[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Page 79877]
[FR Doc No: 2015-32274]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP16-303-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Sec.  4(d) rate filing per 154.204: Settlement Rates
(2015) to be effective 11/1/2015.
    Filed Date: 12/16/15.
    Accession Number: 20151216-5062.
    Comments Due: 5 p.m. ET 12/28/15.

    Docket Numbers: RP16-304-000.
    Applicants: Bear Creek Storage Company, L.L.C.
    Description: Annual Fuel Assessment Report of Bear Creek Storage
Company, L.L.C. under RP16-304.
    Filed Date: 12/16/15.
    Accession Number: 20151216-5107.
    Comments Due: 5 p.m. ET 12/28/15.

    Docket Numbers: RP16-305-000.
    Applicants: NGO Transmission, Inc.
    Description: Sec.  4(d) rate filing per 154.204: Negotiated Rate
Filing to be effective 1/1/2016.
    Filed Date: 12/16/15.
    Accession Number: 20151216-5111.
    Comments Due: 5 p.m. ET 12/28/15.

    Docket Numbers: RP16-306-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Neg Rate 2015-12-
16 Encana to be effective 12/16/2015.
    Filed Date: 12/16/15.
    Accession Number: 20151216-5133.
    Comments Due: 5 p.m. ET 12/28/15.

    Docket Numbers: RP16-307-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) rate filing per 154.204: 12/16/15
Negotiated Rates--Spotlight Energy, LLC (RTS) 7725-02 to be effective
12/16/2015.
    Filed Date: 12/16/15.
    Accession Number: 20151216-5182.
    Comments Due: 5 p.m. ET 12/28/15.

    Docket Numbers: PR16-9-000.
    Applicants: Arcadia Gas Storage, LLC.
    Description: Tariff filing per 284.123(b)(2)/.: Arcadia Gas
Storage--Dec15 SOC Modifications to be effective 12/15/2015; Filing
Type: 760.
    Filed Date: 12/15/15.
    Accession Number:<PHONE_NUMBER>29.
    Comments/Protests Due: 5 p.m. ET 1/5/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 17, 2015.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2015-32274 Filed 12-22-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 31 (Thursday, February 16, 2017)]
[Rules and Regulations]
[Pages 10859-10860]
[FR Doc No: 2017-02772]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-7003; Directorate Identifier 2016-CE-015-AD;
Amendment 39-18766; AD 2016-26-08]
RIN 2120-AA64

Airworthiness Directives; PILATUS AIRCRAFT LTD. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting an airworthiness directive (AD) that
published in the Federal Register. That AD applies to all PILATUS
AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E
airplanes. The second reference to the main landing gear (MLG) in
paragraph (f)(6) is incorrect. This document corrects that error. In
all other respects, the original document remains the same; however we
are publishing the entire rule in the Federal Register.

DATES: This final rule is effective February 16, 2017. The effective
date of AD 2016-26-08 remains February 9, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of February 9,
2017 (82 FR 1172, January 5, 2017).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
7003; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Airworthiness Directive 2016-26-08,
Amendment 39-18766 (82 FR 1172, January 5, 2017), requires
incorporating new revisions into the Limitations section, Chapter 4, of
the FAA-approved maintenance program (e.g., maintenance manual). The
limitations were revised to include repetitive inspections of the main
landing gear (MLG) attachment bolts.
    As published, in paragraph (f)(6) there is a typographical error to
the second reference of the MLG. The published reference is MLB and it
is should be MLG.
    Although no other part of the preamble or regulatory information
has been corrected, we are publishing the entire rule in the Federal
Register.
    The effective date of this AD remains February 9, 2017.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Correction

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Corrected]

0
2. The FAA amends Sec.  39.13 by removing 39-18005 (79 FR 67343,
November 13, 2014) and adding the following new AD:

2016-26-08 PILATUS AIRCRAFT LTD.: Amendment 39-18766; Docket No.
FAA-2016-7003; Directorate Identifier 2016-CE-015-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective February 9, 2017.

(b) Affected ADs

    This AD replaces AD 2014-22-01, 39-18005 (79 FR 67343, November
13, 2014).

(c) Applicability

    This AD applies to PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45,
PC-12/47, and PC-12/47E airplanes, all manufacturer serial numbers
(MSNs), certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 5: Time Limits.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as a need to
incorporate new revisions into the Limitations section, Chapter 4,
of the FAA-approved maintenance program (e.g., maintenance manual).
The limitations were revised to include repetitive inspections of
the main landing gear (MLG) attachment bolts. These actions are
required to ensure the continued operational safety of the affected
airplanes.

(f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(6) of this AD:
    (1) Before further flight after February 9, 2017 (the effective
date of this AD), insert the following revisions into the
Limitations section of the FAA-approved maintenance program (e.g.,
maintenance manual). Compliance with an electronic version of the
Limitations section is acceptable provided the specifically
referenced sections are followed even though there may be
differences with the pagination:
    (i) STRUCTURAL, COMPONENT AND MISCELLANEOUS--AIRWORTHINESS
LIMITATIONS, Data module code 12-A-04-00-00-00A-000A-A, dated July
12, 2016, of the Pilatus Model type--PC-12, PC-12/45, PC-12/47 MSN-
101-888, Aircraft Maintenance Manual (AMM), Document No. 02049, 12-
A-AM-00-00-00-I, revision 32, dated July 18, 2016; and
    (ii) STRUCTURAL AND COMPONENT LIMITATIONS--AIRWORTHINESS
LIMITATIONS, Data module code 12-B-04-00-00-00A-000A-A, dated July
19, 2016, of the Pilatus Model type--PC-12/47E MSN-1001-UP, Aircraft
Maintenance Manual (AMM), Document No. 02300, 12-B-AM-00-00-00-I,
revision 15, dated July 30, 2016.
    (2) The new limitations section revisions listed in paragraphs
(f)(1)(i) and (ii) of this AD specify the following:
    (i) Establish inspections of the MLG attachment bolts,
    (ii) Specify replacement of components before or upon reaching
the applicable life limit, and
    (iii) Specify accomplishment of all applicable maintenance tasks
within certain thresholds and intervals.
    (3) Only authorized Pilatus Service Centers can do the
Supplemental Structural Inspection Document (SSID) as required by
the documents in paragraphs (f)(1)(i) and (ii) of this AD because
deviations from the type design in critical locations could make the
airplane ineligible for this life extension.
    (4) If no compliance time is specified in the documents listed
in paragraphs (f)(1)(i) and (ii) of this AD when doing any
corrective actions where discrepancies are found as required in
paragraph (f)(2)(iii) of this AD, do these corrective actions before
further flight after doing the applicable maintenance task.
    (5) During the accomplishment of the actions required in
paragraph (f)(2) of this AD, including all subparagraphs, if a
discrepancy is found that is not identified in the documents listed
in paragraphs (f)(1)(i) and (ii) of this AD, before further flight
after finding the discrepancy, contact PILATUS AIRCRAFT LTD. at the
address specified in paragraph (h) of this AD for a repair scheme
and incorporate that repair scheme.
    (6) Before or upon accumulating 6 years time-in-service (TIS) on
the MLG attachment bolts or within the next 3 months TIS after
February 9, 2017 (the effective date of this AD), whichever occurs
later, inspect the MLG attachment bolts for cracks and corrosion and
before further flight take all necessary corrective actions.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (i) Before using any approved AMOC on any airplane to which the
AMOC applies, notify your appropriate principal inspector (PI) in
the FAA Flight Standards District Office (FSDO), or lacking a PI,
your local FSDO.
    (ii) AMOCs approved for AD 2014-22-01, 39-18005 (79 FR 67343,
November 13, 2014) are not approved as AMOCs for this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2016-0083, dated April 28, 2016, for related information. You may
examine the MCAI on the Internet at https://www.regulations.gov/document?D=FAA-2016-7003-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) STRUCTURAL, COMPONENT AND MISCELLANEOUS--AIRWORTHINESS
LIMITATIONS, Data module code 12-A-04-00-00-00A-000A-A, dated July
12, 2016, of the Pilatus Model type--PC-12, PC-12/45, PC-12/47 MSN-
101-888, Aircraft Maintenance Manual (AMM), Document No. 02049, 12-
A-AM-00-00-00-I, revision 32, dated July 18, 2016.
    (ii) STRUCTURAL AND COMPONENT LIMITATIONS--AIRWORTHINESS
LIMITATIONS, Data module code 12-B-04-00-00-00A-000A-A, dated July
19, 2016, of the Pilatus Model type--PC-12/47E MSN-1001-UP, Aircraft
Maintenance Manual (AMM), Document No. 02300, 12-B-AM-00-00-00-I,
revision 15, dated July 30, 2016.
    (3) For PILATUS AIRCRAFT LTD. service information identified in
this AD, contact PILATUS AIRCRAFT LTD., Customer Service Manager,
CH-6371 STANS, Switzerland; telephone: +41 (0) 41 619 33 33; fax:
+41 (0) 41 619 73 11; Internet: http://www.pilatus-aircraft.com or
email<EMAIL_ADDRESS>    (4) You may view this service information at FAA, FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2016-7003.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on January 24, 2017.
Melvin Johnson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-02772 Filed 2-15-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67108-67110]
[FR Doc No: 2021-25624]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93612; File No. SR-OCC-2021-012]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Correct an Inadvertent Omission in a Prior Proposed Rule Change
Concerning OCC's Schedule of Fees

