[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Notices]
[Pages 28822-28823]
[FR Doc No: 2019-13122]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1482]

Scientific Data and Information About Products Containing
Cannabis or Cannabis-Derived Compounds; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the notice that appeared in the Federal Register of
April 3, 2019. The notice announced a public hearing to obtain
scientific data and information about the safety, manufacturing,
product quality, marketing, labeling, and sale of products containing
cannabis or cannabis-derived compounds. In addition, it notified the
public that FDA was establishing a docket for public comment on this
hearing and that the docket would close on July 2, 2019. We are
extending the comment period to give interested parties more time to
comment.

DATES: FDA is extending the comment period on the notice published in
the Federal Register of April 3, 2019 (84 FR 12969). Submit either
electronic or written comments by July 16, 2019.

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 July 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 16, 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-1482 for ``Scientific Data and Information About Products
Containing Cannabis or Cannabis-Derived Compounds.'' 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.'' We will review
this copy, including the claimed confidential information, in our
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: April Alexandrow, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Room 3147, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 3, 2019,
FDA published a notice announcing a public hearing to obtain scientific
data and information about the safety, manufacturing, product quality,
marketing, labeling, and sale of products containing cannabis or
cannabis-derived compounds. In addition, we notified the public that
FDA was establishing a docket for public comment on this hearing. The
information from the hearing and comments provided to the docket will
inform our regulatory oversight of these products and is an important
step in our continued evaluation of cannabis and cannabis-derived
compounds in FDA-regulated products. We asked that comments be
submitted by July 2, 2019.
    At the public hearing, we received requests for a 30-day extension
of the comment period for the notice. The requests conveyed concern
that the current 60-day comment period does not allow sufficient time
to develop meaningful or thoughtful responses to the questions that
appeared in the notice requesting data and other evidence in support of
answers.
    We have considered the requests and are extending the comment
period for another 14 days, until July 16, 2019. We believe that a 14-
day extension allows adequate time for interested persons to submit
comments without significantly delaying any potential further action on
these important issues.

    Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13122 Filed 6-19-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 217 (Wednesday, November 9, 2016)]
[Notices]
[Pages 78873-78875]
[FR Doc No: 2016-27025]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79232; File No. SR-NYSEMKT-2016-96]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Add to the Rules of
the Exchange the Eleventh Amended and Restated Operating Agreement of
the New York Stock Exchange LLC

