an exception or alternative described in
paragraph (a) of this section to the
Center Director.
(ii) The Center Director may grant an
exception or alternative described in
paragraph (a) of this section on his or
her own initiative.
(2) A written request for an exception
or alternative described in paragraph (a)
of this section must:
(i) Identify the specified lots, batches,
or other units of the biological product
that would be subject to the exception
or alternative;
(ii) Identify the labeling provision(s)
listed in paragraph (f) of this section
that are the subject of the exception or
alternative request;
(iii) Explain why compliance with
such labeling provision(s) could
adversely affect the safety, effectiveness,
or availability of the specified lots,
batches, or other units of the biological
product that are or will be included in
the Strategic National Stockpile;
(iv) Describe any proposed safeguards
or conditions that will be implemented
so that the labeling of the product
includes appropriate information
necessary for the safe and effective use
of the product, given the anticipated
circumstances of use of the product;
(v) Provide a draft of the proposed
labeling of the specified lots, batches, or
other units of the biological product
subject to the exception or alternative;
and
(vi) Provide any other information
requested by the Center Director in
support of the request.
(c) The Center Director must respond
in writing to all requests under this
section.
(d) A grant of an exception or
alternative under this section will
include any safeguards or conditions
deemed appropriate by the Center
Director so that the labeling of product
subject to the exception or alternative
includes the information necessary for
the safe and effective use of the product,
given the anticipated circumstances of
use.
(e) If you are a sponsor receiving a
grant of a request for an exception or
alternative to the labeling requirements
under this section:
(1) You need not submit a supplement
under §601.12(f)(1) through (f)(2) of this
chapter; however,
(2) You must report any grant of a
request for an exception or alternative
under this section as part of your annual
report under §601.12(f)(3) of this
chapter.
(f) The Center Director may grant an
exception or alternative under this
section to the following provisions of
this chapter, to the extent that the
requirements in these provisions are not
explicitly required by statute:
(1) §610.60;
(2) §610.61(c) and (e) through (r);
(3) §610.62;
(4) §610.63;
(5) §610.64;
(6) §610.65; and
(7) §312.6.
PART 801—LABELING
ٱ
11. The authority citation for 21 CFR
part 801 continues to read as follows:
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Authority: 21 U.S.C. 321, 331, 351, 352,
360i, 360j, 371, 374.
ٱ
12. Add §801.128 to subpart D to read
as follows:
§801.128
Exceptions or alternatives to
labeling requirements for medical devices
held by the Strategic National Stockpile.
(a) The appropriate FDA Center
Director may grant an exception or
alternative to any provision listed in
paragraph (f) of this section and not
explicitly required by statute, for
specified lots, batches, or other units of
a medical device, if the Center Director
determines that compliance with such
labeling requirement could adversely
affect the safety, effectiveness, or
availability of such devices that are or
will be included in the Strategic
National Stockpile.
(b)(1)(i) A Strategic National Stockpile
official or any entity that manufactures
(including labeling, packing, relabeling,
or repackaging), distributes, or stores
devices that are or will be included in
the Strategic National Stockpile may
submit, with written concurrence from
a Strategic National Stockpile official, a
written request for an exception or
alternative described in paragraph (a) of
this section to the Center Director.
(ii) The Center Director may grant an
exception or alternative described in
paragraph (a) of this section on his or
her own initiative.
(2) A written request for an exception
or alternative described in paragraph (a)
of this section must:
(i) Identify the specified lots, batches,
or other units of the medical device that
would be subject to the exception or
alternative;
(ii) Identify the labeling provision(s)
listed in paragraph (f) of this section
that are the subject of the exception or
alternative request;
(iii) Explain why compliance with the
labeling provision(s) could adversely
affect the safety, effectiveness, or
availability of the specified lots,
batches, or other units of a medical
device that are or will be held in the
Strategic National Stockpile;
(iv) Describe any proposed safeguards
or conditions that will be implemented
so that the labeling of the device
includes appropriate information
necessary for the safe and effective use
of the device, given the anticipated
circumstances of use of the device;
(v) Provide a draft of the proposed
labeling of the specified lots, batches, or
other units of the medical device subject
to the exception or alternative; and
(vi) Provide any other information
requested by the Center Director in
support of the request.
(c) The Center Director must respond
in writing to all requests under this
section. The Center Director may
impose appropriate conditions when
granting such an exception or
alternative under this section.
(d) A grant of an exception or
alternative under this section will
include any safeguards or conditions
deemed appropriate by the Center
Director so that the labeling of devices
subject to the exception or alternative
includes the information necessary for
the safe and effective use of the device,
given the anticipated circumstances of
use.
(e) If the Center Director grants a
request for an exception or alternative to
the labeling requirements under this
section:
(1) The Center Director may
determine that the submission and grant
of a written request under this section
satisfies the provisions relating to
premarket notification submissions
under §807.81(a)(3) of this chapter.
(2)(i) For a Premarket Approval
Application (PMA)-approved device,
the submission and grant of a written
request under this section satisfies the
provisions relating to submission of
PMA supplements under §814.39 of
this chapter; however,
(ii) The grant of the request must be
identified in a periodic report under
§814.84 of this chapter.
