jackson Kelly)

Ben	Brandes	National Mining Association

Peter	Glaser	National Mining Association (Troutman Sanders)

Rae	Cronmiller	National Rural Electric Cooperative Association

Verne	Shortelle	NRG

Reid	Clemmer	PPL

Daniel	Cunningham	PSEG

John	Shimshock	Reliant

John	Jansen	Southern Company

Norm	Fichthorn	Utility Air Regulatory Group (Hunton & Williams)

Eugene 	Trisko	United Mine Workers of America

Dwight	Alpern	EPA

Kevin	Culligan	EPA

Bill	Harnett	EPA

Jim	Ketcham-Colwill	EPA

Sam	Napolitano	EPA

Sonja	Rodman	EPA

Tim	Smith	EPA

Gabrielle	Stevens	EPA

Meg	Victor	EPA

		Page   PAGE   \* MERGEFORMAT  2


[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34400-34401]
[FR Doc No: 2019-15268]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2808]

Advanced Prostate Cancer: Developing Gonadotropin-Releasing
Hormone Analogues; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Advanced
Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.''
This draft guidance describes the FDA's current recommendations
regarding the overall development program and clinical trial designs
for developing gonadotropin-releasing hormone (GnRH) analogues to treat
advanced prostate cancer.

DATES: Submit either electronic or written comments on the draft
guidance by September 16, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-2808 for ``Advanced Prostate Cancer: Developing
Gonadotropin-Releasing Hormone Analogues.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elaine Chang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New

Hampshire Ave., Bldg. 22, Rm. 2169, Silver Spring, MD 20993-0002, 240-
402-2628.

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Advanced Prostate Cancer: Developing Gonadotropin-Releasing
Hormone Analogues.'' This draft guidance describes the FDA's current
recommendations regarding the overall development program and clinical
trial designs for developing GnRH analogues to treat advanced prostate
cancer.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Advanced
Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft 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
collection of information in 21 CFR part 312 has been approved under
OMB control number 0910-0014. The collections of information in 21 CFR
parts 50 and 56 (``Protection of Human Subjects: Informed Consent;
Institutional Review Boards'') have been approved under OMB control
number 0910-0755. The collections of information in 21 CFR parts 201.56
and 201.57 (Prescription Drug Labeling) have been approved under OMB
control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15268 Filed 7-17-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Notices]
[Pages 55155-55158]
[FR Doc No: 2019-22345]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2565]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 510(k) Third-Party
Review Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
November 14, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0375.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

510(k) Third-Party Review Program

OMB Control Number 0910-0375--Extension With Revision

    Information collections (ICs) associated with the 510(k) third-
party (3P510k) review program have been approved under OMB control
number 0910-0375. We request extension, including revisions, of the
information collection approval as described in this document.
    Section 210 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) established section 523 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360m), directing FDA to accredit
persons in the private sector to review certain premarket notifications
(510(k)s; see 21 U.S.C. 360(k)). Participation in the 3P510k review
program by accredited persons is entirely voluntary. A third party
wishing to participate will submit a request for accreditation to FDA.
Accredited third-party reviewers have the ability to review a
manufacturer's 510(k) submission for selected devices. After reviewing
a submission, the reviewer will forward a copy of the 510(k)
submission, along with the

