? Need to return call by / at/ between and . Signature: Project No.: 0<IP_ADDRESS> DISTRIBUTION Page __ 1_ of _ 1_

Project Name: 304m National Strategy TELEPHONE CALL RECORD Outgoing Call Date: 11/ 25/ 03 Time: 5: 30 pm Company Name: Naval Facilities Engineering Service Center Contact Name: Richard Lee, Ph. D.

Phone No.: ( 805) 982 1670 Name: Cortney Itle Eastern Research Group, Inc.

GENERAL SUBJECT : Sodium Nitrite TOPICS DISCUSSED AND ACTION TAKEN After some introductory e mail correspondence, I called Dr. Richard Lee of the Naval Facilities Engineering Service Center to discuss sodium nitrite as a water pollutant and the removal of sodium nitrite from water.

Dr. Lee explained that the Navy uses sodium nitrite mainly as a corrosion inhibitor in ships with steam boilers. Solutions with high concentrations of sodium nitrite are placed in the boiler tubes when the ship is out of commission for periods of time to prevent corrosion. This is the main use of sodium nitrite, although minor amounts are used to test for leaks; the boiler tubes are filled with a sodium nitrite solution until the leaks are detected. Other uses include hydroblast cleaning and rinsing.

Dr. Lee told me that the Navy was producing wastewater with high concentrations sodium nitrite. The nitrite would oxidize to nitrate, and the wastewater treatment plant would not accept the Navy's wastewater. The Navy had to pay to have the waste hauled off site. This was expensive, and the Navy wanted to develop a treatment method to allow for the reuse of the sodium nitrite and the removal of the sodium nitrite from the water. Dr. Lee helped to design a system that performed these tasks.

Dr. Lee's treatment system stores sodium nitrite for reuse and prevents it from oxidizing to nitrate. The system also removes the nitrite from the water by converting it to nitrogen gas.

I asked Dr. Lee if he thought that the Navy had unique uses of sodium nitrite, and if sodium nitrite use could be expected in any other industries. Dr Lee responded that he had no knowledge of industries outside of the Navy, but he mentioned that other industries might use chemicals other than sodium nitrite to prevent corrosion and extend boiler life. He was not sure what those chemicals might be.

Dr. Lee thought that there were other systems in use similar to the one that he helped design. He did not know exactly how many systems there were, or if any of them were still operational. He was also unsure of any person to contact for more information.


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34332-34333]
[FR Doc No: 2016-12704]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3127-023]

Ware River Power, Inc.; Notice of Application Accepted for
Filing, Soliciting Comments, Motions to Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Application to amend 5 MW exemption from
licensing.
    b. Project No.: 3127-023.
    c. Date Filed: January 27, 2016.
    d. Applicant: Ware River Power, Inc.
    e. Name of Project: Ware River Project.
    f. Location: The project is located on the Ware River in Hampshire
County, Massachusetts.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708.
    h. Applicant Contact: Mr. Lucus Wright, Ware River Power, Inc., 48
Allen Drive, P.O. Box 512, Barre, MA 01005<PHONE_NUMBER>.
    i. FERC Contact: Mr. Mark Pawlowski,<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, protests,
and recommendations is 15 days from the date of issuance of this notice
by the Commission. The Commission strongly encourages electronic
filing. Please file motions to intervene, protests, comments, or
recommendations using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. Please include the project number (P-3127-023) on
any comments, motions to intervene, protests, or recommendations filed.
    k. Description of Request: The Ware River Project consists of an
Upper and Lower development. The applicant proposes to replace the
lower development's single 250-kilowatt (kW) turbine with a 280-kW
turbine and install a new 110-kW minimum flow turbine. The lower
development's installed capacity would increase by 140 kW and the
hydraulic capacity would increase by 94 cubic feet per second. In
addition, the applicant proposes replace the lower development's
existing 30-foot-wide by 10-foot-deep trashrack structure with a new
50-foot-wide by 10-foot deep trashrack structure. The new trashrack
would maintain the current 1.5-inch spacing between the trashrack bars.
To facilitate the trashrack replacement the applicant proposes to draw
down the 10-acre lower development's impoundment from June 2016 through
September 2016.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208- 3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but

only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading,
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the license amendment.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: May 24, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-12704 Filed 5-27-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40655-40658]
[FR Doc No: 2020-14517]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1411]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for Data to Support Cross-Center
Collaboration for Social Behavioral Sciences Associated With Disease
Prevention, Treatment, and the Safety, Efficacy, and Usage of Food and
Drug Administration Regulated Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a new collection of information to collect
entitled ``Generic Clearance for Data to Support Cross-Center
Collaboration for Social Behavioral Sciences Associated with Disease
Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA
Regulated Products.''

