[Federal Register Volume 83, Number 103 (Tuesday, May 29, 2018)]
[Notices]
[Pages 24543-24547]
[FR Doc No: 2018-11456]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83306; File No. SR-ISE-2018-46]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Schedule of Fees Related to Complex Orders

May 23, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 10, 2018, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Schedule of Fees related to
Complex Orders traded on the Exchange.
    The text of the proposed rule change is available on the Exchange's
website at http://ise.cchwallstreet.com/, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the Schedule of
Fees related to Complex Orders traded on the Exchange, including: (1)
Priority Customer \3\ Complex Order rebates, (2) Market Maker \4\ fees,
(3) the non-Priority Customer Complex Order taker surcharge, and (4)
formatting and other non-substantive changes to the tables. Each of the
proposed changes is described in more detail below.
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    \3\ A ``Priority Customer'' is a person or entity that is not a
broker/dealer in securities, and does not place more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s), as defined in Nasdaq ISE Rule
100(a)(37A).
    \4\ ``Market Maker'' refers to ``Competitive Market Makers'' and
``Primary Market Makers'' collectively. See ISE Rule 100(a)(28).
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I. Priority Customer Complex Order Rebates
    Currently, the Exchange has a fee structure in place for Complex
Orders that provides rebates to Priority Customer Complex Orders in
order to encourage Members to bring that order flow to the Exchange.
Specifically, Priority Customer Complex Orders are provided rebates in
Select Symbols \5\ and Non-Select Symbols \6\ (other than NDX and MNX)
based on Priority Customer average daily volume (``ADV'') in eight
tiers as shown in the table below:\7\
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    \5\ ``Select Symbols'' are options overlying all symbols listed
on the Nasdaq ISE that are in the Penny Pilot Program.
    \6\ ``Non-Select Symbols'' are options overlying all symbols
excluding Select Symbols.
    \7\ The Priority Customer Complex Order rebates are provided per
contract per leg if the order trades with non-Priority Customer
orders in the Complex Order Book or trades with quotes and orders on
the regular order book.
    The rebate for the highest tier volume achieved is applied
retroactively to all eligible Priority Customer Complex volume once
the threshold has been reached.
    Members will not receive rebates for net zero complex orders.
For purposes of determining which complex orders qualify as ``net
zero'' the Exchange will count all complex orders that leg in to the
regular order book and are executed at a net price per contract that
is within a range of $0.01 credit and $0.01 debit.

------------------------------------------------------------------------
                                            Rebate for    Rebate for non-
                                          select symbols  select symbols
------------------------------------------------------------------------
Priority Customer Complex ADV 0-14,999..         ($0.26)         ($0.40)
Priority Customer Complex ADV 15,000-             (0.30)          (0.60)
 44,999.................................
Priority Customer Complex ADV 45,000-             (0.36)          (0.70)
 59,999.................................
Priority Customer Complex ADV 60,000-             (0.41)          (0.75)
 74,999.................................
Priority Customer Complex ADV 75,000-             (0.42)          (0.75)
 99,999.................................
Priority Customer Complex ADV 100,000-            (0.45)          (0.80)
 124,999................................
Priority Customer Complex ADV 125,000-            (0.46)          (0.81)
 224,999................................
Priority Customer Complex ADV 225,000+..          (0.50)          (0.85)
------------------------------------------------------------------------

    The Exchange now proposes to modify this rebate structure such that
Priority Customer Complex Order rebates will be paid a rebate based on
a percentage of industry volume rather than straight volume thresholds.
In addition, the Exchange proposes to move away from a tier calculation
based solely on Priority Customer Complex ADV to one that includes
Complex Orders entered for other market participant types, and orders
entered by affiliates of the Member. Specifically, the Exchange
proposes to adopt Priority Customer Complex Tiers that are based on
Total Affiliated Member Complex Order Volume (Excluding Crossing Orders
and Responses to Crossing Orders) Calculated as a Percentage of
Customer Total Consolidated Volume. All Complex Order volume executed
on the Exchange, including volume executed by Affiliated Members, will
be included in the volume calculation, except for volume executed as
Crossing Orders and Responses to Crossing Orders. An ``Affiliated
Member'' is a Member that shares at least 75% common ownership with a
particular Member as reflected on the Member's Form BD, Schedule A.
Furthermore, ``Customer Total Consolidated Volume'' means the total
national volume cleared at The Options Clearing Corporation in the
Customer range in equity and ETF options in that month.
    As proposed, there will be nine Priority Customer Complex Order
Tiers based on the percentage of industry volume calculation: 0.000%-
0.200% (Tier 1); above 0.200%-0.400% (Tier 2); above 0.400%-0.600%
(Tier 3), above 0.600%-0.800% (Tier 4), above 0.800%-1.000% (Tier 5),
above 1.000%-1.600% (Tier 6), above 1.600%-2.000% (Tier 7), above
2.000%-3.500% (Tier 8), above 3.500% (Tier 9). Furthermore, the
associated rebates will be modified such that in Select Symbols the
proposed rebate will be $0.25 per contract for Tier 1, $0.30 per
contract for Tier 2, $0.35 per contract for Tier 3, $0.40 per contract
for Tier 4, $0.45 per contract for Tier 5, $0.46 per contract for Tier
6, $0.48 per contract for Tier 7, and $0.50 per contract for Tiers 8
and 9. Furthermore, in Non-Select Symbols the proposed rebate will be
$0.40 per contract for Tier 1, $0.55 per contract for Tier 2, $0.70 per
contract for Tier 3, $0.75 per contract for Tier 4, $0.80 per contract
for Tiers 5-7, and $0.85 per contract for Tiers 8 and 9.
II. Market Maker Fees
    Market Maker Complex Orders in Select Symbols are charged a maker
fee of $0.47 per contract when trading against Priority Customer
Complex Orders, and a $0.50 per contract taker fee regardless of the
counterparty. Currently, each of these fees is reduced to $0.44 per
contract for Market Makers with total affiliated Priority Customer
Complex ADV of 150,000 or more contracts.\8\ The Exchange proposes to
base this fee discount on the proposed Priority Customer Complex Tiers,
and introduce a second tier of reduced fee for Market Makers that
achieve a higher Priority Customer Complex Tier. Specifically, the
Exchange proposes to keep the current $0.44 per contract fee for Market
Makers Market Makers that achieve Priority Customer Complex Tier 9, and
charge a fee of $0.47 per contract for Market Makers that achieve
Priority Customer Complex Tier 8.
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    \8\ All eligible volume from affiliated Members is aggregated in
determining total affiliated Priority Customer Complex ADV, provided
there is at least 75% common ownership between the Members as
reflected on each Member's Form BD, Schedule A.
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    In addition, Market Makers that qualify for the Market Maker Plus
program are currently charged a fee $0.10 per contract instead of the
applicable Market Maker Plus rebate when trading against Priority
Customer Complex Orders that leg into the regular order book.
Regardless of the counterparty, a $0.10 per contract maker fee also
applies to Market Makers that do not qualify for Market Maker Plus and
Non-Nasdaq ISE Market Makers. With the proposed Priority Customer
Complex Order Tiers described above, which in some cases may result in
higher rebates being provided to Priority Customer Complex Orders,
including Complex Orders that leg into the regular order book, the
Exchange proposes to increase the fee for trading against Priority
Customer Complex Orders that leg into the regular order book.
Specifically, the Exchange proposes to increase this fee to $0.15 per
contract and apply it to all Market Maker Orders and Non-Nasdaq ISE
Market Maker Orders. Furthermore, there is currently no fee charged or
rebate provided to Market Maker Orders submitted by Market Makers that
qualify for Market Maker Plus when trading against non-Priority
Customer Complex Orders that leg into the regular order book. As
proposed, this treatment will be afforded to all Market Maker Orders
when trading against non-Priority Customer Complex Orders that leg into
the regular order book. The fees for Non-Nasdaq ISE Market Makers for
trading against non-Priority Customer Complex Orders that leg into the
regular order book will remain unchanged.
III. Non-Priority Customer Complex Order Taker Surcharge
    Currently, the Exchange assesses a $0.03 per contract surcharge to
non-Priority Customer Complex Orders in Non-Select Symbols that take
liquidity from the Complex Order Book, excluding Complex Orders
executed in the Facilitation Mechanism, Solicited Order Mechanism,
Price Improvement Mechanism (``PIM'') and ``exposure'' auctions
pursuant to Rule 722(b)(3)(iii). The Exchange proposes to increase this
taker surcharge to $0.05 per contract.
IV. Formatting and Other Non-Substantive Changes to the Tables
    With the changes described above, which add additional content to
the Schedule of Fees, the Exchange proposes to make certain non-
substantive formatting changes that are designed to make the flow of
the Schedule of Fees easier for Members to understand. None of these
changes affect the fees charged or rebates provided to members. With
the proposed changes, the Exchange will

