[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34445-34451]
[FR Doc No: 2019-15254]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86363; File No. SR-PEARL-2019-22]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the MIAX
PEARL Fee Schedule

July 12, 2019.
    Pursuant to the provisions of 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 June 28, 2019, MIAX PEARL, LLC (``MIAX PEARL''
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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX PEARL Fee
Schedule (the ``Fee Schedule'') to establish certain non-transaction
fees applicable to participants and new members trading options on and/
or using services provided by MIAX PEARL.
    MIAX PEARL commenced operations as a national securities exchange
registered under Section 6 of the Act \3\ on February 6, 2017.\4\ The
Exchange adopted its transaction fees and certain of its non-
transaction fees in its filing SR-PEARL-2017-10.\5\
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    \3\ 15 U.S.C. 78f.
    \4\ See Securities Exchange Act Release No. 79543 (December 13,
2016), 81 FR 92901 (December 20, 2016) (File No. 10-227) (order
approving application of MIAX PEARL, LLC for registration as a
national securities exchange).
    \5\ See Securities Exchange Act Release No. 80061 (February 17,
2017), 82 FR 11676 (February 24, 2017) (SR-PEARL-2017-10).
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    While changes to the Fee Schedule pursuant to this proposal are
effective upon filing, the Exchange has designated these changes to be
operative on July 1, 2019.
    The Exchange initially filed the proposal on March 27, 2019 (SR-
PEARL-2019-12).\6\ That filing was withdrawn on May 20, 2019. It is
replaced with the current filing (SR-PEARL-2019-22).
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    \6\ See Securities Exchange Act Release No. 85541 (April 8,
2019), 84 FR 14983 (April 12, 2019) (SR-PEARL-2019-12) (the ``First
Proposed Rule Change'').
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    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/pearl at MIAX
PEARL'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
Proposal
    The Exchange proposes to amend the Fee Schedule to establish
certain non-transaction fees applicable to participants and new members
trading options on and/or using services provided by MIAX PEARL. The
Exchange initially filed the proposal on March 27, 2019, designating
the proposed fees effective April 1, 2019.\7\ The First Proposed Rule
Change was published for comment in the Federal Register on April 12,
2019.\8\ The proposed fee changes remained in effect until the Exchange
withdrew the First Proposed Rule Change on May 20, 2019.\9\ The
Exchange is now re-filing the proposal to establish certain non-
transaction fees applicable to market participants and new members
trading options on and/or using certain services provided by the
Exchange, to include additional information.
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    \7\ See id.
    \8\ See id.
    \9\ See Letter from Gregory P. Ziegler, AVP and Senior Associate
Counsel, MIAX PEARL, LLC, to Vanessa Countryman, Acting Secretary,
Commission, dated May 17, 2019.
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    The Exchange introduced the structure of certain non-transaction
fees in its filing SR-PEARL-2017-10 \10\ (without proposing actual fee
amounts), but also explicitly waived the assessment of any such fees
for the period of time which the Exchange defined as the ``Waiver
Period.'' \11\ The Exchange now proposes to adopt certain non-
transaction fees as described below, and thereby terminate the Waiver
Period applicable to such non-transaction fees. In general, the
Exchange proposes to amend the Fee Schedule to establish a one-time
membership application fee for MIAX PEARL Members; \12\ Application
Programming Interface (``API'') Testing and Certification fees; and
MIAX PEARL Member Participant Identifier (``MPID'') \13\ fees.
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    \10\ See supra note 5.
    \11\ ``Waiver Period'' means, for each applicable fee, the
period of time from the initial effective date of the MIAX PEARL Fee
Schedule until such time that the Exchange has an effective fee
filing establishing the applicable fee. The Exchange will issue a
Regulatory Circular announcing the establishment of an applicable
fee that was subject to a Waiver Period at least fifteen (15) days
prior to the termination of the Waiver Period and effective date of
any such applicable fee. See the Definitions Section of the Fee
Schedule.
    \12\ ``Member'' means an individual or organization that is
registered with the Exchange pursuant to Chapter II of the Exchange
Rules for purposes of trading on the Exchange as an ``Electronic
Exchange Member'' or ``Market Maker.'' Members are deemed
``members'' under the Exchange Act. See Exchange Rule 100.
    \13\ An MPID is a code used in the MIAX PEARL system to identify
the participant to MIAX PEARL and to the participant's Clearing
Member respecting trades executed on MIAX PEARL. Participants may
use more than one MPID.
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    The Exchange also proposes to amend the Fee Schedule to remove the
text and application of the three-month New Member Non-Transaction Fee
Waiver.\14\ The Exchange adopted the three-month New Member Non-
Transaction Fee Waiver in its filing SR-PEARL-2018-07.\15\
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    \14\ ``New Member Non-Transaction Fee Waiver'' means the waiver
of certain non-transaction fees, as explicitly set forth in specific
sections of the Fee Schedule, for a new Member of the Exchange, for
the waiver period. For purposes of this definition, the waiver
period consists of the calendar month the new Member is credentialed
to use the System in the production environment following approval
as a new Member of the Exchange and the two (2) subsequent calendar
months thereafter. For purposes of this definition, a new Member
shall mean any Member who has not previously been approved as a
Member of the Exchange. See the Definitions Section of the Fee
Schedule.
    \15\ See Securities Exchange Act Release No. 82867 (March 13,
2018), 83 FR 12044 (March 19, 2018) (SR-PEARL-2018-07).
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    The Exchange proposes to remove the New Member Non-Transaction Fee
Waiver as described below, and thereby terminate the New Member Non-
Transaction Fee Waiver as it applies to all relevant fees, which would
include the Monthly Trading Permit fee; Port fees; and MIAX PEARL Top
of Market (``ToM'') and MIAX PEARL Liquidity Feed (``PLF'') market data
fees. The Exchange also proposes to amend the Definitions section of
the Fee Schedule to delete the definitions of ``New Member Non-
Transaction Fee Waiver''