DATES: Submit either electronic or written comments on the collection
of information by September 8, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 8, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 8, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1411 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Clearance for Data to
Support Cross-Center Collaboration for Social Behavioral Sciences
Associated with Disease Prevention, Treatment and the Safety, Efficacy,
and Usage of FDA Regulated Products.'' 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,<PHONE_NUMBER>.
     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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information 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.

Generic Clearance for Data To Support Cross-Center Collaboration for
Social Behavioral Sciences Associated With Disease Prevention,
Treatment and the Safety, Efficacy, and Usage of FDA Regulated Products

OMB Control Number 0910-NEW

    FDA is seeking to conduct qualitative and quantitative research
studies to better understand consumers', patients', caregivers',
academic/scientific experts', and public health professionals'
perceptions and behaviors regarding various issues and outcomes
associated with disease prevention, treatment, and the safety and
efficacy off all FDA-regulated products. These studies may consist of
small groups, focus groups, individual indepth interviews, and surveys
relating to the evaluation of disease prevention and treatment and the
safety, efficacy, and usage of FDA-regulated products and communication
messages and strategies, and other materials directed to consumers,
patients, caregivers, and public health professionals (e.g., evaluate
the effectiveness of communication messages, educational materials, and
interventions directed toward promoting and protecting human and animal
health).
    Among the general provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), FDA is charged with promoting the public
health through regulatory oversight as well as clinical research.
Specifically, section 1003 of the FD&C Act (21 U.S.C. 393(d)(2)(C) and
(D)) provides that the Commissioner of Food and Drugs shall be
responsible for research. Accordingly, FDA is seeking to conduct
qualitative and quantitative research studies. These studies may
consist of small groups, focus groups, individual in-depth interviews,
and surveys relating to the evaluation of disease prevention and
treatment and the safety, efficacy, and usage of FDA-regulated products
and communication messages and strategies, and other materials directed
to consumers, patients, caregivers, and public health professionals
(e.g., evaluate the effectiveness of communication messages,
educational materials, and interventions directed toward promoting and
protecting human and animal health).
    The information collection is intended to support research
conducted by, or on behalf of, FDA. Understanding consumers, patients,
caregivers, academic/scientific experts, and public health
professionals' perceptions and behaviors plays an important role in
improving FDA's decision-making processes and communications impacting
various stakeholders. To better understand consumers, patient,
caregivers, academic/scientific experts, and public health
professionals' perceptions and behaviors regarding various issues and
outcomes associated the disease prevention, treatment, and the safety,
efficacy, and usage of products overseen by the Agency, FDA is
requesting approval of this generic information collection request.
    The qualitative and quantitative research anticipated by FDA aligns
with Agency objectives. For example, among

