[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Page 57205]
[FR Doc No: 2020-20330]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-2839-000]

Inova Energy LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Inova Energy LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 29, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: September 9, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-20330 Filed 9-14-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16006-16008]
[FR Doc No: 2022-05814]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0093]

Agency Information Collection Activities; Proposed Collection;
Comment Request; New Molecular Entity New Drug Applications and
Original Biologics License Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in

response to the notice. This notice solicits comments on information
collection associated with evaluating FDA's program for Enhanced Review
Transparency and Communication (the Program) of new molecular entity
new drug applications and original biologics license applications
(BLAs).

DATES: Submit either electronic or written comments on the collection
of information by May 20, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 20, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 20, 2022. 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-2013-N-0093 for ``New Molecular Entity New Drug Applications and
Original Biologics License Applications.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Evaluation of the Program for Enhanced Review Transparency and
Communication for New Molecular Entity New Drug Applications and
Original 351(a) Biologics License Applications in Prescription Drug
User Fee Acts and 351(k) Biologics License Applications in Biosimilar
User Fee Acts

OMB Control Number 0910-0746--Extension

    This information collection supports the evaluation of certain
performance goals and procedures set forth in what is known as FDA's
``goals letter'' or ``commitment letter'' under the sixth authorization
of the Prescription Drug User Fee Act (PDUFA VI) and the

second authorization of the Biosimilar User Fee Act (BsUFA II). The
goals letters are the result of Agency, industry, and public input, as
Congressionally mandated under the applicable statutes. The documents
entitled ``PDUFA Reauthorization Performance Goals and Procedures
Fiscal Years 2018 Through 2022,'' and ``Biosimilar Biological Product
Reauthorization Performance Goals and Procedures Fiscal Years 2018
Through 2022'' represent current performance goals agreed to by FDA in
support of these respective programs. These documents are available at:
https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf; and https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf.
Work to reauthorize these authorities from Fiscal Years 2023 to 2027 is
ongoing.
    To implement certain performance goals, we established the Program
to promote greater transparency and increased communication between the
FDA review team and the applicant on the most innovative products that
we review. The Program goals are intended to increase the efficiency
and effectiveness of the first review cycle and decrease the number of
review cycles necessary for approval so that patients have timely
access to safe, effective, and high-quality new drugs and biologics. A
key aspect of the extension of the Program to BsUFA II is to conduct an
interim and final assessment that will evaluate how well the parameters
of the Program have achieved the intended goals. Based on sponsors'
responses and other data, on December 2, 2020, we published an interim
report that is available on FDA's website at https://www.fda.gov/media/144130/download. We learned that under BsUFA II review, teams have been
effective in enhancing review transparency and communication, with
milestone meetings also enhancing the predictability of the review
process. We have also adapted certain good practices identified through
the Program, including providing pre-submission advice and templates;
allocating time for applicant-identified discussion topics in late-
cycle meetings where feasible; and recommending request response times
of greater than 2 days for applicants with a global presence. We expect
to continue these assessments.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Pretest.........................               5               1               5             1.5             7.5
Interviews......................              75               1              75             1.5           112.5
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............              80  ..............             120
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We plan interviews with up to three applicant representatives per
each 351(k) BLA first-cycle action issued for applications reviewed
under the Program. In addition, a pretest of the interview protocol
with five respondents will also be conducted. Based on our prior
experience with the Program and communications with the regulated
industry, we assume that five applicant representatives will expend
approximately 1.5 hours to complete the pretest, for a total of 7.5
burden hours. We further assume that up to 75 applicant representatives
(up to 3 representatives for each of up to 25 applications) will
participate in the post-action interviews each year and that each
interview will last approximately 1.5 hours, for a total of 120 burden
hours. Cumulatively, we estimate an overall decrease to the information
collection, which corresponds to a decrease in submissions received by
the Agency over the last 3 years.

    Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05814 Filed 3-18-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 133 (Thursday, July 13, 2017)]
[Notices]
[Pages 32438-32439]
[FR Doc No: 2017-14637]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Approval of Noise Compatibility Program for Akron-Canton Airport,
North Canton, Ohio

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
findings on the noise compatibility program submitted by Akron-Canton
Airport. On July 22, 2016, the FAA determined that the noise exposure
maps submitted by Akron-Canton Airport Authority were in compliance
with applicable requirements. On January 13, 2017 the FAA approved the
Akron-Canton Airport noise compatibility program. All of the
recommendations of the program were approved. No program elements
relating to new or revised flight procedures for noise abatement were
proposed by the airport operator.

DATES: Effective Date: The effective date of the FAA's approval of the
Noise Compatibility Program for Akron-Canton Airport is January 13,
2017.

FOR FURTHER INFORMATION CONTACT: Ms. Katherine Delaney, Community
Planner, DET ADO 604, Federal Aviation Administration, Detroit Airports
District Office, 11677 Wayne Road, Suite 107, Romulus, MI 48174.
Telephone number:<PHONE_NUMBER>. Documents reflecting this FAA action
may be reviewed at this same location.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA has given
its overall approval to the Noise Compatibility Program for Akron-
Canton Airport, effective January 13, 2017.
    Under section 47504 of the Act, an airport operator who has
previously submitted a Noise Exposure Map may submit to the FAA a Noise
Compatibility Program which sets forth the measures taken or proposed
by the airport operator for the reduction of existing non-compatible
land uses and prevention of additional non-compatible land uses within
the area covered by the Noise Exposure Maps. The Act requires such
programs to be developed in consultation with interested and affected
parties including local communities, government agencies, airport
users, and FAA personnel.
    Each airport noise compatibility program developed in accordance
with Part 150 is a local program, not a Federal program. The FAA does
not substitute its judgment for that of the airport proprietor with
respect to which measures should be recommended for action. The FAA's
approval or disapproval of Part 150 program recommendations is measured
according to the standards expressed in Part 150 and the Act and is
limited to the following determinations:
    a. The Noise Compatibility Program was developed in accordance with
the provisions and procedures of Part 150;
    b. Program measures are reasonably consistent with achieving the
goals of reducing existing non-compatible land uses around the airport
and preventing the introduction of additional non-compatible land uses;
    c. Program measures would not create an undue burden on interstate
or foreign commerce, unjustly discriminate against types or classes of
aeronautical uses, violate the terms of airport grant agreements, or
intrude into areas preempted by the Federal Government; and
    d. Program measures relating to the use of flight procedures can be
implemented within the period covered by the program without derogating
safety, adversely affecting the efficient use and management of the
navigable airspace and air traffic control systems, or adversely
affecting other powers and responsibilities of the Administrator
prescribed by law.
    Specific limitations with respect to FAA's approval of an airport
noise compatibility program are delineated in Part 150, section 150.5.
Approval is not a determination concerning the acceptability of land
uses under Federal, state, or local law. Approval does not by itself
constitute an FAA implementing action. A request for Federal action or
approval to implement specific noise compatibility measures may be
required. Prior to an FAA decision on a request to implement the
action, an environmental review of the proposed action may be required.
Approval does not constitute a commitment by the FAA to financially
assist in the implementation of the program nor a determination that
all measures covered by the program are eligible for grant-in-aid
funding from the FAA under applicable law contained in Title 49 U.S.C.
Where federal funding is sought, requests for project grants must be
submitted to the FAA Detroit Airports District Office in Romulus, MI.
    The Akron-Canton Airport study contains a proposed noise
compatibility program comprised of actions designed for phased
implementation by airport management and adjacent jurisdictions from
2016 to the year 2019 (or beyond). It was requested that the FAA
evaluate and approve this material as a Noise

