[Federal Register Volume 81, Number 124 (Tuesday, June 28, 2016)]
[Notices]
[Pages 42024-42027]
[FR Doc No: 2016-15177]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78129; File No. SR-Phlx-2016-67]

Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to the
Risk Monitor Mechanism

June 22, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 9, 2016, NASDAQ PHLX LLC (``Exchange'') filed with the
Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I and II 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 proposes to proposal to amend Rule 1095, entitled
``Automated Removal of Quotes.''
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 1095, entitled ``Automated
Removal of Quotes'' to modify the minimum Specified Percentage (as
described below) determined by a Market Maker \3\ to enable a Market

Maker to enhance their risk management for an underlying security as
market conditions warrant, based on their own risk tolerance level and
quoting behavior. The manner in which Rule 1095 operates is not being
amended in this rule change. The Exchange proposes to permit the Market
Maker to set the Specified Percentage more broadly, at not less than 1%
with this rule change. The Exchange also proposes to memorialize the
definition of disseminated size in the rule text.
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    \3\ Market Makers include Specialists and Registered Options
Traders or ``ROTs.'' An ROT is defined in Exchange Rule 1014(b) as a
is a regular member or a foreign currency options participant of the
Exchange located on the trading floor who has received permission
from the Exchange to trade in options for his own account. A ROT
includes Streaming Quote Traders or ``SQTs'' and Remote Streaming
Quote Traders or ``RSQTs'' as well as on and off-floor ROTS. An SQT
is defined in Exchange Rule 1014(b)(ii)(A) as an ROT who has
received permission from the Exchange to generate and submit option
quotations electronically in options to which such SQT is assigned.
An RSQT is defined in Exchange Rule in 1014(b)(ii)(B) as an ROT that
is a member affiliated with an RSQTO with no physical trading floor
presence who has received permission from the Exchange to generate
and submit option quotations electronically in options to which such
RSQT has been assigned. A Remote Streaming Quote Trader Organization
or ``RSQTO,'' which may also be referred to as a Remote Market
Making Organization (``RMO''), is a member organization in good
standing that satisfies the RSQTO readiness requirements in Rule
507(a). RSQTs may also be referred to as Remote Market Markers
(``RMMs'').
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Background
    Today, Rule 1095 permits Market Makers to monitor risk arising from
multiple executions across multiple options series of a single
underlying security. A Market Maker may provide a specified time period
and a specified percentage by which the Exchange's Phlx XL System
(``System'') will automatically remove a Market Maker's quotes in all
series of an underlying security submitted through designated Phlx
protocols, as specified by the Exchange, during a specified time period
not to exceed 15 seconds (``Percentage-Based Specified Time
Period'').\4\
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    \4\ A specified time period commences for an option when a
transaction occurs in any series in such option.
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    For each series in an option, the System determines: (i) The
percentage that the number of contracts executed in that series
represents relative to the Market Maker's disseminated \5\ size of each
side in that series (``Series Percentage''); and (ii) the sum of the
Series Percentage in the option issue (``Issue Percentage''). The
System tracks and calculates the net impact of positions in the same
option issue during the Percentage-Based Specified Time Period. The
System tracks transactions, i.e., the sum of buy-side put percentages,
the sum of sell-side put percentages, the sum of buy-side call
percentages, and the sum of sell-side call percentages, and then
calculates the absolute value of the difference between the buy-side
puts and the sell-side puts plus the absolute value of the difference
between the buy-side calls and the sell-side calls. If the Issue
Percentage, rounded to the nearest integer, equals or exceeds a
percentage established by the Market Maker, not less than 100%
(``Specified Percentage''), the System automatically removes a Market
Maker's quotes in all series of an underlying security submitted
through designated Phlx protocols, as specified by the Exchange, during
the Percentage-Based Specified Time. The Exchange counts Specialized
Quote Feed (``SQF'') \6\ quotes only in determining the number of
contracts traded and removed by the System.
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    \5\ The disseminated size is the original size quoted by the
Market Maker.
    \6\ SQF permits the receipt of quotes. SQF Auction Responses and
market sweeps are also not included.
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    The Percentage-Based Specified Time Period commences for an option
every time an execution occurs in any series in such option and
continues until the System removes quotes as described in current Rule
1095(iv) or (v) or the Percentage-Based Time Period expires. The
Percentage-Based Specified Time Period operates on a rolling basis
among all series in an option in that there may be multiple Percentage-
Based Specified Time Periods occurring simultaneously and such
Percentage-Based Specified Time periods may overlap.
Proposal
    The Exchange proposes to lower the Specified Percentage from 100%
to 1%. The proposal would provide that if the Issue Percentage, rounded
to the nearest integer, equals or exceeds a percentage established by
the Market Maker, not less than 1% (``Specified Percentage''), the
System automatically removes a Market Maker's quotes in all series of
an underlying security submitted through designated Phlx protocols, as
specified by the Exchange, during the Percentage-Based Specified Time.
This proposal would allow a Market Maker to establish a Specified
Percentage at any percentage level no less than 1% for an option in
which the Market Maker is appointed. Today, the Specified Percentage
would be set at greater than or equal to 100%. This amendment will
allow Market Makers to better manage their risk and assist them to
avoid trading a number of contracts that exceeds the Marker Maker's
risk tolerance level across multiple series of a single underlying when
such series are executed in rapid succession.
    Market Makers will be able to more precisely customize their risk
management within the System, taking into account such factors as
present and anticipated market conditions, news in an option sudden
change in volatility of an option without any limitation regarding the
Specified Percentage. Market Makers will be able to adopt more precise
controls based on the Market Maker's risk tolerance level.
    Market Makers must utilize either the Percentage-Based \7\ or
Volume-Based risk controls. Market Makers must contact Market
Operations to set their percentage and specified time period.
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    \7\ Market Makers selecting the Percentage-Based risk control in
Rule 1095(i) are required to provide a specified time period, up to
15 seconds, and a specified percentage with a number of 1% or
greater, as proposed herein, to the Market Operations staff to
select this risk control. If a Market Maker does not desire to
utilize the Percentage-Based risk control the Market Maker must
utilize the Volume-Based risk control. Market Makers must set-up
their risk control settings initially, when they become a Phlx
Market Maker, and then subsequent changes by contacting Market
Operations.
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    By way of example, if a Market Maker has a rapid fire percentage
setting of 50% and a Specified Time Period of 15 seconds and the Order
Book reflects:

    MM1 has a displayed quote of 1.10 (100) x 1.20 (100) for IBM May
20, 2016 70 puts and MM1 is the only displayed size on Phlx and an
order is submitted to buy 75 IBM May 20, 2016 70 Puts for 1.20
    Rule 1095 would:
    (1) Provide MM1 with an execution--Sld 75 @ 1.20; and
    (2) Trigger the Percentage-Based Threshold and remove MM1's
quotes in IBM.

    Another example is with multiple executions. Presume MM1 has a
rapid fire percentage setting of 80% by 5 seconds and MM1 has a
displayed quote of 2.00 (100) x 2.25 (100) for IBM May 20, 2016 70 puts
and he is the only displayed size on the Phlx. Also, presume an order
comes in to buy 50 IBM May 20, 2016 70 puts for 2.25. The following
executions would result:

MM1 receives an execution Sold 50 @2.25
MM1 quote updates to 2.00 (100) x 2.25 (50)
Within 1 second an order comes in to buy 45 IBM May 20, 2016 70 puts
for 2.25
MM1 receives an execution Sold 45 @2.25
MM1 receives rapid fire for IBM

    The Exchange also proposes to memorialize the definition of
disseminated size, which is the original size quoted by the Market
Maker, within Rule 1095.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(5) of the Act \9\ in particular, 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.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    Market Makers are obligated to submit continuous two-sided
quotations in a

certain number of series in their appointed option classes for a
certain percentage of each trading session,\10\ rendering them
vulnerable to risk from unusual market condition, volatility in
specific options, and other market events that may cause them to
receive multiple, extremely rapid automatic executions before they can
adjust their quotations and overall risk exposure in the market.
Without adequate risk management tools in place on the Exchange, the
incentive for Market Makers to quote aggressively, respecting both
price and size could be diminished. Such a result may undermine the
quality of the markets, which are enhanced by the depth and liquidity
such Market Makers provide in the marketplace.
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    \10\ See Rule 1014 titled ``Obligations and Restrictions
Applicable to Specialists and Registered Options Traders.''
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    By allowing the percentage to be reduced from 100% to 1%, the
Exchange provides its Market Makers the desired flexibility to take
into account such factors as present and anticipated market conditions,
news in an option or sudden change in volatility of an option without
any limitation regarding the Specified Percentage. This should
encourage Market Makers to provide additional depth and liquidity to
the Exchange's markets, thereby removing impediments to and perfecting
the mechanisms of a free and open market and a national market system
and, in general, protecting investors and the public interest.
    The proposal is consistent with the Act because the reduction of
the Specified Percentage to not less than 1% provides more alternatives
to Market Makers in setting their percentage without impacting their
firm quote obligations. The System operates consistently with the firm
quote obligations of a broker-dealer pursuant to Rule 602 of Regulation
NMS. Specifically, with respect to Market Makers, their obligation to
provide continuous two-sided quotes on a daily basis is not diminished
by the removal of such quotes by the Percentage-Based Threshold. Market
Makers are required to provide continuous two-sided quotes on a daily
basis.\11\ Market Makers that utilize the Percentage-Based Threshold
will not be relieved of the obligation to provide continuous two-sided
quotes on a daily basis, nor will it prohibit the Exchange from taking
disciplinary action against a Market Maker for failing to meet the
continuous quoting obligation each trading day. All quotes entered into
the System are considered firm. Quotes will only be removed from the
System once the Percentage-Based Threshold has been met if the quote
was not otherwise executed by an incoming order.
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    \11\ Id.
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    This risk feature will continue to remove impediments to and
perfect the mechanism of a free and open market and a national market
system and protect investors and the public interest by allowing Market
Makers to remove their quotes in the event that market conditions
warrant, based on their own risk tolerance level. Market Makers provide
liquidity to the market place and have obligations unlike other market
participants.\12\ This risk feature is important because it will enable
Market Makers to manage their exposure at the Exchange. Further,
permitting a broader setting would continue to allow Market Makers to
have flexibility in setting their risk exposure to prevent unintended
triggers of the Percentage-Based Threshold and it continues to allow
Market Makers to set a Specified Time Period. Each Market Maker has
different levels of sensitivity and their own system safeguards as
well. The proposed setting would permit each Market Maker to select a
setting that is appropriate to capture the needs of that Market Maker.
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    \12\ Id.
