[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Page 48791]
[FR Doc No: 2016-17708]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0684; FRL-9949-60-ORD]

External Peer Review Meeting for Draft Guidelines for Human
Exposure Assessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) is
announcing that Versar, a contractor to the EPA, will convene an
independent panel of experts to review the draft document, Guidelines
for Human Exposure Assessment (draft guidelines). EPA previously
announced release of the draft guidance for comment. The public comment
period ended on March 22, 2016.
    The public may register to attend this peer review meeting and time
will be set aside at the meeting for brief oral comments from the
public regarding the draft document. The draft document is available:
Via the internet at http://www.regulations.gov or www.epa.gov/osa/guidelines-human-exposure-assessment; or from Dr. Michael Broder via
the contact information below.

DATES: The peer review meeting on the draft document, Guidelines for
Human Exposure Assessment will be held on August 15-16, 2016. The
meeting will run from approximately 1 p.m. to 5 p.m. Eastern Daylight
Time on August 15 and from 8:30 a.m. to 5 p.m. Eastern Daylight Time on
August 16, 2016.

ADDRESSES: The meeting will be held at the following address: Crystal
City Marriott at Reagan National Airport, located at 1999 Jefferson
Davis Highway, Arlington, VA 22202. Versar, Inc. invites the public to
register to attend this meeting, either in-person or via
teleconference. The phone number for the teleconference line will be
provided to register prior to the meeting.
     Internet: The draft document can be downloaded from http://www.regulations.gov Docket ID No. EPA-HQ-ORD-2015-0684.
     Instructions: To attend the peer review meeting, either
in-person or via teleconference, you must register no later than August
12, 2016. You may do this by calling Versar at<PHONE_NUMBER>; sending
a facsimile to<PHONE_NUMBER> ATTN: Exposure Guidelines Peer Review
Registration (include your name, title, affiliation, full address,
email, and phone number); or sending an email to Mr. David Bottimore of
Versar, Inc. at<EMAIL_ADDRESS>(Subject line: Exposure
Guidelines Peer Review Registration and include your name, title,
affiliation, full address, email, and phone number). Please indicate
which day(s) you plan to attend the meeting and whether you plan to
attend via teleconference or in-person. Space is limited, and
registrations will be accepted on a first-come, first-served basis.
There will be a limited amount of time for comments from the public at
the peer review meeting. Please inform Versar if you wish to make oral
comments during the meeting.
     Information on Services for Individuals with Disabilities:
The Agency welcomes public attendance at the peer review meeting on the
draft document, Guidelines for Human Exposure Assessment, and will make
every effort to accommodate persons with disabilities. For information
on access or services for individuals with disabilities, contact David
Bottimore of Versar at<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Dr. Michael Broder, Office of the
Science Advisor, Mail Code 8105R, U.S. Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number
(202) 564-3393; fax number<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The current guidance document for human
exposure assessment, Guidelines for Exposure Assessment, was published
in 1992, reflecting the state-of-the-science in the 1970s and 1980s.
Since its publication, the field of exposure science has undergone
significant transformation in methods and approaches, which EPA has
incorporated into its policies and practices to better align with the
current state-of-the-science. The 1992 guidelines are being updated to
reflect the advancement in exposure science and assessment and Agency
policies.
    The draft guidelines benefit from over two decades of experience
with EPA assessments conducted by Agency programs under their
respective authorities and constraints, and from input from external
panels, including the National Academy of Sciences and EPA's Science
Advisory Board. This draft document builds on topics covered in the
1992 exposure guidelines including planning and scoping for an
assessment, data acquisition and use, modeling, and considerations of
uncertainty in exposure assessment. It also includes new material on
planning and conducting an observational human exposure measurement
study and considerations of lifestages and sensitive populations in
exposure assessments. These draft guidelines present the most current
science used in EPA exposure assessments and incorporates information
about the Agency's current policies.

    Dated: July 19, 2016.
Thomas Burke,
EPA Science Advisor.
[FR Doc. 2016-17708 Filed 7-25-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 22, 2006 (Volume 71, Number 246)]
[Notices]
[Page 77010-77012]
[DOCID:fr22de06-62]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting; Notice

December 14, 2006.
    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C
552b:

AGENCY HOLDING MEETING: Federal Energy Regulatory Commission.

DATE AND TIME: December 21, 2006; 10 A.M.

PLACE: Room 2C, 888 First Street, NE., Washington, DC 20426.

STATUS: Open.

MATTERS TO BE CONSIDERED: Agenda.
    * Note.--Items listed on the agenda may be deleted without further
notice.

CONTACT PERSON FOR MORE INFORMATION: Magalie R. Salas, Secretary,
Telephone<PHONE_NUMBER>. For a recorded message listing items struck
from or added to the meeting, call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does not include a listing of all documents relevant to the items on
the agenda. All public documents, however, may be viewed on line at the
Commission's Web site at http://www.ferc.gov using the eLibrary link,

or may be examined in the Commission's Public Reference Room.

                             911th--Meeting
              [Regular Meeting December 21, 2006; 10 a.m.]
------------------------------------------------------------------------
     Item No.              Docket No.                   Company
------------------------------------------------------------------------
                          Administrative Agenda
------------------------------------------------------------------------
A-1..............  AD02-1-000................  Agency Administrative
                                                Matters.
A-2..............  AD02-7-000................  Customer Matters,
                                                Reliability, Security
                                                and Market Operations.
A-3..............  AD06-3-000................  Energy Market Update.
------------------------------------------------------------------------
                                Electric
------------------------------------------------------------------------
E-1..............  RM06-4-001................  Promoting Transmission
                                                Investment through
                                                Pricing Reform.
E-2..............  EC06-160-000..............  Duquesne Light Holdings,
                                                Inc., Duquesne Light
                                                Company, Duquesne Power,
                                                LLC, Duquesne Keystone,
                                                LLC, Duquesne Conemaugh,
                                                LLC, Monmouth Energy,
                                                Inc., DQE Holdings, LLC,
                                                DQE Merger Sub, Inc.,
                                                DUET Investment Holdings
                                                Limited, GIF2-MFIT
                                                United Pty Limited,
                                                Industry Funds
                                                Management (Nominees)
                                                Limited, as trustee of
                                                the IFM (International
                                                Infrastructure)
                                                Wholesale Trust, CLH
                                                Holdings, GP.
E-3..............  ER05-1410-001, EL05-148-    PJM Interconnection,
                    001, ER05-1410-000, EL05-   L.L.C.
                    148-000.
E-4,.............  EC05-1-000, EC05-1-001....  Old Dominion Electric
                                                Cooperative.
                   ..........................  New Dominion Energy
                                                Cooperative
E-5..............  EL06-105-000..............  NorthWestern Corporation.
E-6..............  ER06-1552-000.............  Midwest Independent
                                                Transmission System
                                                Operator, Inc.
E-7..............  ER07-99-000...............  New York Independent
                                                System Operator, Inc.
E-8..............  ER06-1517-000, EL07-14-     Wisconsin Power & Light
                    000, ER06-1518-000.         Co.
                   ..........................  Wisconsin Public Power
                                                Inc., Municipal
                                                Wholesale Power Group,
                                                and Great Lakes
                                                Utilities v. Wisconsin
                                                Power & Light Co.
E-9..............  ER07-106-000..............  Midwest Independent
                                                Transmission System
                                                Operator, Inc. and
                                                Ameren Services Company.