reviewer's documented review and recommendation, to FDA. Third-party
reviewers should maintain records of their 510(k) reviews and a copy of
the 510(k) for a reasonable period of time, usually 3 years.
    Respondents to this information collection are businesses or other
for-profit organizations.
    In the Federal Register of September 14, 2018 (83 FR 46742), FDA
announced the availability of the draft guidance entitled ``510(k)
Third-Party Review Program; Draft Guidance for Industry, Food and Drug
Administration Staff, and Third-Party Review Organizations.'' The draft
guidance was intended to provide a comprehensive look into FDA's
current thinking regarding the 3P510k review program authorized under
the FD&C Act. Under the FDA Reauthorization Act of 2017, FDA was
directed to issue draft guidance on the factors that will be used in
determining whether a class I or class II device type, or subset of
such device types, is eligible for review by an accredited person. The
3P510k review program is intended to allow review of devices by third-
party 510k review organizations (3PROs) to provide manufacturers of
these devices an alternative review process that allows FDA to best
utilize our resources on higher risk devices.
    The September 14, 2018, notice requested comment on the draft
guidance and related revision of the information collection in OMB
control number 0910-0375. We describe and respond below to the comments
related to the information collection. We have numbered each comment to
help distinguish between different comments. We have grouped similar
comments together under the same number, and, in some cases, we have
separated different issues discussed in the same comment and designated
them as distinct comments for purposes of our responses. The number
assigned to each comment or comment topic is purely for organizational
purposes and does not signify the comment's value or importance or the
order in which comments were received.
    (Comment 1) One comment suggested that the 3P510k review program
reduces the burden for FDA staff and industry and increases the burden
on patients and doctors to figure out which devices are safe and which
are not.
    Another comment suggested that FDA has not demonstrated that its
proposed changes to the 3P510k review program will benefit patients and
that the 3P510k review program reduces patient safety, rather than
protecting patients from potentially harmful devices.
    (Response 1) FDA disagrees with these comments. Section 523 of the
FD&C Act requires FDA to accredit persons for the purpose of reviewing
reports submitted under section 510(k) of the FD&C Act and making a
recommendation to FDA. All devices subject to the 510(k) requirements,
including devices cleared through the 3P510k review program, must
demonstrate substantial equivalence to a legally marketed device prior
to introduction into interstate commerce (see 21 U.S.C. 360(k), 360(n),
360c(f)(1) and 360c(i); 21 CFR 807.92(a)(3)). Under the 3P510k review
program, the objective is for the 3PRO to provide a review equivalent
to that of an FDA reviewer, including making a recommendation, which it
submits to FDA. FDA reviews that information to make a final
determination of substantial equivalence and where appropriate, FDA
will limit its review to a supervisory-level review. Therefore, the
burden to demonstrate substantial equivalence remains unchanged.
    In addition, this guidance describes the factors FDA will use to
ensure only appropriate device types are eligible for the 3P510k review
program and benefits the public health by allowing new, low-to-moderate
risk devices to obtain FDA-equivalent review while enabling FDA to
focus more resources on higher risk and more complex devices that
necessitate more rigorous review benefitting the public health.
Accordingly, no change to the guidance is necessary.
    (Comment 2) One comment suggested that the proposed definition of a
510(k) Submitter is too narrow by referring to ``scientific and
technical data'' and should be revised to reflect the additional
components of a 510(k) submission, such as intended use.
    (Response 2) FDA agrees that a 510(k) submission can include more
than scientific and technical data. Rather than trying to define the
appropriate components of a 510(k) submission in this guidance, FDA has
modified the definition of 510(k) Submitter by removing reference to
submitting ``scientific and technical data.''
    (Comment 3) One comment requested clarification regarding to whom
the 3PROs should provide copies of written communications between the
510(k) submitter and the 3PRO and, if these copies are submitted to
FDA, that this is unnecessarily burdensome to both the 510(k) submitter
and the 3PRO.
    (Response 3) FDA agrees that this language should be, and therefore
it has been, clarified as FDA's intent was that these communications
would be provided to FDA and that the context of these communications
is the communication and response to deficiencies in the submission.
However, FDA disagrees that providing the Agency this information is
unnecessarily burdensome. FDA believes that to understand and evaluate
whether the 3PRO conducted an FDA-equivalent review, it is necessary to
understand how the 3PRO documented and communicated any deficiencies it
found during its review, how the 510(k) submitter responded to those
deficiencies, and how the 3PRO evaluated those responses.
    (Comment 4) Several comments suggested that the language in the
guidance is unclear as to whether the 510(k) submitter should provide
the 3PRO with all subsequent correspondence that the submitter has with
FDA and that once a 3PRO has submitted its recommendation to FDA that
any substantive interactions between FDA and the 510(k) submitter are
not always relevant and any mandate to supply such correspondence
creates additional burden.
    Additionally, a comment requested clarification regarding to whom
the 3PRO should provide a copy of all written communications.
    (Response 4) To the extent that the commenter refers to subsequent
correspondence on the 510(k) submission in question, FDA disagrees with
the comment. The 3PRO's responsibilities to provide an FDA-equivalent
review do not end with the initial submission to FDA. As discussed in
subsection VI.J of the guidance, FDA will contact the 3PRO by telephone
or email if additional information is needed. FDA not only expects the
3PRO to communicate with the 510(k) submitter to resolve any issues
needing the submitter's input, FDA also expects the 3PRO to thoroughly
evaluate any responses received and to document those in its updated
review memo. Therefore, the 3PRO should be involved in any discussions
between FDA and the 510(k) submitter regarding the request for
additional information. FDA does not believe that the continued
involvement of the 3PRO creates an unnecessary burden given their
responsibilities, whereas their involvement in those discussions
ensures the response is evaluated in a timely and efficient manner.
    (Comment 5) One comment requested clarification on what a new
review memo provided by a 3PRO in response to FDA's request for
additional information should include or whether a documented
evaluation result referring to the evaluation of the 510(k)

