[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Proposed Rules]
[Pages 23225-23226]
[FR Doc No: 2016-09171]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket No. USCG-2014-0142]
RIN 1625-AA01

Anchorage Regulations; Special Anchorage Areas, Marina del Rey
Harbor, California

AGENCY: Coast Guard, DHS.

ACTION: Notice of public meeting; request for comments and change in
comment period.

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SUMMARY: The Coast Guard announces a public meeting to receive comments
on a supplemental notice of proposed rulemaking (NPRM) to revise the
special anchorage in Marina del Rey Harbor, California. Based on the
comments received in response to the NPRM that was published in the
Federal Register on May 28, 2014, we published a supplemental NPRM
proposing to amend the shape and reduce the size of the special
anchorage in Marina del Rey Harbor, California. Additionally, we

propose to clarify the language in the note section of the existing
regulation.

DATES: A public meeting will be held on Tuesday, April 12, 2016, from 6
to 7:30 p.m. to provide an opportunity for oral comments. Written
comments and related material may also be submitted to Coast Guard
personnel specified at that meeting. The comment period for the
supplemental notice of proposed rulemaking will close April 30, 2016.
All comments and related material must be received by the Coast Guard
on or before April 30, 2016.

ADDRESSES: The public meeting will be held at Burton W. Chace Park
Community Room, 13650 Midanao Way, Marina del Rey, CA 90292, telephone
310-305-9595.
    You may submit written comments identified by docket number USCG-
2014-0142 using the Federal eRulemaking Portal at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning the
meeting or the proposed rule, please call or email Lieutenant Junior
Grade Colleen Patton Waterways Management Branch, Eleventh Coast Guard
District, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background and Purpose

    We published a notice of proposed rulemaking (NPRM) in the Federal
Register on May 28, 2014 (79 FR 30509), entitled ``Anchorage
Regulations: Subpart A--Special Anchorage Areas, Marina del Rey Harbor,
California.'' That NPRM proposed to disestablish the special anchorage
area. In response to comments received, we published a supplemental
NPRM (81 FR 10156, February 29, 2016) to retain the special anchorage,
but amend the shape and reduce the size of the anchorage to remove the
anchorage area from a location where it could endanger vessel traffic.
We have concluded that a public meeting would aid this rulemaking.
Therefore, we are publishing this document announcing a public meeting
and changing the end of the comment period from April 14, 2016, to
April 30, 2016.
    You may view the supplemental NPRM in our online docket, in
addition to supporting documents prepared by the Coast Guard and
comments submitted thus far by going to http://www.regulations.gov.
Once there, insert ``USCG-2014-0142'' in the ``Keyword'' box and click
``Search.''
    We encourage you to participate in this rulemaking by submitting
comments either orally at the meeting or in writing. If you bring
written comments to the meeting, you may submit them to Coast Guard
personnel specified at the meeting to receive written comments. These
comments will be submitted to our online public docket. All comments
received will be posted without change to http://www.regulations.gov
and will include any personal information you have provided.
    Comments submitted after the meeting must reach the Coast Guard on
or before April 30, 2016. We encourage you to submit comments through
the Federal eRulemaking Portal at http://www.regulations.gov. If your
material cannot be submitted using http://www.regulations.gov, contact
the person in the FOR FURTHER INFORMATION CONTACT section of this
document for alternate instructions.
    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the March 24, 2005, issue of the
Federal Register (70 FR 15086).

Information on Service for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact Lieutenant Junior Grade Colleen Patton at the telephone number
or email address indicated under the FOR FURTHER INFORMATION CONTACT
section of this notice.

Public Meeting

    The Coast Guard will hold a public meeting regarding its
``Anchorage Regulations: Subpart A--Special Anchorage Areas, Marina del
Rey Harbor, California'' proposed rule on Tuesday, April 12, 2016 from
6 p.m. to 7:30 p.m., at Burton W. Chace Park Community Room, 13650
Mindanao Way, Marina del Rey, CA 90292, telephone<PHONE_NUMBER>. Public
parking lots are available on a pay basis. For Public transit
information to the Community Room, contact the Los Angeles County
Metropolitan Transportation Authority (Metro) at<PHONE_NUMBER> or search
at http://www.metro.net for additional information. We will provide a
written summary of the meeting and additional comments received at the
meeting in the docket. The meeting may conclude before the allotted
time if all who have come to submit oral comments have done so before
7:30 p.m.

    Dated: March 24, 2016.
J.A. Servidio,
Rear Admiral, U.S. Coast Guard, Commander, Eleventh Coast Guard
District.
[FR Doc. 2016-09171 Filed 4-19-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: January 5, 2006 (Volume 71, Number 3)]
[Notices]
[Page 629]
[DOCID:fr05ja06-56]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Regulation AC; SEC File No. 270-517; OMB Control No. 3235-0575.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collections
of information summarized below. The Commission plans to submit a
request for approval of the previously approved collection of
information discussed below.

Regulation Analyst Certification (Regulation AC)

    Regulation Analyst Certification requires that any research report
disseminated by broker, dealer, or person associated with a broker or
dealer include certifications by the research analyst that the views
expressed in the research report accurately reflect the analyst's
personal views, and whether the analyst received compensation in
connection with his or her specific recommendations or views. A
research analyst would also be required to provide certifications and
disclosures in connection with public appearances. Although research
analysts are often viewed by investors as experts and as important
sources of information about the securities and companies they cover,
many factors can create pressure on their independence and objectivity.
By requiring these certifications and disclosures, Regulation AC should
promote the integrity of research reports and investor confidence in
the recommendations contained in those reports. Commission estimates
that Regulation AC would result in a total annual time burden of
approximately 11,296 hours (10,950 hours to comply with research report
requirements + 346 hours to comply with public appearance
requirements).
    The collections of information under Regulation AC are necessary
for covered persons to obtain certain benefits or to comply with
certain requirements. The collections of information are necessary to
provide investors with information with which to determine the value of
the research available to them. The Commission may review this
information during periodic examinations or with respect to
investigations. Covered persons must also promptly provide copies of
statements that the analyst is unable to provide the certifications in
connection with public appearances to its examining authority,
designated pursuant to Section 17(d) of the Exchange Act and Rule 17d-2
thereunder. Further, broker-dealers must keep and maintain these
records pursuant to Rule 17a-4(b)(4).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless the agency displays a
valid OMB control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Office of Information Technology, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549.

    Dated: December 28, 2005.
Nancy M. Morris,
Secretary.
[FR Doc. E5-8284 Filed 1-4-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 158 (Thursday, August 15, 2013)]
[Notices]
[Pages 49749-49750]
[FR Doc No: 2013-19820]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP13-1031-000]

Trailblazer Pipeline Company LLC; Notice of Technical Conference

    Take notice that a technical conference will be held on Tuesday,
September 10, 2013, at 10:00 a.m., in a room to be designated at the
offices of the Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426.
    The Commission's July 31, 2013 Order in the above-captioned
proceeding \1\ directed that a technical conference be held to address
certain non-rate issues raised by Trailblazer Pipeline Company LLC's
(Trailblazer) July 1, 2013 filing. At the technical conference,
Trailblazer should be prepared to address all the issues set for
technical conference by the July 31, 2013 Order, and to provide support
for its positions, including technical, engineering, and operational
support for its proposed gas quality specifications. Consistent with
the Commission's Policy Statement, Trailblazer should be prepared to
explain how its proposal differs from the Natural Gas Council Plus
Interim Guidelines. See Natural Gas Interchangeability, Policy
Statement on Provisions Governing Natural Gas Quality and
Interchangeability in Interstate Natural Gas Pipeline Company Tariffs,
115 FERC ] 61,325, at P 34, 37 (2006).
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    \1\ Trailblazer Pipeline Company LLC, 144 FERC ] 61,084 (2013)
(July 31, 2013 Order).
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    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an email to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    All interested persons are permitted to attend. For further
information please contact Andrew Knudsen at<PHONE_NUMBER> or email
<EMAIL_ADDRESS>

    Dated: August 8, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-19820 Filed 8-14-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Notices]
[Pages 41131-41133]
[FR Doc No: 2015-17171]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75393; File No. SR-EDGX-2015-29]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use of EDGX Exchange, Inc.

