[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Notices]
[Page 41991]
[FR Doc No: 2013-16677]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2013-0051]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated May 6, 2013, the Erie Lackawanna Dining Car Preservation Society
(ELDCPS) has petitioned the Federal Railroad Administration (FRA) for a
waiver of compliance from certain provisions of the Federal railroad
safety regulations contained at 49 CFR section 223.15, Requirements for
existing passenger cars. FRA assigned the petition Docket Number FRA-
2013-0051.
    This petition relates to the operation of a sleeping car, ``The
City of Lima,'' Reporting Mark RPCX 211. The petitioner is requesting
permission to continue to operate the car that does not have window
glazing meeting the requirements of 49 CFR 223.15. This car is
interchanged with railroads operating on the general system, moved
short distances over freight railroads for storage when not in use, and
operated behind Amtrak passenger trains or in special trains made up of
similar passenger cars. ELDCPS is a not-for-profit corporation,
incorporated in the State of New Jersey since 2001.
    The private passenger car fleet is a small fraction of the total
passenger fleet operating in the country, and continues to have an
excellent safety record, due in part to the operating characteristics
and the operating environment of the cars. Operation of this private
passenger car has been injury-free as related to window glazing for the
past 20 years, and the car has operated in the service described in
this petition since 2008.
    Specifically, Car RPCX 211 was built by Pullman Standard in
February 1950 and is equipped with 20 Adams & Westlake 64
sash, double-glazed, 30'' x 42'' side windows with a mixture of
unmarked polycarbonate and automotive-type, windshield-grade, laminated
safety glass. FRA Type II polycarbonate glazing is present in the
vestibule's Dutch doors, but is badly hazed. Carbody end-door windows
are unmarked polycarbonate.
    ELDCPS seeks relief from the glazing requirements for operation of
this passenger car for short distances over freight lines, behind
Amtrak passenger trains, or in special trains made up of similar
passenger cars. Typically, these cars are operated over scenic, long-
distance routes through rural countryside, which are low-risk areas for
window damage or breakage. The car is operated at a maximum track
speed, as authorized by the railroad that is controlling the movement.
    Since ELDCPS purchased RPCX 211, in 2007, FRA has not received any
reports of personal injuries involving the operation of this equipment
as the result of the presently installed noncompliant glazing. There
have not been any acts of vandalism to this car while in storage or in
operation. When not in use, this equipment is stored at a private
siding on the Delaware-Lackawanna Railroad in Scranton, PA.
    ELDCPS has a current and feasible emergency egress plan for this
car. The plan includes four, clearly marked emergency exit windows,
emergency battery lights throughout the car, and standard emergency
tools in a well-marked cabinet near Bedroom A in the hallway.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Ave. SE.,
W12-140, Washington, DC 20590. The Docket Operations Facility is open
from 9 a.m. to 5 p.m., Monday through Friday, except Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by August 26, 2013 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2013-16677 Filed 7-11-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Page 70675]
[FR Doc No: 2016-24726]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL17-2-000]

Arizona Public Service Company; Pinnacle West Capital
Corporation; Notice of Petition for Declaratory Order

    Take notice that on September 7, 2016, pursuant to Rule 207 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure,\1\ Arizona Public Service Company (APS) and Pinnacle
West Capital Corporation (Pinnacle West) filed a petition for
declaratory order concerning the treatment of certain funds that APS
and its parent company, Pinnacle West, have placed in trust to fund
future Post-Employment Benefits other than Pensions liabilities, all as
more fully explained in the petition.
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    \1\ 18 CFR 385.207(a)(2) (2016).
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    Any person desiring to intervene or to protest in this proceeding
must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
will be considered by the Commission in determining the appropriate
action to be taken, but will not serve to make protestants parties to
the proceeding. Any person wishing to become a party must file a notice
of intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    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 should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above proceeding are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on November 7, 2016.

    Dated: October 6, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-24726 Filed 10-12-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Rules and Regulations]
[Pages 60803-60805]
[FR Doc No: 2015-25557]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0880]
RIN 1625-AA87

Security Zone: Escorted Vessels, Los Angeles-Long Beach, CA,
Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Interim rule and request for comments.

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SUMMARY: The Coast Guard is establishing a security zone around any
vessel escorted by one or more Coast Guard, State, or local law
enforcement assets on the navigable waters of the Captain of the Port
(COTP) Zone, Los Angeles-Long Beach, California. This action is
necessary to protect personnel, vessels, and facilities from sabotage
or other subversive acts, accidents, or other events of a similar
nature. No vessel or person is allowed in this zone unless authorized
by the Captain of the Port or a designated representative.

DATES: This rule is effective without actual notice from October 8,
2015. For the purposes of enforcement, actual notice will be used from
September 18, 2015, until October 8, 2015.
    Comments and related material must be received by the Coast Guard
on or before December 17, 2015. Requests for public meetings must be
received by the Coast Guard on or before November 18, 2015.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-0880 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Jevon James, Waterways Management, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. We encourage you to submit comments through the Federal
eRulemaking Portal at http://www.regulations.gov. If your material
cannot be submitted using http://www.regulations.gov, contact the
person in the FOR FURTHER INFORMATION CONTACT section of this document
for alternate instructions. We accept anonymous comments. All comments
received will be posted without change to http://www.regulations.gov
and will include any personal information you have provided. For more
about privacy and the docket, you may review a Privacy Act notice
regarding the Federal Docket Management System in the March 24, 2005,
issue of the Federal Register (70 FR 15086). Documents mentioned in
this rule as being available in the docket, and all public comments,
will be in our online docket at http://www.regulations.gov and can be
viewed by following that Web site's instructions. Additionally, if you
go to the online docket and sign up for email alerts, you will be
notified when comments are posted or a final rule is published.

B. Regulatory History and Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM. Publishing a NPRM and delaying
the effective date would be impracticable, as publication of an NPRM
would delay the effective date of this rule past the time where it was
needed. To ensure safe boating and the appropriate distance away from
the escorted vessel is maintained, it is imperative that a standard
exclusionary zone be broadcast and safe speeds be followed for all
escorted vessels.
    For the same reason above, under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making this rule effective less
than 30 days after publication in the Federal Register.

C. Basis and Purpose

    The terrorist attacks of September 2001 heightened the need for
development of various security measures throughout the seaports of the
United States, particularly around vessels and facilities whose
presence or movement creates a heightened vulnerability to terrorist
acts; or those for which the consequences of terrorist acts represent a
threat to national security. The President of the United States has
found that the security of the United States is and continues to be
endangered following the attacks of September 11 (E.O. 13,273, 67 FR
56215, Sep. 3, 2002 and 79 FR 56475, Sep. 19, 2014).
    The Captain of the Port Los Angeles-Long Beach, California conducts
port security operations involving vessels that require additional
security, including, but not limited to, high capacity passenger
vessels, vessels carrying sensitive Department of Defense cargoes,
vessels carrying dangerous cargoes, and foreign naval vessels. The
Captain of the Port has determined that these vessels have a
significant vulnerability to subversive activity by other vessels or
persons, or, in some cases, themselves pose a risk to a port and the
public within the Captain of the Port Zone, as described in 33 CFR
3.55-10. This rule enables the COTP Los Angeles-Long Beach to provide
effective port security, while minimizing the public's confusion and
easing the administrative burden of implementing separate temporary
security zone rules for each escorted vessel.

D. Discussion of the Interim Rule

    This rule establishes a security zone that prohibits persons and
vessels from coming within 500 yards of all escorted

vessels within navigable waters, as defined in 33 CFR 2.36, of the
Captain of the Port Zone Los Angeles-Long Beach, CA, as described in 33
CFR 3.55-10. Persons or vessels that receive permission to enter the
security zone must proceed at a minimum safe speed, at a safe distance
from the escorted vessel as directed by the on scene Coast Guard,
State, or local law enforcement agency, and must comply with all orders
issued by the COTP or a designated representative. Outside of this
arrangement, no vessel or person may enter within a 500-yard radius of
an escorted vessel.
    An escorted vessel is defined as a vessel, other than a large U.S.
naval vessel as defined in 33 CFR 165.2015, that is accompanied by one
or more Coast Guard assets or other Federal, State or local law
enforcement agency assets clearly identifiable by lights, vessel
markings, or with agency insignia as listed below:
    (1) Coast Guard surface or air asset displaying the Coast Guard
insignia.
    (2) State and/or local law enforcement asset displaying the
applicable agency markings and/or equipment associated with the agency.
    When escorted vessels are moored, dayboards or other visual
indications such as lights or buoys may be used. In all cases,
broadcast notice to mariners will be issued to advise mariners of these
restrictions.

E. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, the rule has not
been reviewed by the Office of Management and Budget. The limited
geographic area impacted by the security zone will not restrict the
movement or routine operation of commercial or recreational vessels
through the Ports within the Captain of the Port Zone Los Angeles-Long
Beach.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small
entities: The owners or operators of vessels intending to transit in
the vicinity of escorted vessels. This rule would not have a
significant impact on a substantial number of small entities because
the zones are limited in size, in most cases leaving ample space for
vessels to navigate around them. The zones will not significantly
impact commercial and passenger vessel traffic patterns, and mariners
will be notified of the zones via Broadcast Notice to Mariners. Where
such space is not available and security conditions permit, the Captain
of the Port will attempt to provide flexibility for individual vessels
to transit through the zones as needed.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

3. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

4. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

5. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

6. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded from further review
under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

7. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.

Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.11731 to read as follows:

Sec.  165.11731  Security Zone: Escorted Vessels, Los Angeles-Long
Beach, CA, Captain of the Port Zone.

    (a) Definitions. The following definitions apply to this section:
    COTP means Captain of the Port Los Angeles-Long Beach, CA (LALB).
    Designated representatives means Coast Guard Patrol Commanders
including Coast Guard coxswains, petty officers and other officers
operating Coast Guard vessels, and Federal, State, and local officers
designated by or assisting the COTP, in the enforcement of the security
zone.
    Escorted vessel means a vessel, other than a large U.S. naval
vessel as defined in Sec.  165.2015, that is accompanied by one or more
Coast Guard assets or other Federal, State or local law enforcement
agency assets clearly identifiable by lights, vessel markings, or with
agency insignia as listed below:
    (1) Coast Guard surface or air asset displaying the Coast Guard
insignia.
    (2) State and/or local law enforcement asset displaying the
applicable agency markings and/or equipment associated with the agency.
    (3) When escorted vessels are moored, dayboards or other visual
indications such as lights or buoys may be used. In all cases,
broadcast notice to mariners will be issued to advise mariners of these
restrictions.
    Minimum safe speed means the speed at which a vessel proceeds when
it is fully off plane, completely settled in the water and not creating
excessive wake. Due to the different speeds at which vessels of
different sizes and configurations may travel while in compliance with
this definition, no specific speed is assigned to minimum safe speed.
In no instance should minimum safe speed be interpreted as a speed less
than that required for a particular vessel to maintain steerageway. A
vessel is not proceeding at minimum safe speed if it is:
    (1) On a plane;
    (2) In the process of coming up onto or coming off a plane; or
    (3) Creating an excessive wake.
    (b) Regulated area. All navigable waters, as defined in 33 CFR
2.36, within the Captain of the Port Zone, Los Angeles-Long Beach,
California 33 CFR 3.55-10.
    (c) Security zone. A 500-yard security zone is established around
each escorted vessel within the regulated area described in paragraph
(b) of this section. This is a moving security zone when the escorted
vessel is in transit and becomes a fixed zone when the escorted vessel
is anchored or moored. A security zone will not extend beyond the
boundary of the regulated area in this section.
    (d) Regulations. (1) The general regulations for security zones
contained in Sec.  165.33 apply to this section.
    (2) A vessel may request the permission of the COTP LALB or a
designated representative to enter the security zone described in
paragraph (c) of this section. If permitted to enter the security zone,
a vessel must proceed at the minimum safe speed and must comply with
the orders of the COTP or a designated representative.
    (e) Notice of security zone. The COTP will inform the public of the
existence or status of the security zones around escorted vessels in
the regulated area by Broadcast Notice to Mariners. Coast Guard assets
or other Federal, State or local law enforcement agency assets will be
clearly identified by lights, vessel markings, or with agency insignia.
When escorted vessels are moored, dayboards or other visual indications
such as lights or buoys may be used.
    (f) Contact information. The COTP LALB may be reached via phone at
(310) 521-3801. Any on scene Coast Guard or designated representative
assets may be reached via VHF-FM channel 16.

    Dated: September 15, 2015.
J. F. Williams,
Captain, U.S. Coast Guard, Captain of the Port Los Angeles--Long Beach.
[FR Doc. 2015-25557 Filed 10-7-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 139 (Wednesday, July 20, 2016)]
[Notices]
[Pages 47198-47205]
[FR Doc No: 2016-17092]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78333; File No. SR-BatsBYX-2016-17]

Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of
Filing of a Proposed Rule Change To Amend Exchange Rule 11.27 To
Describe Changes to System Functionality Necessary To Implement the
Regulation NMS Plan To Implement a Tick Size Pilot Program

July 14, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on 29 June, 2016, Bats BYX Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``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.
---------------------------------------------------------------------------

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

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

    The Exchange filed a proposal to adopt paragraph (c) to Exchange
Rule 11.27 to describe changes to System \3\ functionality necessary to
implement the Regulation NMS Plan to Implement a Tick Size Pilot
Program (``Plan'' or ``Pilot'').\4\ In determining the scope of the
proposed changes to implement the Pilot,\5\ the Exchange carefully
weighed the impact on the Pilot, System complexity, and the usage of
such order types in Pilot Securities. The Exchange also proposes to
amend paragraph (a) of Rule 11.27 to specify that orders entered into
the Exchange's Retail Price Improvement (``RPI'') Program qualify for
certain exceptions to the Plan.
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    \3\ The term ``System'' is defined as the ``electronic
communications and trading facility designated by the Board through
which securities orders of Users are consolidated for ranking,
execution and, when applicable, routing away.'' See Exchange Rule
1.5(aa).
    \4\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (``Approval Order'').
    \5\ Unless otherwise specified, capitalized terms used in this
rule filing are defined as set forth in the Plan.
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 parts of such
statements.

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

1. Purpose
Background
    On August 25, 2014, NYSE Group, Inc., on behalf of the Exchange,
Bats BZX Exchange, Inc. (``BZX''), Chicago Stock Exchange, Inc., Bats
EDGA Exchange, Inc. (``EDGA''), Bats EDGX Exchange, Inc. (``EDGX''),
Financial Industry Regulatory Authority, Inc. (``FINRA''), NASDAQ OMX
BX, Inc., NASDAQ OMX PHLX LLC, the Nasdaq Stock Market LLC, New York
Stock Exchange LLC (``NYSE''), NYSE MKT LLC, and NYSE Arca, Inc.
(collectively ``Participants''), filed with the Commission, pursuant to
Section 11A of the Act \6\ and Rule 608 of Regulation NMS thereunder,
the Plan to implement a tick size pilot program.\7\ The Participants
filed the Plan to comply with an order issued by the Commission on June
24, 2014.\8\ The Plan was published for comment in the Federal Register
on November 7, 2014, and approved by the Commission, as modified, on
May 6, 2015.\9\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78k-1.
    \7\ See Letter from Brendon J. Weiss, Vice President,
Intercontinental Exchange, Inc., to Secretary, Commission, dated
August 25, 2014.
    \8\ See Securities Exchange Act Release No. 72460 (June 24,
2014), 79 FR 36840 (June 30, 2014).
    \9\ See Approval Order, supra note 4.