November 18, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'' or ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on November 8, 2021, The Options Clearing
Corporation (``OCC'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared primarily by
OCC. OCC filed the proposed rule change pursuant to Section
19(b)(3)(A)(ii) \3\ of the Act and Rule 19b-4(f)(2) \4\ thereunder so
that the proposal was effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change by OCC would correct an inadvertent
omission in OCC's schedule of fees that was the subject of a prior rule
filing. OCC's schedule of fees is included as Exhibit 5 to File No. SR-
OCC-2021-012. Material proposed to be added to OCC's schedule of fees
as currently in effect is underlined and material proposed to be
deleted is marked in strikethrough text.

All capitalized terms not defined herein have the same meaning as set
forth in the OCC By-Laws and Rules.\5\
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    \5\ OCC's By-Laws and Rules can be found on OCC's public
website: https://www.theocc.com/Company-Information/Documents-and-Archives/By-Laws-and-Rules.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(1) Purpose
    The purpose of this proposed rule change is to revise OCC's
schedule of fees to correct an inadvertent omission in the prior rule
filing that established a fee holiday for the period from November 1,
2021, and ending December 31, 2021.\6\ Based on OCC's financial
position as a result of historic contract volume, and consistent with
OCC's Capital Management Policy, that prior filing reduced its per
contract and per trade clearing fees to $0 for the last two months of
2021. However, through an inadvertent oversight, two line items in the
schedule of fees related to clearing fees were not reduced accordingly:
(1) The minimum monthly clearing fee of $200 and (2) a fee of $0.02 per
side for linkage transactions, capped at $55 per trade per side.\7\ OCC
is now proposing to correct the schedule of fees set forth in Exhibit 5
to File No. SR-OCC-2021-012 to reflect that OCC will not collect these
fees during the fee holiday.
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    \6\ See Exchange Act Release No. 93195 (Sept. 29, 2021), 86 FR
55039 (Oct. 5, 2021) (File No. SR-OCC-2021-009).
    \7\ The linkage fee was added to OCC's schedule of fees in 2012
so that OCC could, for the purposes of charging a clearing fee,
treat routing trades executed in accordance with the Options Order
Protection and Locked/Crossed Market Plan the same as market maker/
specialist scratch trades, which were subject to a reduced ``scratch
fee.'' See Exchange Act Release No. 68025 (Oct. 10, 2012), 77 FR
63398 (Oct. 16, 2012) (File No. SR-OCC-2012-18). In 2016, OCC
simplified its schedule of fees by, among other things, eliminating
the scratch fee but retained the linkage per side fee. See Exchange
Act Release No. 77336 (Mar. 10, 2016), 81 FR 14153 (Mar. 16, 2016)
(File No. SR-OCC-2016-005).

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

----------------------------------------------------------------------------------------------------------------
Clearing fees effective June 1, 2021              Proposed fee holiday from November 1, 2021 to
                                                                December 31, 2021
----------------------------------------------------------------------------------------------------------------
Linkage per side..............................         * $0.02  Linkage per side................           $0.00
Minimum Monthly Clearing Fee..................          200.00  Minimum Monthly Clearing Fee....            0.00
----------------------------------------------------------------------------------------------------------------
* A Linkage transaction that includes more than 2,750 contracts will be charged a flat fee of $55.00 per trade
  per side.

    The listing of the fees in the schedule of fees would be reordered
to group these two fees with the other clearing fees that are subject
to the fee holiday. Like the changes to OCC's clearing fees set forth
in File No. SR-OCC-2021-009, the linkage per side fee and the minimum
monthly clearing fee will revert to the fee schedule in effect before
November 1, 2021 and OCC will remove the fee holiday from its schedule
of fees effective the first trading day of 2022.
    No fees for transactions occurring within the fee holiday period
have been collected because clearing fees are due to OCC the month
after the fees are incurred. OCC will not collect fees for transactions
that occurred between November 1, 2021 through the first date it may
implement the corrected fee schedule after completing all regulatory
actions necessary to make the proposed corrections.
(2) Statutory Basis
    Section 17A(b)(3)(D) of the Act \8\ requires that the rules of a
clearing agency provide for the equitable allocation of reasonable
dues, fees, and other charges among its participants. OCC believes that
the proposed correction of inadvertent omissions to OCC's schedule of
fees would facilitate the equitable allocation of fees among its
participants because it would eliminate inadvertent discrepancies in
the application of the fee holiday that might otherwise impact certain
market participants differently depending on the business they conduct
through OCC. The corrected fees would be equally applicable to all
market participants. As a result, OCC believes that the proposed
corrections would provide for the equitable allocation of reasonable
fees in accordance with Section 17A(b)(3)(D) of the Act.\9\
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    \8\ 15 U.S.C. 78q-1(b)(3)(D).
    \9\ 15 U.S.C. 78q-1(b)(3)(D).
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    In addition, SEC Rule 17Ad-22(e)(23)(ii) \10\ provides that a
covered clearing agency must establish, implement, maintain and enforce
written policies and procedures reasonably designed to provide
sufficient information to enable participants to identify and evaluate
the risks, fees, and other material costs they incur by participating
in the covered clearing agency. By correcting OCC's schedule of fees
consistent with the intent of the fee holiday, OCC would eliminate
ambiguity that might otherwise persist about whether OCC intends to
charge the minimum monthly clearing fee and the fee for linkage
transactions while the fee holiday is in effect, which it does not.
Accordingly, OCC believes that the proposed corrections are reasonably
designed to provide participants sufficient information to evaluate
OCC's fees, in accordance with SEC Rule 17Ad-22(e)(23)(ii).\11\
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    \10\ 17 CFR 240.17AD-22(e)(23)(ii).
    \11\ 17 CFR 240.17AD-22(e)(23)(ii).
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    The proposed rule change is not inconsistent with the existing
rules of OCC, including any other rules proposed to be amended.

