[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72341-72342]
[FR Doc No: 2012-29346]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC06-129-005.
    Applicants: Capital Research and Management Company.
    Description: Request for Amended Order Under Section 203 of the
Federal Power Act of Capital Research and Management Company, et. al.
    Filed Date: 11/28/12.
    Accession Number: 20121128-5025.
    Comments Due: 5 p.m. ET 12/19/12.

    Docket Numbers: EC13-48-000.
    Applicants: NewPage Corporation, GS Funds.
    Description: Joint Application of New Page Corporation, et. al. for
Authorization Under Section 203 of the Federal Power Act and Request
for Expedited Consideration.
    Filed Date: 11/27/12.
    Accession Number: 20121127-5264.
    Comments Due: 5 p.m. ET 12/18/12.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER12-2480-002.
    Applicants: Alcoa Power Generating Inc.
    Description: Refiling of Yadkin OATT--ER12-2480 to be effective 11/
15/2012.
    Filed Date: 11/19/12.
    Accession Number: 20121119-5200.
    Comments Due: 5 p.m. ET 12/10/12.

    Docket Numbers: ER13-242-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: SA 2013 G586 2nd Amended GIA to be effective 11/1/
2012.
    Filed Date: 11/27/12.
    Accession Number: 20121127-5237.
    Comments Due: 5 p.m. ET 12/18/12.

    Docket Numbers: ER13-413-002.
    Applicants: USG Oregon LLC.
    Description: Amended USGO Tariff Filing to be effective 1/17/2013.
    Filed Date: 11/27/12.
    Accession Number: 20121127-5120.
    Comments Due: 5 p.m. ET 12/18/12.

    Docket Numbers: ER13-464-000.
    Applicants: Arizona Public Service Company.
    Description: APS Service Agreement No. 324 Foothills Solar Project
LGIA, Amendment 1 to be effective 11/30/2012.
    Filed Date: 11/27/12.
    Accession Number: 20121127-5135.
    Comments Due: 5 p.m. ET 12/18/12.

    Docket Numbers: ER13-465-000.
    Applicants: New England Power Pool Participants Committee, ISO New
England Inc.
    Description: MR1 Rev. Rel. to Procurement of 10-Min. Non-Spinning
Res in FRM to be effective 3/1/2013.
    Filed Date: 11/27/12.
    Accession Number: 20121127-5163.
    Comments Due: 5 p.m. ET 12/18/12.

    Docket Numbers: ER13-466-000.
    Applicants: Shipley Choice, LLC.
    Description: Initial Application for Market-Based Rate Authority to
be effective 1/26/2013.
    Filed Date: 11/27/12.
    Accession Number: 20121127-5243.
    Comments Due: 5 p.m. ET 12/18/12.

    Docket Numbers: ER13-467-000.
    Applicants: Southern California Edison Company.
    Description: Amended SGIA and DSA to Sunshine Canyon Landfill
Project to be effective 11/29/2012.
    Filed Date: 11/28/12.
    Accession Number: 20121128-5000.
    Comments Due: 5 p.m. ET 12/19/12.

    Docket Numbers: ER13-468-000.
    Applicants: Footprint Power LLC.
    Description: Request for Waiver of Footprint Power LLC.
    Filed Date: 11/28/12.
    Accession Number: 20121128-5056.
    Comments Due: 5 p.m. ET 12/19/12.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings

must file in accordance with Rules 211 and 214 of the Commission's
Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern
time on the specified comment date. Protests may be considered, but
intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 28, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-29346 Filed 12-4-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Notices]
[Page 46668-46670]
[DOCID:fr11au08-118]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58282; File No. SR-NASDAQ-2008-067]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding Letters of Guarantee for Options Participants

August 1, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 29, 2008, The NASDAQ Stock Market LLC (``Nasdaq'') 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 Nasdaq. Nasdaq has designated the proposed rule
change as constituting a non-controversial rule change under Rule 19b-
4(f)(6) under the Act,\3\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    Nasdaq is filing a proposed rule change for the NASDAQ Options
Market (``NOM'') to modify Chapter VII, Section 8 of its options rules
to require Letters of Guarantee for each options participant, rather
than each market maker.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.\4\
---------------------------------------------------------------------------

    \4\ Changes are marked to the rule text that appears in the
electronic manual of The NASDAQ Stock Market, LLC found at http://
nasdaq.cchwallstreet.com/.
---------------------------------------------------------------------------

* * * * *

Chapter VII Market Participants

* * * * *

Sec. 8 Letters of Guarantee

    (a) Required of Each Options Participant [Market Maker]. No Options
Participant [Market Maker] shall make any transactions on NOM unless a
Letter of Guarantee has been issued for such Participant by a Clearing
Participant and filed with Nasdaq Regulation, and unless such Letter of
Guarantee has not

been revoked pursuant to paragraph (c) of this Section.
    (b)-(c) No change.
* * * * *

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

    In its filing with the Commission, Nasdaq 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. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    Nasdaq has determined that requiring a Letter of Guarantee for each
options participant would decrease the individual risk exposure of each
options participant as well as the systemic risk of exposure to
Nasdaq's options marketplace. Requiring a Letter of Guarantee of market
makers provides a measure of protection but it does not provide
protection with respect to options participants that enter orders and
liquidity into the market in the same fashion as market makers but to a
lesser degree. It will also provide incremental protection to clearing
brokers by providing advanced notice and requiring acknowledgment that
a new firm will be using their clearing services.
    Nasdaq's determination is based in part on conversations with
current options participants as well as potential options participants.
It is also based on Rule 3.28 of the Chicago Board Options Exchange
which requires letters of guarantee for all trading activity on that
exchange regardless of whether the firm is a registered specialist or
not. In addition, all options participants are required by Chapter VI,
Section 15 of Nasdaq's options rules to document its relationship with
a clearing firm by submitting one of several documents, including a
Letter of Guarantee.
    Nasdaq will work with its membership to ensure full and timely
compliance with this proposed rule change. While many members are
familiar with Letters of Guarantee through, for example, compliance
with Chapter VI, Section 15 or their membership at other exchanges,
Nasdaq will provide all members 45 days from the date of filing of the
proposed rule change to comply with the new requirement. In addition,
Nasdaq will issue an Options Trader Alert to members explaining the new
requirement and providing notice of the compliance date.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Securities Exchange Act of
1934, in general and with Section 6(b)(5) of the Act, in particular, in
that it is designed to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest; and are not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers, or to regulate by virtue of any authority
conferred by this title matters not related to the purposes of this
title or the administration of the exchange. The proposed changes are
consistent with the statute in that they are designed to facilitate
transactions in options on the Nasdaq Options Market by minimizing
counter-party risk and encouraging participants to provide liquidity in
Quarterly Options Series.