July 8, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 30, 2015, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to EDGX Rules
15.1(a) and (c). Changes to the fee schedule pursuant to this proposal
are effective upon filing.
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    \5\ The term ``Member'' is defined as ``any registered broker or
dealer that has been admitted to membership in the Exchange.'' See
Exchange Rule 1.5(n).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to amend its Fee Schedule to: (i) Modify its
fees for physical connectivity; and (ii) delete the MidPoint Match
Volume Tier under footnote 3.
Physical Connectivity
    A physical port is utilized by a Member or non-Member to connect to
the Exchange at the data centers where the Exchange's servers are
located. The Exchange currently maintains a presence in two third-party
data centers: (i) The primary data center where the Exchange's business
is primarily conducted on a daily basis, and (ii) a secondary data
center, which is predominantly maintained for business continuity
purposes. The Exchange currently assesses the following physical
connectivity fees for Members and non-Members on a monthly basis: $500
per physical port that connects to the System \6\ via 1 gigabyte copper
circuit; $1,000 per physical port that connects to the System via 1
gigabyte fiber circuit; and $2,000 per physical port that connects to
the System via 10 gigabyte fiber circuit.
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    \6\ The term ``System'' is defined as ``the electronic
communications and trading facility designated by the Board through
which securities orders of Users are consolidated for ranking,
execution and, when applicable, routing away.'' See Exchange Rule
1.5(cc).
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    The Exchange now proposes to amend its physical connectivity fees
to align the Exchange's fees with its affiliates.\7\ First, the
Exchange proposes to amend its Fee Schedule to no longer distinguish
between fiber and copper circuits. Therefore, it proposes to delete the
charge of $500 per month per physical port that connects to the System
via 1 gigabyte copper circuit and to assess a monthly fee of $2,000 per
physical port that connects to the System via 1 gigabyte circuit
regardless of the type of connection. Second, the Exchange proposes to
increase the fee per physical port that connects to the System via 10
gigabyte circuit from $2,000 per month to $4,000 per month. The
Exchange also proposes to replace the reference to ``fiber'' with
``physical port'' within the description of the 1 gigabyte and 10
gigabyte physical connectivity fees as it proposes to no longer
distinguish between fiber and copper circuits within its Fee Schedule.
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    \7\ The Exchange's affiliates are EDGA Exchange, Inc.
(``EDGA''), BATS Y-Exchange, Inc. (``BYX'') and BATS Exchange, Inc.
(``BZX'', together with the Exchange, EDGA and BYX, the ``BATS
Exchanges''). The Exchange notes that each of its affiliates will
also file proposed rule changes with Commission to adopt similar
physical connectivity fees to be effective July 1, 2015.
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    Lastly, to further align its physical connectivity fees with its
affiliates, the Exchange proposes to pass through in full any hardware
costs or connectivity fees incurred that are directly related to
completing a cross-connect where the expense to the Exchange billed by
a third party exceeds $1,000.\8\ The Exchange proposes to pass through
the expense as an alternative to the flat installation fees charged by
the Exchange's primary competitors. The Exchange does not anticipate
that passing through these expenses will affect many of the Exchange's
constituents, because the majority of cross-connect completions cost
less than $1,000. For this reason, the Exchange proposes to pass-
through the charges associated with cross-connect completions that cost
more than $1,000 rather than to charge an installation fee for all
completions regardless of their cost.
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    \8\ See BZX fee schedule available at http://batstrading.com/support/fee_schedule/bzx/ and the BYX fee schedule available at
http://batstrading.com/support/fee_schedule/byx/.
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MidPoint Match Volume Tier
    The Exchange proposes to delete the MidPoint Match Volume Tier
under footnote 3 of its Fee Schedule. Under fee code MM, a Member is
currently charged a fee of $0.00120 per share for orders that add
liquidity at midpoint of NBBO using: (1) A MidPoint Match \9\ order;
(2) an order with a Hide Not Slide \10\ instruction; or (3) an order
with a Non-Displayed \11\ instruction. However, under the MidPoint
Match Volume Tier, a Member would pay no

fee for its orders that yielded fee code MM where that Member added or
removed a combined ADV \12\ of at least 2,500,000 shares yielding fee
codes AA, AM, MM, or MT. Currently, no Member satisfies the tier's
criteria. Therefore, the Exchange proposes to delete the MidPoint Match
Volume Tier.
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    \9\ See Exchange Rule 11.8(d).
    \10\ See Exchange Rule 11.6(l)(1)(B).
    \11\ See Exchange Rule 11.6(e)(2).
    \12\ ``ADV'' is defined in the Exchange Fee Schedule available
at http://batstrading.com/support/fee_schedule/edgx/.
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    The Exchange also notes that the MidPoint Match Volume Tier would
no longer be necessary as of July 6, 2015. The Exchange intends to file
with the Commission a separate proposal to amend it Fee Schedule for
July 6, 2015 effectiveness to, among other things: (i) Delete fee codes
AA, AM, and MT; and (ii) amend fee code MM to (a) only apply to orders
that add liquidity at the midpoint of the NBBO using MidPoint Peg
orders; (b) delete references to MidPoint Match orders, orders
utilizing the Hide Not Slide instruction, and orders with a Non-
Displayed instruction. These changes are a result of proposed rule
change to be filed with the Commission to align certain Exchange
functionality with BZX.\13\ Therefore, removing the MidPoint Match
Volume Tier as of July 1, 2015 would avoid Members confusion and
prevent them from attempting to achieve the tier's criteria as the
functionality necessary to achieve the tier may be discontinued before
the end of July 2015.
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    \13\ A description of the changes proposed in this filing may be
found in BATS EDGX Exchange Modifications, Effective July 6, 2015,
available at http://cdn.batstrading.com/resources/release_notes/2015/BATS-EDGX-Exchange-Modifications-Effective-July-6-2015.pdf.
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    Lastly, as a result of the above, the Exchange also proposes to
remove a reference to footnote 3 from fee code MM under the Fee Codes
and Associated Fee table within its Fee Schedule.
Implementation Date
    The Exchange proposes to implement these amendments to its Fee
Schedule on July 1, 2015.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\14\ in general, and
furthers the objectives of Section 6(b)(4),\15\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities. The Exchange also notes that it operates in a highly-
competitive market in which market participants can readily direct
order flow to competing venues if they deem fee levels at a particular
venue to be excessive. The proposed rule change reflects a competitive
pricing structure designed to incent market participants to direct
their order flow to the Exchange. The Exchange believes that the
proposed rates are equitable and non-discriminatory in that they apply
uniformly to all Members. The Exchange believes the fees and credits
remain competitive with those charged by other venues and therefore
continue to be reasonable and equitably allocated to Members.
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    \14\ 15 U.S.C. 78f.
    \15\ 15 U.S.C. 78f(b)(4).
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Physical Connectivity
    The Exchange believes that the proposed physical connectivity fees
represent an equitable allocation of reasonable dues, fees, and other
charges as its fees for physical connectivity are reasonably
constrained by competitive alternatives. If a particular exchange
charges excessive fees for connectivity, affected Members and non-
Members may opt to terminate their connectivity arrangements with that
exchange, and adopt a possible range of alternative strategies,
including routing to the applicable exchange through another
participant or market center or taking that exchange's data indirectly.
Accordingly, if the Exchange charges excessive fees, it would stand to
lose not only connectivity revenues but also revenues associated with
the execution of orders routed to it, and, to the extent applicable,
market data revenues. The Exchange believes that this competitive
dynamic imposes powerful restraints on the ability of any exchange to
charge unreasonable fees for connectivity.
    Furthermore, the proposed rule change is also an equitable
allocation of reasonable dues, fees, and other charges as the Exchange
believes that the increased fees obtained will enable it to cover its
increased infrastructure costs associated with establishing physical
ports to connect to the Exchange's Systems. The additional revenue from
the increased fees will also enable the Exchange to continue to
maintain and improve its market technology and services. The Exchange
believes that the proposed fees for 1 gigabyte circuit of $2,000 per
month and for 10 gigabyte circuit of $4,000 per month are reasonable in
that they are less than analogous fees charged by the Nasdaq Stock
Market LLC (``Nasdaq''), which are $2,500 per month for 1 gigabyte
connectivity and range from $10,000-$15,000 per month for 10 gigabyte
circuits.\16\ In addition, the Exchange proposed physical connectivity
fees are designed to align the Exchange's fees with its affiliates.\17\
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    \16\ See Nasdaq Rule 7034(b).
    \17\ See supra notes 7 and 8.
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    The Exchange also believes that passing through the cross-connect
related expenses in excess of $1,000 as an alternative to the flat
installation fees is equitable and reasonable. The proposed pass
through would be in lieu of the flat installation fees charged by the
Exchange's primary competitors. The Exchange does not anticipate that
passing through these expenses will affect many of the Exchange's
constituents, because the majority of cross-connect completions cost
less than $1,000.
    Finally, the Exchange believes that the proposed rates are
equitable and non-discriminatory in that they apply uniformly to all
Members and non-Members. Members and non-Members will continue to
choose whether they want more than one physical port and choose the
method of connectivity based on their specific needs. All Exchange
Members that voluntarily select various service options will be charged
the same amount for the same services. As is true of all physical
connectivity, all Members and non-Members have the option to select any
connectivity option, and there is no differentiation with regard to the
fees charged for the service.
MidPoint Match Volume Tier
    The Exchange believes that the proposal to delete the MidPoint
Match Volume Tier represents an equitable allocation of reasonable
dues, fees, and other charges as it would avoid confusion by removing a
tier from its Fee Schedule for which no Member currently qualifies. It
is also reasonable as it would prevent a Member from attempting to
achieve the tier's criteria as the functionality necessary to achieve
the tier is to be discontinued in the near future. Furthermore,
removing the MidPoint Match Volume Tier as of July 1, 2015 would
prevent Members attempting to achieve the tier's criteria when they
will be unable to do so because the functionality necessary to achieve
the tier will be discontinued before the end of July 2015, thereby
avoiding Member or investor confusion. Lastly, the Exchange believes
that removal of the MidPoint Match Volume Tier is equitable and non-
discriminatory in that they apply uniformly to all Members.