(B) Clearing Agency's Statement on Burden on Competition

    Section 17A(b)(3)(I) of the Act \12\ requires that the rules of a
clearing agency not impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act. OCC does not
believe that the proposed rule change would have any impact or impose a
burden on competition. Although this proposed rule change affects
clearing members, their customers, and the markets that OCC serves, OCC
believes that the proposed rule change would not disadvantage or favor
any particular user of OCC's services in relationship to another user
because the proposed fee holiday with respect to these fees applies
equally to all users of OCC. Accordingly, OCC does not believe that the
proposed rule change would have

any impact or impose a burden on competition.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments on the proposed rule change were not and are not
intended to be solicited with respect to the proposed rule change and
none have been received.

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

    Pursuant to Section 19(b)(3)(A)(ii) \13\ of the Act, and Rule 19b-
4(f)(2) thereunder,\14\ the proposed rule change is filed for immediate
effectiveness as it constitutes a change in fees charged to OCC's
members. 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. The proposal shall
not take effect until all regulatory actions required with respect to
the proposal are completed.\15\
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    \13\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \14\ 17 CFR 240.19b-4(f)(2).
    \15\ Notwithstanding its immediate effectiveness, implementation
of this rule change will be delayed until this change is deemed
certified under CFTC Regulation 40.6.
---------------------------------------------------------------------------

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-OCC-2021-012 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OCC-2021-012. 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 such filing also will be available for inspection
and copying at the principal office of OCC.
    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-OCC-2021-012 and should be
submitted on or before December 15, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-25624 Filed 11-23-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Page 57018]
[FR Doc No: 2019-23223]

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ENVIRONMENTAL PROTECTION AGENCY

[Petition IV-2017-10; FRL-10001-39-Region 4]

Clean Air Act Operating Permit Program; Petition for Objection to
State Operating Permit for Mill Creek Generating Station (Jefferson
County, Kentucky)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final order on petitions to object to state operating
permits.

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SUMMARY: The EPA Administrator signed an Order, dated October 3, 2019,
denying the petition submitted by Sierra Club (Petitioner) objecting to
a proposed Clean Air Act (CAA) title V operating permit issued to Mill
Creek Generating Station (Mill Creek) located in Jefferson County,
Kentucky. The Order responds to a June 2, 2017, petition requesting
that the EPA object to the final operating permit number O-0127-16-V.
This permitting action was issued by the Louisville Metro Air Pollution
Control District (LMAPCD). The Order constitutes a final action on the
petition addressed therein.

ADDRESSES: Copies of the Order, the petition, and all pertinent
information relating thereto are on file at the following location: EPA
Region 4; Air and Radiation Division; 61 Forsyth Street SW; Atlanta,
Georgia 30303-8960. The Order is also available electronically at the
following address: https://www.epa.gov/title-v-operating-permits/2019-order-denying-petition-object-title-v-operating-permit-mill-creek.

FOR FURTHER INFORMATION CONTACT: Art Hofmeister, Air Permits Section,
EPA Region 4, at<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The CAA affords the EPA a 45-day period to
review and, as appropriate, the authority to object to operating
permits proposed by state permitting authorities under title V of the
CAA, 42 U.S.C. 7661-7661f. Section 505(b)(2) of the CAA and 40 CFR
70.8(d) authorize any person to petition the EPA Administrator to
object to a title V operating permit within 60 days after the
expiration of the EPA's 45-day review period if the EPA has not
objected on its own initiative. Petitions must be based only on
objections to the permit that were raised with reasonable specificity
during the public comment period provided by the state, unless the
petitioner demonstrates that it was impracticable to raise these issues
during the comment period or the grounds for the issues arose after
this period. Pursuant to sections 307(b) and 505(b)(2) of the CAA, a
petition for judicial review of those parts of the Order that deny
issues in the petition may be filed in the United States Court of
Appeals for the appropriate circuit within 60 days from the date this
notice is published in the Federal Register.
    Petitioner submitted a petition requesting that the EPA object to
the proposed CAA title V operating permit no. O-0127-16-V issued by
LMAPCD to Mill Creek. Petitioner claims that this permitting action:
Includes an impermissible long-term emission limit that is inadequate
to protect the 1-hour sulfur dioxide National Ambient Air Quality
Standards (NAAQS) and, even if it were permissible, the long-term limit
is too high to protect the NAAQS.
    On October 3, 2019, the Administrator issued an Order denying the
petition. The Order explains the EPA's basis for denying the petition.

    Dated: October 10, 2019.
Mary S. Walker,
Acting Regional Administrator, Region 4.
[FR Doc. 2019-23223 Filed 10-23-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 23 (Monday, February 6, 2017)]
[Notices]
[Pages 9406-9413]
[FR Doc No: 2017-02374]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79906; File No. SR-CBOE-2017-008]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the Fees Schedule

January 31, 2017.
    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 January 18, 2017, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

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

    The Exchange proposes to amend its Fees Schedule. The text of the
proposed rule change is also available on the Exchange's Web site
(http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the
Exchange's Office of the Secretary, 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 make a number of changes to its Fees
Schedule.\3\
---------------------------------------------------------------------------

    \3\ The Exchange initially filed the proposed fee changes on
January 3, 2017 (SR-CBOE-2017-001). On January 18, 2017, the
Exchange withdrew that filing and submitted this filing.
---------------------------------------------------------------------------

Electronic Transaction Fees for Clearing Trading Permit Holder
Proprietary
    The Exchange proposes to increase the transaction fees for
electronic executions for Clearing Trading Permit Holder Proprietary
(origin codes ``F'' and ``L'') orders in Penny Pilot equity, ETF, ETN
and index options (excluding Underlying Symbol List A \4\) classes from
$0.35 per contract to $0.38 per contract and in Non-Penny Pilot equity,
ETF, ETN and index options (excluding Underlying Symbol List A) classes
from $0.35 per contract to $0.65 per contract. The Exchange notes that
this increase is in line with the amounts assessed by others exchanges
for similar transactions.\5\
---------------------------------------------------------------------------

    \4\ As of January 3, 2017, Underlying Symbol List A includes
Underlying Symbol List A consists of OEX, XEO, RUT, RLG, RLV, RUI,
AWDE, FTEM, FXTM, UKXM SPX/SPXW, SPXpm, SRO, VIX, Volatility Indexes
and binary options.
    \5\ See e.g., NASDAQ PHLX LLC (``PHLX'') Pricing Schedule,
Section II, Multiply Listed Options Fees and NYSE Amex Options Fees
Schedule, Section I.A, Options Transaction Fees and Credits, Rates
for Standard Options Transactions.
---------------------------------------------------------------------------

Complex Taker Fee
    Currently, the Complex Taker Fee is $0.08 per contract per side for
non-customer complex order executions that take liquidity from the COB
and auction responses in the Complex Order Auction (``COA'') and the
Automated Improvement Mechanism (``AIM'') in all classes except
Underlying Symbol List A and Mini-Options. Additionally, the Complex
Taker Fee is not assessed on orders originating from a Floor Broker
PAR, electronic executions against single leg markets, or stock-option
order executions. The Exchange proposes to increase the amount of the
fee from $0.08 per contract to $0.10 per contract. The Exchange also
proposes to provide that auction responses in COA and AIM for
noncustomer complex orders in Penny classes will be subject to a cap of
$0.50 per contract, which includes the applicable transaction fee,
Complex Surcharge and Marketing Fee (if applicable).\6\ The Exchange
also wishes to rename the fee from ``Complex Taker Fee'' to ``Complex
Surcharge''.
---------------------------------------------------------------------------