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    The Plan is designed to allow the Commission, market participants,
and the public to study and assess the impact of increment conventions
on the liquidity and trading of the common stocks of small-
capitalization companies. Each Participant is required to comply, and
to enforce compliance by its member organizations, as applicable, with
the provisions of the Plan.
    The Pilot will include stocks of companies with $3 billion or less
in market capitalization, an average daily trading volume of one
million shares or less, and a volume weighted average price of at least
$2.00 for every trading day. The Pilot will consist of a Control Group
of approximately 1400 Pilot Securities and three Test Groups with 400
Pilot Securities in each Test Group selected by a stratified
sampling.\10\ During the Pilot, Pilot Securities in the Control Group
will be quoted and traded at the currently permissible increments.
Pilot Securities in the first Test Group (``Test Group One'') will be
quoted in $0.05 minimum increments but will continue to trade at any
price increment that is currently permitted.\11\ Pilot Securities in
the second Test Group (``Test Group Two'') will be quoted in $0.05
minimum increments and will trade at $0.05 minimum increments subject
to a midpoint exception, a retail investor order exception, and a
negotiated trade exception.\12\ Pilot Securities in the third Test
Group (``Test Group Three'') will be subject to the same restrictions
as Test Group Two and also will be subject to the ``Trade-at''
requirement to prevent price matching by a market participant that is
not displaying at a price of a Trading Center's \13\ ``Best Protected
Bid'' or ``Best Protected Offer,'' unless an enumerated exception
applies.\14\ The same exceptions provided under Test Group Two will
also be available under the Trade-at Prohibition, with an additional
exception for Block Size orders and exceptions that mirror those under
Rule 611 of Regulation NMS.\15\
---------------------------------------------------------------------------

    \10\ See Section V of the Plan for identification of Pilot
Securities, including criteria for selection and grouping.
    \11\ See Section VI(B) of the Plan.
    \12\ See Section VI(C) of the Plan.
    \13\ The Plan incorporates the definition of ``Trading Center''
from Rule 600(b)(78) of Regulation NMS. Regulation NMS defines a
Trading Center as ``a national securities exchange or national
securities association that operates an SRO trading facility, an
alternative trading system, an exchange market maker, an OTC market
maker, or any other broker or dealer that executes orders internally
by trading as principal or crossing orders as agent.''
    \14\ See Section VI(D) of the Plan.
    \15\ 17 CFR 242.611.
---------------------------------------------------------------------------

    The Plan requires the Exchange to establish, maintain, and enforce
written policies and procedures that are reasonably designed to comply
with applicable quoting and trading requirements specified in the Plan.
Accordingly, the Exchange adopted paragraph (a) of Rule 11.27 to
require Members \16\ to comply with the quoting and trading provisions
of the Plan.\17\ The Exchange also adopted paragraph (b) of Rule 11.27
to require Members to comply with the data collection provisions under
Appendix B and C of the Plan.\18\
---------------------------------------------------------------------------

    \16\ The term ``Member'' is defined as ``any registered broker
or dealer that has been admitted to membership in the Exchange.''
See Exchange Rule 1.5(n).
    \17\ See Securities Exchange Act Release No. 77793 (May 10,
2016), 81 FR 30366 (May 16, 2016) (SR-BatsBYX-2016-07).
    \18\ See Securities Exchange Act Release No. 77418 (March 22,
2016), 81 FR 17213 (March 28, 2016) (SR-BatsBYX-2016-01).
---------------------------------------------------------------------------

Proposed System Changes
    The Exchange proposes to amend paragraph (a) of Rule 11.27 to
specify that orders entered into the Exchange's RPI Program qualify for
certain exceptions to the Plan. The Exchange also proposes to adopt
paragraph (c) of Exchange Rule 11.27 to describe changes to System
functionality necessary to implement the Plan. Paragraph (c) of Rule
11.27 would set forth the Exchange's specific procedures for handling,
executing, re-pricing and displaying of certain order types and order
type instructions applicable to Pilot Securities. Unless otherwise
indicated, paragraph (c) of Rule 11.27 would apply to order types and
order type instructions in Pilot Securities in Test Groups One, Two,
and Three and not to Pilot Securities included in the Control Group.
The proposed changes include select and discrete amendments to the
operation of: (i) BYX Market Orders; (ii) Market Pegged Orders; (iii)
Mid-Point Peg Orders; (iii) Discretionary Orders; (iv) Non-Displayed
Orders; (v) Market Maker Peg Orders; (vi) Supplemental Peg Orders; and
(vii) orders subject to the Display-Price Sliding process.
    In determining the scope of these proposed changes to implement the
Plan, the Exchange carefully weighed the impact on the Pilot, System
complexity, and the usage of such order types in Pilot Securities.
These proposed changes are designed to directly comply with the Plan
and to assist the Exchange in meeting its regulatory obligations
pursuant to the Plan. As discussed below, certain of these changes are
also intended to reduce risk in the System by eliminating unnecessary
complexity based on infrequent current usage of certain order types in
Pilot Securities and/or their limited ability to execute under the
Trade-at Prohibition. Therefore, the Exchange firmly believes that
these changes will have little or no impact on the operation and data
collection elements of the Plan. The Exchange further believes that the
proposed rule changes are reasonably designed to comply with applicable
quoting and trading requirements specified in the Plan.
RPI Program
    In November 2012, the Commission approved the RPI Program on a
pilot basis.\19\ The Program is designed to attract retail order flow
to the Exchange, and allow such order flow to receive potential price
improvement. Under the Program, all Exchange Users \20\ are permitted
to provide potential price improvement for Retail Orders \21\ in the
form of non-displayed interest that is better than the national best
bid that is a Protected Quotation or the national best offer that is a
Protected Quotation.\22\
---------------------------------------------------------------------------

    \19\ See Securities Exchange Act Release No. 68303 (November 27,
2012), 77 FR 71652 (December 3, 2012) (``RPI Approval Order'') (SR-
BYX-2012-019).
    \20\ A ``User'' is defined as any member or sponsored
participant of the Exchange who is authorized to obtain access to
the System pursuant to Rule 11.3. See Exchange Rule 1.5(cc).
    \21\ A ``Retail Order'' is defined in Exchange Rule 11.24(a)(2)
as an agency order that originates from a natural person and is
submitted to the Exchange by a RMO, provided that no change is made
to the terms of the order with respect to price or side of market
and the order does not originate from a trading algorithm or any
computerized methodology. The definition of Retail Order is also
substantially similar to the definition of Retail Investor Order
under the Plan. See Section I(DD) of the Plan.
    \22\ The term Protected Quotation is defined in Exchange Rule
1.5(t) and has the same meaning as is set forth in Regulation NMS
Rule 600(b)(58). The terms Protected NBB and Protected NBO are
defined in Exchange Rule 1.5(s). The Protected NBB is the best-
priced protected bid and the Protected NBO is the best-priced
protected offer. Generally, the Protected NBB and Protected NBO and
the national best bid (``NBB'') and national best offer (``NBO'',
together with the NBB, the ``NBBO'') will be the same. However, a
market center is not required to route to the NBB or NBO if that
market center is subject to an exception under Regulation NMS Rule
611(b)(1) or if such NBB or NBO is otherwise not available for an
automatic execution. In such case, the Protected NBB or Protected
NBO would be the best-priced protected bid or offer to which a
market center must route interest pursuant to Regulation NMS Rule
611.
---------------------------------------------------------------------------

    Exchange Rule 11.27(a)(4) sets forth the applicable limitations for
securities in Test Group One. Consistent with the language of the Plan,
Rule 11.27(a)(4) provides that no Member may display, rank, or accept
from any person any displayable or non-displayable bids or

offers, orders, or indications of interest in any Pilot Security in
Test Group One in increments other than $0.05. Pilot Securities in Test
Group One may continue to trade at any price increment that is
currently permitted by the applicable Participant, SEC and Exchange
rules.\23\ Exchange Rule 11.27(a)(5) sets forth the applicable quoting
and trading requirements for securities in Test Group Two. This
provision states that no Member may display, rank, or accept from any
person any displayable or non-displayable bids or offers, orders, or
indications of interest in any Pilot Security in Test Group Two in
increments other than $0.05. In Test Groups One and Two, however,
orders entered in a Participant-operated retail liquidity program may
be ranked and accepted in increments of less than $0.05. Therefore, the
Exchange proposes to amend Rule 11.27(a)(4) and (5) to also specify
that the RPI Program qualifies as a Participant-operated liquidity
program under the Plan and that orders entered into the RPI Program may
be ranked and accepted in increments of less than $0.05 in Test Groups
One and Two.
---------------------------------------------------------------------------

    \23\ The Exchange proposes to amend the last sentence of Rule
11.27(a)(4) to specify that the current permissible price increments
are set forth under Exchange Rule 11.11, Price Variations.
---------------------------------------------------------------------------

