[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56297-56300]
[FR Doc No: 2017-25686]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82141; File No. SR-ISE-2017-98]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Schedule of Fees for Regular Orders in Select Symbols

November 22, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 13, 2017, 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 for regular
orders in Select Symbols to: (1) Adjust rebates and tier thresholds for
the Market Maker Plus program, and (2) increase taker fees for certain
Firm-Proprietary, Broker-Dealer, and Priority Customer orders.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.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 for regular orders in Select Symbols to: (1) Adjust rebates and
tier thresholds for the Market Maker Plus program, and (2) increase
taker fees for certain Firm-Proprietary,\3\ Broker-Dealer,\4\ and
Priority Customer \5\ orders.
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    \3\ A ``Firm Proprietary'' order is an order submitted by a
member for its own proprietary account.
    \4\ A ``Broker-Dealer'' order is an order submitted by a member
for a broker-dealer account that is not its own proprietary account.
    \5\ 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).
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    The Exchange initially filed the proposed pricing changes on
November 1, 2017 (SR-ISE-2017-97). On November 13, 2017, the Exchange
withdrew that filing and submitted this filing.
Market Maker Plus
    The Exchange proposes to increase Market Maker Plus rebates in SPY
and QQQ, and modify the associated tier thresholds to make it easier
for Market Makers \6\ to qualify for higher Market Maker Plus tiers in
these symbols. The Market Maker Plus program is designed to attract
additional liquidity from Market Makers and encourage Market Makers to
maintain tight markets on ISE. The Exchange believes that the proposed
fee changes will further these objectives.
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    \6\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See Rule
100(a)(25).
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    A Market Maker Plus is a Market Maker who is on the National Best
Bid or National Best Offer (``NBBO'') a specified percentage of the
time for series trading between $0.03 and $3.00 (for options whose
underlying stock's previous trading day's last sale price was less than
or equal to $100) and between $0.10 and $3.00 (for options whose
underlying stock's previous trading day's last sale price was greater
than $100) in premium in each of the front two expiration months.
Currently, the specified percentage for time at the NBBO for all
symbols is at least 80% but lower than 85% of the time for Tier 1, at
least 85% but lower than 95% of the time for Tier 2 and at least 95% of
the time for Tier 3.\7\ The Exchange proposes to modify the tier
thresholds for SPY and QQQ only by adding a new Tier 1 and adjusting
the other Market Maker Plus tiers such that: (1) Tier 1 rebates are
provided to Market Makers that are on the NBBO at least 70% but lower
than 80% of the time; (2) Tier 2 rebates are provided to market Makers
that are on the NBBO at least 80% but lower than 85% of the time; (3)
Tier 3 rebates are provided to Market Makers that are on the NBBO at
least 85% but lower than 90% of the time; and (4) Tier 4 and

rebates are provided to Market Makers that are on the NBBO at least 90%
of the time.
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    \7\ A Market Maker's single best and single worst quoting days
each month based on the front two expiration months, on a per symbol
basis, will be excluded in calculating whether a Market Maker
qualifies for this rebate, if doing so will qualify a Market Maker
for the rebate. Other than days where the Exchange closes early for
holiday observance, any day that the market is not open for the
entire trading day or the Exchange instructs members in writing to
route their orders to other markets may be excluded from the Market
Maker Plus tier calculation; provided that the Exchange will only
remove the day for members that would have a lower time at the NBBO
for the specified series with the day included.
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    The Exchange is not proposing any changes to the tier thresholds
for Select Symbols other than SPY and QQQ. However, in connection with
the changes described above for SPY and QQQ, the Exchange proposes to
reformat the Schedule of Fees so that all Market Maker Plus tier
thresholds and rebate amounts, including those for SPY and QQQ, and
those for other Select Symbols, are clearly described in footnote 5
under Regular Order Fees and Rebates. With the proposed changes, this
footnote will state that Market Makers that qualify for Market Maker
Plus will receive rebates based on a table contained therein that
separately identifies tier thresholds and rebate amounts for SPY and
QQQ, and for Select Symbols other than SPY and QQQ. While tier
thresholds and rebate amounts for Select Symbols other than SPY and QQQ
are being moved to this section of the Schedule of Fees, the Exchange
is not proposing any changes to those values. Therefore, the Market
Maker Plus program will continue to operate in the same way that it
does today for all symbols other than SPY and QQQ.
    Currently, Market Makers that qualify for Market Maker Plus are
provided a rebate for regular orders in Select Symbols of $0.15 per
contract for Tier 1, $0.18 per contract for Tier 2, and $0.22 per
contract for Tier 3.\8\ For SPY and QQQ only, this rebate is $0.16 per
contract for Tier 2 and $0.20 per contract for Tier 3.\9\ A Market
Maker that achieves a higher tier of Market Maker Plus in either SPY or
QQQ receives the higher rebate in both SPY and QQQ. Market Makers that
do not qualify for Market Maker Plus are not eligible for rebates and
are instead charged a fee of $0.10 per contract. With the introduction
of a new Tier 1 and adjustment of other tier thresholds for SPY and
QQQ, the Exchange proposes to provide an increased Market Maker Plus
rebate in SPY and QQQ that is: (1) $0.00 Per contract (i.e., no fee or
rebate) for new Tier 1; (2) $0.18 per contract for new Tier 2, (3)
$0.22 per contract for new Tier 3, and (3) $0.26 per contract for new
Tier 4. Each of these regular maker rebates is increased from current
Market Maker Plus rebates provided to Market Makers that are at the
NBBO for the same percentage of time today--or in the case of Tier 1,
represents the elimination of a fee that would have been charged to
Market Makers that are on the NBBO for the same percentage of the time.
In addition, the Exchange proposes to adopt a ``linked maker rebate''
for proposed Tiers 2-4 that applies to executions in SPY or QQQ if the
Market Maker does not achieve the applicable tier in that symbol but
achieves the tier (i.e., proposed Tiers 2-4) in the other symbol. Once
the applicable tier--any of proposed Tiers 2, 3 or 4--is achieved for
one symbol, the Market Maker will be eligible for the linked maker
rebate in the other symbol, regardless of time at the NBBO in that
symbol (i.e., there is no minimum tier threshold to be met in that
symbol for the proposed linked maker rebate). This linked maker rebate
would be $0.16 per contract for Tier 2, $0.20 per contract for Tier 3,
and $0.24 per contract for Tier 4. The regular maker rebate will be
provided in the symbol that qualifies the Market Maker for the tier
based on percentage of time at the NBBO. Thus, for example, if a Market
Maker achieves Tier 3 in SPY and Tier 1 in QQQ, the Market Maker would
receive the Tier 3 regular maker rebate in SPY (i.e., $0.22 per
contract) and the Tier 3 linked maker rebate in QQQ (i.e., $0.20 per
contract). This linked maker rebate is similar to how Market Maker Plus
rebates are currently provided in SPY and QQQ--i.e., a Market Maker
that qualifies for a tier in one qualifies for both--but is more
beneficial to the Market Maker because the Market Maker may earn the
higher regular maker rebate in the symbol for which they qualify for
that tier normally.
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    \8\ For all tiers, a $0.10 per contract fee applies when trading
against Priority Customer complex orders that leg into the regular
order book. There will be no fee charged or rebate provided when
trading against non-Priority Customer complex orders that leg into
the regular order book.
    \9\ As with other rebates provided under the Market Maker Plus
program, this rebate does not apply when trading against complex
orders that leg into the regular book.
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Taker Fees
    Currently, the Exchange charges a taker fee for regular orders in
Select Symbols that is $0.44 per contract for Market Maker and Priority
Customer orders (other than Priority Customer orders in SPY, QQQ, IWM,
and VXX) and $0.45 per contract for Non-Nasdaq ISE Market Maker,\10\
Firm Proprietary, Broker-Dealer, and Professional Customer \11\ orders.
The taker fee for Priority Customer orders is $0.34 per contract in
SPY, and $0.35 per contract in QQQ, IWM, and VXX. The Exchange proposes
to: (1) Increase the taker fee for Firm Proprietary and Broker-Dealer
orders in Select Symbols to $0.46 per contract; and (2) increase the
taker fee for Priority Customer orders in SPY, QQQ, IWM, and VXX to
$0.37 per contract.
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    \10\ A ``Non-Nasdaq ISE Market Maker'' is a market maker as
defined in Section 3(a)(38) of the Securities Exchange Act of 1934,
as amended, registered in the same options class on another options
exchange.
    \11\ A ``Professional Customer'' is a person or entity that is
not a broker/dealer and is not a Priority Customer.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\12\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\13\ 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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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4) and (5).
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Market Maker Plus
    The Exchange believes that the proposed changes to the Market Maker
Plus program in SPY and QQQ are reasonable and equitable as these
changes would increase rebates for Market Makers that qualify for
Market Maker Plus in these symbols, including linked maker rebates that
will now be provided in a manner more beneficial to members--i.e., by
providing the higher maker rebate in the symbol where a member
qualifies normally. Furthermore, the proposed rule change would also
introduce a new tier that eliminates maker fees for Market Makers that
do not meet the current requirements for time at the NBBO in SPY and
QQQ, and ease the requirements needed to qualify for higher tiers of
Market Maker Plus in these symbols. The Market Maker Plus program is
designed to attract liquidity from Market Makers on ISE and provide
incentives for those Market Makers to maintain tight markets, measured
by time spent quoting at the NBBO. The Exchange believes the proposed
rule change will further encourage Market Makers to maintain quality
markets in SPY and QQQ, which are two of the most actively traded
symbols on ISE, to the benefit of all market participants that trade on
the Exchange.\14\
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    \14\ The proposed rule change also reformats the way that Market
Maker Plus rebates and tier thresholds are displayed, which will
make the program easier to understand.
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    The Exchange also believes that these changes are not unfairly
discriminatory as all Market Makers can qualify for Market Maker Plus
in these symbols by meeting program requirements that are designed to
incentivize Market Markets