    \6\ For example, a Market-Maker COA response in a Penny class
that is subject to the Marketing Fee ($0.25 per contract), the
Liquidity Provider Sliding Scale Tier 1 rate ($0.23 per contract)
and Complex Surcharge ($0.10 per contract), would only be charged
$0.50 per contract, instead of $0.58 per contract.
---------------------------------------------------------------------------

SPX Index License Surcharge
    The Exchange proposes to increase the Index License Surcharge Fee
for SPX (including SPXW) and SPXpm (the ``SPX Surcharge'') from $0.13
per contract to $0.14 per contract. The Exchange licenses from Standard
& Poor's the right to offer an index option product based on the S&P
500 index (that product being SPX and other SPX-based index option
products). In order to recoup the costs of the SPX license, the
Exchange assesses the SPX Surcharge. However, the cost of that license
works out to more than the current SPX Surcharge amount of $0.13 per
SPX contract traded (or even the proposed SPX Surcharge amount of $0.14
per contract), so the Exchange ends up subsidizing that SPX license
cost. The Exchange therefore proposes to increase the SPX Surcharge
from $0.13 per contract to $0.14 per contract in order to recoup more
of the costs associated with the SPX license.
VIX License Index Surcharge
    The Exchange proposes to extend the current waiver of the VIX Index
License Surcharge of $0.10 per contract for Clearing Trading Permit
Holder Proprietary (``Firm'') (origin codes ``F'' or ``L'') VIX orders
that have a premium of $0.10 or lower and have series with an
expiration of seven (7) calendar days or less. The Exchange adopted the
current waiver to reduce transaction costs on expiring, low-priced VIX
options, which the Exchange believed would encourage Firms to seek to
close and/or roll over such positions close to expiration at low
premium levels, including facilitating customers to do so, in order to
free up capital and encourage additional trading. The Exchange had
proposed to waive the surcharge through December 31, 2016, at which
time the Exchange had stated that it would evaluate whether the waiver
has in fact prompted Firms to close and roll over these positions close
to expiration as intended. The Exchange believes the proposed change
has in fact encouraged Firms to do so and as such, proposes to extend
the waiver of the surcharge through June 30, 2017, at which time the
Exchange will again reevaluate whether the waiver has continued to
prompt Firms to close and roll over positions close to expiration at
low premium levels. Accordingly, the Exchange proposes to delete the
reference to the current waiver period of December 31, 2016 from the
Fees Schedule and replace it with June 30, 2017.
Liquidity Provider Sliding Scale for SPX, SPXW and SPXpm
    The Exchange proposes to adopt a sliding scale for Liquidity
Provider (origin code ``M'') (``LP'') transaction fees in SPX, SPXW and
SPXpm (``SPX LP Sliding Scale''). Currently, LPs are assessed $0.20 per
contract for SPX, SPXW and SPXpm (collectively, ``SPX options'')
executions. The new SPX LP Sliding Scale will assess LPs increased
transaction fees in SPX. Of the increased rates however, the SPX LP
Sliding Scale will provide progressively lower rates if certain volume
thresholds in SPX options are attained during a month. The SPX LP
Sliding Scale will be as follows:

------------------------------------------------------------------------
            Tier                       Volume thresholds           Rate
------------------------------------------------------------------------
1...........................  0.00%-1.50%.......................   $0.25
2...........................  Greater than 1.50%-10.0%..........    0.23
3...........................  Above 10.0%.......................    0.21
------------------------------------------------------------------------

    The volume thresholds will be based on total Liquidity Provider
Volume in SPX, SPXW and SPXpm. The purpose of the SPX LP Sliding Scale
is to provide an incremental incentive for LPs to reach the highest
tier level and encourage trading of SPX options.

Volume Incentive Program
    The Exchange proposes to amend its Volume Incentive Program
(``VIP''). By way of background, under VIP, the Exchange credits each
Trading Permit Holder (``TPH'') the per contract amount set forth in
the VIP table resulting from each public customer (``C'' origin code)
order transmitted by that TPH (with certain exceptions) which is
executed electronically on the Exchange, provided the TPH meets certain
volume thresholds in a month.\7\ The Exchange proposes to adopt
separate pricing for orders executed electronically via AIM. The
proposed pricing is as follows:
---------------------------------------------------------------------------

    \7\ See CBOE Fees Schedule, Volume Incentive Program.

----------------------------------------------------------------------------------------------------------------
                                                                        Per contract credit
                          Percentage thresholds  ---------------------------------------------------------------
          Tier             of national customer               Simple                          Complex
                             multiply- listed    ---------------------------------------------------------------
                              monthly volume          Non-AIM           AIM           Non-AIM           AIM
----------------------------------------------------------------------------------------------------------------
1......................  0.00%-0.75%............           $0.00           $0.00           $0.00           $0.00
2......................  Above 0.75% to 1.80%...            0.10            0.09            0.21            0.20
3......................  Above 1.80% to 3.00%...            0.12            0.11            0.24            0.23
4......................  Above 3.00%............            0.15            0.14            0.25            0.24
----------------------------------------------------------------------------------------------------------------

    The Exchange notes that AIM transactions are assessed lower
transaction fees than non-AIM transactions. As such, the Exchange no
longer wishes to provide the same amount in credits for these
transactions.\8\
---------------------------------------------------------------------------

    \8\ See CBOE Fees Schedule, Equity, ETF, ETN and Index Options
(excluding Underlying Symbol List A) rate tables.
---------------------------------------------------------------------------

    The Exchange also proposes to amend the aggregation timer under
VIP. The Exchange notes that currently, credits on orders executed
electronically in AIM are capped at 1,000 contracts per order for
simple executions and 1,000 contracts per leg for complex executions.
Additionally, credits on orders executed electronically in HAL are be
capped at 1,000 contracts per auction quantity. Additionally, multiple
simple orders from the same affiliated TPH(s) in the same series on the
same side of the market that are executed in AIM or HAL within a 300
second period will be aggregated for purposes of determining the order
quantity subject to the cap. The AIM aggregation timer begins with an
order entered into AIM and continues for 300 seconds, aggregating any
other orders entered into AIM in the same series on the same side of
the market by the same affiliated TPH. The HAL aggregation timer also
begins at the start of a HAL auction and continues for 300 seconds,
aggregating any other orders executed in HAL in the same series on the
same side of the market for the same affiliated TPH. The Exchange had
adopted the aggregation timer to prevent TPHs from breaking up their
orders in order to avoid the fee cap. The Exchange believes however,
that it can accomplish its objective with a shorter timer period. As
such, the Exchange proposes to reduce the aggregation timer for AIM and
HAL to 3 seconds.
Permit Fees
    The Exchange proposes to reduce Market-Maker Trading Permit monthly
costs from $5,500 per permit to $5,000 per permit. Furthermore, for
those who commit to the Market-Maker Trading Permit Holder Sliding
Scale, which is available for all Market-Maker Trading Permits held by
affiliated TPHs and TPH organizations that are used for appointments in
any options classes other than RUT, SPX, SPXpm, VIX, OEX and XEO, the
Exchange proposes to reduce the monthly cost from $5,500 per permit to
$5,000 per permit for the first 10 permits, from $4,000 to $3,700 per
permit for permits 11-20, and from $2,500 to $1,800 per permit for
permits 21 and greater. The purpose of this change is to reduce access
costs and thereby encourage greater Market-Maker access, which thereby
brings greater trading activity, volume and liquidity, benefitting all
market participants.
    The Exchange next notes that the ``Notes'' section of the Market-
Maker Trading Permit Sliding Scale table provides that the sliding
scale is available for Market-Maker Trading Permits used for
appointments ``in any options classes other than SPX, SPXpm, VIX, OEX,
and XEO.'' The Exchange notes that last year, the Exchange also
excepted from the scale RUT appointments.\9\ While the Exchange
acknowledged this change in Footnote 24, it inadvertently did not add
``RUT'' to the exclusion list in the Notes section described above. The
Exchange therefore proposes to correct that error and add the reference
to ``RUT'' being excluded.
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 76923 (January 15,
2016), 81 FR 3841 (January 22, 2016) (SR-CBOE-2016-002).
---------------------------------------------------------------------------

