[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19545-19548]
[FR Doc No: 2020-07224]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88532; File No. 4-443]

Joint Industry Plan; Order Approving Amendment No. 5 to the Plan
for the Purpose of Developing and Implementing Procedures Designed To
Facilitate the Listing and Trading of Standardized Options To Adopt a
Penny Interval Program

April 1, 2020.

I. Introduction

    On July 18, 2019, BOX Exchange LLC; Cboe BZX Exchange, Inc.; Cboe
C2 Exchange, Inc.; Cboe Exchange, Inc.; Cboe EDGX Exchange, Inc.; Miami
International Securities Exchange, LLC; MIAX Emerald, LLC; MIAX PEARL,
LLC; Nasdaq BX, Inc.; Nasdaq GEMX, LLC; Nasdaq ISE, LLC; Nasdaq MRX,
LLC; Nasdaq PHLX LLC; The Nasdaq Stock Market LLC; NYSE American, LLC;
NYSE Arca, Inc. (collectively, ``Exchanges''); and The Options Clearing
Corporation (``OCC'') (together with the OCC, ``Plan Sponsors'') filed
with the Securities and Exchange Commission (``Commission'') pursuant
to Section 11A(a)(3) of the Securities Exchange Act of 1934 (``Act'')
\1\ and Rule 608 thereunder,\2\ a proposal to amend the Plan for the
Purpose of Developing and Implementing Procedures Designed to
Facilitate the Listing and Trading of Standardized Options (the
``Plan'').\3\ Amendment No. 5 was published for comment in the Federal
Register on December 17, 2019.\4\
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    \1\ 15 U.S.C. 78k-1(a)(3).
    \2\ 17 CFR 242.608.
    \3\ See Letter from BOX Exchange LLC, CBOE BZX Exchange, Inc.,
CBOE Exchange, Inc., CBOE C2 Exchange, Inc, CBOE EDGX Exchange,
Inc., Miami International Securities Exchange, LLC, MIAX Emerald,
LLC, MIAX PEARL, LLC, NASDAQ BX, Inc., NASDAQ GEMX, LLC, NASDAQ ISE,
LLC, NASDAQ MRX, LLC, NASDAQ PHLX, LLC, The NASDAQ Stock Market LLC,
NYSE American, LLC, NYSE Arca, Inc., and the OCC, to Vanessa
Countryman, Secretary, Commission, dated July 18, 2019. (``Amendment
No. 5''). On July 6, 2001, the Commission approved the Plan, which
was proposed by the American Stock Exchange LLC, Chicago Board
Options Exchange, Incorporated, International Securities Exchange
LLC, OCC, Philadelphia Stock Exchange, Inc., and Pacific Exchange,
Inc. See Securities Exchange Act Release No. 44521, 66 FR 36809
(July 13, 2001). See also Securities Exchange Act Release Nos. 49199
(February 5, 2004), 69 FR 7030 (February 12, 2004) (adding Boston
Stock Exchange, Inc. as a Plan Sponsor); 57546 (March 21, 2008), 73
FR 16393 (March 27, 2008) (adding The Nasdaq Stock Market, LLC as a
Plan Sponsor); 61528 (February 17, 2010), 75 FR 8415 (February 24,
2010) (adding BATS Exchange, Inc. as a Plan Sponsor); 63162 (October
22, 2010), 75 FR 66401 (October 28, 2010) (adding C2 Options
Exchange Incorporated as a Plan Sponsor); 66952 (May 9, 2012), 77 FR
28641 (May 15, 2012) (adding BOX Options Exchange LLC as a Plan
Sponsor); 67327 (June 29, 2012), 77 FR 40125 (July 6, 2012) (adding
Nasdaq OMX BX, Inc. as a Plan Sponsor); 70765 (October 28, 2013), 78
FR 65739 (November 1, 2013) (adding Topaz Exchange, LLC as a Plan
Sponsor); 70764 (October 28, 2013), 78 FR 65733 (November 1, 2013)
(adding Miami International Securities Exchange, LLC as a Plan
Sponsor); 76822 (January 1, 2016), 81 FR 1251 (January 11, 2016)
(adding EDGX Exchange, Inc. as a Plan Sponsor); 77323 (March 8,
2016), 81 FR 13433 (March 14, 2016) (adding ISE Mercury, LLC as a
Plan Sponsor); 79897 (January 30, 2017), 82 FR 9263 (February 3,
2017) (adding MIAX PEARL, LLC as a Plan Sponsor); and 85228 (March
1, 2019), 84 FR 8355 (March 7, 2019) (adding MIAX Emerald, LLC as a
Plan Sponsor). The full text of the Plan is available at: https://www.theocc.com/components/docs/clearing/services/options_listing_procedures_plan.pdf.
    \4\ See Securities Exchange Act Release No. 87681 (December 9,
2019), 84 FR 68960 (``Notice'').
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    The Commission received no comment letters regarding the Amendment.
This order approves Amendment No. 5 to the Plan.

II. Description of the Amendment

A. Background

    In January 2007, the Commission approved rules that allowed the six
registered options exchanges that then existed to begin quoting certain
multiply listed options classes overlying thirteen stocks and Exchange
Traded Funds (``ETFs'') in penny increments pursuant to a six-month
Penny Pilot