(f) The Center Director may grant an
exception or alternative under this
section to the following provisions of
this chapter, to the extent that the
requirements in these provisions are not
explicitly required by statute:
(1) §801.1(d);
(2) §801.60;
(3) §801.61;
(4) §801.62;
(5) §801.63;
(6) §801.109; and
(7) Part 801, subpart H.
PART 807—ESTABLISHMENT
REGISTRATION AND DEVICE LISTING
FOR MANUFACTURERS AND INITIAL
IMPORTERS OF DEVICES
ٱ
13. The authority citation for 21 CFR
part 807 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
360, 360c, 360e, 360i, 360j, 371, 374, 381,
393; 42 U.S.C. 264, 271.
ٱ
14. Section 807.81 is amended by
revising paragraph (b) to read as follows:
§807.81
When a premarket notification
submission is required.
* * * * *
(b)(1) A premarket notification under
this subpart is not required for a device
for which a premarket approval
application under section 515 of the act,
or for which a petition to reclassify
under section 513(f)(2) of the act, is
pending before the Food and Drug
Administration.
(2) The appropriate FDA Center
Director may determine that the
submission and grant of a written
request for an exception or alternative
under §801.128 or §809.11 of this
chapter satisfies the requirement in
paragraph (a)(3) of this section.
* * * * *
PART 809—IN VITRO DIAGNOSTIC
PRODUCTS FOR HUMAN USE
ٱ
15. The authority citation for 21 CFR
part 809 continues to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 355,
360b, 360c, 360d, 360h, 360i, 360j, 371, 372,
374, 381.
ٱ
16. Add §809.11 to subpart B to read
as follows:
§809.11
Exceptions or alternatives to
labeling requirements for in vitro diagnostic
products for human use held by the
Strategic National Stockpile.
(a) The appropriate FDA Center
Director may grant an exception or
alternative to any provision listed in
paragraph (f) of this section and not
explicitly required by statute, for
specified lots, batches, or other units of
an in vitro diagnostic product for
human use, if the Center Director
determines that compliance with such
labeling requirement could adversely
affect the safety, effectiveness, or
availability of such products that are or
will be included in the Strategic
National Stockpile.
(b)(1)(i) A Strategic National Stockpile
official or any entity that manufactures
(including labeling, packing, relabeling,
or repackaging), distributes, or stores an
in vitro diagnostic product for human
use that is or will be included in the
Strategic National Stockpile may
submit, with written concurrence from
a Strategic National Stockpile official, a
written request for an exception or
alternative described in paragraph (a) of
this section to the Center Director.
(ii) The Center Director may grant an
exception or alternative described in
paragraph (a) of this section on his or
her own initiative.
(2) A written request for an exception
or alternative described in paragraph (a)
of this section must:
(i) Identify the specified lots, batches,
or other units of an in vitro diagnostic
product for human use that would be
subject to the exception or alternative;
(ii) Identify the labeling provision(s)
listed in paragraph (f) of this section
that are the subject of the exception or
alternative request;
(iii) Explain why compliance with
such labeling provision(s) could
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adversely affect the safety, effectiveness,
or availability of the specified lots,
batches, or other units of the in vitro
diagnostic product for human use that
are or will be held in the Strategic
National Stockpile;
(iv) Describe any proposed safeguards
or conditions that will be implemented
so that the labeling of the product
includes appropriate information
necessary for the safe and effective use
of the product, given the anticipated
circumstances of use of the product;
(v) Provide a draft of the proposed
labeling of the specified lots, batches, or
other units of the in vitro diagnostic
products for human use subject to the
exception or alternative; and
(vi) Provide any other information
requested by the Center Director in
support of the request.
(c) The Center Director must respond
in writing to all requests under this
section. The Center Director may
impose appropriate conditions or
safeguards when granting such an
exception or alternative under this
section.
(d) A grant of an exception or
alternative under this section will
include any safeguards or conditions
deemed appropriate by the Center
Director to ensure that the labeling of
the product subject to the exception or
alternative includes the information
necessary for the safe and effective use
of the product, given the anticipated
circumstances of use.
(e) If the Center Director grants a
request for an exception or alternative to
the labeling requirements under this
section:
(1) The Center Director may
determine that the submission and grant
of a written request under this section
satisfies the provisions relating to
premarket notification submissions
under §807.81(a)(3) of this chapter.
(2)(i) For a Premarket Approval
Application (PMA)-approved in vitro
diagnostic product for human use, the
submission and grant of a written
request under this section satisfies the
provisions relating to submission of
PMA supplements under §814.39 of
this chapter; however,
(ii) The grant of the request must be
identified in a periodic report under
§814.84 of this chapter.
(f) The Center Director may grant an
exception or alternative under this
section to the following provisions of
this part, to the extent that the
requirements in these provisions are not
explicitly required by statute:
(1) §809.10(a)(1) through (a)(6) and
(a)(9);
(2) §809.10(b);
(3) §809.10(c)(2);
(4) §809.10(d)(1)(i) through (d)(1)(v),
(d)(1)(viii), and (d)(2); and
(5) §809.10(e)(1)(i) through (e)(1)(vi)
and (e)(1)(ix) through (e)(1)(xi).