    The Exchange also proposes to reduce the Floor Broker Trading
Permit monthly fee for Tier 1 of the Floor Broker Trading Permit Holder
Sliding Scale. Specifically, Tier 1 of the Floor Broker Trading Permit
Holder Sliding Scale is available for TPHs and TPH Organizations that
commit in advance to that tier each calendar year. The Exchange
proposes to reduce the monthly cost from $6,000 per Floor Broker
Trading Permit to $5,000 per Floor Broker Trading Permit for permits 2-
7.
Extended Trading Hour Fees
    In order to promote and encourage trading during the Extended
Trading Hours (``ETH'') session, the Exchange currently waives ETH
Trading Permit and Bandwidth Packet fees for one (1) of each initial
Trading Permits and one (1) of each initial Bandwidth Packet, per
affiliated TPH. The Exchange notes that waiver is set to expire
December 31, 2016. The Exchange also waives fees through December 31,
2016 for a CMI and FIX login ID if the CMI and/or FIX login ID is
related to a waived ETH Trading Permit and/or waived Bandwidth packet.
In order to continue to promote trading during ETH, the Exchange wishes
to extend these waivers through June 30, 2017.
CBOE Command Connectivity Charges
    Next, the Exchange proposes to increase CBOE Command Connectivity
Fees. First, the Exchange proposes to increase the monthly fee for 10
gigabit per second (``Gbps'') Network Access Ports from $3,500 per port
to $4,000 per port. The Exchange has expended significant resources
setting up, providing and maintaining this connectivity, and the costs
related to such provision and maintenance has increased. The Exchange
desires to recoup such increased costs. This fee amount is still within
the range of, and

in some cases less than, similar fees assessed by other exchanges.\10\
---------------------------------------------------------------------------

    \10\ See e.g., Miami International Securities Exchange LLC
(``MIAX'') Options Fees Schedule, Section 5(a), which lists
connectivity fees of $5,500 per month for 10 Gbps.
---------------------------------------------------------------------------

    The Exchange also proposes to increase the fees charged for a CMI
Login ID and FIX Login ID from $500 per month to $750 per month TPHs
may access CBOE Command via either a CMI Client Application Server or a
FIX Port, depending on how their systems are configured. As with
Network Access Ports, the Exchange has expended significant resources
setting up, providing and maintaining this connectivity, and the costs
related to such provision and maintenance has increased. The Exchange
desires to recoup such increased costs. This fee amount is still within
the range of, and in some cases less than, similar fees assessed by
other exchanges.\11\
---------------------------------------------------------------------------

    \11\ See e.g., International Securities Exchange (``ISE'')
Schedule of Fees, Section V(C), FIX Session/API Session Fees. See
also PHLX Pricing Schedule, Section VII(B)., Port Fees.
---------------------------------------------------------------------------

Linkage
    The Exchange proposes to increase the Linkage fee (in addition to
the applicable away fees) for Customer orders from $0.05 to $0.10. The
Fees Schedule currently provides that, in addition to the customary
CBOE execution charges, for each customer order that is routed, in
whole or in part, to one or more exchanges in connection with the
Options Order Protection and Locked/Crossed Market Plan referenced in
Rule 6.80, CBOE shall pass through the actual transaction fee assessed
by the exchange(s) to which the order was routed. The Exchange proposes
to assess an additional $0.10 per contract for customer orders routed
away in addition to the applicable pass through fees. The purpose of
these proposed increase is to help recoup costs incurred by the
Exchange associated with routing customer orders through linkage. The
Exchange notes that other exchanges also assess an additional fee on
top of passing through transaction fees for customer orders and that
the proposed amount of the fee is in line with the amount assessed at
other exchanges.\12\
---------------------------------------------------------------------------

    \12\ See e.g., PHLX Pricing Schedule, Section V., Customer
Routing Fees. See also, MIAX Options Fees Schedule, Section 1(c),
Fees and Rebates for Customer Orders Routed to Another Options
Exchange.
---------------------------------------------------------------------------

Frequent Trader
    The Exchange next proposes to amend its Frequent Trader Program. By
way of background, the Frequent Trader Program offers transaction fee
rebates to registered Customers, Professional Customers and Voluntary
Professionals (origin codes ``C'' and ``W'') that meet certain volume
thresholds in CBOE VIX Volatility Index options (``VIX options''),
Russell 2000 Index (``RUT'') options, and S&P 500 Index options
(``SPX''), weekly S&P 500 options (``SPXW'') and p.m.-settled SPX Index
options (``SPXpm'') (collectively referred to as ``SPX options'')
provided the Customer registers for the program. The Exchange proposes
to amend the Frequent Trader Program to (i) increase the volume
thresholds and (ii) reduce the rebates. Specifically, the proposed
changes will be as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 VIX                              SPX, SPXW and SPXpm                              RUT
                              --------------------------------------------------------------------------------------------------------------------------
             Tier                 Monthly contracts                        Monthly contracts
                                        traded          Fee rebate (%)           traded          Fee rebate (%)  Monthly contracts trade  Fee rebate (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1............................  10,000-49,999..........               3  10,000-49,999..........               3  5,000-9,999............               3
2............................  50,000-99,999..........               6  50,000-99,999..........               6  10,000-12,999..........               6
3............................  100,000 and above......               9  100,000 and above......               9  13,000 and above.......               9
--------------------------------------------------------------------------------------------------------------------------------------------------------