have three tables located under Section II of the Schedule of Fees
(Complex Order Fees and Rebates): (1) ``Priority Customer Rebates,''
(2) ``Maker and Taker Fees,'' and (3) ``Crossing Order Fees and
Rebates.''
    The first table, i.e., Priority Customer Rebates, will contain the
Priority Customer Complex Tiers described above rather than all rebates
as is currently the case. As such, the Exchange proposes to move the
column on Facilitation and Solicitation Break-up Rebate for Select
Symbols to the third table on Crossing Order Fees and Rebates. These
rebates will continue to be applied in exactly the same manner as
today. Furthermore, the Exchange proposes to delete references in this
table to other market participant types, which are not eligible for
rebates in Complex Orders other than the Facilitation and Solicitation
Break-up Rebate in Select Symbols described above. The second table,
i.e., Maker and Taker Fees, will include both the maker fees described
there today as well as the taker fees that are currently included in
the following table. As such, the Exchange proposes to move the columns
that describe the taker fee for Select Symbols and the taker fee for
Non-Select Symbols to this table. No changes to these taker fees are
proposed. Finally, the third table, i.e., Crossing Order Fees and
Rebates, will include only fees and rebates that relate to the
Exchange's various crossing mechanisms. The fees and rebates moved to
and from this table are described above.
    Finally, the footnote referenced in the column on Facilitation and
Solicitation Break-up Rebates for Select Symbols contains an outdated
reference to the PIM. Specifically, the footnote provides that rebates
are provided per contract per leg for contracts that are submitted to
PIM, Facilitation and Solicitation Mechanisms . . .'' As indicated in
the header to the column, these break-up rebates apply to the
Facilitation and Solicitation Mechanisms only. The language related to
the PIM was included in the Schedule of Fees when the Exchange offered
a break-up rebate for the PIM. When the Exchange eliminated PIM break-
up rebates, the Exchange deleted the column that included those rebates
but did not remove the related reference in this footnote.\9\ The
Exchange therefore proposes to update this footnote now by deleting the
PIM reference, which is no longer applicable.
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    \9\ See Securities Exchange Act Release No. 80684 (May 16,
2017), 82 FR 23435 (May 22, 2017) (SR-ISE-2017-39).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\10\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\11\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees, and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4) and (5).
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I. Priority Customer Complex Order Rebates
    The Exchange believes that the proposed changes to the Priority
Customer Complex Order Tiers are reasonable and equitable as these
changes are designed to incentivize Members to trade Complex Orders,
and, in particular Priority Customer Complex Orders, on the Exchange.
The Exchange is proposing to base Priority Customer Complex Order Tiers
on a percentage of industry volume in recognition of the fact that the
volume executed by a Member may rise or fall with industry volume. A
percentage of industry volume calculation allows the Exchange's tiers
to be calibrated to current market volumes rather than requiring the
same amount of volume regardless of market conditions. While the amount
of volume required by the proposed tiers may change in any given month
due to increases or decreases in industry volume, the Exchange believes
that the proposed tier requirements are set at a level that roughly
corresponds to the current ADV requirements for Priority Customer
Complex Tiers. The Exchange is also proposing to include additional
types of Complex Order volume in the tier calculation. Although the
current tier structure counts solely Priority Customer Complex ADV, the
proposed structure would allow Members to qualify for higher tier based
on all Complex Order volume except for Crossing Orders and Responses to
Crossing Orders. The Exchange believes that increasing the volume
counted for purposes of calculating tiers will encourage Members to
bring different types of Complex Order volume to the Exchange (i.e., to
qualify for a higher tier), while continuing to incentivize Members to
bring Priority Customer Complex Orders specifically to earn the
associated rebates. Crossing Orders and Responses to Crossing Orders
will be excluded from the proposed tier calculation as this type of
order flow is subject to separate pricing, with various incentives for
Members that trade in the Exchange's crossing mechanisms.
    In addition, the Exchange believes that the proposed changes are
equitable and not unfairly discriminatory as these changes are designed
to bring more order flow, and in particular, Priority Customer Complex
Orders, to the Exchange. The Exchange does not believe that it is
unfairly discriminatory provide rebates only to Priority Customer
Complex Orders as this is the order flow that the Exchange is seeking
to incentivize. A Priority Customer is by definition not a broker or
dealer in securities, and does not place more than 390 orders in listed
options per day on average during a calendar month for its own
beneficial account(s). This limitation does not apply to participants
whose behavior is substantially similar to that of market
professionals, including Professional Customers, who will generally
submit a higher number of orders than Priority Customers. The Exchange
currently has Priority Customer Complex Order Tiers in place to
incentivize that order flow, and is simply modifying those tiers in a
way that the Exchange believes will increase participation in Complex
Orders. The Exchange believes that the proposed changes to the Priority
Customer Complex Tiers will benefit all market participants that trade
on the Exchange by increasing their opportunities to trade.
    Furthermore, the Exchange believes that its proposed definitions of
``Affiliated Member'' and ``Customer Total Consolidated Volume'' are
reasonable, equitable, and not unfairly discriminatory as these
definitions clarify terms that the Exchange is using to describe its
Priority Customer Complex Tiers. The proposed definitions are
consistent with definitions adopted for these concepts on the
Exchange's affiliated exchanges, Nasdaq MRX, LLC (``MRX'') and Nasdaq
GEMX, LLC (``GEMX'') respectively.\12\ Furthermore, with respect to the
definition of ``Affiliated Member'' in particular the Exchange is
adopting a definition that is consistent with the Exchange's current
practice of aggregating volume from Members that share at least 75%
common ownership.
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    \12\ See MRX Schedule of Fees, Preface; GEMX Schedule of Fees,
I. Regular Order Fees and Rebates, Qualifying Tier Thresholds.
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II. Market Maker Fees
    The Exchange believes the proposed changes to the Market Maker
Complex Order fees in Select Symbols are reasonable and equitable as
the