eight scientific priorities is the goal to support social and
behavioral sciences. Such research helps the Agency meet this goal by:
     Identifying gaps in the target audience's knowledge
regarding FDA-regulated products, and outcomes associated the disease
prevention, treatment;
     reaching diverse audiences;
     assessing target audiences' knowledge, perceptions, and
behaviors about FDA-regulated products;
     evaluating the effectiveness of FDA's communications;
     exploring ways to incorporate patient input into decision-
making;
     leveraging real-world data;
     evaluating outcomes; and
     integrating the knowledge gained from the research into
Agency communications, activities, interventions, and programs.
    FDA will only submit a collection for approval under this generic
clearance if it meets the following conditions: information provided by
respondents will be kept private and anonymous, except as otherwise
required by law. This will be communicated to respondents by means of
introductory letters, explanatory texts on the cover pages of
questionnaires, scripts read prior to focus groups or telephone
interviews, and consent forms as appropriate. Respondents also will be
advised of the following: (1) The nature of the activity; (2) the
intended purpose and use of the data collected; (3) FDA sponsorship
(when appropriate); and (4) the fact that participation is voluntary at
all times. Because responses are voluntary, respondents will be assured
that there will be no penalties if they decide not to respond, either
to the information collection as a whole or to any individual
questions.
    Only Agency or Agency-sponsored personnel will have access to
individual-level surveys, interviews, or focus group data. All project
staff from a contractor or cooperative agreement grantee conducting the
information collection must take required measures to ensure respondent
privacy and confidentiality of data. Personally identifiable
information (PII) shall be limited to data that may be required in the
process of respondent enrollment. PII will be accessible to only those
contractors or cooperative agreement grantee who need it and will not
be linked to interview data. Neither FDA employees nor any Federal
employee of any other agency will have access to PII. All PII will be
destroyed by contractors as soon as feasible following data collected
during interviews.
    All electronic and hard-copy data will be maintained securely
throughout the information collection and data processing phases. While
under review, electronic data will be stored in locked files on secured
computers; hard-copy data will be maintained in secure building
facilities in locked filing cabinets. As a further guarantee of privacy
and anonymity, all data will be reported to FDA in aggregate form, with
no links to individuals preserved. Reports generated by this
information collection will be used only for research purposes and for
the development of communication messages.
    Social and behavioral testing efforts described in this proposal
are typically considered exempt from the ``Regulations for the
Protection of Human Subjects'' in accordance with 45 CFR 46.101(b)(3).
Before data are collected, FDA researchers must obtain either an
exemption or an expedited or full approval for all research from FDA's
institutional review board (IRB).
    When FDA's IRB determines that minors are capable of giving assent,
the IRB shall determine whether adequate provisions are made for
soliciting assent. Generally, assent requires securing the signature of
a minor potentially participating in the research in a separate assent
form, in addition to the consent form the parent or legal guardian
signs. An assent document should: (1) Contain an explanation of the
study; (2) a description of what is required of the subject (e.g., what
he or she will experience (whether the minor will be in the hospital,
whether the minor's parents will be with him or her, etc.)); (3) an
explanation of any risks and pain associated with the study; (4) an
explanation of any anticipated change in the minor's appearance; and
(5) an explanation of the benefits to the minor or others.
    FDA plans to use the data collected under this generic clearance to
inform its FDA-regulated products educational, interventions, outcomes,
and regulatory science programs, materials and resources and disease
prevention and treatment. FDA expects the data to guide the formulation
of the Agency's educational and public health objectives on FDA-
regulated products and support development of subsequent research
efforts. The data will not be used to make policy or regulatory
decisions. Rather, these data will: (1) Inform FDA's public education
campaigns and other educational/interventional materials directed to
informing consumers, patients, caregivers, and public health
professionals about human and animal health issues and (2) provide
information on the safety, efficacy, and usage of FDA-regulated
products.
    If these conditions are not met, FDA will submit an information
collection request to OMB for approval through the normal PRA process.
    To obtain approval for a collection that meets the conditions of
this generic clearance, an abbreviated supporting statement will be
submitted to OMB along with supporting documentation (e.g., a copy of
the interview or moderator guide, screening questionnaire).
    FDA will submit individual qualitative and quantitative collections
under this generic clearance to the OMB. Individual collections will
also undergo review by FDA's IRB, senior leadership in the for the
primary investigator's respective offices, and PRA specialists.
    Description of Respondents: The respondents to this collection of
information are all FDA stakeholders including, general population
individuals, as well as consumers of certain products, patients and
their caregivers, academic/scientific experts, individuals from
specific target labor groups such as physicians, medical specialists,
pharmacists, dentists, nurses, veterinarians, dietitians, and other
public health professionals.
    FDA estimates 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 per response       Total hours
                                                    respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys/Focus Groups.................           2,520             14.6           36,792   0.25 (15 minutes).................           9,198
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This is a new collection of information whose total estimated
annual reporting burden is 9,198 hours. The number of participants to
be included in each individual generic submission under this collection
of information will vary, depending on the nature of the compliance
efforts and the target audience.

    Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14517 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 109 (Tuesday, June 7, 2011)]
[Notices]
[Pages 33017-33018]
[FR Doc No: 2011-13949]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64579; File No. SR-NASDAQ-2011-071]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding the Correction of an Inadvertent Error in NASDAQ Rule 7019(d)

 June 1, 2011.
    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 May 20, 2011, The NASDAQ Stock Market LLC (``NASDAQ'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been substantially prepared by NASDAQ. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

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

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

    NASDAQ proposes to make a correction to the definition of ``Direct
Access'' in NASDAQ Rule 7019(d). NASDAQ proposes to implement the
proposed rule change immediately.
    The text of the proposed rule change is available on NASDAQ Web
site http://nasdaq.cchwallstreet.com, at NASDAQ's principal office, 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, NASDAQ included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NASDAQ has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    NASDAQ proposes to make a correction to NASDAQ Rule 7019(d) of its
Market Data Distributor Fees rule to correct an inadvertent error in
the definition of ``Direct Access'' contained in a recent filing
(``previous filing'').\3\ The previous filing intended to amend the fee
schedule to correct an anomaly that effectively exempted certain
customers residing within NASDAQ's co-location facility from paying a
monthly fee for direct access to NASDAQ data, while customers that
received data from an extranet and resided outside the co-location
facility were assessed the fee. The previous filing also deleted
outdated verbiage in the fee schedule in order to eliminate confusion
regarding application of the fees. However, the rule language contained
an inadvertent error that effectively still exempts certain co-located
customers receiving NASDAQ data feeds from paying a direct access fee.
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 63441 (December 6,
2010), 75 FR 77022, (December 10, 2010) (SR-NASDAQ-2010-152).

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

    The definition should be corrected to make clear that the
definition of ``Direct Access'' is also applicable to a
telecommunications interface with NASDAQ for receiving NASDAQ data
feeds (and not NASDAQ data) within the NASDAQ co-location facility as
well. NASDAQ is making this change due to an inadvertent clerical error
in the previous filing and is making no other changes to NASDAQ Rule
7019.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\4\ in general, and with
Sections 6(b)(5) of the Act,\5\ in particular. The proposal is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. The proposed rule change is
to correct an inadvertent error in the definition of ``Direct Access''
in NASDAQ Rule 7019(d) of its Market Data Distributor Fees rule.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Pursuant to Section 19(b)(3)(A) of the Act \6\ and Rule 19b-4(f)(3)
thereunder,\7\ NASDAQ has designated this proposal as one that is
concerned solely with the administration of the self-regulatory
organization. Accordingly, NASDAQ believes that its proposal should
become immediately effective.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-071 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2011-071. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for 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 such 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-
NASDAQ-2011-071 and should be submitted on or before June 28, 2011.

    For the Commission, by the Division of Trading & Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-13949 Filed 6-6-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37158-37159]
[FR Doc No: 2021-14935]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0191]

Determination That STROMECTOL (Ivermectin) Tablets, 6 Milligrams,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that STROMECTOL (ivermectin) tablets, 6 milligrams (mg),
were not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for STROMECTOL (ivermectin) tablets, 6 mg, if all
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    STROMECTOL (ivermectin) tablets, 6 mg, are the subject of NDA
050742, held by Merck Sharp and Dohme Corp., and initially approved on
November 22, 1996. STROMECTOL is indicated for strongyloidiasis of the
intestinal tract and onchocerciasis.
    In a letter dated September 14, 2007, Merck and Co., Inc. notified
FDA that STROMECTOL (ivermectin) tablets, 6 mg, were being
discontinued, and FDA

moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book.
    Foley and Lardner, LLP submitted a citizen petition dated February
16, 2021 (Docket No. FDA-2021-P-0191), under 21 CFR 10.30, requesting
that the Agency determine whether STROMECTOL (ivermectin) tablets, 6
mg, were withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that STROMECTOL (ivermectin) tablets, 6 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that STROMECTOL
(ivermectin) tablets, 6 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of STROMECTOL (ivermectin) tablets, 6 mg,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have reviewed the
available evidence and determined that this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list STROMECTOL
(ivermectin) tablets, 6 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to STROMECTOL (ivermectin) tablets, 6
mg, may be approved by the Agency as long as they meet all other legal
and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: July 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14935 Filed 7-13-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Rules and Regulations]
[Pages 52199-52201]
[FR Doc No: 2014-20958]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2014-0658]
RIN 1625-AA00