and ``Waiver Period'' as those definitions would no longer be
applicable in accordance with this proposal to remove the Waiver Period
for all remaining waived non-transaction fees, as described below,
including the three-month fee waiver applicable to certain non-
transaction fees for new Members of the Exchange.
MIAX PEARL Membership Application Fee
    The Exchange proposes to assess a one-time membership application
fee based upon the applicant's status as either an Electronic Exchange
Member \16\ (``EEM'') or as a Market Maker.\17\ The Exchange proposes
that applicants for MIAX PEARL Membership as an EEM will be assessed a
one-time application fee of $500. The Exchange proposes that applicants
for MIAX PEARL Membership as a Market Maker will be assessed a one-time
application fee of $1,500. The difference in the proposed membership
application fee to be charged to EEMs and Market Makers reflects the
additional review and processing costs and effort needed for Market
Maker applications. MIAX PEARL's proposed one-time membership
application fees are similar to and generally lower than one-time
application fees in place at the Cboe Exchange, Inc. (``Cboe'') ($3,000
for an individual applicant and $5,000 for an applicant organization)
\18\ and at Nasdaq ISE, LLC (``Nasdaq ISE'') ($7,500 per firm for a
primary market maker, $5,500 per firm for a competitive market maker,
and $3,500 per firm for an electronic market maker).\19\ Below is the
table for the proposed one-time membership application fee for MIAX
PEARL:
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    \16\ ``Electronic Exchange Member'' or ``EEM'' means the holder
of a Trading Permit who is a Member representing as agent Public
Customer Orders or Non-Customer Orders on the Exchange and those
non-Market Maker Members conducting proprietary trading. Electronic
Exchange Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100. See the Definitions Section of the Fee Schedule.
    \17\ ``Market Maker'' means a Member registered with the
Exchange for the purpose of making markets in options contracts
traded on the Exchange and that is vested with the rights and
responsibilities specified in Chapter VI of Exchange Rules. See
Exchange Rule 100. See the Definitions Section of the Fee Schedule.
    \18\ See Cboe Fees Schedule, p. 12, Cboe Trading Permit Holder
Application Fees.
    \19\ See Nasdaq ISE, Options Rules, Options 7, Pricing Schedule,
Section 9. Legal and Regulatory A. Application.

------------------------------------------------------------------------
                                                            Application
                   Type of membership                           fee
------------------------------------------------------------------------
Electronic Exchange Member..............................         $500.00
Market Maker............................................        1,500.00
------------------------------------------------------------------------
MIAX PEARL will assess a one-time Membership Application Fee on the
  earlier of (i) the date the applicant is certified in the membership
  system, or (ii) once an application for MIAX PEARL membership is
  finally denied.

Member API Testing and Certification Fee
    Next, the Exchange proposes to assess an API Testing and
Certification fee to Members. An API makes it possible for Member
software to communicate with MIAX PEARL software applications, and is
subject to Member testing with, and certification by, MIAX PEARL. API
testing and certification includes, for EEMs, testing all available
order types, new order entry, order management, order throughput and
mass order cancellation. For Market Makers, API testing and
certification also includes testing of all available quote types, quote
throughput, quote management and cancellation, Aggregate Risk Manager
settings and triggers, and confirmation of quotes within the trading
engines.
    The API Testing and Certification fees for Members are based upon
the type of interface that the Member has been credentialed to use. The
Exchange proposes to assess an API testing and certification fee for
Members (i) initially per API for FIX,\20\ MEO,\21\ FXD\22\ and CTD\23\
in the month the Member has been credentialed to use one or more ports
in the production environment for the tested API, and (ii) each time a
Member initiates a change to its system that requires testing and
certification. The Exchange also proposes that API Testing and
Certification fees will not be assessed in situations where the
Exchange initiates a mandatory change to the Exchange's System \24\
that requires testing and certification.
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    \20\ ``FIX Interface'' means the Financial Information Exchange
interface for certain order types as set forth in Exchange Rule 516.
See Exchange Rule 100. See the Definitions Section of the Fee
Schedule.
    \21\ ``MEO Interface'' means a binary order interface for
certain order types as set forth in Rule 516 into the MIAX PEARL
System. See Exchange Rule 100. See the Definitions Section of the
Fee Schedule.
    \22\ ``FXD Interface'' or ``FIX Drop Copy Port'' means a
messaging interface that provides a copy of real-time trade
execution, trade correction and trade cancellation information to
FIX Drop Copy Port users who subscribe to the service. FXD Port
users are those users who are designated by an EEM to receive the
information and the information is restricted for use by the EEM
only. See the Definitions Section of the Fee Schedule.
    \23\ ``CTD Port'' or ``Clearing Trade Drop Port'' provides an
Exchange Member with a real-time clearing trade updates. The updates
include the Member's clearing trade messages on a low latency, real-
time basis. The trade messages are routed to a Member's connection
containing certain information. The information includes, among
other things, the following: (i) Trade date and time; (ii) symbol
information; (iii) trade price/size information; (iv) Member type
(for example, and without limitation, Market Maker, Electronic
Exchange Member, Broker-Dealer); and (v) Exchange MPID for each side
of the transaction, including Clearing Member MPID. See the
Definitions Section of the Fee Schedule.
    \24\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
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    Any Member can select any type of interface (FIX Interface, MEO
Interface, FXD Interface, and/or the CTD Port) to test and certify. The
Exchange proposes the following fees: Each Member who uses the FIX
Interface to connect to the System will be assessed an API Testing and
Certification fee of $1,000; each Member who uses the MEO Interface to
connect to the System will be assessed an API Testing and Certification
fee of $1,500; each Member who uses the FXD Interface to connect to the
system will be assessed an API Testing and Certification fee of $500;
and each Member who uses the CTD Port to connect to the system will be
assessed an API Testing and Certification fee of $500.
    Below is the proposed fee table for API Testing and Certification
fees for Members:

------------------------------------------------------------------------
                                                   API testing and
             Type of interface                    certification fee
------------------------------------------------------------------------
FIX.......................................                     $1,000.00
MEO.......................................                      1,500.00
FXD.......................................                        500.00
CTD.......................................                        500.00
------------------------------------------------------------------------
API Testing and Certification Fees will be assessed (i) initially per
  API for FIX, MEO, FXD and CTD in the month the Member has been
  credentialed to use one or more ports in the production environment
  for the tested API, and (ii) each time a Member initiates a change to
  its system that requires testing and certification. API Testing and
  Certification Fees will not be assessed in situations where the
  Exchange initiates a mandatory change to the Exchange's system that
  requires testing and certification.