E-10.............  ER07-95-000...............  Michigan Electric
                                                Transmission Company,
                                                LLC and Midwest
                                                Independent Transmission
                                                System Operator, Inc.
E-11.............  ER07-166-000..............  Public Service Company of
                                                New Mexico and Texas-New
                                                Mexico Power Company.
E-12.............  ER07-108-000..............  ISO New England Inc.
E-13.............  ER07-116-000..............  ISO New England Inc.
E-14.............  ER07-93-000...............  Entergy Services, Inc.
E-15.............  ER07-169-000..............  Ameren Energy Marketing
                                                Company.
                   ER07-170-000..............  Ameren Energy, Inc.
E-16.............  ER07-173-000..............  Tampa Electric Company.
E-17.............  ER07-205-000..............  Ameren Energy Marketing,
                                                Central Illinois Light
                                                Company, Central
                                                Illinois Public Service
                                                Company, Illinois Power
                                                Company, Union Electric
                                                Company.
E-18.............  EC06-152-000..............  WPS Resources Corp. and
                                                Peoples Energy Corp.
E-19.............  ER06-919-000, ER06-919-001  Southern Company
                                                Services, Inc.
E-20.............  OMITTED...................
E-21.............  ER05-406-002..............  Williams Power Company,
                                                Inc.
E-22.............  EL07-7-000, QF89-251-009..  Las Vegas Cogeneration
                                                Limited Partnership.
E-23.............  EL06-90-000...............  PPL EnergyPlus, LLC, PPL
                                                Martins Creek, LLC, PPL
                                                Susquehanna, LLC, PPL
                                                Montour, LLC, PPL
                                                Brunner Island, LLC, PPL
                                                Holtwood, LLC, PPL
                                                University Park, LLC,
                                                Lower Mount Bethel
                                                Energy, LLC v. PJM
                                                Interconnection, L.L.C.
E-24.............  ER04-835-000..............  California Independent
                                                System Operator
                                                Corporation.
                   EL04-103-000..............  Pacific Gas and Electric
                                                Company v. California
                                                Independent System
                                                Operator Corporation.
E-25.............  OMITTED...................
E-26.............  OMITTED...................
E-27.............  ER06-1065-001.............  Northeast Utilities
                                                Service Company.
E-28.............  ER06-731-003..............  Midwest Independent
                                                Transmission System
                                                Operator, Inc.
E-29.............  ER07-114-000, ER05-516-     Pacific Gas & Electric
                    000, ER05-516-001, ER05-    Company.
                    911-000, ER05-1264-000,
                    ER05-95-000, ER06-948-
                    000, ER06-1306-000..
E-30.............  RM07-2-000................  Accounting and Reporting
                                                Requirements for
                                                Nonoperating Public
                                                Utilities and Licensees.
E-31.............  ER00-2268-017, EL05-10-008  Pinnacle West Capital
                                                Corporation.
                   ER99-4124-014, EL05-11-007  Arizona Public Service
                                                Company.
                   ER00-3312-015, EL05-12-007  Pinnacle West Energy
                                                Corporation.
                   ER99-4122-017, EL05-13-007  APS Energy Services
                                                Company, Inc.
------------------------------------------------------------------------
                              Miscellaneous
------------------------------------------------------------------------
M-1..............  AD07-4-000................  Process for Assessing
                                                Civil Penalties.
------------------------------------------------------------------------
                                   Gas
------------------------------------------------------------------------
G-1..............  RP07-34-000...............  Panhandle Complainants v.
                                                Southwest Gas Storage
                                                Company.
G-2..............  RP06-407-000, RP06-407-002  Gas Transmission
                                                Northwest Corporation.
G-3..............  OMITTED...................
------------------------------------------------------------------------
                                  Hydro
------------------------------------------------------------------------
H-1..............  P-7019-063................  Eastern Hydroelectric
                                                Corporation.
H-2..............  P-2686-051, P-2698-045, P-  Duke Power, a division of
                    2602-012.                   Duke Energy Corporation.
H-3..............  P-2503-107................  Duke Power Company, LLC.
H-4..............  P-516-435.................  South Carolina Electric &
                                                Gas Company.
H-5..............  P-459-166.................  AmerenUE.
H-6..............  EL06-91-000, P-12252-023..  Fourth Branch Associates
                                                (Mechanicsville) v.
                                                Hudson River--Black
                                                River Regulating
                                                District.
------------------------------------------------------------------------
                              Certificates
------------------------------------------------------------------------
C-1..............  CP98-150-006, CP98-150-     Millennium Pipeline
                    007, CP98-150-008.          Company, L.L.C.
                   CP98-151-003, CP98-151-004  Columbia Gas Transmission
                                                Corporation.
                   CP05-19-000...............  Columbia Gas Transmission
                                                Corporation.
                   CP06-5-000, CP06-5-000,     Empire State Pipeline and
                    CP06-5-002, CP06-6-000,     Empire Pipeline, Inc.
                    CP06-6-002, CP06-7-000,
                    CP06-7-002.
                   CP06-76-000...............  Algonquin Gas
                                                Transmission, LLC.
                   CP02-31-002...............  Iroquois Gas Transmission
                                                System, L.P.
C-2..............  CP06-102-000, CP06-102-001  Trunkline LNG Company,
                                                LLC.
------------------------------------------------------------------------

Magalie R. Salas,
Secretary.
    A free webcast of this event is available through http://www.ferc.gov.
 Anyone with Internet access who desires to view this

event can do so by navigating to http://www.ferc.gov's Calendar of Events and

locating this event in the Calendar. The event will contain a link to
its webcast. The Capitol Connection provides technical support for the
free webcasts. It also offers access to this event via television in
the DC area and via phone bridge for a fee. If you have any questions,
visit http://www.CapitolConnection.org or contact Danelle Perkowski or

David Reininger at<PHONE_NUMBER>.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in the Commission Meeting Room. Members of
the public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters, but will not be telecast through the Capitol
Connection service.