submitter's responses to FDA's request for additional information is
sufficient.
    (Response 5) FDA has clarified in the final guidance that the
initial review memo provided by the 3PRO should be updated with this
new information in response to FDA's request for additional
information. This is consistent with FDA's expectation that the 3PRO
provide a review equivalent to that of an FDA reviewer.
    FDA estimates the burden of this collection of information as
follows:

Estimated Annual Reporting Burden

    Requests for accreditation (initial): On average, the Agency has
received one application for accreditation for 3P510k review per year.
There is no change to this information collection (IC) from the
currently approved burden estimate.
    Requests for accreditation (re-recognition): We have added an IC
for re-recognition requests to be consistent with the guidance, which
states that requests for re-recognition will be handled in the same
manner as initial recognition requests. Based on the estimated number
of 3PROs (seven) and the frequency of re-recognition (3 years), we
expect to receive approximately two re-recognition requests per year.
We expect the average burden per response to be the same as an initial
request (24 hours).
    510(k) reviews conducted by accredited third parties: Based on
FDA's recent experience with this program, we estimate the number of
510(k)s submitted for third-party review to be 147 annually;
approximately 21 annual reviews for each of the 7 3PROs. This IC has
been adjusted based on current trends, however, there is no program
change to this IC.
    Complaints: The guidance recommends that the 3PRO should forward to
FDA information on any complaint (e.g., whistleblowing) it receives
about a 510(k) submitter that could indicate an issue related to the
safety or effectiveness of a medical device or a public health risk.
Therefore, we have added an IC for complaints to the reporting burden.
We expect to receive one forwarded complaint per year. Based on similar
information collections, we estimate the average burden per complaint
to be 0.25 hours (15 minutes).

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response           \2\
----------------------------------------------------------------------------------------------------------------
Requests for accreditation                     1               1               1              24              24
 (initial) \3\..................
Requests for accreditation (re-                2               1               2              24              48
 recognition) \5\...............
510(k) reviews conducted by                    7              21             147              40           5,880
 accredited third parties \4\...
Complaints \5\..................               1               1               1            0.25               1
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............           5,953
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals have been rounded.
\3\ There is no change to this IC from the currently approved burden estimate.
\4\ This IC has been adjusted based on current trends, however, there is no program change to this IC.
\5\ This IC revises OMB control number 0910-0375 to reflect the draft guidance entitled ``510(k) Third Party
  Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review
  Organizations.''

Estimated Annual Recordkeeping Burden

    510(k) reviews: The 3PROs should retain copies of all 510(k)
reviews and associated correspondence. Based on FDA's recent experience
with this program, we estimate the number of 510(k)s submitted for
3P510k review to be 147 annually; approximately 21 annual reviews for
each of the 7 3PROs. We estimate the average burden per recordkeeping
to be 10 hours. The estimated number of records and recordkeepers have
been adjusted based on current trends, however, there is no program
change to this IC.
    Records regarding qualifications to receive FDA recognition as a
3PRO: Under section 704(f) of the FD&C Act (21 U.S.C. 374(f)), a 3PRO
must maintain records that support their initial and continuing
qualifications to receive FDA recognition, including documentation of
the training and qualifications of the 3PRO and its personnel; the
procedures used by the 3P510k review organization for handling
confidential information; the compensation arrangements made by the
3PRO; and the procedures used by the 3PRO to identify and avoid
conflicts of interest. Additionally, the draft guidance states that
3PROs should retain information on the identity and qualifications of
all personnel who contributed to the technical review of each 510(k)
submission and other relevant records. Therefore, we have added an IC
for ``Records regarding qualification to receive FDA recognition as a
3PRO.'' Because most of the burden of compiling the records is
expressed in the reporting burden for requests for accreditation, we
estimate the maintenance of such records to be 1 hour per recordkeeping
annually.
    Recordkeeping system regarding complaints: Section 523(b)(3)(F)(iv)
of the FD&C Act requires 3PROs to agree in writing that they will
promptly respond and attempt to resolve complaints regarding their
activities. The guidance recommends that 3PROs establish a
recordkeeping system for tracking the submission of those complaints
and how those complaints were resolved, or attempted to be resolved.
Therefore, we have added an IC for ``Recordkeeping system regarding
complaints.'' Based on our experience with the program and the
recommendations in the guidance, we estimate the average burden per
recordkeeping to be 2 hours.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews \2\..............               7              21             147              10           1,470

