              Email Exchanges Relevant to April 10, 2023 Meeting

These email exchanges followed up on the April 10, 2023 meeting with the subject "Follow Up on SIP Reporting Requirements":

 Email from Leah Martland, CDPHE, to Abby Fulton, EPA, subject "foam manufacturing records" (April 11, 2023, 6:54 AM). Attachments:  "Aurora_Bead_Usage Through November 2021.pdf"  "PentaneRecoveryDaily.pdf"  "PentaneRecoveryAnnual.pdf"  "Records.xlsx"               Email from Abby Fulton, EPA, to Leah Martland, CDPHE, subject "RE: Foam Manufacturing Follow Up" (April 11, 2023, 3:06 PM) (includes earlier emails in same thread)

This document was created on September 27, 2023, for posting to the "Supporting & Related Material" section of docket EPA-R08-OAR-2022-0632.


[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Proposed Rules]
[Page 15963-15964]
[DOCID:fr26mr08-34]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. 2007-0048]
RIN 2127-AJ44, RIN 2127-AJ49

Federal Motor Vehicle Safety Standards, Child Restraint Systems;
Anthropomorphic Test Devices

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Reopening of comment period.

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

SUMMARY: This document reopens the comment period on a supplemental
notice of proposed rulemaking (SNPRM) to amend Federal Motor Vehicle
Safety Standard (FMVSS) No. 213, ``Child Restraint Systems.'' Among
other things, the SNPRM proposed to specify procedures the agency would
use to position a Hybrid III 10-year-old child dummy and a Hybrid III
6-year-old child dummy in booster seats when conducting FMVSS No. 213
compliance tests. Comments on the SNPRM were due March 24, 2008. The
Juvenile Products Manufacturers Association (JPMA) petitioned NHTSA to
extend the comment period by a minimum of 60 days to appropriately
respond with comments to the notice. We have granted the request to
extend the comment period and are reopening the comment period for 45
days.

DATES: Comments must be received by May 12, 2008.

ADDRESSES: You may submit comments (identified by the Docket ID Number
above) by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Submission of
Comments heading of the SNPRM published January 23, 2008. Note that all
comments received will be posted without change to http://
www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: For technical issues, you may call Dr.
Roger Saul, Office of Rulemaking (Telephone:<PHONE_NUMBER>) (Fax: 202-
493-2990). For legal issues, you may call Ms. Deirdre Fujita, Office of
Chief Counsel (Telephone:<PHONE_NUMBER>) (Fax:<PHONE_NUMBER>). You may
send mail to these officials at the National Highway Traffic Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., West Building, Washington, DC 20590.

SUPPLEMENTARY INFORMATION: On January 23, 2008, NHTSA published an
SNPRM that, among other things, proposed seating procedures for
positioning the Hybrid III (HIII) 10-year-old child dummy and the HIII
6-year-old child dummy in booster seats when the dummies are used in
FMVSS No. 213 compliance tests (73 FR 3901; Docket No. 2007-0048). The
SNPRM supplemented a notice of proposed rulemaking (NPRM) published on
August 31, 2005 that proposed to expand the applicability of FMVSS No.
213 to restraints recommended for children weighing up to 80 pounds,
and require booster seats and other child restraints produced for older
children to meet performance criteria when tested with the HIII 10-
year-old child test dummy (70 FR 51720; DMS Docket No. 21245).\1\ The
SNPRM provided a 60-day comment period, which ended March 24, 2008.
---------------------------------------------------------------------------

    \1\ The agency also issued an NPRM that proposed to adopt
specifications and performance requirements for the HIII 10-year-old
child test dummy into 49 CFR Part 572 (notice of proposed rulemaking
published July 13, 2005, 70 FR 40281; Docket No. NHTSA 2004-2005-
21247).
---------------------------------------------------------------------------

    On March 20, 2008, JPMA petitioned NHTSA to extend the comment
period by a minimum of 60 days in order to provide more time to
thoroughly evaluate the seating procedures proposed to position the
HIII 10-year-old and 6-year-old child dummies in booster seats. JPMA
noted that CRS manufacturers do not have immediate access to the HIII
10-year-old child dummy, and with additional time will be able to
obtain the HIII 10-year-old child dummy and gain familiarity with the
seating procedures. JPMA believes that extending the comment period by
a minimum of 60 days will provide enough time to complete ongoing
testing and evaluation of the new seating procedures, which will in
turn lead to more meaningful responses based on real experience and
test data.

Agency Decision

    The agency is reopening the comment period for the January 23, 2008
SNPRM for 45 days in order to balance the interest of receiving
meaningful responses and relevant test data with the interest of
completing the rulemaking as soon as possible. The JPMA petition
indicated that CRS manufacturers are already involved in activities to
test and evaluate the seating procedure. Because these efforts have
already begun, we believe a 45-day comment period should provide
commenters sufficient time to obtain the HIII 10-year-old child dummy,
evaluate the seating procedures for the two child dummies, and gain
experience using the test dummies in sled testing of booster seats. It
is further noted that the agency will consider comments submitted after
the 45-day period to the extent possible.

(Authority: 49 U.S.C. 322, 30111, 30115, 30117 and 30166; delegation
of authority at 49 CFR 1.50.)

    Issued on March 21, 2008.
Roger A. Saul,
Director, Office of Crashworthiness Standards.
[FR Doc. 08-1072 Filed 3-21-08; 12:20 pm]

BILLING CODE 4910-59-P


[Federal Register Volume 85, Number 10 (Wednesday, January 15, 2020)]
[Notices]
[Pages 2468-2474]
[FR Doc No: 2020-00482]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87927; File No. SR-NYSE-2019-46)

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Amendment No. 1 to Proposed Rule Change Amending
the Exchange's Price List Related to Co-Location Services in the
Mahwah, New Jersey Data Center

