[Federal Register: October 12, 2005 (Volume 70, Number 196)]
[Notices]
[Page 59385-59386]
[DOCID:fr12oc05-115]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52561; File No. SR-PCX-2005-107]

Self-Regulatory Organizations; Pacific Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Amending
Rules Regarding Lead Market Maker's Guaranteed Participation in Trades
Executed by Public Outcry

October 4, 2005.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 23, 2005, the Pacific Exchange, Inc. (``PCX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The PCX filed
the proposal as a ``non-controversial'' proposed rule change pursuant
to Section 19(b)(3)(A)(iii) \3\ of the Act and Rule 19b-4(f)(6)
thereunder,\4\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The PCX proposes to amend PCX Rule 6.82(d) to better describe a
Lead Market Maker's (``LMM'') guaranteed participation on trades that
are executed via public outcry. The text of the proposed rule change,
is available on the PCX's Web site (http://www.pacificex.com), at the

PCX's principal office, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of those statements may be examined at the places specified in
Item IV below. The PCX 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 submits that the purpose of the proposed rule change
is to adopt clarifying language to better describe an LMM's guaranteed
participation in trades that occur via public outcry. The Commission
recently approved changes to PCX rules pertaining to LMMs.\5\ These
changes allow an LMM to operate from a location other than the PCX
trading floor.
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    \5\ See Securities Exchange Act Release No. 51937 (June 29,
2005), 70 FR 38997 (July 6, 2005) (SR-PCX-2005-31).
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    According to the Exchange, its intention at all times was that if
an LMM is not present on the trading floor they will not be entitled to
a 40% guaranteed participation (as specified in PCX Rule 6.82(d)(2)) on
any trade that occurs in the trading crowd via public outcry. While
this provision was described in the purpose statement of SR-PCX-2005-
31, the PCX at this time feels that a change to the rule text will
clarify when an LMM is actually entitled to their guaranteed
participation on trades in accordance with Rule 6.82(d)(2). The
proposed rule change now clearly states that LLMs will be entitled to
their 40% guaranteed participation on public outcry trades only when
they are preset in the trading crowd.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\6\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) \7\
requirements that rules of an exchange be designed to facilitate
transactions in securities, to promote just and equitable principles of

trade, to enhance competition and to protect investors and the public
interest.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    The PCX neither solicited nor received comments on the proposal.

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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) does not become operative for 30-days from the date on which it
was filed, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest, it
has become effective pursuant to section 19(b)(3)(A) of the Act \8\ and
Rule 19b-4(f)(6) thereunder.\9\ A proposed rule change filed under
Commission Rule 19b-4(f)(6) \10\ normally does not become operative
prior to 30 days after the date of filing. The PCX requests that the
Commission waive the 30-day operative delay, as specified in Rule 19b-
4(f)(6)(iii), and designate the proposed rule change to become
operative immediately. The Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest because such waiver will allow the PCX to immediately
clarify its rule governing LMM's guaranteed participation in trades
that occur by public outcry. Accelerating the operative date will allow
for a more efficient and effective market operation by offering clarity
to existing PCX rules. For these reasons, the Commission designates the
proposed rule change as effective and operative immediately.\11\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ Id.
    \11\ For the purposes only of waiving the operative date of this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
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    At any time within 60 days after the filing of the proposed rule
change, the Commission may summarily abrogate the 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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-PCX 2005-107 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.

All submissions should refer to File Number SR-PCX-2005-107. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the PCX. 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-PCX 2005-107 and
should be submitted on or before November 2, 2005.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
 [FR Doc. E5-5581 Filed 10-11-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37859-37861]
[FR Doc No: 2022-13522]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3815]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishment
Registration and Device Listing for Manufacturers and Importers of
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
25, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0625.
Also include the FDA docket number found in brackets in the heading of
this document.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Establishment Registration and Device Listing for Manufacturers and
Importers of Devices--21 CFR Part 807, Subparts A Through D

OMB Control Number 0910-0625--Extension

    Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360) and implementing regulations in 21 CFR part 807,
subparts A through D (part 807, subparts A through D), medical device
establishment owners and operators are required to electronically
submit establishment registration and device listing information.
Complete and accurate registration and listing information is necessary
to accomplish a number of statutory and regulatory objectives, such as:
(1) identification of establishments producing marketed medical
devices; (2) identification of establishments producing a specific
device when that device is in short supply or is needed for national
emergency; (3) facilitation of recalls for devices marketed by owners
and operators of device establishments; (4) identification and
cataloging of marketed devices; (5) administering postmarketing
surveillance programs for devices; (6) identification of devices
marketed in violation of the law; (7) identification and control of
devices imported into the country from foreign establishments; and (8)
scheduling and planning inspections of registered establishments under
section 704 of the FD&C Act (21 U.S.C. 374).
    Respondents to this information collection are owners or operators
of establishments that engage in the manufacturing, preparation,
propagation, compounding, or processing of a device or devices, who
must register their establishments and