    Exchange Rule 11.27(a)(5) also sets forth the applicable trading
restrictions for Test Group Two securities. Absent any of the
exceptions listed in the Rule, no Member may execute orders in any
Pilot Security in Test Group Two in price increments other than $0.05.
Consistent with the language of the Plan, the Rule provides that Pilot
Securities in Test Group Two may trade in increments of less than $0.05
where a Retail Investor Order is provided with price improvement that
is at least $0.005 better than the best protected bid and best
protected offer (``PBBO'').\24\ The Exchange proposes to amend Rule
11.27(a)(5) to specify that Retail Orders entered into the Exchange's
RPI Program qualify as Retail Investor Orders and may be provided with
price improvement that is at least $0.005 better than the PBBO.
---------------------------------------------------------------------------

    \24\ Regulation NMS defines a protected bid or protected offer
as a quotation in an NMS stock that (1) is displayed by an automated
trading center; (2) is disseminated pursuant to an effective
national market system plan; and (3) is an automated quotation that
is the best bid or best offer of a national securities exchange, the
best bid or best offer of The Nasdaq Stock Market, Inc., or the best
bid or best offer of a national securities association other than
the best bid or best offer of The Nasdaq Stock Market, Inc. See 17
CFR 242.600(57). In the Approval Order, the Commission noted that
the protected quotation standard encompasses the aggregate of the
most aggressively priced displayed liquidity on all Trading Centers,
whereas the NBBO standard is limited to the single best order in the
market. See Approval Order, supra note 4.
---------------------------------------------------------------------------

    Exchange Rule 11.27(a)(6) sets forth the applicable quoting and
trading restrictions for Pilot Securities in Test Group Three. The rule
provides that no Member may display, rank, or accept from any person
any displayable or non-displayable bids or offers, orders, or
indications of interest in any Pilot Security in Test Group Three in
increments other than $0.05. However, orders entered in a Participant-
operated retail liquidity program may be ranked and accepted in
increments of less than $0.05. As proposed for Rules 11.27(a)(4) and
(5) above, the Exchange similarly proposes to amend Rule 11.27(a)(6) to
also specify that the RPI Program qualifies as a Participant-operated
liquidity program under the Plan and that orders entered into the RPI
Program may be ranked and accepted in increments of less than $0.05.
    The rule also states that, absent any of the applicable exceptions,
no Member that operates a Trading Center may execute orders in any
Pilot Security in Test Group Three in price increments other than
$0.05. Exchange Rule 11.27(a)(6)(C) sets forth the exceptions pursuant
to which Pilot Securities in Test Group Three may trade in increments
of less than $0.05. One exception is that Retail Investor Orders may be
provided with price improvement that is at least $0.005 better than the
PBBO. As proposed for Rule 11.27(a)(5) above, the Exchange similarly
proposes to amend Rule 11.27(a)(6) to specify that Retail Orders
entered into the Exchange's RPI Program qualify as Retail Investor
Orders and may be provided with price improvement that is at least
$0.005 better than the PBBO.
    Exchange Rule 11.27(a)(6)(D) sets forth the Trade-at Prohibition,
which is the prohibition against executions by a Member that operates a
Trading Center of a sell order for a Pilot Security in Test Group Three
at the price of a Protected Bid or the execution of a buy order for a
Pilot Security in Test Group Three at the price of a Protected Offer
during Regular Trading Hours,\25\ absent any of the exceptions set
forth in Rule 11.27(a)(6)(D). Consistent with the Plan, Exchange Rule
11.27(a)(6)(D) excepts an order that is a Retail Investor Order that is
executed with at least $0.005 price improvement from the Trade-at
Prohibition. The Exchange proposes to amend Rule 11.27(a)(6)(D) to
specify that Retail Orders entered into the Exchange's RPI Program
qualify as Retail Investor Orders and may be provided with price
improvement that is at least $0.005 better than the PBBO.
---------------------------------------------------------------------------

    \25\ The term ``Regular Trading Hours'' is defined as ``the time
between 9:30 a.m. and 4:00 p.m. Eastern Time.'' See Exchange Rule
1.5(w).
---------------------------------------------------------------------------

BYX Market Orders
    A BYX Market Order is an order to buy or sell a stated amount of a
security that is to be executed at the NBBO when the order reaches the
Exchange. BYX Market Orders shall not trade through Protected
Quotations.\26\ Any portion of a BYX Market Order that would execute at
a price more than $0.50 or 5 percent worse than the NBBO at the time
the order initially reaches the Exchange, whichever is greater, will be
cancelled.\27\ In order to comply with the minimum quoting increments
set forth in the Plan, the Exchange proposes to state under proposed
Rule 11.27(c)(1) that for purposes of determining whether a BYX Market
Order's execution price is more than 5 percent worse than the NBBO
under Rule 11.9(a)(2), the execution price for a buy (sell) order will
be rounded down (up) to the nearest $0.05 increment.
---------------------------------------------------------------------------

    \26\ See Exchange Rule 11.9(a)(2).
    \27\ Id.
---------------------------------------------------------------------------

Market Pegged Orders
    The Exchange proposes to amend the operation of Market Pegged
Orders to reduce risk in its System by eliminating unnecessary
complexity based on infrequent current usage in Pilot Securities and
their limited ability to execute under the Trade-at Prohibition in Test
Group Three. A Pegged Order is a limit order that after entry into the
System, the price of the order is automatically adjusted by the System
in response to changes in the NBBO. A Pegged Order will peg to the NBB
or NBO or a certain amount away from the NBB or NBO.\28\ A Market
Pegged Order is pegged to the contra-side NBBO.\29\ A User entering a
Market Pegged Order can specify that such order's price will offset the
inside quote on the contra-side of the market by an amount (the
``Offset Amount'') set by the User. Market Pegged Orders are not
eligible to be displayed on the Exchange.
---------------------------------------------------------------------------

    \28\ See Exchange Rule 11.9(c)(8).
    \29\ See Exchange Rule 11.9(c)(8)(B).
---------------------------------------------------------------------------

    In Test Groups One and Two, the Exchange proposes to modify the
behavior of Market Pegged Order when it is locked by an incoming BYX
Post Only Order \30\ or Partial Post Only at Limit Order \31\ that does
not remove liquidity pursuant to Rule 11.9(c)(6) or Rule
11.9(c)(7),\32\ respectively. In such

case, the Market Pegged Order would be converted to an executable order
and will remove liquidity against such incoming order.\33\ In no case
would a Market Pegged Order execute against an incoming BYX Post Only
Order or Partial Post Only at Limit Order if an order with higher
priority is on the BYX Book.\34\ Specifically, if an order other than a
Market Pegged Order maintains higher priority than one or more Market
Pegged Orders, the Market Pegged Order(s) with lower priority will not
be converted, as described above, and the incoming BYX Post Only Order
or Partial Post Only at Limit Order will be posted or cancelled in
accordance with Rule 11.9(c)(6) or Rule 11.9(c)(7).
---------------------------------------------------------------------------

    \30\ See Exchange Rule 11.9(c)(6).
    \31\ See Exchange Rule 11.9(c)(7).
    \32\ A BYX Post Only Order will remove contra-side liquidity
from the BYX Book if the order is an order to buy or sell a security
priced below $1.00 or if the value of such execution when removing
liquidity equals or exceeds the value of such execution if the order
instead posted to the BYX Book and subsequently provided liquidity,
including the applicable fees charged or rebates provided. See
Exchange Rule 11.9(c)(6). A Partial Post Only at Limit Order will
remove liquidity from the BYX Book up to the full size of the order
if, at the time of receipt, it can be executed at prices better than
its limit price. See Exchange Rule 11.9(c)(7).
    \33\ The Exchange notes that a BYX Post Only will, in most
cases, remove liquidity from the BYX Book because under its current
taker-maker pricing structure, the remover of liquidity is provided
a rebate while the provider of liquidity is charged a fee.
Therefore, in most cases, value of the execution to remove liquidity
will equal or exceed the value of such execution once posted to the
BYX Book, including the applicable fees charged or rebates received.
    \34\ The term ``BYX Book'' is defined as the ``System's
electronic file of orders.'' See Exchange Rule 1.5(e).
---------------------------------------------------------------------------

