[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Notices]
[Pages 42715-42716]
[FR Doc No: 2011-18093]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Quarantine Release Errors in Blood Establishments; Public
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Quarantine Release Errors in Blood
Establishments.'' The purpose of this public workshop is to provide a
forum for discussion of quarantine release errors (QREs) and provide
FDA and industry with information necessary to reduce the rates of
QREs. The workshop will focus on the extent and characteristics of QREs
in blood establishments and the specifications of blood establishment
computer software

(BECS) as they relate to inventory control. The public workshop has
been planned in partnership with the Department of Health and Human
Services (HHS) Office of the Assistant Secretary for Health, America's
Blood Centers, and AABB. This public workshop will include
presentations and panel discussions by experts knowledgeable in this
field from government Agencies and industry.
    Date and Time: The public workshop will be held on September 13,
2011, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Universities at
Shady Grove Conference Center, 9630 Gudelsky Dr., Rockville, MD 20850-
5820,<PHONE_NUMBER>.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>    Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone, and fax numbers)
to Rhonda Dawson (see Contact Person) by September 1, 2011. There is no
registration fee for the public workshop. Early registration is
recommended because seating is limited. Registration on the day of the
public workshop will be provided on a space available basis beginning
at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: QREs refer to the inadvertent release of
blood or blood components either before completion of testing and
determination that all other criteria affecting the safety, purity, or
potency of the product have been met, or despite findings that would
render the blood or blood components unsuitable for release. Although
QREs that result in the distribution of blood or blood components are
required to be reported to FDA as biologic product deviation reports
(BPDRs), the amount of information provided in BPDRs varies and often
represents a summary of information rather than a detailed description
and analysis of the problem. Thus, the root causes of QREs are not
known with certainty. Further, the rates of QREs are also not known
with certainty, and actions necessary to correct and prevent them are
unclear.
    There has been a recent focus on QREs related to the release of
units with incomplete or absent testing for transfusion-transmitted
infectious diseases. On June 10 and 11, 2010, the HHS Advisory
Committee on Blood Safety and Availability (the Committee) met to
discuss the current FDA blood donor deferral policy on men who have sex
with other men. While the Committee recommended that the current
deferral policy not be changed at the present time, it found the
current policy to be suboptimal in permitting some potentially high
risk donations while preventing some low risk donations. The Committee
made a number of recommendations and indicated that HHS should take
action to investigate and reduce the risk of QREs in blood collection
establishments.
    This public workshop will serve as a forum for discussion of QREs
and provide FDA and industry with information necessary to reduce the
rates of QREs. The public workshop presentations and panel discussions
will: (1) Review recent BPDR data to better determine the root causes
for QREs and identify activities that could address those causes; (2)
evaluate the use of 510(k) cleared BECS or implementation of BECS
performance standards in reducing the rate of QREs; and (3) explore
other potential strategies to address QREs. The public workshop will
conclude with a summary of the issues discussed.
    Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
on the Internet at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857.

    Dated: July 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-18093 Filed 7-18-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: January 7, 2010 (Volume 75, Number 4)]
[Proposed Rules]
[Page 950-952]
[DOCID:fr07ja10-14]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1249; Directorate Identifier 2009-NM-100-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 777 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Model 777 airplanes. This proposed AD would require inspecting
the bolt, nut, and downstop of the slat track assembly to determine if
the bolt, nut, or stops are missing and to determine if the thread
protrusion of the bolt from the nut is within specified limits and
parts are correctly installed, and related investigative and corrective
actions if necessary. For certain airplanes, this proposed AD would
also require inspecting the slat cans at the outboard slat number 3 and
12 outboard main track locations for holes and wear damage, and
corrective actions if necessary; and replacing the downstop hardware
for the outboard slats number 3 and 12 outboard and inboard main track
locations. This proposed AD results from a report of a hole in the
inboard main track slat can for outboard slat number 12 on a Model 777
airplane. The hole was caused when the bolt securing the downstop
migrated out of the fitting and contacted the slat can. We are
proposing this AD to detect and correct damage to the outboard slat
main track slat cans, which can allow fuel leakage into the fixed wing
leading edge in excess of the capacity of the draining system. Excess
fuel leakage could result in an uncontained fire.