proposed fees replace a fee that was previously tied to the Priority
Customer Complex ADV with a new fees based on the proposed Priority
Customer Complex Tiers. Furthermore, the Exchange believes that it is
reasonable and equitable to provide a differentiated fee based on
whether the Market Maker achieves Priority Customer Complex Tier 8 or
9. With the proposed changes, Market Makers that achieve Priority
Customer Complex Tier 9 will pay the same fee as would be applicable
today based on achieving the required total affiliated Priority
Customer ADV, while Market Makers that achieve Priority Customer
Complex Tier 8 will pay a slightly higher fee that is nonetheless
discounted compared to the fees applicable to Market Makers that do not
achieve these tiers. The Exchange believes that this two tiered
structure will encourage firms to reach for the highest tier of the
under Priority Customer Complex Order rebate program, while nonetheless
incentivizing firms that do not have sufficient volume to reach that
tier to work towards the second highest tier introduced under that
program.
    Furthermore, the Exchange believes that the proposed changes to
Market Maker Complex Order fees are equitable and not unfairly
discriminatory the changes apply equally to all Market Maker Complex
Orders based on achieving the required Priority Customer Complex Tier.
As is the case today, the Exchange will continue to charge lower fees
to Market Makers that execute, through their affiliates, a significant
volume of Priority Customer Complex Orders, as this will incentivize
members to bring order flow to the Exchange, creating additional
liquidity in Complex Orders to the benefit of all Members. The Exchange
does not believe that it is unfairly discriminatory only to provide
these lower fees to Market Maker Orders as Market Makers are subject to
additional requirements and obligations (such as quoting requirements)
that other market participants are not.
    The Exchange also believes that that it is reasonable and equitable
to increase the maker fee charged to Market Makers and Non-Nasdaq ISE
Market Makers that provide liquidity to Priority Customer Complex
Orders that leg into the regular order book. Today, Market Makers that
do not qualify for Market Maker Plus and Non-Nasdaq ISE Market Makers
pay a small fee for providing liquidity in Select Symbols. In addition,
Market Makers that qualify for Market Maker Plus and would typically be
eligible for a maker rebate are instead charged a maker fee when
trading against Priority Customer Complex Orders that leg into the
regular order book. At the same time, the Exchange pays high rebates to
Priority Customer Complex Orders, including when those Complex Orders
leg into the regular order book. In some cases these rebates may be
increased with the proposed changes described above to the Priority
Customer Complex Order Tiers. The Exchange believes that it is
reasonable and equitable to increase the fees charged for all Market
Maker and Non-Nasdaq ISE Market Maker Orders that provide liquidity to
Priority Customer Complex Orders that leg into the regular market as
this will help offset potentially significant rebates paid on the other
side of these trades. In this regard, the proposed fee increase would
decrease but not completely eliminate the negative economics associated
with these trades as the Exchange pays out significantly more in rebate
opportunity for Priority Customer Complex Orders than it receives from
other side of the trade when those orders leg into the regular order
book. Furthermore, the Exchange believes that it is reasonable and
equitable to reduce fees for all Market Maker Orders trading against
non-Priority Customer Complex Orders that leg into the regular order
book. Currently, this benefit is provided only to Market Makers that
achieve Market Maker Plus status. The Exchange believes, however, that
it is appropriate to extend this benefit to all Market Maker Orders as
an additional incentive for Market Makers that have an obligation to
maintain quotes and provide liquidity in the regular market rather than
only those Market Makers that meet the heightened requirements of
Market Maker Plus. Non-Nasdaq ISE Market Makers who have no obligations
to provide liquidity will not be eligible for this incentive.
    Furthermore, the Exchange believes that the proposed changes to
these fees for Market Maker and Non-Nasdaq ISE Market Maker Orders are
equitable and not unfairly discriminatory as they are designed to
reduce the negative economics associated with Priority Customer Complex
Orders that leg into the regular order book. The proposed fees will
apply equally to all Market Makers and Non-Nasdaq ISE Market Makers.
The Exchange pays significant rebates to that Priority Customer Complex
Orders, including when those orders leg into the regular order book
where they may trade with Market Makers and Non-Nasdaq ISE Market
Makers providing liquidity in the regular market. The Exchange does not
believe it is unfairly discriminatory to charge increased maker fees
only to Market Maker and Non-Nasdaq ISE Market Maker Orders as these
market participants are typically the ones providing liquidity and
trading with Priority Customer Complex Orders that leg into the regular
order book.
III. Non-Priority Customer Complex Order Taker Surcharge
    The Exchange believes that the proposed increase the taker
surcharge for non-Priority Customer Complex Orders in Non-Select
Symbols that take liquidity from the complex order book is reasonable
and equitable. The proposed fees are modestly increased and the
Exchange believes that such fees will remain attractive to market
participants, who will continue to be charged lower fees for adding
liquidity to the complex order book than for removing liquidity, and
who may be granted additional opportunities to trade by virtue of the
incentives being granted to attract Priority Customer Complex Orders to
the Exchange. Furthermore, the Exchange believes that the proposed
change is equitable and not unfairly discriminatory as it applies to
all non-Priority Customer Complex Orders that take liquidity in Non-
Select Symbols.
IV. Formatting and Other Non-Substantive Changes to the Tables
    The Exchange believes that the proposed formatting changes to the
tables are reasonable, equitable, and not unfairly discriminatory. As
explained in the purpose section of this filing, these changes are
entirely cosmetic and merely move around columns in various tables so
that these are grouped in a manner that the Exchange believes will be
easier for Members to follow. The Exchange hopes that these changes
will increase the readability of the Schedule of Fees by grouping fees
and rebates for Complex Orders under three headings--i.e., Priority
Customer Rebates, Maker and Taker Fees, and Crossing Order Fees and
Rebates. None of the proposed formatting changes impact the fees
charged or rebates provided to Members. Furthermore, the Exchange
believes that it is reasonable, equitable, and not unfairly
discriminatory to remove the outdated reference to the PIM in the
Facilitation and Solicitation break-up rebate footnote. As explained in
the purpose section of this proposed rule change, the Exchange does not
have break-up rebates for the PIM. Although the column correctly refers
to Facilitation and Solicitation break-up rebates, the PIM reference
was inadvertently left in the footnote at the time the Exchange filed
to remove those