January 9, 2020.
    On August 22, 2019, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') 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 its co-location fee schedule to offer co-
location Users \3\ access to the ``NMS Network''--an alternate,
dedicated network providing connectivity to data feeds for the National
Market System Plans for which Securities Industry Automation
Corporation (``SIAC'') is engaged as the exclusive securities
information processor (``SIP'')--and establish associated fees. The
proposed rule change was published for comment in the Federal Register
on September 10, 2019.\4\ On October 24, 2019, the Commission extended
the time period within which to approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether to approve or disapprove the proposed rule change, to
December 9, 2019.\5\ The Commission received one comment letter on the
proposal, a response from the Exchanges, and a subsequent letter from
the original commenter.\6\ On December 9, 2019, the Commission
instituted proceedings to determine whether to approve or disapprove
the proposed rule change.\7\ On December 23, 2019, the Exchange filed
Amendment No. 1 to the proposed rule change as described in Items I and
II below, which Items have been prepared by Exchange. The Commission is
publishing this notice to solicit comments on Amendment No. 1 to the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See infra note 9 defining ``Users.''
    \4\ See Securities Exchange Act Release Nos. 86865 (September 4,
2019), 84 FR 47592.
    \5\ See Securities Exchange Act Release Nos. 87399, 84 FR 58189
(October 30, 2019).
    \6\ See, respectively, letter dated October 24, 2019 from John
M. Yetter, Vice President and Senior Deputy General Counsel, Nasdaq
Stock Market LLC (``Nasdaq''), to Vanessa Countryman, Secretary,
Commission (``Nasdaq Letter''); letter dated November 8, 2019 from
Elizabeth K. King, Chief Regulatory Officer, ICE, General Counsel
and Corporate Secretary, NYSE to Ms. Vanessa Countryman, Secretary,
Commission (``NYSE Response Letter''); and letter dated November 25,
2019 from Joan C. Conley, Senior Vice President and Corporate
Secretary, Nasdaq, to Vanessa Countryman, Secretary, Commission
(``Second Nasdaq Letter''). All comments received by the Commission
on the proposed rule change are available on the Commission's
website at: https://www.sec.gov/comments/sr-nyse-2019-46/srnyse201946.htm.
    \7\ See infra note 8.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend the services available to Users that
use co-location services in the Mahwah, New Jersey data center to add
the NMS network to connect to the NMS feeds. This Amendment No. 1,
which supersedes the original filing in its entirety, is designed to
address comments in the Commission's Order instituting proceedings to
determine whether to approve or disapprove the original filing.\8\ The
proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 87699 (December 9,
2019), 84 FR 68239 (December 13, 2019) (SR-NYSE-2019-46)
(``Order'').

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

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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
Overview
    This Amendment No. 1 supersedes the original filing in its
entirety. In the original filing, the Exchange proposed to amend its
co-location services \9\ to provide Users \10\ with an alternate,
dedicated network connection to access the NMS feeds (the ``NMS
network'') for which the Securities Industry Automation Corporation
(``SIAC'') is engaged as the securities information processor (``SIP'')
and proposed fees for the NMS network.\11\
---------------------------------------------------------------------------

    \9\ The Exchange initially filed rule changes relating to its
co-location services with the Commission in 2010. See Securities
Exchange Act Release No. 62960 (September 21, 2010), 75 FR 59310
(September 27, 2010) (SR-NYSE-2010-56). The Exchange operates a data
center in Mahwah, New Jersey (the ``data center'') from which it
provides co-location services to Users.
    \10\ For purposes of the Exchange's co-location services, a
``User'' means any market participant that requests to receive co-
location services directly from the Exchange. See Securities
Exchange Act Release No. 76008 (September 29, 2015), 80 FR 60190
(October 5, 2015) (SR-NYSE-2015-40). As specified in the Price List,
a User that incurs co-location fees for a particular co-location
service pursuant thereto would not be subject to co-location fees
for the same co-location service charged by the Exchange's
affiliates NYSE American LLC (``NYSE American''), NYSE Arca, Inc.
(``NYSE Arca''), and NYSE National, Inc. (``NYSE National'' and
together, the ``Affiliate SROs''). See Securities Exchange Act
Release No. 70206 (August 15, 2013), 78 FR 51765 (August 21, 2013)
(SR-NYSE-2013-59).
    \11\ Specifically, as originally proposed, Users would be
eligible for up to eight ``No Fee NMS Network Connections'' that
would not be subject to any fees. Users not eligible for the No Fee
NMS Network Connection or that needed additional NMS network
connections would have been charged at the same rate as the same-
sized IP network.
---------------------------------------------------------------------------

    On December 9, 2019, the Commission issued an Order instituting
proceedings to determine whether to approve or disapprove the original
filing, and in that Order, raised questions about how the Exchange
proposed to charge fees for the NMS network.\12\ Because the purpose of
the NMS network is to enhance performance of the SIP and not to
generate revenue, to address the questions raised in the Order, the
Exchange is amending the proposal to eliminate any fee changes
associated with the introduction of the NMS network. As amended, this
proposed rule change would solely add the NMS network as part of the
services available if a User purchases a 10 Gigabit (``Gb'') or 40 Gb
connection to one of the two local area networks in the Mahwah data
center.
---------------------------------------------------------------------------

    \12\ See Order, supra note 7. The Order also discussed a comment
letter submitted in connection with the original proposal.
---------------------------------------------------------------------------

    As described below, today Users can connect to Regulation NMS
equities and options feeds \13\ disseminated by the SIP using either of
the co-location local area networks. Currently, a User would need to
purchase a service that includes either a 10 Gb or 40 Gb connection to
access a local area network in order to connect to the NMS feeds.\14\
Users do not pay an additional charge to connect to the NMS feeds: It
comes with their connection to the local area network.\15\
---------------------------------------------------------------------------

    \13\ The NMS feeds include the Consolidated Tape System and
Consolidated Quote System data streams, as well as Options Price
Reporting Authority (``OPRA'') feeds. See Securities Exchange Act
Release No. 79730 (January 4, 2017), 82 FR 3045 (January 10, 2017)
(SR-NYSE-2016-92).
    \14\ Because of the volume of data, a 1 Gb connection is not
sufficient to connect to an NMS feed. See id. at 3047.
    \15\ See id.
---------------------------------------------------------------------------

    The Exchange has recently been authorized to build the NMS network
in the Mahwah data center that will only connect to the NMS feeds. The
new network will connect to the NMS feeds faster than either of the
existing local area networks. Because a User currently needs to
purchase a service that includes access to one of the two local area
networks in the data center via either a 10 Gb or 40 Gb connection to
connect to the NMS feeds, the Exchange proposes to expand that service
to include the option to also connect to the NMS network via a same-
sized connection at no additional charge. Accordingly, with this
proposed rule change, Users will have the option to use the NMS network
or either of the existing local area networks to connect to the NMS
feeds. The Exchange is not proposing any changes to its fees.
    Because the NMS network has been built and tested and is ready to
be implemented, subject to approval of this proposed rule change, the
Exchange proposes to implement the NMS network as soon as practicable.
The Exchange will announce the implementation date through a customer
notice.
Background
    The Exchange's affiliate, SIAC, is engaged as the SIP for three
separate Regulation NMS plans (collectively, the ``NMS Plans'').\16\
SIAC operates as the SIP for the NMS Plans in the same data center
where the Exchange and its Affiliate SROs operate. In that data center,
Users can access SIAC as the SIP over the same network connections
through which they access other services. Specifically, a User can
access the SIAC SIP environment via either the IP network or the
Liquidity Center Network (``LCN''), which are the local area networks
in the data center.\17\
---------------------------------------------------------------------------