Program (``Penny Pilot'').\5\ The Penny Pilot was designed to determine
whether investors would benefit from options being quoted in penny
increments, and in which classes the benefits were most significant.
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    \5\ See Securities Exchange Act Release Nos. 55153 (January 23,
2007), 72 FR 4553 (January 31, 2007) (SR-Phlx-2006-74); 55154
(January 23, 2007), 72 FR 4743 (February 1, 2007) (SR-CBOE-2006-92);
55162 (January 24, 2007), 72 FR 4738 (February 1, 2007) (SR-Amex-
2006-106); 55161 (January 24, 2007), 72 FR 4754 (January 24, 2007)
(SR-ISE-2006-62); 55156 (January 23, 2007), 72 FR 4759 (February 1,
2007) (SR-NYSEArca-2006-73); and 55155 (January 23, 2007), 72 FR
4741 (February 1, 2007) (SR-BSE-2006-49).
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    Following that initial approval, the Commission approved additional
Exchange rules that expanded the number of options classes covered by
the Penny Pilot.\6\ In each instance, these approvals relied upon the
consideration of data periodically provided by the Exchanges that
analyzed how quoting options in penny increments affects spreads,
liquidity, quote traffic, and volume. Today, the Penny Pilot includes
363 options classes, which are among the most actively traded, multiply
listed options classes.\7\ The Penny Pilot is scheduled to expire by
its own terms on June 30, 2020.\8\
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    \6\ See, e.g., Securities Act Release Nos. 56568 (September 27,
2007) (NYSEArca-2007-88); 57559 (March 26, 2008) (NYSEArca-2008-34);
and 60711 (September 23, 2009), 74 FR 49419 (September 28, 2009)
(NYSEArca-2009-44).
    \7\ See Securities Exchange Act Release Nos. 60711 (September
23, 2009), 74 FR 49419 (September 28, 2009) (SR-NYSEArca-2009-44);
60865 (October 22, 2009), 74 FR 55880 (October 29, 2009) (SR-ISE-
2009-82); 60864 (October 22, 2009), 74 FR 55876 (October 29, 2009)
(SR-CBOE-2009-076); 60874 (October 23, 2009), 74 FR 56682 (November
2, 2009) (SR-NASDAQ-2009-091); 60873 (October 23, 2009), 74 FR 56675
(November 2, 2009) (SR-Phlx-2009-91); 60886 (October 27, 2009), 74
FR 56897 (November 3, 2009) (SR-BX-2009-067); and 61106 (December 3,
2009), 74 FR 65193 (December 9, 2009) (SR-NYSEAmex-2009-74).
    \8\ See Securities Exchange Act Release Nos. 87632 (November 26,
2019), 84 FR 66255 (December 3, 2019) (SR-BOX-2019-34); 87740
(December 13, 2019), 84 FR 69800 (December 19, 2019) (CboeBZX-2019-
106); 87738 (December 13, 2019), 84 FR 69795 (December 19, 2019)
(C2-2019-027); 87739 (December 13, 2019), 84 FR 69801 (December 19,
2019) (CBOE-2019-119); 87741 (December 13, 2019), 84 FR 69805
(December 19, 2019) (CboeEDGX-2019-074); 87606 (November 25, 2019),
84 FR 66030 (December 2, 2019) (MIAX-2019-47); 87608 (November 25,
2019), 84 FR 66046 (EMERALD-2019-36); 87609 (November 25, 2019), 84
FR 66032 (December 2, 2019) (PEARL-2019-34); 87754 (December 16,
2019), 84 FR 70232 (December 20, 2019) (BX-2019-046); 87753
(December 16, 2019), 84 FR 70243 (December 20, 2019) (GEMX-2019-19);
87752 (December 16, 2019), 84 FR 70230 (December 20, 2019) (ISE-
2019-33); 87766 (December 16, 2019), 84 FR 70214 (December 20, 2019)
(MRX-2019-26); 87746 (December 13, 2019), 84 FR 69803 (December 19,
2019) (Phlx-2019-55); 87831 (December 20, 2019), 84 FR 72013
(December 30, 2019) (Nasdaq-2019-100); 87610 (November 25, 2019), 84
FR 66047 (December 2, 2019) (NYSEArca-2019-83); 87633 (November 26,
2019), 84 FR 66251 (December 3, 2019) (NYSEAmex-2019-51).
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B. Description of the Proposal

    In light of the imminent expiration of the Penny Pilot, the Plan
Sponsors now propose in Amendment No. 5 to the Plan to replace the
Penny Pilot by instituting a permanent program (the ``Penny Program'')
that would permit quoting in penny increments for certain classes of
options. Under the terms of this proposal, designated options classes
would continue to be quoted in $0.01 and $0.05 increments according to
the same parameters for the Penny Pilot. In addition, the Penny Program
would: (1) Establish an annual review process to add and/or remove
options classes from the Penny Program; (2) allow an option class to be
added to the Penny Program outside of the annual review process if it
is a newly listed option class or a class that experiences significant
growth in activity, provided such class meets certain objective
criteria; (3) provide that if a corporate action involves one or more
options classes in the Penny Program, all adjusted and unadjusted
series of the option class would continue to be included in the Penny
Program; (4) provide that any series in an option class participating
in the Penny Program in which the underlying security has been
delisted, or are identified by OCC as ineligible for opening customer
transactions, would continue to quote pursuant to the rules of the
Penny Program until all such options have expired; and (5) establish
voting provisions governing amendments to the Penny Program.\9\
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    \9\ Amendment No. 5 also proposes to make certain administrative
changes to Section 4 of the Plan to replace references to ``the
adjustment panel'' with references to ``the OCC'' to ensure that the
language in the Plan is consistent with changes made in a separate
filing. See Securities Exchange Act Release No. 84565 (November 9,
2018), 83 FR 57778 (November 16, 2018) (SR-ODD-2018-01). See also
Securities Exchange Act Release No. 69977 (July 11, 2013), 78 FR
42815 (July 17, 2013) (SR-OCC-2013-05). In addition, Amendment No. 5
proposes to make non-substantive ministerial changes to Section 9 of
the Plan to update the names and addresses of certain Plan Sponsors.
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1. Minimum Quoting Increments and Initial Selection of Options Classes
for the Penny Program
    The minimum quoting increment requirements that currently apply
under the Penny Pilot would continue to apply for options classes
included in the Penny Program. Specifically, (i) the minimum quoting
increment for all series in the QQQ, SPY, and IWM would continue to be
$0.01, regardless of price; (ii) options classes with a price of less
than $3.00 would be quoted in $0.01 increments for all series; and
(iii) options classes with a price of $3.00 or higher would be quoted
in $0.05 increments for all series.\10\
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    \10\ See Proposed Section 3.1 of the Plan.
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    The Penny Program would initially apply to the 363 most actively
traded, multiply listed options classes \11\ that (i) are currently
included the Penny Pilot or, (ii) if not currently in the Penny Pilot,
overlie securities priced below $200, or any index at an index level
below $200.\12\ As is the case today, the Exchanges will use the OCC
rankings and apply these objective criteria to determine which classes
are eligible for inclusion in the Penny Program. Once an option class
is added to the Penny Program, it would remain in the Program subject
to the annual review process described in further detail below.\13\
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    \11\ This number is taken from the current number of the options
classes in the Penny Pilot. See Notice, supra note 4 at 68961.
    \12\ OCC will rank all multiply listed options classes based on
National Cleared Volume for the six-month period ending in the month
that the Commission approves proposed Amendment No. 5 to determine
whether an option class is among the 363 most activity traded. See
Proposed Section 3.1(a) of the Plan. Eligibility for inclusion in
the Penny Program will be determined at the close of trading on the
monthly expiration Friday of the second full month following
approval of the proposed Amendment. See id. Certain options classes
that currently quote in penny increments pursuant to the Penny Pilot
that are not among the 363 most actively traded multiply listed
options classes at the time of the initial selection will no longer
be eligible to quote in penny increments under the Penny Program.
Any options classes that are currently in the Penny Pilot, but that
are not selected for inclusion in the Penny Program following the
initial selection process would be subject to the minimum trading
increment as described in the rules of the Exchanges. See Notice,
supra note 4, at 68961. Such changes would be effective on the first
trading day of the third full calendar month following the
Amendment's approval date. See Proposed Section 3.1(a) of the Plan.
    \13\ See Notice, supra note 4, at 68961.
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2. Annual Review Process
    The Penny Program provides for an annual review process by which
options classes can be added and removed from the Penny Program based
on objective criteria. The annual review process is designed to ensure
that the most active eligible issues are included in the Penny Program
while also preventing a high rate of turnover for issues that are
removed from the Penny Program. Specifically, on an annual basis
(commencing in December 2020), the OCC would rank all multiply listed
options classes based on National Cleared Volume from June 1 through
November 30 to determine the most actively traded options classes.\14\
Any option class not yet in the Penny Program that is among the 300
most actively traded, multiply listed options