rebates. The proposed change corrects this reference.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes that the
proposed changes will enhance both intermarket and intramarket
competition by amending various fees and rebates related to the trading
of Complex Orders on the Exchange. The Exchange believes that the
proposed fees and rebates remain competitive with those on other
options markets, and will continue to attract order flow to the
Exchange, thereby encouraging additional volume and liquidity to the
benefit of all market participants. The Exchange operates in a highly
competitive market in which market participants can readily direct
their order flow to competing venues. In such an environment, the
Exchange must continually review, and consider adjusting, its fees and
rebates to remain competitive with other exchanges. For the reasons
described above, the Exchange believes that the proposed fee changes
reflect this competitive environment.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\13\ and Rule 19b-4(f)(2) \14\ thereunder.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is: (i) Necessary or
appropriate in the public interest; (ii) for the protection of
investors; or (iii) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \13\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \14\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-ISE-2018-46 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2018-46. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-ISE-2018-46 and should be submitted on
or before June 19, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-11456 Filed 5-25-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: May 10, 2007 (Volume 72, Number 90)]
[Notices]
[Page 26623-26624]
[DOCID:fr10my07-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 3, 2007.
    Take notice that the Commission received the following electric
rate filings
    Docket Numbers: ER05-717-006; ER05-721-006; ER04-374-006; ER99-
2341-008; ER06-230-003; ER06-1334-003; ER07-277-001.
    Applicants: Spring Canyon Energy LLC; Judith Gap Energy LLC;
Invenergy TN LLC; Hardee Power Partners Limited; Wolverine Creek Energy
LLC; Spindle Hill Energy LLC; and Invenergy Cannon Falls LLC;
    Description: Spring Canyon Energy LLC, Judith Gap Energy LLC, and
Invenergy TN LLC's et al Notification of change in status under market-
based rate authority.
    Filed Date: 04/27/2007.
    Accession Number: 20070501-0288.
    Comment Date: 5 p.m. Eastern Time on Friday, May 18, 2007.

    Docket Numbers: ER06-427-006.
    Applicants: Mystic Development, LLC.
    Description: Electric Refund Report of Mystic Development, LLC in
Compliance with Feb. 21, 2007 Letter Order.
    Filed Date: 04/17/2007.
    Accession Number: 20070417-4003.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 08, 2007.

    Docket Numbers: ER07-129-003.
    Applicants: Atlantic Path 15, LLC.
    Description: Atlantic Path 15 LLC submits First Revised Sheet 16 et
al to its FERC Electric Tariff, Original Volume No.1 to reflect the
annual update of the Transmission Balancing Account Adjustment to
become effective 1/1/07.
    Filed Date: 04/30/2007.
    Accession Number: 20070502-0303.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-700-001.
    Applicants: Bangor Hydro-Electric Company.
    Description: Bangor Hydro-Electric Company proposes to amend the 4/
2/07 filing to include the additional ministerial revisions and to
incorporate the tariff revisions.
    Filed Date: 04/30/2007.
    Accession Number: 20070502-0302.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-806-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
proposed revisions to its Market Administration and Control Area
Services Tariff.
    Filed Date: 04/27/2007.
    Accession Number: 20070501-0316.
    Comment Date: 5 p.m. Eastern Time on Friday, May 18, 2007.
    Docket Numbers: ER07-809-000.

    Applicants: Florida Power Corporation.
    Description: Florida Power Corp dba Progress Energy Florida, Inc
submits a modification of the 8/1/90 Interconnection Agreement for
construction of transmission facilities.
    Filed Date: 04/27/2007.
    Accession Number: 20070501-0317.
    Comment Date: 5 p.m. Eastern Time on Friday, May 18, 2007.

    Docket Numbers: ER07-810-000.
    Applicants: Grays Harbor Energy LLC.
    Description: Grays Harbor Energy LLC submits an application for
authorization to make market-based wholesale sales of energy, capacity
and ancillary services and its FERC Electric Tariff No. 1.
    Filed Date: 04/27/2007.
    Accession Number: 20070501-0318.
    Comment Date: 5 p.m. Eastern Time on Friday, May 18, 2007.

    Docket Numbers: ER07-811-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest ISO submits the redispatch agreement with East
Kentucky Power Cooperative.
    Filed Date: 04/30/2007.
    Accession Number: 20070501-0319.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-812-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits its
Seventeenth Quarterly Filing of Facilities Agreements with City and
County of San Francisco. Part 1 of 2.
    Filed Date: 04/30/2007.
    Accession Number: 20070501-0297.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-814-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Co submits their amended
Interconnection Facilities Agreement with Mountainview Power Co LLC
designated as Service Agreement No. 6 under its Transmission Owner
Tariff, 2nd Rev Vol No. 6.
    Filed Date: 04/30/2007.
    Accession Number: 20070502-0308.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-815-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest ISO submits an Amended and Restated Facilities
Construction Agreement among Lousiville Gas and Electric Company and
Kentucky Utilities Company.
    Filed Date: 04/30/2007.
    Accession Number: 20070502-0307.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-816-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits Fifth Revised Sheet Nos. 41
and 59 for inclusion in their open access transmission tariff under
Service Schedule B etc, effective 5/1/07.
    Filed Date: 04/30/2007.
    Accession Number: 20070502-0209.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-817-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Services, Inc agent for the Entergy Operating
Companies submit an executed Second Revised Network Integration
Transmission Service Agreement with Cleco Power LLC.
    Filed Date: 04/30/2007.
    Accession Number: 20070502-0306.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-818-000.
    Applicants: Indeck-Olean Limited Partnership.
    Description: Indeck-Olean Limited Partnership submits a filing to
revise its market-based rate authority tariff.
    Filed Date: 04/30/2007.
    Accession Number: 20070502-0305.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Docket Numbers: ER07-819-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits revised schedule sheets
for inclusion in the rate schedules comprising their Agreements to
Provide Qualifying Facility Transmission Service with Mosaic Fertilizer
LLC et al.
    Filed Date: 04/30/2007.
    Accession Number: 20070502-0304.
    Comment Date: 5 p.m. Eastern Time on Monday, May 21, 2007.