to maintain quality markets. As noted above, SPY and QQQ have been
targeted by the Exchange as these are highly active symbols on the
Exchange. The proposed rule change will allow Market Makers that would
not qualify for Market Maker Plus in SPY or QQQ today to qualify for
free maker executions based on a time at the NBBO of at least 70% of
the time pursuant to proposed Tier 1. And, as is the case today, Market
Makers that show commitment to market quality by maintaining quotes
that qualify them for a higher tier in these symbols will earn higher
rebates, including more favorably applied linked rebates. Furthermore,
the Exchange continues to believe that it is not unfairly
discriminatory to offer these rebates only to Market Makers as Market
Makers, and, in particular, those Market Makers that achieve Market
Maker Plus status, are subject to additional requirements and
obligations (such as quoting requirements) that other market
participants are not.
Taker Fees
    The Exchange believes that the proposed changes to taker fees are
reasonable and equitable as the proposed increases are modest and
reflect reasonable charges to access liquidity on the Exchange. The
Exchange believes that the increased taker fee for Firm Proprietary and
Broker-Dealer orders in Select Symbols and the taker fee for Priority
Customer orders in SPY, QQQ, IWM, and VXX will continue to be
attractive to market participants. Furthermore, Priority Customers will
continue to receive reduced taker fees in SPY, QQQ, IWM, and VXX, which
represent some of the most heavily traded symbols on the Exchange. In
particular, the proposed taker fees are lower than taker fees charged
to Priority Customer orders in other Select Symbols as well as taker
fees charged to other market participants. As such, the Exchange
believes that the proposed taker fees will continue to attract order
flow to the benefit of all market participants that trade on the
Exchange. In addition, the Exchange believes that it is equitable and
not unfairly discriminatory to increase the taker fees described above,
as well as to only offer reduced taker fees in SPY, QQQ, IWM, and VXX
to Priority Customer orders. The proposed taker fee increases apply
equally to members based on a market participants' type. Furthermore, 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 on the
Exchange 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.

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 proposed changes to the
Market Maker Plus program in SPY and QQQ are designed to increase
competition by encouraging Market Makers to provide liquidity and
maintain tight markets in these symbols. Furthermore, the proposed
increases to taker fees are modest and the Exchange does not expect
that such minor increases will have any significant impact on
competition. The Exchange operates in a highly competitive market in
which market participants can readily favor competing venues if they
deem fee levels at a particular venue to be excessive, or rebate
opportunities available at other venues to be more favorable. In such
an environment, the Exchange must continually adjust its fees to remain
competitive. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited.

