[Federal Register Volume 84, Number 211 (Thursday, October 31, 2019)]
[Rules and Regulations]
[Pages 58318-58320]
[FR Doc No: 2019-23398]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0816 Airspace Docket No. 19-AWA-4]
RIN 2120-AA66

Amendment of Class C Airspace; Huntsville, AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies the Huntsville, AL, Class C airspace area
by amending the legal description to update the current airport
reference point (ARP) for the Huntsville International-Carl T. Jones
Field and the name of the Redstone AAF airport information.
Additionally, minor administrative edits to the legal description title
and the Chart Supplement reference are made for readability. This
action does not change the boundaries, altitudes, or operating
requirements of the Class C airspace area.

DATES: Effective date 0901 UTC, December 5, 2019. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of FAA Order 7400.11D at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations

Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it updates the ARP geographic coordinates for the Huntsville
International-Carl T. Jones Field and the airport name for the Redstone
AAF that is contained in the Huntsville, AL, Class C airspace
description.

History

    Class C airspace areas are designed to improve air safety by
reducing the risk of midair collisions in high volume airport terminal
areas and to enhance the management of air traffic operations in that
area. During a recent review of the Huntsville, AL, Class C airspace
area description, the FAA identified that the airport's ARP geographic
coordinates and the Redstone AAF airport name were incorrect. This
action updates the Huntsville International-Carl T. Jones Field ARP
geographic coordinates and the Redstone AAF airport name to coincide
with the FAA's aeronautical database information. There are no changes
to the boundaries, altitudes, or air traffic control services resulting
from this action.
    Class C airspace designations are published in paragraph 4000 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, which is incorporated by reference in 14 CFR part 71.1. The Class
C airspace designation listed in this document will be published
subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending the Huntsville International-Carl T. Jones Field
ARP geographic coordinates and the Redstone AAF airport name contained
in the airspace area description. The Huntsville International-Carl T.
Jones Field ARP geographic position for the airport is changed from
``lat. 34[deg]38'25'' N, long. 86[deg]46'30''; W'' to ``lat.
34[deg]38'14'' N, long. 86[deg]46'23'' W.'' and the airport name
``Redstone Army Air Field'' is changed to ``Redstone AAF''. These
amendments to the Huntsville International-Carl T. Jones Field ARP
geographic coordinates and Redstone AAF airport name reflect the
current information in the FAA's aeronautical database. Additionally,
minor administrative edits to the legal description title and Chart
Supplement reference were made for readability and to comply with
airspace legal description policy guidance.
    This is an administrative change and does not affect the
boundaries, altitudes, or operating requirements of the airspace,
therefore, notice and public procedure under 5 U.S.C. 553(b) is
unnecessary.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a Regulatory Evaluation as the anticipated impact is so minimal.
Since this is a routine matter that only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act, and its agency
implementing regulations in FAA Order 1050.1F, ``Environmental Impacts:
Policies and Procedures'' regarding categorical exclusions for
procedural actions at paragraph 5-6.5a, which categorically excludes
from full environmental impact review rulemaking actions that designate
or modify classes of airspace areas, airways, routes, and reporting
points. Since this action does not change the boundaries, altitudes, or
operating requirements of the Class C airspace area, and only amends
the legal description to contain the current Huntsville International-
Carl T. Jones Field ARP geographic coordinates and Redstone AAF airport
name information, this airspace action is not expected to cause any
potentially significant environmental impacts. In accordance with FAAO
1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this
action has been reviewed for factors and circumstances in which a
normally categorically excluded action may have a significant
environmental impact requiring further analysis, and it is determined
that no extraordinary circumstances exist that warrant preparation of
an environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019,
effective September 15, 2019, is amended as follows:

Paragraph 4000 Class C Airspace.

* * * * *

ASO AL C Huntsville, AL [Amended]

Huntsville International-Carl T. Jones Field, AL
    (Lat. 34[deg]38'14'' N, long. 86[deg]46'30'' W)
Redstone AAF, AL
    (Lat. 34[deg]40'43'' N, long. 86[deg]41'05'' W)

    That airspace within a 5-mile radius of the Huntsville
International-Carl T. Jones Field extending upward from the surface
to and including 4,600 feet MSL, excluding that airspace within a 1-
mile radius of the Redstone AAF; and that airspace within a 10-mile
radius of the airport from the 015[deg] bearing from the airport
clockwise to the 145[deg] bearing from the airport extending upward
from 2,400 feet MSL to and including 4,600 feet MSL; and that
airspace within a 10-mile radius of the airport from the 145[deg]
bearing from the airport clockwise to the 015[deg] bearing from the
airport extending upward from 2,000 feet MSL to and including 4,600
feet MSL. All airspace contained within Restricted Areas R-2104A, R-
2104B, and R-2104C is excluded from this Class C airspace area when
they are active. This Class C airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

    Issued in Washington, DC, on October 21, 2019.
Scott M. Rosenbloom,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2019-23398 Filed 10-30-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3483-3485]
[FR Doc No: 2013-00795]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68618; File No. SR-OCC-2012-801]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of Advance Notice, as Modified by Amendment No. 1
Thereto, in Connection With a Proposed Change To Enter Into an
Unsecured, Committed Credit Agreement

January 10, 2013.
    Pursuant to Section 806(e)(1) of the Payment, Clearing, and
Settlement Supervision Act of 2010 (``Clearing Supervision Act'') \1\
and Rule 19b-4(n)(1)(i),\2\ notice is hereby given that on December 18,
2012, The Options Clearing Corporation (``OCC'') filed with the
Securities and Exchange Commission (``Commission'') the advance notice
described below. On December 21, 2012, OCC filed Amendment No. 1 to the
advance notice.\3\ The advance notice as amended by Amendment No. 1 is
described in Items I, II, and III below, which Items have been prepared
primarily by OCC. The Commission is publishing this notice to solicit
comments on the advance notice and Amendment No. 1 from interested
persons.
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    \1\ 12 U.S.C. 5465(e)(1).
    \2\ 17 CFR 240.19b-4(n)(i).
    \3\ Amendment No. 1 corrects Item 2 of OCC's Form 19b-4 to
indicate that ``[t]he proposed change was approved by the Board of
Directors of OCC at a meeting held on July 24, 2012,'' rather than
September 25, 2012.
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I. Clearing Agency's Statement of the Terms of Substance of the Advance
Notice

    OCC is filing this advance notice in connection with a change to
its operations (the ``Change'') in the form of entering into an
unsecured, committed credit agreement (the ``Agreement'' or the
``Facility''). The Facility would provide OCC with access to additional
liquidity for working capital needs and general corporate purposes. The
Facility would also help satisfy the liquidity requirement of the
Commodity Futures Trading Commission's (``CFTC'') regulation Section
39.11(e)(2).