PART 812—INVESTIGATIONAL
DEVICE EXEMPTIONS
ٱ
17. The authority citation for 21 CFR
part 812 continues to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 353,
355, 360, 360c–360f, 360h–360j, 371, 372,
374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b–263n.
ٱ
18. Section 812.5 is amended by
adding paragraph (d) to read as follows:
§812.5
Labeling of investigational
devices.
* * * * *
(d) The appropriate FDA Center
Director, according to the procedures set
forth in §801.128 or §809.11 of this
chapter, may grant an exception or
alternative to the provisions in
paragraphs (a) and (c) of this section, to
the extent that these provisions are not
explicitly required by statute, for
specified lots, batches, or other units of
a device that are or will be included in
the Strategic National Stockpile.
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
ٱ
19. The authority citation for 21 CFR
part 814 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 371, 372, 373, 374, 375, 379, 379e,
381.
ٱ
20. Section 814.39 is amended by
adding paragraph (g) to read as follows:
§814.39
PMA Supplements.
* * * * *
(g) The submission and grant of a
written request for an exception or
alternative under §801.128 or §809.11
of this chapter satisfies the requirement
in paragraph (a) of this section.
ٱ
21. Section 814.84 is amended by
adding paragraph (b)(3) to read as
follows:
§814.84
Reports.
* * * * *
(b) * * *
(3) Identify changes made pursuant to
an exception or alternative granted
under §801.128 or §809.11 of this
chapter.
Dated: December 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–25165 Filed 12–27–07; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2007–0381; FRL–8510–3]
Approval and Promulgation of Air
Quality Implementation Plans; Virginia;
Clean Air Interstate Rule Budget
Trading Programs
AGENCY:
Environmental Protection
Agency (EPA).
ACTION:
Final rule.
SUMMARY:
EPA is approving a State
Implementation Plan (SIP) revision
submitted by the Commonwealth of
Virginia. This revision establishes
budget trading programs for nitrogen
oxides (NO ) annual, NO
X
X
ozone
season, and sulfur dioxides (SO )
2
annual emissions to address the
requirements of EPA’s Clean Air
Interstate Rule (CAIR). Virginia will
meet its CAIR requirements by
participating in the EPA-administered
regional cap-and-trade program for NO
X
annual, NO
X
ozone season, and SO
2
annual emissions. EPA is determining
that the SIP revision fully implements
the CAIR requirements for Virginia.
Therefore, as a consequence of the SIP
approval, EPA will also withdraw the
CAIR Federal Implementation Plan (FIP)
that addresses NO
X
annual, NO
X
ozone
season, and SO annual emissions in
2
Virginia.
EFFECTIVE DATE:
The final rule is
effective on December 28, 2007.
ADDRESSES:
EPA has established a
docket for this action under Docket ID
Number EPA–R03–OAR–2007–0381. All
documents in the electronic docket are
listed in the
www.regulations.gov
index.


[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42143-42146]
[FR Doc No: 2017-18794]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81500; File Nos. SR-BatsBYX-2017-13; SR-BatsBZX-2017-
39; SR-BatsEDGA-2017-14; SR-BatsEDGX-2017-24; SR-BOX-2017-19; SR-CBOE-
2017-043; SR-IEX-2017-21; SR-ISE-2017-52; SR-MRX-2017-08; SR-MIAX-2017-
24; SR-NASDAQ-2017-059; SR-BX-2017-029; SR-GEMX-2017-24; SR-PHLX-2017-
47; SR-NYSE-2017-24; SR-NYSEArca-2017-60; SR-NYSEMKT-2017-31]

Self-Regulatory Organizations; Bats BYX Exchange Inc.; Bats BZX
Exchange, Inc.; Bats EDGA Exchange, Inc.; Bats EDGX Exchange, Inc.; BOX
Options Exchange LLC; Chicago Board Options Exchange, Incorporated;
Investors Exchange LLC; Nasdaq ISE, LLC; Nasdaq MRX, LLC; Miami
International Securities Exchange, LLC; The NASDAQ Stock Market LLC;
NASDAQ BX, Inc.; Nasdaq GEMX, LLC; NASDAQ PHLX LLC; New York Stock
Exchange LLC; NYSE Arca, Inc.; NYSE MKT LLC; Order Approving Proposed
Rule Changes, as Modified by Amendments, To Adopt a Consolidated Audit
Trail Fee Dispute Resolution Process

August 30, 2017.

I. Introduction

    On May 16, 2017,\1\ May 23, 2017,\2\ May 25, 2017,\3\ June 6,
2017,\4\ June 8, 2017 \5\ and June 9, 2017,\6\ Bats BYX Exchange, Inc.