Records regarding qualifications               7               1               7               1               7
 to receive FDA recognition as a
 3PRO \3\.......................
Recordkeeping system regarding                 7               1               7               2              14
 complaints \3\.................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............           1,491
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This IC has been adjusted based on current trends, however, there is no program change to this IC.
\3\ This IC revises OMB control number 0910-0375 to reflect the draft guidance entitled ``510(k) Third Party
  Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review
  Organizations.''

    We revised our estimates for OMB control number 0910-0375 by adding
new ICs, changing the title of the IC request, and adjusting the
existing ICs based on current trends. Despite the addition of new ICs,
the estimated burden reflects an overall decrease of 5,580 hours. We
attribute this adjustment to a decrease in the number of submissions we
received over the last few years.
    The draft guidance also refers to previously approved ICs found in
FDA regulations. The ICs in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the ICs regarding 3P510k
review of medical devices under FDAMA have been approved under OMB
control number 0910-0375; the ICs for the device appeals processes have
been approved under OMB control number 0910-0738; the ICs for the Q-
Submission Program (Requests for Feedback on Medical Device
Submissions) have been approved under OMB control number 0910-0756.

    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22345 Filed 10-11-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Proposed Rules]
[Pages 74630-74631]
[FR Doc No: 2012-30296]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 10

[Docket No. USCG-2012-0734]

Medical Waivers for Merchant Mariner Credential Applicants With
Anti-Tachycardia Devices or Implantable Cardioverter Defibrillators

AGENCY: Coast Guard, DHS.

ACTION: Notice to reopen public comment period.

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

SUMMARY: On September 7, 2012, the Coast Guard published a notice of
proposed policy change and request for comments regarding criteria for
granting medical waivers to mariners who have anti-tachycardia devices
or implantable cardioverter defibrillators (ICDs). The public comment
period for the notice expired on October 9, 2012. In today's action,
the Coast Guard is reopening the public comment period to provide
additional time for interested parties to submit comments.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before January 16,
2013 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0734 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section below for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice, call or email Lieutenant Ashley Holm, Mariner Credentialing
Program Policy Division (CG-CVC-4), U.S. Coast Guard, telephone 202-
372-1128, email<EMAIL_ADDRESS>If you have questions on viewing
material in the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation

    You may submit comments and related material regarding whether the
proposed policy change should be incorporated into a final policy on
issuing medical waivers to mariners with ICDs. All comments received
will be posted, without change, to http://www.regulations.gov and will
include any personal information you have provided.
    Submitting comments: If you submit a comment, please include the
docket number for this notice (USCG-2012-0734) and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail or hand delivery, but please use only
one of these means. We recommend that you include your name and a
mailing address, an email address, or a telephone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov and
insert ``USCG-2012-0734'' in the ``Search'' box. Click ``Search,'' find
this notice in the list of Results, and then click on the corresponding
``Comment Now'' box. If you submit your comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\ by 11
inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the Facility,
please enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period.
    Viewing the comments: To view comments, as well as documents
mentioned in this notice as being available in the docket, go to http://www.regulations.gov and insert ``USCG-2012-0734'' in the ``Search''
box. Click ``Search'' and use the filters on the left side of the page
to highlight ``Public Submissions'' or other document types. If you do
not have access to the Internet, you may view the docket online by
visiting the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. We have an agreement
with the Department of Transportation to use the Docket Management
Facility.
    Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act system of records notice regarding our public dockets in
the January 17, 2008 issue of the Federal Register (73 FR 3316).

Background and Purpose

    On September 7, 2012, the Coast Guard published a notice of
proposed policy change and request for comments regarding criteria for
granting medical waivers to mariners who have anti-tachycardia devices
or ICDs (77 FR 55174). The notice contains a detailed description of
the relevant regulatory provisions, guidance documents, and policy
considerations. The notice also lists a series of 12 questions we are
considering as the criteria for granting a medical waiver. The notice
requests public comment regarding whether the 12 questions represent an
appropriate and sufficient list of the criteria a mariner should be
required to meet in order to be eligible for waiver consideration, or
whether we should eliminate or modify any of the questions, or add
other questions to the list.
    We received 33 public comments in response to the notice before the
comment period closed on October 9, 2012. Because of the complexity and
importance of the issues involved, we are reopening the comment period
to provide interested parties additional time to submit comments. We
request that you not re-submit comments already in the docket. You may,
however, comment on other comments already in the docket; if you choose
to do so, please ensure you identify which comment you are responding
to.

