[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67296-67298]
[FR Doc No: 2018-28218]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-6736]

Determination of Regulatory Review Period for Purposes of Patent
Extension; XERMELO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for XERMELO and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 26, 2019. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 26,
2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 26, 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-2017-E-6736 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; XERMELO.'' 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 Sec.  10.20 (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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, XERMELO
(telotristat ethyl hippurate). XERMELO is indicated for treatment of
carcinoid syndrome diarrhea in combination with somatostatin analog
(SSA) therapy in adults inadequately controlled by SSA therapy.
Subsequent to this approval, the USPTO received a patent term
restoration application for XERMELO (U.S. Patent No. 7,709,493) from
Lexicon Pharmaceuticals, Inc., and the USPTO requested FDA's assistance
in determining the patent's eligibility for patent term restoration. In
a letter dated January 9, 2018, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of XERMELO represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
XERMELO is 3,329 days. Of this time, 2,993 days occurred during the
testing phase of the regulatory review period, while 336 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 20, 2008. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
January 20, 2008.

    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: March 30,
2016. FDA has verified the applicant's claim that the new drug
application (NDA) for XERMELO (NDA 208794) was initially submitted on
March 30, 2016.
    3. The date the application was approved: February 28, 2017. FDA
has verified the applicant's claim that NDA 208794 was approved on
February 28, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,175 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-28218 Filed 12-27-18; 8:45 am]
 BILLING CODE 4164-01-P


MEMORANDUM TO: File FROM: Seema Schappelle, EPA DATE: February 22, 2006 RE: Meeting with Melissa Powers and Allison LaPlante, Attorneys, Pacific Environmental Advocacy Center On January 30, 2006, Jeff Cohen, Seema Schappelle, and Jan Tierney of EPA met with Melissa Powers and Allison LaPlante of the Pacific Environmental Advocacy Center located in Portland, Oregon. Ms. Powers and Ms. LaPlante requested to meet with EPA to provide additional comments on the proposed rule regarding the Protection of Stratospheric Ozone: Listing of Ozone Depleting Substitutes in Foam Blowing ( published in the Federal Register on November 4, 2005). EPA representatives provided clarification on the " grandfathering" provisions and discussed the definition of an " existing user" as set out in the proposal. Ms. Powers and Ms. LaPlante also provided written comments reflecting the issues they raised with EPA at the meeting and those comments have been placed in the docket.


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 2990-2991]
[FR Doc No: 2013-00637]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-34-000]

Bear Creek Storage Company, L.L.C.; Notice of Request Under
Blanket Authorization

    Take notice that on December 21, 2012, Bear Creek Storage Company,
L.L.C. (Bear Creek), 569 Brookwood Village, Suite 749, Birmingham,
Alabama 35209, filed in Docket No. CP13-34-000, a prior notice request,
pursuant to sections 157.205, 157.208, 157.213 and 157.216 of the
Commission's Regulations under the Natural Gas Act, and Bear Creek's
blanket certificate issued in Docket No. CP10-28-000 on January 12,
2010, for authorization to convert 1.2 billion cubic feet of cushion
gas storage capacity and to make certain modifications at its Bear
Creek Storage Field in order to access such converted capacity, all as
more fully set forth in the application which is on file with the
Commission and open to public inspection. The filing may also be viewed
on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter
the docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this Application should be directed to Tina
Hardy, Regulatory Manager, Bear Creek Storage Company, L.L.C., 569
Brookwood Village, Suite 749, Birmingham, Alabama 35209, or call at
(205) 325-3668 or<EMAIL_ADDRESS>

    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with he Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and ill not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 14 copies of the protest
or intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: January 8, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-00637 Filed 1-14-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Pages 27428-27429]
[FR Doc No: 2020-09848]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4532-DR; Docket ID FEMA-2020-0001]

Vermont; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major

disaster for the State of Vermont (FEMA-4532-DR), dated April 8, 2020,
and related determinations.

DATES: The declaration was issued April 8, 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: Notice is hereby given that, in a letter
dated April 8, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the State of
Vermont resulting from the Coronavirus Disease 2019 (COVID-19)
pandemic beginning on January 20, 2020, and continuing, are of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Vermont.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
State. Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, W. Russell Webster, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Vermont have been designated as
adversely affected by this major disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the State of Vermont.