    Any person desiring to intervene or to protest in any of the above
proceedings

must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or
before 5 p.m. Eastern time on the specified comment date. It is not
necessary to separately intervene again in a subdocket related to a
compliance filing if you have previously intervened in the same docket.
Protests will be considered by the Commission in determining the
appropriate action to be taken, but will not serve to make protestants
parties to the proceeding. Anyone filing a motion to intervene or
protest must serve a copy of that document on the Applicant. In
reference to filings initiating a new proceeding, interventions or
protests submitted on or before the comment deadline need not be served
on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-8963 Filed 5-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Rules and Regulations]
[Pages 36989-36993]
[FR Doc No: 2011-15816]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 50

[Docket No. FDA-2003-N-0212; (formerly Docket No. 2003N-0355)]

Medical Devices; Exception From General Requirements for Informed
Consent

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a final
regulation to confirm, with one change, the interim final rule (IFR)
entitled ``Medical Devices; Exception From General Requirements for
Informed Consent.'' This final rule confirms the IFR's establishment of
a new exception from the general requirements for informed consent to
permit the use of investigational in vitro diagnostic devices to
identify chemical, biological, radiological, or nuclear agents without
informed consent in certain circumstances. FDA has created this
exception to help ensure that individuals who may have been exposed to
a chemical, biological, radiological, or nuclear agent are able to
benefit from the timely use of the most appropriate diagnostic devices,
including those that are investigational. This final rule adds a
requirement that the investigator submit the required documentation to
FDA, in addition to submitting it to the reviewing Institutional Review
Board (IRB).

DATES: The rule is effective June 24, 2011.

FOR FURTHER INFORMATION CONTACT: Claudia M. Gaffey, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5516, Silver Spring, MD 20993-0002, 301-
796-6196.

SUPPLEMENTARY INFORMATION:

I. Background

A. Overview of Final Rule

    In the Federal Register of June 7, 2006 (71 FR 32827), FDA
published an Interim Final Rule that established an exception from the
general requirements for informed consent to permit the use of
investigational in vitro diagnostic devices to identify chemical,
biological, radiological, or nuclear agents without informed consent in
specified circumstances. The IFR amended 21 CFR 50.23, to add paragraph
(e). The rule was issued under the authority set forth in section
520(g)(3)(D) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360j(g)(3)(D)). FDA gave interested parties 60 days to
comment on the IFR. FDA is publishing this final rule that incorporates
one change in response to comments that the rule did not protect
against misuse of the exception. This change is described in section II
of this document.

B. Legal Authority

    This regulation is being issued under the statutory authority
provided in section 520(g)(3)(D) of the FD&C Act, which outlines the
criteria under which an exemption from informed consent may be
permissible. Under section 520(g)(3)(D) of the FD&C Act, informed
consent is required unless the investigator determines the following in
writing: (1) There exists a life threatening situation involving the
human subject of such testing which necessitates the use of such
device; (2) it is not feasible to obtain informed consent from the
subject; and (3) there is not sufficient time to obtain such consent
from the subject's legally authorized representative. Further, a
licensed physician uninvolved in the testing must agree with this
three-part determination in advance of using the device unless use of
the device is required to save the life of the human subject of such
testing and there is not sufficient time to obtain such concurrence.

II. Highlights of Final Rule

    The preamble to the IFR described the provisions of this rule in
detail (71 FR 32827). In issuing this final rule, FDA is making one
change to the IFR, in response to comments that the rule did not
protect against misuse of this limited exception from informed consent
requirements. In response to those concerns, FDA is adding a
requirement that investigators also send the required documentation to
FDA, not just to the reviewing IRB. This new requirement provides an
additional level of oversight to help ensure that the limited exception
criteria are met.

III. Comments on the IFR

    The Agency received comments on the IFR from nine different
entities. Comments were received from four individual consumers, two
from consumer groups, and one each from a health professional, a health
professional group, and a local government. A summary of the comments
received, grouped by subject matter follows.

A. General Comments

    (Comment 1) Three comments expressed support for the IFR, noting
that the rule is needed and greatly improves the ability of public
health laboratories to respond to a public health emergency. In
contrast, six comments expressed general concern that the rule presents
too much risk to the consumer. Some comments raised issues that are
beyond the scope of this rulemaking. For example, one of these comments
suggested that informed consent documents have a line addressing in
vitro diagnostic testing; another encouraged the production of
templates to easily provide the detailed information required to be
included in the reports.
    (Response) FDA agrees with the comments recognizing that the rule
will enable better response in public health emergencies. FDA also
shares the