Request for Comments

    We encourage your participation by submitting your comments to the
Docket Management Facility as specified in the ADDRESSES section above.
We will consider comments received during the reopened comment period
prior to establishing a final policy on whether waivers should be
granted for anti-tachycardia devices or ICDs, and if so, under what
circumstances.

Authority

    We issue this request for public comments under the authority of 5
U.S.C. 552(a).

    Dated: December 7, 2012.
P.F. Thomas,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2012-30296 Filed 12-14-12; 8:45 am]
BILLING CODE 9110-04-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer as well as a small business owner to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer and small business retailer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. While there are parts of the proposal I quickly agree with, there is much more that I don't fully understand.  I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I strongly believe that e-cigarettes are a healthier alternative to combustible cigarettes. Many of these products don't even contain nicotine, making them unrelated to tobacco based products.  Almost everyday a customer, friend or family member tells us their personal story of how these products have saved and positively changed their lives as an alternative to smoking combustible cigarettes and a cessation aid. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24680-24682]
[FR Doc No: 2021-09644]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91742; File No. SR-EMERALD-2021-17]

Self-Regulatory Organizations; MIAX Emerald, LLC: Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the Exchange's Rulebook and Fee Schedule To Reflect a Rebranding of the
Exchange's Affiliate, MIAX PEARL, LLC (``MIAX Pearl'')

May 3, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 22, 2021, MIAX Emerald, LLC (``MIAX Emerald'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Rulebook and Fee
Schedule to reflect a rebranding of the Exchange's affiliate, MIAX
PEARL, LLC (``MIAX Pearl'').
    The Exchange has designated the proposed rule change as one being
concerned solely with the administration of the Exchange pursuant to
Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(3)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission.
---------------------------------------------------------------------------

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

    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/emerald at MIAX
Emerald's principal office, and at the Commission's Public Reference
Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Exchange's Rulebook \5\ and Fee
Schedule \6\ as part of a non-substantive marketing effort to rebrand
the Exchange's affiliate, MIAX Pearl. Pursuant to this proposal, the
Exchange proposes to rebrand references to its affiliate's name, from
the fully-capitalized words ``MIAX PEARL'' to now be ``MIAX Pearl,''
throughout the Exchange's Rulebook and the Fee Schedule.\7\ The
Exchange's affiliate does not propose to amend references to the legal
entity's name, ``MIAX PEARL, LLC,'' and the rebranded term ``MIAX
Pearl'' will represent the same entity as its legal name, ``MIAX
PEARL.''
---------------------------------------------------------------------------

    \5\ See MIAX Emerald Rulebook, as of Apr. 13, 2021, available
at: https://www.miaxoptions.com/sites/default/files/page-files/MIAX_Emerald_Exchange_Rules_04132021.pdf.
    \6\ See MIAX Emerald Fee Schedule, as of Apr. 5, 2021, available
at: https://www.miaxoptions.com/sites/default/files/fee_schedule-files/MIAX_Emerald_Fee_Schedule_04052021.pdf.
    \7\ All references to the MIAX Pearl's legal name will remain
``MIAX PEARL, LLC.'' This includes references to ``MIAX PEARL, LLC''
in Exchange Rule 100 for the definition of ``MIAX PEARL,'' and in
the Exchange's Fee Schedule, Definitions, for the definition of
``MIAX PEARL.'' For marketing purposes throughout the Rulebook and
Fee Schedule, MIAX Pearl will otherwise be referred to as ``MIAX
Pearl.''
---------------------------------------------------------------------------

    Specifically, with the proposed rebranding, references in the
Exchange's Rulebook and Fee Schedule to ``MIAX PEARL'' will be
rebranded to ``MIAX Pearl.''