(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.
Physical Connectivity
    As discussed above, the Exchange believes that fees for
connectivity are constrained by the robust competition for order flow
among exchanges and non-exchange markets. Further, excessive fees for
connectivity, including port fee access, would serve to impair an
exchange's ability to compete for order flow rather than burdening
competition. The proposal to increase the fees for physical
connectivity would bring the fees charged by the Exchange closer to
similar fees charged for physical connectivity by other exchanges.\18\
In addition, the proposal to pass through cross-connect installation
related expenses serves as an alternative to the flat installation fees
charged by the Exchange's primary competitors.
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    \18\ See supra note 16.
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    Lastly, the proposed rule change does not impose any burden on
intramarket competition as the fees are uniform for all Members and
non-Members. The Exchange notes that Members and non-Members also have
the ability to obtain access to these services without the need for an
independent physical port connection, such as through alternative means
of financial extranets and service bureaus that act as a conduit for
orders entered by Members and non-Members.
MidPoint Match Volume Tier
    The Exchange does not believe that its proposal to delete the
MidPoint Match Tier will impose any burden on competition. As stated
above, no Member currently satisfies the tier's criteria and the
Exchange is proposing to remove it to avoid investor confusion as the
functionality necessary to achieve the tier is to be discontinued
before the end of July 2015. Therefore, the Exchange believes deleting
the MidPoint Match Tier will have no impact on competition.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from Members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \19\ and paragraph (f) of Rule 19b-4
thereunder.\20\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f).
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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_ADDRESS>Please include
File Number SR-EDGX-2015-29 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-EDGX-2015-29. 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 will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-2015-29 and should be
submitted on or before August 4, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-17171 Filed 7-13-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80934-80935]
[FR Doc No: 2011-33128]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2011-0228; FRL-9509-8]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NSPS for Petroleum Refineries
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before January 26,
2012.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2011-0228, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, Mail Code
2822IT, 1200 Pennsylvania Avenue NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 9, 2011 (76 FR 26900), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to both EPA and OMB within 30
days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2011-0228, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov.
    Title: NSPS for Petroleum Refineries (Renewal).
    ICR Numbers: EPA ICR Number 2263.03, OMB Control Number 2060-0602.
    ICR Status: This ICR is scheduled to expire on December 31, 2011.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB Control Number. The OMB Control Numbers for EPA regulations
are listed in 40 CFR part 9 and 48 CFR Chapter 15, and are identified
on the form and/or instrument, if applicable.
    Abstract: For the New Source Performance Standards (NSPS) for
Petroleum Refineries, the affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A, and any changes or
additions to the General Provisions specified at 40 CFR part 60,
subpart Ja. The affected facilities include: fluid catalytic cracking
units, fluid coking units, delayed coking units, process heaters and
other fuel gas combustion devices, and sulfur recovery plants.
Emissions limitations would be used to control emissions of particulate
matter (PM), nitrogen oxides (NOX), carbon monoxide (CO),
sulfur dioxide (SO2), hydrogen sulfide (H2S) and/
or reduced sulfur compounds (RSC). Work practice standards would apply
to depressuring operations and flaring of fuel gases.
    All reports are sent to the delegated state or local authority. In
the event that there is no such delegated authority, the reports are
sent directly to the EPA regional office. This information is being
collected to assure compliance with 40 CFR part 60, subpart Ja, as
authorized in sections 112 and 114(a) of the Clean Air Act. The
required information consists of emissions data and other information
that have been determined to be private.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 59
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.

    Respondents/Affected Entities: Petroleum Refineries.
    Number of Respondents: 18.
    Frequency of Response: Semiannually.
    Estimated Total Annual Hour Burden: 2,142.
    Estimated Total Annual Cost: $1,873,880, which includes $197,720 in
labor costs, no capital/startup costs, and $1,676,160 in operating and
maintenance (O&M) costs.
    Changes in the Estimates: There is a decrease in the labor hours
and cost in this ICR compared to the previous ICR. Consultations with
the Office of Air Quality Planning and Standards (OAQPS) and trade
associations revealed that there are approximately eighteen sources
subject to the rule, with no new facilities expected to be constructed
over the next three years of this ICR. Because there are no new sources
with reporting requirements, no capital/startup costs are incurred. The
only cost that is incurred is for the O&M of the monitoring equipment.

    Dated: December 20, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-33128 Filed 12-23-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 31 (Tuesday, February 15, 2022)]
[Notices]
[Pages 8586-8592]
[FR Doc No: 2022-03229]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0105]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; Brorphine; Metonitazene;
Eutylone; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing interested
persons with the opportunity to submit written comments 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 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
2022. This notice is issued under the Controlled Substances Act (CSA).

DATES: Submit either electronic or written comments by February 28,
2022.

ADDRESSES: 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 February 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 28, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2022-N-0105 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; World
Health Organization; Scheduling Recommendations; Brorphine;
Metonitazene; Eutylone; 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, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.

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 protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (1971 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 1971 Convention that the CND proposes to decide
whether to add a drug or other substance to one of the schedules of the
1971 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 one substance to be considered for
control under the 1971 Convention. This notification reflects the
recommendation from the 44th WHO Expert Committee for Drug Dependence
(ECDD), which met in October 2021. In the Federal Register of July 23,
2021 (86 FR 39038), 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 Convention). The Secretary of State has received a
notification from the Secretary-General regarding two substances 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, to provide interested and affected persons an opportunity
to submit comments regarding the WHO recommendations for drugs under
the 1961 Convention, the notification regarding these substances 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 these
substances. 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
Convention.