    \16\ SIAC has been engaged as the SIP to, among other things,
receive, process, validate and disseminate: (1) Last-sale price
information in Tape A and Tape B-listed securities pursuant to the
CTA Plan (``CTA Plan''), which is available here: https://www.nyse.com/publicdocs/ctaplan/notifications/trader-update/CTA%20Plan%20-%20Composite%20as%20of%20August%2027,%202018.pdf; (2)
quotation information in Tape A and B-listed securities pursuant to
the CQ Plan (``CQ Plan''), which is available here: https://www.nyse.com/publicdocs/ctaplan/notifications/trader-update/CQ_Plan_Composite_as_of_July_9_2018.pdf; and (3) quotation and last-
sale price information in all exchange options trading pursuant to
the OPRA Plan (``OPRA Plan''), which is available here: https://uploads-ssl.webflow.com/5ba40927ac854d8c97bc92d7/5bf419a6b7c4f5085340f9af_opra_plan.pdf.
    \17\ See 82 FR 3045, note 12, supra.
---------------------------------------------------------------------------

    The Exchange offers Users connectivity to the SIAC SIP environment
at no additional charge when a User purchases access to a 10 Gb or 40
Gb LCN or IP network.\18\ In connection with the services available
over the local area networks, the SIAC feeds are referred to as the
``NMS feeds.'' As described in General Note 4 of the Price List, when a
User purchases access to the LCN or IP network, it receives
connectivity to certain market data products (the ``Included Data
Products'') that it selects, subject to technical provisioning
requirements and authorization from the provider of the data feed. The
NMS feeds are included in the list of the Included Data Products that
come with connections to the LCN or IP network. The remaining Included
Data Products are proprietary feeds of the Exchange, its Affiliate
SROs, and the Exchange's affiliate NYSE Chicago, Inc. (``NYSE Chicago''
and together with the Exchange and Affiliate SROs, the ``NYSE
Exchanges'').
---------------------------------------------------------------------------

    \18\ As set forth on the Price List, the Exchange offers a range
of LCN and IP network connectivity options at different rates
depending on the bandwidth and latency profile of the applicable
network.
---------------------------------------------------------------------------

    A User that purchases access to the LCN or IP network also receives
the

ability to access the trading and execution systems of the NYSE
Exchanges (the ``Exchange Systems'') and the trading and execution
systems of OTC Global, an alternative trading system (``ATS''),
subject, in each case, to authorization by the relevant entity.\19\
---------------------------------------------------------------------------

    \19\ See 82 FR 3045, note 12, supra, and Securities Exchange
Release No. 85952 (May 29, 2019), 84 FR 25884 (June 4, 2019) (SR-
NYSE-2019-31). Information regarding the Included Data Products is
currently set forth in the second paragraph of General Note 4.
---------------------------------------------------------------------------

    Accordingly, without paying an additional connectivity fee, a User
that purchases access to either the LCN or IP network can use such
network to:
    1. Access the trading and execution services of five registered
exchanges (five equities markets, two options markets, and a fixed
income market) and an ATS;
    2. Connect to the market data of five registered exchanges (five
equities exchanges, two options markets, and a fixed income market);
and
    3. Connect to the NMS feeds.
    A User may connect to the NMS feeds through the IP network or LCN.
Until recently the operating committee for the CTA and CQ Plans (``CTA/
CQ Plans'') mandated use of the IP network to access the NMS feeds.\20\
As a result, all LCN connections to the NMS feeds go through the IP
network before reaching the NMS feeds,\21\ and so using the LCN to
connect to an NMS feed is slower than using the IP network.\22\
---------------------------------------------------------------------------

    \20\ The Operating Committee of the CTA/CQ Plans mandated the
use of the IP network to access the NMS feeds because the IP network
was built as a secure network designed for resiliency and
redundancy.
    \21\ By contrast, the LCN does not connect to the IP network for
access to the Exchange Systems or connectivity to the other Included
Data Products.
    \22\ A User that uses the LCN to connect to an NMS feed does not
need to separately purchase an IP network connection.
---------------------------------------------------------------------------

Alternate, Dedicated Network Connection for NMS Feeds
    As the SIP for the NMS Plans, SIAC continually assesses the
services it provides and has been working with the operating committees
of the NMS Plans and the industry-based advisory committee to the CTA/
CQ Plans to identify potential performance enhancements. Among other
initiatives, this group identified that, because the IP network was not
designed as a low-latency network, the requirement to use the IP
network to access the NMS feeds introduces a layer of latency.
    To reduce network latency, the Exchange sought and received
approval from the operating committees for the CTA/CQ Plans to build an
alternate to the LCN and IP network to connect to the NMS feeds.\23\ As
approved by the CTA/CQ Plans, the Exchange is building a low-latency
network in the data center that will provide Users with dedicated
access to the NMS feeds (the ``NMS network'').\24\
---------------------------------------------------------------------------

    \23\ The alternate network to access the NMS feeds will not be
available outside of the data center.
    \24\ Because SIAC, as the SIP for the NMS Plans, is also
responsible for collecting data from the participants of the CTA/CQ
Plans and members of the OPRA Plan, Users that are participants of
the applicable NMS Plans could use this alternate network connection
for purposes of both transmitting and receiving data. Users that are
not participants of the NMS Plans could use this alternate network
connection for purposes of receiving data. This alternate network
would not be available to connect to the other Included Data
Products or to access the Exchange Systems or Global OTC.
---------------------------------------------------------------------------

    The Exchange currently anticipates that the low-latency network
will have a one-way reduction in latency to access the NMS feeds from
the IP network and LCN of over 140 microseconds.
    Consistent with the current bandwidth needs to connect to the NMS
feeds, connections to the NMS network will be available in 10 Gb and 40
Gb circuits. Because the NMS network will be an alternate network to
access the NMS feeds, once it is available, Users would have the choice
between continuing to use the LCN or IP network to connect to NMS feeds
or switching to the NMS network.
    Even though the NMS network will provide access only to the NMS
feeds, the Exchange is funding the build of the NMS network and is not
being reimbursed for such expenses by either CTA or OPRA. The
Exchange's capital expenditure costs for the build are estimated to be
$3.8 million, which includes procurement of new low-latency network
switches, network devices, and analytics tools and the one-time
operational expenditures to build this new network. In addition to this
initial estimated approximately $3.8 million outlay, the Exchange
anticipates that the ongoing costs to maintain and operate the NMS
network will be approximately $215,000 annually.
Proposed Amendment To Add the NMS Network
    The proposed structure for the NMS network has been designed so
that the services available in co-location would be expanded so that a
User can opt to connect to the NMS network at no additional charge.
    To effect the proposed change, the Exchange proposes to amend the
services available in co-location to provide that if a User purchases a
service that includes a 10 Gb or 40 Gb connection to access either
local area network, that access would include a connection to the NMS
network of the same size. Although the Exchange is funding and
expanding the types of local area network connections that would be
available in the data center, the Exchange does not propose to change
any of the fees related to purchasing a service that includes a
connection to a local area network.
    More specifically, the services available in co-location currently
include LCN Access, IP Network Access, and Partial Cabinet Solution
bundles. In order to implement the proposed change, the Exchange
proposes the following amendments to Exchange Rules that describe the
following services in co-location:
     In the column titled ``Type of Service,'' the Exchange
proposes to amend the text describing the 10 Gb and 40 Gb LCN and IP
Network Access options to include text referencing the NMS network.
     In the column titled ``Description,'' the Exchange
proposes to amend the descriptions of the 10 Gb LX LCN Circuit, 40 Gb
LCN Circuit, Partial Cabinet Solution bundle Option C and Option D, 10
Gb IP Network Circuit and 40 Gb IP Network Circuit to include text
referencing the specific NMS Network connection that would be part of
the service. In addition, because the descriptions of the LCN and IP
network services do not currently reference either ``LCN'' or ``IP
Network,'' respectively, the Exchange proposes to add text references
as applicable.
     Finally, the Exchange proposes to amend text in the column
titled ``Amount of Charge'' to specify that the current initial and
monthly recurring charges would not change and that for purposes of
such charges, the existing local area network connection and NMS
network connection would be together considered one connection. These
text changes would make clear that Users would not be subject to two
initial or two monthly charges. The Partial Cabinet Solution bundle
description already indicates that the charges are ``per bundle'' and
therefore no similar clarifying language is proposed.
    The Exchange proposes to set forth these changes as follows
(proposed new text italicized and proposed text for deletion in
brackets):