general concerns related to ensuring human subject protections. To that
end, the Agency has ensured that the rule confers several layers of
human subject protection, including IRB review, review and evaluation
of the determinations made by the investigator by an independent
physician, and disclosure of the investigational status of device to
the subject's health care provider. FDA believes the rule balances the
need to ensure human subjects are protected with the need to act
quickly during a public health emergency and avoid potentially
dangerous delays in using investigational devices to identify chemical,
biological, radiological, or nuclear agents in human specimens.
    (Comment 2) Two comments noted that the IFR has no provisions to
prevent abuse.
    (Response) FDA disagrees that the rule has no provisions to prevent
abuse. The rule requires that the investigator and an independent
physician each make specific determinations and that an IRB review
these determinations. The determinations that the investigator and
independent physician must make require careful consideration related
to the use of the device and are intended to prevent abuse. However,
FDA does agree that the IFR could have included an additional measure
to prevent abuse of the exception; specifically, the IFR could have
required that an investigator's documentation be submitted to the
Agency, not just to the reviewing IRB. Although FDA relies on IRBs to
adequately monitor the procedures set forth by the rule, the Agency
recognizes that the IFR did not provide a mechanism for FDA to track
the use of this exception from the general requirements for informed
consent. Therefore, FDA is adding a requirement that the investigator
submit to FDA the documentation required in 21 CFR 50.23(e)(1) or
(e)(2) within 5 working days after the use of the device, in addition
to submitting this information to the IRB within the same timeframe.
    (Comment 3) One comment expressed concern that the only oversight
over the determinations made by the investigator and the independent
physician on behalf of the subject is that of the IRB and it will take
5 days. The comment claimed that consumers do not have confidence in
IRB oversight and recommended the development of an open and clear
process for choosing qualified individuals to be granted the
extraordinary emergency power to waive informed consent, with
opportunity for public comment.
    (Response) The Agency agrees that the decision to enter subjects in
clinical trials without informed consent is not a trivial matter and
should be made by qualified individuals. The FD&C Act allows for
carefully considered exceptions to the general requirements for
informed consent in emergency circumstances. The requirements described
in this rule follow section 520(g)(3)(D) of the FD&C Act. This rule is
to be used during emergencies and, among other requirements, only when
there are no cleared or approved available alternative methods of
diagnosis to identify the chemical, biological, radiological, or
nuclear agent that provides an equal or greater likelihood of saving
the life of the subject.
    In general, the rule assures that the determinations designed to
safeguard the subject are made by two different and independent
persons, i.e., the investigator and the independent physician, and that
the use is then reviewed by the IRB. In the final rule, FDA is adding
another level of oversight by requiring that investigators submit to
FDA the same documentation they are required to submit to the IRB. FDA
notes that this rule is intended for use in situations where public
health laboratories must employ investigational in vitro diagnostic
devices to diagnose patients when there are no approved or cleared
diagnostic devices available that provide an equal or greater
likelihood of saving patients' lives.
    (Comment 4) Some comments contended that the rule will allow the
use of experimental tests, which have an unknown rate of inaccurate
test results.
    (Response) FDA agrees that investigational in vitro diagnostic
devices do not yet have established performance characteristics and,
therefore, their accuracy is unknown until data collected during the
investigation demonstrates the device's performance. FDA believes that
when an investigational in vitro diagnostic device is needed to
identify a chemical, biological, radiological, or nuclear agent and no
cleared or approved alternative method of diagnosis is available that
provides an equal or greater likelihood of saving the life of the
subject, the benefits of the investigational in vitro diagnostic device
outweigh the risks. The rule creates an exception to the general
requirement for informed consent under these circumstances.
    (Comment 5) One comment stated that if the patient is awake there
is no justification for not obtaining informed consent.
    (Response) The rule contemplates the scenario when the person
directing the specimen collection does not know, at the time the
specimen is collected, that an investigational device may need to be
used in the future, usually by reference laboratories far from where
the specimen was collected. Because of the geographic and temporal
separation between specimen collection and testing for a life-
threatening agent, to obtain informed consent would require a number of
steps and introduce unacceptable delays, independent of whether the
patient is physically able to provide informed consent.

B. Notification Obligations

    (Comment 6) One comment stated that the notification obligations of
the investigator described in the IFR are too complex, stating it
should be sufficient to have a certification by the laboratory director
declaring that the investigational test was performed in accordance
with the rule and to send to the subject a copy of the notice sent to
the IRB. The comment also noted that the concurrence of an independent
physician adds no value.
    (Response) The Agency believes that the notification obligations of
the investigator described in this rule, which are similar to the
obligations described in other exceptions from the general requirements
of informed consent under 21 CFR 50.23, are needed because they are
intended to provide added human subject protections and to prevent
abuses. Moreover, concurrence of an independent physician is mandated
by section 520(g)(3)(D) of the FD&C Act.

C. Notification of Public Health Authorities

    (Comment 7) One comment requested the inclusion of explicit
language in the rule directing the investigator to notify or report
positive results to public health authorities when appropriate or
required by State or Federal law.
    (Response) FDA agrees that it is important to report the detection
of biologic, chemical, nuclear, or radiological agents to public health
authorities and encourages this practice. FDA expects this reporting to
occur when appropriate or when required under Federal or State law.

D. Interpretation of the Term ``Investigator''

    (Comment 8) One comment asked whether the term ``investigator'' can
be interpreted to mean the single entity that deploys the
investigational device, in which case it would be possible to use a
centralized IRB and have the deploying entity be responsible for the
reporting requirements.

    (Response) For purposes of this regulation, the Agency interprets
the term ``investigator'' to mean the individual who actually conducts
a clinical investigation, i.e., under whose immediate direction the
test article is administered or dispensed or used in the diagnosis or
treatment of a subject. In the event of an investigation conducted by a
team of individuals, we use the term ``investigator'' to mean the
responsible leader of that team. (See 21 CFR 50.3(d)). For purposes of
this rule, we anticipate that the investigator will generally be the
director of the clinical laboratory using the investigational device.
This interpretation does not preclude local IRBs from deferring their
review to a centralized IRB, provided that the IRB meets the
requirements of 21 CFR part 56.

E. Written Certification Timing

    (Comment 9) One comment requested that FDA consider extending the
number of days allowed for submitting the written certification for the
exception. (Under the rule the investigator has 5 working days after
the use of the investigational device to submit the investigator's
determinations and those of the independent physician to the IRB.)
    (Response) FDA disagrees with this comment. The requirement that
the investigator's determinations and those of the independent
physician be submitted to the IRB within 5 working days, which is
similar to the obligations described in other exceptions from the
general requirements of informed consent under 21 CFR 50.23, are
intended to assure prompt action by the IRB, as needed.

F. Other Public Health Emergency

    (Comment 10) Two comments contended that the term ``other public
health emergency'' is vague and should be removed or should be revised
to specify in exact terms what constitutes a public health emergency
worthy of this extraordinary exception from informed consent.
    (Response) For purposes of this rule, the term ``other public
health emergency'' means serious domestic emergencies that have the
potential to significantly impact public health such as those caused by
deadly weather disasters or by widespread infectious disease such as
pandemic influenza.