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Advance Notice

    In its filing with the Commission, OCC included statements
concerning the purpose of and basis for the advance notice and
discussed any comments it received on the advance notice. The text of
these statements may be examined at the places specified in Item IV
below. OCC has prepared summaries, set forth in sections (A), (B), and
(C) below, of the most significant aspects of these statements.\4\
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    \4\ The Commission has modified the text of the summaries
prepared by OCC.
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(A) Advance Notices Filed Pursuant to Section 806(e) of the Payment,
Clearing and Settlement Supervision Act

Description of Change
    The proposed Change would provide OCC with access to an unsecured,
committed credit facility in an aggregate principal amount not to
exceed $25 million. The Facility would be designed to provide OCC with
access to additional liquidity for working capital needs and general
corporate purposes. The Facility will also satisfy the liquidity
requirement of CFTC regulation Section 39.11(e)(2).\5\ OCC also does
not expect any need to draw funds against the Facility. OCC's principal
reason for entering into the Facility is to provide OCC additional
flexibility in managing its liquid assets while ensuring continued
compliance with the liquidity requirements of the CFTC regulations
cited above.
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    \5\ For clarity concerning the scope of the proposed Change, OCC
notes that the Commission recently published a notice of no
objection to an OCC advance notice filing through which OCC replaced
a separate credit facility that is maintained for the purpose of
meeting obligations that may arise out of the default or suspension
of an OCC clearing member or the failure of a bank or securities or
commodities clearing organization to perform its obligations due to
bankruptcy, insolvency, receivership, or suspension of operations.
Securities Exchange Act Release No. 34-68002 (October 5, 2012); 77
FR 62308 (October 12, 2012).
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    Among other things, CFTC regulation Section 39.11(a)(2) requires a
derivatives clearing organization (``DCO'') to hold an amount of
financial resources that, at a minimum, exceeds the total amount that
would enable the DCO to cover its operating costs for a period of at
least one year, calculated on a rolling basis.\6\ In turn, CFTC
regulation Section 39.11(e)(2) provides that these financial resources
must include unencumbered, liquid financial assets (i.e., cash and/or
highly liquid securities), equal to at least six months' operating
costs and that if any portion of such financial resources is not
sufficiently liquid, the DCO may take into account a committed line of
credit or similar facility for the purpose of meeting this
requirement.\7\ Accordingly, under the proposed Change, OCC would enter
into a credit agreement for the Facility with BMO Harris Bank N.A.
(``Lender'') having a maximum aggregate principal loan amount not to
exceed $25 million.
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    \6\ 17 CFR 39.11(a)(2).
    \7\ 17 CFR 39.11(e)(2).
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    One of the conditions of OCC's access to the Facility is the
execution of credit agreement documents between OCC and the Lender. OCC
anticipates that the parties will finalize the forms of the credit
agreement documents in early 2013. Ongoing conditions governing OCC's
ability to access the Facility would include that no default or event
of default by OCC may exist before or during an extension of credit by
the Lender to OCC through the Facility and that certain representations
of OCC must remain true and correct. Events of default would include,
but not be limited to, failure to pay any interest, principal, fees or
other amounts when due, default under any covenant or agreement in any
loan document, materially inaccurate or false representations or
warranties, cross default with other material debt agreements,
insolvency, bankruptcy, dissolution or termination of the existence of
OCC, and unsatisfied judgments.
    The Facility would be available to OCC on a revolving basis for a
364-day term. Upon notice by OCC to the Lender of a request for funds,
whether in writing or by telephone, the Lender would disburse loaned
funds to OCC in U.S. dollars. The date of any loan would be required to
be a business day, and the loans would be unsecured and made and
evidenced by a promissory note provided by OCC. Under the terms of
OCC's Agreement with the Lender, any loan proceeds would be required to
be used by OCC to finance its working capital needs or for OCC's
general corporate purposes. OCC's ability to draw against the Facility,
even though no such draw is actually made, would contribute to OCC's
compliance with the liquidity requirements prescribed by CFTC
regulation Section 39.11(e)(2).
    OCC would have the ability to terminate the Facility at any time.
Termination within the first six months of the Facility would trigger a
termination fee. After six months from the date of entering the
Agreement with the Lender to establish the terms of the Facility, OCC
would be permitted to cancel the Facility with no termination fee. Upon
five days written notice during the term of the Facility, OCC would
also be permitted to reduce the overall size of the Facility at any
time. Any such reductions would be required to be made in an initial
amount of at least $2.5 million. Thereafter, reductions would be able
to be made in multiples of $1 million. In no event, however, would OCC
be permitted to reduce the size of the Facility to an