submit listing information for each of their devices in commercial
distribution. Notwithstanding certain exceptions, foreign device
establishments that manufacture, prepare, propagate, compound, or
process a device that is imported or offered for import into the United
States must also comply with the registration and listing requirements.
The number of respondents is based on data from the FDA Unified
Registration and Listing System (FURLS). Burden estimates are based on
recent experience with the medical device registration and listing
program, electronic system operating experience, and previous data
estimates.
    In the Federal Register of February 8, 2022 (87 FR 7187), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Annual
            21 CFR section; activity                Number of    frequency  per   Total annual             Hours per  response              Total hours
                                                   respondents      response        responses                                                   \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.20(a)(5); \3\ Initial submittal of                    4,125               1           4,125  1.75...................................           7,219
 manufacturer information by initial importers.
807.20(a)(5); \4\ Annual submittal of                     4,125               1           4,125  0.1 (6 minutes)........................             413
 manufacturer information by initial importers.
807.21(a); \3\ Creation of electronic system              5,355               1           5,355  0.5 (30 minutes).......................           2,678
 account.
807.21(b); \4\ Annual request for waiver from                 1               1               1  1......................................               1
 electronic registration & listing.
807.21(b); \3\ Initial request for waiver from                1               1               1  1......................................               1
 electronic registration & listing.
807.22(a); \3\ Initial registration & listing..           5,355               1           5,355  1......................................           5,355
807.22(b)(1); \4\ Annual registration..........          28,496               1          28,496  0.5 (30 minutes).......................          14,248
807.22(b)(2); \4\ Other updates of registration           2,671               1           2,671  0.5 (30 minutes).......................           1,336
807.22(b)(3); \4\ Annual update of listing               26,871               1          26,871  0.5 (30 minutes).......................          13,436
 information.
807.22(b)(4) Changes to listing information
 (outside of annual listing requirement
 period):
    Voluntary reporting of transfer of 510(k)             4,080               1           4,080  0.25 (15 minutes)......................           1,020
     clearance (outside of annual listing
     requirement period).
    Submission of 510(k) transfer documentation           2,033               1           2,033  4......................................           8,132
     when more than one party lists the same
     510(k).
807.26(e); \4\ Labeling & advertisement                       9               1               9  1......................................               9
 submitted at FDA request.
807.34(a); \3\ Initial registration & listing                 1               1               1  1......................................               1
 when electronic filing waiver granted.
807.34(a); \4\ Annual registration & listing                  1               1               1  1......................................               1
 when electronic filing waiver granted.
807.40(b)(3); \4\ Annual update of U.S. agent             6,101               1           6,101  0.5 (30 minutes).......................           3,051
 information.
807.40(b)(2); \4\ U.S. agent responses to FDA             1,535               1           1,535  0.25 (15 minutes)......................             384
 requests for information.
807.41(a); \4\ Identification by foreign                 14,017               1          14,017  0.5 (30 minutes).......................           7,009
 establishments of importers, defined in 807.3,
 of the establishment's devices.
807.41(b); \4\ Identification of other                   14,017               1          14,017  0.5 (30 minutes).......................           7,009
 importers (defined in 807.3(x)-(y)) that
 facilitate import by foreign establishments.
                                                --------------------------------------------------------------------------------------------------------
        Total..................................  ..............  ..............  ..............  .......................................          71,303
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals are rounded to the nearest whole number.
\3\ One-Time Burden--Firm only provides initially.
\4\ Recurring Burden--Firm is required to review annually.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                     Annual
                 21 CFR section                     Number of     frequency per   Total annual              Hours per  record               Total hours
                                                   respondents    recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.25(d); \2\ Labeling and advertisements               17,032               4          68,128  0.5 (30 minutes).......................          34,064
 available for review.
807.26; \2\ List of officers, directors, and             33,851               1          33,851  .25 (15 minutes).......................           8,463
 partners.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................          42,527
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Recurring burden--Firm is required to keep records.

    Our estimates for creating new user accounts under Sec.  807.21(a)
are based on the recent number of owners or operators. An owner or
operator only creates an account one time when they register for the
first time (initial

registration). Once the account is created, the owner or operator uses
the account as long as the establishment is registered. If an owner or
operator changes, the new owner or operator creates a new owner or
operator account and transfers the ownership of the establishment to
their owner or operator account. Once they create an owner or operator
account, they use the account for as long as the company is registered.
Under Sec.  807.22(b)(4), changes to listing information may be made at
times outside of the annual listing requirement period, such as when a
change is made to a previously listed device.
    The draft guidance entitled ``Transfer of a Premarket Notification
(510(k)) Clearance--Questions and Answers'' (December 2014), which
contained instructions for the proposed voluntary information
collection, has recently been withdrawn. While notification of transfer
of ownership information is not currently required, our medical device
registration and listing website \1\ communicates procedures for
notifying FDA of the transfer of a premarket notification (510(k))
clearance from one person to another. The notification is used 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. Although
submission of information regarding the transfer of a 510(k) clearance
is not required under the regulations, we regularly receive such
notifications from respondents.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing.
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    We estimate that annually 78 percent of 510(k)s may be initially
listed or updated outside of the annual registration requirement (about
4,080 510(k)s per year). We assume it will take 15 minutes for each
listing, for a total reporting burden of 1,020 hours.
    We estimate 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. We determined our estimate by identifying the average number
of unique 510(k) device listings entered in FURLS between fiscal years
2017 and 2019 that conflict with a listing already entered by another
party (5,304), dividing that number by the number of years (3) 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),
then dividing the result by 2 (because only one company per listing
will submit the appropriate documentation to show that they are the
current 510(k) holder).
    The registration and listing website identifies potential
documentation a party could submit to FDA to establish the transfer of
a 510(k) clearance to a new owner or operator. Based on the amount of
time to locate the information, copy it, and submit a copy, we assume
it takes respondents an average of 4 hours to establish the transfer of
a 510(k) clearance.
    The estimate for Sec.  807.25(d) in table 2 of this document
(recordkeeping burden) reflects the requirement that owners or
operators maintain a historical file containing the labeling and
advertisements in use. The estimate for Sec.  807.26 reflects the
requirement that owners or operators keep a list of officers,
directors, and partners for each establishment. Owners or operators
will need to provide this information only when requested by FDA.
However, it is assumed that some effort will need to be expended to
keep such records current.
    The recurring burden for the data collection under Sec.  807.41
(import-related information provided by foreign companies exporting to
the United States) was estimated based on data from previous years.
Foreign companies identify readily available contact information at the
time of registration. After completing their initial registration, they
are required to review the importer information annually. When they
review the importer information annually, they simply verify the
importer information is accurate. If it is and no changes are needed,
the foreign establishment's official correspondent checks the
certification and submits the annual registration. If they need to make
changes to the importer information, they can do so at any time and use
a spreadsheet to update more than one importer at a time to their
registration. The use of the spreadsheet reduces the burden to the
official correspondent of the foreign establishment.
    Our estimated burden for the information collection reflects an
overall increase of 10,880 hours and a corresponding increase of 28,430
responses/records. We attribute this adjustment to an increase in the
number of submissions we received over the last 3 years.

    Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13522 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7252-7255]
[FR Doc No: 2018-03308]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82699; File No. SR-ISE-2018-12]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Memorialize
Functionality Designed To Assist Members in the Event that They Lose
Communication

February 13, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 2, 2018, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to memorialize functionality which is
designed to assist Members in the event that they lose communication
with their assigned Specialized Quote Feed (``SQF''),\3\ Financial
Information eXchange (``FIX''),\4\ or Ouch to Trade Options (``OTTO'')
\5\ Ports due to a loss of connectivity.
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    \3\ SQF is an interface that allows market makers to connect and
send quotes, sweeps and auction responses into the Exchange.
    \4\ FIX is an interface that allows market participants to
connect and send orders and auction orders into the Exchange.
    \5\ OTTO is an interface that allows market participants to
connect and send orders, auction orders and auction responses into
the Exchange.
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    The text of the proposed rule change is available on the Exchange's
website at http://ise.cchwallstreet.com/, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to memorialize its detection of loss of
connection risk protection, which is applicable to all Members, at ISE
Rule 711(e). This automated process is in effect if a Member's SQF, FIX
or OTTO Port loses communication with a Client Application due to a
loss of connectivity. This feature is designed to protect ISE Market
Makers \6\ and other market participants from inadvertent exposure to
excessive risk.
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    \6\ The term ``market makers'' refers to ``Competitive ISE
Market Makers'' and ``Primary ISE Market Makers'' collectively.
---------------------------------------------------------------------------

    Members currently enter quotes and/or orders utilizing either an
SQF, FIX or OTTO Port. SQF is utilized by ISE Market Makers and FIX and
OTTO are utilized by all market participants. These ports are trading
system components through which a Member communicates its quotes and/or
orders to the Exchange's match engine through the Member's Client
Application. The Exchange proposes to define ``Client Application'' as
the system component of the Member through which the Member
communicates its quotes and orders to the Exchange at proposed Rule
711(e)(i)(E). Under the proposed rule change, an SQF Port would be
defined as the Exchange's proprietary system component through which
ISE Market Makers communicate their quotes from the Client Application
at proposed Rule 711(e)(i)(B). A FIX Port would be defined as the
Exchange's universal system component through which Members communicate
their orders from the Member's Client Application at proposed Rule
711(e)(i)(D). An OTTO Port would be defined as the Exchange's
proprietary system component through which Members communicate their
orders from the Member's Client Application at proposed Rule
711(e)(i)(C). ISE Market Makers may submit quotes to the Exchange from
one or more SQF Ports. Similarly, market participants may submit orders
to the Exchange from one or more FIX or OTTO Ports. The proposed
cancellation feature will be mandatory for each ISE Market Maker
utilizing SQF for the removal of quotes and optional for any market
participant utilizing FIX or OTTO for the removal of orders.
    When the SQF Port detects the loss of communication with a Member's
Client Application because the Exchange's server does not receive a
Heartbeat message \7\ for a certain period of time (a period of ``nn''
seconds), the Exchange will automatically logoff the Member's affected
Client Application and automatically cancel all of the Member's open
quotes. Quotes will be cancelled across all Client Applications that
are associated with the same ISE Market Maker ID and underlying issues.
---------------------------------------------------------------------------

    \7\ It is important to note that the Exchange separately sends a
connectivity message to the Member as evidence of connectivity.
---------------------------------------------------------------------------

    The Exchange proposes to define a ``Heartbeat'' message as a
communication which acts as a virtual pulse between the SQF, FIX or
OTTO Port and the Client Application at proposed Rule 711(e)(i)(A). The
Heartbeat message sent by the Member and subsequently received by the
Exchange allows the SQF, FIX or OTTO Port to continually monitor its
connection with the Member.
SQF Ports
    The Exchange's system has a default time period, which will trigger
a disconnect from the Exchange and remove quotes, set to fifteen (15)
seconds for SQF Ports. A Member may change the default period of ``nn''
seconds of no technical connectivity to trigger a disconnect from the
Exchange and remove quotes to a number between one hundred (100)
milliseconds and 99,999 milliseconds for SQF Ports prior to each
Session of Connectivity to the Exchange. This feature is enabled for
each ISE Market Maker and may not be disabled.
    There are two ways to change the number of ``nn'' seconds: (1)
Systematically or (2) by contacting the Exchange's operations staff. If
the Member changes the default number of ``nn'' seconds, that new
setting shall be in effect throughout the current Session of
Connectivity and will then default back to fifteen seconds.\8\ The
Member may change the default setting prior to each Session of
Connectivity. A Session of Connectivity would be defined to mean each
time the Member connects to the Exchange's system. If the Member were
to connect and then disconnect within a trading day several times, each

time the Member disconnected the next session would be a new Session of
Connectivity. This definition is proposed at proposed Rule
711(e)(i)(F). The Member may also communicate the time to the Exchange
by calling the Exchange's operations staff. If the time period is
communicated to the Exchange by calling Exchange operations, the number
of ``nn'' seconds selected by the Member shall persist for each
subsequent Session of Connectivity until the Member either contacts
Exchange operations by phone and changes the setting or the Member
selects another time period in the Client Application prior to the next
Session of Connectivity.
---------------------------------------------------------------------------

    \8\ The Exchange's system would capture the new setting
information that was changed by the Member and utilize the amended
setting for that particular session. The setting would not persist
beyond the current Session of Connectivity and the setting would
default back to 15 seconds for the next session if the Member did
not change the setting again.
---------------------------------------------------------------------------