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,\15\ and Rule 19b-4(f)(2) \16\ 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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    \15\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \16\ 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-2017-98 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-2017-98. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. 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-2017-98 and should be
submitted on or before December 19, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-25686 Filed 11-27-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Pages 5432-5433]
[FR Doc No: 2016-01810]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2322-060]

Brookfield White Pine Hydro LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document (PAD), Commencement of
Pre-Filing Process, and Scoping; Request for Comments on the Pad and
Scoping Document, and Identification of Issues and Associated Study
Requests; and Scoping Meeting

    a. Type of Filing: Notice of Intent to File License Application for
a New License and Pre-Application Document (PAD) (including a proposed
process plan and schedule), pursuant to 18 CFR 5.6 of the Commission's
regulations.
    b. Project No.: 2322-060.
    c. Date Filed: September 21, 2015.
    d. Submitted By: Brookfield White Pine Hydro LLC (White Pine
Hydro).
    e. Name of Project: Shawmut Hydroelectric Project.
    f. Location: On the Kennebec River in the towns of Skowhegan,
Fairfield, Clinton, and Benton, within Kennebec and Somerset Counties,
Maine. The project does not occupy United States lands.
    g. Filed Pursuant to: 18 CFR part 5 of the Commission's
Regulations.
    h. Potential Applicant Contact: Frank Dunlap, Licensing Specialist,
Brookfield White Pine Hydro LLC, 150 Main St., Lewiston, ME 04240;
(207) 755-5603<EMAIL_ADDRESS>    i. FERC Contact: Dustin Wilson at<PHONE_NUMBER>, or email at
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise

with respect to environmental issues that wish to cooperate in the
preparation of the environmental document should follow the
instructions for filing such requests described in paragraph o. below.
Cooperating agencies should note the Commission's policy that agencies
that cooperate in the preparation of the environmental document cannot
also intervene. See 94 FERC ] 61,076 (2001).
    k. With this notice, we are initiating informal consultation with:
(1) The U.S. Fish and Wildlife Service and/or the National Marine
Fisheries Service under section 7 of the Endangered Species Act and the
joint agency regulations thereunder at 50 CFR, Part 402; and (2) the
State Historic Preservation Officer, as required by section 106,
National Historical Preservation Act, and the implementing regulations
of the Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating White Pine Hydro as the
Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act and
section 106 of the National Historic Preservation Act.
    m. Commission staff issued a Scoping Document 1 (SD1) on November
20, 2015, which also asked for study requests.
    n. A copy of the PAD and SD1 are available for review at the
Commission in the Public Reference Room, or may be viewed on the
Commission's Web site (http://www.ferc.gov) using the ``eLibrary''
link. Enter P-2322 in the docket number field to access the document.
For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. With this notice, we are soliciting public comments on the PAD
and the SD1, as well as on issues and associated study requests. All
comments and study requests should be sent to the address above in
paragraph h. In addition, all comments on the PAD and SD1, study
requests, requests for cooperating agency status, and all
communications to and from Commission staff related to the merits of
the potential application must be filed with the Commission. Documents
may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
five copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426.
    All filings with the Commission must include on the first page, the
project name (Shawmut Hydroelectric Project) and number (P-2322-060),
and bear the appropriate heading: ``Comments on Pre-Application
Document,'' ``Study Requests,'' ``Comments on Scoping Document 1,''
``Request for Cooperating Agency Status,'' or ``Communications to and
from Commission Staff.'' Any individual or entity interested in
submitting study requests, commenting on the PAD or SD1, and any agency
requesting cooperating status must do so by March 21, 2016.
    Study requests and comments on the PAD or SD1 that have been filed
previously are part of the relicensing record and do not need to be
refiled.
    p. Although our current intent is to prepare an environmental
assessment (EA), there is the possibility that an Environmental Impact
Statement (EIS) will be required. Nevertheless, the scoping meetings
held December 16, 2015, and the scoping meeting to be held February 9,
2016, will satisfy the NEPA scoping requirements, irrespective of
whether an EA or EIS is issued by the Commission.

Scoping Meeting

    Commission staff held scoping meetings December 16, 2015. The
transcripts for the meetings are in the public record for this project,
and are available for review through the Commission's Web site, using
the ``eLibrary'' link.
    Commission staff will hold a third scoping meeting in the vicinity
of the project at the time and place noted below. All interested
individuals and entities, particularly those who were unable to attend
the December 16 scoping meetings, are invited to attend the meeting,
and to assist staff in identifying particular study needs, as well as
the scope of environmental issues to be addressed in the environmental
document. The time and location of the meeting is as follows:

Evening Scoping Meeting

    Date: Tuesday, February 9, 2016.
    Time: 6:00 p.m.
    Location: Skowhegan Community Center, 39 Poulin Dr., Skowhegan,
Maine 04976.
    Phone:<PHONE_NUMBER>.
    As noted in item m. of this notice, SD1 was mailed to the
individuals and entities on the Commission's mailing list. Copies of
SD1 will be available at the scoping meeting, or may be viewed on the
web at http://www.ferc.gov, using the ``eLibrary'' link. Follow the
directions for accessing information in paragraph n. Based on all oral
and written comments, a Scoping Document 2 (SD2) may be issued. SD2 may
include a revised process plan and schedule, as well as a list of
issues.

Meeting Objectives

    At the scoping meeting, Commission staff will: (1) Initiate scoping
of the issues; (2) review and discuss existing conditions and resource
management objectives; (3) review and discuss existing information and
identify preliminary information and study needs; and (4) review and
discuss the process plan and schedule for pre-filing activities.
    Meeting participants should come prepared to discuss their issues
and/or concerns. Please review the PAD in preparation for the scoping
meeting. Directions on how to obtain a copy of the PAD and SD1 are
included in item n. of this notice.

Meeting Procedures

    The meeting will be recorded by a stenographer. The transcript will
be placed in the public record for the project.

    Dated: January 21, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-01810 Filed 2-1-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Rules and Regulations]
[Page 58871]
[DOCID:fr08oc08-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0003; Airspace Docket No. 08-ASW-1]

Establishment of Class E Airspace; Lexington, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: This action confirms the effective date of the direct final
rule that established Class E airspace at Muldrow Army Heliport,
Lexington, OK, published in the Federal Register August 6, 2008 (73 FR
45607) Docket No. FAA-2008-0003.

DATES: Effective Dates: 0901 UTC October 8, 2008. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION: Scott Enander, Central Service Center, System
Support Group, Federal Aviation Administration, Southwest Region, 2601
Meacham Blvd., Fort Worth, TX 76193-0530; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a direct final rule with request for comments in
the Federal Register August 6, 2008 (73 FR 45607), Docket No. FAA-2008-
0003. This rule established Class E airspace at Muldrow Army Heliport,
Lexington, OK. The FAA uses the direct final rule procedure for non-
controversial rules where the FAA believes that there will be no
adverse public comment. This direct final rule advised the public that
no adverse comments were anticipated, and that unless a written adverse
comment, or a written notice of intent to submit an adverse comment,
was received within the comment period, the regulation would become
effective on September 25, 2008. No adverse comments were received;
thus, this notice confirms that the direct final rule became effective
on this date.