amount that is less than the greater of either its aggregate principal
amount of indebtedness outstanding with respect to loans from the
Facility or $15 million.\8\
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    \8\ In the event that OCC seeks to terminate or reduce the
overall size of the Facility, OCC will first file an advance notice
with the Commission.
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    The outstanding principal balance of all loans made to OCC through
the Facility will accrue interest equal to a base rate (generally equal
to a Prime Rate, a Federal Funds Rate, or a LIBOR rate), as in effect
from time to time, plus a certain applicable margin. Regardless of
which method applies to a particular portion of OCC's total outstanding
loan balance, in an event of a default the calculation of the amount of
interest would be subject to a 2.00% increase above the otherwise
applicable rate.
    The Facility would involve a variety of customary fees payable by
OCC to the Lender, including, but not limited to: (1) A one-time
upfront fee payable at closing to the Lender calculated as a percentage
of the total commitment amount of the Facility; (2) commitment fees
payable quarterly in arrears on the average daily unused amount of the
Facility; (3) reasonable out-of-pocket costs and expenses of the Lender
in connection with the negotiation, preparation, execution, and
delivery of the Facility and loan documentation, and costs and expenses
in connection with any default, event of default, or enforcement of the
Facility; and (4) termination fees if OCC elects to terminate the
Facility prior to six months from the date of the credit agreement
underlying the Facility.
Anticipated Effect on and Management of Risk
    OCC believes that any impact of the Facility on the risks presented
by OCC would be to reduce such risks by providing an additional source
of liquidity for the protection of OCC, its clearing members, and the
options market in general. OCC also believes it would provide OCC with
additional liquidity for working capital needs and general corporate
purposes and thereby assist OCC in satisfying the CFTC's requirements
with respect to liquidity under CFTC regulation Section 39.11.
    Like any lending arrangement, OCC notes there is a risk that the
Lender would fail to fund when OCC requests a loan, because of the
Lender's insolvency, operational deficiencies, or otherwise. Even if
OCC were to draw on the Facility for liquidity purposes, which it does
not anticipate, OCC believes that the potential funding risk associated
with the Facility is mitigated in several ways. First, the Lender is a
national banking association that is subject to oversight by prudential
banking regulators with respect to its safety and soundness and its
ability to meet its lending obligations. Furthermore, the $25 million
size of the Facility would be relatively small when compared to the
total resources available to OCC. Therefore, if the Facility proved
unavailable to OCC for any reason, OCC believes that it readily would
be able to access, or arrange for access, to other sources of liquidity
if necessary.
    According to OCC, a second risk associated with the Facility is the
risk that OCC would default on its obligation to make timely payment of
principal or interest. OCC believes the benefits of the Facility
outweigh this risk. Finally, because the Facility would be an unsecured
lending arrangement, OCC would not be at risk in an event of default of
the Lender potentially liquidating OCC assets that are used to secure
loaned funds.

(B) Clearing Agency's Statement on Comments on the Advance Notice
Received From Members, Participants, or Others

    Written comments were not and are not intended to be solicited with
respect to the advance notice and none have been received.

III. Date of Effectiveness of the Advance Notice and Timing for
Commission Action

    The clearing agency may implement the proposed change pursuant to
Section 806(e)(1)(G) of the Clearing Supervision Act \9\ if it has not
received an objection to the proposed change within 60 days of the
later of (i) the date that the Commission received the advance notice
or (ii) the date the Commission receives any further information it
requests for consideration of the notice. The clearing agency shall not
implement the proposed changes contained in the advance notice if the
Commission objects to the proposed change.
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    \9\ 12 U.S.C. 5465.
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    The Commission may extend the period for review by an additional 60
days if the proposed change raises novel or complex issues, subject to
the Commission providing the clearing agency with prompt written notice
of the extension. A proposed change may be implemented in less than 60
days from the date of receipt of the advance notice, or the date the
Commission receives any further information it requested, if the
Commission notifies the clearing agency in writing that it does not
object to the proposed change and authorizes the clearing agency to
implement the proposed change on an earlier date, subject to any
conditions imposed by the Commission.
    The proposal shall not take effect until all regulatory actions
required with respect to the proposal are completed. The clearing
agency shall post notice on its Web site of proposed changes that are
implemented.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing. 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-OCC-2012-801 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-OCC-2012-801. 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 advance notice that are filed
with the Commission, and all written communications relating to the
advance notice between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings also will be available for inspection
and copying at the principal office of OCC and on OCC's Web site at
http://www.theocc.com/about/publications/bylaws.jsp.
    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-OCC-2012-801 and should be submitted on or before
February 6, 2013.

    By the Commission.
Kevin O'Neill,
Deputy Secretary.
[FR Doc. 2013-00795 Filed 1-15-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Notices]
[Page 50730]
[FR Doc No: 2012-20577]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67599A; File No. SR-DTC-2012-03]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing of Amendment No. 1 and Order Granting Accelerated
Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To
Implement a Change in the Practices of The Depository Trust Company as
They Relate to Post-Payable Adjustments; Correction

August 16, 2012.
AGENCY: Securities And Exchange Commission.

ACTION: Notice; correction.

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SUMMARY: The Securities and Exchange Commission published a document in
the Federal Register of August 10, 2012, concerning a Notice of Filing
of Amendment No. 1 and Order Granting Accelerated Approval of a
Proposed Rule Change, as Modified by Amendment No. 1, to Implement a
Change in the Practices of The Depository Trust Company as They Relate
to Post-payable Adjustments; The request for comment information was
inadvertently omitted from the document.

FOR FURTHER INFORMATION CONTACT: Kenneth Riitho, Division of Trading
and Markets, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549,<PHONE_NUMBER>.

Correction

    The following language is added to the end of section III above the
third line from the bottom of the second column in the document
published in the Federal Register of August 10, 2012, in FR Doc. 2012-
19579:

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 (www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2012-03 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-DTC-2012-03. 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 (www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m.
    Copies of the filing also will be available for inspection and
copying at the principal office of the DTC. 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-DTC-2012-03 and should be submitted on
or before August 31, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority (17 CFR 200.30-3(a)(12)).
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-20577 Filed 8-21-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 230 (Wednesday, November 30, 2016)]
[Notices]
[Pages 86368-86369]
[FR Doc No: 2016-28778]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79388; File No. SR-NYSEArca-2016-136]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change Amending NYSE Arca Equities Rule 7.35P To Provide for Widened
Price Collar Thresholds for the Core Open Auction on Volatile Trading
Days

November 23, 2016.
    On September 28, 2016, NYSE Arca, Inc. (the ``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend NYSE Arca Equities Rule 7.35P \3\ to
widen price collar thresholds for the Core Open Auction on volatile
trading days. The proposed rule change was published for comment in the
Federal Register on October 14, 2016.\4\ The Commission received no
comment letters on the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The Commission notes that the Exchange recently re-
designated NYSE Arca Equities Rule 7.35P as NYSE Arca Equities Rule
7.35. See Securities Exchange Act Release No. 79078 (October 11,
2016), 81 FR 71559 (October 17, 2016) (SR-NYSEArca-2016-135).
    \4\ See Securities Exchange Act Release No. 79068 (October 7,
2016), 81 FR 71127.
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    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is November 28, 2016. The Commission is extending this 45-day time
period.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change.
Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\6\ designates January