II. United Nations Notification

    The formal notification from the United Nations that identifies the
drug substances and explains the basis for the scheduling
recommendations is reproduced as follows (non-relevant text removed):

Reference:
NAR/CL.13/2021
WHO/ECDD44; 1961C-Art.3, 1971C-Art.2
CU 2021/453/DTA/SGB

    The Secretariat of the United Nations presents its compliments
to the Permanent Mission of the United States of America and has the
honour to inform the Government that in a letter dated 18 November
2021, 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 1 and 4 of the Convention on
Psychotropic Substances of 1971 (1971 Convention), notified the
Secretary-General of the following recommendations of the forty-
third Meeting of the WHO's Expert Committee on Drug Dependence
(ECDD):
    Substance recommended to be added to Schedule I of the 1961
Convention:
--Brorphine
IUPAC (International Union of Pure and Applied Chemistry) name: 1-
[1-[1-(4-Bromophenyl)ethyl]-piperidin-4-yl]-1,3-dihydro-2H-imidazol-
2-one
--Metonitazene
IUPAC name: N,N-Diethyl-2-(2-(4-methoxybenzyl)-5-nitro-1H-
benzo[d]imidazol-1-yl)ethan-1-amine
    Substances recommended to be added to Schedule II of the 1971
Convention:
--Eutylone (alternate name: 3,4-methylenedioxy-alpha-ethylamino
butiophenone)
IUPAC names: 1-(Benzo[d][1,3]dioxol-5-yl)-2-(ethylamino)butan-1-one
1-(1,3-Benzodioxol-5-yl)-2-(ethylamino)butan-1-one

    Substances to be kept under surveillance:
    In the letter from the Director-General of WHO to the Secretary-
General, reference is also made to the recommendation made by the
WHO Expert Committee on Drug Dependence (ECDD), at its forty-fourth
meeting, to keep the following substances under surveillance:

--4F-MDMB-BICA (alternate name: 4F-MDMB-BUTICA)
IUPAC names: Methyl 2-({[1-(4-fluorobutyl)-1H-indol-3-
yl]carbonyl{time} amino)-3,3-dimethylbutanoate; Methyl 2-(1-(4-
fluorobutyl)-1H-indole-3-carbaxamido)-3,3-dimethylbutanoate
--Benzylone (alternate name: 3,4-Methylenedioxy-N-benzylcathinone)
IUPAC name: 1-(Benzo[d][1,3]dioxol-5-yl)-2-(benzylamino)propan-1-one
--Kratom, mitragynine, and 7-hydroxymitragynine
--Phenibut (alternate name: 4-amino-3-phenyl-butyric acid)
IUPAC name: 4-Amino-3-phenylbutanoic acid

    In accordance with the provisions of article 3, paragraph 2, of
the 1961 Convention and article 2, paragraph 2, of the 1971
Convention, the notification is hereby transmitted as annex I to the
present note. In connection with the notification, WHO also
submitted a summary of the assessments and

findings for these recommendations made by ECDD, which is
transmitted as annex II.
    Also, in accordance with the same provisions, the notification
from WHO will be brought to the attention of the sixty-fifth session
of the Commission on Narcotic Drugs (14-18 March 2022, tent.) in a
pre-session document that will be made available in the six official
languages of the United Nations on the website of the 65th session
of the Commission on Narcotic Drugs: https://www.unodc.org/unodc/en/commissions/CND/session/65_Session_2022/65CND_Main.html.
    In order to assist the Commission in reaching a decision, it
would be appreciated if the Permanent Mission could communicate any
comments it considers relevant to the possible scheduling of
substances recommended by WHO to be placed under international
control under the 1961 Convention, namely:

--Brorphine
--Metonitazene; as well as any economic, social, legal,
administrative or other factors that it considers relevant to the
possible scheduling of substances recommended by WHO to be placed
under international control under the 1971 Convention, namely:
--Eutylone (alternate name: 3,4-methylenedioxy-alpha-ethylamino
butiophenone).
    The Secretariat of the United Nations avails itself of this
opportunity to renew to the Permanent Mission of the United States
of America to the United Nations (Vienna) the assurances of its
highest consideration.

8 December 2021

Annex I

    Letter addressed to the Secretary-General of the United Nations
from the Director-General of the World Health Organization, dated 18
November 2021
    ``The Forty-fourth Meeting of the World Health Organization
(WHO)'s Expert Committee on Drug Dependence (ECDD) was convened in a
virtual format from 11 to 15 October 2021 and was coordinated from
the WHO headquarters in Geneva.
    WHO is mandated by the 1961 and 1971 International Drug Control
Conventions to make recommendations to the United Nations Secretary-
General on the need for, and level of, international control of
psychoactive substances based on the advice of its independent
scientific advisory body, the ECDD. In order to recommend if a
psychoactive substance should be placed under international control
or if its level of control should be changed, the WHO convenes the
ECDD annually to thoroughly review the potential for abuse,
dependence, and harm to health of a psychoactive substance, as well
as any therapeutic applications.
    The Forty-fourth WHO ECDD Meeting critically reviewed five new
psychoactive substances, including one synthetic cannabinoid
receptor agonist (4F-MDMB-BICA), two novel synthetic opioids
(brorphine; metonitazene), and two cathinones/stimulants (eutylone;
benzylone). These substances had not previously been formally
reviewed by WHO and are currently not under international control.
Information was brought to WHO's attention that these substances are
clandestinely manufactured, of especially serious risk to public
health and society, and of no recognised therapeutic use by any
Party. Therefore, a critical review to consider international
scheduling measures was undertaken for each substance so that the
Expert Committee could consider whether information available about
these substances may justify the scheduling or a change in
scheduling of a substance in the 1961 or 1971 Conventions.
    In addition, the Forty-fourth ECDD Meeting carried out pre-
reviews of kratom, mitragynine, and 7-hydroxymitragynine; and
phenibut to consider whether current information justified a
critical review.
    With reference to Article 3, paragraphs 1 and 3 of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol, and Article 2, paragraphs 1 and 4 of the Convention on
Psychotropic Substances (1971), WHO is pleased to endorse and submit
the following recommendations of the Forty-fourth Meeting of the
ECDD:
    To be added to Schedule I of the Single Convention on Narcotic
Drugs (1961):

--Brorphine
IUPAC (International Union of Pure and Applied Chemistry) name: 1-
[1-[1-(4-Bromophenyl)ethyl]- piperidin-4-yl]-1,3-dihydro-2H-
imidazol-2- one
--Metonitazene
IUPAC name: N,N-Diethyl-2-(2-(4- methoxybenzyl)-5-nitro-1H-
benzo[d]imidazol-1-yl)ethan-1-amine

    To be added to Schedule II of the Convention on Psychotropic
Substances (1971):

--Eutylone (alternate name: 3,4-methylenedioxy-alpha-ethylamino
butiophenone)
IUPAC names: 1-(Benzo[d][1,3]dioxol-5-yl)-2-(ethylamino)butan-1-one;
1-(1,3-Benzodioxol-5-yl)-2-(ethylamino)butan-1-one

    To be kept under surveillance:

--4F-MDMB-BICA (alternate name: 4F-MDMB-BUTICA)
IUPAC names: Methyl 2-({[1-(4-fluorobutyl)-1H-indol-3-
yl]carbonyl{time} amino)-3,3- dimethylbutanoate; Methyl 2-(1-(4-
fluorobutyl)-1H-indole-3- carbaxamido)-3,3- dimethylbutanoate
--Benzylone (alternate name: 3,4-Methylenedioxy-N-benzylcathinone)
IUPAC name: 1-(Benzo[d][1,3]dioxol-5-yl)-2- (benzylamino)propan-1-
one
--Kratom, mitragynine, 7-hydroxymitragynine
--Phenibut (alternate name: 4-amino-3-phenyl-butyric acid)
IUPAC name: 4-Amino-3-phenylbutanoic acid

    The assessments and findings on which these recommendations are
based are set out in detail in the Forty-fourth ECDD Meeting Report
of the WHO Expert Committee on Drug Dependence. A summary of the
assessments and findings for these recommendations made by the ECDD
is contained in Annex 1 to this letter.
    I am very pleased with the ongoing collaboration between WHO,
the United Nations Office on Drugs and Crime and the International
Narcotics Control Board, and in particular, how this collaboration
has benefited the work of the WHO Expert Committee on Drug
Dependence and more generally, the implementation of the operational
recommendations of the United Nations General Assembly Special
Session 2016.''