Non-Member API Testing and Certification Fee
    The Exchange proposes to assess an API Testing and Certification
fee for Third Party Vendors,\25\ Service Bureaus \26\ and other non-
Members (i) initially per API for FIX, MEO, FXD, and CTD in the month
the non-Member has been credentialed to use one or more ports in the
production environment for the tested API, and (ii) each time a Third
Party Vendor, Service Bureau, or other non-Member initiates a change to
its system that requires testing and certification. The Exchange also
proposes that API Testing and Certification fees will not be assessed
in situations where the Exchange initiates a mandatory change to the
Exchange's System that requires testing and certification.
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    \25\ Third party vendors are subscribers of MIAX's market and
other data feeds, which they in turn use for redistribution
purposes. Third party vendors do not provide connectivity and
therefore are not subject to Network testing and certification. See
the Definitions Section of the Fee Schedule.
    \26\ ``Service Bureau'' means a technology provider that offers
and supplies technology and technology services to a trading firm
that does not have its own proprietary system. See the Definitions
Section of the Fee Schedule.
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    The Exchange's proposed API Testing and Certification fees for non-
Members are based upon the type of interface used by the non-Member to
connect to the Exchange--the FIX Interface, the MEO Interface, the FXD
Interface, and/or the CTD Port. Any non-Member can select any type of
interface (FIX Interface, MEO Interface, FXD Interface, and/or the CTD
Port) to test and certify. As with Members, an API makes it possible
for third party vendors' and Service Bureaus' software to communicate
with MIAX PEARL software applications, and is subject to testing with,
and certification by, MIAX PEARL. The higher proposed fee charged to
non-Members reflects the greater amount of time spent by MIAX PEARL
employees testing and certifying non-Members. It has been MIAX PEARL's
experience that Member testing takes less time than non-Member testing
because Members have more experience testing these systems with
exchanges; generally fewer questions and issues arise during the
testing and certification process. Also, because Third Party Vendors
and Service Bureaus are redistributing data and reselling services to
other Members and market participants, the number and types of
scenarios that need to be tested are more numerous and complex than
those tested and certified for a single Member.
    The Exchange proposes the following fees: Each non-Member who uses
the FIX Interface to connect to the System will be assessed an API
Testing and Certification fee of $1,200; each non-Member who uses the
MEO Interface to connect to the System will be assessed an API Testing
and Certification fee of $2,000; each non-Member who uses the FXD
Interface to connect to the system will be assessed an API Testing and
Certification fee of $600; and each non-Member who uses the CTD Port to
connect to the system will be assessed an API Testing and Certification
fee of $600.
    Below is the proposed fee table for API Testing and Certification
fees for non-Members:

------------------------------------------------------------------------
                                                   API testing and
             Type of interface                    certification fee
------------------------------------------------------------------------
FIX.......................................                     $1,200.00
MEO.......................................                      2,000.00
FXD.......................................                        600.00
CTD.......................................                        600.00
------------------------------------------------------------------------
API Testing and Certification Fees for Third Party Vendors, Service
  Bureaus and other non-Members will be assessed (i) initially per API
  for FIX, MEO, FXD, and CTD in the month the non-Member has been
  credentialed to use one or more ports in the production environment
  for the tested API, and (ii) each time a Third Party Vendor, Service
  Bureau, or other non-Member initiates a change to its system that
  requires testing and certification. API Testing and Certification Fees
  will not be assessed in situations where the Exchange initiates a
  mandatory change to the Exchange's system that requires testing and
  certification.

MPID Fees
    The Exchange proposes to assess monthly MPID fees to Members based
upon the type of MPID. MPID fees are assessed for assigning and
managing these identifiers for each Member. The Exchange proposes that
Members will be assessed a monthly MPID fee of $125 for each FIX MPID
and Members will be assessed a monthly MPID fee of $125 for each MEO
MPID. MPIDs allow the Exchange to provide additional services to its
Members, including customer reporting, monitoring and risk protection
services, down at the MPID level. MPIDs provide Members the ability to
segment their business operations in a manner that can be tailored to
their business needs, as well as receive certain additional
administrative and operational services provided by the Exchange.
    The Exchange also proposes to introduce a cap on the amount of MPID
fees that can be assessed by the Exchange to a Member of $500 per
month, regardless of the actual number of EEM or MEO MPIDs assigned to
such Member. The Exchange believes that establishing a monthly cap on
MPID fees will provide Members greater flexibility to accommodate their
varying business models and customer configurations, as many Members
often request multiple MPIDs from the Exchange, and the Exchange does
not want MPID costs to serve as a barrier for requesting multiple
MPIDs. The Exchange notes that this fee cap is similar to the MPID fee
cap assessed by the Exchange's affiliate, Miami International
Securities Exchange, LLC (``MIAX'').\27\
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    \27\ See Securities Exchange Act Release No. 82823 (March 7,
2018), 83 FR 10935 (March 13, 2018) (SR-MIAX-2018-09).
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    Below is the proposed MPID fee table:

------------------------------------------------------------------------
                                                               Monthly
                        Type of MPID                          MPID fees
------------------------------------------------------------------------
FIX MPID...................................................      $125.00
MEO MPID...................................................       125.00
------------------------------------------------------------------------
MPID fees are capped at $500.00 per month per Member.

New Member Non-Transaction Fee Waiver
    The Exchange proposes to remove the New Member Non-Transaction Fee
Waiver from the Fee Schedule. The New Member Non-Transaction Fee Waiver
waived the assessment of a fee for a Trading Permit, Port, ToM or PLF
market data feed for a new Member of the Exchange for the first
calendar month during which the new Member was approved as a Member and
was credentialed to use the System in the production environment, and
for the two (2) subsequent calendar months thereafter.