12, 2017, as the date by which the Commission shall either approve or
disapprove or institute proceedings to determine whether to disapprove
the proposed rule change (File Number SR-NYSEArca-2016-136).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-28778 Filed 11-29-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Notices]
[Pages 76331-76333]
[FR Doc No: 2014-29832]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1837]

Transfer of a Premarket Notification (510(k)) Clearance--
Questions and Answers; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Transfer of a Premarket
Notification (510(k)) Clearance--Questions and Answers.'' The purpose
of the draft guidance is to provide information on how to notify FDA of
the transfer of a premarket notification clearance from one holder to
another, and the procedures FDA and industry should use to ensure
public information in FDA's databases about the current 510(k) holder
for a specific device(s) is accurate and up-to-date. This draft
guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 23, 2015. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by February 20, 2015,
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Transfer of a Premarket Notification (510(k)) Clearance--Questions
and Answers'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002 or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research (CBER), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Marjorie Shulman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1536, Silver Spring, MD 20993-0002, 301-
796-6572 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

I. Background

    FDA is announcing the availability of the draft guidance entitled
``Transfer of a Premarket Notification (510(k)) Clearance--Questions
and Answers.'' This draft guidance provides information on how to
notify FDA of the transfer of a 510(k) clearance from one holder to
another, and the procedures FDA and industry should use to ensure
public information in FDA's databases about the current 510(k) holder
for a specific device(s) is accurate and up-to-date.
    Previously, FDA's databases did not reflect changes in the 510(k)
holder that occurred after FDA's clearance of the 510(k). This was in
part because 510(k) holders were not required to list their devices by
510(k) number, which made it difficult for FDA to tie a particular
510(k) to its current holder. Lack of updated, accurate 510(k) holder
information created a number of challenges for FDA, for current 510(k)
holders, future 510(k) submitters, and other stakeholders.
    The Food and Drug Administration Amendments Act of 2007 (FDAAA)
(Public Law 110-85) amended section 510 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by requiring domestic and foreign device
establishments to begin submitting their registration and device
listing information to FDA by electronic means rather than on paper
forms,\1\ and also specified the timeframes within which establishments
are required to submit such information.\2\ In accordance with FDAAA,
the Agency launched FDA's Unified Registration and Listing System
(FURLS), an Internet-based registration and listing system.\3\
---------------------------------------------------------------------------

    \1\ See FD&C Act section 510(p) (21 U.S.C. 360(p)).
    \2\ See FD&C Act sections 510(b)(2), (i), and (j) (21 U.S.C.
360(b)(2), (i), and (j)).
    \3\ See 77 FR 45927 (August 2, 2012).
---------------------------------------------------------------------------

    Notification to FDA of a sale or other transfer of a 510(k)
clearance, whether or not the device is already on the market, is
accomplished by compliance with device listing requirements. As a
result of the launch of the FURLS Device Registration and Listing
Module (DRLM) and the changes to the registration and listing
regulations that became effective on October 1, 2012,\4\ the medical
device listing information provided to FDA changed. Owners and
operators of medical device establishments that market 510(k)-cleared
devices must now supply the FDA-assigned premarket submission number of
the cleared 510(k) when they list their devices in FURLS.\5\ This
listing allows FDA to easily identify the holder of each 510(k) based
on the records created by manufacturers, specification developers,
repackers/relabelers, single-use device reprocessors, or
remanufacturers in FURLS DRLM. Listing information is required to be
updated at least annually \6\ and there may only be one 510(k) holder
for a device at a time; \7\ therefore, this updated listing provides
FDA with current 510(k) holder information by 510(k) number.
---------------------------------------------------------------------------

    \4\ See id.
    \5\ See 21 CFR 807.25(g)(4).
    \6\ See FD&C Act section 510(j) (21 U.S.C. 360(j)) and 21 CFR
807.22.
    \7\ See FD&C Act section 510(k) (21 U.S.C. 360(k)) and 21 CFR
807.81(a).
---------------------------------------------------------------------------

 II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on how to
notify FDA of the transfer of a 510(k) clearance and the procedures FDA
and industry should use to ensure public information in FDA's databases
about the current 510(k) holder for a specific device(s) is accurate
and up-to-date. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by

downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Transfer of a Premarket Notification
(510(k)) Clearance--Questions and Answers,'' may send an email request
to<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1808 to identify the guidance
you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501- 3520), 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.
Title: Transfer of a Premarket Notification (510(k)) Clearance--
Questions and Answers
    This draft guidance is intended to provide information on how to
notify FDA of the transfer of a 510(k) clearance from one person to
another, and the procedures FDA and industry should use to ensure
public information in FDA's databases about the current 510(k) holder
for a specific device(s) is accurate and up-to-date. The proposed
information collection seeks to provide information in order to notify
FDA of the transfer of a premarket notification (510(k)) clearance.
    Description of respondents: The respondents to this collection of
information are 510(k) holders and parties claiming to be 510(k)
holders. The Agency estimates the burden of this collection of
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
  Guidance title: transfer of a                      Number of                    Average burden
 premarket notification (510(k))     Number of     responses per   Total annual    per response     Total hours
clearance--questions and answers    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
Voluntary reporting of transfer            4,080               1           4,080             .25           1,020
 of 510(k) Clearance on FDA's
 Unified Registration and
 Listing System (Outside of
 Annual Listing Reporting
 Requirement)...................
Submission of 510(k) transfer              2,033               1           2,033               4           8,132
 documentation when more than
 one party lists the same 510(k)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           9,152
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Currently, FDA estimates 78% of 510(k)s are listed outside of the
annual registration cycle based on numbers in the FURLS database from
fiscal year 2009 through fiscal year 2014. Fiscal year 2008 was left
out of this cohort as it was the first year that registrants were
required to report the 510(k) number on their listings and, therefore,
an unusually high number of listings were created. An average of 5,231
510(k)s have been listed in each year since 2008. Because listing
outside of the annual requirement is voluntary, FDA estimates that
annually 78% of 510(k)s will continue to be listed outside of the
annual requirement. FDA estimates that 4,080 510(k)s may be listed
outside of the annual registration cycle. FDA estimates that it will
take approximately 15 minutes for each listing, for a total reporting
burden of 1,020 hours.
    FDA estimates it will have 2,033 instances of more than one party
claiming to be a 510(k) holder for a specific device as part of annual
registration and listing. The Agency reached this estimate by
identifying the number of unique 510(k) device listings entered in
FURLS between fiscal years 2009 and 2014 that conflict with a listing
already entered by another party (5,304), dividing that number by the
number of years (six), and multiplying by the average number of parties
claiming to be the 510(k) holder when there is a conflict in the
current FURLS database (2.3). The draft guidance identifies potential
documentation a party could submit to FDA to establish the transfer of
a 510(k) clearance. FDA estimates it will take a party approximately 4
hours to locate and submit information to establish the transfer of the
510(k) clearance, resulting in 8,132 burden hours for those 2,033
parties claiming to be 510(k) holders. FDA reached this estimate based
on its expectation of the amount of time it will take a party to locate
the information, to copy, and to submit a copy to FDA.
    The burden estimate does not include the maintenance of records
used to document transferring a premarket notification (510(k))
clearance. Based on available information, FDA believes that the
maintenance of these records is a usual and customary part of normal
business activities. For example, in the ordinary course of business,
supporting documents should be kept to verify asset information for
calculating the annual depreciation or calculating gain or loss on sale
of an asset on a businesses' tax return. Therefore, this