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
* * * * *

    Issued in Fort Worth, TX, on September 25, 2008.
Donald R. Smith,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. E8-23777 Filed 10-7-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: November 17, 2005 (Volume 70, Number 221)]
[Notices]
[Page 69750-69751]
[DOCID:fr17no05-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER06-125-000]

Kentucky Power Company; Notice of Filing

November 9, 2005.
    Take notice that on November 1, 2005, Kentucky Power Company (KPCo)
tendered for filing a Notice of Cancellation of its Service Agreement
No. 1 under FERC Electric Tariff Original Volume No. 1 and FERC
Electric Tariff Original Volume No. 1, under which KPCo currently
provides service to the City of Olive Hill, Kentucky. KPCo requests an
effective date of January 1, 2006.
    KPCo states that a copy of the filing was served upon the Kentucky
Public Service Commission and the City of Olive Hill.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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 docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

    Comment Date: 5 p.m. Eastern Time on November 18, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6341 Filed 11-16-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 15, 2005 (Volume 70, Number 219)]
[Notices]
[Page 69325-69326]
[DOCID:fr15no05-34]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP96-383-069]

Dominion Transmission, Inc.; Notice of Negotiated Rates

November 8, 2005.
    Take notice that on November 3, 2005, Dominion Transmission, Inc.
(DTI) tendered for filing as part of its FERC Gas Tariff, Third Revised
Volume No. 1, Second Revised Sheet No. 1415, to become effective
December 1, 2005.
    DTI states that the purpose of this filing is to report an
amendment to a negotiated rate transaction between DTI and Dominion
Field Services, Inc., as pool operator for Penn Virginia Oil & Gas
Corporation.
    Any person desiring to intervene or to protest this filing 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). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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 docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6283 Filed 11-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4283-4288]
[FR Doc No: 2015-01408]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0045]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; AH-7921; Gamma-Butyrolactone;
1,4-Butanediol; Ketamine; 9 Additional Substances; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing interested
persons with the opportunity to submit written comments and to request
an informal public meeting concerning recommendations by the World
Health Organization (WHO) to impose international manufacturing and
distributing restrictions, under international treaties, on certain
drug substances. The comments received in response to this notice and/
or public meeting will be considered in preparing the United States
position on these proposals for a meeting of the United Nations
Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2015.
This notice is issued under the Controlled Substances Act (the CSA).

DATES: Submit either electronic or written comments by February 26,
2015. Submit requests for a public meeting on or before February 6,
2015. (For additional information, see also section IV of this
document).

ADDRESSES: Submit electronic comments 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.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (Psychotropic Convention). Section 201(d)(2)(B) of the CSA
(21 U.S.C. 811(d)(2)(B)) provides that when the United States is
notified under Article 2 of the Psychotropic Convention that the CND
proposes to decide whether to add a drug or other substance to one of
the schedules of the Psychotropic Convention, transfer a drug or
substance from one schedule to another, or delete it from the
schedules, the Secretary of State must transmit notice of such
information to the Secretary of Health and Human Services (Secretary of
HHS). The Secretary of HHS must then publish a summary of such
information in the Federal Register and provide opportunity for
interested persons to submit comments. The Secretary of HHS must then
evaluate the proposal and furnish a recommendation to the Secretary of
State that shall be binding on the representative of the United States
in discussions and negotiations relating to the proposal.
    As detailed in the following paragraphs, the Secretary of State has
received notification from the Secretary-General of the United Nations
(the Secretary-General) regarding 13 substances to be considered for
control under the Psychotropic Convention. This notification reflects
the recommendation from the 36th WHO Expert Committee for Drug
Dependence (ECDD), which met in June 2014. In the Federal Register of
December 30, 2013 (78 FR 79465), FDA announced the WHO ECDD review and
invited interested persons to submit information for WHO's
consideration.
    The full text of the notification from the Secretary-General is
provided in section II of this document. Section 201(d)(2)(B) of the
CSA requires the Secretary of HHS, after receiving a notification
proposing scheduling, to publish a notice in the Federal Register to
provide the opportunity for interested persons to submit information
and comments on the proposed scheduling action.
    The United States is also a party to the 1961 Single Convention on
Narcotic Drugs (1961 Single Convention). The Secretary of State has
received a notification from the Secretary-General regarding a
substance to be considered for control under this convention. The CSA
does not require HHS to publish a summary of such information in the
Federal Register. Nevertheless, in an effort to provide interested and
affected persons an opportunity to submit comments regarding the WHO
recommendations for narcotic drugs, the notification regarding this
substance is also included in this Federal Register notice. The
comments will be shared with other relevant agencies to assist the
Secretary of State in formulating the position of the United States on
the control of this substance. The HHS recommendations are not binding
on the representative of the United States in discussions and
negotiations relating to the proposal regarding control of substances
under the 1961 Single Convention.

II. United Nations Notification

    The formal notification from the United Nations that identifies the
drug substances and explains the basis for the recommendations is
reproduced as follows:

Reference:
NAR/CL.11/2014
WHO/ECDD36; 1961C-Art.3; 1971C-Art.2
CU 2014/288/DTA/SGB

    The Secretary-General of the United Nations presents his
compliments to the Secretary of State of the United States of
America and has the honour to inform the Government that the
Director-General of the World Health Organization (WHO), pursuant to
article 3, paragraphs 1 and 3 of the Single Convention on Narcotic
Drugs of 1961 as amended by the 1972 Protocol (1961 Convention) and
article 2, paragraphs 1and 4 of the Convention on Psychotropic
Substances of 1971 (1971 Convention) notified the Secretary-General
of the following recommendations:

AH-7921 be placed in Schedule I of the 1961 Convention
and
Gamma-butyrolactone (GBL)
1,4-butanediol
25B-NBOMe (2C-B-NBOMe)
25C-NBOMe (2C-C-NBOMe)
25I-NBOMe (2C-I-NBOMe)
be placed in Schedule I of the 1971 Convention
and
N-benzylpiperazine (BZP)
JWH-018
AM-2201
3,4-methylenedioxypyrovalerone (MDPV)
Methylone (beta-keto-MDMA)
Mephedrone
be placed in Schedule II of the 1971 Convention.

    In accordance with the provisions of article 3, paragraph 2 of
the 1961 Convention and article 2, paragraph 2 of the 1971
Convention, the Secretary-General hereby transmits the notification
as annex I to the present note. Also in accordance with the same
provisions, the notification from WHO will be brought to the
attention of the fifty-eighth session of the Commission on Narcotic
Drugs, 9-17 March 2015.