------------------------------------------------------------------------
       Type of service             Description        Amount of charge
------------------------------------------------------------------------
LCN and NMS Network Access..  10 Gb LX LCN Circuit  $15,000 initial
                               and 10 Gb NMS         charge per
                               Network Circuit.      connection [initial
                                                     charge] to both the
                                                     LCN and NMS Network
                                                     plus $22,000
                                                     monthly charge per
                                                     connection to both
                                                     the LCN and NMS
                                                     Network.
                                                    For purposes of
                                                     these charges, the
                                                     LCN Circuit and NMS
                                                     Network Circuit are
                                                     together considered
                                                     to be one
                                                     connection, and so
                                                     Users are not
                                                     subject to two
                                                     initial or two
                                                     monthly charges.
LCN and NMS Network Access..  40 Gb LCN Circuit     $15,000 initial
                               and 40 Gb NMS         charge per
                               Network Circuit.      connection [initial
                                                     charge]  to both
                                                     the LCN and NMS
                                                     Network plus
                                                     $22,000 monthly
                                                     charge per
                                                     connection to both
                                                     the LCN and NMS
                                                     Network.
                                                    For purposes of
                                                     these charges, the
                                                     LCN Circuit and NMS
                                                     Network Circuit are
                                                     together considered
                                                     to be one
                                                     connection, and so
                                                     Users are not
                                                     subject to two
                                                     initial or two
                                                     monthly charges.
Partial Cabinet Solution      No change...........  No change.
 bundles. Note: A User and
 its Affiliates are limited
 to one Partial Cabinet
 Solution bundle at a time.
 A User and its Affiliates
 must have an Aggregate
 Cabinet Footprint of 2 kW
 or less to qualify for a
 Partial Cabinet Solution
 bundle. See Note 2 under
 ``General Notes''.
                              No change...........  No change.
                              Option C: 1 kW        No change.
                               partial cabinet, 1
                               LCN connection (10
                               Gb LX), 1 IP
                               network connection
                               (10 Gb), 2 NMS
                               Network connections
                               (10 Gb each), 2
                               fiber cross
                               connections and
                               either the Network
                               Time Protocol Feed
                               or Precision Timing
                               Protocol.
                              Option D: 2 kW        No change.
                               partial cabinet, 1
                               LCN connection (10
                               Gb LX), 1 IP
                               network connection
                               (10 Gb), 2 NMS
                               Network connections
                               (10 Gb each), 2
                               fiber cross
                               connections and
                               either the Network
                               Time Protocol Feed
                               or Precision Timing
                               Protocol.
IP Network and NMS Network    10 Gb IP Network      $10,000 initial
 Access.                       Circuit and 10 GB     charge per
                               NMS Network Circuit.  connection [initial
                                                     charge]  to both
                                                     the IP Network and
                                                     NMS Network plus
                                                     $11,000 monthly
                                                     charge per
                                                     connection to both
                                                     the IP Network and
                                                     NMS Network.
                                                    For purposes of
                                                     these charges, the
                                                     IP Network Circuit
                                                     and NMS Network
                                                     Circuit are
                                                     together considered
                                                     to be one
                                                     connection, and so
                                                     Users are not
                                                     subject to two
                                                     initial or two
                                                     monthly charges.
IP Network and NMS Network    40 Gb IP Network      $10,000 initial
 Access.                       Circuit and 40 Gb     charge per
                               NMS Network Circuit.  connection [initial
                                                     charge] to both the
                                                     IP Network and NMS
                                                     Network plus
                                                     $18,000 monthly
                                                     charge per
                                                     connection to both
                                                     the IP Network and
                                                     NMS Network.
                                                    For purposes of
                                                     these charges, the
                                                     IP Network Circuit
                                                     and NMS Network
                                                     Circuit are
                                                     together considered
                                                     to be one
                                                     connection, and so
                                                     Users are not
                                                     subject to two
                                                     initial or two
                                                     monthly charges.
------------------------------------------------------------------------

    As noted above, Users that purchase access to the LCN or IP Network
currently can use such networks to connect to the NMS feeds. Once the
NMS Network is available, Users can continue to use either their
existing LCN or IP Network connection or the new NMS network connection
to connect to the NMS feeds.
    The Exchange proposes to amend the current General Note 4 to
describe what a User obtains when it purchases a service that includes
access to the LCN, IP network, or NMS Network.
    First, the Exchange proposes to split current Note 4 into three
separate notes. The first paragraph of current Note 4 would continue to
be numbered Note 4, and would specify which trading and execution
services a User can access when it purchases a service that includes
access to the LCN or IP network, which are not changing. Because the
services that a User purchases may include access to the NMS network in
addition to access to the LCN or IP network, the Exchange proposes a
non-substantive amendment to the first sentence of this note to add the
phrase ``a service that includes.''
    Second, the Exchange proposes that the current second paragraph of
Note 4 and following table would be renumbered as Note 5. As the
paragraph does currently, Note 5 would specify the Included Data
Products that a User can connect to if it purchases a service that
includes access to the LCN or IP network. Similar to the proposed
amendment to the first sentence of Note 4, the Exchange proposes a non-
substantive amendment to add the phrase ``a service that includes'' to
the

first sentence of new Note 5. In addition, the Exchange proposes a non-
substantive amendment to the table to clarify that the NMS feeds are
the CTA, CQ, and OPRA feeds.
    Finally, the Exchange proposes new Note 6, which would describe in
more detail the NMS network. As proposed, Note 6 would provide that
when a User purchases a service that includes access to the NMS
Network, upon its request it would receive connectivity to the NMS
network and any of the NMS feeds that it selects, subject to any
technical provisioning requirements and authorization from the provider
of the data feed. Consistent with existing Note 4 (proposed Note 5),
Note 6 would provide that market data fees for the NMS feeds would be
charged by the provider of the NMS data feed. The proposed note would
further state that the NMS Network would provide connectivity to the
NMS feeds only.
Expected Application of the Proposed Change
    The proposed NMS network would be available to all Users that
purchase a service that includes a 10 Gb or 40 Gb connection to access
either the LCN or IP network, which are the networks currently
available to provide connections to the NMS feeds.
General
    As is the case with all Exchange co-location arrangements, (i)
neither a User nor any of the User's customers would be permitted to
submit orders directly to the Exchange unless such User or customer is
a member organization, a Sponsored Participant or an agent thereof
(e.g., a service bureau providing order entry services); (ii) use of
the co-location services proposed herein would be completely voluntary
and available to all Users on a non-discriminatory basis; \25\ and
(iii) a User would only incur one charge for the particular co-location
service described herein, regardless of whether the User connects only
to the Exchange or to the Exchange and one or more of the Affiliate
SROs.\26\
---------------------------------------------------------------------------