recordkeeping requirement creates no additional paperwork burden.
    Before the proposed information collection provisions contained in
this draft guidance become effective, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the information collection provisions. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
    This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR part 807 (registration and listing) are approved under OMB
control number 0910-0625; collections of information in 21 CFR part 807
subpart E (premarket notification submission) have been approved under
OMB control number 0910-0120 and collections of information in 42 CFR
493.17 have been approved under OMB control number 0910-0607.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: December 16, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29832 Filed 12-19-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52477-52478]
[FR Doc No: 2018-22565]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3633]

Oncology Center of Excellence: Pediatric Oncology Program;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Oncology Center of Excellence (OCE) Pediatric Oncology
Program of the Food and Drug Administration (FDA or the Agency)
announces the creation of a list of molecular targets that have been
determined to be substantially relevant to the growth or progression of
a pediatric cancer (Candidate Pediatric Molecular Target List) and a
list of molecular targets of new cancer drugs and biological products
in development for which requirements for studies in pediatric cancers
would be automatically waived. The former list includes molecular
targets for which prevailing evidence and/or a scientific rationale
exists to determine their potential relevance to the growth or
progression of one or more pediatric cancers. The latter list details
those targets that are unlikely to be associated with the growth or
progression of pediatric cancers such that statutory requirements for
early pediatric evaluation would be waived. These lists fulfill one of
FDA's obligations under the FDA Reauthorization Act of 2017 (FDARA) and
provide information to industry in planning for initial pediatric study
plan submissions for certain oncology drugs or biological products in
accordance with the amended provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act). FDA is establishing this docket for public
comment on possible additions to or deletions from the list on the
lists described above.
    The lists can be found on the Oncology Center of Excellence:
Pediatric Oncology website at the following link: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm544641.htm.

DATES: Submit either electronic or written comments. This docket will
remain open indefinitely.

ADDRESSES: You may submit comments as follows:

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 below (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-2018-N-3633 for ``Oncology Center of Excellence: Pediatric Oncology
Program; Establishment of a Public Docket; Request for Comments.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA 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 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 the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://

www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Christine Lincoln, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 22, Rm. 2118, Silver Spring, MD 20993-0002, email:
[email protected].

SUPPLEMENTARY INFORMATION: The use of tumor genetic profiling in cancer
treatment decision making has transformed therapeutic strategies in
many adult cancers. Extension of this approach to treatment decision
making for children with cancer, however, has been greatly diminished
due to delays in evaluation of potentially active drugs. Until the
passage of section 504 of FDARA, section 505B of the FD&C Act (21
U.S.C. 355c) has not typically been a useful mechanism to require the
development of drugs for pediatric cancers, since most of the oncology
drugs approved for adults are used to treat cancers that very rarely or
never occur in children (e.g. cancers of the lung, prostate and
breast). Therefore, historically, drug sponsors have requested and
obtained waivers for conducting the required assessments of these drugs
in pediatric patients. Additionally, drugs developed for rare cancer
indications that received orphan designation are exempted from the pre-
FDARA requirement to conduct pediatric assessments--even if the cancers
those products are intended to treat occur in both adult and pediatric
patients--due to the fact that the orphan designation exempts them from
such studies (see section 505B(k) of the FD&C Act). However, FDARA
amended section 505B so that the requirement for pediatric
investigations of drugs directed at molecular targets determined to be
substantially relevant to the growth and progression of a pediatric
cancer apply even when the adult indication has received an orphan
designation, or when the adult indication does not occur, in the
pediatric population (e.g., prostate cancer).
    Although requirements to study investigational therapies in
pediatric oncology were exceedingly rare, other incentives have been
put into place to promote the development of oncology products for
pediatric cancer. Section 505A of the FD&C Act (21 U.S.C. 355a)
provides incentives, in the form of 6 months of additional marketing
exclusivity, to encourage sponsors of investigational therapies to
conduct pediatric studies of medicines with the potential for use in
children. To date, section 505A has been one of the few mechanisms
available to incentivize evaluation of new oncology products in
children and adolescents. Nevertheless, further development of more
novel products that address the substantial unmet needs of the
pediatric population is needed.
    Section 504 of FDARA requires FDA, with input from the National
Cancer Institute (NCI) and others, to develop and regularly update: (1)
A list of molecular targets that are determined to be substantially
relevant to the growth and progression of a pediatric cancer, and that
may trigger the requirement for pediatric investigations under section
505B of the FD&C Act, and (2) a list of molecular targets of new cancer
drugs and biological products in development for which the requirement
for pediatric investigations under section 505B of the FD&C Act would
be automatically waived.
    To date, a total of 205 candidate molecular targets were identified
from peer-reviewed literature searches, review of publicly available
genomic databases, such as NCI Genomic Data Commons, TARGET
(Therapeutically Applicable Research to Generate Effective Targets),
St. Jude PeCan Data Portal, Ped PanCan, and INFORM (Individualized
Therapy for Relapsed Malignancies in Childhood), and input from
international subject matter experts. Of these, 62 (30.3 percent)
target a gene abnormality, 40 (19.5 percent) target a cell lineage
determinant, 21 (10.2 percent) target the tumor microenvironment or the
immune system, and 77 (37.6 percent) are classified as ``Others.'' Five
(2.4 percent) are candidates for automatic waivers.

    Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22565 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 869-873]
[FR Doc No: 2013-31601]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71210; File No. SR-CHX-2013-24]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Amend the Market Data Revenue Rebates Program

December 31, 2013.
    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 December 23, 2013, the Chicago Stock Exchange, Inc. (``CHX'' or
the ``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 self-regulatory
organization. CHX has filed this proposal pursuant to Exchange Act Rule
19b-4(f)(6) \3\ which is effective upon filing with the Commission
[sic]. 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.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    CHX proposes to amend Section P of its Schedule of Fees and
Assessments (the ``Fee Schedule'') to include Market Data Revenue from
trade reports within the purview of the Market Data Revenue Rebates
Program. The text of this proposed rule change is available on the
Exchange's Web site at (www.chx.com) and in 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 CHX included statements
concerning the purpose of and basis for the proposed rule changes [sic]
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 CHX 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 Exchange proposes to amend Section P of its Fee Schedule to
include Market Data Revenue (``MDR'') from trade reports (``Trade
Reports MDR'') within the purview of the MDR Rebates Program.
Specifically, the amended MDR Rebates Program calls for 50% of MDR that
exceeds fixed thresholds in any one of six quote or trade reports pools
(``Excess MDR'') to be shared with Participants in proportion to their
respective Eligible Quote or Trade Activity in that pool from the
previous calendar quarter. If the sum of a Participant's rebates from
all pools in a given quarter satisfies the de minimis requirement of
current Section P(3), the Participant will receive a payment equal to
that amount. Aside from the proposed sharing of Trade Reports MDR, the
Exchange does not propose to substantively amend the current MDR
Rebates Program in any other way.
Background
    The Securities Information Processors (``SIPs''), which include the
Securities Information [sic] Automation Corporation (``SIAC'') and the
Unlisted Trading Privilege Plan Quotation Data Feed (``UQDF'') [sic],
collect fees from subscribers for trade and quote tape data received
from trading centers and reporting facilities, such as the CHX
(collectively ``SIP Participants''). After deducting the cost of
operating each tape, the profits are allocated among the SIP
Participants on a quarterly basis, according to a complex set of
calculations that consider [sic] estimates of anticipated MDR,
adjustments to comport to actual MDR from previous quarters and a non-
linear aggregation of total trading and quoting activity in Tapes A, B
and C securities in allocating MDR to each SIP Participant. Based on
these calculations, the SIPs provide MDR payments to each SIP
Participant during the first month of each quarter for trade and quote
data from the previous calendar quarter, which are subject to
adjustment through subsequent quarterly payments. These payments can be
divided into six pools

(i.e., quoting and trading activity in Tape A, B and C securities).
Current MDR Rebates Program
    On September 27, 2013, the Exchange adopted Section P of the Fee
Schedule to implement an MDR Rebates Program to share MDR from quotes
(``Quotes MDR'') only, which became operative on October 1, 2013.\4\
Specifically, current Section P(1) provides that assuming that the
requirements of Section P are met, a Participant will receive a
quarterly MDR Rebate attributable to the Participant's quoting of
displayed orders in Tapes A, B and C securities, collectively referred
to as ``eligible quote activity,'' from the previous calendar quarter.
Furthermore, Section P(2) provides that MDR will be calculated
separately for eligible quote activity in Tape A, B and C securities,
for a total of three pools. Specifically, if the MDR received by the
Exchange in any given pool exceeds the following thresholds in any
given calendar quarter, 50% of such Excess MDR will be paid to
Participants in proportion to their respective eligible quote activity
in that pool.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 70546 (September 27,
2013), 78 FR 61413 (October 3, 2013) (SR-CHX-2013-18) (``Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Adopt
a Market Data Revenue Rebates Program'').

----------------------------------------------------------------------------------------------------------------
                            Source                                  Tape A           Tape B           Tape C
----------------------------------------------------------------------------------------------------------------
Quotes.......................................................          $3,000         $204,000          $12,000
----------------------------------------------------------------------------------------------------------------

In addition, Section P(3) provides a de minimis requirement that states
that a Participant will not receive an MDR Rebate in any calendar
quarter in which the total MDR Rebate attributed to a Participant is
less than $500.

    The Exchange utilizes a set of calculations to attribute Quotes MDR
to Participants that are similar to calculations currently utilized by
the SIPs in attributing Quotes MDR to SIP Participants. In sum, if
Excess MDR exists in a given quotes pool, the Exchange assigns quote
credits to each Participant according to their [sic] eligible quote
activity in that pool, which takes into account the actual dollar
amount of the quote and how long the quote was at the National Best Bid
or Offer (``NBBO''). In turn, the actual dollar amount of the rebate
for a Participant is the product of the percentage of the total quote
credits assigned to the Participant in a given pool and 50% of the
Excess MDR in the same pool. If a Participant is eligible for MDR
Rebates from multiple pools, the Participant will be eligible to
receive an MDR Rebate equal to the sum of all the rebates. However, if
the sum of the rebates is less than $500, the Participant will not
receive a payment and the rebate will be kept by the Exchange. The
purpose of the de minimis requirement is to encourage significant quote
activity and for the Exchange to avoid having to pay Participants for
de minimis Excess MDR.
    As for calculating the pool of funds from which MDR Rebates will be
paid, unlike the SIPs, the Exchange derives MDR Rebate allocation from
a fixed value that is not be subject to adjustment (i.e., the amount of
MDR actually received by the Exchange on a quarterly basis). This
avoids the problem of having to adjust MDR Rebates that have already
been paid to Participants to comport to adjustments to MDR made by the
SIPs.\5\
---------------------------------------------------------------------------