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. 2020-09848 Filed 5-7-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Proposed Rules]
[Pages 72743-72745]
[FR Doc No: 2014-28641]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73714; File No. SR-FINRA-2014-049]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Adopt FINRA Rule 2122 (Charges for Services
Performed) in the Consolidated FINRA Rulebook

December 2, 2014.
    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 21, 2014, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as constituting a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 under the Act,\3\ which
renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to adopt NASD Rule 2430 (Charges for Services
Performed) as FINRA Rule 2122 (Charges for Services Performed) without
any substantive changes. FINRA also proposes to update a cross-
reference within FINRA Rule 0150 accordingly.
    Below is the text of the proposed rule change. Proposed new
language is in italics; proposed deletions are in brackets.
* * * * *

FINRA Rules

* * * * *

0150. Application of Rules to Exempted Securities Except Municipal
Securities

    (a) through (b) No Change.
    (c) Unless otherwise indicated within a particular Rule, the
following FINRA and NASD rules are applicable to transactions in, and
business activities relating to, exempted securities, except municipal
securities, conducted by members and associated persons: FINRA Rules
2010, 2020, 2060, 2111, 2122, 2150, 2210, 2212, 2261, 2268, 2269,
2320(g), 3110, 3220, 3270, 4120, 4130, 4210, 4311, 4330, 4360, 4510
Series, 4530, 5160, 5210, 5220, 5230, 5310, 5340, 8110, 8120, 8210,
8310, 8311, 8312, 8320, 8330 and 9552; NASD Rules IM-2210-2, 2340,
[2430,] 2510, 3040, 3050 and 3140.
* * * * *

[2430] 2122. Charges for Services Performed

    Charges, if any, for services performed, including, but not limited
to, miscellaneous services such as collection of monie[y]s due for
principal, dividends, or interest; exchange or transfer of securities;
appraisals, safe-keeping or custody of securities, and other
services[,] shall be reasonable and not unfairly discriminatory
[between] among customers.
* * * * *

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

    In its filing with the Commission, FINRA 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. FINRA 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
    As part of the process of developing a new consolidated rulebook
(``Consolidated FINRA Rulebook''),\4\ FINRA is proposing to transfer
NASD Rule 2430 (Charges for Services Performed) into the Consolidated
FINRA Rulebook as FINRA Rule 2122 (Charges for Services Performed)
without any substantive changes. Proposed FINRA Rule 2122 states that
charges, if any, for services performed, including, but not limited to,
miscellaneous services such as collection of monies due for principal,
dividends, or interest; exchange or transfer of securities; appraisals,
safe-keeping or custody of securities, and other services shall be
reasonable and not unfairly discriminatory among customers. Proposed
FINRA Rule 2122 closely tracks the language of NASD Rule 2430 but makes
non-substantive changes to the text of the NASD rule.\5\
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    \4\ The current FINRA rulebook consists of: (1) FINRA Rules; (2)
NASD Rules; and (3) rules incorporated from New York Stock Exchange
LLC (``NYSE'') (``Incorporated NYSE Rules'') (together, the NASD
Rules and Incorporated NYSE Rules are referred to as the
``Transitional Rulebook''). While the NASD Rules generally apply to
all FINRA members, the Incorporated NYSE Rules apply only to those
members of FINRA that are also members of the NYSE (``Dual
Members''). The FINRA Rules apply to all FINRA members, unless such
rules have a more limited application by their terms. For more
information about the rulebook consolidation process, see
Information Notice, March 12, 2008 (Rulebook Consolidation Process).
    \5\ FINRA previously solicited comment on a proposal to move
NASD Rule 2430 to the Consolidated FINRA Rulebook with substantive
changes. See Regulatory Notice 11-08 (February 2011); see also
Regulatory Notice 13-07 (January 2013). Given that FINRA would like
to proceed with the rulebook consolidation process expeditiously to
provide greater clarity and regulatory efficiency to FINRA members,
FINRA is proposing in this rule change to move NASD Rule 2430 to the
FINRA rules without substantive changes, and will defer proposing
any substantive changes to the rule for a future rule proposal.