Floor Broker Trading Permit Rebates
    Footnote 25, which governs rebates on Floor Broker Trading Permits,
currently provides that any Floor Broker that executes a certain
average of customer open-outcry contracts per day over the course of a
calendar month in all underlying symbols excluding Underlying Symbol
List A (except RLG, RLV, RUI, AWDE, FTEM, FXTM and UKXM), DJX, XSP,
XSPAM, mini-options and subcabinet trades (``Qualifying Symbols''),
will receive a rebate on that TPH's Floor Broker Trading Permit Fees.
Specifically, any Floor Broker Trading Permit Holder that executes an
average of 15,000 customer open-outcry contracts per day over the
course of a calendar month in Qualifying Symbols will receive a rebate
of $7,500 on that Floor Broker Trading Permit Holder's Floor Broker
Trading Permit fees. Additionally, any Floor Broker Trading Permit
Holder that executes an average of 25,000 customer open-outcry
contracts per day over the course of a calendar month in Qualifying
Symbols will receive a rebate of $15,000 on that TPH's Floor Broker
Trading Permit fees. The Exchange proposes to increase the rebate
received for executing an average of 15,000 customer open-outcry
contracts to $9,000 and reduce the rebate received for executing an
average of 25,000 customer open-outcry contracts to $14,000.
RLG, RLV, RUI, AWDE, FTEM, FXTM and UKXM Transaction Fees
    The Exchange recently began trading options on seven FTSE Russell
Indexes (i.e., Russell 1000 Growth Index (``RLG''), Russell 1000 Value
Index (``RLV''), Russell 1000 Index (``RUI''), FTSE Developed Europe
Index (``AWDE''), FTSE Emerging Markets Index (``FTEM''), China 50
Index ``(FXTM'') and FTSE 100 Index (``UKXM'')). In order to promote
and encourage trading of these new products, the Exchange currently
waives all transaction fees (including the Floor Brokerage Fee, Index
License Surcharge and CFLEX Surcharge Fee) for each of these products.
This waiver however is set to expire December 31, 2016. In order to
continue to promote trading of these new options classes, the Exchange
proposes to extend the fee waiver of through June 30, 2017.
FLEX Asian and Cliquet Flex Trader Incentive Program
    By way of background, a FLEX Trader is entitled to a pro-rata share
of the monthly compensation pool based on the customer order fees
collected from customer orders traded against that FLEX Trader's orders
with origin codes other than ``C'' in FLEX Broad-Based Index Options
with Asian or Cliquet style settlement (``Exotics'') each month
(``Incentive Program''). The Fees Schedule provides that the Incentive
Program is set to expire either by December 31, 2016 or until total
average daily volume in Exotics exceeds 15,000 contracts for three
consecutive months, whichever comes first. The Exchange notes that
total average daily volume in

Exotics has not yet exceeded 15,000 contracts for three consecutive
months. In order to continue to incentivize FLEX Traders to provide
liquidity in FLEX Asian and Cliquet options, the Exchange proposes to
extend the program to June 30, 2017 or until total average daily volume
in Exotics exceeds 15,000 contracts for three consecutive months,
whichever comes first.
AWDE, FTEM, FXTM and UKXM DPM Payment
    The Exchange currently offers a compensation plan to the Designated
Primary Market-Maker(s) (``DPM(s)'') appointed in AWDE, FTEM, FXTM or
UKXM to offset the initial DPM costs. Specifically, the Fees Schedule
provides that DPM(s) appointed for an entire month in these classes
will receive a payment of $7,500 per class per month through December
31, 2016. The Exchange notes that DPMs appointed in these products
still have ongoing costs, which the Exchange desires to continue to
help offset. As such, the Exchange proposes to extend the DPM payment
plan through June 30, 2017.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\13\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \14\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with
Section 6(b)(4) of the Act,\15\ which requires that Exchange rules
provide for the equitable allocation of reasonable dues, fees, and
other charges among its Trading Permit Holders and other persons using
its facilities.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    Increasing the fee for electronic executions for Clearing Trading
Permit Holder Proprietary orders in Penny and Non-Penny Pilot equity,
ETF, ETN and index options (excluding Underlying Symbol List A) classes
is reasonable because the proposed fee amount is in line with the
amounts assessed by another exchange for similar transactions.\16\ The
Exchange believes that this proposed change is also equitable and not
unfairly discriminatory because the proposed changes will apply equally
to all Clearing Trading Permit Holders. The Exchange notes that it does
not assess Customers the electronic options transaction fees in Penny
and Non-Penny Pilot options because Customer order flow enhances
liquidity on the Exchange for the benefit of all market participants.
Specifically, Customer liquidity benefits all market participants by
providing more trading opportunities, which attracts Market-Makers. An
increase in the activity of these market participants in turn
facilitates tighter spreads, which may cause an additional
corresponding increase in order flow from other market participants.
The Exchange notes that Market-Makers are assessed lower electronic
options transaction fees in Penny and Non-Penny Pilot options as
compared to Clearing Trading Permit Holders, as well as Professionals,
JBOs, Broker Dealers and non-Trading Permit Holder Market-Makers
because they have obligations to the market and regulatory
requirements, which normally do not apply to other market participants
(e.g., obligations to make continuous markets). Professionals, JBOs,
Broker Dealers and non-Trading Permit Holder Market-Makers are assessed
higher fees as compared to the proposed fees for Clearing Trading
Permit Holder Proprietary orders because Clearing Trading Permit
Holders also have obligations, which normally do not apply to other
market participants (e.g., must have higher capital requirements, clear
trades for other market participants, must be members of OCC).
Accordingly, the differentiation between electronic transaction fees
for Customers, Market-Makers, Clearing Trading Permit Holders and other
market participants recognizes the differing obligations and
contributions made to the liquidity and trading environment on the
Exchange by these market participants. The Exchange also believes it's
equitable and not unfairly discriminatory to assess higher fees for
Non-Penny option classes than Penny option classes because Penny
classes and Non-Penny classes offer different pricing, liquidity,
spread and trading incentives. The spreads in Penny classes are tighter
than those in Non-Penny classes (which trade in $0.05 increments). The
wider spreads in non-Penny option classes allow for greater profit
potential.
---------------------------------------------------------------------------

    \16\ See e.g., PHLX Pricing Schedule, Section II, Multiply
Listed Options Fees and NYSE Amex Options Fees Schedule, Section
I.A, Options Transaction Fees and Credits, Rates for Standard
Options Transactions.
---------------------------------------------------------------------------

    The Exchange believes that the proposed increase of the Complex
Taker Fee from $0.08 per contract per side to $0.10 per contract per
side is reasonable because it helps offset the increased credits given
to complex orders under VIP. Indeed, the Exchange notes that VIP
credits for complex orders have increased since the Complex Taker Fee
was increased to $0.08 per contract.\17\ The Exchange believes capping
noncustomer COA and AIM auction responses in Penny classes is
reasonable because those market participants would be paying lower
fees. Applying the Complex Surcharge to all market participants except
customers is equitable and not unfairly discriminatory because customer
order flow enhances liquidity on the Exchange for the benefit of all
market participants. As noted above, customer liquidity benefits all
market participants by providing more trading opportunities, which
attracts Market-Makers. An increase in the activity of these market
participants in turn facilitates tighter spreads, which may cause an
additional corresponding increase in order flow from other market
participants. By exempting customer orders, the fee will not discourage
the sending of customer orders, and therefore there should still be
plenty of customer orders for other market participants to trade with.
The Exchange also believes capping auction responses in COA and AIM at
$0.50 per contract is reasonable, equitable and not unfairly
discriminatory because the Exchange does not want to discourage the use
of these price improvement mechanisms. The Exchange lastly believes
renaming the fee to Complex Surcharge may alleviate confusion, which
removes impediments to and perfects the mechanism of a free and open
market and a national market system, and, in general, protects
investors and the public interest.
---------------------------------------------------------------------------

    \17\ See Securities Exchange Act Release No. 75188 (June 17,
2015), 80 FR 36021 (June 23, 2015) (SR-CBOE-2015-058) and See CBOE
Fees Schedule, Volume Incentive Program.
---------------------------------------------------------------------------

    The Exchange believes increasing the SPX Surcharge is reasonable
because the Exchange still pays more for the SPX license than the
amount of the proposed SPX Surcharge (meaning that the