    The Exchange notes that Market Pegged Orders are aggressive by
nature and believes executing the order in such circumstance is
appropriate. The Exchange also notes that the proposed behavior for
Market Pegged Orders in Test Groups One and Two is identical to the
operation of orders with the Super Aggressive Routing instruction under
Exchange Rule 11.13(b)(4)(C). When an order with a Super Aggressive
instruction is locked by an incoming BYX Post Only Order or Partial
Post Only at Limit Order that does not remove liquidity pursuant to
Rule 11.9(c)(6) or Rule 11.9(c)(7), respectively, the order is
converted to an executable order and will remove liquidity against such
incoming order. In addition, like as proposed above, in no case would
an order with a Super Aggressive instruction execute against an
incoming BYX Post Only Order or Partial Post Only at Limit Order if an
order with higher priority is on the BYX Book. The Exchange believes
this change is reasonable and appropriate due to the limited usage of
Market Pegged Orders in Pilot Securities, to avoid unnecessary
additional System complexity, and to ensure the Market Pegged Order may
execute in such circumstance.
    The Exchange also proposes to not accept Market Pegged Orders in
Test Group Three based on limited current usage, additional System
complexity, and their limited ability to execute under the Trade-at
Prohibition. The Exchange believes that their de minimis usage and
limited ability to execute due to the Trade-at Prohibition does not
justify the complexity that would be created by supporting Market
Pegged Orders in Test Group Three. A vast majority of Market Pegged
Orders are entered into the System with a zero Offset and, therefore,
create a locked market with the contra-side NBBO. Under the Trade-at
Prohibition, a Market Pegged Order would not be eligible for execution
at the locking price, including when a Trade-at Intermarket Sweep Order
(``ISO'') \35\ is entered, because of non-cleared contra-side Protected
Quotations. For example, assume the NBBO is $10.00 (NYSE) x $10.05
(Nasdaq) in a Test Group 3 security. A Market Pegged Order to buy at
$10.10 with a zero Offset is entered on the Exchange. The order would
be ranked and hidden on the BYX Book at $10.05. A Trade-at ISO to sell
at $10.05 is then entered. In this example, no execution occurs on BYX
because Nasdaq is displaying an order to sell at $10.05. The Trade-at
ISO instruction only indicates that all of the better and equal priced
buy orders have been cleared. It does not indicate that the seller has
cleared any Protected Offers. Therefore, the Exchange proposes to not
accept Market Pegged Orders in Test Group Three in an effort to reduce
unnecessary System complexity, avoid an internally locked book, and due
to the limited execution opportunities for Market Pegged Orders due to
the Trade-at Prohibition.
---------------------------------------------------------------------------

    \35\ A Trade-at ISO is a Limit Order for a Pilot Security that
meets the following requirements: (i) when routed to a Trading
Center, the limit order is identified as a Trade-at Intermarket
Sweep Order; and (ii) simultaneously with the routing of the limit
order identified as a Trade-at Intermarket Sweep Order, one or more
additional limit orders, as necessary, are routed to execute against
the full size of any protected bid, in the case of a limit order to
sell, or the full displayed size of any protected offer, in the case
of a limit order to buy, for the Pilot Security with a price that is
better than or equal to the limit price of the limit order
identified as a Trade-at Intermarket Sweep Order. See Exchange Rule
11.27(a)(7)(A)(i). These additional routed orders also must be
marked as Trade-at Intermarket Sweep Orders. Id.
---------------------------------------------------------------------------

Mid-Point Peg Orders
    A Mid-Point Peg Order is an order whose price is automatically
adjusted by the System in response to changes in the NBBO to be pegged
to the midpoint of the NBBO, or, alternatively, pegged to the less
aggressive of the midpoint of the NBBO or one minimum price variation
\36\ inside the same side of the NBBO as the order.\37\ The Plan and
current Exchange rules permit the acceptance of orders priced to
execute at the midpoint of the NBBO to be ranked and accepted in
increments of less than $0.05.\38\ Consistent with previous guidance
issued by the Participants,\39\ the Exchange proposes to amend the
operation of Mid-Point Peg Orders to explicitly state that Mid-Point
Peg Orders in Pilot Securities may not be entered in increments other
than $0.05. The System will execute a Mid-Point Peg Order: (i) In $0.05
increments priced better than the midpoint of the NBBO; or (ii) at the
midpoint of the NBBO, regardless of whether the midpoint of the NBBO is
in an increment of $0.05. In order to comply with the minimum quoting
and trading increments of the Plan and reduce unnecessary System
complexity, a Mid-Point Peg Order will not be permitted to
alternatively peg to one minimum price variation inside the same side
of the NBBO as the order in Pilot Securities. The Exchange believes
that the current de minimis usage of the alternative pegging
functionality in Pilot Securities does not justify the complexity and
risk that would be created by re-programming the System to support this
functionality under the Plan.
---------------------------------------------------------------------------

    \36\ See Exchange Rule 11.11.
    \37\ See Exchange Rule 11.9(c)(9).
    \38\ See Sections VI(B), (C), and (D) of the Plan. See also
Exchange Rules 11.27(a)(4), (a)(5), and (a)(6).
    \39\ See e.g., Question 42 of the Tick Size Pilot Program
Trading and Quoting FAQs available at http://www.finra.org/sites/default/files/TSPP-Trading-and-Quoting-FAQs.pdf
---------------------------------------------------------------------------

Discretionary Orders
    The Exchange proposes to not accept Discretionary Orders in all
Test Groups, including the Control Group, to reduce risk in the System
by eliminating unnecessary complexity based on infrequent current usage
in Pilot Securities. In sum, a Discretionary Order is a Limit Order
with a displayed or non-displayed ranked price and size and an
additional non-displayed ``discretionary price''.\40\ The discretionary
price is a non-displayed upward offset at which a User is willing to
buy, if necessary, or a non-displayed downward offset at which a User
is willing to sell, if necessary. The System changes necessary for a
Discretionary Order to comply with the Plan become increasingly complex
because both the

displayed price and discretionary price must comply with the Plan's
minimum quoting and trading increments as well as the Trade-at
restriction in Test Group Three. In addition, Users do not currently
set discretionary prices less than $0.05 away from the order's
displayed price and the Exchange does not anticipate Users doing so
under the Plan. To date, Discretionary Orders are rarely entered in
Pilot Securities and the Exchange anticipates their usage to further
decrease due to the Plan's minimum quoting increments. The Exchange
believes that the current extremely limited usage of Discretionary
Orders in Pilot Securities does not justify the additional System
complexity that would be created by supporting Discretionary Orders. As
a result of these factors the Exchange proposes to not accept
Discretionary Orders in all Test Groups and the Control Group.
---------------------------------------------------------------------------

    \40\ See Exchange Rule 11.9(c)(10).
---------------------------------------------------------------------------

Non-Displayed Orders
    The Exchange proposes to re-price to the midpoint of the NBBO Non-
Displayed Orders in Test Group Three that are priced in a permissible
increment better than the midpoint of the NBBO. A Non-Displayed Order
is a Market or Limit Order that is not displayed on the Exchange.\41\
Exchange Rule 11.27(a)(6)(D) incorporates the Trade-at Prohibition in
the Exchange's rules. The Trade-at Prohibition prevents the execution
of a sell order for a Pilot Security in Test Group Three at the price
of a Protected Bid or the execution of a buy order for a Pilot Security
in Test Group Three at the price of a Protected Offer during Regular
Trading Hours, unless an exception applies. A Trading Center that is
displaying a quotation, via either a processor or an SRO quotation
feed, that is a Protected Bid or Protected Offer is permitted to
execute orders at that level, but only up to the amount of its
displayed size. Unless an exception applies, a Non-Displayed Order that
is able to execute at the price of the Protected Quotation would not be
able to do so in Test Group Three due to the Trade-at Prohibition and
the Exchange's priority rule.\42\ Furthermore, such aggressively priced
orders would not be able to post to the BYX Book at the contra-side
Protected Quotation, and re-pricing the order to the midpoint of the
NBBO would increase execution opportunities under normal market
conditions. However, orders that are priced to execute at the midpoint
of the NBBO are exempt from the Trade-at Prohibition. Therefore, to
increase the execution opportunities for Non-Displayed Orders in Test
Group Three, the Exchange proposes to re-price to the midpoint of the
NBBO Non-Displayed Orders that are priced in a permissible increment
better than the midpoint of the NBBO.
---------------------------------------------------------------------------

    \41\ See Exchange Rule 11.9(c)(11).
    \42\ Under Exchange Rule 11.12(a)(2), displayed Limit Orders
have priority over Non-Displayed Limit Orders.
---------------------------------------------------------------------------