G. Withdrawal of Previously Collected Data

    (Comment 11) One comment requested that the following preamble
statement, ``subjects or their legally authorized representatives will
not be entitled to withdraw previously collected data from the research
database * * *'' (71 FR 32827 at 32830), be eliminated because it sets
a dangerous precedent by allowing government research to take priority
over personal privacy.
    (Response) FDA does not agree to eliminate the referenced
statement. While a subject may withdraw from a study, FDA reiterates
that the withdrawal does not extend to the data already obtained during
the time the subject was enrolled. FDA's longstanding position has been
that all data collected up to the point of withdrawal is to be
maintained in the database and included in subsequent analyses, as
appropriate, in order for the study to be scientifically valid.\1\ If a
subject withdraws from a study, removal of already collected data would
undermine the scientific, and therefore the ethical, integrity of the
research.
---------------------------------------------------------------------------

    \1\ See ``Guidance for Sponsors, Clinical Investigators, and
IRBs--Data Retention When Subjects Withdraw from FDA-Regulated
Clinical Trials,'' found at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126489.pdf.
---------------------------------------------------------------------------

IV. Applicability of 45 CFR Part 46 and Other Legal Requirements

    As described in the IFR, some of the activities described in this
rule may also constitute non-exempt human subjects research within the
meaning of 45 CFR part 46, according to the Office for Human Research
Protection (OHRP) in the Department of Health and Human Services (HHS).
In particular, the use of the investigational in vitro diagnostic
device on individually identifiable human specimens as described in
this rule would not be human subjects research under 45 CFR part 46,
while the analysis of the individually identifiable data obtained from
the use of the investigational device to determine the safety and
effectiveness of the device would be considered human subject research
under 45 CFR part 46. If the analysis of individually identifiable data
involves non-exempt human subjects research that is conducted or
supported by HHS, the institution conducting the analysis must obtain
an OHRP-approved assurance. In addition, this means that this research
activity, if not exempt, i.e., the analysis of the individually
identifiable data, must be reviewed prospectively by an IRB and must be
conducted with the informed consent of the subjects unless waived. OHRP
expects that IRBs will often find that informed consent may be waived
under 45 CFR 46.116(d) for the analysis of the individually
identifiable data obtained through the use of the investigational
device. OHRP issued guidance regarding this issue simultaneously with
the publication of the IFR, on June 7, 2006. This guidance can be found
at http://www.hhs.gov/ohrp/policy/invitrodev.html. Those interested in
seeking additional information concerning the application of the
regulations at 45 CFR part 46 should contact OHRP. We note that
research conducted or supported by another Department or Agency may be
subject to other laws and regulations. Sponsors should check to see if
they are complying with all applicable requirements.

V. Analysis of Economic Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs Agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this action provides an exception from an
otherwise applicable requirement for investigators, FDA believes that
it does not impose a significant burden. The Agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth

in Executive Order 13132. Section 4(a) of the Executive order requires
Agencies to ``construe * * * a Federal statute to preempt State law
only where the statute contains an express preemption provision or
there is some other clear evidence that the Congress intended
preemption of State law, or where the exercise of State or authority
conflicts with the exercise of Federal authority under the Federal
statute.'' Federal law includes an express preemption provision that
preempts certain state requirements ``different from or in addition
to'' certain federal requirements applicable to devices. 21 U.S.C.
360k; see Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic,
128 S. Ct. 999 (2008). This final rule creates requirements for
specific medical devices under 21 U.S.C. 360k. Papike v. Tambrands,
Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).

VII. The Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual reporting and recordkeeping burden. Included in the estimate
is the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing each collection of information.
    Title: Medical Devices; Exception From General Requirements for
Informed Consent.
    Description: The final rule amends FDA's informed consent
regulation to provide an exception from the general requirement to
obtain informed consent from the subject of an investigation involving
an unapproved or uncleared in vitro diagnostic device intended to
identify a chemical, biological, radiological, or nuclear agent. For
the exception to apply, it is necessary for the investigator and an
independent licensed physician to make the determination and certify in
writing certain facts concerning the need for use of the
investigational in vitro diagnostic device without informed consent (21
CFR 50.23(e)(1)). When reporting the test results to the subject's
health care provider and, possibly, to the appropriate public health
authorities, the investigator must disclose the investigational status
of the in vitro diagnostic device (21 CFR 50.23(e)(4)). If use of the
device is necessary to preserve the life of the subject and there is
not sufficient time to obtain the determination of the independent
licensed physician in advance of using the investigational device, 21
CFR 50.23(e)(2) provides that the determination must be made within 5
working days of use of the device. In either case, the certifications
are submitted to the IRB within 5 working days after the use of the
device (21 CFR 50.23(e)(3)).
    The information collection requirements in 21 CFR 50.23(e)(1),
(e)(2), and (e)(4) in the IFR have been approved under OMB control
number 0910-0586. The information collection requirement in 21 CFR
50.23(e)(3) (submitting the certifications to the IRB) was considered
part of the burden for 21 CFR 50.23(e)(1) and (e)(2).
    This final rule makes one change to the regulatory requirements
established by the IFR. This change requires the investigator to submit
the documentation required in 21 CFR 50.23(e)(1) and (e)(2) to FDA, in
addition to the reviewing IRB. The documentation the investigator must
submit to FDA is identical to the documentation the investigator must
submit to the IRB.
    Description of Respondents: Clinical laboratory directors,
physicians who are investigators.
    FDA estimates the burden of the collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of                      Average  burden                   Total operating
                    21 CFR Part                        Number of      responses per     Total annual    per  response     Total hours     & maintenance
                                                      respondents       respondent       responses        (in hours)                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
50.23(e)(3).......................................             150                3              450            15/60              113             $100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    From its knowledge of in vitro diagnostic device investigations,
FDA estimates that there are approximately 150 laboratory directors or
physicians who could perform this type of testing and, as
investigators, are required to comply with information collection and
recordkeeping. FDA estimates that there are approximately 450 naturally
occurring cases of this type each year. Based on its knowledge of
similar types of submissions, FDA estimates that it will take about .25
hour or 15 minutes to prepare each written documentation to be
submitted to FDA as required by 21 CFR 50.23(e)(3). The estimated 112.5
total hours was calculated by multiplying the estimated total annual
response by the hours per response.
    In compliance with the Paperwork Reduction Act of 1995, the
collection of information in this final rule has been submitted to OMB
for review. The new information has been submitted as a revision to the
previously approved collection OMB control number 0910-0586.
    This final rule also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by OMB under the Paperwork Reduction Act of 1995.
The collections of information in 21 CFR 56.115 have been approved
under OMB control number 0910-0130; and the collections of information
in 21 CFR 50.23(e)(1), (e)(2), and (e)(4) have been approved under OMB
control number 0910-0586.

VIII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

List of Subjects in 21 CFR Part 50

    Human research subjects, Prisoners, Reporting and recordkeeping
requirements, Safety.
    Accordingly, the interim final rule amending 21 CFR part 50 which
was published at 71 FR 32827 on June 7, 2006, is adopted as a final
rule with the following change:

PART 50--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 21 CFR part 50 continues to read as
follows:

    Authority:  21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352,
353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216,
241, 262, 263b-263n.

0
2. Revise Sec.  50.23(e)(3) to read as follows:

Sec.  50.23  Exception from general requirements.