Annex II

    Summary assessment and recommendations of the 44th Expert
Committee on Drug Dependence, 11-15 October 2021
    Substances to be added to Schedule I of the Single Convention on
Narcotic Drugs (1961):

Brorphine

Substance Identification

    Brorphine (IUPAC chemical name: 1-[1-[1-(4-bromophenyl)ethyl]-
piperidin-4-yl]-1,3-dihydro-2H-imidazol-2-one) has a chemical
structure similar to bezitramide, an opioid listed in Schedule I of
the 1961 Convention. Brorphine freebase has been described as a
white or off-white solid, and the hydrochloride salt as a neat
solid, with seized samples described as white, yellowish, gray,
purple, or white powder, or in crystal form. It is also found in
tablets and capsules as falsified opioid medicines. It is reported
to be used by the oral, inhalation, and intravenous routes of
administration.

WHO Review History

    Brorphine has not been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is manufactured clandestinely,
poses a risk to public health, and is of no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    Brorphine is a full agonist at the [mu]-opioid receptor, with
greater potency than morphine, and less potency than fentanyl. It
has analgesic effects that are reversed by an opioid antagonist and,
based on its mechanism of action, it would be expected to produce
other typical opioid effects such as respiratory depression and
sedation. Brorphine may be convertible to bezitramide, which is an
opioid listed in Schedule I of the 1961 Single Convention on
Narcotic Drugs.

Dependence Potential

    No controlled animal or human studies have examined the
dependence potential of brorphine. As a potent [micro]-opioid
agonist, it would be expected to produce dependence similar to other
opioid substances. Unverified online reports describe tolerance and
withdrawal following repeated brorphine use.

Actual Abuse and/or Evidence of Likelihood of Abuse

    In an animal model predictive of abuse potential, brorphine was
shown to produce effects similar to morphine and fentanyl.
    Deaths involving brorphine have been reported in several
countries. Deaths commonly occur after use of brorphine in

combination with other opioids or with benzodiazepines such as
flualprazolam. Brorphine has been identified in falsified opioid
medicines, suggesting that sometimes its use may be unintentional.
Fatal and non-fatal intoxications due to brorphine share features
with intoxications due to other opioids, such as pulmonary oedema.
Brorphine has been detected with other substances in biological
fluids in cases of driving under the influence.
    Seizures have been reported in multiple countries and regions.

Therapeutic Usefulness

    Brorphine is not known to have any therapeutic use.

Recommendation

    The mechanism of action of brorphine indicates that it is liable
to have similar abuse potential and ill effects as opioids that are
controlled under Schedule I of the 1961 Single Convention on
Narcotic Drugs.
    Its use has been reported in a number of countries and has been
associated with adverse effects, including death. It has no known
therapeutic use and is likely to cause substantial harm.
    Recommendation: The Committee recommended that brorphine (IUPAC
chemical name: 1-[1-[1-(4-bromophenyl)ethyl]-piperidin-4-yl]-1,3-
dihydro-2H-imidazol-2-one) be added to Schedule I of the 1961 Single
Convention on Narcotic Drugs.

Metonitazene

Substance Identification

    Metonitazene (IUPAC chemical name: N,N-Diethyl-2-(2-(4-
methoxybenzyl)-5-nitro-1H-benzo[d]imidazol-1-yl)ethan-1-amine)
belongs to the series of 2-benzylbenzimidazole opioid compounds. It
is a white or off-white/beige or coloured powder, and is sometimes
crystalline in consistency. Reports suggest that it is used
intranasally and by intravenous injection.

WHO Review History

    Metonitazene has not been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is manufactured clandestinely,
poses a risk to public health, and has no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    Metonitazene is a chemical analogue of etonitazene and
isotonitazene, both of which are Schedule I compounds under the
Single Convention on Narcotic Drugs, 1961. Metonitazene is a potent
opioid analgesic with a rapid onset of action and greater potency
than fentanyl and hydromorphone. Limited early clinical research
demonstrated that metonitazene produces analgesia and typical opioid
adverse effects including sedation, respiratory depression, nausea,
and vomiting. The effects of metonitazene have been shown to be
reversed by an opioid antagonist.

Dependence Potential

    Animal studies have demonstrated that metonitazene suppresses
opioid withdrawal and has potent [mu]-opioid agonist effects. No
controlled human studies have reported on the dependence potential
of metonitazene, but as a potent [mu]-opioid agonist, it would be
expected to produce dependence similar to other opioids.

Actual Abuse and/or Evidence of Likelihood of Abuse

    No controlled studies have been reported on the abuse potential
of metonitazene, but as it is a potent [mu]-opioid receptor agonist,
it would be expected to have high abuse liability. Online reports
from people who report use of metonitazene describe its euphoric and
opioid-like effects.
    A number of deaths have been reported in association with use of
metonitazene. In many of these cases metonitazene has been used in
combination with other opioids or benzodiazepines. However, in some
fatalities, metonitazene was the sole substance identified in the
analyzed biological samples.
    Trafficking and use of metonitazene have been reported from a
number of countries across several regions.

Therapeutic Usefulness

    Metonitazene is not known to have any therapeutic use.

Recommendation

    The mechanism of action and effects of metonitazene indicate
that it is liable to have similar abuse potential and ill effects as
opioids that are controlled under Schedule I of the 1961 Single
Convention on Narcotic Drugs. Its use has been reported in a number
of countries and been associated with adverse effects, including
death. Metonitazene has no known therapeutic use and is likely to
cause substantial harm.
    Recommendation: The Committee recommended that metonitazene
(IUPAC chemical name: N,N-Diethyl-2-(2-(4-methoxybenzyl)-5-nitro-1H-
benzo[d]imidazol-1-yl)ethan-1-amine) be added to Schedule I of the
1961 Single Convention on Narcotic Drugs.
    Substances to be added to Schedule II of the Convention on
Psychotropic Substances (1971):

Eutylone (3,4-methylenedioxy-alpha-ethylamino butiophenone)

Substance Identification

    Eutylone (IUPAC chemical name: 1-(Benzo[d][1,3]dioxol-5-yl)-2-
(ethylamino)butan-1-one) is a synthetic cathinone of the
phenethylamine class. The hydrochloride salt of eutylone has been
described as a crystalline solid. Eutylone is mostly found as
tablets, capsules, and crystals. It is used orally and intranasally.

WHO Review History

    Eutylone has not been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is manufactured clandestinely,
poses a risk to public health, and has no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    Eutylone is a synthetic cathinone with a mechanism of action and
effects similar to other cathinones and to stimulants such as
methamphetamine. Related cathinones, such as methylone and N-
ethylnorpentylone, are listed under Schedule II of the Convention on
Psychotropic Substances of 1971. The clinical features described are
similar to other cathinones, including sympathomimetic effects and
psychostimulant effects such as euphoria, insomnia, tachycardia,
agitation, anxiety, delirium and psychosis.

Dependence Potential

    No animal or human studies have been conducted on the dependence
potential of eutylone. Based on its overall profile of effects,
eutylone would be expected to produce dependence similar to other
psychostimulants.