[FR Doc. E6-21962 Filed 12-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9057-9058]
[FR Doc No: 2022-03437]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0386]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Class II Special
Controls for Human Immunodeficiency Virus Serological Diagnostic and
Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid
Diagnostic and Supplemental Tests

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by March 21, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0437. 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 protected].

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.

Medical Device Reporting--21 CFR Part 803

OMB Control Number 0910-0437--Revision

    In the Federal Register of February 21, 2020 (85 FR 10110), we
published a proposed order to reclassify certain human immunodeficiency
virus (HIV) serological diagnostic and supplemental tests and HIV
nucleic acid (NAT) diagnostic and supplemental tests from class III
(premarket approval) into class II (special controls) (the proposed
order). In the proposed order, FDA proposed special controls that the
Agency believes are necessary to provide a reasonable assurance of
safety and effectiveness for these devices. The proposed special
controls would require the submission of a log of all complaints
annually for a period of 5 years following FDA clearance of a
traditional premarket notification (510(k)) submission for a device
within the scope of the proposed order.
    Currently, manufacturers of HIV serological diagnostic and
supplemental tests and HIV NAT diagnostic and supplemental tests are
subject to FDA

regulations in part 820 (21 CFR part 820), which govern the methods
used in, and the facilities and controls used for, the design,
manufacture, packaging, labeling, storage, installation, and servicing
of all finished devices intended for human use. Manufacturers are
required to maintain complaint files and to review and evaluate
complaints for these devices under Sec.  820.198 (21 CFR 820.198)
(approved under OMB control number 0910-0073).
    Complaints required to be reported in the annual logs under the
proposed special controls, such as certain complaints involving
unusually high invalid rates or issues with users conducting the test,
may not meet the definition of a medical device report required to be
reported to FDA under 21 CFR part 803 (Medical Device Reporting;
currently approved under OMB control number 0910-0437), but could
potentially affect the safety and effectiveness of these devices. The
submission of the complaint log would provide us with earlier
notification of concerns and enable us to determine whether they have
been adequately addressed. The Agency usually would not evaluate this
kind of complaint information until an FDA inspection, which typically
occurs less frequently than annually. We believe implementing these
specific reporting measures as part of the special controls would be
necessary to provide a reasonable assurance of safety and effectiveness
for HIV diagnostic and supplemental tests subject to the proposed
order.
    Finalizing the proposed order would add classification regulations
for these devices in 21 CFR part 866 (Immunology and Microbiology
Devices) at 21 CFR 866.3956 for the HIV serological diagnostic and
supplemental tests, and 21 CFR 866.3957 for the HIV NAT diagnostic and
supplemental tests, and establish special controls necessary to provide
reasonable assurance of their safety and effectiveness. As described
above, the special controls would require the submission of a log of
all complaints annually for a period of 5 years following FDA clearance
of a traditional 510(k) submission for one of these devices. We are
requesting approval to revise the scope of the information collections
included in OMB control number 0910-0437 (medical device reporting) to
include the information collection associated with this special control
provision.
    Description of Respondents: The respondents to the information
collection are manufacturers of HIV diagnostic and supplemental test
devices that would be subject to the proposed order, if finalized.
    In the Federal Register of June 25, 2021 (86 FR 33708), we
published a 60-day notice requesting public comment on the new
reporting provisions of the proposed order. One comment was received,
however it was not responsive to the four information collection topics
solicited, nor did it suggest FDA revise its burden estimate.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      21 CFR section; activity                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed 21 CFR 866.3956(b)(1)(iii) and 866.3957(b)(1)(iii),                     10                1               10                3               30
 Submission of log to FDA..........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate of the average burden per response on our
experience with other types of annual report submissions. We base our
estimate of the number of affected respondents on the expected number
of manufacturers that would be submitting a 510(k) for a new device or
changes to an existing device that would require a 510(k).
    As noted above, manufacturers of the devices subject to the
proposed order must already maintain complaint files and review and
evaluate complaints under Sec.  820.198. If the proposed order is
finalized as proposed, we estimate it would take a manufacturer
approximately 3 hours annually to review their existing records,
prepare the complaint log, and submit it to FDA. Although respondents
may submit the information electronically through the FDA Electronic
Submission Gateway, on paper, or electronic media (e.g., CD, DVD) to
the Center for Biologics Evaluation and Research's Document Control
Center, we assume that all manufacturers will submit their logs
electronically.

    Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03437 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Notices]
[Pages 74683-74685]
[FR Doc No: 2022-26443]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96413; File No. SR-GEMX-2022-11]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Definition of Short Term Option Series

November 30, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 18, 2022, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') 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 proposes to amend Options 1, General Provisions. The
Exchange also proposes amendments within General 2, Organization and
Administration.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/gemx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend the description of the term ``Short
Term Option Series'' within Options 1, Section 1, Definitions, to
conform the term to Nasdaq ISE, LLC's (``ISE'') term of Short Term
Option Series which was recently amended.\3\ The Exchange also proposes
certain non-substantive amendments. Each change is described below.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 96281 (November 9,
2022), 87 FR 68769 (November 16, 2022) (SR-ISE-2022-18) (Order
Granting Approval of a Proposed Rule Change to Amend the Short Term
Option Series Program).
---------------------------------------------------------------------------

Short Term Option Series
    Options 1, Section 1(a)(48) describes the term ``Short Term Option
Series'' as follows:

    The term ``Short Term Option Series'' means a series in an
option class that is approved for listing and trading on the
Exchange in which the series is opened for trading on any Monday,
Tuesday, Wednesday, Thursday, or Friday that is a business day and
that expires on the Monday, Wednesday or Friday of the following
business week that is a business day, or, in the case of a series
that is listed on a Friday and expires on a Monday, is listed one
business week and one business day prior to that expiration. If a
Tuesday, Wednesday, Thursday or Friday is not a business day, the
series may be opened (or shall expire) on the first business day
immediately prior to that Tuesday, Wednesday, Thursday or Friday.
For a series listed pursuant to this section for Monday expiration,
if a Monday is not a business day, the series shall expire on the
first business day immediately following that Monday.