classes overlying securities priced below $200, or an index at an index
level below $200, would be added to the Penny Program on the first
trading day in January following the annual review.\15\ In addition,
based on the annual review, options classes that are ranked between the
300 most actively traded and the 425 most actively traded would
continue to be included in the Penny Program,\16\ but any option class
that falls outside of the 425 most actively traded, multiply listed
option class would be removed from the Penny Program and would be
subject to the minimum quoting increment rules set forth in the
Exchanges' rules, effective on the first day of trading in April.\17\
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    \14\ Proposed Section 3.1(b) of the Plan.
    \15\ Proposed Section 3.1(b)(1) of the Plan. After extensive
discussion, the Plan Sponsors concluded that including the top 300
classes would ensure that the Penny Program always includes the most
active issues. See Notice, supra note 4, at 68961-62 and n.14.
    \16\ Proposed Section 3.1(b) of the Plan. The Plan Sponsors
determined that including the top 425 options classes would prevent
high turnover rates of classes and thus provide the least disruptive
means of implementing the annual rebalancing of the Penny Program.
See Notice, supra note 4, at 68961-62 and n.14.
    \17\ Proposed Section 3.1(b)(2) of the Plan.
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3. Changes to the Composition of the Penny Program Outside of the
Annual Review Process
i. Newly Listed Options Classes and Options Classes With Significant
Growth in Activity
    The Penny Program would specify a process and parameters for
including options classes in the Penny Program outside the annual
review process in two circumstances. These provisions are designed to
provide objective criteria for the Exchanges to add to the Penny
Program new options classes in issues with the most demonstrated
trading interest from market participants and investors on an expedited
basis prior to the annual review, with the benefit that market
participants and investors will then be able to trade these new options
classes based upon quotes expressed in finer trading increments.
    First, Section 3.1(c) provides for certain newly listed options
classes to be added to the Penny Program outside of the annual review
process, provided that (i) the class is among the 300 most actively
traded, multiply listed options classes, as ranked by National Cleared
Volume at OCC, in its first full calendar month of trading; and (ii)
the underlying security is priced below $200 or the underlying index is
at an index level below $200. Such newly listed options classes added
to the Penny Program pursuant to this process would remain in the Penny
Program for one full calendar year and then would be subject to the
annual review process.\18\
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    \18\ See Proposed Section 3.1(c) of the Plan.
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    Second, the Penny Program would allow an option class to be added
to the Penny Program outside of the annual review process if it is an
option class that meets certain specific criteria. Section 3.1(d)
provides that an option class may be added to the Penny Program,
provided that (i) it is among the 75 most actively traded, multiply
listed options classes, as ranked by National Cleared Volume at OCC,
for six full calendar months of trading, and (ii) the underlying
security is priced below $200 or the underlying index is at an index
level below $200. Options classes that are added to the Penny Program
pursuant to Section 3.1(d) would remain in the Penny Program for the
rest of the calendar year in which they are added and then would be
subject to the annual review process.\19\
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    \19\ See Proposed Section 3.1(d) of the Plan.
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ii. Corporate Actions
    Section 3.1(e) specifies a process to address options classes in
the Penny Program that undergo a corporate action and is designed to
ensure continuous liquidity in the affected options classes.
Specifically, if a corporate action involves one or more options
classes in the Penny Program, all adjusted and unadjusted series of an
option class would continue to be included in the Penny Program.\20\
Furthermore, neither the trading volume threshold, nor the initial
price test would apply to options classes added to the Penny Program as
a result of the corporate action. Finally, the newly added adjusted and
unadjusted series of the option class would remain in the Penny Program
for one full calendar year and then would become subject to the annual
review process.
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    \20\ For example, if Company A acquires Company B and Company A
is not in the Penny Program but Company B is in the Penny Program,
once the merger is consummated and an options contract adjustment is
effective, then Company A would be added to the Penny Program and
remain in the Penny Program for one calendar year. See Notice, supra
note 4, at 68963 n.19.
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iii. Delisted or Ineligible Options Classes
    Section 3.1(f) provides a mechanism to address options classes that
have been delisted or those that are no longer eligible for listing.
Specifically, any series in an option class participating in the Penny
Program in which the underlying has been delisted, or is identified by
OCC as ineligible for opening customer transactions, would continue to
quote pursuant to the terms of the Penny Program until all options
series have expired.
4. Amendments to the Penny Program
    Section 3.1(h) sets forth an amendment process applicable to
changes to the Penny Program. Currently, amendments to the Plan (other
than an amendment to add a new Plan Sponsor) must be approved
unanimously by the Plan Sponsors.\21\ A new and separate process would
govern amendments to the Penny Program and any changes to Section 3.1.
Under this new process, for the first 60 months following Commission
approval of Amendment No. 5, any change to the Penny Program would
require unanimous approval by the Plan Sponsors. For the period
following the expiration of that initial 60-month period, any changes
to the Penny Program would require a super-majority (\2/3\) vote of the
Plan Sponsors. The Plan Sponsors structured the amendment process this
way because they believe delaying the elimination of the unanimity
requirement by 60 months would preserve the agreed upon provisions of
the Penny Program, except in circumstances where all the Plan Sponsors
agree a change is needed.
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    \21\ See Section 7 of the Plan.
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III. Discussion and Commission Findings