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    Further, it is important to note that any interest that is
executable against a Market Maker's quotes that is received \13\ by the
Exchange prior to the trigger of the Percentage-Based Threshold, which
is processed by the System, automatically executes at the price up to
the Market Maker's size. Further, the Purge Notification Message is
accepted by the System in the order of receipt in the queue and is
processed in that order so that interest that is already accepted into
the System is processed prior to the message.
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    \13\ The time of receipt for an order or quote is the time such
message is processed by the Exchange book.
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    The Exchange notes that Miami International Securities Exchange,
LLC (``MIAX'') implemented a rule which changed its Allowable
Engagement Percentage from 100% to any percentage established by the
Market Maker.\14\ The Phlx rule is similar to MIAX in that a member is
required to have a setting, although MIAX has a default setting in
place in the instance that no percentage is provided. Market Makers
that select the Percentage-Based risk tool must provide the Exchange
with a specified time period and a percentage greater than or equal to
1%.
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    \14\ See Securities Exchange Act Release No. 77817 (May 12,
2016), 81 FR 31286 (May 18, 2016) (SR-MIAX-2016-10).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Percentage-Based Threshold
is meant to protect Market Makers from inadvertent exposure to
excessive risk. This proposal will foster competition by providing
Exchange Market Makers with the ability to enhance and customize their
percentage in order to compete for executions and order flow.
Specifically, the proposal does not impose a burden on intra-market or
inter-market competition, rather, it provides Market Makers with the
opportunity to avail themselves of similar risk tools which are
currently available on other exchanges.\15\ Market Makers quote across
many series in an option creating the possibility of ``rapid fire''
executions that can create large, unintended principal positions that
expose Market Makers. The Percentage-Based Threshold permits Market
Makers to monitor risk arising from multiple executions across multiple
options series of a single underlying security.
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    \15\ See Section 8 of the 19b-4.
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    The Exchange is proposing this rule change to continue to permit
Market Makers to reduce their risk in the event the Market Maker is
suffering from a system issue or due to the occurrence of unusual or
unexpected market activity. Reducing such risk will enable Market
Makers to enter quotations without any fear of inadvertent exposure to
excessive risk, which in turn will benefit investors through increased
liquidity for the execution of their orders. Reducing risk by utilizing
the proposed risk protections enables Market Makers, specifically, to
enter quotations with larger size, which in turn will benefit investors
through increased liquidity for the execution of their orders. Such
increased liquidity benefits investors because they receive better
prices and because it lowers volatility in the options market.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \16\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\17\ The Exchange has
requested that the Commission waive the thirty-day operative delay so
that the proposal may become operative immediately. The Commission
believes that waiving the thirty-day operative delay is consistent with
the protection of investors and the public interest. The Exchange
proposes to change a setting in an existing risk protection feature to
enhance market makers' ability to protect against excessive risk
arising from multiple executions across multiple options series of a
single underlying security. The Commission notes that another options
exchange currently has a similar setting for a like risk protection
feature for market makers. Therefore, the Commission hereby waives the
thirty-day operative delay and designates the proposal effective upon
filing.\18\
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    \16\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \17\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
    \18\ For purposes of waiving the 30-day operative delay, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
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    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2016-67 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-Phlx-2016-67. 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 Web site (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 Web site 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2016-67, and should be
submitted on or before July 19, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-15177 Filed 6-27-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Rules and Regulations]
[Page 55214]
[FR Doc No: 2013-21924]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2013-0723]