    The Exchange initially waived certain non-transaction fees for new
Members in order to attract new business and encourage Members to use
the Exchange. The Exchange now believes that the New Member Non-
Transaction Fee Waiver is no longer necessary since the MIAX PEARL
market is established and MIAX PEARL no longer needs to rely on such
waivers to attract market participants.
    The Exchange notes that any Member who began receiving the New
Member Non-Transaction Fee Waiver prior to the filing of this proposal,
will continue to receive that benefit for the first calendar month
during which they were approved as a Member and were credentialed to
use the System in the production environment, and for the two (2)
subsequent calendar months thereafter.
Applicability to and Impact on Participants \28\
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    \28\ On May 21, 2019, the SEC Division of Trading and Markets
(the ``Division'') issued fee filing guidance titled ``Staff
Guidance on SRO Rule Filings Relating to Fees'' (``Guidance'').
Within the Guidance, the Division noted, among other things, that
the purpose discussion should address ``how the fee may apply
differently (e.g., additional cost vs. additional discount) to
different types of market participants (e.g., market makers,
institutional brokers, retail brokers, vendors, etc.) and different
sizes of market participants.'' See Guidance (available at https://www.sec.gov/tm/staff-guidance-sro-rule-filings-fees). The Guidance
also suggests that the purpose discussion should include numerical
examples. Where possible, the Exchange is including numerical
examples. In addition, the Exchange is providing data to the
Commission in support of its arguments herein. The Guidance covers
all aspects of a fee filing, which the Exchange has addressed
throughout this filing.
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    The Commission has repeatedly expressed its preference for
competition over regulatory intervention in determining prices,
products, and services in the securities markets. In Regulation NMS,
the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \29\
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    \29\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005).
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    There are currently 16 registered options exchanges competing for
order flow. Based on publicly-available information, and excluding
index-based options, no single exchange has more than approximately 16%
market share.\30\ Therefore, no exchange possesses significant pricing
power. More specifically, as of June 2019, the Exchange has less than
5% market share of executed volume of multiply-listed equity & ETF
options trades.\31\ The Exchange believes that the ever-shifting market
share among the exchanges from month to month demonstrates that market
participants can discontinue or reduce use of certain categories of
products, or shift order flow, in response to fee changes. Accordingly,
competitive forces constrain the Exchange's ability to set its fees for
various products, services and transactions.
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    \30\ The Options Clearing Corporation (``OCC'') publishes
options and futures volume in a variety of formats, including daily
and monthly volume by exchange, available here: https://www.theocc.com/market-data/volume/default.jsp.
    \31\ See id.
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    The proposed adoption of certain non-transaction fees would be
applied uniformly to all market participants. Further, as there are
currently 16 registered options exchanges competing for order flow with
no single exchange accounting for more than approximately 16% of market
share, the Exchange cannot predict with certainty whether any
participant is planning to become a Member or utilize any of the
services that the Exchange is planning to establish fees for and thus
would be subject to the proposed fees.
    The Exchange has issued a Regulatory Circular announcing the
establishment of the aforementioned fees that were subject to the
Waiver Period at least 15 days prior to the termination of the Waiver
Period and effective date of the applicable fee.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \32\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \33\ in
particular, in that it is an equitable allocation of reasonable dues,
fees and other charges among its members and issuers and other persons
using its facilities. The Exchange also believes the proposal furthers
the objectives of Section 6(b)(5) of the Act in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest and is not designed to permit unfair discrimination between
customers, issuers, brokers and dealers. Moreover, the Exchange
believes that its proposal complies with Commission guidance on SRO fee
filings that the Commission Staff issued on May 21, 2019.\34\
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    \32\ 15 U.S.C. 78f(b).
    \33\ 15 U.S.C. 78f(b)(4) and (5).
    \34\ See Guidance, supra note 28.
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    The Exchange believes that the proposed change to eliminate the
waiver of the non-transaction fees described above is reasonable in
several respects. As a threshold matter, the Exchange is subject to
significant competitive forces in the market for options transaction
and non-transaction services that constrain its pricing determinations
in that market. The fact that this market is competitive has long been
recognized by the courts. In NetCoalition v. Securities and Exchange
Commission, the D.C. Circuit stated as follows: ``[n]o one disputes
that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .'' \35\
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    \35\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
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    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
options transaction services. The Exchange is one of several options
venues to which market participants may direct their order flow, and it
represents a small percentage of the overall market. Competing options
exchanges offer complex order functionality, with varying pricing
schedules. The Exchange believes its proposed fees are reasonable and
well within the range of non-transaction fees assessed among other
exchanges, including the Exchange's affiliate, MIAX.\36\
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    \36\ See the MIAX Fee Schedule.
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    Within this environment, market participants can freely and often
do shift their order flow among the Exchange and competing venues in
response to changes in their respective pricing schedules.\37\
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    \37\ While MIAX PEARL has not charged certain non-transaction
fees as described above, to date, the Exchange perceives no
regulatory, structure, or cost impediments to market participants
shifting order flow away from it as a result of this rule change.
See Guidance, supra note 28. In particular, the Exchange notes that
these examples of shifts in liquidity and market share, along with
many others, have occurred within the context of market
participants' existing duties of Best Execution and obligations
under the Order Protection Rule under Regulation NMS.

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    There are currently 16 registered options exchanges competing for
order flow. Based on publicly-available information, and excluding
index-based options, no single exchange has more than approximately 16%
of the market share of executed volume of multiply-listed equity and
ETF options trades.\38\ Therefore, no exchange possesses significant
pricing power. More specifically, as of June 2019, the Exchange had
less than 5% market share of executed volume of multiply-listed equity
& ETF options trades.\39\ The Exchange believes that the ever-shifting
market share among the exchanges from month to month demonstrates that
market participants can discontinue or reduce use of certain categories
of products, or shift order flow, in response to fee changes.
Accordingly, competitive forces constrain the Exchange's ability to set
its fees for various products, services and transactions.
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    \38\ The Options Clearing Corporation (``OCC'') publishes
options and futures volume in a variety of formats, including daily
and monthly volume by exchange, available here: https://www.theocc.com/market-data/volume/default.jsp.
    \39\ See id.
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    Further, the Exchange no longer believes it is necessary to waive
these fees to attract market participants to the MIAX PEARL market
since this market is now established and MIAX PEARL no longer needs to
rely on such waivers to attract market participants. The Exchange
believes that the proposed changes are equitable and not unfairly
discriminatory because the elimination of the non-transaction fees will
uniformly apply to all Exchange participants based on market
participant type.
    The Exchange believes its one-time membership application fees are
reasonable, equitable and not unfairly discriminatory. As described
above, the one-time application fees are similar and generally lower
than application fees in place at other options exchanges,\40\ and are
designed to recover costs associated with the processing of such
applications. The Exchange believes that it is reasonable, equitable,
and not unfairly discriminatory that Market Maker applicants are
charged slightly more than EEM applicants because of the additional
costs involved in processing a Market Maker's application.
---------------------------------------------------------------------------

    \40\ See supra notes 18 and 19.
---------------------------------------------------------------------------