Compatibility Program as described in section 47504 of the Act. The FAA
began its review of the program on July 22, 2016 and was required by a
provision of the Act to approve or disapprove the program within 180
days (other than the use of new or modified flight procedures for noise
control). Failure to approve or disapprove such program within the 180-
day period shall be deemed to be an approval of such program.
    The submitted program contained twenty-six proposed actions for
noise abatement, noise mitigation, land use planning, and program
management on and off the airport. The FAA completed its review and
determined that the procedural and substantive requirements of the Act
and Part 150 have been satisfied. The overall program was approved by
the FAA, effective January 13, 2017.
    Outright approval was granted for thirteen specific program
measures. Thirteen measures were either identified as completed, no
longer applicable, or to be discontinued.
    These determinations are set forth in detail in a Record of
Approval signed by the Great Lakes Region Airports Division Director on
January 13, 2017. The Record of Approval, as well as other evaluation
materials and the documents comprising the submittal, are available for
review at the FAA office listed above and at the administrative offices
of the Akron-Canton Airport Authority, 5400 Lauby Road, North Canton,
OH 44720. The Record of Approval also will be available on-line at:
http://www.faa.gov/airports_airtraffic/airports/environmental/airport_noise/part_150/states/.

    Issued in Romulus, MI, on June 23, 2017.
John L. Mayfield, Jr.,
Manager, Detroit Airports District Office.
[FR Doc. 2017-14637 Filed 7-12-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Pages 19743-19744]
[FR Doc No: 2012-7771]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66664; File No. SR-Phlx-2012-36]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
the Options Regulatory Fee

March 27, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 \2\ thereunder, notice is hereby given
that, on March 19, 2012, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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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 increase its Options Regulatory Fee
(``ORF'').
    While changes to the Pricing Schedule pursuant to this proposal are
effective upon filing, the Exchange has designated these changes to be
operative June 1, 2012.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqtrader.com/micro.aspx?id=PHLXfilings, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the ORF to
increase it from $0.004 per contract to $0.0045 per contract in order
to recoup increased regulatory expenses while also ensuring that the
ORF will not exceed costs.
    The ORF is assessed to each member for all options transactions
executed or cleared by the member that are cleared at The Options
Clearing Corporation (``OCC'') in the customer range (i.e., that clear
in the customer account of the member's clearing firm at OCC). The
Exchange monitors the amount of revenue collected from the ORF to
ensure that it, in combination with other regulatory fees and fines,
does not exceed regulatory costs. The ORF is imposed upon all
transactions executed by a member, even if such transactions do not
take place on the Exchange.\3\ The ORF also includes options
transactions that are not executed by an Exchange member but are
ultimately cleared by an Exchange member.\4\ The ORF is not charged for
member proprietary options transactions because members incur the costs
of owning memberships and through their memberships are charged
transaction fees, dues and other fees that are not applicable to non-
members. The dues and fees paid by members go into the general funds of
the Exchange, a portion of which is used to help pay the costs of
regulation. The ORF is collected indirectly from members through their
clearing firms by OCC on behalf of the Exchange.
---------------------------------------------------------------------------

    \3\ The ORF applies to all ``C'' account origin code orders
executed by a member on the Exchange. Exchange Rules require each
member to record the appropriate account origin code on all orders
at the time of entry in order to allow the Exchange to properly
prioritize and route orders and assess transaction fees pursuant to
the Rules of the Exchange and report resulting transactions to OCC.
See Exchange Rule 1063, Responsibilities of Floor Brokers, and
Options Floor Procedure Advice F-4, Orders Executed as Spreads,
Straddles, Combinations or Synthetics and Other Order Ticket Marking
Requirements. The Exchange represents that it has surveillances in
place to verify that members mark orders with the correct account
origin code.
    \4\ In the case where one member both executes a transaction and
clears the transaction, the ORF is assessed to the member only once
on the execution. In the case where one member executes a
transaction and a different member clears the transaction, the ORF
is assessed only to the member who executes the transaction and is
not assessed to the member who clears the transaction. In the case
where a non-member executes a transaction and a member clears the
transaction, the ORF is assessed to the member who clears the
transaction.
---------------------------------------------------------------------------