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, the proposal
is designed to enhance competition and is based upon the rules of
another national securities exchange that trades standardized options.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \5\ and Rule 19b-
4(f)(6) thereunder.\6\ Nasdaq will make the proposed rule change
operative 45 days from the date of filing this proposal.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2008-067 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2008-067. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549 on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at

Nasdaq's principal office. 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-NASDAQ-2008-067, and should be submitted on or before September 2,
2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-18383 Filed 8-8-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Rules and Regulations]
[Pages 2870-2871]
[FR Doc No: 2017-00077]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-3193; Airspace Docket No. 15-AAL-3]
RIN 2120-AA66

Amendment of VOR Federal Airway V-506; Kotzebue, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Alaskan VHF Omnidirectional Range (VOR)
Federal airway V-506 by lowering the floor of class E controlled
airspace due to the establishment of a lower global navigation
satellite system (GNSS) Minimum Enroute Altitude (MEA). This action
allows for maximum use of the airspace within the National Airspace
System in Alaska.

DATES: Effective date 0901 UTC, March 2, 2017. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA, Order 7400.11 and publication of conforming
amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Kenneth Ready, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the air traffic service route structure in
Alaska to maintain the efficient flow of air traffic.

History

    On March 7, 2016, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) (81 FR 11694), Docket No. FAA-
2016-3193, to amend VOR Federal airway V-506 by lowering the floor of
Class E controlled airspace due to the establishment of a lower GNSS
MEA on a segment of the route. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal. One comment was received.

Discussion of Comment

    The comment received generally asked whether there would be any
safety issues by lowering the floor of Class E airspace?
    The FAA finds the proposed modification is in accordance with the
criteria and guidelines in FAA Order 7400.2, and it does not introduce
new or increased safety risk into the National Airspace System,
including Visual Flight Rules (VFR) operations and Instrument Flight
Rules (IFR) operations.
    For VFR operations, the modified Class G (uncontrolled) airspace
stratum would extend upward from the surface to 7,499 feet mean sea
level (MSL). The maximum terrain and obstruction elevation in this area
is 5,300 feet MSL. The depth of the Glass G airspace stratum will
therefore remain at least 2,199 feet, which exceeds the minimum
airspace necessary for VFR cruise flight over non-congested areas in
accordance with 14 CFR 91.119. It should also be noted, VFR flight is
permitted within Class E airspace, with the only additional or
different requirement (from Class G airspace) being increased cloud
clearance and visibility minima.
    Additionally, no safety issues or increased risk would be
introduced for

IFR operations. The airspace modification would lower the floor of
Class E (controlled) airspace along the specific portion of V-506 from
9,500 feet MSL to 7,500 feet MSL. This action would lower the minimum
altitude for air traffic control services and accommodate the minimum
GNSS (MEA) for the airway of 8,000 feet MSL, while maintaining a 500
foot airspace buffer between IFR aircraft and uncontrolled airspace.
The airway would provide a buffer of greater than 2,000 feet between
IFR aircraft and the maximum terrain and obstacle elevation. Lastly it
would provide IFR aircraft experiencing icing conditions the ability to
fly 2,000 feet lower than previously allowed, and remain within
controlled airspace.
    Alaskan VOR Federal Airways are published in paragraph 6010(b) of
FAA Order 7400.11A dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Alaskan
VOR Federal airways listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending Title 14, Code of Federal Regulations (14 CFR)
part 71 to modify VOR Federal airwayV-506 in the vicinity of Kotzebue,
AK, due to the establishment of a lower GNSS Minimum Enroute Altitude.
The route modifications are outlined below.
    V-506: V-506 extends from the intersection of Kodiak, AK, VOR/DME
107[deg] radial and the Anchorage Oceanic CTA/FIR boundary to the
Barrow, AK, VOR/DME. A portion of the route segment between the Hotham,
AK, NDB and the Barrow, AK, VOR/DME is amended to a lower MEA from 95
MSL to 75 MSL.
    All radials in the regulatory text route descriptions below are
stated in True degrees.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of amending Alaskan VHF
Omnidirectional Range (VOR) Federal airway V-506 by lowering the floor
of class E controlled airspace due to the establishment of a lower
global navigation satellite system (GNSS) Minimum Enroute Altitude
(MEA) qualifies for categorical exclusion under the National
Environmental Policy Act, its implementing regulations at 40 CFR part
1500, and in accordance with FAA Order 1050.1F. Environmental Impacts:
Policies and Procedures, Paragraph 5-6.5a which categorically excludes
from further environmental review Rulemaking actions that designate or
modify classes of airspace areas, airways, routes, and reporting points
(see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace
Areas; Air Traffic Service Routes; and Reporting Points). This action
is not expected to cause any potentially significant environmental
impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, this action has been reviewed for factors
and circumstances in which a normally categorically excluded action may
have a significant environmental impact requiring further analysis, and
it is determined that no extraordinary circumstances exist that warrant
preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 is amended to read as follows:

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016 and
effective September 15, 2016, is amended as follows:

Paragraph 6010(b) Alaskan VOR Federal Airways

* * * * *

V-506 [Amended]

    From INT Kodiak, AK, 107[deg] radial and the Anchorage Oceanic
CTA/FIR boundary, 37 miles 20 MSL, 24 miles 12 AGL, Kodiak; 50 miles
12 AGL, 50 miles 95 MSL, 51 miles 12 AGL, King Salmon, AK; 51 miles
12 AGL, 84 miles 70 MSL, 63 miles 12 AGL, Bethel, AK; Nome, AK; 35
miles 12 AGL, 71 miles 55 MSL, 53 miles 12 AGL, Kotzebue, AK;
Hotham, AK, NDB; 69 miles 12 AGL, 124 miles 75 MSL, 98 miles 12 AGL,
Barrow, AK.
* * * * *

    Issued in Washington, DC, on January 3, 2017.
Gemechu Gelgelu,
Acting Manager, Airspace Policy Group.
[FR Doc. 2017-00077 Filed 1-9-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Notices]
[Pages 7064-7070]
[FR Doc No: 2019-03662]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0767]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; Dronabinol (delta-9-
tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin,
Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical
Preparations of Cannabis; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is providing
interested persons with the opportunity to submit comments about the
World Health Organization (WHO) recommendations 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, March 18-22,
2019. This notice is issued under the Controlled Substances Act (CSA).

DATES: Submit either electronic or written comments on the notice by
March 14, 2019. The short time period for the submission of comments is
needed to ensure that the U.S. Department of Health and Human Services
(HHS) may, in a timely fashion, carry out the required action and be
responsive to the United Nations.