Actual Abuse and/or Evidence of Likelihood of Abuse

    In an animal model predictive of abuse potential, eutylone has
been shown to produce effects similar to those of methamphetamine.
Online reports from people reporting use of eutylone suggest that it
has high abuse potential.
    Eutylone has been detected in biological samples from forensic,
post-mortem, and driving under the influence cases. Published case
reports describe fatalities as a result of eutylone use. In addition
to the effects described above, reported adverse events in these
cases have included rhabdomyolysis, hyperthermia, hypertension, and
seizures.
    Eutylone has been detected in seized materials in multiple
countries across several regions.

Therapeutic Usefulness

    Eutylone is not known to have any therapeutic use.

Recommendation

    Eutylone has effects similar to those of related cathinones
listed under Schedule II of the Convention on Psychotropic
Substances of 1971.
    There is evidence that this substance is used in multiple
countries in various regions. Eutylone causes substantial harm,
including severe adverse events and fatal intoxications. Its mode of
action suggests a likelihood of abuse and it poses a substantial
risk to public health. It has no known therapeutic usefulness.
    Recommendation: The Committee recommended that eutylone (IUPAC
chemical name: 1-(Benzo[d][1,3]dioxol-5-yl)-2-(ethylamino)butan-1-
one) be added to Schedule II of the Convention on Psychotropic
Substances of 1971.
    Substances to be kept under surveillance:

4F-MDMB-BICA (4F-MDMB-BUTICA)

Substance Identification

    4F-MDMB-BICA (IUPAC chemical name: Methyl 2-({[1-(4-
fluorobutyl)-1H-indol-3-yl]carbonyl{time} amino)-3,3-
dimethylbutanoate) has a chemical structure similar to a number of
synthetic cannabinoids. It has been identified in seized materials
as a white, off-white, brown or orange powder, and has been
identified in herbal blends, vaping solutions, and infused onto
paper. It is also available as a reference material as crystalline
solid.

WHO Review History

    4F-MDMB-BICA has not been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is manufactured clandestinely,
poses a risk to public health, and has no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    4F-MDMB-BICA is a synthetic cannabinoid, structurally related to
5F-MDMB-PICA, a synthetic cannabinoid, which is included in Schedule
II of the United Nations Single Convention on Psychotropic
Substances of 1971. Some data suggest that 4F-MDMB-BICA has activity
at the cannabinoid CB1 receptor, but this action may not be
identical to that exerted by other CB1 agonists. No animal or human
studies have evaluated the effects of 4F-MDMB-BICA, and there is
insufficient data on 4F-MDMB-BICA overdose cases to confirm that it
has typical cannabinoid effects.

Dependence Potential

    No studies have been reported in animals or humans on the
dependence potential of 4F-MDMB-BICA.

Actual Abuse and/or Evidence of Likelihood of Abuse

    No studies have been reported in animals or humans to indicate
the likelihood of abuse of 4F-MDMB-BICA. A number of countries in
various regions have reported use of 4F-MDMB-BICA. Its use has been
associated with multiple deaths and Emergency Department visits,
although multiple substances have been present in analysed
biological samples, and the relationship between 4F-MDMB-BICA
exposure and cause of death is not established.

Theraputic Usefulness

    4F-MDMB-BICA is not known to have any therapeutic use.

Recommendation

    4F-MDMB-BICA has a structure similar to other synthetic
cannabinoids, but its mechanism of action has yet to be confirmed.
The magnitude of harm due to 4F-MDMB-BICA alone is unclear, and no
animal or human studies have examined the effects or abuse potential
of 4F-MDMB-BICA. Based on the limited information available
concerning abuse, dependence and risks to public health, there is
insufficient evidence to justify placing 4F-MDMB-BICA under
international control.
    Recommendation: The Committee recommended that 4F-MDMB-BICA
(IUPAC chemical name: Methyl 2-({[1-(4-fluorobutyl)-1H-indol-3-
yl]carbonyl{time} amino)-3,3-dimethylbutanoate) be kept under
surveillance by the WHO Secretariat.

Benzylone (3,4-Methylenedioxy-N-benzylcathinone)

Substance Identification

    Benzylone (IUPAC chemical name: 1-(Benzo[d][1,3]dioxol-5-yl)-2-
(benzylamino)propan-1-one) is a ring-substituted synthetic
cathinone. Benzylone is a white powder. The hydrochloride salt of
benzylone is a crystalline solid.

WHO Review History

    Benzylone has not been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is manufactured clandestinely,
poses a risk to public health, and has no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    Benzylone has a mode of action suggestive of stimulant effects
similar to other cathinones. However, these effects are relatively
weak and it fails to produce stimulant effects in animal models.
    Limited information is available on its effects in humans.

Dependence Potential

    There is no information available on the dependence potential of
benzylone in animals or humans

Actual Abuse and/or Evidence of Likelihood of Abuse

    In an animal model predictive of abuse potential, benzylone did
not produce effects similar to MDMA, and its similarity to
methamphetamine is unclear. No human studies have been conducted to
assess abuse liability.
    Benzylone has been detected in seized materials in multiple
countries across several regions.
    There is little information concerning the adverse effects of
benzylone. Although it has been detected in postmortem samples along
with other substances, there is no significant evidence of benzylone
playing a causative role in deaths.

Therapeutic Usefulness

    Benzylone is not known to have any therapeutic use.

Recommendation

    Benzylone is a synthetic cathinone that has some effects in
common with substances listed under Schedule II of the Convention on
Psychotropic Substances of 1971. However, its effects are relatively
weak and there is no consistent evidence supporting the likelihood
of abuse or dependence. In addition, there is no consistent evidence
of the extent of public health and social problems related to use of
benzylone.
    Recommendation: The Committee recommended that benzylone (IUPAC
chemical name: 1-(Benzo[d][1,3]dioxol-5-yl)-2-(benzylamino)propan-1-
one) be kept under surveillance by the WHO Secretariat.

Kratom, mitragynine, and 7-hydroxymitragynine

Substance Identification

    Kratom is the common term for Mitragyna speciosa, a tree native
to Southeast Asia. Kratom use is almost exclusively oral, typically
by chewing the leaves, ingesting powdered leaf, or drinking a kratom
infusion or decoction, or by ingesting powdered leaf as a capsule or
pill or dissolved in a beverage. Other forms such as extracts and
resins are also used.
    Several alkaloids have been detected in kratom plants. The main
known psychoactive components of kratom are mitragynine and 7-
hydroxymitragynine, both of which are found in the leaves of
Mitragyna speciosa. Mitragynine is the most abundant alkaloid in
kratom.
    Whilst 7-hydroxymitragynine is a minor alkaloid, it is also a
metabolite of mitragynine.

WHO Review History

    Kratom has been under ECDD surveillance since 2020 due to a
country level report indicating the potential for abuse, dependence,
and harm to public health from mitragynine and 7-hydroxymitragynine,
and a report from an international organization regarding documented
fatalities associated with kratom use. A pre-review on kratom,
mitragynine, and 7-hydroxymitragynine was initiated following
consideration of these reports.

Similarity to Known Substances and Effects on Central Nervous System

    Mitragynine and 7-hydroxymitragynine are partial agonists at the
mu-opioid receptor. Human studies demonstrate the analgesic effects
of kratom, while kratom extract, mitragynine and 7-
hydroxymitragynine have been shown to be antinociceptive in animal
models. The antinociceptive effects are reversed by an opioid
antagonist.
    Mitragynine also binds to adrenergic receptors, serotonergic and
dopamine receptors. Although there is limited information regarding
its effects at these receptors, kratom extracts and mitragynine have
been reported in animal studies to have a variety of non-opioid-like
behavioural effects, including antidepressant and antipsychotic
effects.
    Reported adverse effects as a result of kratom intoxication have
included neuropsychiatric (agitation, confusion, sedation,
hallucinations, tremor, seizure, coma), cardiovascular (tachycardia,
hypertension), gastrointestinal (abdominal pain, nausea, vomiting)
and respiratory (respiratory depression) symptoms. A number of cases
of kratom-associated liver toxicity have been documented.