    The rebranding of references to ``MIAX PEARL'' to now be to ``MIAX
Pearl'' consists of non-substantive changes due to a recent rebranding
effort conducted by the Exchange, as well as its affiliates, MIAX Pearl
and Miami International Securities Exchange, LLC (``MIAX''). The
Exchange proposes to implement the rebranding changes for marketing
purposes. With the rebranding changes, the term ``MIAX Pearl'' will be
consistent with how the Exchange, MIAX Emerald, is named (i.e., ``MIAX
Emerald''). The Exchange notes that no changes to the ownership or
structure of the MIAX Pearl have taken place and that the term ``MIAX
Pearl'' will represent the same entity as the legal entity's name,
``MIAX PEARL.'' In lieu of providing a copy of the marked changes, the
Exchange represents that it will make the necessary non-substantive
revisions to the Exchange's Rulebook and the Fee Schedule and post
updated versions of each on the Exchange's website pursuant to Rule
19b-4(m)(2).\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 240.19b-4(m)(2).
---------------------------------------------------------------------------

    Additionally, the Exchange's affiliate, MIAX, intends to file a
similar proposal to rebrand its Rulebook and Fee Schedule to amend
references to ``MIAX PEARL'' to now be ``MIAX Pearl,'' which will
reflect the same rebranding changes described herein.
    The Exchange notes that this filing is based on a similar proposal
recently filed by MIAX Pearl to amend MIAX Pearl's Rulebook and Fee
Schedules to reflect these same rebranding efforts.\9\
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 91537 (March 30,
2021), 86 FR 20216 (April 16, 2021) (Notice of Filing and Immediate
Effectiveness of File No. SR-PEARL-2021-08).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \10\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \11\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
promotes just and equitable principles of trade, fosters cooperation
and coordination with persons engaged in facilitating transactions in
securities, removes impediments to and perfects the mechanisms of a
free and open market and a national market system and, in general,
protects investors and the public interest because the proposal will
eliminate potential confusion on the part of market participants using
the products and services of the Exchange in light of the corporate
rebranding that the Exchange and its affiliates, MIAX Pearl and MIAX,
have undergone.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange also believes that the proposed rule change is
consistent with Section 6(b)(1) of the Act \12\ in that it aims to
continue to ensure that the Exchange has the capacity to carry out the
purposes of the Act and to enforce compliance by its Members \13\ with
the provisions of the Act as well as the rules and regulations
thereunder. The Exchange proposes to amend the Rulebook and the Fee
Schedule to rebrand references to ``MIAX PEARL'' to now be ``MIAX
Pearl.'' The proposed rebrand consists of non-substantive changes to
the Rulebook and the Fee Schedule of the Exchange so that its
affiliate's name, ``MIAX Pearl,'' is consistent with its name, ``MIAX
Emerald,'' as part of a broader marketing effort by the Exchange and
its affiliates, MIAX Pearl and MIAX. Therefore, the Exchange believes
that the rebrand will protect investors and the public interest by
eliminating confusion that may exist because of differences in the
other naming conventions of MIAX Pearl. No changes to the ownership or
structure of MIAX Pearl have taken place. The Exchange notes that the
term ``MIAX Pearl'' will represent the same entity as ``MIAX PEARL.''
The Exchange notes that its affiliate, MIAX, will file a similar
proposal to amend its Rulebook and Fee Schedule to rebrand references
to ``MIAX PEARL'' to now be to ``MIAX Pearl,'' to provide uniformity
among the Exchange, MIAX Pearl and MIAX, to avoid potential confusion
by market participants.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(1).
    \13\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe the proposal will impose any burden on intra-market competition
because the proposed rule change is not a competitive filing but rather
is designed to effectuate the Exchange's rebranding of references to
``MIAX PEARL'' to now be ``MIAX Pearl,'' as part of a corporate
rebranding and marketing strategy. The proposed changes to the
Exchange's Rulebook and Fee Schedule will help provide clarity and
uniformity to avoid potential confusion on the part of market
participants because the rebrand of ``MIAX Pearl'' is part of a broader
rebranding and marketing effort by the Exchange and its affiliates,
MIAX Pearl and MIAX. In addition, the Exchange does not believe the
proposal will impose any burden on inter-market competition as the
proposal does not address any competitive issues and is intended to
protect investors by providing further transparency regarding the
Exchange's Rulebook and Fee Schedule.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \14\ and Rule 19b-4(f)(3) \15\ thereunder, in
that the proposed rule change is concerned solely with the
administration of the self-regulatory organization.
---------------------------------------------------------------------------

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

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-EMERALD-2021-17 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-EMERALD-2021-17. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-EMERALD-2021-17 and should be submitted
on or before May 28, 2021.

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

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09644 Filed 5-6-21; 8:45 am]
BILLING CODE 8011-01-P