DATES: We must receive comments on this proposed AD by February 22,
2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER> or
425-227-1152.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Duong Tran, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6452; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-1249;
Directorate Identifier 2009-NM-100-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received a report of a hole in the inboard main track slat
can for outboard slat number 12 on a Model 777 airplane. The hole was
caused when the bolt securing the downstop migrated out of the fitting
and contacted the slat can. Each outboard slat main track has a
downstop attached to the aft end of the slat track assembly. The
downstop consists of two fittings that are secured to the track with a
bolt and nut. The main tracks travel through holes in the front spar
web when the slat is retracted. In areas of the wing where fuel is
stored, a slat can is installed on the fuel side of the spar to
surround the main track and contain the fuel. It is believed that the
locking element of the nut was not fully engaged, and the nut securing
the bolt backed off and allowed the bolt to migrate out of the fitting
and contact the slat can. In addition, in production it was discovered
that a downstop was contacting the weld on a slat can at the outboard
main track location on slat numbers 3 and 12. This contact could cause
wear damage and eventually a hole in the slat can. This condition, if
not corrected, could result in fuel leakage into the fixed wing leading
edge in excess of the capacity of the draining system. Fuel leakage
could result in an uncontained fire.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin 777-57A0064, dated
March 26, 2009. The service bulletin describes procedures for doing a
detailed inspection of the slat main track stop hardware to determine
if the bolt, nut, or stops are missing and to determine if the thread
protrusion of the

bolt from the nut is within specified limits. For airplanes on which
hardware is missing or the thread protrusion is not within limits, the
service bulletin describes procedures for doing applicable related
investigative and corrective actions. These related investigative
actions include measuring torque of the nuts of the slat main track
stop hardware, and doing a detailed inspection of the slat can inside
of the slat can for holes and gouges. The corrective actions include
repairing or replacing the slat can and replacing the slat main track
stop hardware.
    The service bulletin also describes procedures for Group 2
airplanes for doing a detailed inspection of the slat cans at the
outboard slat number 3 and 12 outboard main track locations for holes
and wear damage, and corrective actions if necessary; and for replacing
the downstop hardware for the outboard slats number 3 and 12 outboard
and inboard main track locations. The corrective actions include
replacing the slat main track stop hardware, and repairing or replacing
the slat can.
    The service bulletin specifies that the compliance time for the
detailed inspections and the replacement is within 6 months after the
issue date of the service bulletin. The compliance times for the
related investigative actions range between before further flight and
within 1,125 days or 6,000 flight cycles after the issue date of the
service bulletin (whichever occurs first), depending on whether
hardware is missing or whether damage is within the specified limits.
The compliance times for the corrective actions range between before
further flight and within 1,125 days after wear damage is found,
depending on the severity of the damage.

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs. This proposed AD would require accomplishing the actions
specified in the service information described previously.

Costs of Compliance

    We estimate that this proposed AD would affect 129 airplanes of
U.S. registry. The following table provides the estimated costs for
U.S. operators to comply with this proposed AD.

                                                                 Table--Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                                          Average                                                  U.S.-
                  Action                    Work hours   labor rate     Parts           Cost per product         registered           Fleet cost
                                                          per hour                                               airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection for Group 1 airplanes.........           39          $80           $0  $3,120 per inspection cycle.          127  $396,240 per inspection
                                                                                cycle.
Inspection for Group 2 airplanes.........           55           80            0  $4,400 per inspection cycle.            2  $8,800 per inspection
                                                                                cycle.
Replacement for Group 2 airplanes........            8           80        9,267  $9,907......................            2  $19,814.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979), and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

The Boeing Company: Docket No. FAA-2009-1249; Directorate Identifier
2009-NM-100-AD.