(``Bats BYX''), Bats BZX Exchange, Inc. (``Bats BZX''), Bats EDGA
Exchange, Inc. (``Bats EDGA''), Bats EDGX Exchange, Inc. (``Bats
EDGX''), BOX Options Exchange LLC (``BOX''),

Chicago Board Options Exchange, Incorporated (``CBOE''), Investors
Exchange LLC (``IEX''), Nasdaq ISE, LLC (``ISE''), Nasdaq MRX, LLC
(``MRX''), Miami International Securities Exchange, LLC (``MIAX''), The
NASDAQ Stock Market LLC (``Nasdaq''), NASDAQ BX, Inc. (``BX''), Nasdaq
GEMX, LLC (``GEMX''), NASDAQ PHLX LLC (``Phlx''), New York Stock
Exchange LLC (``NYSE''), NYSE Arca, Inc. (``NYSE Arca'') and NYSE MKT
LLC (``NYSE MKT'') (collectively, the ``Participants'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \7\
and Rule 19b-4 thereunder,\8\ proposed rule changes to establish the
procedures for resolving potential disputes related to CAT Fees charged
to Industry Members. The proposed rule changes submitted by NYSE, NYSE
Arca and NYSE MKT were published for comment in the Federal Register on
June 1, 2017.\9\ The proposed rule changes submitted by MIAX, Bats BYX,
Bats BZX, Bats EDGA, Bats EDGX, BOX and CBOE were published for comment
in the Federal Register on June 7, 2017.\10\ The proposed rule change
submitted by IEX was published for comment in the Federal Register on
June 20, 2017.\11\ The proposed rule change submitted by Nasdaq was
published for comment in the Federal Register on June 22, 2017.\12\ The
proposed rule changes submitted by Phlx, BX, GEMX, ISE and MRX were
published for comment in the Federal Register on June 23, 2017.\13\
Pursuant to Section 19(b)(2) of the Act,\14\ the Commission designated
a longer period within which to approve, disapprove, or institute
proceedings to determine whether to approve or disapprove the proposed
rule changes.\15\ The Commission received no comments in response to
the proposed rule changes. On August 23, 2017,\16\ August 24, 2017 \17\
and August 25, 2017,\18\ the Participants filed Amendments to the
proposed rule change.\19\ This order approves the proposed rule
changes, as modified by the Amendments.\20\
---------------------------------------------------------------------------

    \1\ New York Stock Exchange, LLC, NYSE Arca, Inc., NYSE MKT LLC,
and Miami International Securities Exchange LLC filed their proposed
rule changes on May 16, 2017.
    \2\ Bats BYX Exchange, Inc., Bats BZX Exchange, Inc., Bats EDGA
Exchange, Inc., Bats EDGX Exchange, Inc. and Chicago Board Options
Exchange, Incorporated filed their proposed rule changes on May 23,
2017.
    \3\ BOX Options Exchange LLC filed its proposed rule change on
May 25, 2017.
    \4\ Investors Exchange LLC filed its proposed rule change on
June 6, 2017.
    \5\ The NASDAQ Stock Market LLC and NASDAQ PHLX LLC filed their
proposed rule changes on June 8, 2017.
    \6\ NASDAQ BX, Inc., Nasdaq GEMX, LLC, Nasdaq ISE, LLC, Nasdaq
MRX, LLC filed their proposed rule changes on June 9, 2017.
    \7\ 15 U.S.C. 78s(b)(1).
    \8\ 17 CFR 240.19b-4.
    \9\ See Securities Exchange Act Release Nos. 80780 (May 26,
2017), 82 FR 25382; 80781 (May 26, 2017), 82 FR 25369; 80782 (May
26, 2017), 82 FR 25379.
    \10\ See Securities Exchange Act Release Nos. 80837 (June 1,
2017), 82 FR 26526; 80836 (June 1, 2017), 82 FR 26539; 80834 (June
1, 2017), 82 FR 26542; 80835 (June 1, 2017), 82 FR 26549; 80833
(June 1, 2017), 82 FR 26529; 80831 (June 1, 2017), 82 FR 26536; and
80832 (June 1, 2017), 82 FR 26523.
    \11\ See Securities Exchange Act Release No. 80936 (June 15,
2017), 82 FR 28153.
    \12\ See Securities Exchange Act Release No. 80952 (June 16,
2017), 82 FR 28540 (``Notice'').
    \13\ See Securities Exchange Act Release Nos. 80967 (June 19,
2017), 82 FR 28719; 80968 (June 19, 2017), 82 FR 28705; 80970 (June
19, 2017), 82 FR 28708; 80971 (June 19, 2017), 82 FR 28698; 80966
(June 19, 2017), 82 FR 28702.
    \14\ 15 U.S.C. 78s(b)(2).
    \15\ See Securities Exchange Act Release No. 81110 (July 10,
2017), 82 FR 32598 (July 14, 2017); 81112 (July 10, 2017), 82 FR
32592 (July 14, 2017); 81113 (July 10, 2017), 82 FR 32596 (July 14,
2017); 81156 (July 18, 2017), 82 FR 34337 (July 24, 2017); 81157
(July 18, 2017), 82 FR 34338 (July 24, 2017); 81158 (July 18, 2017),
82 FR 34339 (July 24, 2017); 81159 (July 18, 2017), 82 FR 34338
(July 24, 2017); 81161 (July 18, 2017), 82 FR 34337 (July 24, 2017);
81162 (July 18, 2017), 82 FR 34336 (July 24, 2017); 81164 (July 18,
2017), 82 FR 34346 (July 24, 2017); 81165 (July 18, 2017), 82 FR
34345 (July 24, 2017); 81166 (July 18, 2017), 82 FR 34345 (July 24,
2017); 81167 (July 18, 2017), 82 FR 34337 (July 24, 2017); 81178
(July 20, 2017), 82 FR 34715 (July 26, 2017); 81179 (July 20, 2017),
82 FR 34716 (July 26, 2017); 81180 (July 20, 2017), 82 FR 34728
(July 26, 2017); and 81181 (July 20, 2017), 82 FR 34727 (July 26,
2017).