    The Commission finds that Amendment No. 5 is consistent with the
requirements of the Act and the rules and regulations thereunder.
Specifically, and as discussed in greater detail below, the Commission
finds that Amendment No. 5 is consistent with Section 11A of the Act
\22\ and Rule 608 thereunder \23\ in that it is appropriate in the
public interest, for the protection of investors and the maintenance of
fair and orderly markets, to remove impediments to, and perfect the
mechanisms of, the national market system to allow the Exchanges to
continue to quote certain options classes in penny increments on a
permanent basis pursuant to provisions established by Amendment No. 5.
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    \22\ 15 U.S.C. 78k-1.
    \23\ 17 CFR 242.608.
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    In support of the proposal to establish the Penny Program, the
Exchanges prepared a report that contained the results of their
analysis of the Penny Pilot and its impact on several indicia of market
quality (``Report'').\24\ The

Report contains data and analysis on the impact of the Penny Pilot on
spread width, liquidity, and quote message traffic and shows that
spreads in options classes with a premium of less than $3.00 decreased
upon inclusion in the Penny Pilot.\25\ In addition, the Report shows
that volume increased in Penny Pilot classes \26\ and that while
liquidity at the National Best Bid or Offer decreased, the size
available was nonetheless greater than the size traded.\27\ Further,
the Exchanges represent that they and the Options Price Reporting
Authority (``OPRA'') have demonstrated sufficient capacity to handle
the increase in quotes resulting from quoting in penny increments
during the Penny Pilot. The Exchanges also represent that the OPRA
system and their own respective systems have sufficient quote capacity
to accommodate the projected increase in quote message traffic that is
likely to result from the Penny Program.\28\
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    \24\ See Report on Activity in Options Classes Added to the
Penny Pilot dated March 8, 2019 (``Report''), submitted as Exhibit A
as part of Amendment No. 5. See also Notice, supra note 4, at 68966-
83.
    \25\ Specifically, the Report states, ``[t]he study found that
the average spread width for issues in the Study Group was reduced
during the Pilot period as compared to pre-Pilot period.'' See
Notice, supra note 4, at 68967.
    \26\ See id. at 68976-77.
    \27\ See id. at 68967.
    \28\ See id. at 68965-66.
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    In addition to reviewing the data and analysis provided by the
Exchanges in their Report, the Commission reviewed an independent
analysis of the impact of the Penny Pilot on market quality conducted
by Cornerstone Research (``Cornerstone'').\29\ Cornerstone's analysis
used quoted and effective spreads as measures of market quality and
concluded that the most liquid options classes included in the Penny
Pilot experienced a significant decrease in effective and quoted
spread. For less liquid options classes, however, the results did not
suggest that allowing quoting in penny increments has a significant
effect on market quality. The Exchanges state that the results of their
analysis were consistent with Cornerstone's findings that inclusion in
the Penny Pilot is associated with a decrease in quoted spreads.\30\
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    \29\ See DERA Memorandum on Cornerstone Analysis, dated December
18, 2017 and July 3, 2017 Cornerstone Analysis, available at:
https://www.sec.gov/files/DERA_Memo_on_a_Cornerstone_Penny_Pilot_Analysis.pdf.
    \30\ See Notice, supra note 4, at 68967.
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    The Commission believes that the evidence contained in both the
Exchanges' Report and the Cornerstone analysis demonstrates that the
Penny Pilot has benefitted investors and other market participants in
the form of narrower spreads while also having a minimal negative
impact on the industry. The Commission believes that investors will
benefit from the implementation of a permanent approach to allowing
continued quoting in penny increments for certain options classes. The
Penny Program is designed to facilitate a permanent environment where
investors can continue to enjoy reduced spreads, and concomitantly
potentially reduced costs, in portions of the options market where the
greatest amount of options trading occurs (i.e., the top 300 options
classes). Further, although the Exchanges predict that the Penny
Program will generate a significant increase in quote message
traffic,\31\ the Plan Sponsors have represented that the Exchange's
respective systems and OPRA's system will maintain sufficient capacity
to manage the increase in message traffic.
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    \31\ See id. at 68975-83.
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    The Penny Program annual review process will help facilitate the
maintenance of a fair and orderly market for trading options because it
provides a framework, based upon objective criteria, that rebalances
the composition of the Penny Program on an annual basis, thereby
helping to ensure that the most actively traded options classes are
included in the Penny Program. Further, the parameters of the annual
review process are designed to prevent high turnover for options
classes in the Penny Program by incorporating a buffer to help ensure
that options classes that are actively traded are not prematurely
removed from the Penny Program.
    The Penny Program will also allow options classes to be added
outside the annual review process provided certain objective criteria
(trading volume thresholds and initial price tests) are satisfied.
These procedures should facilitate the maintenance of a fair and
orderly market by permitting options classes that reflect a certain
level of trading interest (either because the class is newly listed or
a class that experience a significant growth in investor interest) to
quote in finer trading increments, which in turn should benefit market
participants by reducing the cost of trading such options.
    In addition, the process to address options classes in the Penny
Program that undergo a corporate action will help to ensure continued
liquidity in such options classes to the benefit of market participants
and investors thereby helping to promote just and equitable principles
of trade, remove impediments to and perfect the mechanism of a free and
open market and a national market system and protect investors and the
public interest by providing clarity and uniformity among the Exchanges
as to how such options classes will be treated.
    Further, requiring that any series in an option class in the Penny
Program in which the underlying security has been delisted, or are
identified by OCC as ineligible for opening customer transactions,
continue to quote pursuant to the rules of the Penny Program until all
such options have expired, will promote the maintenance of fair and
orderly markets by encouraging market participants to continue to
provide liquidity in such options classes on a predictable and
transparent time frame.
    The Exchanges' proposal to permit amendments to be approved by a
super-majority vote of the Exchanges, rather than by a unanimous vote,
as the Plan otherwise requires, should promote the maintenance of fair
and orderly markets and remove impediments by preventing a single
Exchange from having an effective veto over modifications to the Penny
Program that a super-majority of Exchanges support, thus potentially
obstructing improvements to the Program and its operations. The
Commission notes that the Exchanges' proposal to delay the elimination
of the unanimity requirement by 60 months is designed to preserve the
agreed upon provisions contained in Amendment No. 5, except in
circumstances where all the Exchanges agree a change is needed, which
in turn should allow the Penny Program to operate as proposed before
lesser supported changes are proposed.
    The Commission notes that no comments were received in opposition
to continuing to allow the Exchanges to quote in penny increments or
with respect to the specific provisions regarding how the Penny Program
will operate.
    For the reasons discussed above, the Commission finds that
Amendment No. 5 is consistent with Section 11A of the Act \32\ and Rule
608 thereunder.\33\
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    \32\ 15 U.S.C. 78k-1.
    \33\ 17 CFR 242.608.
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IV. Conclusion