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 March 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 14, 2019. Comments received
by mail/hand delivery/courier

(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-0767 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; World
Health Organization; Scheduling Recommendations; Cannabis and Cannabis
Resin; Dronabinol (delta-9-tetrahydrocannabinol); Tetrahydrocannabinol
(Isomers of delta-9-tetrahydrocannabinol); Extracts and Tinctures of
Cannabis; Cannabidiol Preparations; Preparations Produced Either by
Chemical Synthesis or as Preparation of Cannabis; Request for
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

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

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (1971 Psychotropic Convention). Section 201(d)(2)(B) of the
CSA (21 U.S.C. 811(d)(2)(B)) provides that when the United States is
notified under Article 2 of the 1971 Psychotropic Convention that the
CND proposes to decide whether to add a drug or other substance to one
of the schedules of the 1971 Psychotropic Convention, transfer a drug
or substance from one schedule to another, or delete it from the
schedules, the Secretary of State must transmit notice of such
information to the Secretary of Health and Human Services (Secretary of
HHS). The Secretary of HHS must then publish a summary of such
information in the Federal Register and provide opportunity for
interested persons to submit comments. The Secretary of HHS must then
evaluate the proposal and furnish a recommendation to the Secretary of
State that shall be binding on the representative of the United States
in discussions and negotiations relating to the proposal.
    As detailed in the following paragraphs, the Secretary of State has
received notification from the Secretary-General of the United Nations
(the Secretary-General) regarding two substances to be considered for
deleting from the 1971 Psychotropic Convention. This notification
reflects the recommendation from the 41st WHO Expert Committee for Drug
Dependence (ECDD), which met in November 2018. In the Federal Register
of October 10, 2018 (83 FR 50938), FDA announced the WHO ECDD review
and invited interested persons to submit information for WHO's
consideration.
    The full text of the notification from the Secretary-General is
provided in section II of this document. Section 201(d)(2)(B) of the
CSA requires the Secretary of HHS, after receiving a notification
proposing scheduling, to publish a notice in the Federal Register to
provide the opportunity for interested persons to submit information
and comments on the proposed scheduling action.
    The United States is also a party to the 1961 Single Convention on
Narcotic Drugs (1961 Single Convention). The Secretary of State has
received a notification from the Secretary-General regarding several
substances to be considered for changes in 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
narcotic drugs, 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
Single Convention.

II. United Nations Notification

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

    Reference: NAR/CL.3/2019
    WHO/ECDD41; 1961C-Art.3, 1971C-Art.2 CU 2019/36/DTA/SGB (A)

    The Secretary-General of the United Nations presents his
compliments to the Secretary of State of the United States of America
and has the honour to inform the Government that on 28 January 2019, he
received a notification from the Director-General of the World Health
Organization (WHO), pursuant to article 3, paragraphs 1, 3, 5, and 6 of
the Single Convention on Narcotic Drugs of 1961 as amended by the 1972
Protocol (1961 Convention), and article 2, paragraphs 1, 4, and 6 of
the Convention on Psychotropic Substances of 1971 (1971 Convention),
with the following recommendations regarding the review of cannabis and
cannabis-related substances as follows:

--Cannabis and cannabis resin
    To be deleted from Schedule IV of the 1961 Convention.

--Dronabinol (delta-9-tetrahydrocannabinol)

    To be added to Schedule I of the 1961 Convention.
    To be deleted from Schedule II of the 1971 Convention, subject to
the CND's adoption of the recommendation to add dronabinol and its
stereoisomers (delta-9-tetrahydrocannabinol) to Schedule I of the 1961
Convention.

--Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol)

    To be added to Schedule I of the 1961 Convention subject to the
CND's adoption of the recommendation to add dronabinol and its
stereoisomers (delta-9-tetrahydrocannabinol) to Schedule I of the 1961
Convention.
    To be deleted from Schedule I of the 1971 Convention, subject to
the CND's adoption of the recommendation to add tetrahydrocannabinol to
Schedule I of the 1961 Convention on Narcotic Drugs.

--Extracts and tinctures

    To be deleted from Schedule I of the 1961 Convention.

--Cannabidiol preparations

    To give effect to the recommendation of the fortieth meeting of the
ECDD that preparations considered to be pure cannabidiol (CBD) should
not be scheduled within the International Drug Control Conventions by
adding a footnote to the entry for cannabis and cannabis resin in
Schedule I of the 1961 Convention to read, ``Preparations containing
predominantly cannabidiol and not more than 0.2 percent of delta-9-
tetrahydrocannabinol are not under international control.''
    Preparations produced either by chemical synthesis or as
preparation of cannabis, that are compounded as pharmaceutical
preparations with one or more other ingredients and in such a way that
delta-9-tetrahydrocannabinol (dronabinol) cannot be recovered by
readily available means or in a yield which would constitute a risk to
public health.
    To be added to Schedule III of the 1961 Convention.
    In accordance with the provisions of article 3, paragraph 2 of the
1961 Convention, and article 2, paragraph 2 of the 1971 Convention, the
Secretary-General hereby transmits the notification as annex I to the
present note. The relevant extract from the report of the 41st meeting
of the WHO Expert Committee on Drug Dependence is hereby transmitted as
annex II. For time reasons, this notification and its annexes I and II
are transmitted in English only. The notification will be transmitted
in French and Spanish as soon as it becomes available.
    Also in accordance with the same provisions, the notification from
WHO will be brought to the attention of the 62nd session of the
Commission on Narcotic Drugs (from 14 to 22 March 2019) in document E/
CN.7/2019/12, which will be made available on the website of the 62nd
session of the CND: http://www.unodc.org/unodc/en/commissions/CND/session/62_Session_2019/session-62-of-the-commission-on-narcotic-drugs.html.
    To assist the Commission in reaching a decision, it would be
appreciated if the Government could communicate any comments it
considers relevant to the recommendations made by WHO regarding changes
in the scope of control of cannabis and cannabis-related substances
under the 1961 Convention, namely:

--Cannabis and cannabis resin
--Dronabinol (delta-9-tetrahydrocannabinol)
--Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol)
--Extracts and tinctures
--Cannabidiol preparations;
--Preparations produced either by chemical synthesis or as preparation
of cannabis, that are compounded as pharmaceutical preparations with
one or more other ingredients and in such a way that delta-9-
tetrahydrocannabinol (dronabinol) cannot be recovered by readily
available means or in a yield which would constitute a risk to public
health; as well any economic, social, legal, administrative or other
factors that it considers relevant to the recommendations made by WHO
regarding changes in the scope of control of cannabis and cannabis-
related substances under the 1971 Convention, namely:
--Dronabinol (delta-9-tetrahydrocannabinol)
--Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol)

1 February 2019

Annex I

Letter Addressed to the Secretary-General of the United Nations From
the Director-General of the World Health Organization, 24 January 2019
    ``The forty-first meeting of the WHO Expert Committee on Drug
Dependence (ECDD) convened from 12 to 16 November 2018 at WHO
headquarters in Geneva. Following recommendations made by the fortieth
ECDD in June 2018 regarding the pre-review of cannabis and cannabis-
related substances, the forty-first ECDD carried out critical reviews
of these substances to determine the most relevant level of
international control for cannabis and cannabis-related substances and
whether the World Health Organization (WHO) should recommend changes in
their level of control.
    In addition, the forty-first WHO ECDD reviewed ten New Psychoactive
Substances (NPS), five of which are synthetic opioids; and two pain-
relieving medicines, pregabalin and tramadol. The recommendations
regarding these substances are communicated to you through a separate
letter under the same date as this letter.
    The review of cannabis and cannabis-related substances was carried
out in relation to Resolution 52/5 of the Commission on Narcotic Drugs,
in which the Commission stated that it looked forward to an updated
report on cannabis by the Expert Committee.