    \25\ As is currently the case, Users that receive co-location
services from the Exchange will not receive any means of access to
the Exchange's trading and execution systems that is separate from,
or superior to, that of other Users. In this regard, all orders sent
to the Exchange enter the Exchange's trading and execution systems
through the same order gateway, regardless of whether the sender is
co-located in the data center or not. In addition, co-located Users
do not receive any market data or data service product that is not
available to all Users, although Users that receive co-location
services normally would expect reduced latencies in sending orders
to, and receiving market data from, the Exchange.
    \26\ See 78 FR 51765, supra note 9, at 51766. NYSE American,
NYSE Arca and NYSE National have submitted substantially the same
proposed rule change to propose the changes described herein and
will be amending their respective filings in substantially the same
manner. See Securities Exchange Act Release Nos. 86867 (September 4,
2019), 84 FR 47563 (September 10, 2019) (SR-NYSEAmer-2019-34)
(Notice); 86868 (September 4, 2019), 84 FR 47610 (September 10,
2019) (SR-NYSEArca-2019-61) (Notice); and 86869 (September 4, 2019),
84 FR 47600 (September 10, 2019) (SR-NYSENAT-2019-19) (Notice).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\27\ in general, and furthers the
objectives of Sections 6(b)(5) of the Act,\28\ in particular, because
it 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 mechanisms of, a free and open market and a national market
system and, in general, to protect investors and the public interest
and because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers. The Exchange also believes
that the proposed fee change is consistent with Section 6(b)(4) of the
Act,\29\ in particular, because it provides for the equitable
allocation of reasonable dues, fees, and other charges among its
members, issuers and other persons using its facilities and does not
unfairly discriminate between customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78f(b).
    \28\ 15 U.S.C. 78f(b)(5).
    \29\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

The Proposed Rule Change Would Remove Impediments to and Perfect the
Mechanism of a Free and Open Market and a National Market System
    The Exchange believes that the proposed change to include access to
the NMS network as part of existing services available in co-location
would remove impediments to, and perfect the mechanisms of, a free and
open market and a national market system and, in general, protect
investors and the public interest because, by offering access to the
dedicated, low-latency NMS network, the Exchange will be providing
Users with an additional option to connect to the NMS feeds. Until
recently, SIAC was required to provide connectivity to the NMS feeds
via only the IP network. As recently approved by the operating
committees for the CTA/CQ Plans, SIAC is now authorized to offer
connectivity to the NMS feeds in the data center via an alternate,
dedicated, low-latency NMS network. The proposed NMS network has been
designed consistent with this directive and will provide greater choice
to Users that are seeking a low-latency network to connect to the NMS
feeds.
The Proposed Rule Change Is Reasonable
    As an initial matter, as required by Rule 603(b) of Regulation NMS,
SIAC disseminates quotation and transaction information as the single
plan processor for all Tape A and Tape B-listed securities and is also
the single plan processor for all options exchanges. As the single plan
processor, the pricing decisions relating to the dedicated NMS network
are not constrained by competitive market forces.
    Instead, as described above, the Exchange is funding the capital
and operational expenses to build and operate the NMS network. The
implementation costs of approximately $3.8 million are applicable only
to the NMS network, which will be used for the sole purpose of
providing access to the NMS feeds. Simply put, none of the
implementation costs are applicable to any other Exchange services. The
Exchange has based its procurement needs--which correlate to the
Exchange's estimated costs to build the NMS network--based on the
Current Users' usage of the LCN or IP networks to connect to the NMS
feeds, with some room for additional growth.
    The Exchange believes that adding the NMS network as a service that
would be included when a User purchases either a 10 Gb or 40 Gb
connection to access a local area network is reasonable because the
amended service is designed to make the NMS network available at no
additional cost to Users. Specifically, as proposed, the NMS network
would be included as part of specified existing LCN and IP network
services that Users can already purchase, and are already used to
connect to the NMS feeds.
    Because the fees for LCN and IP network services relate to charges
for services either other than or in addition to connectivity to the
NMS feeds, the Exchange currently does not assess any fees that are
specific to connectivity to the NMS feeds. Accordingly, if a User
purchases a service that includes either a 10 Gb or 40 Gb connection to
access either local area network, such User can use such local area
network to connect to the NMS feeds at no additional charge. By adding
access to the NMS network to these existing services, the Exchange
proposes to offer an additional choice to such Users for how they could
connect to the NMS feeds.