    It is therefore ordered, pursuant to Section 11A of the Act,\34\
and Rule 608 thereunder,\35\ that Amendment No. 5 to the Plan (File No.
4-443) be, and it hereby is, approved.
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    \34\ 15 U.S.C. 78k-1.
    \35\ 17 CFR 242.608.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\36\
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    \36\ 17 CFR 200.30-3(a)(29).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-07224 Filed 4-6-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 24, 2006 (Volume 71, Number 15)]
[Notices]
[Page 3841]
[DOCID:fr24ja06-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11588-011, Alaska]

Alaska Power and Telephone Company; Notice of Availability of
Environment Assessment

January 17, 2006.
    An environmental assessment (EA) is available for public review.
The EA was prepared for an application filed by the Alaska Power and
Telephone Company (licensee) on October 17, 2005, requesting Commission
approval to make certain design and site location changes to project
facilities as licensed. The changes include: (1) Constructing a 675-
foot-long, 9 foot horseshoe tunnel to provide a route for the upper
section of the penstock and access to the diversion structure, (2)
altering the penstock composition and alignment and the alignment and
width of the access road for a length of 2,860 feet, (3) moving the
powerhouse 80 feet south of the original location and increase the
tailrace length from 75 feet to 163 fee, (4) moving the marine access
about 600 feet north of the original location and construct a 250-foot-
long jetty with a quay and boat ramp; and (5) constructing a 33,000
square-foot rockfill staging area onshore.
    The EA evaluates the environmental impacts that would result from
approving the licensee's proposed changes to certain project facilities
and locations. Some additional ground disturbance would occur but
impacts to the terrestrial and marine environments are expected to be
minor and short term. The EA finds that approval of the amendment
application would not constitute a major Federal action significantly
affecting the quality of the human environment.
    A copy of the EA is attached to a Commission order titled ``Order
Amending License'', issued January 12, 2006, and is available in the
Commission's Public Reference Room. A copy of the EA may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number (P-11588) in the docket
field to access the document. For assistance, call<PHONE_NUMBER> or
(202) 502-8659 (for TTY).

Magalie R. Salas,
Secretary.
 [FR Doc. E6-791 Filed 1-23-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Notices]
[Pages 10893-10894]
[FR Doc No: 2011-4372]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9272-3; Docket ID No. EPA-HQ-ORD-2011-0050]

Draft Integrated Science Assessment for Ozone and Related
Photochemical Oxidants

AGENCY: Environmental Protection Agency.

ACTION: Notice of Public Comment Period.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a
60-day public comment period and availability of the first external
review draft of a document titled, ``First External Review Draft
Integrated Science Assessment for Ozone and Related Photochemical
Oxidants'' (EPA/600/R-10/076A). The document was prepared by the
National Center for Environmental Assessment (NCEA) within EPA's Office
of Research and Development as part of the review of the national
ambient air quality standards (NAAQS) for ozone.
    EPA is releasing this draft document to seek review by the Clean
Air Scientific Advisory Committee (CASAC) and the public (meeting date
and location to be specified in a separate Federal Register notice).
The draft document does not represent and should not be construed to
represent any final EPA policy, viewpoint, or determination. EPA will
consider any public comments submitted in response to this notice when
revising the document.

DATES: The public comment period begins February 28, 2011, and ends
April 29, 2011. Comments must be received by April 29, 2011.

ADDRESSES: The ``First External Review Draft Integrated Science
Assessment for Ozone and Related Photochemical Oxidants'' will be
available primarily via the Internet on the National Center for
Environmental Assessment's home page under the Recent Additions and
Publications menus at http://www.epa.gov/ncea. A limited number of CD-
ROM or paper copies will be available. Contact Ms. Debbie Wales by
phone<PHONE_NUMBER>), fax<PHONE_NUMBER>), or e-mail
<EMAIL_ADDRESS>to request either of these, and please provide
your name, your mailing address, and the document title, ``First
External Review Draft Integrated Science Assessment for Ozone and
Related Photochemical Oxidants'' (EPA/600/R-10/076A) to facilitate
processing of your request.