    With reference to Article 3, paragraphs 1, 3, 5, and 6 of the
Single Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol, and Article 2, paragraphs 1, 4, and 6 of the Convention on
Psychotropic Substances (1971), I am pleased to submit recommendations
of the forty-first meeting of the ECDD regarding the review of cannabis
and cannabis-related substances as follows:

Cannabis and cannabis-related substances

--Cannabis and cannabis resin

    To be deleted from Schedule IV of the Single Convention on Narcotic
Drugs (1961).

--Dronabinol (delta-9-tetrahydrocannabinol)

    To be added to Schedule I of the Single Convention on Narcotic
Drugs (1961).
    To be deleted from Schedule II of the Convention on Psychotropic
Substances (1971), subject to the CND's adoption of the recommendation
to add dronabinol and its stereoisomers (delta-9-tetrahydrocannabinol)
to Schedule I of the Single Convention on Narcotic Drugs (1961).

--Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol)

    To be added to Schedule I of the Single Convention on Narcotic
Drugs (1961), subject to the CND's adoption of the recommendation to
add dronabinol and its stereoisomers (delta-9-tetrahydrocannabinol) to
Schedule I of the Single Convention on Narcotic Drugs (1961).
    To be deleted from Schedule I of the Convention on Psychotropic
Substances (1971), subject to the CND's adoption of the recommendation
to add tetrahydrocannabinol to Schedule I of the Single Convention on
Narcotic Drugs (1961).

--Extracts and tinctures

    To be deleted from Schedule I of the Single Convention on Narcotic
Drugs (1961).

--Cannabidiol preparations
    To give effect to the recommendation of the fortieth meeting of the
ECDD that preparations considered to be pure CBD should not be
scheduled within the International Drug Control Conventions by adding a
footnote to the entry for cannabis and cannabis resin in Schedule I of
the Single Convention on Narcotic Drugs (1961) to read ``Preparations
containing predominantly cannabidiol and not more than 0.2 percent of
delta-9-tetrahydrocannabinol are not under international control.''

--Preparations produced either by chemical synthesis or as preparation
of cannabis, that are compounded as pharmaceutical preparations with
one or more other ingredients and in such a way that delta-9-
tetrahydrocannabinol (dronabinol) cannot be recovered by readily
available means or in a yield which would constitute a risk to public
health

    To be added to Schedule III of the Single Convention on Narcotic
Drugs (1961).
    The assessments and findings on which they are based are set out in
detail in the forty-first report of the WHO Expert Committee on Drug
Dependence. An extract of the report is attached in Annex 1 of this
letter.
    I am very pleased with the ongoing collaboration between WHO, the
United Nations Office on Drugs and Crime (UNODC), and the International
Narcotics Control Board (INCB), and in particular, how this
collaboration has benefited the work of the WHO Expert Committee on
Drug Dependence (including through the participation of UNODC and INCB
in the forty-first meeting of the ECDD), and more generally, the
implementation of the operational recommendations of the United Nations
General Assembly Special Session (UNGASS) 2016.''

Annex II

Extract From the Report of the 41st Expert Committee on Drug Dependence

5. Cannabis and Cannabis-Related Substances

5.1 Cannabis and Cannabis Resin

    In the 1961 Single Convention on Narcotic Drugs, cannabis and
cannabis resin are described, respectively, as the flowering or
fruiting tops of the cannabis plant (excluding the seeds and leaves
when not accompanied by the tops) from which the resin has not been
extracted and as the separated resin, whether crude or purified,
obtained from the cannabis plant. Reference to cannabis below will be
taken to also include cannabis resin. Of the many compounds in
cannabis, delta-9-tetrahydrocannabinol ([Delta]9-THC) is the principal
psychoactive constituent of cannabis, while CBD is also present but is
not psychoactive.
    Following consumption of cannabis, the adverse effects experienced
include dizziness and impairment of motor control and cognitive
function. As a result of the effects on movement and cognition,
cannabis use can impair driving. There are particular risks of cannabis
use reported for children, such as respiratory depression, tachycardia
and coma. The adverse effects of cannabis consumption are similar to
those produced by [Delta]9-THC alone.
    There are also a number of adverse effects associated with long-
term cannabis use, particularly increased risk of mental health
disorders such as anxiety, depression, and psychotic illness. Chronic
regular cannabis use is particularly problematic for young people
because of its effects on the developing brain.
    Cannabis can cause physical dependence in people who use the drug
daily or near daily. This is evidenced by the onset of cannabis
withdrawal symptoms that occur upon abstinence; these symptoms include
gastrointestinal disturbance, appetite changes, irritability,
restlessness and sleep impairment. Clinical diagnostic guidelines such
as DSM-5 and ICD-10 recognize cannabis dependence and other disorders
related to cannabis use.
    The Committee considered information regarding the therapeutic
indications of cannabis and ongoing research into its possible medical
applications. A number of countries permit the use of cannabis for the
treatment of medical conditions such as chemotherapy-induced nausea and
vomiting, pain, sleep disorders, and spasticity associated with
multiple sclerosis. The Committee recognized the limited robust
scientific evidence on the therapeutic use of cannabis. However, some
oral pharmaceutical preparations of cannabis have therapeutic
advantages for treatment of conditions such as certain forms of pain
and epilepsy. Preparations of cannabis are defined as a mixture, solid,
or liquid containing cannabis and are generally subject to the same
measures of control as cannabis and cannabis resin as per Article 2.3
of the 1961 Single Convention on Narcotic Drugs.
    Cannabis and cannabis resin are included in Schedule I and Schedule
IV of the 1961 Single Convention on Narcotic Drugs. Substances that are
included in both these Schedules are particularly liable to abuse and
to produce ill-effects and have little or no therapeutic use. Other
substances that are included in both Schedules I and IV are fentanyl
analogues, heroin, and other opioids that are considered especially
dangerous. Use of all these substances is associated with a significant
risk of death, whereas cannabis use is not associated with such risk.
    The evidence presented to the Committee did not indicate that
cannabis plant and cannabis resin were particularly liable to produce
ill-effects similar to the effects of the other substances in Schedule
IV of the 1961

Single Convention on Narcotic Drugs. In addition, preparations of
cannabis have shown therapeutic potential for treatment of pain and
other medical conditions such as epilepsy and spasticity associated
with multiple sclerosis. In line with the above, cannabis and cannabis
resin should be scheduled at a level of control that will prevent harm
caused by cannabis use and, at the same time, will not act as a barrier
to access and to research and development of cannabis-related
preparation for medical use.
    The Committee concluded that the inclusion of cannabis and cannabis
resin in Schedule IV is not consistent with the criteria for a drug to
be placed in Schedule IV.
    The Committee then considered whether cannabis and cannabis resin
were better placed in Schedule I or Schedule II of the 1961 Single
Convention on Narcotic Drugs. While the Committee did not consider that
cannabis is associated with the same level of risk to health as most of
the other drugs that have been placed in Schedule I, it noted the high
rates of public health problems arising from cannabis use and the
global extent of such problems and, for these reasons, recommended that
cannabis and cannabis resin continue to be included in Schedule I of
the 1961 Single Convention on Narcotic Drugs.
     Recommendation 5.1: The Committee recommended that
Cannabis and Cannabis Resin be deleted from Schedule IV of the 1961
Single Convention on Narcotic Drugs.