    The Exchange believes it is reasonable, equitable, and not unfairly
discriminatory to begin to assess API Testing and Certification fees
for both Members and non-Members. The Exchange believes the proposed
API Testing and Certification fees are a reasonable allocation of its
costs and expenses among its Members and non-Members using its
facilities since it is recovering the costs associated with providing
such infrastructure testing and certification services.
    MIAX PEARL believes it is reasonable, equitable and not unfairly
discriminatory to assess different API Testing and Certification fees
to Members and non-Members. The higher fee charged to non-Members
reflects the greater amount of time spent by MIAX PEARL employees
testing and certifying non-Members. It has been MIAX PEARL's experience
that Member testing takes less time than non-Member testing because
Members have more experience testing these systems with exchanges;
generally fewer questions and issues arise during the testing and
certification process. Also, with respect to API testing and
certification, because Third Party Vendors and Service Bureaus are
redistributing data and reselling services to other Members and market
participants the number and types of scenarios that need to be tested
are more numerous and complex than those tested and certified for
Members.
    The Exchange believes its proposal to assess monthly MPID fees to
Members based upon the type of MPID is reasonable, equitable and not
unfairly discriminatory because the proposed fees apply to all Members
assigned MPIDs equally and will allow the Exchange to assess fees for
assigning and maintaining such services. The Exchange believes its
proposal is a reasonable allocation of fees because MPIDs provide
Members the ability to segment their business operations in a manner
that can be tailored to their business needs, as well as receive
certain additional administrative and operational services provided by
the Exchange. The proposed monthly MPID fees are equitable and not
unfairly discriminatory because the proposed MPID fees will allow the
Exchange to continue to maintain and enhance value-added services,
including reporting of relevant trade information through enhanced
reporting tools and provide ongoing services to customers that are
assigned each MPID. The Exchange also notes that Members are not
required to purchase multiple MPIDs. As of June 2019, the Exchange had
41 Members (including affiliates of Members) that have at least 1 MPID
each. Of those 41 Members, 20 Members have multiple MPIDs. Further, of
the 20 Members with multiple MPIDs, only 8 of those Members have more
than 4 MPIDs each. Accordingly, with the proposed fee cap of $500,
those 8 Members with the greatest number of MPIDs would benefit from
the proposed fee cap.
    The Exchange also believes that its proposal to establish a fee cap
for Members on MPID fees is reasonable, equitable, and not unfairly
discriminatory. The proposal to cap the total amount of MPID fees that
can be assessed upon a Member to a maximum of $500 per month is
designed to promote just and equitable principles of trade by
encouraging Members to configure their MPID assignments with greater
granularity and for MPID costs to not serve as a barrier for requesting
multiple MPIDs. Because any Member is eligible to take advantage of the
fee cap, the Exchange believes the fee cap is fair and equitable and
not unreasonably discriminatory because it applies equally to all
Members, and access to such fee cap is offered on terms that are not
unfairly discriminatory.
    The Exchange believes that the proposal to remove the New Member
Non-Transaction Fee Waiver is reasonable, equitable, and not unfairly
discriminatory because the removal of the New Member Non-Transaction
Fee Waiver applies equally to all new Members of the Exchange. The
Exchange initially waived certain non-transaction fees for new Members
in order to attract new business and encourage Members to join the
Exchange. The Exchange believes that the New Member Non-Transaction Fee
Waiver is no longer necessary since the MIAX PEARL market is
established and MIAX PEARL no longer relies on such waivers to attract
market participants. Further, the proposed rule change will not apply
to any new Member who began receiving the New Member Non-Transaction
Fee Waiver prior to the filing of this proposal and will continue to
receive that benefit for the first calendar month during which they
were approved as a Member and were credentialed to use the System in
the production environment, and for the two (2) subsequent calendar
months thereafter.
    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive. In such an environment, the Exchange must continually adjust
its fees for services and products, in addition to order flow, to
remain competitive with other exchanges. The Exchange believes that the
proposed changes reflect this competitive environment.

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

    MIAX PEARL does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Intra-Market Competition
    The Exchange does not believe that the proposed rule change would
place certain market participants at the Exchange at a relative
disadvantage compared to other market participants or affect the
ability of such market participants to compete. Unilateral action by
MIAX PEARL in the assessment of certain non-transaction fees for
services provided to its Members and others using its facilities will
not have an impact on competition. As a more recent entrant in the
already highly competitive environment for equity options trading, MIAX
PEARL does not have the market power necessary to set prices for
services that are unreasonable or unfairly discriminatory in violation
of the Act. MIAX PEARL's proposed non-transaction fee levels, as
described herein, are comparable to fee levels charged by other options
exchanges for the same or similar services, including those fees
assessed by its affiliate, MIAX.
    The Exchange believes that the proposed non-transaction fees do not
place certain market participants at a relative disadvantage to other
market participants because the pricing is associated with costs to the
Exchange of the relevant fee being proposed. The proposed non-
transaction fees do not apply unequally to different size market
participants, but instead would allow the Exchange to recoup some of
its costs in reviewing and processing Market Maker and EEM membership
applications; costs for API testing and certification for Members and
non-Members to ensure proper functioning of all available order types,
new order entry, order management, order throughput and mass order
cancellation (as well as, for Market Makers, all available quote types,
quote throughput, quote management and cancellation, Aggregate Risk
Manager settings and triggers, and confirmation of quotes within the
trading engines); and costs associated with assigning and managing
MPIDs for Members to ensure proper reporting, monitoring and risk
protection services for customers. Accordingly, the proposed non-
transaction fees do not favor certain categories of market participants
in a manner that would impose a burden on competition.
    Further, the Exchange believes that the proposed rule change will
promote transparency by making it clear to Members and non-Members the
fees that MIAX PEARL will assess for Membership application to MIAX
PEARL, API testing and certification, and MPID fees, as well as the cap
on MPID fees for EEMs. This will permit Members and non-Members to more
accurately anticipate and account for non-transactional costs, which
promotes consistency.
Inter-Market Competition
    The Exchange believes the proposed non-transaction fees do not
place an undue burden on competition on other SROs that is not
necessary or appropriate. The Exchange operates in a highly competitive
market in which market participants can readily favor one of the 16
competing options venues if they deem fee levels at a particular venue
to be excessive. Based on publicly-available information, and excluding
index-based options, no single exchange has more than 16% market share.
Therefore, no exchange possesses significant pricing power in the
execution of multiply-listed and ETF options order flow. As of June
2019, to date, the Exchange had less than 5% market share and the
Exchange believes that the ever-shifting market share among exchanges
from month to month demonstrates that market participants can
discontinue or reduce use of certain categories of products, or shift
order flow, in response to fee changes. In such an environment, the
Exchange must continually adjust its fees and fee waivers to remain
competitive with other exchanges and to attract order flow to the
Exchange.

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)(ii) of the Act,\41\ and Rule 19b-4(f)(2) \42\ thereunder.
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.
---------------------------------------------------------------------------

    \41\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \42\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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-PEARL-2019-22 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-PEARL-2019-22. 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-PEARL-2019-22 and should be
submitted on or before August 8, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\43\
---------------------------------------------------------------------------

    \43\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-15254 Filed 7-17-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Rules and Regulations]
[Pages 53299-53303]
[FR Doc No: 2014-21306]

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

40 CFR Part 52

[EPA-R06-OAR-2012-0096; FRL-9916-32-Region 6]

Approval and Promulgation of Implementation Plans; Texas;
Revision to Control Volatile Organic Compound Emissions from Storage
Tanks

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a Texas
State Implementation (SIP) revision for control of volatile organic
compound (VOC) emissions from storage tanks. The revision implements
additional controls in the Dallas-Fort Worth 1997 ozone nonattainment
area (DFW area); modifies control requirements in the DFW area, the
Houston-Galveston-Brazoria ozone nonattainment area (HGB area), the
Beaumont-Port Arthur area (BPA area) and El Paso, Gregg, Nueces and
Victoria Counties; and makes non-substantive changes to VOC control
provisions that apply in Aransas, Bexar, Calhoun, Matagorda, San
Patricio and Travis Counties. In addition, EPA finds that the SIP
revision implements serious area reasonable available control
technology (RACT) controls for the VOC storage source category in the
DFW area and continues to implement severe area RACT for this source
category in the HGB area as required by the Clean Air Act (CAA).