FOR FURTHER INFORMATION CONTACT: For technical information, contact Dr.
James Brown, NCEA; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or
e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Document

    Section 108(a) of the Clean Air Act directs the Administrator to
identify certain pollutants which, among other things, ``cause or
contribute to air pollution which may reasonably be anticipated to
endanger public health or welfare'' and to issue air quality criteria
for them. These air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare which may be
expected from the presence of [a] pollutant in the ambient air * * *.''
Under section 109 of the Act, EPA is then to establish national ambient
air quality standards (NAAQS) for each

pollutant for which EPA has issued criteria. Section 109(d) of the Act
subsequently requires periodic review and, if appropriate, revision of
existing air quality criteria to reflect advances in scientific
knowledge on the effects of the pollutant on public health or welfare.
EPA is also to revise the NAAQS, if appropriate, based on the revised
air quality criteria.
    Ozone (O3) is one of six principal (or ``criteria'')
pollutants for which EPA has established NAAQS. Periodically, EPA
reviews the scientific basis for these standards by preparing an
Integrated Science Assessment (ISA) (formerly called an Air Quality
Criteria Document). The ISA, in conjunction with additional technical
and policy assessments, provide the scientific basis for EPA decisions
on the adequacy of the current NAAQS and the appropriateness of
possible alternative standards. The Clean Air Scientific Advisory
Committee (CASAC), an independent science advisory committee whose
existence and whose review and advisory functions are mandated by
Section 109(d)(2) of the Clean Air Act, is charged (among other things)
with independent scientific review of EPA's air quality criteria.
    On Sep 29, 2008 (73 FR 56581), EPA formally initiated its current
review of the air quality criteria for ozone, requesting the submission
of recent scientific information on specified topics. A draft of EPA's
``Integrated Review Plan for the Ozone National Ambient Air Quality
Standards Review'' (EPA/452/P-09/001) was made available in September
2009 for public comment and was discussed by the CASAC via a publicly
accessible teleconference consultation on November 13, 2009 (74 FR
54562). In August 2010, EPA held a workshop to discuss, with invited
scientific experts, initial draft materials prepared in the development
of the ISA (75 FR 42085).
    The first external review draft ISA for Ozone and Related
Photochemical Oxidants will be discussed at a public meeting for review
by CASAC, and public comments received will be provided to the CASAC
review panel. A future Federal Register notice will inform the public
of the exact date and time of that CASAC meeting.

II. How to Submit Technical Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2011-
0050 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334 EPA West Building, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit
three copies of the comments. For attachments, provide an index, number
pages consecutively with the comments, and submit an unbound original
and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0050. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information through http://www.regulations.gov or e-mail that you consider to be CBI or otherwise
protected. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: February 15, 2011.
Darrell A. Winner,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2011-4372 Filed 2-25-11; 8:45 am]
BILLING CODE 6560-50-P


EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING FOR PESTICIDE
PETITION

Docket ID Number: EPA-HQ-OPP-2015-0658

EPA Registration Division Contact: Sidney Jackson<PHONE_NUMBER>

Interregional Research Project Number 4

Pesticide Petition Number: 5E8399

EPA has received a pesticide petition (PP# 5E8399) from the
Interregional Research Project Number 4 (IR-4), IR-4 Project
Headquarters,  Rutgers, The State University of New Jersey, 500 College
Road East, Suite 201 W, Princeton, NJ 08450  proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180, by establishing tolerances for
residues of the herbicide flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5
,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on the raw
agricultural commodities: caneberry, subgroup 13-07A at 0.4 parts per
million (ppm);

brassica, head and stem, subgroup 5A at 0.02 ppm; clover, forage at 0.02
ppm; clover, hay at 0.15 ppm; fruit, citrus, group 10-10 at 0.02 ppm;
citrus oil at 0.1 ppm; vegetable, fruiting group 8-10 at 0.02 ppm;
fruit, pome, group 11-10 at 0.02 ppm; fruit, stone, group 12-12 at 0.02
ppm; nut, tree, group 14-12 at 0.02 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 0.02 ppm; berry, low growing,
subgroup 13-07G at 0.07 ppm; and onion, bulb, subgroup 3-07A at 0.02
ppm.

The petitioner is also proposing revocation of the existing tolerance
for residue of the herbicide flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5
,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione: in or on the raw
agricultural commodities: cabbage at 0.02 ppm; cabbage, Chinese, napa at
0.02 ppm, fruit, pome group 11 at 0.02 ppm, fruit, stone, group 12 at
0.02 ppm, garlic at 0.02 ppm, grape at 0.02 ppm,  nut, tree group 14 at
0.02 ppm, okra at 0.02 ppm, onion, bulb at 0.02 ppm, pistachio 0.02 ppm
shallot bulb at 0.02 ppm, strawberry at 0.07 ppm and vegetable, fruiting
group 8 at 0.02 ppm because flumioxazin tolerances for these commodities
are superseded by above requested tolerances.  EPA has determined that
the petition contains data or information regarding the elements set
forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data support granting of the petition. Additional data may be needed
before EPA rules on the petition.

EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
 Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.  The metabolism of flumioxazin is adequately
understood for the purpose of granting the proposed tolerances.

	2.  Analytical method.  Practical analytical methods for detecting and
measuring levels of flumioxazin have been developed and validated in/on
all appropriate agricultural commodities and respective processing
fractions. The limit of quantitation (LOQ) of flumioxazin in the methods
is 0.02 ppm which will allow monitoring of food with residues at the
levels proposed for the tolerances.

3. Magnitude of residues.  Residue data has been submitted which
adequately support the requested tolerances.

B. Toxicological Profile

The toxicological profile for flumioxazin, which supports this petition
for tolerances was published in the Federal Register on April 5, 2013
(78 FR 20461) (FRL-9381-7).