5.2 Dronabinol (delta-9-tetrahydrocannabinol; [Delta]9-THC)

    The main psychoactive substance in the cannabis plant is one of the
four stereoisomers of delta-9-tetrahydrocannabinol ([Delta]9-THC). This
substance has therapeutic uses and is sometimes known by its
international non-proprietary name dronabinol. It is currently placed
in Schedule II of the 1971 Convention on Psychotropic Substances.
    At the time of the adoption of the 1961 Single Convention on
Narcotic Drugs, scientific research had not identified [Delta]9-THC as
the main psychoactive compound in cannabis. Subsequently, [Delta]9-THC
was included in the 1971 Convention on Psychotropic Substances at its
inception. In previous ECDD reviews, the active and naturally occurring
stereoisomer of [Delta]9-THC known as dronabinol had been considered in
a synthetic form as a pharmaceutical preparation. Following a
recommendation from the 27th ECDD, dronabinol was placed in Schedule II
of the 1971 Convention on Psychotropic Substances. The Commission on
Narcotic Drugs, however, did not adopt a subsequent recommendation to
place dronabinol in Schedule III of the 1971 Convention on Psychotropic
Substances.
    The Committee noted that whereas in these previous ECDD reviews
[Delta]9-THC, and especially its active stereoisomer dronabinol, had
been considered in a synthetic form as a pharmaceutical preparation,
[Delta]9-THC today also refers to the main psychoactive component of
cannabis and the principal compound in illicit cannabis-derived
psychoactive products. Some of these products contain [Delta]9-THC at
concentrations as high as 90 percent. Butane hash oil is an example of
a high purity [Delta]9-THC illicit cannabis-derived product that has
recently emerged and is being used by heating and inhalation of the
vapor. In such high purity illicitly derived forms, [Delta]9-THC
produces ill-effects, dependence, and abuse potential that is at least
as great as for cannabis, which is placed in Schedule I of the 1961
Single Convention on Narcotic Drugs.
    A substance liable to similar abuse and productive of similar ill-
effects as that of a substance already scheduled within the 1961 Single
Convention on Narcotic Drugs would normally be scheduled in the same
way as that substance. As [Delta]9-THC is liable to similar abuse as
cannabis and has similar ill-effects, it meets the criteria for
inclusion in Schedule I of the 1961 Single Convention on Narcotic
Drugs. It was further recognized that cocaine, the principal active
compound in coca, is placed along with coca leaf in Schedule I of the
1961 Single Convention on Narcotic Drugs and morphine; the principal
active compound in opium is placed with opium in the same schedule.
Placing [Delta]9-THC, the principal active compound in cannabis, in the
same schedule as cannabis would be consistent with this approach.
    Based on requests received from Member States and information
received from other United Nations agencies, the Committee understood
that placing [Delta]9-THC under the same Convention and in the same
schedule as cannabis, Schedule I of the 1961 Single Convention on
Narcotic Drugs, would greatly facilitate the implementation of the
control measures of the Conventions in Member States. Accordingly:
     Recommendation 5.2.1: The Committee recommended that
dronabinol and its stereoisomers (delta-9-tetrahydrocannabinol) be
added to Schedule I of the 1961 Single Convention on Narcotic Drugs.
    As indicated in the ``Guidance on the WHO review of psychoactive
substances for international control,'' to facilitate efficient
administration of the international control system, it is not advisable
to place a substance under more than one Convention. Accordingly:
     Recommendation 5.2.2: The Committee recommended the
deletion of dronabinol and its stereoisomers (delta-9-
tetrahydrocannabinol) from the 1971 Convention on Psychotropic
Substances, Schedule II, subject to the Commission's adoption of the
recommendation to add dronabinol and its stereoisomers (delta-9-
tetrahydrocannabinol) to Schedule I of the 1961 Single Convention on
Narcotic Drugs.

5.3 Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol)

    There are currently six isomers of tetrahydrocannabinol (THC)
listed in Schedule I of the 1971 Convention on Psychotropic Substances.
These six isomers are chemically similar to delta-9-
tetrahydrocannabinol ([Delta]9-THC), which is currently listed in
Schedule II of the 1971 Convention on Psychotropic Substances, but
which the Committee has recommended deleting from this Schedule and
including in Schedule I of the 1961 Single Convention on Narcotic
Drugs.
    While these six isomers are chemically similar to [Delta]9-THC,
there is very limited to no evidence concerning the abuse potential and
acute intoxicating effects of these isomers. There are no reports that
the THC isomers listed in Schedule I of the 1971 Convention induce
physical dependence or that they are being abused or are likely to be
abused so as to constitute a public health or social problem. There are
no reported medical or veterinary uses of these isomers.
    While the Committee recognized that available evidence has not
demonstrated abuse and ill-effects of these isomers similar to those
associated with [Delta]9-THC, it noted that, due to the chemical
similarity of each of the six isomers to [Delta]9-THC, it is very
difficult to differentiate any of these six isomers from [Delta]9-THC
using standard methods of chemical analysis. The Committee understood
that placing these six isomers under the same Convention and in the
same Schedule as [Delta]9-THC would facilitate the implementation of
international control of [Delta]9-THC, as well as assist Member States
in the implementation of control measures at country level.
Accordingly:
     Recommendation 5.3.1: The Committee recommended that

tetrahydrocannabinol (understood to refer to the six isomers currently
listed in Schedule I of the 1971 Convention on Psychotropic Substances)
be added to Schedule I of the 1961 Single Convention on Narcotic Drugs,
subject to the Commission's adoption of the recommendation to add
dronabinol (delta-9-tetrahydrocannabinol) to the 1961 Single Convention
on Narcotic Drugs in Schedule I.
    As indicated in the ``Guidance on the WHO review of psychoactive
substances for international control,'' to facilitate efficient
administration of the international control system, it is not advisable
to place a substance under more than one Convention. Accordingly:
     Recommendation 5.3.2: The Committee recommended that
tetrahydrocannabinol (understood to refer to the six isomers currently
listed in Schedule I of the 1971 Convention on Psychotropic Substances)
be deleted from the 1971 Convention on Psychotropic Substances, subject
to the Commission's adoption of the recommendation to add
tetrahydrocannabinol to Schedule I of the 1961 Single Convention on
Narcotic Drugs.