Comments Due Date

    (a) We must receive comments by February 22, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to The Boeing Company Model 777-200, -200LR,
-300, and -300ER airplanes, certificated in any category; as
identified in Boeing Alert Service Bulletin 777-57A0064, dated March
26, 2009.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Unsafe Condition

    (e) This AD results from a report of a hole in the inboard main
track slat can for outboard slat number 12 on a Model 777 airplane.
The Federal Aviation Administration is issuing this AD to detect and
correct damage to the outboard slat main track slat cans, which can
allow fuel leakage into the fixed wing leading edge in excess of the
capacity of the draining system. Excess fuel leakage could result in
an uncontained fire.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Inspect the Slat Track Stop Hardware and Measure the Torque of the Slat
Main Track Stop Hardware

    (g) At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 777-57A0064, dated
March 26, 2009, except as required by paragraph (h) of this AD: Do
the applicable actions specified in paragraphs (g)(1) and (g)(2) of
this AD.
    (1) For all airplanes: Do a detailed inspection of the slat main
track stop hardware to determine if the bolt, nut, or stops are
missing and to determine if the thread protrusion of the bolt from
the nut is within specified limits, and do all applicable related
investigative and corrective actions, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 777-
57A0064, dated March 26, 2009. Do all applicable related
investigative and corrective actions at the applicable time
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 777-57A0064, dated March 26, 2009, except as required by
paragraph (h) of this AD.
    (2) For airplanes identified as Group 2 airplanes in Boeing
Alert Service Bulletin 777-57A0064, dated March 26, 2009: Do a
detailed inspection of the slat cans at the outboard slat number 3
and 12 outboard main track locations for holes and wear damage and
all applicable corrective actions, and replace the downstop hardware
for the outboard slats number 3 and 12 outboard and inboard main
track locations. Do all applicable corrective actions at the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 777-57A0064, dated March 26, 2009.

Exception to the Service Bulletin

    (h) Where Boeing Alert Service Bulletin 777-57A0064, dated March
26, 2009, specifies a compliance time after the date on the service
bulletin, this AD requires compliance within the specified
compliance time after the effective date of this AD.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Duong Tran, Aerospace Engineer, Airframe Branch, ANM-120S,
FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
917-6590. Or, e-mail information to 9-ANM-Seattle-ACO-AMOC-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

    Issued in Renton, Washington, on December 23, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-31431 Filed 1-6-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Pages 73550-73553]
[FR Doc No: 2020-25382]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90400; File No. SR-PEARL-2020-24]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the MIAX
PEARL Equities Fee Schedule