By not changing the existing fees for such expanded service, Users
would not incur any additional charges if they choose to use to the new
low-latency, dedicated alternate network to connect to the NMS feeds
instead of using a connection to one of the existing local area
networks.
    The Exchange further believes that expanding the existing services
that include access to a 10 Gb and 40 Gb connection to either local
area network to also include access to a same-size connection to the
NMS network would be reasonable because there would be no differences
in fees charged to either current or prospective Users that seek to use
co-location services to connect to the NMS feeds. Currently, a User
would need to purchase a service that includes either a 10 Gb or 40 Gb
connection to access a local area network in order to connect to the
NMS feeds. As proposed, when such service is purchased, a User would
continue to receive the same local area network service currently
available, and would also have the option to connect to the NMS feeds
via the NMS network.
    The Exchange believes that the proposed changes to describe the NMS
network are reasonable because they to promote clarity and transparency
regarding which services would be available to Users and the charges
for such services. As noted above, the Exchange proposes that if a User
purchases a service that includes a 10 Gb or 40 Gb connection to access
either local area network, that service would include access to a same-
size connection to the NMS network. The Exchange believes that the text
changes to Exchange's rules for such services is reasonable because the
amendments would provide specificity regarding which specific services
would include access to the NMS network. The proposed amendments would
also provide specificity that the existing initial and monthly charges
would be charged only once, and that a connection to an existing local
area network and an NMS network would be considered a single connection
for purposes of such charges.
    The Exchange also believes that the proposed non-substantive
amendment to split Note 4 into three separate Notes is reasonable
because it would promote clarity and transparency regarding how
services that include a connection to an LCN or IP network could be
used. As now, Note 4 would describe the trading and execution services
that a User may access if it purchases a service that includes access
to the LCN or IP network. Proposed Note 5 would describe the Included
Data Products that a User can connect to if it purchases a service that
includes access to the LCN or IP network. Proposed Note 6 would be new
and is designed to promote clarity and transparency by (a) describing
the connectivity that the User would obtain if it purchased service
that included access to the NMS Network, subject to any technical
provisioning requirements and authorization from the provider of the
data feed, and (b) specifying that the NMS network would provide
connectivity to the NMS feeds only. The Exchange further believes it is
reasonable to identify the specific NMS feeds that are available, which
are the CTA, CQ, and OPRA feeds, as this proposed amendment to Note 4
and proposed Note 6 would promote clarity and transparency in Exchange
rules.
The Proposed Rule Change Is Equitably Allocated
    The Exchange believes that the proposed rule change is equitably
allocated. As described above, the proposed amendment to include the
NMS network as a service available in co-location has been designed so
that Users would not have any new or different charges if they opt to
connect to the NMS network. Rather, because the NMS network would be
included as part of services that include access to a 10 Gb or 40 Gb
connection to either local area network, Users will have a choice
whether to use an IP network, LCN or NMS network connection to connect
to the NMS feeds. A User that voluntarily chooses to exercise the
choice to connect with the NMS network would receive the benefit of a
low-latency connection without any additional charges.
    As noted above, because a User that purchases access to the LCN or
IP network receives connectivity to the NMS feeds, the Exchange
currently does not assess any fees that are specific to connectivity to
the NMS feeds. By offering the NMS network as part of these existing
services, the Exchange proposes to offer an additional choice to such
Users for how they could connect to the NMS feeds. By not charging
different fees for such expanded services, all Users will be treated
equally and charged no differently than how fees are currently charged
for access to a 10 Gb or 40 Gb connection to a local area network
service.
The Proposed Rule Change Is Not Unfairly Discriminatory
    The Exchange believes that the proposed rule change is not unfairly
discriminatory. As described above, the proposed amendment to include
the NMS network as a service available in co-location has been designed
so that Users would not have any new or different charges if they opt
to connect to the NMS network. Rather, because access to the NMS
network would be included as part of access to the 10 Gb and 40 Gb
connection to either local area network, all Users will have a choice
whether to use an IP network, LCN or NMS network connection to connect
to the NMS feeds. The proposed change in services available in co-
location therefore would not impose any meaningful differences to
different types of Users. Any User that voluntarily chooses to exercise
the choice to connect with the NMS network would receive the benefit of
a low-latency connection without any additional charges.
    As noted above, because a User that purchases access to the LCN or
IP network receives connectivity to the NMS feeds, the Exchange
currently does not assess any fees that are specific to connectivity to
the NMS feeds. Accordingly, if a User purchases a service that includes
either a 10 Gb or 40 Gb connection to access either local area network,
such User can use such local area network to connect to the NMS feeds
at no additional charge. By offering the NMS network as part of these
existing services, the Exchange proposes to offer an additional choice
to such Users for how they could connect to the NMS feeds. By not
charging any different fees for such expanded service, all Users will
be treated equally and no differently than how fees are currently
charged for a 10 Gb or 40 Gb connection to a local area network
service.
    For the reasons above, the proposed changes would not unfairly
discriminate between or among market participants that are otherwise
capable of satisfying any applicable co-location fees, requirements,
terms and conditions established from time to time by the Exchange.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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 Exchange believes that
the proposed rule change would not impose any burden on competition
because it is not designed to address any competitive issues. As
described above, SIAC is the single plan processor for Tape A and B
equities securities and all options securities and does not currently

compete with any other providers for these processor services. The
proposed rule change would amend the services available in co-location
to include the NMS network when a User purchases a 10 Gb or 40 Gb
connection to access either local area network service. Accordingly,
the proposed rule change would expand the services available in co-
location without changing any fees for the existing services, or adding
fees for the expanded services. All Users would have access to the NMS
network and it would be their choice of whether and at what level to
subscribe to such services, including whether to utilize the NMS
network connection. Accordingly, the Exchange does not believe that the
proposed rule change would place any User at a relative disadvantage
compared to other Users.

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

    No written comments were solicited or received with respect to the
proposed rule change.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended by Amendment No. 1, 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-NYSE-2019-46 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-NYSE-2019-46. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2019-46 and should be submitted on
or before February 5, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
---------------------------------------------------------------------------

    \30\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-00482 Filed 1-14-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 14, 2009 (Volume 74, Number 176)]
[Notices]
[Page 47008-47010]
[DOCID:fr14se09-67]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0407]

Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs
and Clinically Meaningful Safety and Effectiveness Outcomes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Pediatric Clinical Trials Workshop: Unmet Needs,
Trial Designs and Clinically Meaningful Safety and Effectiveness
Outcomes.'' The purpose of the public workshop is to solicit
information from primary and secondary health care providers, academia,
industry, and professional societies on various aspects of device
clinical trials involving pediatric diseases and patients. Information
from this public workshop will help stimulate interest in pediatric
device clinical trial research methods, and develop topics for further
discussion regarding the safety of pediatric device clinical trials.
The information gathered in this and future workshops will help to
develop future guidance for developing safe clinical trials for devices
intended for pediatric patients. We encourage participation and
comments from workshop attendees on the topics and questions discussed.
Please see instructions for registration and for providing comments in
the sections of this document entitled ``Registration'' and
``Comments.''
    Dates and Times: The public workshop will be held on October 29,
2009, from 8 a.m. to 5:30 p.m. and October 30, 2009, from 8 a.m. to 12
noon.
    Location: The public workshop will be held at the Holiday Inn
College Park located off I-95 at 10000 Baltimore Ave., College Park, MD
20740. The hotel front desk number is 1-301-345-6700. For directions,
please refer to the meeting Web page: http://www.fda.gov/
MedicalDevices/NewsEvents/WorkshopsConferences/ucm170938.htm
    Contact Person: Barbara Buch, Center For Devices and Radiological
Health, Food and Drug Administration, Bldg. 66, rm. 1406, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, FAX: 301-847-
8117, e-mail<EMAIL_ADDRESS>If you need special
accommodations due to a disability, (such as wheelchair access or a
sign language interpreter), please notify Barbara Buch by September 30,
2009.
    Registration: Registration and seating will be on a first-come,
first-served basis and discussion preference will be afforded to
clinical research investigators involved in pediatric clinical device
trials, health care givers, and patient advocates. Please provide your
name, title, organization affiliation, address, and e-mail contact
information. There is no registration fee to attend the workshop. There
will be no onsite registration. Please register electronically at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/
default.htm by September 30, 2009. Due to limited space, and to
maximize participation, attendees are asked to delegate one or two
representatives from their organizations to participate in the general
sessions. A report of The Workshop and The Information presented will
be available following the meeting via a link on the meeting Web page.
If you wish to make an oral comment during or to attend the public
workshop, please note this in your registration information. The online
registration form will instruct you as to the information you should
provide prior to the meeting. In general, a summary of the presentation
and an electronic copy of the presentation should be submitted by
October 1, 2009. We will try to accommodate all persons who wish to
make oral comments during the general sessions. However, we strongly
recommend that you provide written comments as instructed in this
document to ensure that your opinion, comments, and suggestions are
captured. Please refer to the section, ``Comments'' for instructions on
how to submit written comments.
    Comments: The deadline for submitting comments regarding this
public workshop is November 30, 2009.
    Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments. Written comments should be
submitted to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Electronic comments should be submitted to http://www.regulations.gov.
Comments should be identified 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.