Exchange is, and will still be, subsidizing the costs of the SPX
license). This increase is equitable and not unfairly discriminatory
because all non-Customer market participants will be assessed the same
increased SPX Surcharge. Not applying the SPX Surcharge Fee to customer
orders is equitable and not unfairly discriminatory because this is
designed to attract customer SPX orders, which increases liquidity and
provides greater trading opportunities to all market participants.
    The Exchange believes it's reasonable to continue to waive the VIX
Index License Surcharge for Clearing Trading Permit Holder Proprietary
VIX orders that have a premium of $0.10 or lower and have series with
an expiration of 7 calendar days or less because the Exchange wants to
continue encouraging Firms to roll and close over positions close to
expiration at low premium levels. The Exchange notes that without the
waiver, firms are less likely to engage in these transactions, as
opposed to other VIX transactions, due to the associated transaction
costs. The Exchange believes it's equitable and not unfairly
discriminatory to limit the waiver to Clearing Trading Permit Holder
Proprietary orders because they contribute capital to facilitate the
execution of VIX customer orders with a premium of $0.10 or lower and
series with an expiration of 7 calendar days or less. Finally, the
Exchange believes it's reasonable, equitable and not unfairly
discriminatory to provide that the surcharge will be waived through
June 2017, as it gives the Exchange additional time to evaluate if the
waiver is continuing to have the desired effect of encouraging these
transactions.
    The Exchange believes increasing SPX transaction fees for Liquidity
Providers is reasonable because the Exchange has expended considerable
resources developing and maintaining SPX. The Exchange believes that
this proposed change is equitable and not unfairly discriminatory
because although Liquidity Providers still pay lower SPX transaction
fees than certain other market participants, Liquidity Providers are
valuable market participants that provide liquidity in the marketplace
and incur costs that other market participants do not incur. For
example, Liquidity Providers have a number of obligations, including
quoting obligations that other market participants do not have. The
Exchange also believes establishing a Sliding Scale for LPs in SPX
options is reasonable because it will allow LPs who engage in SPX
options trading the opportunity to pay progressively lower fees for
such transactions as increased volume thresholds are met. Specifically,
the SPX LP Sliding Scale allows the Exchange to provide an incremental
incentive for Liquidity Providers to strive for the highest tier level,
which provides increasingly lower fees.
    The Exchange believes the proposed reduced credits for AIM
executions under VIP is reasonable because it still provides TPHs an
opportunity to receive notable credits for reaching certain qualifying
volume thresholds that they would not otherwise receive (now just a
smaller credit). The Exchange also believes it's reasonable, equitable
and not unfairly discriminatory to establish lower credits for AIM
executions than non-AIM executions under VIP because AIM transactions
are already assessed lower transaction fees than non-AIM transactions
and the Exchange no longer wishes to provide the same amount of credits
for these transactions.\18\ Additionally, the Exchange believes the
proposed change is equitable and not unfairly discriminatory because it
applies to all TPHs that meet the qualifying volume thresholds.
---------------------------------------------------------------------------

    \18\ See CBOE Fees Schedule, Equity, ETF, ETN and Index Options
(excluding Underlying Symbol List A) rate tables.
---------------------------------------------------------------------------

    The Exchange also believes it's reasonable, equitable and not
unfairly discriminatory to provide that multiple simple orders from the
same TPH in the same series on the same side of the market that are
received within three (3) seconds (instead of three hundred (300)
seconds) will be aggregated for purposes of determining the order
quantity subject to the AIM and HAL cap because the Exchange believes
this amount of time is still sufficient to prevent TPHs from breaking
up their orders in order to avoid the fee cap and it would apply to all
TPHs.
    The lowered costs for Market-Maker Trading Permits is reasonable
because the fees will be lower than previously, and the reduced access
costs may encourage greater Market-Maker access, which thereby brings
greater trading activity, volume and liquidity, benefitting all market
participants. The Exchange believes the proposed change is equitable
and not unfairly discriminatory because it applies to all Market-
Makers.
    The Exchange believes adding ``RUT'' to the Notes section of the
Market-Maker Trading Permits Sliding Scale will alleviate confusion as
to what Trading Permits the sliding scale does and does not apply to.
The alleviation of confusion removes impediments to and perfects the
mechanism of a free and open market and a national market system, and,
in general, protects investors and the public interest.
    The lowered costs for Floor Broker Trading Permits in Tier 1 of the
Floor Broker Trading Permits Sliding Scale is reasonable because the
fee for that tier will be lower than previously, and the reduced access
costs may encourage greater Floor Broker access, which thereby brings
greater trading activity, volume and liquidity, benefitting all market
participants. The Exchange believes the proposed change is equitable
and not unfairly discriminatory because it applies to all Floor
Brokers.
    The Exchange believes extending the waiver of ETH Trading Permit
and Bandwidth Packet fees for one of each type of Trading Permit and
Bandwidth Packet, per affiliated TPH through June 30, 2017 is
reasonable, equitable and not unfairly discriminatory, because it
promotes and encourages trading during the ETH session and applies to
all ETH TPHs. The Exchange believes it's also reasonable, equitable and
not unfairly discriminatory to waive fees for Login IDs related to
waived Trading Permits and/or Bandwidth Packets in order to promote and
encourage ongoing participation in ETH and also applies to all ETH
TPHs.
    The proposed change to increase the 10 Gbps Network Access Port fee
is reasonable because the fees are within the same range as those
assessed on other exchanges,\19\ and because such increase will assist
in recouping ongoing expenditures made by the Exchange. This proposed
change is equitable and not unfairly discriminatory because the
proposed change will apply to all TPHs. The proposed change to increase
the fees assessed for CMI Login IDs and FIX Login IDs is also
reasonable because the Exchange desires to recoup increasing costs
associated with maintaining connectivity to the Exchange. The Exchange
believes it's equitable and not unfairly discriminatory because all
TPHs will be assessed the same amount for Login ID fees.
---------------------------------------------------------------------------

    \19\ See supra Note 10.
---------------------------------------------------------------------------

    The Exchange's proposal to increase the Linkage fee from $0.05 per
contract to $0.10 per contract (in addition to applicable transaction
fees) for customer orders is reasonable because the increase will help
offset the costs associated with routing orders through Linkage.
Additionally, the proposed amount is reasonable as it is in line with
amounts charged by other Exchanges for similar transactions.\20\ The
Exchange

believes it's equitable and not unfairly discriminatory because the
proposed change will apply to all customer orders that are linked away.
---------------------------------------------------------------------------

    \20\ See supra Note 12.
---------------------------------------------------------------------------