FIX and OTTO Ports
    The Exchange's system has a default time period, which will trigger
a disconnect from the Exchange and remove orders, set to thirty (30)
seconds for FIX Ports and fifteen (15) seconds for OTTO Ports. The
Member may disable the removal of orders feature, but not the
disconnect feature. If the Member elects to have its orders removed, in
addition to the disconnect for FIX, the Member may determine a time
period of no technical connectivity to trigger the disconnect and
removal of orders between one (1) second and thirty (30) seconds. If
the Member elects to have its orders removed, in addition to the
disconnect for OTTO, the Member may determine a time period of no
technical connectivity to trigger the disconnect and removal of orders
between one hundred (100) milliseconds and 99,999 milliseconds. All
orders will be automatically cancelled.
    There are two ways to change the number of ``nn'' seconds: (1)
Systematically or (2) by contacting the Exchange's operations staff. If
the Member changes the default number of ``nn'' seconds, that new
setting shall be in effect throughout that Session of Connectivity and
will then default back to thirty seconds for FIX Ports or fifteen
seconds for OTTO Ports at the end of that session. The Member may
change the default setting prior to each Session of Connectivity. The
Member may also communicate the time to the Exchange by calling the
Exchange's operations staff. If the time period is communicated to the
Exchange by calling Exchange operations, the number of ``nn'' seconds
selected by the Member shall persist for each subsequent Session of
Connectivity until the Member either contacts Exchange operations by
phone and changes the setting or the Member selects another time period
through the Client Application prior to the next Session of
Connectivity.
    Similar to SQF Ports, when a FIX or OTTO Port detects the loss of
communication with a Member's Client Application for a certain time
period (a period of ``nn'' seconds), the Exchange will automatically
logoff the Member's affected Client Application and if elected,
automatically cancel all orders. The Member may have an order which has
routed away prior to the cancellation, in the event that the order
returns to the Order Book, because it was either not filled or
partially filled, that order will be cancelled.
    The disconnect feature is mandatory for FIX and OTTO users however
the user has the ability to elect to also enable a removal feature,
which will cancel all orders submitted through that FIX or OTTO Port.
If the removal of orders feature is not enabled, the system will simply
disconnect the FIX and/or OTTO user and not cancel any orders. The FIX
and/or OTTO user would have to commence a new Session of Connectivity
to add, modify or cancel its orders once disconnected.
    The trigger for the SQF, FIX and OTTO Ports is Client Application
specific. The automatic cancellation of the ISE Market Maker's quotes
for SQF Ports and open orders, if elected by the Member for FIX or OTTO
Ports, entered into the respective SQF, FIX or OTTO Ports via a
particular Client Application will neither impact nor determine the
treatment of the quotes of other ISE Market Makers (not associated with
the same Market Maker ID) entered into SQF Ports or orders of the same
or other Members entered into the FIX or OTTO Ports via a separate and
distinct Client Application.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \9\ in general, and furthers the objectives of Section
6(b)(5) of the Act \10\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, by imposing this mandatory removal functionality on ISE
Market Makers to prevent disruption in the marketplace and also
offering this removal feature to other market participants. Requiring
ISE Market Makers to utilize the disconnect feature will avoid risks
associated with inadvertent executions in the event of a loss of
connectivity. Other market participants will have the option to either
enable or disable the cancellation feature, thereby offering the same
risk protections throughout the market.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    ISE Market Makers will be required to utilize this disconnect and
removal functionality with respect to SQF Ports. This feature will
remove impediments to and improve the mechanism of a free and open
market and a national market system aimed at protecting investors and
the public interest by requiring ISE Market Makers quotes to be removed
in the event of a loss of connectivity with the Exchange's system. ISE
Market Makers provide liquidity to the market place and have
obligations unlike other market participants.\11\ This risk feature is
important because it will enable ISE Market Makers to avoid risks
associated with inadvertent executions in the event of a loss of
connectivity with the Exchange. The proposed rule change is designed to
not permit unfair discrimination among market participants, as it would
apply uniformly to all ISE Market Makers utilizing SQF Ports.
---------------------------------------------------------------------------

    \11\ See ISE Rule 804(e).
---------------------------------------------------------------------------

    The disconnect feature of FIX and OTTO is mandatory, however market
participants will have the option to either enable or disable the
cancellation feature, which would result in the cancellation of all
orders submitted over the applicable FIX or OTTO Port when such port
disconnect [sic]. It is appropriate to offer this removal feature as
optional to all market participants utilizing FIX or OTTO, because
unlike ISE Market Makers who are required to provide quotes in all
products in which they are registered, market participants utilizing
FIX or OTTO do not bear the same magnitude of risk of potential
erroneous or unintended executions. In addition, market participants
utilizing FIX or OTTO may desire their orders to remain on the order
book despite a technical disconnect, so as not to miss any
opportunities for execution of such orders while the FIX and/or OTTO
port is disconnected.
    Utilizing a time period for SQF and OTTO Ports of fifteen (15)
seconds and permitting ISE Market Makers and Members to modify the
setting to between 100 milliseconds and 99,999 milliseconds is
consistent with the Act because the Exchange does not desire to trigger
unwarranted logoffs of Members and therefore allows Members the ability
to set their time in order to enable the Exchange the authority to
disconnect the Member with this feature. Both SQF and OTTO are
proprietary system components offered by ISE. The Exchange believes
that the proposed settings for SQF and OTTO

are appropriate timeframes. Each ISE Market Maker and Member has
different levels of sensitivity with respect to this disconnect setting
and each ISE Market Maker and Member has their own system safeguards as
well. A default setting of fifteen (15) seconds is appropriate to
capture the needs of all ISE Market Makers and Members and high enough
not to trigger unwarranted removal of quotes and orders.
    Further, ISE Market Makers and Members are able to customize their
settings. The Exchange's proposal to permit a timeframe for SQF and
OTTO Ports between 100 milliseconds and 99,999 milliseconds is
consistent with the Act and the protection of investors because the
purpose of this feature is to mitigate the risk of potential erroneous
or unintended executions associated with a loss in communication with a
Client Application. Members are able to better anticipate the
appropriate time within which they may require prior to a logoff as
compared to the Exchange. The Member is being offered a timeframe by
the Exchange within which to select the appropriate time. The Exchange
does not desire to trigger unwarranted logoffs of Members and therefore
permits Members to provide an alternative time to the Exchange, within
the Exchange's prescribed timeframe, which authorizes the Exchange to
disconnect the Member. The ``nn'' seconds serve as the Member's
instruction to the Exchange to act upon the loss of connection and
remove quotes from the system, and if elected, orders from the System.
This range will accommodate Members in selecting their appropriate
times within the prescribed timeframes.
    With respect to SQF, the Exchange's proposal is further consistent
with the Act because it will mitigate the risk of potential erroneous
or unintended executions associated with a loss in communication with a
Client Application which protects investors and the public interest.
Also, any interest that is executable against a ISE Market Maker's
quotes that is received \12\ by the Exchange prior to the trigger of
the disconnect to the Client Application, which is processed by the
system, automatically executes at the price up to the ISE Market
Maker's size. In other words, the system will process the request for
cancellation in the order it was received by the system.
---------------------------------------------------------------------------