Annual Marine Events in the Eighth Coast Guard District, Sabine
River; Orange, TX

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce Special Local Regulations for the
Southern Professional Outboard Racing Tour (S.P.O.R.T.) boat races to
be held on the Neches River in Orange, TX from 3 p.m. on September 20,
2013, through 6 p.m. on September 22, 2013. This action is necessary to
provide for the safety of the participants, crew, spectators,
participating vessels, non-participating vessels and other users of the
waterway. During the enforcement period no person or vessel may enter
the zone established by the Special Local Regulation without permission
of the Captain of the Port (COTP) Port Arthur or his designated on-
scene Patrol Commander.

DATES: The regulation in 33 CFR 100.801 will be enforced from 3 p.m. to
6 p.m. on September 20, 2013; and from 9 a.m. to 6 p.m. on September 21
and 22, 2013.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
of enforcement, call or email Mr. Scott Whalen. U.S. Coast Guard Marine
Safety Unit Port Arthur, TX; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce Special Local
Regulation for the annual S.P.O.R.T. boat races in 33 CFR 100.801(60)
on September 21, 2012, from 3 p.m. to 6 p.m. and on September 22 and
23, 2012 from 9 a.m. to 6 p.m.
    Under the provisions of 33 CFR 100.801, a vessel may not enter the
regulated area, unless it receives permission from the Captain of the
Port or his designated on-scene Patrol Commander. Spectator vessels may
safely transit outside the regulated area but may not anchor, block,
loiter, or impede participants or official patrol vessels. The Coast
Guard may be assisted by other federal, state or local law enforcement
agencies in enforcing this regulation.
    This notice is issued under authority of 33 CFR 100.801 and 33
U.S.C. 1233. In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with notification of
this enforcement period via Local Notice to Mariners, Marine
Information Broadcasts, and Marine Safety Information Bulletins.
    If the Captain of the Port or his designated on-scene Patrol
Commander determines that the regulated area need not be enforced for
the full duration stated in this notice, he or she may use a Broadcast
Notice to Mariners to grant general permission to enter the regulated
area.