November 12, 2020.
    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 October 30, 2020, MIAX PEARL, LLC (``MIAX PEARL'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
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 is filing a proposal to amend the fee schedule
applicable for MIAX PEARL Equities, an equities trading facility of the
Exchange (the ``Fee Schedule'').\3\ The proposed fees are scheduled to
become operative November 2, 2020.
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    \3\ See Exchange Rule 1901.
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    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/pearl at MIAX
PEARL'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 these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to amend the Fee
Schedule applicable to MIAX PEARL Equities to increase the rebate for
displayed orders \4\ on the MIAX PEARL Equities Book \5\ that add
liquidity in securities priced at or above $1.00. The Exchange
currently provides a rebate of $0.0028 per share to displayed orders
that add liquidity in securities priced at or above $1.00. The Exchange
now proposes to increase the rebate for displayed orders that add
liquidity in securities priced at or above $1.00 to $0.0032 per share.
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    \4\ See Exchange Rule 2614(c)(3).
    \5\ The term ``MIAX PEARL Equities Book'' means the electronic
book of orders in equity securities maintained by the System. See
Exchange Rule 1901.
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    The purpose of this proposed change is for business and competitive
reasons. As a new entrant into the equities market, the Exchange
initially adopted the rebate of $0.0028 per share for displayed orders
that add liquidity in securities priced at or above $1.00 in order to
encourage market participants to submit displayed orders to the
Exchange. The Exchange now believes that it is appropriate to increase
the rebate to $0.0032 per share for displayed orders that add liquidity
in securities price at or above $1.00, thereby continuing to encourage
market participants to submit more displayed orders to the Exchange and
increase displayed order flow. The Exchange believes that this proposal
will result in encouraging market participants to submit more displayed
orders to the Exchange, thereby increasing displayed order liquidity,
which benefits all Exchange participants by providing more trading
opportunities and tighter spreads.
    The proposed rebate increase will become effective on November 2,
2020. The Exchange does not propose any other changes to the MIAX PEARL
Equities Fee Schedule.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \6\ in general, and furthers
the objectives of Section 6(b)(4) of the Act \7\ in particular, in that
it is an equitable allocation of reasonable fees and other charges
among its members and issuers and other persons using its facilities.
As discussed above, the Exchange operates in a highly fragmented and
competitive market. The Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Market
participants can readily direct order flow to competing venues if they
deem fee levels at a particular venue to be excessive or rebates/
incentives to be insufficient. The Exchange believes that the Fee
Schedule reflects a simple and competitive pricing structure, which is
designed to incentivize market participants to add aggressively priced
displayed liquidity and direct their order flow to the Exchange. The
Exchange believes the proposed increased rebate for displayed orders
that add liquidity in securities priced at or above $1.00 will continue
to promote price discovery and price formation and deepen liquidity
that is subject to the Exchange's transparency, regulation, and
oversight as an exchange, thereby enhancing market quality to the
benefit of all Equity Members \8\ and investors.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4) and (5).
    \8\ The term ``Equity Member'' means a Member authorized by the
Exchange to transact business on MIAX PEARL Equities. See Exchange
Rule 1901.
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    In particular, the Exchange believes the proposed increase to the
rebate for displayed orders in securities priced above $1.00 from
$0.0028 to $0.0032 per share is reasonable because it would uniformly
provide a rebate of $0.0032 per share to displayed orders in all equity
securities priced at or above $1.00 traded on the Exchange. Further,
the Exchange believes the proposed increased rebate will encourage
additional order flow on the Exchange, which may result in greater
liquidity to the benefit of all market participants on the Exchange by
providing more trading opportunities. The Exchange also believes that
it is reasonable, equitable and not unfairly discriminatory to provide
a higher rebate to displayed orders that add liquidity than to non-
displayed orders as this rebate structure is designed to incentivize
Equity Members to send the Exchange displayed orders, thereby
contributing to price discovery and price formation, consistent with
the overall goal of enhancing market quality. The Exchange further
believes that it is appropriate and reasonable to provide a standard
rebate of $0.0032 per share for displayed orders that add liquidity in
securities priced at or above $1.00 because this rebate is consistent
with similar rebates provided by other exchanges.\9\ The proposed
increased rebate is not unfairly discriminatory because it will apply
equally to all Equity Members.
---------------------------------------------------------------------------

    \9\ For example, the New York Stock Exchange, Inc. (``NYSE'')
fee schedule sets forth various tiers that provide the ability of
their Designated Market Makers to receive a rebate as high as
$0.0045 per share. See https://www.nyse.com/markets/nyse/trading-info/fees. Nasdaq Stock Market LLC (``Nasdaq'') fee schedule set
forth various tiers that provide the ability of a firm to receive a
rebate as high as $0.0033 per share. See http://nasdaqtrader.com/Trader.aspx?id=PriceListTrading2. The Cboe BZX Exchange, Inc.
(``BZX'') sets forth various tiers that provide the ability of a
firm to receive a rebate as high as $0.0033 per share or higher. See
the Tier 1 of the Total Volume Tier and Tier 2 of the Step Up Tier
available at https://markets.cboe.com/us/equities/membership/fee_schedule/bzx/.
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    Further, the Commission and the courts have repeatedly expressed
their preference for competition over regulatory intervention in
determining prices, products, and services in the securities markets.
In Regulation NMS, while adopting a series of steps to improve the
current market model, the Commission highlighted the importance of
market forces in determining prices and SRO revenues and, also,
recognized that current regulation of the market system ``has been
remarkably successful in promoting market competition in its broader
forms that are most important to investors and listed companies.'' \10\
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    \10\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (File No. S7-10-04) (``Regulation
NMS'').
---------------------------------------------------------------------------