    \12\ The time of receipt for an order or quote is the time such
message is processed by the Exchange book.
---------------------------------------------------------------------------

    With respect to FIX, a universal system component, the Exchange's
proposal would set a default timeframe of thirty (30) seconds and
permit a FIX user to modify the timeframe for FIX Ports to between 1
second and 30 seconds for the removal of orders. This proposal is
consistent with the Act and the protection of investors because this
feature, which is optional, will mitigate the risk of potential
erroneous or unintended executions associated with a loss in
communication with a Client Application. With respect to the longer
timeframe for FIX, as compared to SQF and OTTO, the Exchange notes that
unlike SQF and OTTO which are proprietary system components, FIX is a
universal component. The settings on FIX remain different given FIX is
not a proprietary system component. ISE Market Makers require a quicker
timeframe (15 seconds as compared to 30 seconds). ISE Market Makers
have quoting obligations \13\ and are more sensitive to price movements
as compared to other market participants. It is consistent with the Act
to provide a longer timeframe within which to customize settings for
FIX as compared to SQF Ports because ISE Market Makers need to remain
vigilant of market conditions and react more quickly to market
movements as compared to other Members entering orders into the system.
The proposal acknowledges this sensitivity borne by ISE Market Makers
and reflects the reaction time of ISE Market Makers as compared to
Members entering orders. Of note, the proposed customized timeframe for
FIX might be too long for ISE Market Makers given their quoting
requirements and sensitivity to price movements. ISE Market Makers
would be severely impacted by a loss of connectivity of more than
several seconds. The ISE Market Maker would have exposure during the
time period in which they are unable to manage their quote and update
that quote. The Member is best positioned to determine their setting.
With respect to other market participants that enter orders, they have
the option of selecting either OTTO or FIX and therefore are able to
obtain a shortened timeframe with OTTO if they desire.
---------------------------------------------------------------------------

    \13\ See note 11 above.
---------------------------------------------------------------------------

    The system operates consistently with the firm quote obligations of
a broker-dealer pursuant to Rule 602 of Regulation NMS. Specifically,
with respect to ISE Market Makers, their obligation to provide
continuous two-sided quotes on a daily basis is not diminished by the
automatic removal of such quotes triggered by the disconnect. ISE
Market Makers are required to provide continuous two-sided quotes on a
daily basis.\14\ ISE Market Makers will not be relieved of the
obligation to provide continuous two-sided quotes on a daily basis, nor
will it prohibit the Exchange from taking disciplinary action against a
ISE Market Maker for failing to meet the continuous quoting obligation
each trading day as a result of disconnects.
---------------------------------------------------------------------------

    \14\ See note 11 above.
---------------------------------------------------------------------------

    With respect to FIX and OTTO Ports, the Exchange will offer this
optional removal functionality to all market participants. Offering the
removal feature on a voluntary basis to all other market participants
is consistent with the Act because it permits them an opportunity to
utilize this risk feature, if desired, and avoid risks associated with
inadvertent executions in the event of a loss of connectivity with the
Exchange. The removal feature is designed to mitigate the risk of
missed and/or unintended executions associated with a loss in
communication with a Client Application. The proposed rule change is
designed to not permit unfair discrimination among market participants,
as this optional removal feature will be offered uniformly to all
Members utilizing FIX and/or OTTO.
    The Exchange will disconnect Members from the Exchange and not
cancel a Member's orders if the removal feature is disabled. The
disconnect feature is mandatory and will cause the Member to be
disconnected within the default timeframe or the timeframe otherwise
specified by the Member. This feature is consistent with the Act
because it enables FIX and OTTO users the ability to disconnect from
the Exchange, assess the situation and make a determination concerning
their risk exposure. The Exchange notes that in the event that orders
need to be removed, the Member may elect to utilize the Kill Switch
\15\ feature. The Exchange believes that it is consistent with the Act
to require other market participants to be disconnected because the
participant is otherwise not connected to the Exchange's system and the
Member simply needs to reconnect to commence submitting and cancelling
orders. The Exchange believes requiring a disconnect when a loss of
communication is detected is a rational course of action for the
Exchange to alert the Member of the technical connectivity issue.
---------------------------------------------------------------------------

    \15\ See ISE Rule 711(d).
---------------------------------------------------------------------------

    The proposed rule change will help maintain a fair and orderly
market which promotes efficiency and protects investors. This mandatory
removal feature for ISE Market Makers and optional removal for all
other market

participants will mitigate the risk of potential erroneous or
unintended executions associated with a loss in communication with a
Client Application.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Specifically, the Exchange does
not believe the proposed rule change will cause an undue burden on
intra-market competition because ISE Market Makers, unlike other market
participants, have greater risks in the market place. Quoting across
many series in an option creates large principal positions that expose
ISE Market Makers, who are required to continuously quote in assigned
options, to potentially significant market risk. Providing a broader
timeframe for the disconnect and removal of orders for FIX as compared
to the removal of quotes for SQF Ports and OTTO orders does not create
an undue burden on competition because ISE Market Makers have quoting
obligations \16\ and are more sensitive to price movements as compared
to other market participants. ISE Market Makers need to remain vigilant
of market conditions and react more quickly to market movements as
compared to other Members entering multiple orders into the system. The
proposal reflects this sensitivity borne by ISE Market Makers and
reflects the reaction time of ISE Market Makers as compared to other
Members entering orders. With respect to other market participants that
enter orders, they have the option of selecting either OTTO or FIX and
therefore are able to obtain a shortened timeframe with OTTO if they
desire.
---------------------------------------------------------------------------

    \16\ See note 11 above.
---------------------------------------------------------------------------

    Offering the removal feature to other market participants on an
optional basis does not create an undue burden on intra-market
competition because unlike ISE Market Makers, other market participants
do not bear the same risks of potential erroneous or unintended
executions. FIX and OTTO users have the opportunity to disable the
cancellation feature and simply disconnect from the Exchange. FIX and
OTTO users may also set a timeframe that is appropriate for their
business. It is appropriate to offer this optional cancellation
functionality to other market participants for open orders, because
those orders are subject to risks of missed and/or unintended
executions due to a lack of connectivity which the participants needs
to weigh. Finally, the Exchange does not believe that such change will
impose any burden on inter-market competition that is not necessary or
appropriate in furtherance of the purposes of the Act. Other options
exchanges offer similar functionality.\17\
---------------------------------------------------------------------------

    \17\ See Phlx Rule 1019(c), NOM Rules at Chapter VI, Section
6(e) and BX Rules at Chapter VI, Section 6(e).
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \18\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\19\
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \19\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-ISE-2018-12 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-ISE-2018-12. 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-ISE-2018-12, and should be submitted on
or before March 13, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-03308 Filed 2-16-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 204 (Tuesday, October 22, 2019)]
[Notices]
[Pages 56507-56509]
[FR Doc No: 2019-22932]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87317; File No. SR-NYSEAMER-2019-42]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Change To Amend the
Certificate of Incorporation of Intercontinental Exchange, Inc.