DATES: This rule is effective on November 10, 2014 without further
notice, unless EPA receives relevant adverse comment by October 9,
2014. If EPA receives such comment, EPA will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2012-0096, by one of the following methods:
     www.regulations.gov. Follow the online instructions.
     Email: Mr. Carl Young at<EMAIL_ADDRESS>     Mail or delivery: Mr. Guy Donaldson, Chief, Air Planning
Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue,
Suite 1200, Dallas, Texas 75202-2733.
    Instructions: Direct your comments to Docket No. EPA-R06-OAR-2012-
0096. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 6,
1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the
docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available at either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment with
the person listed in the FOR FURTHER INFORMATION CONTACT paragraph
below or Mr. Bill Deese at<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Carl Young,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

Table of Contents

I. Background
II. EPA's Evaluation
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

A. CAA and SIPs

    Section 110 of the CAA requires states to develop and submit to EPA
a SIP to ensure that state air quality meets National Ambient Air
Quality Standards. These ambient standards currently address six
criteria pollutants: carbon monoxide, nitrogen dioxide, ozone, lead,
particulate matter, and sulfur dioxide. Each federally-approved SIP
protects air quality primarily by addressing air pollution at its point
of origin through air pollution regulations and control strategies. EPA
approved SIP regulations and control strategies are federally
enforceable. As needed, States revise the SIP as needed and submit
revisions to EPA for approval.

B. SIP Revision Submitted on January 17, 2012

    A SIP revision for controlling VOC emissions from storage tanks was
adopted by Texas on December 7, 2011, and submitted to us on January
17, 2012. VOCs are an ``ozone precursor'', as they react with oxygen,
nitrogen oxides (NOX) and sunlight to form ozone.
Controlling sources of VOC and NOX emissions can lower ozone levels in
the ambient air.
    The revision amends Title 30, Chapter 115 of the Texas
Administrative Code (30 TAC 115) to (1) revise Sec. Sec.  115.110,
115.112-115.117, and 115.119, and (2) add new Sec. Sec.  115.111 and
115.118. The revision (1) implements additional VOC controls for
storage tanks in the DFW area; (2) modifies VOC control requirements in
the DFW area, the HGB area, the BPA area and El Paso, Gregg, Nueces and
Victoria Counties and (3) makes non-substantive changes to VOC control
provisions that apply in Aransas, Bexar, Calhoun, Matagorda, San
Patricio and Travis Counties.
    The DFW area consists of Collin, Dallas, Denton, Ellis, Johnson,
Kaufman, Parker, Rockwall and Tarrant Counties. The DFW area was
reclassified as serious ozone nonattainment for the 1997 ozone standard
(75 FR 79302, December 20, 2010). The SIP revision for storage tanks
was adopted by Texas to meet the CAA RACT requirements for the VOC
storage emission source category in serious ozone nonattainment areas.
In the DFW area the revision (1) requires control of VOC flash
emissions from storage tanks in the DFW area that might otherwise emit
50 tons per year (tpy) of VOC or more, (2) adds requirements for low-
leaking storage tank fittings and (3) limits situations when a floating
roof storage tank is allowed to emit VOCs because the roof is not
floating on the stored VOC liquid.
    The revision also adds a requirement for the DFW and HGB areas that
a vapor recovery unit used for VOC control must be designed to process
all VOC vapor generated by the maximum crude oil and condensate
throughput of the storage tank and must transfer recovered vapors to a
pipe or container that is vapor-tight. The HGB area consists of
Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery
and Waller counties. The HGB area is classified as a severe ozone
nonattainment area for the 1997 ozone NAAQS (73 FR 56983, October 1,
2008).
    In the DFW, HGB and BPA areas and in El Paso, Gregg, Nueces and
Victoria Counties the revision (1) adds an explicit requirement that
any flare used for control must be designed and

operated according to 40 CFR 60.18(b)--(f) as amended through December
22, 2008, and (2) amends monitoring and testing requirements that
ensure effectiveness of VOC controls. The BPA area consists of Hardin,
Jefferson, and Orange Counties.
    VOC control requirements for storage tanks also apply in Aransas,
Bexar, Calhoun, Matagorda, San Patricio, and Travis Counties. The
revision did not substantially change requirements for these counties.
    The SIP revision submitted by Texas may be accessed online at
www.regulations.gov, Docket No. EPA-R06-OAR-2012-0096.

C. CAA Requirements for the SIP Revision

    The primary CAA requirements pertaining to the SIP revision
submitted by Texas are found in CAA sections 110(l) and 182(b)(2). CAA
section 110(l) requires that a SIP revision submitted to EPA be adopted
after reasonable notice and public hearing. Section 110(l) also
requires that we not approve a SIP revision if the revision would
interfere with any applicable requirement concerning attainment and
reasonable further progress, or any other applicable requirement of the
CAA. CAA section 182(b)(2) requires that ozone nonattainment areas
classified as moderate or above implement RACT controls on all major
VOC and NOX emission sources and on all sources and source
categories covered by a control technique guideline (CTG) issued by us.
RACT is defined as the lowest emissions limitation that a particular
source is capable of meeting by the application of control technology
that is reasonably available considering technological and economic
feasibility (44 FR 53762, September 17, 1979). The CTG and Alternative
Control Technique (ACT) documents that we issue provide states with
guidance concerning what types of controls could constitute RACT for a
given source category. The documents we have issued pertaining to
storage tanks are (1) Control of Volatile Organic Emissions from
Storage of Petroleum Liquids in Fixed-Roof Tanks (EPA-450/2-77-036,
December 1977), (2) Control of Volatile Organic Emissions from
Petroleum Liquid Storage in External Floating Roof Tanks (EPA-450/2-78-
047, December 1978) and (3) Alternative Control Techniques Document--
Volatile Organic Liquid Storage In Floating and Fixed Roof Tanks (EPA-
453/R-94-001, January 1994). These documents are accessible online at
www.epa.gov/airquality/ozonepollution/SIPToolkit/ctgs.html. Because the
DFW area was classified as a serious ozone nonattainment area, a major
source is a source having the potential to emit 50 tpy of VOC or more
(CAA 182(c)). Because the HGB area is classified as a severe ozone
nonattainment area, a major source is a source having the potential to
emit 25 tpy of VOC or more (CAA 182(d)).