    Dated: July 30, 2013.
G.J. Paitl,
Captain, U.S. Coast Guard, Captain of the Port, Port Arthur.
[FR Doc. 2013-21924 Filed 9-9-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14224-14225]
[FR Doc No: 2017-05302]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0117]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Providing Information
About Pediatric Uses of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by April
17, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0762.
Also include the FDA docket number found in brackets in the heading of
this document.

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

Providing Information About Pediatric Uses of Medical Devices Under
Section 515A of the Federal Food, Drug, and Cosmetic Act

OMB Control Number 0910-0762--Extension

    The guidance document entitled ``Providing Information About
Pediatric Uses of Medical Devices--Guidance for Industry and Food and
Drug Administration Staff'' suggests that applicants who submit certain
medical device applications include, if readily available, pediatric
use information for diseases or conditions that the device is being
used to treat, diagnose, or cure that are outside the device's approved
or proposed indications for use, as well as an estimate of the number
of pediatric patients with such diseases or conditions. The information
submitted will allow FDA to identify pediatric uses of devices outside
their approved or proposed indication for use to determine areas where
further pediatric device development could be useful. This
recommendation applies to applicants who submit the following
applications: (1) Any request for a humanitarian device exemption
submitted under section 520(m) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360j(m)); (2) any premarket approval
application (PMA) or supplement to a PMA submitted under section 515 of
the FD&C Act (21 U.S.C. 360e); and (3) any product development protocol
submitted under section 515 of the FD&C Act.
    Respondents are permitted to submit information relating to uses of
the device outside the approved or proposed indication if such uses are
described or acknowledged in acceptable sources of readily available
information. We estimate that 20 percent of respondents submitting
information required by section 515A of the FD&C Act will choose to
submit this information and that it will take 30 minutes for them to do
so.
    In the Federal Register of December 5, 2016 (81 FR 87575), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                   Number of
                 Description                      Number of      responses per     Total annual        Average burden per response         Total hours
                                                 respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uses outside approved indication.............             148                1              148   0.5 (30 minutes).....................              74
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05302 Filed 3-16-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Rules and Regulations]
[Pages 32239-32241]
[FR Doc No: 2016-11965]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2015-0783; FRL-9946-66-Region 6]

Approval and Promulgation of Implementation Plans; Arkansas; New
Mexico; Oklahoma; Disapproval of Greenhouse Gas Biomass Deferral, Step
2 and Minor Source Permitting Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is disapproving
severable portions of the February 6, 2012 Oklahoma State
Implementation Plan (SIP) submittal that are inconsistent with federal
laws based on recent decisions by the United States Courts and
subsequent EPA rulemaking. This submittal established Minor New Source
Review permitting requirements for greenhouse gas (GHG) emissions and
includes Prevention of Significant Deterioration (PSD) permitting
provisions for sources that are classified as major, and, thus,
required to obtain a PSD permit, based solely on their potential GHG
emissions. The PSD permitting provisions also require a PSD permit for
modifications of otherwise major sources because they increased only
GHG emissions above applicable levels. Additionally, we are
disapproving severable portions of SIP submittals for the States of
Arkansas, New Mexico, and Oklahoma addressing the EPA's July 20, 2011
rule deferring PSD requirements for carbon dioxide (CO2)
emissions from bioenergy and other biogenic sources (``Biomass
Deferral''). We are disapproving the provisions adopting the Biomass
Deferral because they are no longer consistent with federal laws and
regulations. The EPA is finalizing this disapproval under section 110
and part C of the Clean Air Act (Act or CAA).

DATES: This rule is effective on June 22, 2016.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2015-0783. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy. Publicly available docket materials are available
either electronically through http://www.regulations.gov or in hard
copy at EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-
2733.

FOR FURTHER INFORMATION CONTACT: Ms. Adina Wiley,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' means the EPA.