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    FINRA also proposes to update a cross-reference within FINRA Rule
0150 to reflect the transfer of NASD Rule 2430 to FINRA Rule 2122.
    FINRA has filed the proposed rule change for immediate
effectiveness pursuant to Section 19(b)(3) of the Act \6\ and paragraph
(f)(6) of Rule 19b-4 thereunder,\7\ in that the proposed rule change
does not significantly affect the protection of investors or the public
interest; does not impose any significant burden on competition; and
does not become operative for 30 days after filing or such shorter time
as the Commission may designate. FINRA has requested that the SEC waive
the requirement that the proposed rule change not become operative for
30 days after the date of the filing so that FINRA can implement the
proposed rule change immediately.
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    \6\ 15 U.S.C. 78s(b)(3).
    \7\ 17 CFR 240.19b-4(f)(6).
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2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\8\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest, and Section 15A(b)(9) of the Act,\9\ which requires
that FINRA rules not impose any burden on competition that is not
necessary or appropriate in furtherance of the Act. FINRA believes that
this proposed rule change, which does not substantively change the
rule, is consistent with the Act because it is being undertaken
pursuant to the rulebook consolidation process, which is designed to
provide additional clarity and regulatory efficiency to FINRA members
by consolidating the applicable NASD, Incorporated NYSE, and FINRA
rules into one rule set.
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    \8\ 15 U.S.C. 78o-3(b)(6).
    \9\ 15 U.S.C. 78o-3(b)(9).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA 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. As noted above, this proposal
will not substantively change either the text or application of the
rule. FINRA would like to proceed with the rulebook consolidation
process expeditiously, which it believes will provide additional
clarity and regulatory efficiency to members.

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 with respect
to this proposal to transfer NASD Rule 2430 into the Consolidated FINRA
Rulebook without any substantive changes.\10\
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    \10\ But see note 5 supra.
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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 \11\ and Rule 19b-
4(f)(6) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19(b)(3)(A) of the Act \13\
normally does not become operative prior to 30 days after the date of
the filing. However, pursuant to Rule 19b-4(f)(6)(iii),\14\ the
Commission may designate a shorter time if such action is consistent
with the protection of investors and the public interest. FINRA has
asked the Commission to waive the 30-day operative delay so that the
proposal may become operative upon filing. The Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest. Because FINRA is proposing to
transfer NASD Rule 2430 (Charges for Services Performed) into the
Consolidated FINRA Rulebook as FINRA Rule 2122 (Charges for Services
Performed) without any substantive changes, and because the rulebook
consolidation process is designed to provide additional clarity and
regulatory efficiency to members, the Commission believes that a waiver
of the requirement is appropriate so that the rule change may become
operative immediately. Therefore, the Commission hereby waives the 30-
day operative delay and designates the proposal operative upon
filing.\15\
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    \13\ Id.
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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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 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-FINRA-2014-049 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-FINRA-2014-049. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of

10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of FINRA. 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-FINRA-2014-049 and
should be submitted on or before December 29, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-28641 Filed 12-5-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22550-22552]
[FR Doc No: 2018-10272]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83205; File No. SR-CBOE-2018-008]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Order
Approving a Proposed Rule Change Relating to Flexibly Structured
Options

May 9, 2018.

I. Introduction

    On January 18, 2018, Cboe Exchange, Inc. (``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change amending Cboe Options's rules relating to the
fungibility of Flexible Exchange Options (``FLEX Options''). The
proposed rule change was published for comment in the Federal Register
on February 8, 2018.\3\ On March 23, 2018, the Commission designated a
longer period within which to approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved.\4\
The Commission received no comment letters on the proposed rule change.
This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 82622 (Feb. 2,
2018), 83 FR 5668 (Feb. 8, 2018) (``Notice'').
    \4\ See Securities Exchange Act Release No. 82936 (Mar. 23,
2018), 83 FR 13552 (Mar. 29, 2018).
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II. Description of the Proposed Rule Change

    In its filing, the Exchange proposed to amend Interpretation and
Policy .02 to Rule 24A.4, which sets forth requirements relating to a
FLEX Option that has the same terms as a Non-FLEX Option.\5\
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    \5\ See Cboe Options Rule 24A.1(q).
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    First, Cboe Options has proposed to amend the rule to make all FLEX
Options fungible with Non-FLEX Options that have identical terms.\6\
Currently, FLEX Options that have quarterly expirations,\7\ short term
expirations,\8\ weekly expirations,\9\ and End of Month (``EOM'')
expirations \10\ are not fungible with Non-FLEX Options with identical
terms.\11\ The OCC