    ISE's Options 4 rules were recently amended to expand the Short
Term Option Series program to permit the listing and trading of options
series with Tuesday and Thursday expirations for options on SPY and QQQ
listed pursuant to the Short Term Option Series Program.\4\ In
conjunction with that change, ISE amended its definition of Short Term
Option Series, within Options 1, Section 1(a)(49), to accommodate the
listing of options series that expire on Tuesdays and Thursdays.\5\
Specifically, the Exchange added Tuesday and Thursday to the permitted
expiration days, which currently include Monday, Wednesday, and Friday,
that it may open for trading.
---------------------------------------------------------------------------

    \4\ See note 3 above. GEMX's Options 4 Rules are incorporated by
reference to ISE's Options 4 Rules.
    \5\ See note 3 above.
---------------------------------------------------------------------------

    At this time, the Exchange proposes to amend the term ``Short Term
Option Series'' at Options 1, Section 1(a)(48) to provide,

    The term ``Short Term Option Series'' means a series in an
option class that is approved for listing and trading on the
Exchange in which the series is opened for trading on any Monday,
Tuesday, Wednesday, Thursday, or Friday that is a business day and
that expires on the Monday, Tuesday, Wednesday, Thursday, or Friday
of the following business week that is a business day, or, in the
case of a series that is listed on a Friday and expires on a Monday,
is listed one business week and one business day prior to that
expiration. If a Tuesday, Wednesday, Thursday or Friday is not a
business day, the series may be opened (or shall expire) on the
first business day immediately prior to that Tuesday, Wednesday,
Thursday or Friday. For a series listed pursuant to this section for
Monday expiration, if a Monday is not a business day, the series
shall expire on the first business day immediately following that
Monday.

    Today, GEMX's listing rules permit the listing and trading of
options series with Tuesday and Thursday expirations for options on SPY
and QQQ listed pursuant to the Short Term Option Series Program.\6\
---------------------------------------------------------------------------

    \6\ GEMX's Options 4 Rules are incorporated by reference to
ISE's Options 4 Rules and therefore the approval of ISE's Options 4
rules permits the listing and trading of options series with Tuesday
and Thursday expirations for options on SPY and QQQ on GEMX.

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

Other Non-Substantive Amendments
    The Exchange proposes to make other amendments to reserve certain
sections of the Rulebook. These sections contain content in other
Nasdaq affiliated rulebooks. To harmonize the section numbers across
the Nasdaq affiliated markets, the Exchange proposes to reserve General
2, Sections 23 and 24. These amendments are non-substantive.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

Short Term Option Series
    The Exchange's proposal to amend the term ``Short Term Option
Series'' at Options 1, Section 1(a)(48) to reflect the recent change
\9\ to GEMX's listing rules to permit the listing and trading of
options series with Tuesday and Thursday expirations for options on SPY
and QQQ listed pursuant to the Short Term Option Series Program is
consistent with the Exchange Act. This proposal will align the
description of Short Term Option Series within Options 1, Section
1(a)(48) to the expirations permitted within the Short Term Option
Series Program within Supplementary .03(a) to Options 4, Section 5.
---------------------------------------------------------------------------

    \9\ See note 3 above.
---------------------------------------------------------------------------

Other Non-Substantive Amendments
    The Exchange's proposal to reserve certain sections of the
Rulebook, namely General 2, Sections 23 and 24, to harmonize section
numbers across the Nasdaq affiliated markets is non-substantive.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.
Short Term Option Series
    The Exchange's proposal to amend the term ``Short Term Option
Series'' at Options 1, Section 1(a)(48) to reflect the recent change
\10\ to GEMX's listing rules to permit the listing and trading of
options series with Tuesday and Thursday expirations for options on SPY
and QQQ listed pursuant to the Short Term Option Series Program does
not impose an undue burden on competition, rather this proposal will
align the description of Short Term Option Series within Options 1,
Section 1(a)(48) to the expirations permitted within the Short Term
Option Series Program within Supplementary .03(a) to Options 4, Section
5.
---------------------------------------------------------------------------

    \10\ See note 3 above.
---------------------------------------------------------------------------

Other Non-Substantive Amendments
    The Exchange's proposal to make other amendments to reserve certain
sections of the Rulebook, namely General 2, Sections 23 and 24, to
harmonize section numbers across the Nasdaq affiliated markets is non-
substantive.

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

    No written comments were either solicited or received.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
Because the foregoing proposed rule change does not: (i) significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, it has become effective pursuant to
Section 19(b)(3)(A)(iii) of the Act \13\ and subparagraph (f)(6) of
Rule 19b-4 thereunder.\14\ The Exchange has stated that the Options 4
listing rules were recently amended to expand the Short Term Option
Series program to permit the listing and trading of options series with
Tuesday and Thursday expirations for options on SPY and QQQ listed
pursuant to the Short Term Option Series Program,\15\ and that waiver
of the 30-day operative delay will allow the Exchange to conform the
definition of a Short Term Option Series to the Options 4 listing
rules. The Commission believes that waiver of the 30-day operative
delay is consistent with the protection of investors and the public
interest because the proposed rule change does not raise any new or
novel issues. Accordingly, the Commission hereby waives the operative
delay and designates the proposed rule change operative upon
filing.\16\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
    \15\ See supra note 4.
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-GEMX-2022-11 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-GEMX-2022-11. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written

communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
GEMX-2022-11, and should be submitted on or before December 27, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12), (59).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-26443 Filed 12-5-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 117 (Tuesday, June 22, 2021)]
[Rules and Regulations]
[Page 32635]
[FR Doc No: 2021-13022]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0401]

Safety Zone; Southern California Annual Fireworks for the San
Diego Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a safety zone for the Sea World
Fireworks for nightly shows from Memorial Day to Labor Day in 2021, to
provide for the safety of life on navigable waterways during this
event. Our regulation for the Southern California annual fireworks for
the San Diego Captain of the Port Zone identifies the regulated area
for the events. During the enforcement period, no spectators shall
anchor, block, loiter in, or impede the transit of official patrol
vessels in the regulated area without the approval of the Captain of
the Port, or his designated representative.

DATES: The regulations 33 CFR 165.1123 will be enforced for the
location identified in Item 7 of Table 1 to Sec.  165.1123 from 8:30
p.m. until 10 p.m., each day without actual notice from June 22, 2021
through September 6, 2021. For the purposes of enforcement, actual
notice will be used from June 15, 2021 until June 22, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Lieutenant Commander John
Santorum, Waterways Management, U.S. Coast Guard Sector San Diego, CA;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the regulations
in 33 CFR 165.1123 for a safety zone for the Sea World Fireworks on the
waters of Mission Bay, CA in Sec.  165.1123, Table 1, Item 7 of that
section, from 8:30 p.m. until 10 p.m. on specific evenings from
Memorial Day to Labor Day in 2021. This action is being taken to
provide for the safety of life on navigable waterways during the
fireworks events. Our regulation for Southern California annual
fireworks events for the San Diego Captain of the Port Zone identifies
the regulated area for the events. Under the provisions of Sec.
165.1123, a vessel may not enter the regulated area, unless it receives
permission from the Captain of the Port, or his designated
representative. Spectator vessels may safely transit outside the
regulated area but may not anchor, block, loiter, or impede the transit
of participants or official patrol vessels. The Coast Guard may be
assisted by other Federal, State, or Local law enforcement agencies in
enforcing this regulation.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard plans to provide notification of this enforcement
period via the Local Notice to Mariners.