5.4 Extracts and Tinctures of Cannabis

    Extracts and tinctures of cannabis are preparations that are
produced by application of solvents to cannabis and that are currently
placed in Schedule I of the 1961 Single Convention on Narcotic Drugs.
These include both medical preparations such as that containing an
approximately equal mixture of delta-9-tetrahydrocannabinol
(dronabinol; [Delta]9-THC) and cannabidiol and non-medical preparations
with high concentrations of [Delta]9-THC such as butane hash oil. While
the medical extracts and tinctures are administered orally, those
produced and used illicitly are normally inhaled following heating and
vaporization.
    The Committee recognized that the term Extracts and Tinctures of
Cannabis as cited in the 1961 Single Convention on Narcotic Drugs
encompasses these diverse preparations that have psychoactive
properties as well as those that do not. The Committee also recognized
that the variability in psychoactive properties of these preparations
is due principally to varying concentrations of [Delta]9-THC, which is
currently scheduled in the 1971 Convention on Psychotropic Substances,
and that some extracts and tinctures of cannabis without psychoactive
properties and including predominantly cannabidiol have promising
therapeutic applications. The fact that diverse preparations with a
variable concentration of delta-9-THC are controlled within the same
entry ``Extract and Tinctures'' and the same schedule, is a challenge
for responsible authorities that implement control measures in
countries.
    As per the 1961 Single Convention on Narcotic Drugs, preparations
are defined as mixtures, solid, or liquid containing a substance in
Schedule I or II and are generally subject to the same measures of
control as that substance. The Committee noted that, by this
definition, the 1961 Single Convention on Narcotic Drugs may cover all
products that are ``extracts and tinctures'' of cannabis as
``preparations'' of cannabis and also, if the Committee`s
recommendation to move dronabinol to Schedule I of the 1961 Single
Convention on Narcotic Drugs was followed, as ``preparations'' of
dronabinol and its stereoisomers. Accordingly:
     Recommendation 5.4: The Committee recommended deleting
Extracts and Tinctures of Cannabis from Schedule I of the 1961 Single
Convention on Narcotic Drugs.

5.5 Cannabidiol Preparations

    At its 40th Meeting, the ECDD considered a critical review of
cannabidiol and recommended that preparations considered to be pure
cannabidiol should not be scheduled within the International Drug
Control Conventions. Cannabidiol is found in cannabis and cannabis
resin but does not have psychoactive properties and has no potential
for abuse and no potential to produce dependence. It does not have
significant ill-effects. Cannabidiol has been shown to be effective in
the management of certain treatment-resistant, childhood-onset epilepsy
disorders. It was approved for this use in the United States in 2018
and is currently under consideration for approval by the European
Union.
    Cannabidiol can be chemically synthesized or it can be prepared
from the cannabis plant. The approved medication (Epidiolex) is a
preparation of the cannabis plant. The Committee noted that medicines
without psychoactive effects that are produced as preparations of the
cannabis plant will contain trace amounts of delta-9-
tetrahydrocannabinol ([Delta]9-THC; dronabinol). The cannabidiol
preparation approved for the treatment of childhood-onset epilepsy,
Epidiolex, contains not more than 0.15 percent [Delta]9-THC by weight
and has no effects indicative of potential for abuse or dependence. In
keeping with the recommendation that preparations considered pure
cannabidiol not be controlled and recognizing that trace levels of
[Delta]9-THC may be found in such preparations, such as the
concentration of 0.15 percent in Epidiolex, while acknowledging that
chemical analysis of [Delta]9-THC to an accuracy of 0.15 percent may be
difficult for some Member States:
     Recommendation 5.5: The Committee recommended that a
footnote be added to Schedule I of the 1961 Single Convention on
Narcotic Drugs to read: ``Preparations containing predominantly
cannabidiol and not more than 0.2 percent of delta-9-
tetrahydrocannabinol are not under international control.''

5.6 Pharmaceutical Preparations of Cannabis and Dronabinol (delta-9-
tetrahydrocannabinol)

    There are currently two main types of registered medicines that
contain delta-9-tetrahydrocannabinol ([Delta]9-THC; dronabinol).
    One type is a preparation of cannabis that contains both the
psychoactive [Delta]9-THC and the non-psychoactive cannabidiol in
approximately equal concentrations, e.g., Sativex. This is used for the
treatment of spasticity due to multiple sclerosis.
    A second type contains only [Delta]9-THC as the active compound and
is used for the treatment of anorexia associated with weight loss in
patients with Acquired Immune Deficiency Syndrome (AIDS) and for nausea
and vomiting associated with cancer chemotherapy in patients who have
failed to respond adequately to conventional antiemetic treatments.
    Currently, approved medicines with [Delta]9-THC as the only active
compound use synthetically produced [Delta]9-THC, e.g., Marinol,
Syndros, although it is possible in the future that medicines with
equivalent amounts of [Delta]9-THC could be prepared from cannabis.
There is no difference in the therapeutic effects or adverse effects of
synthetic [Delta]9-THC compared to [Delta]9-THC from the cannabis
plant.
    These medicines are all taken orally and are approved for use in a
number of countries.
    The evidence concerning the use of these [Delta]9-THC containing
medicines is that they are not associated with problems of abuse and
dependence and they are not diverted for the purpose of non-medical
use.
    The Committee recognized that such preparations are formulated in a
way that they are not likely to be abused, and there is no evidence of
actual abuse or ill-effects to an extent that would justify

the current level of control associated with Schedule I of the 1961
Single Convention on Narcotic Drugs for cannabis-based preparations
such as Sativex and the level of control associated with Schedule II of
the 1971 Convention on Psychotropic Substances, for preparations using
synthetic delta-9 THC, e.g., Marinol and Syndros.
    To impede access to these medicines and in reference to Article 3.4
of the 1961 Single Convention on Narcotic Drugs:
     Recommendation 5.6: The Committee recommended that
preparations containing delta-9-tetrahydrocannabinol (dronabinol),
produced either by chemical synthesis or as a preparation of cannabis,
that are compounded as pharmaceutical preparations with one or more
other ingredients and in such a way that delta-9-tetrahydrocannabinol
(dronabinol) cannot be recovered by readily available means or in a
yield which would constitute a risk to public health, be added to
Schedule III of the 1961 Convention on Narcotic Drugs.