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

    The purpose of the public workshop is to solicit expert input on
topics related to pediatric device clinical trials. The agency seeks
discussion between FDA and other interested parties regarding the
conduct of clinical trials to investigate device use in pediatric
populations. Other purposes of the public workshop are, to identify any
gaps in such research, and to provide information about evaluating the
short- and long-term safety and effectiveness of pediatric medical
devices using valid and sound scientific methods. Since the 2007 Food
and Drug Administration Amendments Act was signed into law, there has
been increased interest in conducting scientifically sound clinical
research related to pediatric populations. It is hoped that this
meeting will provide a forum for open discussion and information
exchange among interested parties, FDA, and other stakeholders to lay a
framework for further research into the use of devices to treat
disorders and diseases that affect pediatric patients.

II. What Will Be the Format for the Meeting?

    The format for the meeting will include a general session in the
morning on the first day. Invited expert speakers will present
information regarding current needs and concerns about clinical trials
that involve pediatric patients. These presentations will provide the
topics for the small breakout groups, which will begin in the afternoon
session of day one and continue through the morning of day two of the
public workshop. Each of the smaller breakout group discussion sessions
will be led and moderated by a panel of experts in each of the
specialty focus areas listed in section III of this document. Each
small group session will begin with an invited presentation to describe
the issues of concern in the specific specialty. This will be followed
by a moderated question and comment session including both prespecified
questions posed to the assembled group and any that arise during the
workshop's discussions. Those in attendance will have the opportunity
in these small group discussions to participate in the discussion, ask
questions, and provide comments for consideration. Small group
discussions will be concluded in the morning of day two. Small group
participation will be limited by space and will be available on a
first-come, first-served basis. When registering for

the meeting, you should also designate which small group discussion you
would like to attend because each participant may register for only one
of the small group sessions.
    At the conclusion of day two's small group discussions, the general
session will reconvene. After the general session reconvenes, each
small group will report to the general session the results of the
discussions related to the general questions posed to each group in
outline form.

III. What Are the General Topic Areas We Intend to Address at the
Public Workshop?

    We plan to discuss a number of general disease/anatomical topical
issues at the conference, including the following issues:
     Musculoskeletal disease,
     Cardiovascular disease,
     Abdominal disorders and gastrointestinal (GI) diseases,
     Neurologic disorders and conditions,
     Renal diseases, and
     Audiologic disorders.
    The challenges posed by developing diagnostic tests for pediatric
patients will be addressed as a part of discussion under each topical
area breakout session. For each of the general disease/anatomical topic
areas, we will pose questions to elicit and solicit scientific and
clinical discussion in the breakout sessions. These include, but are
not limited to the following questions:
    What are the most urgent unmet needs?
    What are the best practices for conduct of clinical research,
including clinical trial design?
    What are specific patient/caregiver issues to consider?
    What are the surrogate endpoints for lifelong patient safety and
effectiveness?
    What are appropriate clinical assessments?
    What are appropriate endpoints that determine clinical success?
    The questions, listed in section IV of this document, will be the
focus of the expert-moderated breakout discussions in the afternoon of
day one and the morning of day two.

IV. What Are the Issues That Will Be Discussed and Considered?

Questions for Discussion Regarding Pediatric Device Clinical Trials

1. What Are the Five Most Important Unmet Research Needs in Each
Specific Disease/Anatomic Category? (musculoskeletal disease,
cardiovascular disease, abdominal disorders and GI diseases, neurologic
disorders and conditions, renal diseases, and audiologic disorders)
    Although there are obvious barriers to clinical trials such as
concerns about the effects on child development, there are significant
needs in both rare and common diseases or disorders that have not been
met with modifications of adult devices. We will start by asking
questions such as:
    a. What are the most important unmet device needs in each category?
    b. What are the scientific or clinical barriers or other potential
barriers to developing devices to meet those needs?
2. What Are Some Clinical Trial Designs That Encourage Enrollment of
Pediatric Patients While Providing Quality Data to Support Safety and
Effectiveness of Devices?
    We need to understand:
    a. What are appropriate controls to use in pediatric trials to
satisfy the legal regulatory definitions of valid scientific evidence
as described in 21 CFR 860.7?
    b. How can followup be maximized?
    c. What timeframes are needed given the age of patients and the
expected lifetime of the device/disease being treated?
    d. How do we understand the long term effect on development and
growth in a short clinical trial?
3. Preclinical and Animal Studies
    Although there are examples of immature and fetal animal studies
that are well established for pharmaceuticals, how do we translate
those concepts for devices?
    a. What types of endpoints and timeframes translate into outcomes
in the human population? How do we know that?
    b. How do we set a standard to judge subsequent trial outcomes as
acceptable and safe?
    c. What animal models exist or are appropriate for studying each of
the diseases or disorders we identify as significant unmet needs?
4. How Do We Measure Safety and Effectiveness in a Pediatric
Population?
    The pediatric population cannot always describe symptoms or
functional problems in the same way that adults can. It therefore
follows that the same assessment tools and surrogate endpoints will not
apply to a pediatric population.
    Therefore we are striving to understand:
    a. What validated assessments are needed or exist for the pediatric
population being treated?
    b. What surrogate markers or endpoints are needed for each disease?
    c. What surrogates are needed or are available to determine long-
term outcomes?
    d. How do we validate surrogate endpoints?
5. How Do We Know That the Study and the Treatment Are Successful?
    Assessment and judgment of patient outcomes varies considerably for
a pediatric population. The needs of the patient and his caregiver or
parent must be considered. The longevity of, and durability of, devices
captures a new meaning when the lifespan is 50 to 60 years; remaining
lifespan in adults is very different. We are soliciting feedback on:
    a. What constitutes successful or unsuccessful treatment outcomes?
    b. What criteria should be used to determine successful or
unsuccessful treatment outcomes?
    c. What human factors in each case need to be considered?
    d. What patient factors unique to the pediatric population have to
be considered?
    e. What criteria are required to acknowledge that successful
treatment for a patient has been achieved?
    f. What constitutes a successful clinical trial?
    g. How long should a device or treatment last to be considered
effective?
    Please note funding options for research have already been
discussed at prior public meetings and will not be discussed at this
workshop. Information regarding funding sources is available on
government Web sites as well as other public Web sites dedicated to
pediatric health.

V. Where Can I Find Out More About This Public Workshop?

    Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/
default.htm.