Market Maker Peg Orders
    A Market Maker Peg Order is a Limit Order that is automatically
priced by the System at the Designated Percentage (as defined in
Exchange Rule 11.8) away from the then current NBB and NBO, or if no
NBB or NBO, at the Designated Percentage away from the last reported
sale from the responsible single plan processor in order to comply with
the quotation requirements for Market Makers set forth in Exchange Rule
11.8(d).\43\ Should the above pricing result in a Market Maker Peg
Order being priced at an increment other than $0.05, the Exchange
proposes to round an order to buy (sell) up (down) to the nearest $0.05
increment in order to comply with the minimum quoting increments of the
Plan.
---------------------------------------------------------------------------

    \43\ See Exchange Rule 11.9(c)(16).
---------------------------------------------------------------------------

Supplemental Peg Orders
    The Exchange proposes to not accept Supplemental Peg Orders in Test
Group Three in order to reduce risk in the System by eliminating
unnecessary complexity based on infrequent current usage in Pilot
Securities and their limited ability to execute under the Trade-at
Prohibition. A Supplemental Peg Order is a non-displayed Limit Order
that posts to the BYX Book, and thereafter is eligible for execution at
the NBB for buy orders and NBO for sell orders against routable orders
that are equal to or less than the aggregate size of the Supplemental
Peg Order interest available at that price.\44\ In sum, Supplemental
Peg Orders are only executable at the NBBO against an order that is in
the process of being routed away. In such case, the Exchange is not
displaying a Protected Quotation and, therefore, the Supplemental Peg
Order would be unable to execute in Test Group Three due to the Trade-
at Prohibition.\45\ Therefore, the Exchange proposes to not accept
Supplemental Peg Orders in Test Group Three.
---------------------------------------------------------------------------

    \44\ See Exchange Rule 11.9(c)(19).
    \45\ The Exchange notes that the likelihood of a Supplemental
Peg Order qualifying for an exception to the Trade-at Prohibition is
small. For example, Supplemental Peg Orders are only executable
against orders that are to be routed away and would not be eligible
to execute against an incoming ISO or Trade-at ISO. Also, the
Exchange would not be displaying a Protected Quotation. In addition,
the Exchange does not frequently receive orders of Block Size and,
in order to qualify for the Block exception, the contra-side Block
Order must be routable and the Supplemental Peg Order be of Block
Size.
---------------------------------------------------------------------------

Display-Price Sliding
    Under the Display-Price Sliding process, an order eligible for
display by the Exchange that, at the time of entry, would create a
violation of Rule 610(d) of Regulation NMS by locking or crossing a
Protected Quotation of an external market, will be ranked at the
locking price in the BYX Book and displayed by the System at one
minimum price variation (i.e., $0.05) below the current NBO (for bids)
or one minimum price variation above the current NBB (for offers).\46\
The ranked and displayed prices of an order subject to the Display-
Price Sliding process may be adjusted once or multiple times depending
upon the instructions of a User and changes to the prevailing NBBO.\47\
---------------------------------------------------------------------------

    \46\ See Exchange Rule 11.9(g)(1)(A).
    \47\ See Exchange Rule 11.9(g)(1)(C).
---------------------------------------------------------------------------

    As described above, Exchange Rule 11.27(a)(6)(D) sets forth the
Trade-at Prohibition, which is the prohibition against executions by a
Member that operates a Trading Center of a sell order for a Pilot
Security in Test Group Three at the price of a Protected Bid or the
execution of a buy order for a Pilot Security in Test Group Three at
the price of a Protected Offer during Regular Trading Hours, unless an
exception applies. Orders that are priced to execute at the midpoint of
the NBBO are exempt from the Trade-at Prohibition. Therefore, to
increase the execution opportunities and qualify for the mid-point
exception to the Trade-at Prohibition, the Exchange proposes to rank
orders in Test Group Three that are subject to the Display-Price
Sliding process at the midpoint of the NBBO in the BYX Book and display
such orders one minimum price variation below the current NBO (for
bids) or one minimum price variation above the current NBB (for
offers).
    The Exchange also proposes to cancel orders subject to Display-
Price Sliding in Test Group Three that are only to be adjusted once and
not multiple times in the event the NBBO widens and a contra-side Non-
Displayed Order is resting on the BYX Book at the price to which the
order subject to Display-Price Sliding would be adjusted. Due to the
increased minimum quoting increments under the Plan, the Exchange is
unable to safely re-price an order subject to single Display-Price
Sliding in Test Group Three to the original locking price in such
circumstances and doing so would add additional System complexity and
risk. As discussed

above, the Exchange proposes to rank orders in Test Group Three subject
to the Display-Price Sliding process at the midpoint of the NBBO. In
the event the NBBO changes such that an order subject to Display-Price
Sliding would not lock or cross a Protected Quotation of an external
market, the order will receive a new timestamp, and will be displayed
at the order's limit price.\48\ Due to technological limitations
arising from the increased minimum quoting increments under the Plan,
however, the Exchange is unable to safely re-program its System to re-
price such order to the original locking price when the NBBO widens and
a contra-side Non-Displayed Order is resting on the BYX Book at the
price to which the order subject to Display-Price Sliding would be
adjusted. Therefore, the Exchange proposes to cancel orders subject to
the single Display-Price Sliding process in such circumstances. Users
who prefer an execution in such a scenario may elect to use the
multiple Display-Price Sliding process.
---------------------------------------------------------------------------

    \48\ Id.
---------------------------------------------------------------------------

Ministerial Change
    Currently, both Interpretation and Policy .03 to Rule 11.27(a) and
Interpretation and Policy .11 to Rule 11.27(b) state that Rule 11.27
shall be in effect during a pilot period to coincide with the pilot
period for the Plan (including any extensions to the pilot period for
the Plan). The Exchange proposes to include this language at the
beginning of Rule 11.27 and, therefore, proposes to delete both
Interpretation and Policy .03 to Rule 11.27(a) and Interpretation and
Policy .11 to Rule 11.27(b) as those provisions would be redundant and
unnecessary.
Implementation Date
    If the Commission approves the proposed rule change, the proposed
rule change will be effective upon Commission approval and shall become
operative upon the commencement of the Pilot Period.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \49\ in general, and furthers the objectives of Section
6(b)(5) of the Act \50\ in particular, in that it is designed to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, 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. The Plan requires the
Exchange to establish, maintain, and enforce written policies and
procedures that are reasonably designed to comply with applicable
quoting and trading requirements specified in the Plan. The proposed
rule change is designed to comply with the Plan, reduce complexity and
enhance System resiliency while not adversely affecting the data
collected under the Plan. Therefore, the Exchange believes that the
proposed rule changes are reasonably designed to comply with applicable
quoting and trading requirements specified in the Plan and, as
discussed further below, other applicable regulations.
---------------------------------------------------------------------------

    \49\ 15 U.S.C. 78f(b).
    \50\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed changes regarding its
Retail Price Improvement Program, BYX Market Orders, Mid-Point Peg
Orders, Market Maker Peg Orders, and Display-Price Sliding are
consistent with the Act because they are intended to modify the
Exchange's System to comply with the provisions of the Plan, and are
designed to assist the Exchange in meeting its regulatory obligations
pursuant to the Plan. In approving the Plan, the SEC noted that the
Pilot was an appropriate, data-driven test that was designed to
evaluate the impact of a wider tick size on trading, liquidity, and the
market quality of securities of smaller capitalization companies, and
was therefore in furtherance of the purposes of the Act. To the extent
that these proposals are intended to comply with the Plan, the Exchange
believes that these proposals are in furtherance of the objectives of
the Plan, as identified by the Commission, and is therefore consistent
with the Act.
    The Exchange also believes that its proposed changes to Market
Pegged Orders, Discretionary Orders, Non-Displayed Orders, Supplemental
Peg Orders, and Display-Price Sliding are also consistent with the Act
because they are intended to eliminate unnecessary System complexity
and risk based on the de minimis current usage of such order types and
instructions in Pilot Securities and/or their limited ability to
execute under the Plan's minimum trading and quoting increments or
Trade-at Prohibition.\51\ For example, during March 2016, the
alternative pegging functionality of Mid-Point Peg Orders, Market
Pegged Orders, Non-Displayed Orders, and Supplemental Peg Orders
accounted for 0.01%, 0.02%, 0.92%, and 0.01%, respectively, of volume
in eligible Pilot Securities on the Exchange, BZX, EDGA and EDGX
combined. Notably, Discretionary Orders accounted for 0.00% of volume
in eligible Pilot Securities on the Exchange, BZX, EDGA and EDGX
combined. The Commission adopted Regulation Systems Compliance and
Integrity (``Regulation SCI'') in November 2014 to strengthen the
technology infrastructure of the U.S. securities markets.\52\
Regulation SCI is designed to reduce the occurrence of systems issues,
improve resiliency when systems problems do occur, and enhance the
Commission's oversight and enforcement of securities market technology
infrastructure.
---------------------------------------------------------------------------