    \16\ NYSE, NYSE Arca and NYSE MKT filed Amendment No. 1 to their
proposed rule changes on August 23, 2017. Amendment No. 1 is
available on the Commission's Web site for NYSE, NYSE Arca, and NYSE
MKT, respectively, at: https://www.sec.gov/comments/sr-nyse-2017-24/nyse201724-2241267-160850.pdf; https://www.sec.gov/comments/sr-nysearca-2017-60/nysearca201760-2241265-160861.pdf; and https://www.sec.gov/comments/sr-nysemkt-2017-31/nysemkt201731-2241266-160862.pdf.
    \17\ Bats BYX, Bats BZX, Bats EDGA, Bats EDGX, CBOE and BOX
filed Amendment No. 1 to their proposed rule changes on August 24,
2017. Amendment No. 1 is available on the Commission's Web site for
Bats BYX, Bats BZX, Bats EDGA, Bats EDGX, CBOE and BOX,
respectively, at: https://www.sec.gov/comments/sr-batsbyx-2017-13/batsbyx201713-2253932-160942.pdf; https://www.sec.gov/comments/sr-batsbzx-2017-39/batsbzx201739-2251466-160921.pdf; https://www.sec.gov/comments/sr-batsedga-2017-14/batsedga201714-2251458-160938.pdf; https://www.sec.gov/comments/sr-batsedgx-2017-24/batsedgx201724-2251462-160919.pdf; https://www.sec.gov/comments/sr-cboe-2017-043/cboe2017043-2251469-160922.pdf; and https://www.sec.gov/comments/sr-box-2017-19/box201719-2250011-160918.pdf.
MIAX filed Amendment No. 1 on August 22, 2017, but withdrew it on
August 24, 2017. MIAX then filed Amendment No. 2 on August 24, 2017.
Amendment No. 2 for MIAX is available on the Commission's Web site
at: https://www.sec.gov/comments/sr-miax-2017-24/miax201724-2243335-160869.pdf.
    \18\ IEX, Phlx, Nasdaq, BX, GEMX, ISE and MRX filed Amendment
No. 1 to their proposed rule changes on August 25, 2017. Amendment
No. 1 is available on the Commission's Web site for IEX, Phlx,
Nasdaq, BX, GEMX, ISE and MRX, respectively, at: https://www.sec.gov/comments/sr-iex-2017-21/iex201721-2243778-160880.pdf;
https://www.sec.gov/comments/sr-phlx-2017-47/phlx201747-2257687-160924.pdf; https://www.sec.gov/comments/sr-nasdaq-2017-059/nasdaq2017059-2257689-160925.pdf; https://www.sec.gov/comments/sr-bx-2017-029/bx2017029-2251461-160940.pdf; https://www.sec.gov/comments/sr-gemx-2017-24/gemx201724-2244452-160897.pdf; https://www.sec.gov/comments/sr-ise-2017-52/ise201752-2244293-160891.pdf;
and https://www.sec.gov/comments/sr-mrx-2017-08/mrx201708-2251467-160941.pdf.
    \19\ The Amendments amended the original filings to make
technical changes to the proposed rule changes. Specifically, each
Participant amended the proposed rule text to remove references to
proposed ``Consolidated Audit Trail Funding Fees,'' as such fees are
currently suspended, and replaced such term with the phrase ``any
fees contemplated by the CAT NMS Plan and imposed on Industry
Members pursuant to Exchange Rules.'' See infra note 24. Each
Participant also removed references to ``Consolidated Audit Trail
Funding Fees'' from paragraphs (a)(1), (b) and (c)(1) of the
proposed rule text. In addition, in connection with the merger of
NYSE Arca Equities with and into NYSE Arca, Amendment No. 1 for NYSE
Arca also combines NYSE Arca Equities Rule 6.6900 and NYSE Arca Rule
11.6900 into a single rule NYSE Rule 11.6900. See Securities
Exchange Act Release No. 80781 (May 26, 2017), 82 FR 25369. See also
Securities Exchange Act Release No. 81419 (August 17, 2017), 82 FR
40044 (August 23, 2017). The Amendments are not subject to notice
and comment because they are technical amendments that do not
materially alter the substance of the proposed rule changes or raise
any novel regulatory issues.
    \20\ The Commission notes that for purposes of this Order,
unless otherwise specified, capitalized terms used in this Order are
defined as set forth in the proposals, as modified by the
Amendments, or in the CAT NMS Plan. See supra notes 16-18; see also
infra note 23.