Dependence Potential

    In animal models, repeated dosing with mitragynine produced
dependence, evidenced by naloxone-precipitated withdrawal. The
withdrawal syndrome from kratom appears to be less severe than
withdrawal from morphine.
    In humans, opioid-like withdrawal symptoms have been reported
following cessation of kratom use. Limited epidemiological evidence
indicates that withdrawal is usually mild. There are a small number
of cases of neonatal opioid withdrawal symptoms in neonates born to
mothers who used kratom regularly.

Actual Abuse and/or Evidence of Likelihood of Abuse

    Animal studies with kratom extracts have not shown abuse
liability in one animal model. Mitragynine and 7-hydroxymitragynine
have effects indicative of abuse liability in some animal models but
not in others. Mitragynine is not self-administered by animals,
while 7-hydroxymitragynine has been shown to be

self-administered, supporting a likely abuse liability.
    Kratom can produce serious toxicity in people who use high
doses, but the number of cases is probably low as a proportion of
the total number of people who use kratom. Although mitragynine has
been analytically confirmed in a number of deaths, almost all
involve use of other substances, so the degree to which kratom use
has been a contributory factor to fatalities is unclear.
    Kratom and mitragynine have been associated with cases of
driving under the influence, but their role in driving impairment
could not be established in most instances.
    Multiple countries across various regions report nonmedical use
of kratom. Seizures of kratom and related products have been
reported in several countries.

Therapeutic Usefulness

    People report using kratom to self-medicate a variety of
disorders and conditions, including pain, opioid withdrawal, opioid
use disorder, anxiety, and depression. Kratom is being used as a
part of traditional medicine in some countries.
    Research is ongoing to determine the basic pharmacology and the
potential therapeutic value of kratom, mitragynine, and 7-
hydroxymitragynine.

Recommendation

    Kratom contains multiple alkaloids. The two main known
psychoactive alkaloids, mitragynine and 7-hydroxymitragynine,
produce at least some effects similar to opioids under international
control.
    Mitragynine, the most abundant of these alkaloids, also has non-
opioid actions, the significance of which is unclear. There is mixed
evidence on the abuse liability of mitragynine in animal models.
Kratom is used for self-medication for a variety of disorders but
there is limited evidence of abuse liability in humans.
    Cessation of regular use of kratom may lead to withdrawal
symptoms.
    The Committee considered information regarding the traditional
use and investigation into possible medical applications of kratom.
    The Committee concluded that there is insufficient evidence to
recommend a critical review of kratom. With respect to mitragynine
and 7-hydroxymitragynine, the Committee, except for one member, also
concluded that there is insufficient evidence to recommend a
critical review at this time.
    Recommendation: The Committee recommended that kratom,
mitragynine, and 7-hydroxymitragynine be kept under surveillance by
the WHO Secretariat.

Phenibut (4-amino-3-phenyl-butyric acid)

Substance Identification

    Phenibut (IUPAC chemical name: 4-Amino-3-phenylbutanoic acid) is
a structural analogue of baclofen and gabapentin. It is produced in
various formulations including tablets and powder for oral use, and
crystalline form. Phenibut is a registered pharmaceutical in some
countries and is also marketed online for a number of uses including
as a sleep aid, mood enhancer, treatment for anxiety and a cognitive
enhancer.

WHO Review History

    Phenibut has not been formally reviewed by WHO and is not
currently under international control. Phenibut has been under ECDD
surveillance since 2017 due to reports from Member States of its
abuse and dependence potential. A pre-review was initiated following
consideration of these reports.

Similarity to Known Substances and Effects on Central Nervous System

    Phenibut acts primarily as an agonist at the GABAB
receptor, similar to baclofen, and at the [alpha]2-[delta] subunit
of voltage dependent calcium channels, similar to gabapentin.
    Animal studies show that phenibut has dose-dependent analgesic,
antidepressant, and anxiolytic effects, which are mediated both by
its GABAB agonist effects and actions at voltage
dependent calcium channels.
    Phenibut intoxication has presented with central nervous system
depressive symptoms including decreased level of consciousness,
muscle tone, stupor, depressed respiration, temperature
dysregulation, hyper- or hypotension, and coma. However, in other
cases individuals have presented with agitation, hallucinations,
seizures, and delirium.

Dependence Potential

    There are no studies conducted in animals examining the
dependence potential of phenibut. People who use phenibut describe
escalating dosing suggestive of tolerance and difficulty in
cessation.
    There are a limited number of case reports of withdrawal
symptoms following abrupt discontinuation of high dose phenibut use.
Reported symptoms have included insomnia, psychomotor agitation,
delusions, psychosis, disorganized thought patterns, auditory/visual
hallucinations, anxiety, depression, fatigue, dizziness, seizures,
decreased appetite, nausea and vomiting, palpitations, and
tachycardia. However, in most cases the use of phenibut was not
verified analytically, and the clinical picture was complicated by
the use of other drugs.

Actual Abuse and/or Evidence of Likelihood of Abuse

    No controlled animal or human studies have examined the abuse
potential of phenibut.
    There are reports from different countries of adverse effects
due to nonmedical use of phenibut. Medically unsupervised use of
phenibut obtained via the internet is often at doses much higher
than those used clinically. However, many cases involve multiple
drugs, and the role of phenibut in these cases remains unclear.
    Multiple countries over several regions report seizures of
phenibut. However, the extent of non-medical use is unknown.

Therapeutic Usefulness

    Phenibut is approved in a few countries as a medicine for a
range of psychiatric and neurological conditions.

Recommendation

    The Committee noted that there has been concern in several
countries regarding the nonmedical use of phenibut. While there are
reports of adverse effects and of a withdrawal syndrome following
cessation of use, the information on these cases is very limited. In
addition, there is very little information on the abuse liability of
phenibut, on the magnitude of its misuse or abuse, and on its
similarity to currently internationally controlled substances.
    The Committee also noted that phenibut is used therapeutically
in a small number of countries.
    Recommendation: The Committee recommended that phenibut (IUPAC
chemical name: 4-Amino-3-phenylbutanoic acid) should not proceed to
critical review but should be kept under surveillance by the WHO
Secretariat.

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 1971 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.
    Brorphine (chemical name: 1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-
yl)-1,3- dihydro-2H-benzo[d]imidazol-2-one) is a potent synthetic
opioid encountered as both a single substance of abuse and in
combination with other opioid substances, such as heroin and fentanyl.
The appearance of brorphine on the illicit drug market is similar to
other designer drugs trafficked for their psychoactive effects.
Beginning in June 2019, brorphine emerged in the United States illicit,
synthetic drug market as evidenced by its identification in drug
seizures. The use of brorphine has been associated with at least seven
fatalities between June and July 2020 in the United States. Brorphine
is not approved for medical use in the United States. On March 1, 2021,
the U.S. Drug Enforcement Administration (DEA) issued a temporary order
to control brorphine as a Schedule I substance under the CSA, therefore
additional permanent controls may be needed if brorphine is placed in
Schedule I of the 1961 Convention.
    Metonitazene (chemical name: N,N-diethyl-2-(2-(4-methoxybenzyl)-5-
nitro-1H-benzo[d]imidazol-1-yl)ethan-1-amine) belongs to the series of
2-benzylbenzimidazole opioid compounds and is classified as a potent
opioid structurally resembling etonitazene and dissimilar in structure
to other synthetic opioids such as fentanyl analogues. Novel opioids
such as metonitazene have been reported to