currently prohibits fungibility in quarterly and short-term
options,\12\ so, as described in more detail below, Cboe Options
proposes to delay the effectiveness of this proposed rule change to
allow time for OCC to amend its bylaws.
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    \6\ See proposed Cboe Options Rule 24A.4.02(a) (`[t]his
Interpretation and Policy shall apply to all FLEX Options'').
    \7\ See Cboe Options Rules 5.5(e), 24.9(a)(2)(B), and 24.9(c).
    \8\ See Cboe Options Rules 5.5(d) and 24.9(a)(2)(A).
    \9\ See Cboe Options Rule 24.9(e). These are currently traded
pursuant to the Nonstandard Expirations Pilot Program.
    \10\ Id. These are also traded pursuant to the Nonstandard
Expiration Pilot Program.
    \11\ Cboe Options states in its proposal that FLEX Options with
these expirations were not originally intended to be fungible. See
Securities Exchange Release Act Nos. 62658 (August 5, 2010), 75 FR
49010, 49011 n.8 (August 12, 2010) (SR-CBOE-2009-075) (notice). The
notice states that FLEX Options do not become fungible with
subsequently introduced Non-FLEX structured quarterly and short term
options, and that they will not be with End of Week (``EOW'') and
EOM expirations because of their similarities to the quarterly and
short term options. EOW expirations are now called weekly
expirations as Cboe Options Rule 24.9(e) was amended to include
Monday and Wednesday expirations. See also Securities Exchange
Release Act No. 62911 (September 14, 2010), 75 FR 57539 (September
21, 2010) (SR-CBOE-2009-075) (approval order).
    \12\ See Article I of OCC By-Laws.
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    Second, the Exchange has proposed to clarify that if the expiration
date is an Exchange holiday, Cboe Options Rule 24A.4.02 shall designate
the previous business day as the expiration date.\13\ However, for
weekly expirations that expire on a Monday that is an Exchange
holiday,\14\ Cboe Options Rule 24A.4.02 shall designate the business
day that immediately follows the Exchange holiday as the expiration
date.\15\ According to the Exchange, the proposed rule is designed to
clarify that when the expiration of a Non-FLEX Option is moved to the
business day immediately before (or after) the Exchange holiday, the
FLEX Option that also expires on the day before (or after) will be
fungible with the Non-FLEX Option.\16\
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    \13\ See Proposed Cboe Options Rule 24A.4.02(a).
    \14\ See Cboe Options Rule 24.9(e)(1).
    \15\ See Proposed Cboe Options Rule 24A.4.02(a).
    \16\ See Notice, supra note 3, at 5669.
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    Third, Cboe Options has proposed to clarify that in the event a
Non-FLEX American-style series is added intra-day, a FLEX position is
permitted to be closed using FLEX trading procedures for the balance of
the trading day on which the Non-FLEX series is added against another
closing only FLEX position.\17\ The Exchange notes that when it was
adopted, the Exchange intended to limit this provision to American-
style exercises. According to the Exchange, American-style options face
assignment risk because when a Non-FLEX Option is listed, the OCC
cannot net the positions of the Non-FLEX Option and the FLEX Option
with identical terms until the next business day.\18\
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    \17\ See proposed Cboe Options Rule 24A.4.02(b).
    \18\ See Notice, supra note 3, at 5669 n.7. See also Securities
Exchange Act Release No. 62870 (September 8, 2010), 75 FR 56147
(September 15, 2010) (SR-CBOE-2010-078) (stating that there is
assignment risk for American-style options only). The Commission
notes that an American-style option may be exercised at any time
during its life, whereas, a European-style option may only be
exercised at the end of its life.
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    Fourth, the Exchange has proposed several non-substantive changes
that are designed to make the text easier to read. The Exchange
believes that such changes will clarify that the fungibility provisions
apply to FLEX Options series with terms identical to the terms of a
Non-FLEX Options series.\19\
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    \19\ See Notice, supra note 3, at 5669.
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    Finally, the proposed rule text provides that the Exchange's
current rule will remain in effect until the effective date specified
by the Exchange in a Regulatory Circular.\20\ The Regulatory Circular
announcing the effective date shall be issued at least 30 days prior to
the effective date \21\ and such effective date shall be no later than
July 31, 2018.\22\ As noted in Cboe Options's proposal,\23\ the delayed
effectiveness is intended to allow OCC time to amend its bylaws to
eliminate its current restriction on fungibility of certain options.
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    \20\ Id. at 5670.
    \21\ Id.
    \22\ Id.
    \23\ Id.
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act \24\ and the
rules and regulations thereunder applicable to a national securities
exchange.\25\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\26\ which
requires that the rules of an exchange be 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.
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    \24\ 15 U.S.C. 78f.
    \25\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \26\ 15 U.S.C. 78f(b)(5).
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    The Commission notes that the rules concerning the fungibility of
certain FLEX Options and Non-FLEX Options were previously approved by
the Commission.\27\ The proposed rule change extends fungibility to
quarterly expirations, short term expirations, and, to the nonstandard
expiration pilot program weekly and EOM expirations. The Commission
believes that amending Rule 24A.4.02 to allow these additional FLEX
Options to become fungible with standardized options with identical
terms could result in some benefits to FLEX Options participants in
that it may potentially increase the liquidity available to traders of
FLEX Options. As the Exchange noted in its rule proposal, this is
because there are more market participants in the Non-FLEX Options and
thus there is potentially more liquidity available to market
participants with FLEX Options that will be able to exit their FLEX
Options positions in the standardized Non-FLEX Option market.\28\
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    \27\ See Securities Exchange Act Release No. 59417 (Feb. 18,
2009), 74 FR 8591 (Feb. 25, 2009) (SR-CBOE-2009-115).
    \28\ See Notice, supra note 3, at 5670.
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    Because FLEX Options in quarterly, short term, weekly, and EOM
expirations are not fungible with their Non-FLEX counterparts, parallel
markets in these expirations exist--one FLEX and one Non-FLEX. The
Commission previously stated that it is concerned that FLEX Options
could act as a surrogate for trading in standardized options.\29\ The
Commission recognizes that the FLEX Options market is designed to
combine the benefits of an auction market with the features of
negotiated transactions, and therefore continuous quotes may not always
be available. Permitting more expirations in FLEX Options to be
fungible with their Non-FLEX counterparts could help to ensure that
market participants cannot avoid the protections provided to investors
in the standardized market for these expirations by trading FLEX
Options. Specifically, once a Non-FLEX series is open for trading, new
FLEX Options are not permitted in that series. In addition, once a Non-
FLEX Options series is open, all outstanding FLEX Options in the same
series become fungible with Non-FLEX Options in the standardized
market, are traded pursuant to standardized market trading rules, and
are aggregated for position and exercise limit purposes. Allowing these
FLEX Options to be fungible with their Non-FLEX counterparts could
potentially address some of these surrogacy concerns.
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    \29\ See 74 FR at 8593.
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    Nevertheless, the FLEX market was originally intended to allow
customization of option terms that were not available in the
standardized options. While this has evolved over time with the current
fungibility provisions, as the additional classes of options noted
above are allowed to become fungible with identical term standardized
options, some of which have much shorter terms to expiration, we expect
the Exchange to carefully monitor the fungible FLEX Options (and
standardized options counterparts) to ensure that they are not being
used in a way to trade ahead and/or gain an advantage over other market
participants prior to the standardized