    The Exchange believes it is reasonable to increase the volume
thresholds in Frequent Trader because it adjusts for current volume
trends. The Exchange notes that the rebalance of tiers still allows the
Exchange to maintain an incremental incentive for Customers to strive
for the highest tier level. The Exchange believes the proposed change
is also equitable and not unfairly discriminatory because it applies to
all Customers. The Exchange believes it's reasonable to reduce the
Frequent Trader rebates because it still provides Customers an
opportunity to receive notable discounted rates for reaching certain
qualifying volume thresholds that they would not otherwise receive (now
just a smaller discount). The Exchange believes that the proposed
change is not unfairly discriminatory because it will apply to all
Customers that meet the qualifying volume thresholds.
    The Exchange believes that increasing the first tier of the Floor
Broker Access Rebate (i.e., the rebate received when executing 15,000
contracts or more per day) is reasonable because it allows the
qualifying Floor Brokers to pay even lower Floor Broker Trading Permit
fees than before. The Exchange believes that it is reasonable to reduce
the second tier rebate of the Floor Broker Access (i.e., the rebate
received when executing 25,000 contracts or more per day), because
qualifying Floor Brokers are still paying lower Floor Broker Trading
Permit fees than they otherwise would have. The Exchange notes that the
purpose of both rebates incentives is to encourage the execution of
orders via open outcry, which should increase volume, which would
benefit all market participants (including Floor Brokers who do not hit
the either contracts-per-day thresholds) trading via open outcry (and
indeed, this increased volume could make it possible for some Floor
Brokers to hit the contracts-per-day thresholds). The Exchange believes
the proposed changes are equitable and not unfairly discriminatory
because they apply to qualifying Floor Brokers equally.
    The Exchange believes it is reasonable, equitable and not unfairly
discriminatory to extend the waiver of all transaction fees for RLG,
RLV, RUI, AWDE, FTEM, FXTM and UKXM transactions, including the Floor
Brokerage fee, the License Index Surcharge and CFLEX Surcharge Fee,
because it promotes and encourages trading of these products which are
still new and applies to all TPHs.
    The Exchange believes extending the FLEX Asian and Cliquet Flex
Trading Incentive Program is reasonable, equitable and not unfairly
discriminatory because providing FLEX Traders with incentives to trade
FLEX Asian and Cliquet options should result in a more robust price
discovery process that will result in better execution prices for
customers. In addition, the proposed change applies equally to all FLEX
Traders.
    Finally, the Exchange believes that it is reasonable, equitable and
not unfairly discriminatory to extend the compensation plan to the
DPM(s) appointed in AWDE, FTEM, FXTM or UKXM to continue to offset
their ongoing DPM costs.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition that are not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe that the proposed rule change will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because, while different fees
and rebates are assessed to different market participants in some
circumstances, these different market participants have different
obligations and different circumstances (as described in the
``Statutory Basis'' section above). For example, Clearing TPHs have
clearing obligations that other market participants do not have.
Market-Makers have quoting obligations that other market participants
do not have. There is a history in the options markets of providing
preferential treatment to customers, as they often do not have as
sophisticated trading operations and systems as other market
participants, which often makes other market participants prefer to
trade with customers. Further, the Exchange fees and rebates, both
current and those proposed to be changed, are intended to encourage
market participants to bring increased volume to the Exchange (which
benefits all market participants), while still covering Exchange costs
(including those associated with the upgrading and maintenance of
Exchange systems).
    The Exchange does not believe that the proposed rule changes will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
proposed changes are intended to promote competition and better improve
the Exchange's competitive position and make CBOE a more attractive
marketplace in order to encourage market participants to bring
increased volume to the Exchange (while still covering costs as
necessary). Further, the proposed changes only affect trading on CBOE.
To the extent that the proposed changes make CBOE a more attractive
marketplace for market participants at other exchanges, such market
participants are welcome to become CBOE market participants.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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 \22\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \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-CBOE-2017-008 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-CBOE-2017-008. 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-CBOE-2017-008, and should be
submitted on or before February 27, 2017.

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

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-02374 Filed 2-3-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 99 (Wednesday, May 22, 2019)]
[Notices]
[Pages 23569-23571]
[FR Doc No: 2019-10667]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2102]

Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations.'' This
draft guidance describes the Agency's recommendations on the design and
evaluation of comparative analytical studies intended to support a
demonstration that a proposed therapeutic protein product is biosimilar
to a reference product licensed under the Public Health Service Act
(PHS Act). Additionally, this draft guidance is intended to provide
recommendations to sponsors on the scientific and technical information
for the chemistry, manufacturing, and controls (CMC) portion of a
marketing application for a proposed product submitted under the PHS
Act. This draft guidance revises the guidance entitled ``Quality
Considerations in Demonstrating Biosimilarity of a Therapeutic Protein
Product to a Reference Product'' that was published on April 30, 2015.

DATES: Submit either electronic or written comments on the draft
guidance by July 22, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-2102 for ``Development of Therapeutic Protein Biosimilars:
Comparative Analytical Assessment and Other Quality-Related
Considerations.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 75, Rm. 6522, Silver Spring, MD 20993-0002, 301-
796-1042; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations.'' This
draft guidance describes the Agency's recommendations on the design and
evaluation of comparative analytical studies intended to support a
demonstration that a proposed therapeutic protein product is biosimilar
to a reference product licensed under section 351(a) of the PHS Act (42
U.S.C. 262(a)). Additionally, this draft guidance is intended to
provide recommendations to sponsors on of the scientific and technical
information for the CMC portion of a marketing application for a
proposed product submitted under section 351(k) of the PHS Act.
Although the 351(k) pathway applies generally to biological products,
this guidance focuses on therapeutic protein products.
    The Biologics Price Competition and Innovation Act of 2009 was
enacted as part of the Patient Protection and Affordable Care Act (Pub.
L. 111-148) on March 23, 2010, and created an abbreviated licensure
pathway under section 351(k) of the PHS Act for biological products
demonstrated to be biosimilar to, or interchangeable with, a reference
product. Under this abbreviated licensure pathway, FDA will license a
proposed biological product submitted under section 351(k) of the PHS
Act if, among other things, FDA determines that the information
submitted in the application is sufficient to show that the biological
product is biosimilar to the reference product.
    In the Federal Register of February 15, 2012 (77 FR 8884), FDA
announced the availability of the draft guidance entitled ``Quality
Considerations in Demonstrating Biosimilarity to a Reference Protein
Product.'' FDA received a number of comments on the draft guidance. In
response to these comments, FDA provided further clarification on the
general principles described through a final guidance entitled
``Quality Considerations in Demonstrating Biosimilarity of a
Therapeutic Protein Product to a Reference Product,'' which was
announced in the Federal Register of April 30, 2015 (80 FR 24257).
    In the Federal Register of September 22, 2017 (82 FR 44425), FDA
announced the availability of the draft guidance entitled ``Statistical
Approaches to Evaluate Analytical Similarity.'' FDA received a number
of comments on the draft guidance. Comments submitted to the docket
addressed a range of issues that could impact the cost and efficiency
of biosimilar development, including the number of reference product
lots the draft guidance would have recommended that biosimilar
developers sample in their evaluation of high similarity and the
statistical methods for this evaluation. After considering the public
comments that FDA received, FDA determined it would withdraw the draft
guidance to give further consideration to the scientific and regulatory
issues involved. FDA announced the withdrawal of the draft

guidance on June 21, 2018, with the intention of issuing future draft
guidance on the evaluation of analytical data to support a
demonstration that a proposed biosimilar product is highly similar to a
reference product.
    This draft guidance revises the guidance issued on April 30, 2015.
FDA has adjusted the title of this draft guidance to more clearly
communicate that this draft guidance includes the Agency's
recommendations on the design and evaluation of comparative analytical
studies intended to support a demonstration that a proposed therapeutic
protein product is biosimilar to a reference product. In addition to
editorial and clarifying edits, the draft guidance includes a section
that fulfills the Biosimilar User Fee Act II commitment to publish a
revised draft or final guidance, describing statistical considerations
for the analysis of analytical similarity data intended to support a
demonstration of ``highly similar'' for biosimilar biological products
within 18 months after the close of the public comment period for the
withdrawn guidance, ``Statistical Approaches to Evaluate Analytical
Similarity.''
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Development
of Therapeutic Protein Biosimilars: Comparative Analytical Assessment
and Other Quality-Related Considerations.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations, which are not expected to change
as a result of the guidance. These collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information related to the submission of: (1) An
investigational new drug application, which is covered under 21 CFR
part 312 and approved under OMB control number 0910-0014; (2) a new
drug application, which is covered under 21 CFR 314.50 and approved
under OMB control number 0910-0001; (3) a biologics license application
(BLA) under section 351(a) of the PHS Act, which is covered under part
601 (21 CFR part 601) and approved under OMB control number 0910-0338;
and (4) a BLA under section 351(k), which is covered under part 601 and
approved under OMB control number 0910-0719.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: May 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10667 Filed 5-21-19; 8:45 am]
 BILLING CODE 4164-01-P