cause psychoactive effects and adverse events, including deaths similar
to heroin, fentanyl, and other opioids. As of January 2021,
metonitazene has been identified in eight blood specimens associated
with postmortem death investigations in the United States. There are no
commercial or approved medical uses for metonitazene. On December 7,
2021, the DEA issued a temporary order (86 FR 69182) to control
metonitazene as a Schedule I substance under the CSA, therefore
additional permanent controls may be needed if metonitazene is placed
in Schedule I of the 1961 Convention.
    Eutylone (chemical name: 1-(1,3-benzodioxol-5-yl)-2-
(ethylamino)butan-1-one) is a designer drug of the phenethylamine
class. Eutylone is a synthetic cathinone with chemical structural and
pharmacological similarities to Schedule I and II amphetamines and
cathinones, such as to 3,4-methylenedioxymethamphetamine, methylone,
and pentylone. Eutylone emerged in the United States illicit, synthetic
drug market in 2014 as evidenced by its identification in drug
seizures. Other evidence indicates that eutylone, like other Schedule I
synthetic cathinones, is abused for its psychoactive effects. Adverse
effects associated with synthetic cathinones abuse include agitation,
hypertension, tachycardia, and death. Eutylone is not approved for
medical use in the United States. As a positional isomer of pentylone,
eutylone is controlled in Schedule I of the CSA. As such, additional
permanent controls will not be needed if eutylone is placed in Schedule
II of the Convention on Psychotropic Substances.
    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 1971 Convention at
the CND meeting in March 2022.
    Comments regarding the WHO recommendations for control of brorphine
and metonitazene 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.

    Dated: February 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03229 Filed 2-14-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Page 77011]
[FR Doc No: 2014-30012]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1104]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; State Petitions for Exemption From
Preemption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``State Petitions for Exemption from
Preemption'' has been approved by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 27, 2014, the Agency submitted a
proposed collection of information entitled ``State Petitions for
Exemption from Preemption'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0277.
The approval expires on November 30, 2017. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: December 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30012 Filed 12-22-14; 8:45 am]
BILLING CODE 4164-01-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Wednesday, June 24, 2020 2:49 PM
To:
BATTEN, KATIE M<EMAIL_ADDRESS>SINGLETON, KRIS E<EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
Re: Updated Enclosure 2 Data - May 20, 2020

Yes, of course we will deal with nonrecovery differently, especially for regulatory purposes, i.e., any changes to the current MACT. The by-product chemical recovery plants will be noncategory emissions and included in the risk assessment for by-product plants but the locations will indicate that these are not co-located at nonrecovery plants.

You bring up a good point, however, about separating risk for subcategories. Although we are compiling all of the industry data together in same modelling file for ease of data entry and QA, we will likely want to separate the subcategories into separate modelling files before modeling. But we will report separate and combined risk in the preamble and risk documents, but we will only use the individual subcategory risk and emission data for any regulatory decisions. Even if combined, we would indicate zero risk reduction for nonrecovery plants if, for example, we lowered one of the emission limits for by-product, and vice versa.

I don't know anything off hand that we might need to do as far as "gap filling."  I will check with RTI on this to be sure. Did you have anything specifically in mind? For noncategory sources other than chemical recovery, we use the NEI, but the database has specific locations, which will indicate at which plants the noncategory sources are co-located, so that wont be a problem either.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

From: BATTEN, KATIE M<EMAIL_ADDRESS>Sent: Wednesday, June 24, 2020 2:16 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>SINGLETON, KRIS E<EMAIL_ADDRESS>Subject: RE: Updated Enclosure 2 Data - May 20, 2020

Hi Donna Lee,

You should now have all the reviewed Enclosure I and II data from SunCoke.   Thanks for your patience with us.

I also wanted to reach out to you on a related MACT Subpart CCCCC RTR issue.  As you know, SunCoke plants have a different technology and different source profile than byproduct plants; there are numerous emissions units and processes at a byproduct plant that are not present at a nonrecovery plant, resulting in a very different emissions profile.  For example, some of those processes at byproduct plants are regulated under Part 61 Subpart L for benzene emissions.  Additionally, the MACT floor for Subpart CCCCC was set independently for nonrecovery and byproduct plants when those regulations were first promulgated, and as a result, different regulations apply to them.

We are therefore wondering whether EPA is planning to conduct the risk assessment for nonrecovery plants separately from its risk assessment for byproduct plants?  SunCoke's view is that separate risk assessments should be conducted (i.e. determining cancer risk and hazard index independently) because they are distinct subcategories of sources.  We also have a concern that a joint risk assessment using the same gap-filling methodology to estimate emissions for both subcategories of sources would potentially overestimate emissions and risk for nonrecovery plants.

Please let us know your thoughts and if it would be helpful to discuss further.

Thanks,

Katie Batten
Director of Health, Safety and Environmental

SunCoke Energy, Inc.
<EMAIL_ADDRESS>cell:<PHONE_NUMBER>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Thursday, June 18, 2020 3:30 PM
To: SINGLETON, KRIS E<EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Cc: BATTEN, KATIE M<EMAIL_ADDRESS>Subject: Re: Updated Enclosure 2 Data - May 20, 2020

Yeh! Thank you very much, I appreciate all your work on this. Take care.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

From: SINGLETON, KRIS E<EMAIL_ADDRESS>Sent: Thursday, June 18, 2020 3:13 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Cc: BATTEN, KATIE M<EMAIL_ADDRESS>Subject: RE: Updated Enclosure 2 Data - May 20, 2020

Hello,

Please see the attached updated Enclosure 2 data files for SunCoke Granite City and Middletown. Sorry for the delay.
Let us know if you have further questions.
Thanks,

Kris

Kris Singleton
Corporate Engineer  -
Health, Environmental & Safety

 SunCoke Energy
office:<PHONE_NUMBER>
cell:<PHONE_NUMBER>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Wednesday, May 20, 2020 8:05 PM
To: SINGLETON, KRIS E<EMAIL_ADDRESS>BATTEN, KATIE M<EMAIL_ADDRESS>Cc: Raymond, Gabrielle<EMAIL_ADDRESS>Subject: Re: Updated Enclosure 2 Data - May 20, 2020

Thanks for letting me know. Look forward to your files. Take care.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

From: SINGLETON, KRIS E<EMAIL_ADDRESS>Sent: Wednesday, May 20, 2020 4:34 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>BATTEN, KATIE M<EMAIL_ADDRESS>Cc: Raymond, Gabrielle<EMAIL_ADDRESS>Subject: RE: Updated Enclosure 2 Data - May 20, 2020

Hello!

We haven't forgot about this and are actively working on it. Hope to get you something soon. As you can imagine, things have been a little crazy with COVID and all...
Sorry for the delay!

Kris

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Wednesday, May 20, 2020 2:48 PM
To: SINGLETON, KRIS E<EMAIL_ADDRESS>BATTEN, KATIE M<EMAIL_ADDRESS>Cc: Raymond, Gabrielle<EMAIL_ADDRESS>Subject: Re: Updated Enclosure 2 Data - May 20, 2020

".... checking on the status of the Enclosure 2 data files for the SunCoke Granite City, IL and Middletown, OH facilities."

Hope you all are doing OK.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

From: Raymond, Gabrielle<EMAIL_ADDRESS>Sent: Friday, May 8, 2020 10:59 AM
To: SINGLETON, KRIS E<EMAIL_ADDRESS>BATTEN, KATIE M<EMAIL_ADDRESS>Cc: Jones, DonnaLee<EMAIL_ADDRESS>Subject: Updated Enclosure 2 Data

Hello,

Thank you for submitting the SunCoke test reports to the FTP site and the revised SunCoke Enclosure 1 data file.

We were just checking on the status of the Enclosure 2 data files for the SunCoke Granite City, IL and Middletown, OH facilities.

Attached are the files sent to you on 9/4/2019 in case you need another copy.

Thank you,
Gabrielle

Gabrielle Raymond
RTI International
3040 Cornwallis Road
P.O. Box 12194
Research Triangle Park, NC 27709
Phone:<PHONE_NUMBER>