options becoming available to all market participants.
    Furthermore, the Commission expects the Cboe Options to report any
undue effects that may occur as a result of these fungibility rule
changes, including taking prompt action should any unanticipated
consequences occur. The Commission also expects, prior to the effective
date of the new rule, the Exchange to address whether additional
position limit aggregation rules should be adopted prior to the rule's
delayed implementation date. We note that currently the FLEX rules
require that certain FLEX Options positions be aggregated with the
position limits in the standardized market.\30\
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    \30\ See Cboe Options Rule 24A.7, concerning FLEX position
limits and reporting requirements.
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    The Commission believes that the remaining proposed changes will
help protect investors and the public interest by providing clarity and
transparency to the rules. The proposed rule text regarding Exchange
holidays will clarify the fungibility of FLEX Options with expiration
dates on Exchange holidays and are consistent with the expiration of
the same standardized options on Exchange holidays. Amending the intra-
day add provision to state that it applies solely to American-style
expirations will codify in the rule text the Exchange's original intent
with respect to this provision. Further, the other non-substantive,
clarifying changes will make the rule easier to read and understand.
    Finally, as noted above the Exchange cannot actually implement this
rule change immediately because OCC bylaws currently restrict
fungibility of quarterly and short term options. The Commission
believes that the delayed implementation date of July 31, 2018 should
provide OCC with time to consider fungibility in quarterly and short-
term options and determine whether to amend the OCC By-laws to
accommodate the changes being adopted by the Exchange. The Exchange has
also committed to announce the implementation of the change at least 30
days prior to the effective date pursuant to a Regulatory Circular,
which should provide adequate advance notice to market participants. To
the extent OCC is not able to implement a bylaw change at or prior to
the July 31, 2018, we would expect the Exchange to amend its rules or
extend the implementation date.
    For the reasons above, the Commission finds that the proposed rule
change is consistent with the Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\31\ that the proposed rule change (SR-CBOE-2018-008) be, and
hereby is, approved.
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    \31\ 15 U.S.C. 78s(b)(2).
    \32\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-10272 Filed 5-14-18; 8:45 am]
 BILLING CODE 8011-01-P