October 16, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 3, 2019, NYSE American LLC (``NYSE American'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend the certificate of incorporation of
Intercontinental Exchange, Inc. (``ICE'') to make a technical change
updating the registered office and registered agent in the State of
Delaware and make non-substantive and conforming changes. The proposed
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.

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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the certificate of incorporation of
ICE to make a technical change updating the registered office and
registered agent in the State of Delaware and make non-substantive and
conforming changes.
    The proposed amendments to the certificate of incorporation were
approved by the Board of Directors of ICE on September 19, 2019. The
Exchange proposes that the amendments would be effective upon filing
with the Secretary of State of the State of Delaware.
Change in Registered Office and Registered Agent
    ICE is a corporation organized under the laws of the State of
Delaware. As such, ICE is required to have and maintain a registered
office and registered agent in the State of Delaware.\3\ The Exchange
proposes to change the address of ICE's registered office and the name
of ICE's registered agent, which would make them consistent with the
governing documents of the Exchange and its intermediate holding
companies.\4\
---------------------------------------------------------------------------

    \3\ See Del. Code tit 8, Sec. Sec.  131 and 132.
    \4\ See Securities Exchange Release Nos. 82637 (February 6,
2018), 83 FR 6055 (February 12, 2018) (notice of filing and
immediate effectiveness of proposed change to amend certain of the
governing documents of its intermediate parent companies) (SR-
NYSEAmer-2018-003); and 82923 (March 22, 2018), 83 FR 13161 (March
27, 2018) (SR-NYSEAmer-2018-10) (notice of filing and immediate
effectiveness of proposed change amending certain governing
documents of the Exchange and NYSE Market, Inc.).
---------------------------------------------------------------------------

    In order to implement the change, ICE intends to file with the
Secretary of State of the State of Delaware a Certificate of Change of
Registered Agent and/or Registered Office (``Certificate of
Change''),\5\ which will change the address of its registered office
and the name of its registered agent set forth in the Fourth Amended
and Restated Certificate of Incorporation of ICE (``Fourth
Certificate''). Immediately thereafter, ICE intends to file with the
Secretary of State of the State of Delaware the Fifth Amended and
Restated Certificate of Incorporation of ICE (the ``Fifth
Certificate''), which will integrate the changes made by the
Certificate of Change.
---------------------------------------------------------------------------

    \5\ See Del. Code tit 8, Sec.  133.
---------------------------------------------------------------------------

    With respect to the change in the registered agent and registered
office, in the Fifth Certificate, Article II would identify United
Agent Group Inc. as the registered agent and provide that the address
of the registered office in the State of Delaware, County of New
Castle, is 3411 Silverside Road, Tatnall Building No. 104, Wilmington,
Delaware 19810. Currently, Article II of the Fourth Certificate
identifies 1209 Orange Street, Wilmington, Delaware 19801 as the
address of the registered office in the State of Delaware, County of
New Castle, and provides that the name of its registered agent at such
address is The Corporation Trust Company.
Conforming Changes
    The Exchange proposes to make technical conforming changes to the
Fifth Certificate.
    The General Corporation Law of the State of Delaware (``DGCL'')
provides that the board of directors of a corporation may adopt a
restated certificate of incorporation that integrates a certificate of
incorporation and any prior amendments to such certificate of
incorporation, such as the Certificate of Change.\6\ Accordingly, the
proposed second introductory paragraph would state that the Fifth
Certificate restates and integrates, and does not further amend, the
provisions of the Fourth Certificate, as amended by the Certificate of
Change, and there is no discrepancy between them. Similarly, the fourth
introductory paragraph would state that the Fourth Certificate was
thereby restated and integrated to read as set forth in the Fifth
Certificate. The proposed changes would delete a reference in the
Fourth Certificate to the amendment of the Third Amended and Restated
Certificate.
---------------------------------------------------------------------------

    \6\ See Del. Code tit 8, Sec.  245(a).
---------------------------------------------------------------------------

    Pursuant to Section 245(b) of the DGCL, stockholder approval is not
required for a restated certificate of incorporation that, like the
proposed Fifth Certificate, restates and integrates but does not
further amend the existing certificate of incorporation.\7\
Accordingly, the proposed third and fourth introductory paragraphs
would delete the references to Section 242 of the DGCL, as it refers to
stockholder approval, which would not be required.\8\
---------------------------------------------------------------------------

    \7\ See Del. Code tit 8, Sec.  245(b).
    \8\ See Del. Code tit 8, Sec.  242.
---------------------------------------------------------------------------

    References to the ``Third Amended and Restated Certificate of
Incorporation'' and the ``Fourth Amended and Restated Certificate of
Incorporation'' in the titles, introductory paragraphs, and signature
lines would be changed to refer to the ``Fourth Amended and Restated
Certificate of Incorporation'' and ``Fifth Amended and

Restated Certificate of Incorporation,'' respectively.
    Finally, the time and date of effectiveness and execution in the
introductory certifications and signature line would be updated.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Exchange Act \9\ in general, and with Section
6(b)(1) \10\ in particular, in that it enables the Exchange to be so
organized as to have the capacity to be able to carry out the purposes
of the Exchange Act and to comply, and to enforce compliance by its
exchange members and persons associated with its exchange members, with
the provisions of the Exchange Act, the rules and regulations
thereunder, and the rules of the Exchange.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(1).
---------------------------------------------------------------------------