II. EPA's Evaluation

    VOC flash emissions occur during transfer of the VOCs from a higher
pressure storage tank to a lower pressure tank, reservoir, or other
container. Floating roof landing loss emissions occur when the liquid
level in a floating roof tank is lowered and the roof rests (lands) on
the legs, or supports, rather than on the liquid, severely limiting the
VOC control efficiency of the floating roof. The storage tank
requirements, to control flash emissions, use low-leaking tank fittings
and further limit emissions from floating roof storage tanks were
previously implemented in the HGB area and approved by us as RACT (75
FR 15348, March 29, 2010). For the DFW area, we previously found that
Texas rules for storage tanks met RACT requirements (64 FR 3841,
January 26, 1999 and 74 FR 1903, January 14, 2009). The RACT rules must
address major sources that have the potential to emit 50 tpy of VOC or
more in the DFW area (serious area requirement) and 25 tpy of VOC or
more in the HGB area (severe area requirement).
    Our evaluation found that the revision to the Texas SIP (1)
improves the rules that were previously approved, (2) results in
additional VOC reductions in the DFW area and (3) ensures that RACT is
met for storage tanks with flash emissions in the DFW area and
continues to be met in the HGB area. Additionally we found that (1)
Texas adopted after reasonable notice and public hearing and (2)
approval would not interfere with any applicable requirement concerning
attainment and reasonable further progress or any other applicable
requirement of the CAA. A technical support document (TSD) was prepared
which details our evaluation. Our TSD may be accessed online at
www.regulations.gov, Docket No. EPA-R06-OAR-2012-0096.

III. Final Action

    We are approving a Texas SIP revision for control of VOC emissions
from storage tanks adopted on December 7, 2011, and submitted on
January 17, 2012. The revision (1) revises 30 TAC Sec. Sec.  115.110,
115.112-115.117, and 115.119 and (2) adds new 30 TAC Sec. Sec.  115.111
and 115.118. The revision (1) implements additional VOC controls for
storage tanks in the DFW area; (2) modifies VOC control requirements in
the DFW area, the BPA area, the HGB area and the counties of El Paso,
Gregg, Nueces and Victoria and (3) makes non-substantive changes to VOC
control provisions that apply in Aransas, Bexar, Calhoun, Matagorda,
San Patricio and Travis Counties. In addition, we find that this
revision implements serious area RACT controls for the VOC storage
source category in the DFW area for the 1997 ozone NAAQS and continues
to implement severe area RACT controls for this source category in the
HGB area.
    We are publishing this rule without prior proposal because we view
this as a non-controversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the SIP revision if relevant adverse
comments are received. This rule will be effective on November 10, 2014
without further notice unless we receive relevant adverse comment by
October 9, 2014. If we receive relevant adverse comments, we will
publish a timely withdrawal in the Federal Register informing the
public that the rule will not take effect. We will address all public
comments in a subsequent final rule based on the proposed rule. We will
not institute a second comment period on this action. Any parties
interested in commenting must do so now. Please note that if we receive
relevant adverse comment on an amendment, paragraph, or section of this
rule and if that provision may be severed from the remainder of the
rule, we may adopt as final those provisions of the rule that are not
the subject of an adverse comment.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions

of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 10, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: August 22, 2014.
Samuel Coleman,
Acting Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart SS--Texas

0
2. In Sec.  52.2270 (c), the table titled ``EPA Approved Regulations in
the Texas SIP'' is amended by revising the entries for sections
115.110, 115.112 through 115.117, and 115.119 and adding in sequential
order new entries for sections 115.111 and 115.118.
    The amendments read as follows:

Sec.  52.2270  Identification of plan.

* * * * *
    (c) * * *

                                    EPA Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                       State approval/
         State citation              Title/subject        submittal      EPA approval date       Explanation
                                                            date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                  Chapter 115 (Reg 5)--Control of Air Pollution from Volatile Organic Compounds
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                             Subchapter B--General Volatile Organic Compound Sources
----------------------------------------------------------------------------------------------------------------
                                    Division 1: Storage of Organic Compounds
----------------------------------------------------------------------------------------------------------------
Section 115.110................  Applicability and          12/1/2011  9/9/2014 [Insert      ...................
                                  Definitions.                          Federal Register
                                                                        citation].
Section 115.111................  Exemptions..........       12/1/2011  9/9/2014 [Insert      ...................
                                                                        Federal Register
                                                                        citation].
Section 115.112................  Control Requirements       12/1/2011  9/9/2014 [Insert      ...................
                                                                        Federal Register
                                                                        citation].
Section 115.113................  Alternate Control          12/1/2011  9/9/2014 [Insert      ...................
                                  Requirements.                         Federal Register
                                                                        citation].
Section 115.114................  Inspection                 12/1/2011  9/9/2014 [Insert      ...................
                                  Requirements.                         Federal Register
                                                                        citation].
Section 115.115................  Monitoring                 12/1/2011  9/9/2014 [Insert      ...................
                                  Requirements.                         Federal Register
                                                                        citation].
Section 115.116................  Testing Requirements       12/1/2011  9/9/2014 [Insert      ...................
                                                                        Federal Register
                                                                        citation].

Section 115.117................  Approved Test              12/1/2011  9/9/2014 [Insert      ...................
                                  Methods.                              Federal Register
                                                                        citation].
Section 115.118................  Recordkeeping              12/1/2011  9/9/2014 [Insert      ...................
                                  Requirements.                         Federal Register
                                                                        citation].
Section 115.119................  Compliance Schedules       12/1/2011  9/9/2014 [Insert      ...................
                                                                        Federal Register
                                                                        citation].

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

* * * * *
[FR Doc. 2014-21306 Filed 9-8-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 133 (Thursday, July 13, 2023)]
[Notices]
[Pages 44798-44799]
[FR Doc No: 2023-14861]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-2336-000]

Vineyard Wind 1 LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Vineyard Wind 1 LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene, or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 27, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC

20426. Hand delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 7, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-14861 Filed 7-12-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 213 (Monday, November 6, 2023)]
[Rules and Regulations]
[Pages 76122-76123]
[FR Doc No: 2023-24353]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-0916; Airspace Docket No. 22-AAL-85]
RIN 2120-AA66

Revocation of Alaskan Very High Frequency Omnidirectional Range
(VOR) Federal Airway V-318; Level Island, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action revokes Alaskan VOR Federal Airway V-318 in the
vicinity of Level Island, AK. The FAA is taking this action due to the
airway's lack of use.