III. Discussion

    At this time, it is uncertain whether the above notification from
WHO of recommendations for proposed scheduling action on cannabis and
cannabis related substances will be acted upon by 62nd session of the
Commission on Narcotic Drugs (from 14 to 22 March 2019). The Bureau of
the 62nd Commission is currently considering whether to postpone voting
on the cannabis-related recommendations until the reconvened meeting in
December, or the 63rd session of the Commission on Narcotic Drugs,
March 2020. If voting is deferred to a later date the comment period
will be reopened.
    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 Psychotropic Convention include the
following: (1) Accept the WHO recommendations; (2) accept the
recommendations to control but control the drug substance in a schedule
other than that recommended; or (3) reject the recommendations
entirely.
    Cannabis, also known as marijuana, is a plant known by biological
names Cannabis sativa or Cannabis indica. It is a complex plant
containing multiple cannabinoids and other compounds, including the
psychoactive substance THC and other structurally similar compounds.
Cannabinoids are defined as having activity at cannabinoid 1 and 2 (CB1
and CB2, respectively) receptors. Agonists of CB1 receptors are widely
abused and are known to modulate motor coordination, memory processing,
pain, and inflammation, and have anxiolytic effects. Marijuana is the
most commonly used illicit drug in the United States.
    The principal cannabinoids in the cannabis plant include THC, CBD,
and cannabinol. These substances are controlled in Schedule I under the
CSA. The synthetically derived single pure stereoisomer, delta-9-
tetrahydrocannabinol (also known as dronabinol) is the active
ingredient in two approved drug products in the United States, MARINOL
(dronabinol) capsules, also available as a generic, and SYNDROS
(dronabinol) oral solution. MARINOL is controlled in Schedule III,
while SYNDROS is controlled in Schedule II under the CSA. Both MARINOL
and SYNDROS are approved to treat anorexia associated with weight loss
in patients with AIDS, and nausea and vomiting associated with cancer
chemotherapy in patients who have failed to respond adequately to
conventional treatment.
    CBD is another cannabinoid constituent of the cannabis plant. In
the United States, one CBD-containing product, Epidiolex oral solution,
has received marketing approval by the FDA for the treatment of
seizures associated with two rare and severe forms of epilepsy, Lennox-
Gastaut syndrome and Dravet syndrome, in patients 2 years of age and
older. On September 28, 2018, the Drug Enforcement Administration
placed FDA-approved product Epidiolex to be marketed into Schedule V of
the CSA. Currently, CBD that is not contained in an FDA-approved
product with less than 0.1 percent THC is controlled as a Schedule I
substance under the CSA. CBD is not specifically listed in the
schedules of the 1961, 1971, or 1988 International Drug Control
conventions.
    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 Psychotropic
Convention at the CND meeting in March 2019.
    Comments regarding the WHO recommendations for control of Cannabis
and Cannabis Resin; Dronabinol (delta-9-tetrahydrocannabinol);
Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol);
Extracts and Tinctures of cannabis; Cannabidiol Preparations;
Preparations Produced Either by Chemical Synthesis or as Preparation of
Cannabis; 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 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03662 Filed 2-28-19; 8:45 am]
 BILLING CODE 4164-01-P


Appendix II.E.8.

Water Outputs – Region F

This appendix is available on EPA’s website at

  HYPERLINK "http://www.epa.gov/pesticides/cumulative/common_mech_groups.htm#op"  http://www.epa.gov/pesticides/cumulative/common_mech_groups.htm#op

A CD containing the data in this appendix may also be obtained by

contacting the Office of Pesticide Programs Public Docket

Docket #  EPA-HQ-OPP-2006-0618

One Potomac Yard

12777 S. Crystal Drive Room S-4400

Arlington, Virginia, 22202

703-305-5805

Monday through Friday, 8:30 am – 4:00 pm


[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Page 53837]
[FR Doc No: 2020-19128]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4536-DR;Docket ID FEMA-2020-0001]

Mississippi; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, Homeland Security (DHS).

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Mississippi (FEMA-4536-DR), dated April 16, 2020, and
related determinations.

DATES: This change occurred on August 24, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Brett H.
Howard, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Jose M. Girot as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-19128 Filed 8-28-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16369-16370]
[FR Doc No: 2020-06031]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2020-N-0956]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff; Combination Products: How To Prepare a Pre-Request for
Designation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension, and to allow 60 days for public comment in
response to the notice. This notice solicits comments on the type of
information recommended for a Pre-Request for Designation (Pre-RFD)
submission.

DATES: Submit either electronic or written comments on the collection
of information by May 22, 2020.

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 May 22, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 22, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitte, marked and identified, as
confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA 2020-N-0956 for ``Combination Products: How to Prepare a Pre-
Request for Designation.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget

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

Guidance for Industry and Food and Drug Administration Staff;
Combination Products: How to Write a Pre-Request For Designation

OMB Control Number 0845--Extension

    The purpose of this guidance is to clarify the type of information
the Office of Combination Products (OCP) recommends that a sponsor
include in a Pre-RFD. This goal of this guidance is to assist sponsors
in obtaining a preliminary assessment from the U.S. Food and Drug
Administration (FDA or Agency) through the Pre-RFD process. The Pre-RFD
process is available to provide informal, non-binding feedback
regarding the regulatory identity or classification of a human medical
product as a drug, device, biological product, or combination product.
In addition, this informal process provides information about a non-
combination or combination product's assignment to the appropriate
Agency Center (Center for Drug Evaluation and Research (CDER), Center
for Devices and Radiological Health (CDRH), or Center for Biologics
Evaluation and Research (CBER)) for premarket review and regulation.
Specifically, this guidance explains the Pre-RFD process at the Office
of Combination Products (OCP) and helps a sponsor understand the type
of information to provide in a Pre-RFD. This guidance describes how to
prepare a Pre-RFD submission. The guidance provides recommendations
regarding the information that should be submitted in a Pre-RFD request
and procedures that should be followed for meetings or conference calls
between the Office of Combination Products, the Centers, and industry
representatives or sponsors.
    The proposed collections of information are necessary to allow the
Agency to receive Pre-RFD requests in order to implement this voluntary
submission program.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
Pre-RFD Submissions.............              83               1              83              12             996
Pre-RFD Meetings................              83               1              83               1              83
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,079
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall decrease of 689 hours. We attribute this adjustment to a
decrease in response time for the number of submissions we received
over the past 3 years.

    Dated: March 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06031 Filed 3-20-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51705-51707]
[FR Doc No: 2019-21099]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87073; File No. SR-Phlx-2019-37]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change Relating to the
Pricing of a Technology Infrastructure Migration

September 24, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 18, 2019, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') 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 Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Phlx pricing at Options 7, Section 9
titled ``Other Member Fees.'' The amendment will describe the pricing
with respect to a technology infrastructure migration.
    While the changes proposed herein are effective upon filing, the
Exchange has designated the amendments become operative on October 1,
2019.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Phlx pricing at Options 7, Section 9
titled ``Other Member Fees.'' The Exchange previously filed a fee
proposal to not assess a fee for duplicative FIX Ports \3\ and CTI
Ports \4\ to new FIX Ports and CTI Ports, during the month of September
2019, in connection with an upcoming technology infrastructure
migration.\5\ With this rule change, the Exchange proposes to not
assess a fee for duplicative FIX Ports and CTI Ports to new FIX Ports
and CTI Ports, during the month of October 2019 to allow additional
time for the Exchange to migrate its technology.
---------------------------------------------------------------------------