Safety Zone: Urban Shield 2014, South San Francisco Bay, Oakland,
CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone in the
navigable waters of South San Francisco Bay in Oakland, CA in support
of the Urban Shield maritime training exercises. This safety zone is
established to ensure the safety of the exercise participants and
mariners transiting the area. Unauthorized persons or vessels are
prohibited from entering into, transiting through, or remaining in the
safety zone without permission of the Captain of the Port or their
designated representative.

DATES: This rule is effective on September 6 and 7, 2014. This rule
will be enforced from 8 a.m. to 7 p.m. on September 6 and 7, 2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2014-0658. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Lieutenant Junior Grade Joshua Dykman,
U.S. Coast Guard Sector San Francisco; telephone<PHONE_NUMBER> or
email at<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.''
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. The Coast Guard received the
information about the event on July 12, 2014, and the event would occur
before the rulemaking process would be completed. Law enforcement
officers will be conducting maritime interdiction operations that
require freedom of movement in a defined area. The safety zone is
necessary to provide for the safety of the law enforcement officers
participating in the training exercises as well as provide for the
safety of vessels transiting near the training area. For the safety
concerns noted, it is in the public interest to have these regulations
in effect during the event.

B. Basis and Purpose

    The legal basis for the proposed rule is 33 U.S.C. 1231; 46 U.S.C.
Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1,
6.04-6, 160.5; Public Law 107-295, 116 Stat. 2064; Department of
Homeland Security Delegation No. 0170.1, which collectively authorize
the Coast Guard to establish safety zones.
    The Alameda County Fire Department will host Urban Shield 2014 on
September 6 and 7, 2014 in the navigable waters of South San Francisco
Bay in Oakland, CA. The safety zone is issued to establish a temporary
restricted area on the waters surrounding the training exercise. This
restricted area is necessary to provide freedom of movement for law
enforcement officers conducting maritime interdiction training and to
ensure the safety of mariners transiting the area.

C. Discussion of the Final Rule

    The Coast Guard will enforce a safety zone in navigable waters
around the Urban Shield maritime training exercises. The Urban Shield
2014 Safety Zone establishes a temporary restricted area on the water
within an area connecting the following points: 37[deg]41'57'' N,
122[deg]13'17'' W; 37[deg]41'49'' N, 122[deg]17'42'' W; 37[deg]40'16''
N, 122[deg]17'42'' W; 37[deg]40'27'' N, 122[deg]14'49'' W; thence back
to the point of origin (NAD 83). This safety zone will be enforced from
8 a.m. until 7 p.m. on September 6 and 7, 2014. At the conclusion of
the training exercises the safety zone shall terminate.
    The effect of the temporary safety zone will be to restrict
navigation in the vicinity of the training exercise. Except for persons
or vessels authorized by the Coast Guard Patrol Commander, no person or
vessel may enter or remain in the restricted area. These regulations
are needed to keep vessels a safe distance away from the vicinity of
the training exercise to ensure the safety of law enforcement officers
conducting training and other mariners transiting the area.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and

Budget has not reviewed it under those Orders.
    We expect the economic impact of this rule will not rise to the
level of necessitating a full Regulatory Evaluation. The safety zone is
limited in duration, and is limited to a narrowly tailored geographic
area. In addition, although this rule restricts access to the waters
encompassed by the safety zone, the effect of this rule will not be
significant because the local waterway users will be notified via
public Broadcast Notice to Mariners to ensure the safety zone will
result in minimum impact. The entities most likely to be affected are
waterfront facilities, commercial vessels, and pleasure craft engaged
in recreational activities.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    This rule may affect owners and operators of waterfront facilities,
commercial vessels, and pleasure craft engaged in recreational
activities and sightseeing. This safety zone would not have a
significant economic impact on a substantial number of small entities
for the following reasons. This safety zone would be activated, and
thus subject to enforcement, for a limited duration. When the safety
zone is activated, vessel traffic could pass safely around the safety
zone. The maritime public will be advised in advance of this safety
zone via Broadcast Notice to Mariners.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone of limited size and duration. This rule is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add temporary Sec.  165.T11-652 to read as follows:

Sec.  165.T11-652  Safety zone; Urban Shield 2014, South San Francisco
Bay, Oakland, CA.