His Excellency
Mr. John Kerry
Secretary of State of the United States of America

    In connection with the notification, WHO has also submitted the
relevant extract from the report of the thirty-sixth session of the
WHO Expert Committee on Drug Dependence which is hereby transmitted
as annex II.
    Reference is made to the notification concerning the proposed
recommendation for international control of mephedrone (4-
methylmethcathinone) by the Government of the United Kingdom of
Great Britain and Northern Ireland and to the respective note NAR/
CL.2/2014 of 7 February 2014 of the Secretary-General to all Member
States.
    Furthermore reference is made to the notification concerning the
proposed recommendation for international control of ketamine by the
Government of the People's Republic of China and to the respective
note NAR/CL.4/2014 of 14 March 2014 by the Secretary-General to all
Member States, as well as to the recommendation of the Expert
Committee on Drug Dependence related to ketamine (see annex I, page
2).
    In order to assist the Commission in reaching a decision, it
would be appreciated if the Government could communicate any
economic, social, legal, administrative or other factors that it
considers relevant to the possible scheduling of the afore-mentioned
substances under the 1961 Convention and the 1971 Convention, at the
latest by 30 January 2015 to the Executive Director of the United
Nations Office on Drugs and Crime, c/o Secretary, Commission on
Narcotic Drugs, P.O. Box 500, 1400 Vienna, Austria, fax: +43-1-
26060-5885, email<EMAIL_ADDRESS>
17 December 2014
NAR/CL.11/2014
Annex I

Annex I

Letter Addressed to the Secretary-General of the United Nations
From the Director-General of the World Health Organization

    ``With reference to Article 2, paragraphs 1, 4 and 6 of the
Convention on Psychotropic Substances (1971) and Article 3,
paragraphs 1, 3 and 5 of the Single Convention on Narcotic Drugs
(1961), as amended by the 1972 Protocol, and following the 36th
meeting of the Expert Committee on Drug Dependence in June 2014, I
am pleased to submit recommendations of the World Health
Organization.

    The recommendations are that:

--AH-7921, be placed in Schedule I of the Single Convention on
Narcotic Drugs (1961), that:
--Gamma-butyrolactone (GBL); 1,4-butanediol; 25B-NBOMe (2C-B-NBOMe);
25C-NBOMe (2C-C-NBOMe) and 25I-NBOMe (2C-I-NBOMe), be placed in
Schedule I of the Convention on Psychotropic Substances (1971) and
that:
--N-benzylpiperazine (BZP); JWH-018; AM-2201; 3,4-
methylenedioxypyrovalerone (MDPV); Methylone (beta-keto-MDMA);
Mephedrone, be placed in Schedule II of the Convention on
Psychotropic Substances (1971).

    The recommendations and the assessments and findings on which
they are based are set out in detail in the Report of the 36th
Expert Committee on Drug Dependence, which is

the Committee that advises me on these issues. An extract of the
Committee's Report is attached in Annex 1 to this letter.
    A notification has been made by the United Kingdom of Great
Britain and Northern Ireland, pursuant to article 2, paragraphs 1
and 3 of the Convention on Psychotropic Substances, 1971 concerning
a proposed recommendation for international control of mephedrone.
The Expert Committee critically reviewed this substance and
considered that the degree of risk to public health and society
associated with the abuse liability of mephedrone is substantial and
therefore considered that the evidence of its abuse warranted its
placement under international control, in Schedule II of the
Convention on Psychotropic Substances (1971).
    Following a notification under Article 2, paragraph 1 of the
Convention on Psychotropic Substances (1971) by the Government of
the People's Republic of China concerning proposed recommendation
for international control of ketamine, the Expert Committee
critically reviewed this substance, following its previous critical
reviews of ketamine at its 35th and 34th meeting and the pre-review
undertaken at its 33rd meeting. The information provided by China
with its notification to the Secretary-General was brought to the
Expert Committee's attention. The Expert Committee's assessment was
that ketamine ``is widely used as an anaesthetic in human and
veterinary medicine, and is included in the WHO Model List of
Essential Medicines and the WHO Model List of Essential Medicines
for Children as well as in many national lists of essential
medicines''. The Expert Committee found that it was presented with
``compelling evidence [. . .] about the prominent place of ketamine
as an anaesthetic in developing countries and crisis situations''.
While the Expert Committee ``acknowledged the concerns raised by
some countries and UN organizations'', it stated that ``ketamine
abuse currently does not appear to pose a sufficient public-health
risk of global scale to warrant scheduling'' and recommended ``that
ketamine not be placed under international control at this time''.
``Countries with serious abuse problems may decide to introduce or
maintain control measures, but should ensure ready access to
ketamine for surgery and anaesthesia for human and veterinary
care''.
    During its meeting, the Expert Committee also discussed the
importance of having reliable and sufficient data that could inform
the review process in particular for New Psychoactive Substances
(NPS), acknowledging the fact that more and more NPS will likely be
reviewed in the future, for which data will not always be readily
available. UNODC and WHO will hold an international experts
consultation in December 2014 to identify selection criteria for
prioritisation of NPS to be reviewed by the Committee as well as
relevant indicators, methods and tools for data collection on NPS.
    I am very pleased with the ongoing collaboration between WHO,
UNODC and INCB for improving access to controlled medicines while
preventing misuse and trafficking and for preparing the Special
Session of the United Nations General Assembly on the World Drug
Problem in 2016.''

NAR/CL.11/2014
Annex II

Annex II

Extract From the Report of the 36th Expert Committee on Drug Dependence

    Substance recommended to be scheduled in Schedule I of the
Single Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol:

AH-7921

    AH-7921 is an N-substituted cyclohexylmethylbenzamide and is
chemically 3,4-dichloro-N-{[1-
(dimethylamino)cyclohexyl]methyl{time} benzamide.
    AH-7921 had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that AH-7921 is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
Preliminary data collected from literature and different countries
indicated that this substance may cause substantial harm and that it
has no medical use.
    AH-7921 is an opioid with ``morphine-like'' effects. The
Committee considered that the degree of risk to public health and
society associated with the abuse liability and accompanying
evidence warranted its placement under international control. The
Committee recommended that AH-7921 be placed in Schedule I of the
Single Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol.
    Substances recommended to be scheduled in Schedule I of the
Convention on Psychotropic Substances (1971):

Gamma-butyrolactone (GBL)
Gamma-butyrolactone (GBL) is chemically oxolan-2-one. GBL can be
synthesised from gamma-hydroxybutyric acid (GHB) or tetrahydrofuran.

    During the discussion of GHB at the 34th Meeting of the WHO
Expert Committee on Drug Dependence (ECDD), the Committee ``noted
information relating to the abuse of GBL itself (convertible to GHB
in the body) and suggested this substance for pre-review''. Based on
the evidence presented in the pre-review of GBL during its 35th
Meeting, given its close association with GHB, and the
recommendation made by the Committee to reschedule GHB from Schedule
IV to Schedule II of the Convention on Psychotropic Substances
(1971), the Committee recommended that a critical review of GBL be
undertaken.
    The Committee considered that the degree of risk to public
health and society associated with the abuse liability of GBL is
especially serious. Whilst the Committee recognized widespread and
important industrial use, it has no defined therapeutic usefulness.
The Committee considered that the evidence of its abuse warranted
its placement under international control within Schedule I of the
Convention on Psychotropic Substances (1971).

1,4-butanediol
1,4-butanediol (butane-1,4-diol, 1,4-BDO or 1,4-BD) is one of four
stable isomers of butanediol.