Organization and Basic Instructions for Comments

    To facilitate information gathering, we invite written comments on
the questions presented in section IV of this document. We intend to
discuss and expand on these same questions during the small group
discussions. If you wish to comment in writing on a particular
question, please identify the question that you are addressing before
providing your response to the question. For example, your comment
could take the following format:
    ``Question 1--[Quote the question].''
    ``Response--[Insert your response].''
    You do not have to address each question. Additionally, for those
questions pertaining to the prevalence of a particular need, problem or
scientific question, please provide data and/or references so that we
may understand the basis for your comment, figures, and any assumptions
that you used. Additionally, the goal of this public workshop is to
gain a greater understanding of treatment needs and needs for
innovative solutions to those needs. Accordingly, we look forward to
participation and comments from manufacturers, innovators, and
organizations that either market or have in development technologies
that could be used to treat pediatric patients.

    Dated: September 3, 2009.
Catherine M. Cook,
Associate Director for Regulations and Policy, Center for Devices and
Radiological Health.
[FR Doc. E9-22012 Filed 9-11-09; 8:45 am]

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[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Proposed Rules]
[Pages 12127-12129]
[FR Doc No: 2021-03951]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0105; Project Identifier MCAI-2020-01422-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus Helicopters Model SA330J helicopters. This proposed AD
was prompted by the failure of a second stage planet gear installed in
the main gearbox (MGB). This proposed AD would require repetitively
inspecting the MGB particle detector and the MGB bottom housing (oil
sump) for metal particles, analyzing any metal particles that are
found, and replacement of the MGB if necessary, as specified in a
European Aviation Safety Agency (now European Union Aviation Safety
Agency) (EASA) AD, which is proposed for incorporation by reference
(IBR). The FAA is proposing this AD to address the unsafe condition on
these products.

DATES: The FAA must receive comments on this proposed AD by April 16,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that is proposed for IBR in this AD, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999
000; email<EMAIL_ADDRESS>internet: www.easa.europa.eu. You may
find this material on the EASA website at https://ad.easa.europa.eu.
You may view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available in the AD docket on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0105.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0105; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Mahmood G. Shah, Aviation Safety
Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0105; Project Identifier
MCAI-2020-01422-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposal.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Mahmood G. Shah, Aviation Safety Engineer, Fort Worth ACO Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Any commentary that the FAA receives that is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2018-0272, dated December 13, 2018
(EASA AD 2018-0272) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus Helicopters Model SA330J helicopters.
    This proposed AD was prompted by the failure of a second stage
planet gear installed in the MGB of an Airbus Helicopters Model EC225LP
helicopter. Airbus Helicopters Model SA330J helicopters have a similar
design, therefore, these models may be subject to the unsafe condition
revealed on the Model EC225LP helicopter. The FAA is proposing this AD
to address failure of

a second stage planet gear installed in the MGB, which could result in
failure of the MGB and subsequent loss of control of the helicopter.
See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2018-0272 describes procedures for repetitively inspecting
the MGB particle detector and the MGB bottom housing (oil sump) for
metal particles, analyzing any metal particles that are found, and
replacement of the MGB if necessary. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2018-0272, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2018-0272
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2018-0272 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2018-0272 that is required for compliance with EASA AD 2018-
0272 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0105 after the FAA
final rule is published.

Interim Action

    The FAA considers this proposed AD interim action. If final action
is later identified, the FAA might consider further rulemaking then.

Costs of Compliance

    The FAA estimates that this proposed AD affects 15 helicopters of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
5 work-hours x $85 per hour = $425...........................              $0             $425           $6,375
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition replacements that would be required based on the results of
any required actions. The FAA has no way of determining the number of
helicopters that might need these on-condition replacements:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
           Labor cost                   Parts cost            product
------------------------------------------------------------------------
40 work-hours x $85 per hour =   $600,000 (overhauled)..        $603,400
 $3,400.
------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and

    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Airbus Helicopters: Docket No. FAA-2021-0105; Project Identifier
MCAI-2020-01422-R.

(a) Comments Due Date

    The FAA must receive comments by April 16, 2021.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to all Airbus Helicopters Model SA330J
helicopters, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 6320, Main Rotor
Gearbox.

(e) Reason

    This AD was prompted by a failure of a second stage planet gear
installed in the main gearbox (MGB). The FAA is issuing this AD to
address failure of an MGB second stage planet gear, which could
result in failure of the MGB and subsequent loss of control of the
helicopter.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD 2018-0272, dated December 13, 2018
(EASA AD 2018-0272).

(h) Exceptions to EASA AD 2018-0272

    (1) Where EASA AD 2018-0272 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2018-0272 refers to March 30, 2018 (the
effective date of EASA AD 2018-0065, dated March 23, 2018), this AD
requires using the effective date of this AD.
    (3) The ``Remarks'' section of EASA AD 2018-0272 does not apply
to this AD.
    (4) Where EASA AD 2018-0272 refers to flight hours (FH), this AD
requires using hours time-in-service.
    (5) Where paragraph (1) of EASA AD 2018-0272 specifies to
inspect the MGB particle detector ``in accordance with the
instructions of Section 3 of the ASB'' for this AD use ``in
accordance with the instructions in step 3.B.2.a. of the ASB.''
    (6) Where paragraph (2) of EASA AD 2018-0272 specifies to
inspect the MGB bottom housing (oil sump) ``in accordance with the
instructions of Section 3 of the ASB'' for this AD use ``in
accordance with the instructions in step 3.B.2.b. of the ASB.''
    (7) Where the service information referenced in EASA AD 2018-
0272 specifies to perform a metallurgical analysis and contact the
manufacturer if unsure about the characterization of the particles
collected, this AD does not require contacting the manufacturer to
determine the characterization of the particles collected.
    (8) Although the service information referenced in EASA AD 2018-
0272 specifies that if any 16NCD13 particles are found to contact
the manufacturer and send a 1-liter sample of oil to the
manufacturer, this AD does not require that action.
    (9) Although the service information referenced in EASA AD 2018-
0272 specifies returning certain parts to the manufacturer, this AD
does not require that action.
    (10) Where EASA AD 2018-0272 specifies actions be done after the
last flight of the day or ``ALF,'' this AD requires doing those
actions before the first flight of the day.
    (11) Although the service information referenced in EASA AD
2018-0272 specifies discarding certain parts, this AD requires
removing the parts from service.

(i) Special Flight Permit

    Special flight permits may be issued in accordance with 14 CFR
21.197 and 21.199 to operate the helicopter to a location where the
helicopter can be modified (if the operator elects to do so),
provided that the helicopter is operated during the day, under
visual flight rules, and with no passengers onboard.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Strategic Policy Rotorcraft Section, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. Send your proposal to:
Manager, Strategic Policy Rotorcraft Section, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; phone:<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For EASA AD 2018-0272, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
<EMAIL_ADDRESS>internet: www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. This material may be found in the AD docket
on the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0105.
    (2) For more information about this AD, contact Mahmood G. Shah,
Aviation Safety Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
    Issued on February 19, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.

[FR Doc. 2021-03951 Filed 3-1-21; 8:45 am]
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