    Dated: June 15, 2021.
T.J. Barelli,
Captain, U. S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2021-13022 Filed 6-21-21; 8:45 am]
BILLING CODE 9110-04-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

			Issued by the Department of Transportation on December 22, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-13472

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  CityJet Limited						Date Filed: December 1, 2003

Relief requested:  Renew exemption from 49 U.S.C. 41301 to permit
CityJet to display the airline designator code of Delta Air Lines on
intra-European city-pair segments on which CityJet operates flights for
Air France.

If renewal, date and citation of last action:  December 4, 2002, in this
docket

Applicant representative:  Michael Goldman<PHONE_NUMBER>		DOT analyst:
Shelita Smith<PHONE_NUMBER>

Responsive pleadings:  None

	DISPOSITION

Action:  Approved									Action date:  December 22, 2003

Effective dates of authority granted:  December 22, 2003 – December
22, 2004

Basis for approval (bilateral agreement/reciprocity):  U.S.-France Air
Transport Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

_X_ Standard exemption conditions (attached)        __ Foreign air
carrier permit conditions (Order   -  -  )

Code-share conditions contained in Notice of Action taken dated December
4, 2002, in Docket OST-2000-6939

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
____________________________________________________________

We found that the applicant was qualified to perform its proposed
operations.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that  (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its Principal Security Inspector (PSI) to advise the PSI of its
plans and to find out whether the Transportation Security Administration
has determined that security is adequate to allow such airport(s) to be
served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

08/2003


[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Rules and Regulations]
[Pages 14169-14170]
[FR Doc No: 2022-05315]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 112, 117, 121, and 507

[Docket No. FDA-2021-D-0563]

Current Good Manufacturing Practice and Preventive Controls,
Foreign Supplier Verification Programs, Intentional Adulteration, and
Produce Safety Regulations: Enforcement Policy Regarding Certain
Provisions; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a final guidance for industry entitled
``Current Good Manufacturing Practice and Preventive Controls, Foreign
Supplier Verification Programs, Intentional Adulteration, and Produce
Safety Regulations: Enforcement Policy Regarding Certain Provisions.''
This guidance states Agency policy regarding enforcement of certain
requirements related to supply-chain programs for contract
manufacturers/processors, the intentional adulteration regulation, and
supplier approval and verification requirements in the Current Good
Manufacturing Practice and Preventive Controls Regulations and the
Foreign Supplier Verification Programs (FSVP) Regulation.

DATES: The announcement of the guidance is published in the Federal
Register on March 14, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0563 for ``Current Good Manufacturing Practice and
Preventive Controls, Foreign Supplier Verification Programs,
Intentional Adulteration, and Produce Safety Regulations: Enforcement
Policy Regarding Certain Provisions.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    For questions relating to CGMP, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.
    For questions relating to CGMP, Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals: Jennifer Erickson, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.
    For questions relating to Foreign Supplier Verification Programs
for Importers of Food for Humans and Animals: Kevin Kwon, Center for
Food Safety and Applied Nutrition (HFS-600), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.
    For questions relating to Mitigation Strategies to Protect Food
Against Intentional Adulteration: Ryan Newkirk, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.
    For questions relating to Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption: Samir Assar,
Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Current Good Manufacturing Practice and Preventive Controls,
Foreign Supplier Verification Programs, Intentional Adulteration, and
Produce Safety Regulations: Enforcement Policy Regarding Certain
Provisions.'' We are issuing the guidance consistent with our good
guidance practices regulation (21 CFR 10.115). We are implementing the
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (Sec.
10.115(g)(2)). We made this determination because the guidance presents
a less burdensome policy consistent with the public health. Although
this guidance is immediately in effect, it remains subject to comment
in accordance with FDA's good guidance practices regulation.
    This guidance concerns five of the seven foundational rules that we
have established in Title 21 of the Code of Federal Regulations (21
CFR) as part of our implementation of the FDA Food Safety Modernization
Act (Pub. L. 111-353). The five final rules are entitled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food'' (published in the Federal Register of
September 17, 2015, 80 FR 55908) (part 117); ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals'' (published in the Federal Register of
September 17, 2015, 80 FR 51670) (part 507); ``Foreign Supplier
Verification Programs for Importers of Food for Humans and Animals''
(published in the Federal Register of November 27, 2015, 80 FR 74226)
(FSVP regulation); ``Mitigation Strategies to Protect Food Against
Intentional Adulteration'' (published in the Federal Register of May
27, 2016, 81 FR 34166) (IA regulation or part 121); and ``Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption'' (published in the Federal Register of November 27, 2015,
80 FR 74354) (https://www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm) (Produce Safety regulation or part 112).
    In the guidance we state that, at this time and based on our
current understanding of the risks, we do not intend to enforce certain
regulatory requirements for certain entities and/or activities covered
by these five rules:
     Extension of FDA's intent not to take enforcement action
in certain circumstances against a receiving facility that is a
contract manufacturer/processor not in compliance with certain supply-
chain program requirements for food manufactured for a brand owner.
     Under the intentional adulteration regulation:
    [cir] Intent not to enforce the intentional adulteration regulation
requirements for facilities under the preexisting farm-activity related
enforcement policy, and
    [cir] Intent not to enforce the requirement for reanalysis in
certain circumstances, for example, when there is a single failure that
is addressed through implementation of corrective action procedures.
     Intent not to enforce the supplier approval and
verification requirements in parts 117 and 507 and the FSVP regulation
with regard to supplier compliance with requirements that are already
associated with an enforcement discretion policy.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in part 117 have been approved under OMB control number
0910-0751. The collections of information in part 507 have been
approved under OMB control number 0910-0789. The collections of
information in 21 CFR part 1, subpart L have been approved under OMB
control number 0910-0752. The collections of information in 21 CFR part
121 have been approved under OMB control number 0910-0812. The
collections of information in part 112 have been approved under OMB
control number 0910-0816.

III. Electronic Access

    Persons with access to the internet may obtain the document at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed
in the previous sentence to find the most current version of the
guidance.

    Dated: March 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05315 Filed 3-11-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Notices]
[Pages 49136-49140]
[FR Doc No: 2014-19578]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72830; File No. SR-BATS-2014-030]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use of BATS Exchange, Inc.