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II. Description of the Proposed Rule Changes, as Modified by the
Amendments

    The Participants, along with C2 Options Exchange, Inc., Chicago
Stock Exchange, Inc., Financial Industry Regulatory Authority, Inc.,
MIAX PEARL, LLC, and NYSE National, Inc., filed with the Commission,
pursuant to Section 11A of the Act \21\ and Rule 608 of Regulation NMS
thereunder,\22\ the National Market System Plan Governing the
Consolidated Audit Trail (``CAT NMS Plan'' or ``Plan'').\23\ The Plan
is designed to create, implement and maintain a consolidated audit
trail (``CAT'') that would capture customer and order event information
for orders in NMS Securities and OTC Equity Securities, across all
markets, from the time of order inception through routing,
cancellation, modification, or execution in a single consolidated data
source. The Plan accomplishes this by creating CAT NMS, LLC
(``Company''), of which each Participant is a member, to operate the
CAT.
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    \21\ 15 U.S.C. 78k-1.
    \22\ 17 CFR 242.608.
    \23\ See Letter from the Participants to Brent J. Fields,
Secretary, Commission, dated September 30, 2014; and Letter from
Participants to Brent J. Fields, Secretary, Commission, dated
February 27, 2015. On December 24, 2015, the Participants submitted
an amendment to the CAT NMS Plan. See Letter from Participants to
Brent J. Fields, Secretary, Commission, dated December 23, 2015. The
Plan was published for comment in the Federal Register on May 17,
2016, and approved by the Commission, as modified, on November 15,
2016. See Securities Exchange Act Release Nos. 77724 (April 27,
2016), 81 FR 30614 (May 17, 2016); 79318 (November 15, 2016), 81 FR
84696 (November 23, 2016).
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    Under the CAT NMS Plan, the Operating Committee of the Company
(``Operating Committee'') has the discretion to establish funding for
the Company to operate the CAT, including establishing fees that the
Participants

and Industry Members will pay (``CAT Fees'').\24\ Section 11.5 of the
CAT NMS Plan requires the Participants to adopt rules requiring that
disputes with respect to fees charged to Industry Members pursuant to
the CAT NMS Plan be determined by the Operating Committee or a
designated Subcommittee. Section 11.5 of the CAT NMS Plan also states
that decisions by the Operating Committee or a designated Subcommittee
on such matters shall be binding on Industry Members, without prejudice
to the right of any Industry Member to seek redress from the Commission
pursuant to Rule 608 \25\ or in any other appropriate forum. The
Participants filed the proposed rule changes to establish the
procedures for resolving potential disputes related to CAT Fees charged
to Industry Members.
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    \24\ Section 11.1(b) of the CAT NMS Plan. The Commission notes
that the Participants filed proposed rule changes to adopt fees to
be charged to Industry Members, including Industry Members that are
Execution Venues. See Securities Exchange Act Release Nos. 80675
(May 15, 2017), 82 FR 23100 (May 19, 2017) (SR-MIAX-2017-18); 80697
(May 16, 2017), 82 FR 23398 (May 22, 2017) (SR-BX-2017-023); 80692
(May 16, 2017), 82 FR 23325 (May 22, 2017) (SR-IEX-2017-16); 80696
(May 16, 2017), 82 FR 23439 (May 22, 2017) (SR-NASDAQ-2017-046);
80693 (May 16, 2017), 82 FR 23363 (May 22, 2017) (SR-NYSE-2017-22);
80698 (May 16, 2017), 82 FR 23457 (May 22, 2017) (SR-NYSEArca-2017-
52); 80694 (May 16, 2017), 82 FR 23416 (May 22, 2017) (SR-NYSEMKT-
2017-26); 80721 (May 18, 2017), 82 FR 23864 (May 24, 2017) (SR-BOX-
2017-16); 80713 (May 18, 2017), 82 FR 23956 (May 24, 2017) (SR-GEMX-
2017-17); 80715 (May 18, 2017), 82 FR 23895 (May 24, 2017) (SR-ISE-
2017-45); 80726 (May 18, 2017), 82 FR 23915 (May 24, 2017) (SR-MRX-
2017-04); 80725 (May 18, 2017), 82 FR 23935 (May 24, 2017) (SR-PHLX-
2017-37); 80785 (May 26, 2017), 82 FR 25404 (June 1, 2017) (SR-CBOE-
2017-040); 80784 (May 26, 2017), 82 FR 25448 (June 1, 2017) (SR-
BatsEDGA-2017-13); 80809 (May 30, 2017), 82 FR 25837 (June 5, 2017)
(SR-BatsBYX-2017-11); 80822 (May 31, 2017), 82 FR 26148 (June 6,
2017) (SR-BatsBZX-2017-38); and 80821 (May 31, 2017), 82 FR 26177
(June 6, 2017) (SR-BatsEDGX-2017-22). On June 30, 2017, the
Commission temporarily suspended the proposed rule changes and
instituted proceedings to determine whether to approve or disapprove
the proposed rule changes. See Securities Exchange Act Release No.
81067, 82 FR 31656 (July 7, 2017).
    \25\ 17 CFR 242.608.