    As the Commission itself recognized, the market for trading
services in NMS stocks has become ``more fragmented and competitive.''
\11\ Indeed, equity trading is currently dispersed across 16
exchanges,\12\ 31 alternative trading systems,\13\ and numerous broker-
dealer internalizers and wholesalers, all competing for order flow.
Based on publicly-available information, no single exchange currently
has more than 20% market share (whether including or excluding auction
volume).\14\ Therefore, no exchange possesses significant pricing power
in the execution of equity order flow. More specifically, the Exchange
only recently launched trading operations on September 25, 2020, and
thus has a market share of approximately less than 1% of executed
volume of equities trading.
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    \11\ See Securities Exchange Act Release No. 82873 (March 14,
2018), 83 FR 13008 (March 26, 2018) (File No. S7-05-18) (Transaction
Fee Pilot for NMS Stocks).
    \12\ See Cboe Global Markets, U.S Equities Market Volume
Summary, available at https://markets.cboe.com/us/equities/market_share/.
    \13\ See FINRA ATS Transparency Data, available at https://otctransparency.finra.org/otctransparency/AtsIssueData. A list of
alternative trading systems registered with the Commission is
available at https://www.sec.gov/foia/docs/atslist.htm.
    \14\ See supra note 12.
---------------------------------------------------------------------------

    The Exchange has designed its proposed increased rebate to balance
the need to attract order flow as a new

exchange entrant with the desire to continue to provide a simple fee
structure to market participants. The Exchange believes its proposed
increased rebate structure enables the Exchange to compete for order
flow. The Exchange believes that the ever-shifting market share among
the exchanges from month to month demonstrates that market participants
can shift order flow, or discontinue to reduce use of certain
categories of products, in response to fee changes. With respect to
nonmarketable orders which provide liquidity on an exchange, Equity
Members can choose from any one of the 16 currently operating
registered exchanges to route such order flow. Accordingly, competitive
forces reasonably constrain exchange transaction fees that relate to
orders that would provide displayed liquidity on an exchange. Stated
otherwise, changes to exchange transaction fees can have a direct
effect on the ability of an exchange to compete for order flow. Given
this competitive environment, the Exchange's proposed increased rebate
represents a reasonable attempt to attract order flow to a new exchange
entrant.

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. Rather, the Exchange believes
that the proposed change would encourage the submission of additional
order flow to a public exchange, thereby promoting market depth,
execution incentives and enhanced execution opportunities, as well as
price discovery and transparency for all Equity Members and non-Equity
Members. As a result, the Exchange believes that the proposed change
furthers the Commission's goal in adopting Regulation NMS of fostering
competition among orders, which promotes ``more efficient pricing of
individual stocks for all types of orders, large and small.'' \15\
---------------------------------------------------------------------------

    \15\ See supra note 10.
---------------------------------------------------------------------------