    The ORF is designed to recover a portion of the costs to the
Exchange of the supervision and regulation of its members, including
performing routine surveillances, investigations, examinations,
financial monitoring, and policy, rulemaking, interpretive, and
enforcement activities. The Exchange believes that revenue generated
from the ORF, when combined with all of the Exchange's other regulatory
fees, will cover a material portion, but not all, of the Exchange's
regulatory costs. The Exchange will continue to monitor the amount of
revenue collected from the ORF to ensure that it, in combination with
its other regulatory fees and fines, do not exceed regulatory costs. If
the Exchange determines regulatory revenues exceed regulatory costs,
the Exchange will adjust the ORF by submitting a fee change filing to
the Commission.

    While changes to the Pricing Schedule pursuant to this proposal are
effective upon filing, the Exchange has designated these changes to be
operative on June 1, 2012.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Pricing
Schedule is consistent with Section 6(b) of the Act \5\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \6\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among Exchange members. The Exchange believes that
the fee change is reasonable because the Exchange's collection of ORF
has declined due to a decrease in industry volume and the adjustment
would serve to provide the Exchange with additional ORF. The additional
ORF offsets regulatory expenses, but does not exceed regulatory costs.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that the ORF is equitable and not unfairly
discriminatory because it is objectively allocated to Exchange members
in that it would continue to be charged to all members on all of their
transactions that clear as customer at OCC. The Exchange is assessing
higher fees to those member firms that require more Exchange regulatory
services based on the amount of customer options business they conduct.
In addition, the ORF seeks to recover the costs of supervising and
regulating members, including performing routine surveillances,
investigations, examinations, financial monitoring, and policy,
rulemaking, interpretive, and enforcement activities. The ORF is not
charged for member proprietary options transactions because members
incur the costs of owning memberships and through their memberships are
charged transaction fees, dues and other fees that are not applicable
to non-members. Additionally, the dues and fees paid by members go into
the general funds of the Exchange, a portion of which is used to help
pay the costs of regulation.

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.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\7\ 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.
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    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
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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-Phlx-2012-36 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2012-36. 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
a.m. and 3 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-Phlx-2012-36 and should be
submitted on or before April 23, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-7771 Filed 3-30-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 59 (Wednesday, March 27, 2019)]
[Notices]
[Pages 11597-11599]
[FR Doc No: 2019-05806]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85389; File No. SR-NASDAQ-2019-016]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Delay the Protocol Ouch To Trade Options or OTTO on The Nasdaq Options
Market LLC