DATES: Effective date 0901 UTC, January 25, 2024. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11H, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Steven Roff, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the route structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System (NAS).

History

    The FAA published an NPRM for Docket No. FAA 2023-0916 in the
Federal Register (88 FR 23597; April 18, 2023), proposing to revoke
Alaskan VOR Federal Airway V-318. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal. No comments were received.

Incorporation by Reference

    Alaskan VOR Federal Airways are published in paragraph 6010 of FAA
Order JO 7400.11, Airspace Designations and Reporting Points, which is
incorporated by reference in 14 CFR 71.1 on an annual basis. This
document amends the current version of that order, FAA Order JO
7400.11H, dated August 11, 2023, and effective September 15, 2023.
These updates will be published in the next update to FAA Order JO
7400.11. That order is publicly available as listed in the ADDRESSES
section of this document.
    FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by revoking Alaskan VOR Federal
Airway V-318 in its entirety.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of revoking Federal Airway
V-318 and replacing it with existing route T-269 in the vicinity of
Level Island, AK qualifies for categorical exclusion under the National
Environmental Policy Act (42 U.S.C. 4321 et seq.) and its implementing
regulations at 40 CFR part 1500, and in accordance with FAA Order
1050,1F, Environmental Impacts: Policies and Procedures, paragraph 5-6-
5a, which categorically excludes from further environmental impact
review rulemaking actions that designate or modify classes of airspace
areas, airways, routes, and reporting points (see 14 CFR part 71,
Designation of Class A, B, C, D and E Airspace Areas; Air Traffic
Service Routes; and Reporting Points); and paragraph 5-6.5.k., which
categorically excludes from further environmental review the
publication of existing air traffic control procedures that do not
essentially change existing tracks, create new tracks, change altitude,
or change concentration of aircraft on these tracks. As such, this
action is not expected to result in in any potentially significant

environmental impacts. In accordance with FAA Order 1050.1f, paragraph
5-2 regarding Extraordinary Circumstances, the FAA has reviewed this
action for factors and circumstances in which a normally categorically
excluded action may have a significant environmental impact requiring
further analysis. Accordingly, the FAA has determined that no
extraordinary circumstances exist that warrant prepared of the
environmental impact statement.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11H, Airspace Designations and Reporting Points, dated August 11,
2023, and effective September 15, 2023, is amended as follows:

Paragraph 6010(b) Alaskan VOR Federal Airways

* * * * *

V-318 [Remove]

* * * * *

    Issued in Washington, DC, on September 25, 2023.
Karen L. Chiodini,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2023-24353 Filed 11-3-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56610-56612]
[FR Doc No: 2017-25774]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5625]

Recommendations for Dual 510(k) and Clinical Laboratory
Improvement Amendments Waiver by Application Studies; Draft Guidance
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Recommendations for
Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA)
Waiver by Application Studies.'' It describes study designs for
generating data that supports both 510(k) clearance and CLIA waived
categorization. Use of the Dual 510(k) and CLIA Waiver by Application
pathway is optional; however, FDA believes this pathway is in many
instances the least burdensome and fastest approach for manufacturers
to obtain a CLIA waived categorization in addition to 510(k) clearance
for new In Vitro Diagnostic (IVD) devices. FDA believes increased use
of this pathway will speed up the process of bringing simple and
accurate IVD devices to CLIA waived settings, which will better serve
patients and providers. This draft guidance is not final nor is it in
effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by January 29, 2018 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-2017-D-5625 for ``Recommendations for Dual 510(k) and CLIA Waiver
by Application Studies.'' 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 21CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Recommendations for Dual 510(k) and CLIA Waiver by Application
Studies'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Peter Tobin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5645, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In an application for CLIA waived categorization (CLIA Waiver by
Application) a manufacturer submits evidence to FDA that a test,
initially categorized as moderate complexity, meets the CLIA statutory
criteria for waiver, 42 U.S.C. 263a(d)(3), and requests that FDA
categorize the test as waived. Historically, CLIA Waiver by Application
has followed clearance or approval of an IVD test. This stepwise
approach currently remains the most utilized path by manufacturers. For
additional information, please see FDA's Guidance, ``Administrative
Procedures for CLIA Categorization'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070889).
    While a premarket notification (510(k)) and CLIA Waiver by
Application each include discrete elements not required in the other,
both submissions include comparison and reproducibility studies. For a
510(k), such studies are often performed by trained operators (i.e.,
laboratory professionals who meet the qualifications to perform
moderate complexity testing and with previous training in performing
the test; sometimes referred to as ``moderate complexity users''). For
a CLIA Waiver by Application, such studies must be conducted by
untrained operators (i.e., operators in waived settings with limited or
no training or hands on experience in conducting laboratory testing;
sometimes referred to as ``waived users'').
    An applicant may choose to conduct a single set of comparison and
reproducibility studies with untrained operators to satisfy associated
requirements for both 510(k) and CLIA Waiver by Application. To
streamline the review of such data, the Dual 510(k) and CLIA Waiver by
Application (Dual Submission) pathway, was established as part of the
Medical Device User Fee Amendments of 2012 (MDUFA III), allowing the
review of both a 510(k) and CLIA Waiver Application within a single
submission with a reduced overall review time.
    This guidance leverages FDA's experience implementing this pathway
in MDUFA III in order to make the Dual Submission pathway least
burdensome. Use of this guidance is expected to reduce study-related
costs and provide time savings for manufacturers of certain Class II
IVD devices intended for CLIA waived settings.

II. Significance of Guidance

    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
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.
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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available

at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
https://www.regulations.gov. Persons unable to download an electronic
copy of ``Recommendations for Dual 510(k) and CLIA Waiver by
Application Studies'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 16038 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR 54 have been approved under 0910-0396; the collections of
information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0755, the collections of information in 21 CFR 807
have been approved under 0910-0120; the collections of information in
the guidance document entitled ``Recommendations for Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications
for Manufacturers of In Vitro Diagnostic Devices'' have been approved
under 0910-0598, the collections of information in the guidance
document entitled ``Requests for Feedback on Medical Device
Submissions'' have been approved under 0910-0756; and the collections
of information in the guidance document entitled ``Administrative
Procedures for Clinical Laboratory Improvement Amendments of 1988
Categorization'' have been approved under 0910-0607.

    Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25774 Filed 11-28-17; 8:45 am]
 BILLING CODE 4164-01-P