    The proposed rule change is a non-substantive administrative change
that does not impact the governance or ownership of the Exchange. The
Exchange believes that the proposed rule change would enable the
Exchange to continue to be so organized as to have the capacity to
carry out the purposes of the Exchange Act and comply and enforce
compliance with the provisions of the Exchange Act by its members and
persons associated with its members, because ensuring that the Fifth
Certificate identifies the name of ICE's registered agent and address
of ICE's registered office in the State of Delaware would contribute to
the orderly operation of the Exchange by adding clarity and
transparency to its rules. The proposed change would ensure that ICE
continues to comply with Delaware requirements for corporations to have
a registered agent and registered office in the State of Delaware. In
addition, the proposed changes to the introductory paragraphs would
ensure that the Fifth Certificate correctly describes the proposed
restatement and integration of the existing certificate of
incorporation, as amended by the Certificate of Change, and references
the correct provisions of the DGCL in accordance with the requirements
of Delaware law, ensuring clarity and transparency.
    For similar reasons, the Exchange also believes that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\11\ in that
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 facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
a national market system by ensuring that market participants can more
easily navigate, understand and comply with its rules. The Exchange
believes that, by ensuring that such rules accurately identify the name
of ICE's registered agent and the address of ICE's registered office in
the State of Delaware, the proposed rule change would reduce potential
investor or market participant confusion. In addition, the proposed
changes to the introductory paragraphs and the proposed conforming
changes would ensure that the Fifth Certificate correctly describes the
proposed restatement and integration of the existing certificate of
incorporation, as amended by the Certificate of Change, and references
the correct provisions of the DGCL in accordance with the requirements
of Delaware law, reducing potential confusion that may result from
having an incorrect description or reference in the Fifth Certificate.

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 Exchange Act. The proposed rule
change is not designed to address any competitive issue but rather is
concerned solely with making a technical change updating the registered
office and registered agent of ICE and conforming changes.

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

    The proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and Rule 19b-4(f)(3) \13\ thereunder in
that the proposed rule change is concerned solely with the
administration of the Exchange.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may 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 under Section
19(b)(2)(B) \14\ of the Act to determine whether the proposed rule
change should be approved or disapproved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEAMER-2019-42 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-NYSEAMER-2019-42. 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 such

filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. 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-
NYSEAMER-2019-42, and should be submitted on or before November 12,
2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-22932 Filed 10-21-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Rules and Regulations]
[Pages 33116-33118]
[FR Doc No: 2014-13428]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2014-0311; FRL-9911-90-Region-4]

Approval and Promulgation of Implementation Plans Alabama:
Volatile Organic Compounds

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a revision to the Alabama State Implementation
Plan (SIP) submitted by the Alabama Department of Environmental
Management (ADEM) on September 3, 2013. The revision modifies the
definition of ``volatile organic compounds'' (VOCs). Specifically, the
revision adds four hydrofluoropolyethers (HFPEs) compounds, to the list
of those excluded from the VOC definition on the basis that these
compounds make a negligible contribution to tropospheric ozone
formation. ADEM is updating its SIP to be consistent with EPA rule
finalized on February 12, 2013, which excludes these compounds from the
regulatory VOC definition.

DATES: This rule is effective on August 11, 2014 without further
notice, unless EPA receives relevant adverse comment by July 10, 2014.
If EPA receives such comment, EPA will publish a timely withdrawal in
the Federal Register informing the public that this rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2014-0311, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2014-0311,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. ``EPA-R04-OAR-
2014-0311.'' EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through
www.regulations.gov or email, information that you consider to be CBI
or otherwise protected. The www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Richard Wong, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. Mr. Richard Wong may be
reached by phone at<PHONE_NUMBER> or by electronic mail address
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Tropospheric ozone, commonly known as smog, occurs when VOCs and
nitrogen oxides (NOX) react in the atmosphere. Because of
the harmful health effects of ozone, EPA limits the amount of VOCs and
NOX that can be released into the atmosphere. VOCs are those
compounds of carbon (excluding carbon monoxide, carbon dioxide,
carbonic acid, metallic carbides or carbonates, and ammonium carbonate)
that form ozone through atmospheric photochemical reactions. Compounds
of carbon (or organic compounds) have different levels of reactivity;
they do not react at the same speed, or do not form ozone to the same
extent.
    It has been EPA's policy that compounds of carbon with negligible
reactivity need not be regulated to reduce ozone. See 42 FR 35314, July
8, 1977. EPA determines whether a given carbon compound has
``negligible'' reactivity by comparing the compound's reactivity to the
reactivity of ethane. EPA lists these compounds in its

regulations at 40 CFR 51.100(s) and excludes them from the definition
of VOC. The chemicals on this list are often called ``negligibly
reactive.'' EPA may periodically revise the list of negligibly reactive
compounds to add or delete compounds.
    On February 12, 2013, EPA issued a final rule approving the
addition of four HFPEs to the list of those compounds excluded from the
regulatory definition of VOC. See 78 FR 9823. The four HFPEs--HCF2OCF2H
(HFE-134), HCF2OCF2OCF2H (HFE-236cal2), HCF2OCF2CF2OCF2H (HFE-
338pcc13), and HCF2OCF2OCF2CF2OCF2H (H-Galden 1040X and H-Galden ZT 130
(or 150 or 180)), have been used in some heat transfer applications (as
refrigerants) and as fire suppressants. Because HFPEs do not contain
chlorine or bromine, these compounds do not contribute to the depletion
of the ozone layer and have ozone depletion potential values of zero.
ADEM is updating its SIP to be consistent with federal regulations.