Immunotoxicity and neurotoxicity studies have been submitted to the
Agency to fulfill revised FIFRA 40 CFR part 158.340 data requirements.
The results of these studies show no indication of immunotoxicity or
neurotoxicity and do not result in any changes to the toxicology
endpoints used for risk assessment purposes.

C. Aggregate Exposure

1. Dietary exposure.

The newly petitioned crops and the proposed tolerances will have
negligible impact on dietary exposure.

Food.  Dietary exposures are reviewed in 78 FR 20461 (FRL-9381-7).

Drinking water.  Drinking water exposures are reviewed in 78 FR 20461

    (FRL-9381-7).

2. Non-dietary exposure.  Non-dietary (residential and recreational)
aggregate exposures to flumioxazin may occur because people may swim in
flumioxazin-treated water bodies or come into contact with treated turf
in residential or recreational (golf) areas.  Aggregate exposure
scenarios were conducted and reported previously and are not being
revisited herein because the proposed tolerances will have no impact on
non-dietary exposures.

D. Cumulative Effects

Section 408(b)(2)(D)(v) requires that the Agency must consider
"available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common
mechanism of toxicity." Available information in this context includes
not only toxicity, chemistry, and exposure data, but also scientific
policies and methodologies for understanding common mechanisms of
toxicity and conducting cumulative risk assessments. EPA does not have,
at this time, available data to determine whether flumioxazin has a
common mechanism of toxicity with other substances or how to include
this pesticide in a cumulative risk assessment.  For the purposes of
this tolerance action, EPA has not assumed that flumioxazin has a common
mechanism of toxicity with other substances.

E. Safety Determination

1.  U.S. population.

Acute Risk.  See 78 FR 20461 (FRL-9381-7)

Chronic Risk.  See 78 FR 20461 (FRL-9381-7).

2. Infants and children.  See 78 FR 20461 (FRL-9381-7)

i. 	Acute Risk. See 78 FR 20461 (FRL-9381-7)

ii 	Chronic Risk.  See 78 FR 20461 (FRL-9381-7)

F. International Tolerances. No Codex Maximum Residue Limits (MRL) for
flumioxazin have been established.


[Federal Register: May 8, 2008 (Volume 73, Number 90)]
[Notices]
[Page 26087-26088]
[DOCID:fr08my08-57]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC08-603-001, FERC-603]

Commission Information Collection Activities, Proposed
Collection; Comment Request; Submitted for OMB Review

May 1, 2008.
AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice.

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

SUMMARY: In compliance with the requirements of section 3507 of the
Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the Federal Energy
Regulatory Commission (Commission) has submitted the information
collection described below to the Office of Management and Budget (OMB)
for review of this information collection requirement. Any interested
person may file comments directly with OMB and should address a copy of
those comments to the Commission as explained below. The Commission
received no comments in response to an earlier Federal Register notice
of February 7, 2008 (73 FR 8651-52) and has made this notation in its
submission to OMB.

DATES: Comments on the collection of information are due by June 6,
2008.

ADDRESSES: Address comments on the collection of information to the
Office of Management and Budget, Office of Information and Regulatory
Affairs, Attention: Federal Energy Regulatory Commission Desk Officer.
Comments to OMB should be filed electronically, c/o oira--
<EMAIL_ADDRESS>and include the OMB Control No. as a point of
reference. The Desk Officer may be reached by telephone at 202-395-
4650. A copy of the comments should also be sent to the Federal Energy
Regulatory Commission, Office of the Executive Director, ED-34,
Attention: Michael Miller, 888 First Street, NE., Washington, DC 20426.
Comments may be filed either in paper format or electronically. Those
persons filing electronically do not need to make a paper filing. For
paper filings, such comments should be submitted to the Office of the
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426 and should refer to Docket No. IC08-603-001.
    Documents filed electronically via the Internet must be prepared in
the acceptable filing format and in compliance with the Federal Energy
Regulatory Commission's submission guidelines. Complete filing
instructions and acceptable filing formats are available at (http://
www.ferc.gov/help/submission-guide/electronic-media.asp). To file the
document electronically, access the Commission's Web site at http://
www.ferc.gov/docs-filing/efiling.asp, and then follow the instructions
for each screen. First time users will have to establish a user name
and password. The Commission will send an automatic acknowledgement to
the sender's e-mail address upon receipt of comments.
    All comments may be viewed, printed or downloaded remotely via the
Internet through FERC's homepage using the eLibrary link. For user
assistance, contact<EMAIL_ADDRESS>or toll-free at (866)
208-3676 or for TTY, contact<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by

telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Description

    The information collection submitted for OMB review contains the
following:
    1. Collection of Information: FERC-603 ``Critical Energy
Infrastructure Information.''
    2. Sponsor: Federal Energy Regulatory Commission.
    3. Control No.: 1902-0197.
    The Commission is now requesting that OMB approve with a three-year
extension of the expiration date, with no changes to the existing
collection. The information filed with the Commission is mandatory.
    4. Necessity of the Collection of Information: The information is
used by the Commission to implement procedures for gaining access to
critical energy infrastructure information (CEII) that would not
otherwise be available under the Freedom of Information Act (FOIA) (5
U.S.C. 552). On February 21, 2003, the Commission issued Order No. 630
(68 FR 9857-9873), and then issued subsequent Order Nos. 630-A (68 FR
46456-60), and 649 (69 FR 48386-91) to address the appropriate
treatment of CEII in the aftermath of the September 11, 2001 terrorist
attacks and to restrict unrestrained general access due to the ongoing
terrorism threat. These steps enable the Commission to keep sensitive
infrastructure information out of the public domain, decreasing the
likelihood that such information could be used to plan or execute
terrorist attacks. The process adopted in these orders is a more
efficient alternative for handling request for previously public
documents than FOIA.
    The Commission has defined CEII to include information about
existing or proposed critical infrastructure that (i) Relates to the
production, generation, transportation, transmission, or distribution
of energy; (ii) could be useful to a person planning an attack on
critical infrastructure, (iii) is exempt from mandatory disclosure
under the Freedom of Information Act, and (iv) does not simply give the
location of the critical infrastructure. Critical infrastructure means
existing and proposed systems and assets, whether physical or virtual,
the incapacity or destruction of which would negatively affect
security, economic security, public health or safety, or any
combination of those matters. A person seeking access to CEII may file
a request for that information by providing information about their
identity and reason for the need for the information. Through this
process, the Commission is able to review the requester's need for the
information against the sensitivity of the information. The Commission
implements these requirements in 18 CFR 388.113 of its regulations.
    5. Respondent Description: The respondent universe currently
comprises all entities requesting access to CEII information submitted
to or issued by the Commission.
    6. Estimated Burden: 46 total hours, 182 respondents (average per
year), 1 response per respondent, and .25 hours per response (average).
    7. Estimated Cost Burden to respondents: The estimated total cost
to respondents is $3,646. The cost per respondent = $18. (60 hours @
$61 hourly rate / 200).