    During the discussion of gamma-hydroxybutyric acid (GHB) at its
34th Meeting, the Committee ``noted information relating to the
abuse of 1,4-BD itself (convertible to GHB in the body) and
suggested this substance for pre-review''. Based on the evidence
presented in the pre-review of GBL during its 35th Meeting, given
its close association with GHB, and the recommendation made by the
Committee to reschedule GHB from Schedule IV to Schedule II of the
Convention on Psychotropic Substances (1971), the Committee
recommended that a critical review of 1,4-BD be undertaken.
    1,4-butanediol produces its effects in the body through the in
vivo formation of the scheduled substance GHB. The Committee
considered that the degree of risk to public health and society
associated with the abuse liability of 1,4-butanediol is especially
serious. Whilst the Committee recognized widespread and important
industrial use, it has no defined therapeutic usefulness. The
Committee considered that the evidence of its abuse warranted its
placement under international control within Schedule I of the
Convention on Psychotropic Substances (1971).

25B-NBOMe
25B-NBOMe (2C-B-NBOMe) is chemically 2-(4-bromo-2,5-
dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine.

    25B-NBOMe had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that 25B-NBOMe is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
Preliminary data collected from literature and different countries
indicated that this substance may cause substantial harm and that it
has no medical use.
    The Committee noted the challenges associated with the evidence
base concerning the substance. The Committee considered that the
degree of risk to public health and society associated with the
abuse liability of 25B-NBOMe is especially serious. Whilst the
Committee noted its use in medical research, it has no recorded
therapeutic use.
    The Committee considered that the evidence of its abuse
warranted its placement under international control and recommended
that 25B-NBOMe be placed in Schedule I of the Convention on
Psychotropic Substances (1971).

25C-NBOMe
25C-NBOMe (2C-C-NBOMe) is chemically 2-(4-chloro-2,5-
dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine.

    25C-NBOMe had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that 25C-NBOMe is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use

by any party. Preliminary data collected from literature and
different countries indicated that this substance may cause
substantial harm and that it has no medical use.
    The Committee noted the challenges associated with the evidence
base concerning the substance. The Committee considered that the
degree of risk to public health and society associated with the
abuse liability of 25C-NBOMe is especially serious. Whilst the
Committee noted its use in medical research, it has no recorded
therapeutic use. The Committee considered that the evidence of its
abuse warranted its placement under international control and
recommended that 25C-NBOMe be placed in Schedule I of the Convention
on Psychotropic Substances (1971).

25I-NBOMe
25I-NBOMe (2C-I-NBOMe) is chemically 2-(4-iodo-2,5-dimethoxyphenyl)-
N-[(2-methoxyphenyl)methyl]ethanamine.

    25I-NBOMe had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that 25I-NBOMe is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
Preliminary data collected from literature and different countries
indicated that this substance may cause substantial harm and that it
has no medical use.
    The Committee noted the challenges associated with the evidence
base concerning the substance. The Committee considered that the
degree of risk to public health and society associated with the
abuse liability of 25I-NBOMe is especially serious. Whilst the
Committee noted its use in medical research, it has no recorded
therapeutic use. The Committee considered that the evidence of its
abuse warranted its placement under international control and
recommended that 25I-NBOMe be placed in Schedule I of the Convention
on Psychotropic Substances (1971).
    Substances recommended to be scheduled in Schedule II of the
Convention on Psychotropic Substances (1971):

N-benzylpiperazine (BZP)
N-benzylpiperazine (BZP) is an aryl-substituted piperazine and is
chemically 1-benzyl-1,4-diazacyclohexane.

    BZP was pre-reviewed at the 35th ECDD meeting and based on the
reported psychostimulant effects, evidence of abuse and adverse
effects, the Expert Committee concluded that a critical review was
warranted.
    BZP has been shown to have effects similar to amphetamine. The
Committee considered that the degree of risk to public health and
society associated with the abuse liability of BZP is substantial.
Its therapeutic usefulness has been assessed to be little, as it is
not currently licensed for use. The Committee considered that the
evidence of its abuse warranted its placement under international
control. The Committee recommended that BZP be placed in Schedule II
of the Convention on Psychotropic Substances (1971).

JWH-018
JWH-018 is chemically naphthalen-1-yl(1-pentyl-1H-indol-3-
yl)methanone.

    JWH-018 had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that JWH-018 is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
Preliminary data collected from literature and different countries
indicated that this substance may cause substantial harm and that it
has no medical use.
    The Committee noted the challenges associated with the evidence
base concerning the substance. The Committee noted analytically
confirmed cases of non-fatal and fatal intoxications involving JWH-
018. The Committee therefore considered that the degree of risk to
public health associated with the abuse liability of JWH-018 is
substantial. Its therapeutic usefulness has been assessed to be
none. As per the Guidance on the WHO review of psychoactive
substances for international control, higher regard was made to the
substantial public health risk as opposed to the lack of therapeutic
usefulness [p.18, paragraph 56, penultimate sentence]. The Committee
recommended that JWH-018 be placed under international control in
Schedule II of the Convention on Psychotropic Substances (1971).

AM-2201
AM-2201 is chemically [1-(5-fluoropentyl)-1H-indol-3-yl]-naphthalen-
1-ylmethanone.

    AM-2201 had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that AM-2201 is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
Preliminary data collected from literature and different countries
indicated that this substance may cause substantial harm and that it
has no medical use.
    The Committee noted the challenges associated with the evidence
base concerning the substance. The Committee noted analytically
confirmed cases of non-fatal and fatal intoxications involving AM-
2201. The Committee therefore considered that the degree of risk to
public health associated with the abuse liability of AM-2201 is
substantial. Its therapeutic usefulness has been assessed to be
none. As per the Guidance on the WHO review of psychoactive
substances for international control, higher regard was made to the
substantial public health risk as opposed to the lack of therapeutic
usefulness [p.18, paragraph 56, penultimate sentence]. The Committee
recommended that AM-2201 be placed under international control in
Schedule II of the Convention on Psychotropic Substances (1971).

3,4-methylenedioxypyrovalerone (MDPV)
3,4-methylenedioxypyrovalerone (MDPV) is chemically (R,S)-1-(1,3-
benzodioxol-5-yl)-2-(pyrrolidin-1-yl)pentan-1-one.

    MDPV had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that MDPV is clandestinely manufactured,
of especially serious risk to public health and society, and of no
recognized therapeutic use by any party. Preliminary data collected
from literature and different countries indicated that this
substance may cause substantial harm and that it has no medical use.
    The Committee considered that the degree of risk to public
health and society associated with the abuse liability of MDPV is
substantial. Its therapeutic usefulness has been assessed to be
none. The Committee considered that the evidence of its abuse
warranted its placement under international control. As per the
Guidance on the WHO review of psychoactive substances for
international control, higher regard was made to the substantial
public health risk as opposed to the lack of therapeutic usefulness
[p.18 paragraph 56, penultimate sentence]. The Committee recommended
that MDPV be placed in Schedule II of the Convention on Psychotropic
Substances (1971).