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Fee Dispute Resolution

    The proposals state that disputes initiated by an Industry Member
with respect to CAT Fees charged to such Industry Member, including
disputes related to the designated tier and the fee calculated pursuant
to such tier, shall be resolved by the Operating Committee, or a
Subcommittee designated by the Operating Committee, pursuant to the Fee
Dispute Resolution Procedures adopted by the Operating Committee
pursuant to the CAT NMS Plan.\26\ The proposals further indicate that
decisions on such matters shall be binding on Industry Members, without
prejudice to the rights of any such Industry Member to seek redress
from the Commission or in any other appropriate forum.\27\
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    \26\ See, e.g., Notice, supra note 12, at 28541-42. The
Participants also represent that the Fee Dispute Resolution
Procedures were modeled after the adverse action procedures adopted
by various exchanges and that such Procedures will be posted on the
CAT NMS Plan Web site (www.catnmsplan.com). See, e.g., id. at 28542.
    \27\ See, e.g., id. at 28541.
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    Under the Fee Dispute Resolution Procedures, an Industry Member
that disputes CAT Fees charged to such Industry Member and that desires
to have an opportunity to be heard with respect to such disputed CAT
Fees must file a written application with the Company within 15
business days after being notified of such disputed CAT Fees.\28\ The
application must identify the disputed CAT Fees, state the specific
reasons why the applicant takes exception to such CAT Fees, and set
forth the relief sought.\29\ In addition, if the applicant intends to
submit any additional documents, statements, arguments or other
material in support of the application, the same should be so stated
and identified under the Fee Dispute Resolution Procedures.\30\
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    \28\ See, e.g., id. at 28542.
    \29\ See, e.g., id.
    \30\ See, e.g., id.
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    The Participants state that the Company will refer applications for
hearing and review promptly to the Fee Review Subcommittee designated
by the Operating Committee with responsibility for conducting the
reviews of CAT Fee disputes pursuant to these Fee Dispute Resolution
Procedures.\31\ The proposals note that the Fee Review Subcommittee
will keep a record of the proceedings.\32\
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    \31\ See, e.g., id. The Participants further indicate that the
members of the Fee Review Subcommittee will be subject to the
provisions of Section 4.3(d) of the CAT NMS Plan regarding recusal
and Conflicts of Interest. See, e.g., id.
    \32\ See, e.g., id.
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    The proposals further specify that the Fee Review Subcommittee will
hold hearings promptly and will set a hearing date.\33\ Under the
proposed rule changes, the parties to the hearing shall furnish the Fee
Review Subcommittee with all materials relevant to the proceedings at
least 72 hours prior to the hearing, and each party will have the right
to inspect and copy the other party's materials prior to the
hearing.\34\
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    \33\ See, e.g., id.
    \34\ See, e.g., id.
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    The Participants state that the parties to the hearing will consist
of the applicant and a representative of the Company who shall present
the reasons for the action taken by the Company that allegedly
aggrieved the applicant.\35\ The applicant is entitled to be
accompanied, represented and advised by counsel at all stages of the
proceedings under the proposed rule changes.\36\
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    \35\ See, e.g., id.
    \36\ See, e.g., id.
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    The proposals further indicate that the Fee Review Subcommittee
will determine all questions concerning the admissibility of evidence
and will otherwise regulate the conduct of the hearing.\37\ Each of the
parties will be permitted, under the proposed rule changes, to make an
opening statement, present witnesses and documentary evidence, cross
examine opposing witnesses and present closing arguments orally or in
writing as determined by the Fee Review Subcommittee.\38\ In addition,
the Fee Review Subcommittee will have the right to question all parties
and witnesses to the proceeding.\39\ The proposals require the Fee
Review Subcommittee to keep a record of the hearing, to set forth its
decision in writing, and to send the written decision to the parties to
the proceeding.\40\ Such decisions must contain the reasons supporting
the conclusions of the Fee Review Subcommittee under the proposed rule
changes.\41\
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    \37\ See, e.g., id. The proposed rule changes note, however,
that the formal rules of evidence will not apply.
    \38\ See, e.g., id.
    \39\ See, e.g., id.
    \40\ See, e.g., id.
    \41\ See, e.g., id.
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    The Participants state that the decision of the Fee Review
Subcommittee will be subject to review by the Operating Committee
either on its own motion within 20 business days after issuance of the
decision or upon written request submitted by the applicant within 15
business days after issuance of the decision.\42\ The applicant's
petition for review must be in writing and must specify the findings
and conclusions to which the applicant objects, together with the
reasons for such objections.\43\ According to the proposed rule
changes, any objection to a decision not specified in writing will be
considered to have been abandoned and may be disregarded.\44\ The
proposed rule changes allow parties to petition to submit a written
argument to the Operating Committee and to request an opportunity to
make an oral argument before the Operating

Committee.\45\ The Operating Committee will then have sole discretion
to grant or deny either request.\46\
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    \42\ See, e.g., id.
    \43\ See, e.g., id.
    \44\ See, e.g., id.
    \45\ See, e.g., id.
    \46\ See, e.g., id.
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    Under the proposed rule changes, any review conducted by the
Operating Committee will be made upon the record and will be made after
such further proceedings, if any, as the Operating Committee may
order.\47\ Based upon such record, the Operating Committee may affirm,
reverse or modify, in whole or in part, the decision of the Fee Review
Subcommittee.\48\ The Participants state that the decision of the
Operating Committee will be in writing, will be sent to the parties to
the proceeding, and will be final.\49\
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    \47\ See, e.g., id.