August 13, 2014.
    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 August 1, 2014, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to BATS Rules
15.1(a) and (c). Changes to the fee schedule pursuant to this proposal
are effective upon filing.
---------------------------------------------------------------------------

    \5\ A Member is defined as ``any registered broker or dealer
that has been admitted to membership in the Exchange.'' See Exchange
Rule 1.5(n).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to modify its fee schedule applicable to use
of the Exchange in order to: (i) Add an additional ``Step-Up Tier'' for
purposes of tiered pricing applicable to the Exchange's equities
trading platform (``BATS Equities''); (ii) introduce an ``Options Step-
Up Tier'' and a corresponding definition of ``Options Step-Up Add TCV''
for purposes of tiered pricing applicable to the Exchange's equity
options trading platform (``BATS Options''); (iii) reduce the fee
charged by BATS Options to remove liquidity for all Customer \6\ orders
in securities subject to the options penny pilot program (``Penny Pilot
Securities''); and (iv) increase the fee charged by BATS Options for
Professional,\7\ Firm, and Market Maker \8\ orders routed to and
executed at certain venues.
---------------------------------------------------------------------------

    \6\ As defined on the Exchange's fee schedule, a ``Customer''
order is any transaction identified by a Member for clearing in the
Customer range at the Options Clearing Corporation (``OCC''), except
for those designated as ``Professional''.
    \7\ The term ``Professional'' is defined in Exchange Rule 16.1
to mean any person or entity that (A) is not a broker or dealer in
securities, and (B) places more than 390 orders in listed options
per day on average during a calendar month for its own beneficial
account(s).
    \8\ As defined on the Exchange's fee schedule, the terms
``Firm'' and ``Market Maker'' apply to any transaction identified by
a member for clearing in the Firm or Market Maker range,
respectively, at the Options Clearing Corporation (``OCC'').
---------------------------------------------------------------------------

Additional Step-Up Tier--BATS Equities
    Currently, with respect to BATS Equities, the Exchange determines
the liquidity adding rebate that it will provide to Members using the
Exchange's tiered pricing structure, which is based on the Member
meeting certain volume tiers based on their

ADAV \9\ as a percentage of TCV \10\ or ADV \11\ as a percentage of
TCV. Under such pricing structure, a Member will receive an adding
rebate of anywhere between $0.0020 and $0.0032 per share executed,
depending on the volume tier for which such Member qualifies. The
Exchange also maintains two additional types of tiers in addition to
the volume tiers described above: Step-Up Tiers and a Cross-Asset Step-
Up tier. The Step-Up Tier and Cross-Asset Step-Up tier provide Members
with additional ways to qualify for enhanced rebates.
---------------------------------------------------------------------------

    \9\ As provided in the fee schedule, for purposes of BATS
Equities pricing, ``ADAV'' means average daily added volume
calculated as the number of shares added per day on a monthly basis;
the Exchange excludes from the ADAV calculation routed shares as
well as shares added on any day that the Exchange's system
experiences a disruption that lasts for more than 60 minutes during
regular trading hours (``Exchange System Disruption''), on any day
with a scheduled early market close and on the last Friday in June
(the ``Russell Reconstitution Day'').
    \10\ As provided in the fee schedule, for purposes of BATS
Equities pricing, ``TCV'' means total consolidated volume calculated
as the volume reported by all exchanges and trade reporting
facilities to a consolidated transaction reporting plan for the
month for which the fees apply, excluding volume on any day that the
Exchange experiences an Exchange System Disruption, on any with a
scheduled early market close and the Russell Reconstitution Day.
    \11\ As provided in the fee schedule, for purposes of BATS
Equities pricing, ``ADV'' means average daily volume calculated as
the number of shares added or removed, combined, per day on a
monthly basis; the Exchange excludes from the ADV calculation routed
shares, and shares added on any day that the Exchange's system
experiences an Exchange System Disruption, on any day with a
scheduled early market close and on the Russell Reconstitution Day.
---------------------------------------------------------------------------

    As proposed, the existing volume tiers, including the Step-Up Tiers
and Cross-Asset Step-Up Tier will remain the same. However, the
Exchange proposes to add a new tier to its fee schedule as Step-Up Tier
1, and to re-number the existing tiers as Step-Up Tiers 2 and 3. The
new proposed Step-Up Tier 1 would provide a rebate of $0.0025 per share
where the Member's Step-Up Add TCV is equal to or greater than 0.07%.
For purposes of BATS Equities pricing, the Exchange defines the term
``Step-Up Add TCV'' within the definition of ADAV as a percentage of
TCV in January 2014 subtracted from current ADAV as a percentage of
TCV. This definition would remain unchanged.
    A Member's Step-Up Add TCV is calculated as the increase in the
Member's current ADAV as a percentage of TCV (``Current ADAV'') over
the Member's ADAV as a percentage of TCV from January 2014 (``Baseline
ADAV''). By way of example, where a Member's Baseline ADAV is 0.07%,
the Member would qualify for new Step-Up Tier 1 if the Member's Current
ADAV is at least 0.14%. The Exchange is not proposing any changes to
pricing for BATS Equities other than the addition of the new Step-Up
Tier 1 and the re-numbering of the existing Step-Up Tiers.
    The Exchange's Step-Up Tiers, including the new proposed tier, are
designed to incentivize Members to increase their participation on the
Exchange in terms of their ADAV compared to their January 2014 ADAV.
The Exchange notes that the Step-Up tiers are similar to step-up tiers
currently employed by NYSE Arca, Inc. (``Arca'').\12\ As is currently
the case pursuant to the fee schedule, a Member will receive the higher
of the volume rebates, step-up rebates, or cross-asset step-up rebates
for which they qualify.
---------------------------------------------------------------------------

    \12\ See Exchange Act Release No. 64820 (July 12, 2011), 76 FR
40974 (July 6, 2011) (SR-NYSEArca-2011-41) [sic].
---------------------------------------------------------------------------

Options Step-Up Tier--BATS Options
    The Exchange also proposes to introduce an ``Options Step-Up Tier''
and a corresponding definition of ``Options Step-Up Add TCV'' for
purposes of tiered pricing applicable to adding liquidity in Penny
Pilot Securities to BATS Options. The Exchange notes that it already
maintains an Options Step-Up Tier for purposes of tiered pricing
applicable to BATS Equities. The Exchange also notes that the
definitions within the Options Pricing portion of the fee schedule of
TCV (``Options TCV'') \13\ and ADAV (``Options ADAV'') \14\ are similar
to but different than those under the Equities Pricing portion of the
fee schedule.
---------------------------------------------------------------------------