    \5\ For example, if MDR paid to the Exchange was less than
anticipated in Q3 2014 due to an adjustment to the MDR paid to the
Exchange in Q2 2014 (i.e., actual MDR in Q2 fell short of
estimates), the Exchange will not recoup the difference from the
Participants that had been paid the Q2 MDR Rebate. Instead, the MDR
Rebate for Q3 will be calculated based on the actual MDR paid to the
Exchange in Q3.
---------------------------------------------------------------------------

    Moreover, the Excess MDR thresholds were selected based on
historical data of the Exchange's quote activity and MDR that has been
paid to the Exchange in previous quarters. The dollar values represent
the amount of MDR that must be paid to the Exchange by the SIPs before
the 50% of the Excess MDR would be eligible for sharing pursuant to the
MDR Rebates Program.
Amended MDR Rebates Program
    The Exchange now proposes to expand the current MDR Rebates Program
to share Trade Reports MDR. Aside from this, the Exchange does not
propose to substantively amend the current MDR Rebates Program in any
other way.
    Specifically, proposed Section P(1) provides that assuming that the
requirements of this Section are met, a Participant will receive a
quarterly MDR Rebate in proportion to the Participant's quoting of
displayed orders in Tapes A, B and C securities (``Eligible Quote
Activity'') \6\ and trades resulting from single-sided resting orders
submitted by the Participant in Tapes A, B and C securities (``Eligible
Trade Activity'') from the previous calendar quarter. Initially, the
Exchange proposes to replace the term ``attributable'' with ``in
proportion'' in order to be consistent with the use of the phrase ``in
proportion'' in current Section P(2). Also, trades resulting from cross
orders \7\ and single-sided orders submitted by the Participant that
executed against resting order(s) on the CHX Book are not ``Eligible
Trade Activity.'' The purpose of excluding these types of orders from
the definition of ``Eligible Trade Activity'' is to specifically
encourage Participants to post marketable limit orders on the CHX Book
and, thereby, increase liquidity on the Exchange.
---------------------------------------------------------------------------

    \6\ The Exchange proposes to capitalize the current ``eligible
quote activity'' and proposed ``Eligible Trade Activity,'' as they
are defined terms.
    \7\ CHX Article 1, Rule 2(a)(2) defines a ``cross'' order, in
pertinent part, as ``an order to buy and sell the same security at a
specific price better than the best bid and offer displayed in the
Matching System and which would not constitute a trade-through under
Reg NMS (including all applicable exceptions and exemptions).''
---------------------------------------------------------------------------

    Furthermore, proposed Section P(2) provides that MDR will be
calculated separately for quotes and trade reports in Tape A, B and C
securities, for a total of six pools. Notably, the Exchange proposes to
replace the term ``eligible quote activity'' with the more general
``quotes and trade reports'' to clarify that the MDR thresholds in each
of the six pools are calculated not based on Eligible Quote or Trading
Activity, but rather, on all Quotes and Trade Reports MDR received by
the Exchange. Moreover, proposed Section P(2) also provides that if the
MDR received by the Exchange in any given pool exceeds the following
proposed thresholds in any given calendar quarter, 50% of such Excess
MDR will be paid to Participants in proportion to their respective
Eligible Quote or Trade Activity in that pool.
---------------------------------------------------------------------------

    \8\ Like the current Quotes MDR thresholds, the proposed Trade
Reports MDR thresholds were selected based on historical data of the
Exchange's trading activity and MDR that has been paid to the
Exchange in previous quarters.

----------------------------------------------------------------------------------------------------------------
                            Source                                  Tape A           Tape B           Tape C
----------------------------------------------------------------------------------------------------------------
Quotes.......................................................          $3,000         $204,000          $12,000
Trade Reports \8\............................................          27,000           36,000           18,000
----------------------------------------------------------------------------------------------------------------

    The Exchange notes that the SIPs do not distinguish between trades
from single-sided orders and trades from cross orders in attributing
Trade Reports MDR to a SIP Participant. As such, the Exchange proposes
to similarly consider all Trade Reports MDR received from the SIPs in
determining whether or not Excess MDR exists in a given trade reports
pool. However, given that the Exchange's proposed definition of
``Eligible Trade Activity,'' Excess MDR in a given trade reports pool
will be allocated to Participants based solely on trades resulting from
single-sided resting orders submitted by the Participant. [sic] That
is, a Participant's trading activity based on cross orders or single-
sided orders that take liquidity from the CHX Book will not count as
Eligible Trade Activity.
    The Exchange does not propose to amend current Section P(3), which
provides an aggregate $500.00 de minimis threshold that must be met
before an MDR Rebate is payable to a Participant.
    The Exchange proposes to utilize a set of calculations to attribute
Trade Reports MDR to Participants that are similar to calculations
currently utilized by the SIPs in attributing Trade Reports MDR to SIP
Participants. If Excess MDR exists in any given trade reports pool, the
Exchange proposes to assign trade credits to each Participant according
to their [sic] Eligible Trade Activity per trade reports pool.
Specifically, the trade credit values will be derived from a set of
calculations that will consider, inter alia, a Participant's percentage
of (A) the total dollar amount of trades in a given security and (B)
the total number of qualified trade reports in the same security. In
turn, similar to how Quotes MDR is currently attributed to
Participants, the actual dollar amount of Trade Reports MDR attributed
to a Participant in a given pool will be the product of the percentage
of the total trade credits assigned to the Participant in that pool and
50% of the Excess MDR in that pool. If a Participant is eligible for
MDR Rebates from multiple quotes and trade reports pools, the
Participant will be eligible to receive a payment that is equal to the
sum of all the rebates for a given calendar quarter. However, if the
sum of the rebates is less than $500, the Participant will not receive
a payment and the rebate will be kept by the Exchange.
    Similar to the current Quote MDR Rebates, the Exchange does not
propose to adjust the Trade Reports MDR Rebates paid to Participants in
subsequent quarters to comport to adjustments made by the SIPs to
previous MDR payments made to the Exchange. This avoids the problem of
having to adjust Trade Reports MDR Rebates that have already been paid.
    The following Examples 1 and 2 illustrate how Excess MDR will be
calculated and distributed.
    Example 1. The following table represents the proposed MDR pool
thresholds:

----------------------------------------------------------------------------------------------------------------
                             Source                                   Tape A          Tape B          Tape C
----------------------------------------------------------------------------------------------------------------
Quotes..........................................................          $3,000        $204,000         $12,000
Trade Reports (single-sided orders only)........................          27,000          36,000          18,000
----------------------------------------------------------------------------------------------------------------

    Assume that the Q1 2014 MDR paid to the Exchange is apportioned as
follows:

----------------------------------------------------------------------------------------------------------------
                             Source                                   Tape A          Tape B          Tape C
----------------------------------------------------------------------------------------------------------------
Quotes..........................................................          $2,900        $244,000         $12,000
Trade Reports (single-sided orders only)........................          20,000          50,000          18,000
----------------------------------------------------------------------------------------------------------------

    With respect to quotes, the Tape B quotes pool has Excess MDR in
the amount of $40,000. However, the Tapes A and C quotes pools have no
Excess MDR because the actual MDR received by the Exchange in the Tape
A pool was $100 short of its $3,000 threshold and the Tape C pool was
equal to its $12,000 threshold. Thus, Participants may be paid MDR
Rebates in proportion to their quote credits from 50% of the Excess MDR
in the Tape B pool, which is $20,000.
    With respect to trade reports, the Tape B trade reports pool has
Excess MDR in the amount of $14,000. However, the Tapes A and C trade
reports pools have no Excess MDR because the actual MDR received by the
Exchange in the Tape A pool was $7,000 short of its $27,000 threshold
and the Tape C pool was equal to its $18,000 threshold. Thus,
Participants may be paid MDR Rebates in proportion to their trade
credits from 50% of the Excess MDR in the Tape B trade reports pool,
which is $7,000.
    Example 2. Assume the same as Example 1 and there are five
Participants (i.e., Participants A, B, C, D and E) that had Eligible
Quote and Trading Activity in Tape B securities in the previous
calendar quarter. After calculating the Tape B quote credits and Tape B
trade credits for each Participant, the attributed MDR for each
Participant would be as follows:

                         Table 1--Quotes Credits
------------------------------------------------------------------------
                                           Tape B Quotes
               Participant                    Credits     Attributed MDR
------------------------------------------------------------------------
A.......................................          24,000            $480
B.......................................          75,000           1,500
C.......................................         201,000           4,020
D.......................................         300,000           6,000
E.......................................         400,000           8,000
                                         -------------------------------
Total...................................       1,000,000          20,000
------------------------------------------------------------------------

                         Table 2--Trade Credits
------------------------------------------------------------------------
                                           Tape B Trade
               Participant                    Credits     Attributed MDR
------------------------------------------------------------------------
A.......................................             500           $3.50
B.......................................          77,500          542.50
C.......................................         210,000        1,470
E.......................................         407,000        2,849
                                         -------------------------------
Total...................................       1,000,000        7,000
------------------------------------------------------------------------

    Each Participant is attributed MDR according to their [sic]
respective percentage of the total Tape B quote or trade credits
assigned. For instance, Participant A was allocated 2.4% (i.e., 24,000
credits) of the total 1,000,000 Tape B quotes credits attributed to all
five Participants. As such, Participant A would be attributed 2.4% of
the Excess MDR in the Tape B quotes pool, which is $480 (i.e., 2.4% x
$20,000 = $480). Participant A was also allocated .05% (i.e., 500
credits) of the total 1,000,000 Tape B trade credits attributed to all
five Participants. As such, Participant A would also be attributed
0.05% of the Excess MDR in the Tape B trade reports pool, which is
$3.50. In total, Participant A would be attributed a total of $483.50
for the quarter. However, since the total MDR attributed to Participant
A is less than $500 and there are no other MDR pools with Excess MDR,
the de minimis exception would result in Participant A not receiving an
MDR payment for that quarter. In contrast, since the other Participants
were attributed MDR in amounts greater than $500, these Participants
would be paid an MDR Rebate in an amount that is the sum of their
attributed MDR in each of the two Tape B pools.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \9\ in general, and furthers the
objectives of Section 6(b)(4) of the Act \10\ in particular, in that it
provides for the equitable allocation of MDR Rebates among members and
other persons using any facility or system which the Exchange operates
or controls. The Exchange believes that the amended MDR Rebates Program
will promote display liquidity and order flow to the Exchange. In
addition, these changes to the Fee Schedule would equitably allocate
MDR Rebates among Participants by paying MDR Rebates in proportion to
their Eligible Quote and Trade Activity in Tape A, B and C securities
in any given calendar quarter.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed change to amend
the MDR Rebates Program contributes to the protection of investors and
the public interest by promoting display liquidity on, and order flow
to, the Exchange. Consequently, the MDR rebates, as amended, will
promote competition that is necessary and appropriate in furtherance of
the purpose 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

    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 after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6) \12\
thereunder.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest. The Exchange proposes to implement the program in time for
the initial calendar quarter for 2014. Waiver would allow the Exchange
to adhere to this proposed timetable. Also, prompt implementation of
the changes to the program may encourage competition among exchanges
that have market data revenue sharing programs. For these reasons, and
because the proposed rule change presents no novel issues, the
Commission designates the proposal operative upon filing.\13\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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-CHX-2013-24 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-CHX-2013-24. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices 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-CHX-2013-24,
and should be submitted on or before January 28, 2014.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-31601 Filed 1-6-14; 8:45 am]
BILLING CODE 8011-01-P[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][NOTICES]


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Page 54133]
[FR Doc No: 2018-23380]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4393-DR;
Docket ID FEMA-2018-0001]

North Carolina; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Carolina (FEMA-4393-DR), dated September 14,
2018, and related determinations.

DATES: This amendment was issued October 14, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Carolina is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of September 14, 2018.

    Anson and Union Counties for Individual Assistance (already
designated for Public Assistance).
    Orange County for Individual Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-23380 Filed 10-25-18; 8:45 am]
 BILLING CODE 9111-11-P