    \51\ The Commission has also expressed concern regarding
potential market instability caused by technological risks. See
e.g., Chair Mary Jo White, Commission, Enhancing Our Equity Market
Structure (June 5, 2014) available at https://www.sec.gov/News/Speech/Detail/Speech/1370542004312#.VD2HW610w6Y.
    \52\ See Securities Exchange Act Release No. 73639 (November 19,
2014), 79 FR 72251 (December 5, 2014) (``Regulation SCI Approval
Order'').
---------------------------------------------------------------------------

    Regulation SCI required the Exchange to establish written policies
and procedures reasonably designed to ensure that their systems have
levels of capacity, integrity, resiliency, availability, and security
adequate to maintain their operational capability and promote the
maintenance of fair and orderly markets, and that they operate in a
manner that complies with the Exchange Act. Each of these proposed
changes are intended to reduce complexity and risk in the System to
ensure the Exchange's technology remains robust and resilient. In
determining the scope of the proposed changes, the Exchange carefully
weighed the impact on the Pilot, System complexity, and the usage of
such order types in Pilot Securities.\53\ The potential complexity
results from code changes for a majority of the Exchange's order types,
which requires the implementation and testing of a separate branch of
code for each Test Group. For example, the Exchange currently utilizes
one branch of code for which to implement and test changes. Development
work for the Tick Pilot results in the creation of four additional
branches of code that are to be developed and tested (e.g., Control
Group + three Test Groups). The Exchange determined that the changes
proposed herein are necessary to ensure continued System resiliency in
accordance with the requirements of Regulation SCI. Therefore, the
Exchange believes the proposed rule change

promotes just and equitable principles of trade, removes impediments to
and perfects the mechanism of a free and open market and a national
market system and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \53\ But for the Plan, the Exchange notes that it would not have
proposed to amend the operation of Market Pegged Orders,
Discretionary Orders, Non-Displayed Orders, Supplemental Peg Orders,
and Display-Price Sliding as described herein.
---------------------------------------------------------------------------

    In addition, each of these proposed changes would have a de minimis
to zero impact on the data reported pursuant to the Plan. As evidenced
above, Market Pegged Orders, Discretionary Orders, the alternative
pegging functionality of Mid-Point Peg Orders, and Supplemental Peg
Orders are infrequently used in Pilot Securities or the execution of
such orders would be scarce due to the Plan's minimum trading and
quoting requirement and Trade-at Prohibition. The limited usage and
execution scenarios do not justify the additional system complexity
which would be created by modifying the System to support such order
types in order to comply with the Plan. Therefore, the Exchange
believes each proposed change is a reasonable means to ensure that the
System's integrity, resiliency, and availability continues to promote
the maintenance of fair and orderly markets. Due to the additional
complexity, limited usage and execution opportunities, the Exchange
believes it is not unfairly discriminatory to apply the changes
proposed herein to only Pilot Securities as such changes are necessary
to reduce complexity and ensure continued System resiliency in
accordance with the requirements of Regulation SCI. The Exchange also
believes the proposed changes to Non-Displayed Orders, and orders
subject to the Display-Price Sliding process in Test Group Three are
consistent with the Act because they are designed to increase the
execution opportunities for such order types in compliance with the
mid-point exception to the Trade-at Prohibition. The Exchange also
believes the proposed change to Market Pegged Orders in Test Groups One
and Two is consistent with the Act because it is identical to the
operation of the Super Aggressive instruction under Exchange Rule
11.13(b)(4)(C). The Exchange notes that Market Pegged Orders are
aggressive by nature and believes executing the order in such
circumstance is reasonable and appropriate.
    The Exchange also believes it is reasonable and appropriate to
cancel an order subject to the single Display-Price Sliding process in
Test Group Three in the event that the NBBO widens and a contra-side
Non-Displayed Order is resting on the BYX Book at the price to which
the order subject to Display-Price Sliding would be adjusted. Due to
technological limitations and the Plan's increased minimum quoting
increments, the Exchange is unable to safely re-program its System to
re-price such orders to the original locking price in such
circumstances. The Exchange also anticipates that the scenario under
which it proposes to cancel the Display-Price Sliding order will be
infrequent in Tick Pilot Securities. Users who prefer an execution in
such a scenario may elect to use the multiple Display-Price Sliding
process. Therefore, the Exchange believes it is consistent with the Act
to set forth this scenario in its rules so that Users will understand
how the System operates and how their orders would be handled in this
discrete scenario.
    Lastly, the Exchange believes the ministerial changes to Rule 11.27
are also consistent with the Act as they would: (i) Clarify a provision
under paragraph (a)(4); and (ii) remove redundant provisions from the
rule.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
notes that the proposed rule change is designed to assist the Exchange
in meeting its regulatory obligations pursuant to the Plan, reduce
System complexity and enhance resiliency. The Exchange also notes that
the proposed rule change will apply equally to all Members that trade
Pilot Securities.

(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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal is
consistent with the Act. In particular, the Commission seeks comment on
the issue described below.
    In the Approval Order, the Commission stressed the importance of
testing the impact of wider tick sizes on the trading and liquidity of
the securities of small capitalization companies, and doing so in a way
that produces robust results that inform future policy decisions.\54\
The Commission acknowledged the complexity of the Pilot and the costs
that its implementation would create for market participants, but
concluded that the benefits of the empirical data that would be
produced by the Pilot warranted incurring those costs.\55\ As a result,
the Plan requires that each Participant, including the Exchange, adopt
rules that are necessary for compliance with the provisions of the
Plan.\56\
---------------------------------------------------------------------------

    \54\ See Approval Order, supra note 4, at 80 FR 27515.
    \55\ Id at 27516.
    \56\ See Sections II(B) of the Plan. See also Section IV of the
Plan.
---------------------------------------------------------------------------

    While the Exchange states that the proposed rule change describes
the system changes necessary to implement the Pilot, the Commission
notes that the scope of the proposed changes extends beyond those
required for compliance with the Plan, and would eliminate certain
order types for Pilot Securities during the Pilot Period, or modify
their operation in ways not required by the Plan. For example, the
Exchange proposes not to accept Market Pegged Orders, Discretionary
Orders, and Supplemental Peg Orders, and certain types of Mid-Point Peg
Orders, in some or all Test Groups of Pilot Securities for the duration
of the Pilot Period.\57\ These proposals appear designed to permit the
Exchange to avoid the costs of modifying these order types to comply
with the Plan. The Exchange notes that these order types are
infrequently used in Pilot Securities, and takes the position that
``[t]he limited usage and execution scenarios do not justify the
additional system complexity which would be created by modifying the
System to support such order types in order to comply with the Plan.''
\58\ At the same time, the Exchange also does not appear prepared to
propose to eliminate these order types indefinitely. By contrast, the
Exchange proposes to modify, in ways not required by the

Plan, the operation of Market Pegged Orders and Non-Displayed Orders,
and certain orders subject to the Display-Price Sliding process, in
some or all Test Groups of Pilot Securities, and to incur the
associated system change costs, in order to increase the ``execution
opportunities'' for these order types for the duration of the Pilot
Period.\59\
---------------------------------------------------------------------------

    \57\ The Exchange also proposes to cancel certain orders subject
to the Display-Price Sliding process in certain Pilot Securities for
the duration of the Pilot Period.
    \58\ See supra Item II.A.2.
    \59\ See supra Item II.A.1-2.
---------------------------------------------------------------------------

    The Commission is concerned that proposed rule changes, other than
those necessary for compliance with Plan, that are targeted at Pilot
Securities, that have a disparate impact on different Test Groups and
the Control Group, and that are to apply temporarily only for the Pilot
Period, could bias the results of the Pilot and undermine the value of
the data generated in informing future policy decisions. Accordingly,
the Commission is concerned that the proposed rule change may not be
consistent with Act, including Section 6(b)(5) thereof and Rule 608 of
Regulation NMS, or with the Plan.
    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 No. SR-BatsBYX-2016-17 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-BatsBYX-2016-17. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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 such filing will also 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 No. SR-BatsBYX-2016-17 and should be
submitted on or before August 10, 2016.
---------------------------------------------------------------------------

    \60\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\60\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2016-17092 Filed 7-19-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42926-42927]
[FR Doc No: 2019-17713]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0093]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Review Transparency
and Communication in Reviews of 351(k) Biologics License Applications
in Biosimilars User Fee Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by
September 18, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0746.
Also include the FDA docket number found in brackets in the heading of
this document.