November 3, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on October 24, 2016, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to add to the rules of the Exchange the
Eleventh Amended and Restated Operating Agreement of the New York Stock
Exchange LLC (``NYSE LLC''). The proposed rule change is available on
the Exchange's Web site at www.nyse.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 self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to add to the rules of the Exchange the
Eleventh Amended and Restated Operating Agreement of NYSE LLC (the
``Eleventh NYSE Operating Agreement'').
    In September 2015, the Exchange filed the Eighth Amended and
Restated Operating Agreement of NYSE LLC (the ``Eighth NYSE Operating
Agreement'') as a ``rule of the exchange'' under Section 3(a)(27) of
the Act because NYSE LLC has a wholly-owned subsidiary, NYSE Market
(DE), Inc., which owns a majority interest in NYSE Amex Options LLC
(``NYSE Amex Options''), a facility of the Exchange.\4\ The Exchange
subsequently removed the obsolete Eighth NYSE Operating Agreement and
replaced it with the Ninth Amended and Restated Operating Agreement of
NYSE LLC as a ``rule of the exchange'' under Section 3(a)(27) of the
Act.\5\ In turn, when the Ninth Amended and Restated Operating
Agreement of NYSE LLC was amended, the Exchange removed it and replaced
it with the Tenth Amended and Restated Operating Agreement of NYSE LLC
(the ``Tenth NYSE Operating Agreement'') as a ``rule of the exchange''
under Section 3(a)(27) of the Act.\6\
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    \4\ See 15 U.S.C. 78c(a)(27); Securities Exchange Act Release
No. 75984 (September 25, 2015), 80 FR 59213, 59214 (October 1, 2015)
(SR-NYSEMKT-2015-71).
    \5\ See 15 U.S.C. 78c(a)(27); Securities Exchange Act Release
No. 76637 (December 14, 2015), 80 FR 79124 (December 18, 2015) (SR-
NYSEMKT-2015-102).
    \6\ See Securities Exchange Act Release No. 78436 (July 28,
2016), 81 FR 51249 (August 3, 2016) (SR-NYSE-2016-51).
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    On October 6, 2016, NYSE LLC filed on an immediately effective
basis to amend Section 4.05 of the Tenth NYSE Operating Agreement
regarding the use of regulatory assets, fees, fines and penalties, and
to make additional, non-substantive edits.\7\ On October 18, 2016, NYSE
LLC's rule filing amending the Tenth NYSE Operating Agreement was
noticed.\8\ Such rule change will become operative 30 days from the
date on which it was filed, or such shorter time as the Commission may
designate.\9\
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    \7\ See Securities Exchange Act Release No. 79115 (October 18,
2016), 81 FR 73187 (October 24, 2016) (SR-NYSE-2016-66).
    \8\ Id.
    \9\ Id. at 73189.
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    The Exchange is accordingly filing to remove the obsolete Tenth
NYSE Operating Agreement as a ``rule of the exchange'' under Section
3(a)(27) of the Act, and replace it with the Eleventh NYSE Operating
Agreement as a ``rule of the exchange'' under Section 3(a)(27) of the
Act.\10\ The Exchange proposes that the rule change become effective on
the date that the rule change amending the Tenth NYSE Operating
Agreement becomes operative.
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    \10\ See 15 U.S.C. 78c(a)(27).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Exchange Act \11\ in general, and with Section
6(b)(1) \12\ in particular, in that it enables the Exchange to be so
organized as to have the capacity to be able to carry out the purposes
of the Exchange Act and to comply, and to enforce compliance by its
exchange members and persons associated with its exchange members, with
the provisions of the Exchange Act, the rules and regulations
thereunder, and the rules of the Exchange.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(1).
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    The Exchange believes that the proposed rule change would
contribute to the orderly operation of the Exchange and would enable
the Exchange to be so organized as to have the capacity to carry out
the purposes of the Act and comply and enforce compliance by its
members and persons associated with its members, with the provisions of
the Act because, by removing the obsolete Tenth NYSE Operating
Agreement and making the Eleventh NYSE Operating Agreement a rule of
the Exchange, the Exchange would be ensuring that its rules remain
consistent with the NYSE LLC operating agreement in effect.
    The Exchange notes that, as with the Tenth NYSE Operating
Agreement, it would be required to file any changes to the Eleventh
NYSE Operating Agreement with the Commission as a proposed rule
change.\13\ In addition, the Exchange believes that the proposed
changes are consistent with and will facilitate an ownership structure
of the Exchange's facility NYSE Amex Options that will provide the
Commission with appropriate oversight tools to ensure that the
Commission will have the ability to enforce the Act with respect to
NYSE Amex Options and its direct and indirect parent entities.
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    \13\ The Exchange notes that any amendment to the NYSE LLC
Operating Agreement would also require that NYSE LLC file a proposed
rule change with the Commission.
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    The Exchange also believes that this filing furthers the objectives
of Section 6(b)(5) of the Act \14\ because the proposed rule change
would be consistent with and facilitate a governance and regulatory
structure that is designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, 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.
The Exchange believes that removing the obsolete Tenth NYSE Operating
Agreement and making the Eleventh NYSE Operating Agreement a rule of
the Exchange will remove impediments to the operation of the Exchange
by ensuring that its rules remain consistent with the NYSE LLC
operating agreement in effect. The Exchange notes that, as with the
Tenth NYSE Operating Agreement, no amendment to the Eleventh NYSE
Operating Agreement could be made without the Exchange filing a
proposed rule change with the Commission. For the same reasons, the
proposed rule change is also designed to protect investors as well as
the public interest.
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    \14\ 15 U.S.C. 78f(b)(5).
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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 that is not necessary or appropriate
in furtherance of the purposes of the Exchange Act. The proposed rule
change is not intended to address competitive issues but rather is
concerned solely with ensuring that the Commission will have the
ability to enforce the Act with respect to NYSE Amex Options and its
direct and indirect parent entities.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \15\ and Rule 19b-4(f)(6) thereunder.\16\
Because the 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, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)(iii)
thereunder.\17\
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    \15\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of the Exchange's intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \18\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative on November 5, 2016, the same date that the
proposed rule change to amend the Tenth NYSE Operating Agreement and to
renumber it as the Eleventh NYSE Operating Agreement becomes
operative.\19\ The Commission believes that waiver of the 30-day
operative delay is appropriate because it would permit the Eleventh
NYSE Operating Agreement to become ``rules of an exchange'' of NYSE MKT
without delay.\20\ Based on the foregoing, the Commission believes that
the waiver of the operative delay is consistent with the protection of
investors and the public interest.\21\ The Commission hereby grants the
waiver and designates the proposal operative upon November 5, 2016, the
same date that the rule change amending the Tenth NYSE Operating
Agreement and renumbering it as the Eleventh NYSE Operating Agreement
becomes operative.\22\
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    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ See supra note 7.
    \20\ See 15 U.S.C. 78c(a)(27).
    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \22\ See supra note 7.
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \23\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \23\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2016-96 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2016-96. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090, 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; 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-NYSEMKT-2016-96 and should
be submitted on or before November 30, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-27025 Filed 11-8-16; 8:45 am]
BILLING CODE 8011-01-P