    The Exchange does not believe that the proposed increased rebate
will impose any burden on intermarket competition that is not necessary
or appropriate in furtherance of the purposes of the Act. To the
contrary, the Exchange believes that the proposed increased rebate will
increase competition and is intended to draw volume to the Exchange.
The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow or discontinue to reduce use of certain categories of
products, in response to new or different pricing structures being
introduced into the market. Accordingly, competitive forces constrain
the Exchange's transaction fees and rebates, and market participants
can readily trade on competing venues if they deem pricing levels at
those other venues to be more favorable. As a new exchange, the
Exchange faces intense competition from existing exchanges and other
non-exchange venues that provide markets for equities trading. Although
this increased rebate is intended to attract liquidity to the Exchange,
most other exchanges in operation today already offer multiple
incentives to their participants, including tiered pricing that
provides higher rebates or discounted executions, and other exchanges
will be able to modify such incentives in order to compete with the
Exchange.
    Further, while pricing incentives do cause shifts of liquidity
between trading centers, market participants make determinations on
where to provide liquidity or route orders to take liquidity based on
factors other than pricing, including technology, functionality, and
other considerations. Consequently, the Exchange believes that the
degree to which its proposed increased rebate could impose any burden
on competition is extremely limited, and does not believe that such
increased rebate would burden competition of Equity Members or
competing venues in a manner that is not necessary or appropriate in
furtherance of the purposes of the Act.
    The Exchange does not believe that the proposed increased rebate
will impose any burden on intramarket competition that is not necessary
or appropriate in furtherance of the purposes of the Act because the
proposed increased rebate will apply equally to all Equity Members. The
proposed increased rebate is intended to encourage market participants
to add liquidity to the Exchange by providing a rebate that is
comparable to those offered by other exchanges, which the Exchange
believes will help to encourage Equity Members to send orders to the
Exchange to the benefit of all Exchange participants. As the proposed
rates are equally applicable to all market participants, the Exchange
does not believe there is any burden on intramarket competition.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\16\ and Rule 19b-4(f)(2) \17\ thereunder.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings to determine whether
the proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \17\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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-PEARL-2020-24 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-PEARL-2020-24. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet 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-PEARL-2020-24 and should be
submitted on or before December 9, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-25382 Filed 11-17-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Notices]
[Page 21039-21041]
[DOCID:fr06my09-150]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59845; File No. SR-OCC-2009-08]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change Relating to Stock as Margin

April 29, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934,\1\ notice is hereby given that on April 14, 2009, The Options
Clearing Corporation (``OCC'') filed with the Securities and Exchange
Commission the proposed rule change as described in Items I, II and III
below, which Items have been prepared primarily by OCC. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons and to grant accelerated approval of the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

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

    The proposed rule change will revise OCC's eligibility requirements
for the deposit of stocks as margin.

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

    In its filing with the Commission, OCC 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. OCC 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

    OCC is proposing to amend its rules to facilitate the deposit of
common stocks as margin collateral by: (1) Reducing the minimum price
for stocks from $10 to $3 and (2) eliminating the 10% concentration
test for certain Exchange-Traded Funds (``ETFs'').
1. Minimum Price Test
    Prior to this rule change, OCC Rule 604(b)(4) required that all
stocks (``Valued Securities'') including common and preferred stocks,
submitted as margin collateral had to have a market value greater than
$10 per share. The dramatic fall in equity prices over the last several
months has led to a significant increase in the number of stocks that
are priced below $10. Approximately one year ago, eleven stocks in the
S&P 500 were priced below $10. As of April 13, 2009, sixty-six stocks
were priced below $10. Although OCC's $10 minimum price requirement for
stock collateral was intended to exclude stocks that might be volatile,
illiquid, close to delisting, etc., it did so at the expense of
excluding many stocks that if looked at individually would be deemed
appropriate for margin collateral purposes.
    Under this filing, OCC will reduce the minimum market value for
stocks from $10 to $3. OCC has performed an analysis of the impact of
reducing the minimum share price for common stock and has concluded
that such a change can be implemented for both option and non-option
securities without materially increasing risk to OCC. OCC states that
its approach to valuing Valued Securities is conservative because the
current 30% haircut is high relative to the haircuts that will be
applied upon implementation of its Collateral in Margins project.\2\
Moreover, OCC has examined the member accounts that hold the most
volatile Valued Securities and found no instance where the amount of
such holdings in any particular account was excessive. OCC nevertheless
intends to closely monitor any account with a large amount of

deposited Valued Securities that would be subject to a high haircut
(i.e., greater than 40%) under STANS. Preferred stocks, which will not
be included in the Collateral in Margin program, will remain subject to
a minimum share price of greater than $10.
---------------------------------------------------------------------------