    Statutory Authority: 15 U.S.C. 717, et seq., 16 U.S.C. 791a, et
seq., section 313(b) of the Federal Power Act, 16 U.S.C. 824 l(b)
and section 19(b) of the Natural Gas Act, 15 U.S.C. 717r(b).

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-10197 Filed 5-7-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2710-2711]
[FR Doc No: 2015-00856]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0025]

Medical Device Accessories: Defining Accessories and
Classification Pathway for New Accessory Types; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Medical Device
Accessories: Defining Accessories and Classification Pathway for New
Accessory Types.'' This draft document provides proposed guidance to
industry and FDA staff about the regulation of accessories in medical
devices. The guidance explains what FDA considers to be an
``accessory,'' outlines how the risk-based framework for the
classification of devices applies to accessories, and describes the use
of the de novo classification process for the classification of new
types of accessories. This draft guidance is not final nor is it in
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 20, 2015. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by March 23, 2015. See
section IV of this document, the ``Paperwork Reduction Act of 1995.''

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Medical Device Accessories: Defining Accessories and Classification
Pathway for New Accessory Types'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.
    Submit electronic comments on the draft guidance or the information
collection to http://www.regulations.gov. Submit written comments to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Identify comments with the docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: Sugato De, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5435, Silver Spring, MD 20993-0002, 301-
796-6270 or Stephen Ripley, Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document is intended to provide guidance to
industry and FDA staff about the regulation of accessories to other
medical devices. In doing so, this guidance document explains what FDA
considers to be an ``accessory'' and outlines how the risk-based
framework for the classification of devices applies to accessories. In
addition, this guidance describes use of the de novo classification
process to classify new types of accessory devices under Section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360c(f)(2)) based on risk and the ability of general and
special controls to assure safety and effectiveness.
    For the purposes of this guidance document, FDA considers an
``accessory'' as a medical device that is intended to support,
supplement, and/or augment the performance of one or more medical
devices. In practice, the distinctions among devices that support,
supplement, and/or augment parent devices are subtle and many devices
that we would consider to be an accessory may do more than one of these
things. Thus, if the device is intended to support, supplement, and/or
augment the performance of one or more parent devices, we intend to
consider the device as an accessory.
    Once a specific article has been determined to be an accessory, the
guidance document describes how the accessory is classified based on
its risks when used as intended with the intended parent device(s). In
practice, FDA may classify individual accessories either by inclusion
in the classification regulation of the parent device (either via a
premarket submission or via express inclusion in the language of the
regulation or order) or via development of a unique, separate
classification regulation or order for the accessory.
    For accessories of a new type, the guidance outlines the use of the
de novo process for classification. This process provides a pathway to
class I or class II classification for accessory devices for which
general controls, or general and special controls, provide a reasonable
assurance of safety and effectiveness, but for which there are no
legally marketed predicate device.

II. Significance of Guidance

    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 Agency's current thinking on the
regulation of medical device accessories. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov. Persons unable to download an electronic
copy of ``Medical Device Accessories: Defining Accessories and
Classification Pathway for New Accessory Types'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 1770 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Accessory Classification De Novo Request--(OMB Control Number 0910-NEW)

    The draft guidance encourages manufacturers and other parties to
utilize the process defined in section 513(f)(2) of the FD&C Act to
request risk-based classifications of new types of accessories. This
process provides a pathway to class I or class II classification for
accessory devices for which general controls, or general and special
controls, provide a reasonable assurance of safety and effectiveness,
but for which there is no legally marketed predicate device.
    In accordance with section 513(f)(2) of the FD&C Act, manufacturers
and other parties may submit a de novo requesting FDA to make a
classification determination for the accessory device according to the
criteria in section 513(a)(1) of the FD&C Act. The de novo must include
a description of the device and detailed information and reasons for
any recommended classification (see section 513(f)(2)(A)(v) of the FD&C
Act).
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accessory classification de novo request...........................               8                1                8              180            1,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents are medical device manufacturers seeking to market
device accessories. Of the approximately 41 de novo applications
received per year, only two have been associated with accessories. With
heightened awareness of the availability of the de novo pathway for
accessories, we expect to receive four to six additional accessories
applications per year. Therefore, we estimate that we will receive
approximately eight accessory classification de novo requests per year.
    Based on estimates by FDA administrative and technical staff who
are familiar with the proposed submission process for accessory
classification requests and on our burden estimate for a similar
information collection request (see ``De Novo Classification Process
Evaluation of Automatic Class III Designation; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability,'' 79 FR
47651 at 47653, August 14, 2014), we estimate that the submission
process for each accessory classification request will take
approximately 180 hours.
    The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR parts 801 and 809 have been approved under OMB control number
0910-0485; the collections of information in 21 CFR part 807, subpart E
have been approved under OMB control number 0910-0120; the collections
of information in 21 CFR part 814 have been approved under OMB control
number 0910-0231; and the collections of information in 21 CFR part
860, subpart C, have been approved under OMB control number 0910-0138.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00856 Filed 1-16-15; 8:45 am]
BILLING CODE 4164-01-P