[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Pages 63910-63912]
[FR Doc No: 2019-24978]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87517; File No. SR-Phlx-2019-49]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Remove Rule Text
From Phlx Rule 1101A

November 13, 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 November 8, 2019, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to remove rule text from Phlx Rule 1101A,
``Terms of Options Contracts'' at Commentary .05 in connection to the
listing of P.M.-settled Nasdaq-100 Index Options expiring on the third
Friday of the month (``NDXPM'').
    The Exchange also proposes to remove other obsolete rule text
regarding indices within Rule 1101A(1)(2), Rule 1104A, ``SIG Indices,
LLLP'', Rule 1106A, ``Lehman Brothers Inc. Indexes'', Rule 1108A,
``MSCI EM Index'' and Rule 1109A ``MSCI EAFE Index.''
    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
    Phlx proposes to remove rule text from Phlx Rule 1101A, ``Terms of
Options Contracts'' at Commentary .05 in connection to the listing of
P.M.-settled Nasdaq-100 Index Options expiring on the third Friday of
the month (``NDXPM''). The Exchange also proposes to remove other
obsolete rule text regarding indices within Rule 1101A(1)(2), Rule
1104A, ``SIG Indices, LLLP'', Rule 1106A, ``Lehman Brothers Inc.
Indexes'', Rule 1108A, ``MSCI EM Index'' and Rule 1109A ``MSCI EAFE
Index.''
Pilot
    In August 2017, the Commission approved a proposed rule change for
the listing of NDXPM options on a pilot basis on Phlx, with the Pilot
to terminate on the earlier to occur of (i) 12 months following the
date of the first listing of the NDXPM options, or (ii) December 29,
2018 pursuant to Phlx Rule 1101A, ``Terms of Options Contracts''
Commentary .05.\3\ By way of background, the Pilot permitted the
listing and trading, on a pilot basis, of NASDAQ-100 options with
third-Friday-of-the month expiration dates, whose exercise settlement
value was based on the closing index value, symbol XQC, of the NASDAQ-
100 on the expiration day (``P.M.-settled'').
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    \3\ See Securities Exchange Act Release No. 81293 (August 2,
2017), 82 FR 37138 (August 8, 2017) (approving SR-Phlx-2017-04)
(Order Granting Approval of a Proposed Rule Change, as Modified by
Amendment Nos. 1 and 2, To Permit the Listing and Trading of P.M.-
Settled Nasdaq-100 Index Options on a Pilot Basis) See also
Securities Exchange Act Release No. 85692 (April 18, 2019), 84 FR
17213 (April 24, 2019) (Notice of Filing and Immediate Effectiveness
of Proposed Rule Change To Extend the Pilot Period for the Listing
of P.M.-Settled Nasdaq-100 Index Options Expiring on the Third
Friday of the Month)(``Pilot'').

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    The Exchange extended the pilot through May 6, 2019, and,
subsequently through November 4, 2019, because P.M.-settled options on
the NASDAQ-100 Index (``NASDAQ-100'') had not yet been listed by
Phlx.\4\ The Exchange did not renew this Pilot a third time and
therefore the Pilot expired on November 4, 2019.
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    \4\ See Securities Exchange Act Release Nos. 84685 (November 29,
2019), 83 FR 62942 (December 6, 2018) (SR-Phlx-2018-76) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
the Pilot Period for the Listing of P.M.-Settled Nasdaq-100 Index
Options Expiring on the Third Friday of the Month) and 85692 (April
18, 2019), 84 FR 17213 (April 24, 2019) (SR-Phlx-2019-16) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Extend
the Pilot Period for the Listing of P.M.-Settled Nasdaq-100 Index
Options Expiring on the Third Friday of the Month).
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    At this time, the Exchange proposes to remove Commentary .05 to
Phlx Rule 1101A as this Pilot has expired. The Exchange also proposes
to renumber Commentary .06 to Phlx 1101A as .05.
Other Amendments
    The Exchange proposes to remove the following indexes at Rule
1001A(a)(2)(xxii) SIG Oil Exploration & Production Index\TM\, (xxiv)
KBW Capital Markets Index, (xxv) KBW Insurance Index, (xxvi) KBW
Mortgage Finance Index, (xxvii) KBW Regional Banking Index, (xxxiii)
NASDAQ China Index\SM\, and (xxxiv) SIG Energy MLP Index\TM\. The
Exchange proposes to remove the reserved rules and re-letter the
remaining rule text. These indexes are no longer traded so the rule
text is obsolete. There is no outstanding interest in any of the
aforementioned indexes. If Phlx determines to list any of these indexes
at a future date the Exchange will file a proposal with the Commission.
    The Exchange proposes to remove other obsolete rule text regarding
indices. The Exchange no longer lists SIG Indices and therefore
proposes to remove rule text which permits the listing of such index
options within Rule 1104A, ``SIG Indices, LLLP.'' The Exchange no
longer lists Lehman Brothers Indexes and therefore proposes to remove
rule text which permits the listing of such index options within Rule
1106A, ``Lehman Brothers Inc. Indexes.'' The Exchange also no longer
lists the MSCI EM or MSCI EAFE index options. The Exchange proposes to
remove Rule 1108A, ``MSCI EM Index'' and Rule 1109A ``MSCI EAFE
Index.'' There is no outstanding interest in any of the aforementioned
indexes. These indexes have not been listed in some time on Phlx. If
Phlx determines to list any of these indexes at a future date the
Exchange will file a proposal with the Commission.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\6\ in particular, in that it is designed to promote
just and equitable principles of trade, 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 rule text related to the
expired Pilot within Commentary .05 to Phlx Rule 1101A will protect
investors and the public interest by avoiding confusion as to the
existence of this Pilot. Further the Exchange believes that removing
obsolete language related to the listing of index options which have
not been listed for some time on Phlx will also protect investors and
the public interest by avoiding confusion as to the availability of
these listings. There is no outstanding interest in any of the
aforementioned indexes. If Phlx determines to list any of these indexes
at a future date the Exchange will file a proposal with the Commission.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 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 not necessary or appropriate in
furtherance of the purposes of the Act. With the expiration of the
Pilot, NDXPM options would not be listed by Phlx and therefore would
not be available to any market participant. Further, no market
participant may trade any of the index options which are being deleted.