* * * * *
    (e) * * *
    (3) The investigator must submit the written certification of the
determinations made by the investigator and an independent physician
required in paragraph (e)(1) or (e)(2) of this section to the IRB and
FDA within 5 working days after the use of the device.
* * * * *

    Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15816 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67432-67433]
[FR Doc No: 2015-27821]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-H022k-2006-0062]

Preparations for the 30th Session of the UN Sub-Committee of
Experts on the Globally Harmonized System of Classification and
Labelling of Chemicals (UNSCEGHS)

AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor

ACTION: Notice of public meeting.

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SUMMARY: This notice is to advise interested persons that on Thursday,
November 12, 2015, OSHA will conduct a public meeting to discuss
proposals in preparation for the 30th session of the United Nations
Sub-Committee of Experts on the Globally Harmonized System of
Classification and Labelling of Chemicals (UNSCEGHS) to be held
December 9 to December 11, 2015 in Geneva, Switzerland. OSHA, along
with the U.S. Interagency GHS (Globally Harmonized System of
Classification and Labelling of Chemicals) Coordinating Group, plans to
consider the comments and information gathered at this public meeting
when developing the U.S. Government positions for the

UNSCEGHS meeting. Members of the Regulatory Cooperation Council (RCC)
will be present to update Canada's status of their GHS policy and
procedures. International conference call capability will be available
for this portion of the public meeting.
    Also, on Thursday, November 12, 2015, the Department of
Transportation (DOT), Pipeline and Hazardous Materials Safety
Administration (PHMSA) will conduct a public meeting (See Docket No.
PHMSA-2015-0188, Notice No. 15-19) to discuss proposals in preparation
for the 48th session of the United Nations Sub-Committee of Experts on
the Transport of Dangerous Goods (UNSCOE TDG) to be held November 30 to
December 9, 2015, in Geneva, Switzerland. During this meeting, PHMSA is
also requesting comments relative to potential new work items that may
be considered for inclusion in its international agenda. PHMSA will
also provide an update on recent actions to enhance transparency and
stakeholder interaction through improvements to the international
standards portion of its Web site.

DATES: Thursday November 12, 2015

ADDRESSES: Both meetings will be held at the DOT Headquarters
Conference Center, West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590.
    Times and Locations: PHMSA public meeting: 9:00 a.m. to 12:00 p.m.
EDT, Conference Rooms 8-10.
    OSHA public meeting: 1:00 p.m. to 2:30p.m. EDT, Conference Rooms 8-
10.
    RCC public meeting: 3:00 p.m. to 4:30 p.m. EDT, Conference Rooms 8-
10.
    Advanced Meeting Registration: The DOT requests that attendees pre-
register for these meetings by completing the form at: https://www.surveymonkey.com/r/LVXNWYT.
    Attendees may use the same form to pre-register for both the PHMSA
and the OSHA meetings. Failure to pre-register may delay your access
into the DOT Headquarters building. Additionally, if you are attending
in-person, arrive early to allow time for security checks necessary to
access the building.
    Conference call-in and ``live meeting'' capability will be provided
for both meetings.
    The number is reserved and the Live Meeting link is setup for all
day.

Toll Free (USA)

    Toll Free:<PHONE_NUMBER>
    Access code: 3614708

International Callers

    International Toll:<PHONE_NUMBER>
    Access: 3614708
    Attendee URL: https://www.livemeeting.com/cc/phmsa/join?id=JKJ4DF&role=attend&pw=w5%3CPP%28%5D%2Cs

FOR FURTHER INFORMATION CONTACT: For information about the PHMSA
Meeting at 9:00 a.m.: Mr. Steven Webb or Mr. Aaron Wiener, Office of
Hazardous Materials Safety, Department of Transportation, Washington,
DC 20590: Telephone:<PHONE_NUMBER>.
    For information about the OSHA Meeting at 1:00 p.m. and the RCC
Meeting at 3:00 p.m.: Ms. Maureen Ruskin, Office of Chemical Hazards-
Metals, OSHA Directorate of Standards and Guidance, Department of
Labor, Washington, DC 20210: Telephone:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The OSHA Meeting: OSHA is hosting an open informal public meeting
of the U.S. Interagency GHS Coordinating Group to provide interested
groups and individuals with an update on GHS-related issues and an
opportunity to express their views orally and in writing for
consideration in developing U.S. Government positions for the upcoming
UNSCEGHS meeting. Interested stakeholders may also provide input on
issues related to OSHA's activities in the U.S.-Canada Regulatory
Cooperation Council (RCC) at the meeting.
    General topics on the agenda include:
     Review of Working papers
     Correspondence Group updates
     Regulatory Cooperation Council (RCC) Update
    Information on the work of the UNSCEGHS including meeting agendas,
reports, and documents from previous sessions, can be found on the
United Nations Economic Commission for Europe (UNECE) Transport
Division Web site located at the following web address: http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html. The UNSCEGHS
bases its decisions on Working Papers. The Working Papers for the 30th
session of the UNSCEGHS are located at: http://www.unece.org/trans/main/dgdb/dgsubc3/c32015.html.
    Informal Papers submitted to the UNSCEGHS provide information for
the Sub-committee and are used either as a mechanism to provide
information to the Sub-committee or as the basis for future Working
Papers. Informal Papers for the 30th session of the UNSCEGHS are
located at: http://www.unece.org/trans/main/dgdb/dgsubc4/c4inf30.html.
    The PHMSA Meeting: The Federal Register notice and additional
detailed information relating to PHMSA's public meeting will be
available upon publication at http://www.regulations.gov (Docket No.
PHMSA-2015-0188 No.) and on the PHMSA Web site at: http://www.phmsa.dot.gov/hazmat/regs/international.
    The primary purpose of PHMSA's meeting will be to prepare for the
47th session of the UNSCE TDG. The 48th session of the UNSCE TDG is the
first of four meetings scheduled for the 2015-2016 biennium. The UNSCE
will consider proposals for the 20th Revised Edition of the United
Nations Recommendations on the Transport of Dangerous Goods Model
Regulations, which may be implemented into relevant domestic, regional,
and international regulations from January 1, 2019. Copies of working
documents, informal documents, and the meeting agenda may be obtained
from the United Nations Transport Division's Web site at http://www.unece.org/trans/danger/danger.html.
    Authority and Signature: This document was prepared under the
direction of David Michaels, Ph.D., MPH, Assistant Secretary of Labor
for Occupational Safety and Health, U.S. Department of Labor, pursuant
to sections 4, 6, and 8 of the Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657), and Secretary's Order 1-2012 (77 FR
3912), (Jan. 25, 2012).

    Signed at Washington, DC, on October 26, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2015-27821 Filed 10-30-15; 8:45 am]
BILLING CODE 4510-26-P