Methylone (bk-MDMA)
Methylone (beta-keto-MDMA) is chemically (R,S)-1-(1,3-benzodioxol-5-
yl)-2-(methylamino)propan-1-one.

    Methylone had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that methylone is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
Preliminary data collected from literature and different countries
indicated that this substance may cause substantial harm and that it
has no medical use.
    The Committee considered that the degree of risk to public
health and society associated with the abuse liability of methylone
is substantial. Its therapeutic usefulness has been assessed to be
none. The Committee considered that the evidence of its abuse
warranted its placement under international control. As per the
Guidance on the WHO review of psychoactive substances for
international control, higher regard was made to the substantial
public health risk as opposed to the lack of therapeutic usefulness
[p.18, paragraph 56, penultimate sentence]. The Committee
recommended that methylone be placed in Schedule II of the
Convention on Psychotropic Substances (1971).

Mephedrone
Mephedrone (4-methylmethcathinone, 4-MMC) is chemically (R,S)-2-
(methylamino)-1-(4-methylphenyl)propan-1-one.

    Mephedrone had not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that mephedrone is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
Preliminary data collected from literature and different countries
indicated that this substance may cause substantial harm. A critical
review was further undertaken by the Committee given that the
Government of the United Kingdom of Great Britain and Northern
Ireland had made a notification concerning a proposed recommendation
for international control of mephedrone (4-methylmethcathinone),
under

article 2, paragraphs 1 and 3 of the Convention on Psychotropic
Substances, 1971.
    The Committee considered that the degree of risk to public
health and society associated with the abuse liability of mephedrone
is substantial. Its therapeutic usefulness has been assessed to be
none. The Committee considered that the evidence of its abuse
warranted its placement under international control. As per the
Guidance on the WHO review of psychoactive substances for
international control, higher regard was made to the substantial
public health risk as opposed to the lack of therapeutic usefulness
[p.18, paragraph 56, penultimate sentence].
    The Committee recommended that mephedrone be placed in Schedule
II of the Convention on Psychotropic Substances (1971).

III. Discussion

    Although WHO has made specific scheduling recommendations for each
of the drug substances, the CND is not obliged to follow the WHO
recommendations. Options available to the CND for substances considered
for control under the Psychotropic Convention include the following:
(1) Accept the WHO recommendations; (2) accept the recommendations to
control, but control the drug substance in a schedule other than that
recommended; or (3) reject the recommendations entirely.
    AH-7921, or 1-(3,4-dichlorobenzamidomethyl)cyclohexyldimethylamine,
is an opioid analgesic drug substance selective for the [micro]-opioid
receptor. The WHO ECDD met in June 2014 and recommended that AH-7921 be
placed in Schedule I of the 1961 Single Convention. AH-7921 is not
controlled under the CSA in the United States. As such, additional
controls will be necessary to fulfill U.S. obligations if AH-7921 is
controlled under Schedule I of the 1961 Single Convention.
    Gamma-butyrolactone (GBL) is used as an industrial solvent. GBL can
be converted in the body to the central nervous system depressant drug
gamma-hydroxybutyric acid (GHB). GBL is controlled as a List I chemical
in the United States under the CSA. The WHO ECDD met in June 2014 and
recommended that GBL be placed in Schedule I of the Psychotropic
Convention. Additional controls will be necessary to fulfill U.S.
obligations if GBL is controlled under Schedule I of the Psychotropic
Convention.
    1,4-Butanediol is used as an industrial solvent for manufacturing
and also used for the synthesis of GBL. 1,4-Butanediol can also be
converted to the central nervous depressant drug GHB. It has no medical
use in the United States. 1,4-Butanediol is not controlled under the
CSA in the United States, but it is subject to controls in several
States under state law. 1,4-Butanediol was reviewed by the WHO ECDD at
its 36th meeting, at which the WHO ECDD recommended that 1,4-butanediol
be placed in Schedule I of the Psychotropic Convention. Additional
controls will be necessary to fulfill U.S. obligations if 1,4-
butanediol is controlled under Schedule I of the Psychotropic
Convention.
    The substances 25B-NBOMe (2C-B-NBOMe), 25C-NBOMe (2C-C-NBOMe), and
25I-NBOMe (2C-I-NBOMe) are synthetic 2C phenethylamine substances and
were developed for use in mapping and investigating the serotonin
receptors in the mammalian brain. The WHO ECDD at its 36th meeting
recommended that 25B-NBOMe, 25C-NBOMe, and 25I-NBOMe be placed in
Schedule I of the Psychotropic Convention. On November 15, 2013, 25B-
NBOMe, 25C-NBOMe, and 25I-NBOMe were temporarily placed in Schedule I
of the CSA under the temporary scheduling provision of section 201(h)
of the CSA. These provisions provide the Attorney General with the
authority to temporarily place a substance into Schedule I of the CSA
for 2 years, without regard to the requirements of 21 U.S.C. 811(b), if
he finds that such action is necessary to avoid an imminent hazard to
the public safety. In addition, if proceedings to control a substance
are initiated under 21 U.S.C. 811(a)(1), the Attorney General may
extend the temporary scheduling for up to 1 year (21 U.S.C. 811(h)(2)).
Therefore, considering the previously mentioned time limitations of
temporary scheduling under section 201(h) of the CSA, additional
controls will be necessary to fulfill U.S. obligations if 25B-NBOMe,
25C-NBOMe, and 25I-NBOMe are controlled under Schedule I of the
Psychotropic Convention.
    N-benzylpiperazine (BZP) is used as an intermediate in chemical
synthesis but has been taken orally as either powder or tablets and by
other routes, including smoking or snorting. It has no medical use in
the United States. The WHO ECDD at its 36th meeting recommended that
BZP be placed in Schedule II of the Psychotropic Convention on
Psychotropic Substances (1971). BZP is controlled in Schedule I under
the CSA in the United States. As such, no additional controls will be
necessary to fulfill U.S. obligations if these substances are
controlled under Schedule II of the Psychotropic Convention.
    The substances 1-pentyl-1H-indol-3-yl)-1-naphthalenyl-methanone
(JWH-018) and [1-(5-fluoropentyl)-1H-indol-3-yl]-1-naphthalenyl-
methanone (AM-2201) are classified as synthetic cannabinoids with
pharmacological properties like tetrahydrocannabinol. The WHO ECDD at
its 36th meeting recommended that JWH-018 and AM-2201 be placed in
Schedule II of the Psychotropic Convention. These two substances are
controlled in Schedule I under the CSA in the United States. As such,
no additional controls will be necessary to fulfill U.S. obligations if
JWH-018 and AM-2201 are controlled under Schedule II of the
Psychotropic Convention.
    The substances 3,4-methylenedioxypyrovalerone (MDPV), 3,4-
methylenedioxy-N-methylcathinone (beta-keto-MDMA; methylone), and 4-
methylmethcathinone (4-MMC; mephedrone) are classified as synthetic
cathinones in the phenethylamine class and are structurally and
pharmacologically similar to amphetamine. The WHO ECDD at its 36th
meeting recommended that MDPV, methylone, and mephedrone be placed in
Schedule II of the Psychotropic Convention. MDPV, methylone, and
mephedrone are controlled in Schedule I under the CSA in the United
States. As such, no additional controls will be necessary to fulfill
U.S. obligations if these three substances are controlled under
Schedule II of the Psychotropic Convention.
    In addition to the above substances recommended for international
control by the WHO Expert Committee at its 36th meeting, the United
Nations Economic and Social Council published recommendations for
action to be taken by the CND at the March 2015 meeting (http://www.un.org/Docs/journal/asp/ws.asp?m=E/CN.7/2015/7). Among these
recommendations is that the CND should decide whether it wishes to
place ketamine in Schedule I of the Psychotropic Convention or, if not,
what other action, if any, might be required. Pursuant to article 2,
paragraph 1, of the Convention on Psychotropic Substances of 1971, the
Government of China, in its correspondence dated 8 March 2014, notified
the Secretary-General of the United Nations that China recommended that
ketamine be placed in Schedule I of the 1971 Convention. In accordance
with article 2 of the Psychotropic Convention, this proposal has been
recommended for consideration by the CND.
    Ketamine is classified as a rapid-acting general anesthetic agent
used for short diagnostic and surgical procedures that do not require
skeletal muscle relaxation. It is marketed in the United States as an
injectable. Ketamine is controlled in Schedule III of the CSA in