I. Background

    The background for this action is discussed in detail in our
January 11, 2016 proposal. See 81 FR 1141. In that document we proposed
to disapprove severable portions of the February 6, 2012 Oklahoma SIP
submittal establishing GHG permitting requirements for minor sources
and for sources that are classified as major, and thus, required to
obtain a PSD permit based solely on their potential GHG emissions
(referred to as ``Step 2'' PSD sources in our proposed action) because
we determined that these revisions to the Oklahoma SIP establish
permitting requirements that are inconsistent with federal laws
resulting from recent decisions by United States Courts. We also
proposed to disapprove severable portions of the November 6, 2012
Arkansas SIP submittal, the January 8, 2013 New Mexico SIP, and the
January 18, 2013 Oklahoma SIP submittal that include the Biomass
Deferral in the Arkansas, New Mexico, and Oklahoma PSD programs. Our
analysis found that these revisions to the Arkansas, New Mexico, and
Oklahoma SIPs should be disapproved because adoption or implementation
of these provisions is no longer consistent with federal laws and
regulations for PSD permitting.

II. Response to Comments

    We received one comment on our proposed action. Our response to the
submitted comment is provided below.
    Comment: One commenter stated that ``not requiring states to
continue step two of the permitting for GHG as a major source thus
requiring a PSD or Title V permit is the right decisions based on
law.'' Additionally, the commenter stated that ``GHG emission issues
would be better addressed in it's [sic] own statute rather than having
the supreme court [sic] dictate the regulatory framework of GHG
emissions.''
    Response: We acknowledge the support of the commenter in finding
that our proposed disapproval action is consistent with current law.
GHG

emissions are regulated under the CAA \1\ and the CAA includes
provisions for citizens, states, and regulated entities to seek
judicial review of EPA's final regulatory decisions.\2\ Therefore our
current action to disapprove the Step 2 permitting requirements is
consistent with current law and is consistent with the statutory
requirements of the CAA.
---------------------------------------------------------------------------

    \1\ See section 160 of the Act and the Act's implementing
regulations at 40 CFR 52.21.
    \2\ See section 307 of the Act.
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III. Final Action

    We are taking this final action under section 110 and part C of the
Act; as such, we are not imposing sanctions as a result of this
disapproval. This final disapproval does not require the EPA to
promulgate a Federal Implementation Plan because we are finding that
the submitted provisions are inconsistent with federal laws for the
regulation and permitting of GHG emissions.
    We are disapproving the following severable portions of the
February 6, 2012 Oklahoma SIP submittal that establish GHG permitting
requirements for minor sources and Step 2 PSD:
     Substantive revisions to the Oklahoma SIP establishing
Minor NSR GHG permitting requirements at OAC 252:100-7-2.1 as submitted
on February 6, 2012; and
     Substantive revisions to the Oklahoma PSD program in OAC
252:100-8-31 establishing PSD permitting requirements for Step 2
sources at paragraph (E) of the definition of ``subject to regulation''
as submitted on February 6, 2012.
    We are also disapproving as inconsistent with federal laws and
regulations for PSD permitting, severable portions of the following SIP
submittals that include the Biomass Deferral:
     Substantive revisions to the Arkansas SIP definition of
``CO2 Equivalent Emissions'' at Regulation 19, Chapter 2 to
implement the Biomass Deferral as submitted on November 6, 2012;
     Substantive revisions to the New Mexico SIP definition of
``Subject to Regulation'' at <IP_ADDRESS> (AZ)(2)(a) NMAC to implement the
Biomass Deferral as submitted on January 8, 2013; and
     Substantive revisions to the Oklahoma SIP definitions of
``carbon dioxide equivalent emissions'' at OAC 252:100-1-3 and
``subject to regulation'' at OAC 252:100-8-31 as submitted on January
18, 2013.
    As a result of the final disapproval actions listed above, the EPA
is also updating the ``Approval status'' section of the Arkansas SIP at
40 CFR 52.172, New Mexico SIP at 40 CFR 52.1622, and Oklahoma SIP at 40
CFR 52.1922. Additionally, we are renumbering 40 CFR 52.172 of the
Arkansas SIP for consistency.