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

    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, it has become effective pursuant to Section
19(b)(3)(A) of the Act \7\ and subparagraph (f)(6) of Rule 19b-4
thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its 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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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change 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-2019-49 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-2019-49. 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-2019-49 and should be submitted on or before December 10, 2019.
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    \9\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-24978 Filed 11-18-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49612-49632]
[FR Doc No: 2017-23224]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1486]

Authorizations of Emergency Use of In Vitro Diagnostic Devices
for Detection of Zika Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations) for in vitro diagnostic devices for detection of the
Zika virus in response to the Zika virus outbreak in the Americas. FDA
issued these Authorizations under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by Thermo Fisher Scientific and The
Center for Infection and Immunity, Columbia University. The
Authorizations contain, among other things, conditions on the emergency
use of the authorized in vitro diagnostic devices. The Authorizations
follow the February 26, 2016, determination by the Secretary of Health
and Human Services (HHS) that there is a significant potential for a
public health emergency that has a significant potential to affect
national security or the health and security of U.S. citizens living
abroad and that involves Zika virus. On the basis of such
determination, the Secretary of HHS declared on February 26, 2016, that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection, subject to the terms of any authorization issued
under the FD&C Act. The Authorizations, which include an explanation of
the reasons for issuance, are reprinted in this document.

DATES: The Authorization for Thermo Fisher Scientific is applicable as
of August 2, 2017; the Authorization for The Center for Infection and
Immunity, Columbia University is effective as of August 11, 2017.

ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for

a public health emergency, that affects, or has a significant potential
to affect, national security or the health and security of U.S.
citizens living abroad, and that involves a biological, chemical,
radiological, or nuclear agent or agents, or a disease or condition
that may be attributable to such agent or agents; or (4) the
identification of a material threat by the Secretary of Homeland
Security under section 319F-2 of the Public Health Service (PHS) Act
(42 U.S.C. 247d-6b) sufficient to affect national security or the
health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360(e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \1\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) The product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
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    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Requests for In Vitro Diagnostic Devices for Detection of the
Zika Virus

    On February 26, 2016, the Secretary of HHS determined that there is
a significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves Zika virus.
On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on
the basis of such determination, the Secretary of HHS declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection, subject to the terms of any authorization issued
under section 564 of the FD&C Act. Notice of the determination and
declaration of the Secretary was published in the Federal Register on
March 2, 2016 (81 FR 10878). On June 5, 2017, Thermo Fisher Scientific
requested, and on August 2, 2017, FDA issued, an EUA for the TaqPath
Zika Virus Kit (ZIKV), subject to the terms of the Authorization. On
July 31, 2017, The Center for Infection and Immunity, Columbia
University requested, and on August 11, 2017, FDA issued, an EUA for
the CII-ArboViroPlex rRT-PCR assay, subject to the terms of the
Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the internet at https://www.regulations.gov.

IV. The Authorizations

    Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of two in vitro diagnostic devices for
detection of Zika virus subject to the terms of the Authorizations. The
Authorizations in their entirety (not including the authorized versions
of the fact sheets and other written materials) follows and provides an
explanation of the reasons for issuance, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

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    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23224 Filed 10-25-17; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51906-51907]
[FR Doc No: 2017-24331]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Aviation
Insurance

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of

Management and Budget (OMB) approval to renew an information
collection. The collection involves obtaining basic information from
new aviation insurance applicants about eligible aviation insurance
applicants needed to establish a legally binding, non-premium insurance
policy with the FAA, as requested by another Federal agency, such as
the applicants name and address. The information collected will be used
to determine whether applicants are eligible for Chapter 443 insurance
and the amount of coverage necessary; and to populate non-premium
insurance policies with the legal name and address of the applicant.

DATES: Written comments should be submitted by January 8, 2018.

ADDRESSES: Send comments to the FAA at the following address: Barbara
Hall, Federal Aviation Administration, ASP-110, 10101 Hillwood Parkway,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Barbara Hall by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0514.
    Title: Aviation Insurance.
    Form Numbers: 2120-0514.
    Type of Review: Renewal of an information collection.
    Background: Title 49 U.S.C. 44305 authorizes the Administrator of
the Federal Aviation Administration, acting pursuant to a delegation of
authority from the Secretary of Transportation, to provide aviation
insurance at the request of another Federal agency, without premium,
provided that the head of the Federal agency agrees to indemnify the
FAA from loss.
    The FAA Non-Premium Aviation War Risk Insurance Program offers war
risk coverage, without premium, to air carriers at the request of DoD
and other Federal agencies. DoD and other Federal agencies rely on the
FAA to provide aviation war risk insurance to contracted air carriers
supporting mission objectives and operations that is not available
commercially on reasonable terms and conditions. Air carriers never
insured under the FAA Non-Premium War Risk Insurance Program must
submit an application before the FAA can provide coverage.
    Respondents: FAA estimates only one air carrier will be required to
apply annually.
    Frequency: One time only.
    Estimated Average Burden per Response: 4 hours.
    Estimated Total Annual Burden: 4 hours.

    Issued in Fort Worth, TX, on November 2, 2017.
Barbara L. Hall,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2017-24331 Filed 11-7-17; 8:45 am]
 BILLING CODE 4910-13-P