    (a) Location. This temporary safety zone will encompass the
navigable waters of the South San Francisco Bay within an area
connecting the following points: 37[deg]41'57'' N, 122[deg]13'17'' W;
37[deg]41'49'' N, 122[deg]17'42'' W; 37[deg]40'16'' N, 122[deg]17'42''
W; 37[deg]40'27'' N, 122[deg]14'49'' W; thence back to the point of
origin (NAD 83), as depicted in National Oceanic and Atmospheric
Administration (NOAA) Chart 18651.
    (b) Enforcement Period. The zone described in paragraph (a) of this
section will be enforced from 8 a.m. until 7 p.m. on September 6 and 7,
2014. The Captain of the Port San Francisco (COTP) will notify the
maritime community of periods during which this zone will be enforced
via Broadcast Notice to Mariners in accordance with 33 CFR 165.7.
    (c) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer on a Coast Guard
vessel or a Federal, State, or local officer designated by or assisting
the COTP in accordance with a memorandum of understanding in the
enforcement of the safety zone.
    (d) Regulations. (1) Under the general regulations in 33 CFR part
165, subpart C, entry into, transiting or anchoring within this safety
zone is prohibited unless authorized by the COTP or a designated
representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or a designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or a designated representative to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zone must comply with all directions given to
them by the COTP or a designated representative. Persons and vessels
may request permission to enter the safety zone on VHF-23A or through
the 24-hour Command Center at telephone<PHONE_NUMBER>.

    Dated: August 18, 2014.
Gregory G. Stump,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2014-20958 Filed 9-2-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 203 (Monday, October 21, 2019)]
[Notices]
[Pages 56265-56267]
[FR Doc No: 2019-22829]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87309; File No. SR-CBOE-2019-085]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
to Move Certain Rules in Chapter XXVIII of the Currently Effective
Rulebook to Proposed Section D of Chapter 4 of the Shell Structure for
the Exchange's Rulebook That Will Become Effective Upon the Migration
of the Exchange's Trading Platform

October 15, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 3, 2019, Cboe Exchange, Inc. (the ``Exchange'' or
``Cboe Options'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to move certain Rules in Chapter XXVIII of the currently effective
Rulebook (``current Rulebook''), which governs Corporate Debit Security
options, to proposed Section D of Chapter 4 of the shell structure for
the Exchange's Rulebook that will become effective upon the migration
of the Exchange's trading platform to the same system used by the Cboe
Affiliated Exchanges (as defined below) (``shell Rulebook''). The text
of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, 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
    In 2016, the Exchange's parent company, Cboe Global Markets, Inc.
(formerly named CBOE Holdings, Inc.) (``Cboe Global''), which is also
the parent company of Cboe C2 Exchange, Inc. (``C2''), acquired Cboe
EDGA Exchange, Inc. (``EDGA''), Cboe EDGX Exchange, Inc. (``EDGX'' or
``EDGX Options''), Cboe BZX Exchange, Inc. (``BZX'' or ``BZX
Options''), and Cboe BYX Exchange, Inc. (``BYX'' and, together with
Cboe Options, C2, EDGX, EDGA, and BZX, the ``Cboe Affiliated
Exchanges''). The Cboe Affiliated Exchanges are working to align
certain system functionality, retaining only intended differences,
between the Cboe Affiliated Exchanges, in the context of a technology
migration. Cboe Options

intends to migrate its trading platform to the same system used by the
Cboe Affiliated Exchanges, which the Exchange expects to complete on
October 7, 2019. In connection with this technology migration, the
Exchange has a shell Rulebook that resides alongside its current
Rulebook, which shell Rulebook will contain the Rules that will be in
place upon completion of the Cboe Options technology migration.
    The Exchange proposes to relocate certain rules in Chapter XXVIII,
which govern Corporate Debt Security options, to proposed Section D of
Chapter 4 in the shell Rulebook. The Exchange notes that in addition to
relocating certain rules regarding Corporate Debt Security options to
proposed Section D of Chapter 4 in the shell Rulebook, the proposed
rule change deletes the rules from the current Rulebook. The proposed
rule change relocates the rules as follows:

------------------------------------------------------------------------
              Current rule                        Proposed rule
------------------------------------------------------------------------
Introduction...........................  Introductory paragraph under
                                          Section D heading.
Rule 28.1 Definitions..................  Rule 4.30 Definitions.
Rule 28.5 Designation of Corporate Debt  Rule 4.31 Designation of
 Security Options.                        Corporate Debt Security
                                          Options.
Rule 28.6 Approval of Underlying         Rule 4.32 Approval of
 Corporate Debt Securities.               Underlying Corporate Debt
                                          Securities.
Rule 28.7 Terms of Corporate Debt        Rule 4.33 Terms of Corporate
 Security Options.                        Debt Security Options.
Rule 28.8 Series of Corporate Debt       Rule 4.34 Series of Corporate
 Security Options Open for Trading.       Debt Security Options Open for
                                          Trading.
Rule 28.17. FLEX Trading...............  Rule 4.35. FLEX Trading.
------------------------------------------------------------------------

    The proposed changes are of a non-substantive nature and will not
amend the relocated rules other than to update their rule numbers,
conform paragraph structure \3\ and number/lettering format to that of
the shell Rulebook, and make cross-reference changes to shell rules.
---------------------------------------------------------------------------

    \3\ The Exchange notes that the paragraph structure for
definitions listed under rules in the shell Rulebook is in
alphabetized format. Therefore, the same structure is used under
proposed Rule 4.30.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\4\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \5\ requirements 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. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \6\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
    \6\ Id.
---------------------------------------------------------------------------

    As stated, the proposed rule change makes no substantive changes to
the rules. The proposed rule change is merely intended to relocate the
Exchange's rules to the shell Rulebook and update their numbers,
paragraph structure, including number and lettering format, and cross-
references to conform to the shell Rulebook as a whole in anticipation
of the technology migration on October 7, 2019. As such, the proposed
rule change 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 improving the way the Exchange's
Rulebook is organized, making it easier to read, and, particularly,
helping market participants better understand the rules of the
Exchange, which will also result in less burdensome and more efficient
regulatory compliance.

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 proposed rule change is not
intended as a competitive change, but rather, seeks to make non-
substantive rule changes in relocating the rules and updating cross-
references to shell rules in anticipation of the October 7, 2019
technology migration. The Exchange also does not believe that the
proposed rule change will impose any undue burden on competition
because the relocated rule text is exactly the same as the Exchange's
current rules, all of which have all been previously filed with the
Commission.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
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    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Commission has waived that requirement in this case.
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    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\12\ the Commission
may 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 proposed
rule change may become operative immediately. The Exchange notes that
the proposed rule change is merely relocating certain rules to its
shell rulebook--which includes corresponding updates to rule numbers,
paragraph structure, and internal references--in order to conform these
rules to the shell rulebook upon the technology migration explained
above. The Exchange believes that the proposed rule change will make
its rules easier to read and understand for all investors. The Exchange
also asserts that the relocation of the rules explained above will not
impose any significant burden on competition because the substance of
the rules remains unchanged. The Commission agrees that allowing this
proposed rule change to become operative upon filing in order to
facilitate the Exchange's technology migration--without changing the
substance of these Exchange Rules--is consistent with the protection of
investors and the public interest. For this reason, the Commission
hereby waives the 30-day operative delay and designates the proposal
operative upon filing.\13\
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    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ 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 change should be approved or
disapproved.

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-CBOE-2019-085 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-CBOE-2019-085. 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 offices 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-CBOE-2019-085, and should be submitted
on or before November 12, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12), (59).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-22829 Filed 10-18-19; 8:45 am]
 BILLING CODE 8011-01-P