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, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. We have concluded that
the state choices under review in this action do not meet the criteria
of the CAA. Accordingly, this action disapproves state law as not
meeting Federal requirements for the regulation and permitting of GHG
emissions.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA. There is no burden imposed under the PRA because this action
disapproves submitted revisions that are no longer consistent with
federal laws for the regulation and permitting of GHG emissions.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. This action
disapproves submitted revisions that are no longer consistent with
federal laws for the regulation and permitting of GHG emissions, and
therefore will have no impact on small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector. This action
disapproves submitted revisions that are no longer consistent with
federal laws for the regulation and permitting of GHG emissions, and
therefore will have no impact on small governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This action disapproves provisions of state law
that are no longer consistent with federal laws for the regulation and
permitting of GHG emissions; there are no requirements or
responsibilities added or removed from Indian Tribal Governments. Thus,
Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it disapproves state permitting
provisions that are inconsistent with federal laws for the regulation
and permitting of GHG emissions.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse

human health or environmental effects on minority, low-income or
indigenous populations. This action is not subject to Executive Order
12898 because it disapproves state permitting provisions that are
inconsistent with federal laws for the regulation and permitting of GHG
emissions.
    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. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 22, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purpose 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, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: May 11, 2016.
Ron Curry,
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 E--Arkansas

0
2. Section 52.172 is revised to read as follows:

Sec.  52.172  Approval status.

    With the exceptions set forth in this subpart, the Administrator
approves Arkansas's state implementation plan under section 110 of the
Clean Air Act. Furthermore, the Administrator finds that the plan
satisfies all applicable requirements of Parts C and D, Title I, of the
Clean Air Act as amended in 1990, except as noted below.
    (a) 1997 PM2.5 NAAQS: The SIP submitted March 28, 2008
is disapproved for CAA element 110(a)(2)(D)(ii).
    (b) 2006 PM2.5 NAAQS: The SIPs submitted March 28, 2008
and September 16, 2009 are disapproved for CAA element
110(a)(2)(D)(ii).
    (c) GHGs: The revisions to the Arkansas SIP definition of
``CO2 Equivalent Emissions'' at Regulation 19, Chapter 2 to
implement the GHG Biomass Deferral as submitted on November 6, 2012 are
disapproved.

Subpart GG--New Mexico

0
3. Section 52.1622 is revised to read as follows:

Sec.  52.1622  Approval status.

    With the exceptions set forth in this subpart, the Administrator
approves New Mexico's state implementation plan under section 110 of
the Clean Air Act. Furthermore, the Administrator finds that the plan
satisfies all applicable requirements of Parts C and D, Title I, of the
Clean Air Act as amended in 1990, except as noted below.
    (a) The revisions to the New Mexico SIP definition of ``Subject to
Regulation'' at <IP_ADDRESS> (AZ)(2)(a) NMAC to implement the GHG Biomass
Deferral as submitted on January 8, 2013 are disapproved.
    (b) [Reserved]

Subpart LL--Oklahoma

0
4. Section 52.1922 is revised to read as follows:

Sec.  52.1922  Approval status.

    With the exceptions set forth in this subpart, the Administrator
approves Oklahoma's state implementation plan under section 110 of the
Clean Air Act. Furthermore, the Administrator finds that the plan
satisfies all applicable requirements of Parts C and D, Title I, of the
Clean Air Act as amended in 1990, except as noted below.
    (a) Revisions to the Oklahoma SIP establishing Minor NSR GHG
permitting requirements at OAC 252:100-7-2.1 as submitted on February
6, 2012.
    (b) Revisions to the Oklahoma PSD program in OAC 252:100-8-31
establishing PSD permitting requirements for sources that are
classified as major and thus required to obtain a PSD permit based
solely on their potential GHG emissions (``Step 2 sources'') at
paragraph (E) of the definition of ``subject to regulation'' as
submitted on February 6, 2012.
    (c) Revisions to the Oklahoma SIP definitions of ``carbon dioxide
equivalent emissions'' at OAC 252:100-1-3 and ``subject to regulation''
at OAC 252:100-8-31 to implement the GHG Biomass Deferral as submitted
on January 18, 2013.

[FR Doc. 2016-11965 Filed 5-20-16; 8:45 am]
 BILLING CODE 6560-50-P