    \13\ As provided in the fee schedule, for purposes of BATS
Options pricing, ``TCV'' means total consolidated volume calculated
as the volume reported by all exchanges to the consolidated
transaction reporting plan for the month for which the fees apply,
excluding volume on any day that the Exchange experiences an
Exchange System Disruption and on any day with a scheduled early
market close.
    \14\ As provided in the fee schedule, for purposes of BATS
Options pricing, ``ADAV'' means average daily volume calculated as
the number of contracts added or removed, combined, per day on a
monthly basis; the Exchange excludes from the ADAV calculation
routed contracts, contracts added or removed on any day that the
Exchange experiences an Exchange System Disruption, and contracts
added or removed on any day with a scheduled early market close.
---------------------------------------------------------------------------

    The Exchange notes that its proposed definition of Options Step-Up
Add TCV for BATS Options pricing mirrors the definition of Options
Step-Up Add TCV under BATS Equities pricing with the exception of the
applicable baseline, which, for BATS Options is proposed to be June
2014 and for BATS Equities is January 2014. Thus, for purposes of BATS
Options pricing, the Exchange proposes to define ``Options Step-Up Add
TCV'' within the definition of ADAV as ``ADAV as a percentage of TCV in
June 2014 subtracted from current ADAV as a percentage of TCV, using
the definitions of ADAV and TCV.''
    Currently, for BATS Options, the Exchange provides a rebate of
$0.40 per contract for any Professional, Firm or Market Maker order
that adds liquidity in Penny Pilot Securities to the BATS Options order
book. In addition, Professional, Firm and Market Maker orders can
qualify for additional rebates to the extent they establish a new NBBO
and are submitted by a Member that qualifies based on volume conducted
on BATS Options (the ``NBBO Setter Program''). Further, Market Makers
(but only Market Makers) can qualify for additional rebates under the
Quoting Incentive Program (``QIP''), which is a program that
incentivizes Market Maker registration and quoting.
    In order to provide an additional incentive to Members to submit to
the Exchange Professional and Firm orders, the Exchange proposes to
adopt an Options Step-Up Tier for BATS Options that would provide a
rebate of $0.44 per contract for any Professional or Firm order that
adds liquidity to BATS Options and was submitted by a Member that has
an Options Step-Up Add TCV equal to or greater than 0.50%.
    A Member's Options Step-Up Add TCV would be calculated as the
increase in the Member's current ADAV as a percentage of TCV (``Current
Options ADAV'') over the Member's ADAV as a percentage of TCV from June
2014 (``Baseline Options ADAV''). By way of example, where a Member's
Baseline Options ADAV is 0.04% the Member would need to achieve a
Current Options ADAV of 0.54% in order to qualify for the Options Step-
Up Tier and its $0.44 per contract rebate.
    The Exchange proposes to continue to provide a rebate $0.40 per
contract for all other Professional, Firm and Market Maker orders and
does not propose any changes to applicable additional rebates such as
QIP and NBBO Setter rebates.
Customer Fee To Remove Liquidity--BATS Options
    The Exchange proposes to reduce the fee charged by BATS Options to
remove liquidity for all Customer orders in Penny Pilot Securities.
Currently, pricing on BATS Options for removing liquidity is based on
the capacity of the order that is executed (i.e., Customer or ``non-
Customer'', which includes all Professional, Firm and Market Maker
orders) as well as whether or not the

security is a Penny Pilot Security. BATS Options currently charges a
fee of $0.47 per contract for all Customer orders that remove liquidity
in Penny Pilot Securities. To encourage Members to submit Customer
orders to the Exchange, the Exchange proposes to reduce this fee to a
fee of $0.45 per contract for all Customer orders that remove liquidity
in Penny Pilot Securities.
Routing Fees--BATS Options
    Finally, the Exchange proposes to increase the fee charged by BATS
Options for Professional, Firm, and Market Maker orders routed to and
executed at certain venues.
    The Exchange currently charges certain flat rates for routing to
other options exchanges that have been placed into groups based on the
approximate cost of routing to such venues. The grouping of away
options exchanges is based on the cost of transaction fees assessed by
each venue as well as costs to the Exchange for routing (i.e., clearing
fees, connectivity and other infrastructure costs, membership fees,
etc.) (collectively, ``Routing Costs'').
    The Exchange currently charges $0.57 per contract for Professional,
Firm, and Market Maker orders routed to and executed at NYSE MKT LLC
(``AMEX''), the Chicago Board Options Exchange, Incorporated
(``CBOE''), the Miami International Securities Exchange, LLC
(``MIAX''), NASDAQ OMX BX, Inc. (``BX Options'') in Penny Pilot
Securities and the International Securities Exchange, LLC (``ISE'') in
Non-Penny Pilot Securities.
    Based on execution fees charged by some of these venues that exceed
the fees currently charged by the Exchange for Professional, Firm and
Market Maker orders routed to and executed at such venues (even without
taking other Routing Costs into consideration), the Exchange proposes
to increase fees for the options venues listed above.\15\ Specifically,
the Exchange proposes to charge $0.60 per contract for Customer orders
executed at AMEX, CBOE, MIAX, BX Options (Penny Pilot Securities) and
ISE (Non-Penny Pilot Securities). The Exchange is not proposing any
changes to pricing for Customer orders routed to and executed at these
options venues, which is currently set at a fee of $0.11 per contract.
---------------------------------------------------------------------------

    \15\ In particular, AMEX currently charges $0.58 to non-Customer
orders that remove liquidity in non-Penny Pilot Securities and CBOE
currently charges $0.60 to non-Customer orders that remove liquidity
in non-Penny Pilot Securities.
---------------------------------------------------------------------------

Implementation Date
    The Exchange proposes to implement these amendments to its fee
schedule on August 1, 2014.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\16\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\17\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues if they deem fee levels at a
particular venue to be excessive.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

Step-Up Tiers--BATS Equities and BATS Options
    The Exchange believes that providing additional financial
incentives to Members that demonstrate an increase over their Baseline
ADAV (or Options Baseline ADAV) through the Step-Up Tiers already in
place on BATS Equities and the proposed Step-Up Tier for BATS Options
offer additional, flexible ways to achieve financial incentives from
the Exchange and encourage Members to add increasing amounts of
liquidity to both BATS Equities and BATS Options. The Exchange believes
that these incentives are reasonable, fair and equitable because the
increased liquidity from each of these proposals also benefits all
investors by deepening the BATS Equities and BATS Options liquidity
pools, offering additional flexibility for all investors to enjoy cost
savings, supporting the quality of price discovery, promoting market
transparency and improving investor protection. Such pricing programs
thereby reward a Member's growth pattern and such increased volume
increase potential revenue to the Exchange, and will allow the Exchange
to continue to provide and potentially expand the incentive programs
operated by the Exchange. These pricing programs are also fair and
equitable in that they are available to all Members and will result in
Members receiving either the same or an increased rebate than they
would currently receive. Although non-Customer orders are typically
treated consistently by the Exchange and the Options Step-Up Tier will
only be applied to Professional and Firm orders, and not Market Maker
orders, the Exchange believes that this proposal is reasonable not
unfairly discriminatory because Market Makers are already able to reach
the same rebate level through the QIP, which is not available to
Professional or Firm orders. The Exchange also notes that the proposed
step-up tier are similar to pricing tiers currently available on
Arca.\18\
---------------------------------------------------------------------------