    \3\ Financial Information eXchange or ``FIX'' is an interface
that allows members and their Sponsored Customers to connect, send,
and receive messages related to orders and auction orders and
responses to and from the Exchange. Features include the following:
(1) Execution messages; (2) order messages; and (3) risk protection
triggers and cancel notifications. See Rule 1080(a)(i)(A).
    \4\ Clearing Trade Interface or ``CTI'' is a real-time clearing
trade update message that is sent to a member after an execution has
occurred and contains trade details specific to that member. The
information includes, among other things, the following: (i) The
Clearing Member Trade Agreement or ``CMTA'' or ``OCC'' number; (ii)
Exchange badge or house number; (iii) the Exchange internal firm
identifier; (iv) an indicator which will distinguish electronic and
non-electronically delivered orders; (v) liquidity indicators and
transaction type for billing purposes; and (vi) capacity. See Rule
1070(b)(1).
    \5\ See Securities and Exchange Act Release No. 86795 (August
28, 2019), 84 FR 46578 (September 4, 2019) (SR-Phlx-2019-30).
---------------------------------------------------------------------------

Description of Migration and Pricing Impact
    In connection with this migration, members may request new FIX
Ports and CTI Ports during the month of October 2019, which are
duplicative of the type and quantity of their current ports, at no
additional cost to allow for testing of the new ports and allow for
continuous connection to the match engine during the transition
period.\6\ For example, a Phlx member with 3 FIX Ports and 1 CTI Port
on October 1, 2019 could request 3 new FIX Ports and 1 new CTI Port for
the month of October 2019 at no additional cost. The Phlx member would
be assessed only for the legacy market ports, in this case 3 FIX Ports
and 1 CTI Port for the month of October 2019 and would not be assessed
for the new ports, which are duplicative of the current ports. A member
may acquire any additional legacy ports during the month of October
2019 and would be assessed the charges indicated in the current Pricing
Schedule. The migration does not require a member to acquire any
additional ports, rather the migration requires a new port to replace
any existing ports provided the member desired to maintain the same
number of ports.\7\ A member desiring to enter orders into Phlx is
required to obtain 1 FIX Port. A member may also obtain order and
execution ports, such as a CTI Port, to receive clearing messages. The
number of additional FIX or order and execution ports obtained by a
member is dependent on the member's business needs.
---------------------------------------------------------------------------

    \6\ Members would contact Market Operations to acquire new
duplicative FIX Ports and CTI Ports. See Options Technical Update
#2019-3.
    \7\ The migration is 1:1 and therefore would not require a
member to acquire new ports, nor would it reduce the number of ports
needed to connect.
---------------------------------------------------------------------------

Applicability to and Impact on Members \8\
---------------------------------------------------------------------------

    \8\ On May 21, 2019, the SEC Division of Trading and Markets
(the ``Division'') issued fee filing guidance titled ``Staff
Guidance on SRO Rule Filings Relating to Fees'' (``Guidance'').
Within the Guidance, the Division noted, among other things, that
the purpose discussion should address ``how the fee may apply
differently (e.g., additional cost vs. additional discount) to
different types of market participants (e.g., market makers,
institutional brokers, retail brokers, vendors, etc.) and different
sizes of market participants.'' See Guidance (available at https://www.sec.gov/tm/staff-guidance-sro-rule-filings-fees). The Guidance
also suggests that the purpose discussion should include numerical
examples. Where possible, the Exchange is including numerical
examples. In addition, the Exchange is providing data to the
Commission in support of its arguments herein. The Guidance covers
all aspects of a fee filing, which the Exchange has addressed
throughout this filing.
---------------------------------------------------------------------------

    The proposal is not intended to impose any additional fees on any
Phlx members. All members may enter orders on Phlx. As noted above, a
Phlx member may enter all orders on Phlx through one FIX Port. The
Exchange does not require a Phlx member to obtain more than one FIX
Port, however, a member may obtain multiple FIX Ports or a CTI Port to
meet its individual business needs. This proposal is intended to permit
a Phlx member to migrate its current FIX Ports and CTI Ports at no
additional costs during the month of October 2019 to allow for
continuous connection to the Exchange. Members would only be assessed a
fee for their current FIX Ports and CTI Ports and not be assessed a fee
for any new duplicative ports they acquire in connection with the
technology

infrastructure migration. This proposal is not intended to have a
pricing impact.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\10\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers. The proposal is also consistent with
Section 11A of the Act relating to the establishment of the national
market system for securities. Moreover, the Exchange believes that its
proposal complies with Commission guidance on SRO fee filings that the
Commission Staff issued on May 21, 2019.\11\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(4) and (5).
    \11\ See Guidance, supra note 8. Although the Exchange believes
that this filing complies with the Guidance, the Exchange does not
concede that the standards set forth in the Guidance are consistent
with the Exchange Act and reserves its right to challenge those
standards through administrative and judicial review, as
appropriate.
---------------------------------------------------------------------------

The Proposal is Reasonable
    The Exchange's proposal is reasonable in several respects. As a
threshold matter, the Exchange is subject to significant competitive
forces in the market for options transaction services that constrain
its pricing determinations in that market. The fact that this market is
competitive has long been recognized by the courts. In NetCoalition v.
Securities and Exchange Commission, the D.C. Circuit stated as follows:
``[n]o one disputes that competition for order flow is `fierce.' . . .
As the SEC explained, `[i]n the U.S. national market system, buyers and
sellers of securities, and the broker-dealers that act as their order-
routing agents, have a wide range of choices of where to route orders
for execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .'' \12\
---------------------------------------------------------------------------

    \12\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
options transaction services. The Exchange is one of several options
venues to which market participants may direct their order flow, and it
represents a small percentage of the overall market. The Exchange
believes its proposal is reasonable because it will not cause a pricing
impact on any Phlx member, rather the proposal is intended to permit
Phlx members to migrate their FIX Ports and CTI Ports to new technology
at no additional cost during the month of October 2019. This proposal,
which offers duplicative ports to members at no cost, will allow
members to test and maintain continuous connection to the Exchange
during the month of October 2019.
The Proposal Represents an Equitable Allocation and Is Not Unfairly
Discriminatory
    The Exchange believes its proposal allocates its fees fairly among
its market participants. The proposal is equitable and not unfairly
discriminatory. All members may enter orders on Phlx. As noted above, a
Phlx member may enter all orders on Phlx through one FIX Port. The
Exchange does not require a Phlx member to obtain more than one FIX
Port, however, a member may obtain multiple FIX Ports or a CTI Port to
meet its individual business needs. This proposal is not intended to
have a pricing impact to any Phlx member.

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.
Inter-Market Competition
    The proposal does not impose an undue burden on inter-market
competition. This proposal does not amend pricing or functionality.
Rather, this technology migration will enable Phlx members to continue
to connect to Phlx, as is the case today, for the entry of orders.
Intra-Market Competition
    The proposal does not impose an undue burden on intra-market
competition. All members may enter orders on Phlx. As noted above, a
Phlx member may enter all orders on Phlx through one FIX Port. The
Exchange does not require a Phlx member to obtain more than one FIX
Port, however, a member may obtain multiple FIX Ports or a CTI Port to
meet its individual business needs. This proposal is not intended to
have a pricing impact to any Phlx member.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\13\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

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-Phlx-2019-37 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2019-37. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than

those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2019-37 and should be
submitted on or before October 21, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-21099 Filed 9-27-19; 8:45 am]
BILLING CODE 8011-01-P