the United States. It is not controlled internationally under the
Convention on Psychotropic Substances or the Single Convention on
Narcotic Drugs. The WHO Expert Committee on Drug Dependence reviewed
ketamine at its 34th, 35th, and 36th meetings. Ketamine is controlled
in schedule III of the CSA in the United States, and additional
controls may be necessary to fulfill U.S. obligations if ketamine is
controlled under Schedule I of the Psychotropic Convention. FDA, on
behalf of the Secretary of HHS, invites interested persons to submit
comments on the notifications from the United Nations concerning these
drug substances. FDA, in cooperation with the National Institute on
Drug Abuse, will consider the comments on behalf of HHS in evaluating
the WHO scheduling recommendations. Then, under section 201(d)(2)(B) of
the CSA, HHS will recommend to the Secretary of State what position the
United States should take when voting on the recommendations for
control of substances under the Psychotropic Convention at the CND
meeting in March 2015.
    Comments regarding the WHO recommendations for control of AH-7921
under the 1961 Single Convention will also be forwarded to the relevant
Agencies for consideration in developing the U.S. position regarding
narcotic substances at the CND meeting.

IV. Submission of Comments and Opportunity for Public Meeting

    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.
    FDA does not presently plan to hold a public meeting. If any person
believes that, in addition to written comments, a public meeting would
contribute to the development of the U.S. position on the substances to
be considered for control under the Psychotropic Convention, a request
for a public meeting and the reasons for such a request should be sent
to James R. Hunter (see FOR FURTHER INFORMATION CONTACT) on or before
February 6, 2015.
    The short time period for the submission of comments and requests
for a public meeting is needed to ensure that HHS may, in a timely
fashion, carry out the required action and be responsive to the United
Nations.

    Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01408 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 46 (Thursday, March 8, 2018)]
[Notices]
[Pages 9857-9859]
[FR Doc No: 2018-04629]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0756]

Study Design Considerations for Devices Including Digital Health
Technologies for Sleep Disordered Breathing in Adults; Public Workshop;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Study Design
Considerations for Devices including Digital Health Technologies for
Sleep Disordered Breathing in Adults.'' The topic to be discussed is
the appropriate design of clinical studies to evaluate devices
including digital health technologies intended for the diagnosis,
monitoring, or treatment of sleep disordered breathing (SDB) in adults.
Study design considerations to be discussed include definitions for SDB
conditions, inclusion/exclusion criteria for studies of these
conditions, use of SDB assessment technologies, controls, and study
endpoints.

DATES: The public workshop will be held on April 16, 2018, from 8 a.m.
to 5 p.m. Submit either electronic or written comments on this public
workshop by April 30, 2018. See the SUPPLEMENTARY INFORMATION section
for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before April 30, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end April 30, 2018. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-0756 for ``Study Design Considerations for Devices including
Digital Health Technologies for Sleep Disordered Breathing in Adults;
Public Workshop; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sageev George, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2443, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Over the past several years, FDA has seen a marked increase in
premarket submissions for devices intended for both the diagnosis and
treatment of SDB. These include novel technologies for in-home
assessment, intra-oral appliances, externally worn devices that
generate increased upper airway pressures, passive implants, active
implantable devices that stimulate the upper airway neuromusculature,
and mobile apps for assessing and monitoring sleep. The large variety
of technologies often poses different and challenging questions of
safety and effectiveness and differing benefit-risk profiles for these
devices. We have planned this workshop to bring together device
regulators, clinical experts in sleep medicine, patients, and other
stakeholders to discuss these challenges and potential solutions. The
goal is to expedite innovation in SDB devices including digital health
technologies and make sure that patients have timely access to
reasonably safe and effective devices. To this end, we are actively
seeking input and participation from several professional societies and
patient advocacy groups with interests in the field of SDB.

II. Topics for Discussion at the Public Workshop

    The topics to be discussed are the appropriate design of clinical
studies to evaluate devices and digital health technologies intended
for the diagnosis, monitoring, or treatment of SDB in adults. Study
design considerations to be discussed include definitions for SDB
conditions, inclusion/exclusion criteria for studies of these
conditions, use of SDB assessment technologies (e.g., polysomnography,
home sleep studies), controls, and study endpoints.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit
FDA's Medical Devices News & Events--Workshops & Conferences calendar
at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by April 9, 2018, by 4 p.m. Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive

confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public workshop will be provided
beginning at 7:30 a.m. We will let registrants know if registration
closes before the day of the public workshop.
    If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected], no later than April 9, 2018.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. The webcast link will be available on the registration
web page after April 9, 2018. Organizations are requested to register
all participants, but to view using one connection per location.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available
approximately 45 days after the public workshop on the internet at
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

    Dated: March 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04629 Filed 3-7-18; 8:45 am]
 BILLING CODE 4164-01-P