March 21, 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 March 13, 2019, The Nasdaq Stock Market LLC (``Nasdaq'' 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 delay the protocol ``Ouch to Trade
Options'' or ``OTTO'' on The Nasdaq Options Market LLC (``NOM'').
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.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
    Nasdaq filed a rule change \3\ which adopted a new protocol ``Ouch
to Trade Options'' or ``OTTO'' \4\ and proposed to rename and modify
the current OTTO protocol as ``Quote Using Orders'' or ``QUO.'' \5\ The
Exchange subsequently filed a rule change to amend Chapter VI, Section
6(e), titled ``Detection of Loss of Communication'' which describes the
impact to NOM protocols in the event of a loss of a communication. The
Exchange accounted for both the new OTTO and renamed and modified QUO
within this rule. Similarly, the Exchange amended Chapter VI, Section
8, ``Nasdaq Opening and Halt Cross'' to account for the new OTTO and
renamed and modified QUO within this rule. Finally, the Exchange
amended Chapter VI, Section 19, ``Data Feeds and Trade Information'' to
amend ``OTTO DROP'' to ``QUO DROP'' and noted within Chapter VI,
Section 18(a)(1) related to Order Price Protection rule or ``OPP'' that
OPP shall not apply to orders entered through QUO.\6\
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    \3\ See Securities Exchange Act Release No. 83888 (August 20,
2018), 83 FR 42954 (August 24, 2018) (SR-NASDAQ-2018-069) (``Prior
Rule Change''). In the Prior Rule Change the Exchange stated that it
would issue an Options Trader Alert announcing the implementation
date in Q4 2019 [sic].
    \4\ As modified by the Prior Rule Change, OTTO is an interface
that allows Participants and their Sponsored Customers to connect,
send, and receive messages related to orders to and from the
Exchange. Features include the following: (1) Options symbol
directory messages (e.g., underlying); (2) system event messages
(e.g., start of trading hours messages and start of opening); (3)
trading action messages (e.g., halts and resumes); (4) execution
messages; (5) order messages; and (6) risk protection triggers and
cancel notifications. See NOM Rules at Chapter VI, Section
21(a)(i)(C).
    \5\ QUO is an interface that allows NOM Market Makers to
connect, send, and receive messages related to single-sided orders
to and from the Exchange. Order Features include the following: (1)
Options symbol directory messages (e.g., underlying); (2) system
event messages (e.g., start of trading hours messages and start of
opening); (3) trading action messages (e.g., halts and resumes); (4)
execution messages; (5) order messages; and (6) risk protection
triggers and cancel notifications. Orders submitted by NOM Market
Makers over this interface are treated as quotes. See NOM Rules at
Chapter VI, Section 21(a)(i)(D).
    \6\ See Securities Exchange Act Release No. 84559 (November 9,
2019), 83 FR 57774 (November 16, 2018) (SR-NASDAQ-2018-085)
(``Subsequent Rule Change'').
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    Both the Prior Rule Change and the Subsequent Rule Change indicated
the aforementioned rule changes would be implemented for QUO and OTTO
in Q4 of 2018 with the date announced via an Options Traders Alert. The
Exchange filed a rule change implementing QUO and delaying the
introduction of the OTTO functionality until Q1 2019 by announcing the
date of implementation via an Options Traders Alert.\7\ The Exchange
proposes to further delay the implementation of OTTO functionality
until Q3 2019. The Exchange will issue an Options Trader Alert
notifying Participants when this functionality will be available.
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    \7\ See Securities Exchange Act Release No. 84723 (December 4,
2018), 83 FR 63692 (December 11, 2018) (SR-NASDAQ-2018-097). The
Exchange proposed to immediately implement QUO as of the
effectiveness of SR-NASDAQ-2018-097 and delay the implementation of
OTTO by issuing an Options Trader Alert announcing the
implementation date in Q1 2019. The QUO implementation became
effective upon filing on November 26, 2018.
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    The Exchange proposes this delay to allow the Exchange additional
time to implement this functionality and for Participants to sign-up
for this new port and test with the Exchange.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\8\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\9\ 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 by
delaying the OTTO functionality to allow the Exchange additional time
to implement this functionality and for Participants to sign-up for
this new port and test with the Exchange.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 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. The Exchange's proposal to
delay the adoption of the OTTO functionality does not impose an undue
burden on competition. Delaying the OTTO functionality will allow the
Exchange additional time to implement this functionality and for
Participants to sign-up for this new port and test with the Exchange.

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 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 \10\ and Rule 19b-
4(f)(6) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-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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    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \13\ 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 immediately upon filing. The Exchange states that
the waiver will allow the Exchange additional time to implement this
functionality and for Participants to sign-up for this new port and
test with the Exchange and ensure a successful implementation of the
OTTO. The Commission believes that waiver of the 30-day operative delay
is consistent with the protection of investors and the public interest.
Accordingly, the Commission hereby waives the operative delay and
designates the proposed rule change as operative upon filing.\14\
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 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).
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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-NASDAQ-2019-016 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2019-016. 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-NASDAQ-2019-016 and should be submitted
on or before April 17, 2019.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-05806 Filed 3-26-19; 8:45 am]
 BILLING CODE 8011-01-P