II. Analysis of the State's Submittal

    On September 3, 2013, ADEM submitted a SIP revision \1\ to EPA for
review and approval. The revision modifies the definition of VOCs found
at Alabama Administrative Code section 335-3-1-.02(gggg). Specifically,
the revision adds four HFPEs compounds--HCF2OCF2H (HFE-134),
HCF2OCF2OCF2H (HFE-236cal2), HCF2OCF2CF2OCF2H (HFE-338pcc13), and
HCF2OCF2OCF2CF2OCF2H (H-Galden 1040X and H-Galden ZT 130 (or 150 or
180)) to the list of those excluded from the VOC definition on the
basis that these compounds make a negligible contribution to
tropospheric ozone formation.
---------------------------------------------------------------------------

    \1\ Alabama's September 3, 2013 submission to EPA also included
changes to Chapters 335-3-10 New Source Performance Standards and
335-3-11 National Emissions Standards for Hazardous Air Pollutants
which are not part of the Alabama federally approved SIP.
---------------------------------------------------------------------------

    This action amends Rule 335-3-1-.02(gggg) to update the definition
of VOC to be consistent with EPA regulations. These changes are
consistent with the section 110 of the Clean Air Act (CAA or Act).

III. Final Action

    Pursuant to section 110 of the CAA, EPA is approving the revision
to the Alabama SIP revising the VOC definition. EPA has evaluated
Alabama's September 3, 2013, submittal and has determined that it meets
the applicable requirements of the CAA and EPA regulations and is
consistent with EPA policy. EPA is publishing this rule without prior
proposal because the Agency views this as a noncontroversial submittal
and anticipates no adverse comments. However, in the proposed rules
section of this Federal Register publication, EPA is publishing a
separate document that will serve as the proposal to approve the SIP
revision should adverse comments be filed. This rule will be effective
August 11, 2014 without further notice unless the Agency receives
adverse comments by July 10, 2014. If the EPA receives such comments,
then EPA will publish a document withdrawing the final rule and
informing the public that the rule will not take effect. All public
comments received will then be addressed in a subsequent final rule
based on the proposed rule. EPA will not institute a second comment
period. Parties interested in commenting should do so at this time. If
no such comments are received, the public is advised that this rule
will be effective on August 11, 2014 and no further action will be
taken on the proposed rule.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq, as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 11, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that

EPA can withdraw this direct final rule and address the comment in the
proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements. See CAA section 307(b)(2), 42
U.S.C. 7607(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Nitrogen dioxides,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: May 28, 2014.
Heather McTeer Toney.
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart B--Alabama

0
2. Section 52.50(c) is amended by revising the entry for ``Section 335-
3-1-.02'' to read as follows:

Sec.  52.50  Identification of plan.

* * * * *
    (c) * * *

                                        EPA--Approved Alabama Regulations
----------------------------------------------------------------------------------------------------------------
                                                             State
          State citation              Title/subject     effective date   EPA approval date       Explanation
----------------------------------------------------------------------------------------------------------------
                                       Chapter 335-3-1--General Provisions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 335-3-1-.02..............  Definitions........       9/24/2013  6/10/2014 [Insert    ...................
                                                                         citation of
                                                                         publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-13428 Filed 6-9-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30320-30321]
[FR Doc No: 2021-11802]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-2317]

Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine
Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/
Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that QUELICIN PRESERVATIVE FREE (succinylcholine chloride)
Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 mg/mL,
was not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL, is the subject of NDA 008845, held by
Hospira, Inc., and initially approved on May 1, 1953. QUELICIN
PRESERVATIVE FREE is indicated as an adjunct to general anesthesia, to
facilitate tracheal intubation, and to provide skeletal muscle
relaxation during surgery or mechanical ventilation.
    Baxter Healthcare Corp. submitted a citizen petition dated December
21, 2020 (Docket No. FDA-2020-P-2317), under 21 CFR 10.30, requesting
that the Agency determine whether QUELICIN PRESERVATIVE FREE
(succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/
mL, was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, was not
withdrawn for reasons of safety or

effectiveness. The petitioner has identified no data or other
information suggesting that QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of QUELICIN PRESERVATIVE
FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100
mg/mL, from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
reviewed the available evidence and determined that this drug product
was not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list QUELICIN PRESERVATIVE
FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100
mg/mL, in the ``Discontinued Drug Product List'' section of the Orange
Book. The ``Discontinued Drug Product List'' delineates, among other
items, drug products that have been discontinued from marketing for
reasons other than safety or effectiveness. ANDAs that refer to
QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/
mL, 50 mg/mL, and 100 mg/mL, may be approved by the Agency as long as
they meet all other legal and regulatory requirements for the approval
of ANDAs. If FDA determines that labeling for this drug product should
be revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: May 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11802 Filed 6-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Notices]
[Page 70261]
[FR Doc No: 2019-27527]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Random Drug and Alcohol Testing Percentage Rates of Covered
Aviation Employees for the Period of January 1, 2020, Through December
31, 2020

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA has determined that the minimum random drug and
alcohol testing percentage rates for the period January 1, 2020,
through December 31, 2020, will remain at 25 percent of safety-
sensitive employees for random drug testing and 10 percent of safety-
sensitive employees for random alcohol testing.

FOR FURTHER INFORMATION CONTACT: Ms. Vicky Dunne, Office of Aerospace
Medicine, Drug Abatement Division, Program Policy Branch (AAM-820),
Federal Aviation Administration, 800 Independence Avenue SW, Room 806,
Washington, DC 20591; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Discussion: Pursuant to 14 CFR 120.109(b), the FAA Administrator's
decision on whether to change the minimum annual random drug testing
rate is based on the reported random drug test positive rate for the
entire aviation industry. If the reported random drug test positive
rate is less than 1.00%, the Administrator may continue the minimum
random drug testing rate at 25%. In 2018, the random drug test positive
rate was 0.731%. Therefore, the minimum random drug testing rate will
remain at 25% for calendar year 2020.
    Similarly, 14 CFR 120.217(c), requires the decision on the minimum
annual random alcohol testing rate to be based on the random alcohol
test violation rate. If the violation rate remains less than 0.50%, the
Administrator may continue the minimum random alcohol testing rate at
10%. In 2018, the random alcohol test violation rate was 0.099%.
Therefore, the minimum random alcohol testing rate will remain at 10%
for calendar year 2020.
    If you have questions about how the annual random testing
percentage rates are determined please refer to the Code of Federal
Regulations Title 14, section 120.109(b) (for drug testing), and
120.217(c) (for alcohol testing).

    Issued in Washington, DC, on December 17, 2019.
Michael A. Berry,
Federal Air Surgeon.
[FR Doc. 2019-27527 Filed 12-19-19; 8:45 am]
 BILLING CODE 4910-13-P