    \48\ See, e.g., id.
    \49\ See, e.g., id.
---------------------------------------------------------------------------

    A final decision regarding the disputed CAT Fees by the Operating
Committee, or the Fee Review Subcommittee (if there is no review by the
Operating Committee), must be provided within 90 days of the date on
which the Industry Member filed a written application regarding
disputed CAT Fees with the Company.\50\ The proposed rule changes
indicate, however, that the Operating Committee may extend the 90-day
time limit at its discretion.\51\ The Fee Dispute Resolution Procedures
also state that any time limits for the submission of answers,
petitions or other materials may be extended by permission of the
Operating Committee.\52\
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    \50\ See, e.g., id.
    \51\ See, e.g., id.
    \52\ See, e.g., id.
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    Finally, the Participants state that an Industry Member that files
a written application with the Company disputing CAT Fees in accordance
with the Fee Dispute Resolution Procedures is not required to pay such
CAT Fees until the dispute is resolved in accordance with the
Procedures, including any review by the Commission or in any other
appropriate forum.\53\ The Participants state that, if it is determined
that the Industry Member owes any of the disputed CAT Fees, then the
Industry Member must pay such disputed CAT Fees that are owed as well
as interest on such disputed CAT Fees from the original due date until
such disputed CAT Fees are paid at a per annum rate equal to the lesser
of (i) the Prime Rate plus 300 basis points, or (ii) the maximum rate
permitted by applicable law.\54\
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    \53\ See, e.g., id. The Participants clarify that the Industry
Member may only withhold any invoiced CAT Fees that the Industry
Member has disputed; under the proposed rule changes, the Industry
Member must pay any invoiced CAT Fees that are not disputed when
such fees are due, as set forth in the invoice. See, e.g., id.
    \54\ See, e.g., id. at 28542-43.
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III. Discussion and Commission Findings

    After carefully considering the proposed rule changes, the
Commission finds that the proposals, as modified by the Amendments, are
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to national securities exchanges.\55\
Specifically, the Commission finds that the proposed rule changes are
consistent with Section 6(b)(5) \56\ of the Act, which requires, among
other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest, and are not designed to permit unfair discrimination between
customers, issuers, brokers or dealers. In addition, the Commission
finds that the proposed rule changes are consistent with Section
6(b)(8) \57\ of the Act, which requires that the rules of a national
securities exchange not impose any burden on competition that is not
necessary or appropriate.
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    \55\ In approving these proposed rule changes, the Commission
has considered the proposed rules' impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \56\ 15 U.S.C. 78f(b)(5).
    \57\ 15 U.S.C. 78f(b)(8).
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    The Commission believes that the proposals are consistent with
Section 6(b) \58\ of the Act in general, and furthers the objectives of
Section 6(b)(5) \59\ of the Act \60\ in particular, because they are
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general to protect investors and the
public interest, by providing a uniform mechanism by which Industry
Members may dispute CAT Fees and receive a timely review of such
disputes. The Commission notes that the Fee Dispute Resolution
Procedures provide for a hearing before the Fee Review Subcommittee,
and if the Industry Member is not satisfied with the decision of the
Fee Review Subcommittee, it may request a review of the decision by the
Operating Committee. Further, the proposals provide that, although the
decisions of the Operating Committee or Fee Review Subcommittee are
binding on an Industry Member, the Industry Member may seek redress
from the Commission or in any other appropriate forum.
---------------------------------------------------------------------------

    \58\ 15 U.S.C. 78f(b).
    \59\ 15 U.S.C. 78f(b)(5).
    \60\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission also notes that the proposals implement Section 11.5
of the CAT NMS Plan.\61\ Specifically, Section 11.5 states that the
Participants will adopt rules requiring that disputes with respect to
fees charged to Industry Members pursuant to Article XI of the CAT NMS
Plan be determined by the Operating Committee or a designated
Subcommittee. Section 11.5 further provides that such fee disputes will
be determined by the Operating Committee or a designated Subcommittee,
and that decisions on such matters will be binding on Industry Members
without prejudice to the rights of any Industry Member to seek redress
from the Commission pursuant to Rule 608 of Regulation NMS or in any
other appropriate forum.
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    \61\ The Commission previously approved the CAT NMS Plan. See
supra note 23.
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule changes (SR-BatsBYX-2017-13; SR-BatsBZX-2017-39;
SR-BatsEDGA-2017-14; SR-BatsEDGX-2017-24; SR-BOX-2017-19; SR-CBOE-2017-
043; SR-IEX-2017-21; SR-ISE-2017-52; SR-MRX-2017-08; SR-MIAX-2017-24;
SR-NASDAQ-2017-059; SR-BX-2017-029; SR-GEMX-2017-24; SR-PHLX-2017-47;
SR-NYSE-2017-24; SR-NYSEArca-2017-60; SR-NYSEMKT-2017-31), as modified
by the Amendments, are approved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\62\
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    \62\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-18794 Filed 9-5-17; 8:45 am]
 BILLING CODE 8011-01-P