    \18\ See supra note 12.
---------------------------------------------------------------------------

    Volume-based rebates and fees such as the ones maintained on both
BATS Equities and BATS Options as well as the BATS Equities Step-Up
Tiers and the new BATS Options Step-Up Tier proposed herein, have been
widely adopted by equities and options exchanges and are equitable
because they are open to all Members on an equal basis and provide
additional benefits or discounts that are reasonably related to the
value to an exchange's market quality associated with higher levels of
market activity, such as higher levels of liquidity provision and/or
growth patterns, and introduction of higher volumes of orders into the
price and volume discovery processes. Further, the Exchange believes
that the Step-Up Tiers will provide such enhancements in market quality
on both BATS Equities and BATS Options by incentivizing increased
participation on both platforms. The Exchange notes that it is not
proposing to modify any existing tiers (other than to re-number the
Equities Step-Up Tiers), but rather to add new tiers that will provide
Members with additional ways to receive higher rebates. Accordingly,
under the proposal a Member will receive either the same or a higher
rebate than they would receive today. Accordingly, the Exchange
believes that the proposed additions to the Exchange's tiered pricing
structure and incentives are not unfairly discriminatory because they
will apply uniformly to all Members and are consistent with the overall
goals of enhancing market quality on both BATS Equities and BATS
Options. The Exchange again notes that it believes that restricting the
availability of the proposed Options Step-Up Tier for BATS Options to
Professional and Firm orders is reasonable and not unreasonably
discriminatory because Market Maker orders are already afforded an
opportunity to receive QIP rebates up to an additional $0.04 per
contract that is not available to

Professional and Firm orders. Thus, currently, Professional and Firm
orders can never receive the same maximum rebate that Market Maker
orders can receive but, pursuant to the proposal, there would be a way
for all three non-Customer capacities to achieve such maximum rebate.
Customer Fee To Remove Liquidity--BATS Options
    The Exchange believes that its proposal to reduce the Customer fee
to remove liquidity from BATS Options in Penny Pilot Securities is
reasonable, fair and equitably allocated because it will reduce the
cost of removing liquidity for all Customer orders and is intended to
enhance the competitiveness of the Exchange's pricing model. The fee
remains consistent with the fees changes by other markets with similar
fee structures, such as NYSE Arca and NOM. The Exchange believes that
the proposal is not unreasonably discriminatory because it will apply
equally to all Customer orders and is only slightly discounted as
compared to the fee to remove liquidity charged for non-Customer
orders.
Routing Fees--BATS Options
    As explained above, the Exchange generally attempts to approximate
the cost of routing to other options exchanges, including other
applicable costs to the Exchange for routing. The Exchange believes
that a pricing model based on approximate Routing Costs is a
reasonable, fair and equitable approach to pricing. Specifically, the
Exchange believes that its proposal to increase fees applicable to
Professional, Firm and Market Maker orders routed to and executed at
AMEX, CBOE, MIAX, BX Options (Penny Pilot Securities) and ISE (Non-
Penny Pilot Securities) is fair, equitable and reasonable because the
fees are generally an approximation of the cost to the Exchange for
routing orders to such exchanges. The Exchange believes that its flat
fee structure for orders routed to various venues is a fair and
equitable approach to pricing, as it provides certainty with respect to
execution fees at groups of away options exchanges. Under its flat fee
structure, taking all costs to the Exchange into account, the Exchange
may operate at a slight gain or slight loss for orders routed to and
executed at other options exchanges. As a general matter, the Exchange
believes that the proposed fees will allow it to recoup and cover its
costs of providing routing services to such exchanges. The Exchange
also believes that the proposed fee structure for orders routed to and
executed at these away options exchanges is fair and equitable and not
unreasonably discriminatory in that it applies equally to all Members.
    The Exchange reiterates that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels to be excessive or providers
of routing services if they deem fee levels to be excessive. Finally,
the Exchange notes that it constantly evaluates its routing fees,
including profit and loss attributable to routing, as applicable, in
connection with the operation of a flat fee routing service, and would
consider future adjustments to the proposed pricing structure to the
extent it was recouping a significant profit or loss from routing to
other options exchanges.

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, as amended. With
respect to the proposed new tiered rebates, the Exchange does not
believe that any such changes burden competition, but instead, enhance
competition, as they are intended to increase the competitiveness of
and draw additional volume to both BATS Equities and BATS Options. The
Exchange also believes the proposed step-up tiers would enhance
competition because they are similar to pricing tiers currently
available on Arca.\19\ Similarly, the proposal to reduce the fee for
Customer orders that remove liquidity in Penny Pilot Securities is a
competitive proposal that is intended to draw volume to BATS Options.
As stated above, the Exchange notes that it operates in a highly
competitive market in which market participants can readily direct
order flow to competing venues if the deem fee structures to be
unreasonable or excessive. Finally, the Exchange notes that the
proposed change to routing fees to certain options exchanges is not
intended as a competitive change to create an incentive or disincentive
to use the Exchange's routing strategies to route to these exchanges.
Rather, the proposed changes will assist the Exchange in recouping
costs for routing orders to other options exchanges on behalf of its
participants in a manner that is a better approximation of actual costs
than is currently in place. The Exchange also notes that Members may
choose to mark their orders as ineligible for routing to avoid
incurring routing fees.\20\
---------------------------------------------------------------------------

    \19\ See supra note 12.
    \20\ See BATS Rule 21.1(d)(8) (describing ``BATS Only'' orders
for BATS Options) and BATS Rule 21.9(a)(1) (describing the BATS
Options routing process, which requires orders to be designated as
available for routing).
---------------------------------------------------------------------------

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \21\ and paragraph (f) of Rule 19b-4
thereunder.\22\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(A).
    \22\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2014-030 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-BATS-2014-030. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the

submission, all subsequent amendments, all written statements with
respect to the proposed rule change that are filed with the Commission,
and all written communications relating to the proposed rule change
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BATS-2014-030, and should be
submitted on or before September 9, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-19578 Filed 8-18-14; 8:45 am]
BILLING CODE 8011-01-P