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

Evaluation of the Program for Enhanced Review Transparency and
Communication for New Molecular Entity New Drug Applications and
Original Biologics License Applications in Prescription Drug User Fee
Acts and 351(k) Biologics License Applications in Biosimilars User Fee
Act

OMB Control Number 0910-0746--Extension

    This information collection supports the above captioned review
program (``the Program''). The Program is part of our performance
commitment under the fifth and sixth authorizations of the Prescription
Drug User Fee Act (PDUFA), which allows us to collect user fees for the
review of human drug and biologics applications for FYs 2013 through
2021, and the second authorization of the Biosimilars User Fee Act
(BsUFA II), which applies to 351(k) BLAs for FYs 2018 through 2021. The
Program is described in detail in FDA's Commitment Letters for PDUFA VI
and BsUFA II, available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf and https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf.
    The Program goals are to increase the efficiency and effectiveness
of the first review cycle and decrease the number of review cycles
necessary for approval so that patients have timely access to safe,
effective, and high quality new drugs and biologics. A key aspect of
the extension of the Program to BsUFA II is to conduct an interim and
final assessment that will evaluate how well the parameters of the
Program have achieved the intended goals. The BsUFA II Commitment
Letter specifies that an independent contractor can conduct the
assessments and specifies that they include interviews of sponsors who
submit 351(k) BLAs to the Program in BsUFA II. In accordance with the
PDUFA V and BsUFA II Commitment Letters, we contracted Eastern Research
Group, Inc. (ERG) to conduct independent interviews of applicants after
FDA issues a first-cycle action for applications reviewed under the
Program. The purpose of these interviews is to collect feedback from
applicants on the success of the Program in increasing transparency and
communication of reviews during the review process. ERG will anonymize
and aggregate sponsor responses before inclusion in the assessments and
presentation materials at public meetings. We will publish in the
Federal Register for public comment

ERG's assessments with interview results and findings.
    In the Federal Register of March 12, 2019 (84 FR 8877), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        Portion of study             Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Pre-test........................               5               1               5             1.5             7.5
Interviews......................              75               1              75             1.5           112.5
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             120
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since the last OMB approval of the information collection, we have
adjusted our estimate downward by 60 survey respondents. We base our
estimate on the most recent number of annual surveys. ERG interviews
between one and three sponsor representatives for each 351(k) BLA
first-cycle action issued for applications reviewed under the Program.
ERG also conducts a pretest of the interview protocol with five
respondents. Assuming it will take 1 to 1.5 hours to complete the
pretest, we calculate a total of 7.5 annual burden hours. We estimate
that up to 75 respondents will take part in the post-action interviews
each year. Assuming each interview will last 1 to 1.5 hours, we
calculate a total of 112.5 annual burden hours.

    Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17713 Filed 8-16-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Rules and Regulations]
[Page 27039]
[FR Doc No: 2019-12230]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0426]

Safety Zones; Annual Events in the Captain of the Port Buffalo
Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce certain safety zones located in
the federal regulations for Annual Events in the Captain of the Port
Buffalo. This action is necessary and intended to protect the safety of
life and property on navigable waters prior to, during, and immediately
after these events. During each enforcement period, no person or vessel
may enter the respective safety zone without the permission of the
Captain of the Port Buffalo.

DATES: The regulations in 33 CFR 165.939 as listed in Table 165.939
will be enforced for the events and times as stated in the
SUPPLEMENTARY INFORMATION section below.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LT Sean Dolan, Chief of Waterways
Management, U.S. Coast Guard Sector Buffalo telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety
Zones; Annual Events in the Captain of the Port Buffalo Zone listed in
33 CFR 165.939 for the following events:

    1. Boldt Castle 4th of July Fireworks, Heart Island, NY; The
safety zone listed in Table 165.939 as (b)(13) will be enforced from
9 p.m. through 10:30 p.m. on July 4, 2019.
    2. Clayton Chamber of Commerce Fireworks, Calumet Island, NY;
The safety zone listed in Table 165.939 as (b)(14) will be enforced
from 9:30 p.m. through 10:30 p.m. on July 3, 2019.
    3. French Festival Fireworks, Cape Vincent, NY; The safety zone
listed in Table 165.939 as (b)(15) will be enforced from 9:15 p.m.
to 10:45 p.m. on July 13, 2019.
    4. Lyme Community Days, Chaumont, NY; The safety zone listed in
Table 165.939 as (b)(16) will be enforced from 9:15 p.m. through
10:15 p.m. on July 27, 2019.
    5. Brewerton Fireworks, Brewerton, NY; The safety zone listed in
Table 165.939 as (b)(19) will be enforced from 9:30 p.m. through
10:15 p.m. on July 3, 2019 with a rain date of July 6, 2019.
    6. Village Fireworks, Sodus Point, NY; The safety zone listed in
Table 165.939 as (b)(22) will be enforced within a 560-foot radius
of position 43[deg]1'633'' N, 076[deg]58'27'' W, from 9:30 p.m.
until 10:30 p.m. on July 3, 2019 with a rain date of July 5, 2019.
    7. A Salute to our Heroes, Hamlin Beach State Park, NY; The
safety zone listed in Table 165.939 as (b)(23) will be enforced from
10 p.m. until 11 p.m. on June 29, 2019.
    8. Olcott Fireworks, Olcott, NY; The safety zone listed in Table
165.939 as (b)(24) will be enforced from 9:45 p.m. through 10:45
p.m. on July 3, 2019 with a rain date of July 6, 2019.
    9. North Tonawanda Fireworks, North Tonawanda, NY; The safety
zone listed in Table 165.939 as (b)(25) will be enforced within a
700-foot radius of position 43[deg]01'47.3'' N, 078[deg]53'14.7'' W
from 9:15 p.m. through 10:15 p.m. on July 4, 2019 with a rain date
of July 5, 2019.
    10. Tonawanda's Canal Fest Fireworks, Tonawanda, NY; The safety
zone listed in Table 165.939 as (b)(26) will be enforced from 9:15
p.m. until 10:15 p.m. on July 21, 2019.
    11. Tom Graves Memorial Fireworks, Port Bay, NY; The safety zone
listed in Table 165.939 as (b)(27) will be enforced within a 420-
foot radius of position 43[deg]17'54.2'' N, 076[deg]49'50.9'' W from
9:45 p.m. through 10:45 p.m. on July 3, 2019.
    12. Oswego Independence Day Celebration Fireworks, Oswego, NY;
The safety zone listed in Table 165.939 as (b)(29) will be enforced
from 9 p.m. through 9:45 p.m. on July 7, 2019 with a rain date of
July 14, 2019.

    Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring
within the safety zones during an enforcement period is prohibited
unless authorized by the Captain of the Port Buffalo or a designated
representative. Those seeking permission to enter the safety zones may
request permission from the Captain of Port Buffalo via channel 16,
VHF-FM. Vessels and persons granted permission to enter the safety
zones shall obey the directions of the Captain of the Port Buffalo or a
designated representative. While within a safety zone, all vessels
shall operate at the minimum speed necessary to maintain a safe course.
    This notice of enforcement is issued under authority of 33 CFR
165.939 and 5 U.S.C. 552 (a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide the maritime
community with advance notification of this enforcement period via
Broadcast Notice to Mariners or Local Notice to Mariners. If the
Captain of the Port Buffalo determines that the safety zone 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
respective safety zone.

    Dated: June 5, 2019.
Joseph S. Dufresne,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2019-12230 Filed 6-10-19; 8:45 am]
 BILLING CODE 9110-04-P