    \2\ Securities Exchange Act Release No. 58158 (July 15, 2008),
73 FR 42646 (July 15, 2008). Under the Collateral in Margins filing,
OCC will be updating its margin requirement methodology and risk
management system known as ``STANS'' to more accurately measure the
risk in clearing members' accounts. Some of the changes include
providing OCC with greater flexibility to determine the amount of
replacement collateral when securities deposited as margin are
withdrawn and eliminating certain concentration limits and minimum
share prices.
    OCC expects to fully implement the new Collateral in Margins
methodology in the second quarter of 2010. In order to address
current market conditions, OCC is proposing changes now to reduce
the impact of the minimum price requirement and the 10%
concentration test, both of which will be eliminated altogether for
options securities when Collateral in Margins is implemented.
---------------------------------------------------------------------------

2. ETF Concentration Test
    OCC Rule 604(b)(4) provides that ``equity and debt issues of any
one issuer shall not be valued at an amount in excess of 10% of the
margin requirement in the account for which such securities are
deposited.'' The main purpose of the concentration test is to protect
OCC from undue exposure where a single security deposited as collateral
by a member suffers a sudden and extreme fall in value or becomes
illiquid. Under the concentration test, a clearing member that wants to
satisfy its OCC margin requirement solely with Valued Securities must
submit a portfolio that contains at least ten separate securities. The
concentration test was developed before the advent of ETFs representing
an ownership interest in large numbers of securities such as those
based on the S&P 500, Nasdaq 100, and Russell 2000.
    OCC states that it has analyzed such assets from a risk perspective
and has concluded that they should be accepted as margin without regard
to the concentration limits but subject to certain conditions. First,
the assets acceptable for this purpose should be limited to liquid,
broad-based equity index ETFs. Secondly, the applicable STANS margin
interval for each deposited ETF exempted from the 10% concentration
test must be less than or equal to 30%.
    Because this interim proposal for limiting the applicability of the
10% concentration test is narrower than the corresponding change in the
Collateral in Margins filing, OCC proposes to implement this interim
proposal by adding an interpretation under Rule 604. By its terms, the
interpretation will be superseded upon full implementation of the
Collateral in Margins rule change, and OCC will thereafter remove it
from the rule book.
    OCC states that the proposed changes to OCC's rules are consistent
with the purposes and requirements of Section 17A of the Act \3\
because they are designed to promote the accurate and efficient
clearance and settlement of transactions in securities and to safeguard
assets within OCC's custody or control. The changes accomplish this
purpose by facilitating the expanded use of Valued Securities as margin
collateral while implementing certain limitations and monitoring
procedures designed to limit risk. The proposed rule change is not
inconsistent with the existing rules of OCC including any rules
proposed to be amended.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78-1.
---------------------------------------------------------------------------

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

    OCC does not believe that the proposed rule change will impose any
burden on competition.

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

    OCC has not solicited or received written comments with respect to
the proposed rule change. OCC will notify the Commission of any
comments it receives.

III. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a registered clearing agency and, in
particular, the requirements of Section 17A of the Act.\4\
Specifically, the Commission finds that the proposed rule change is
consistent with Section 17A(b)(3)(F) of the Act,\5\ which requires that
the rules of a clearing agency be designed to assure the safeguarding
of securities and funds that are in the custody or control of the
clearing agency or for which it is responsible. Although OCC is
reducing the minimum share price for stocks eligible to be deposited as
margin, the Commission is satisfied with OCC's analysis that such
reduction is accompanied by sufficient risk-management controls to
protect OCC from the risks associated with including such lower-priced
stocks in members' margin accounts. The Commission also finds that
allowing certain ETFs and other fund shares to be deposited as margin
collateral that otherwise could not be deposited because of OCC's
concentration restriction should not pose undue risks because such
funds are broad based and highly liquid. Therefore, the proposed rule
change should not adversely impact OCC's ability to continue to assure
that the securities and funds in its custody or control or for which it
is responsible are properly safeguarded.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78-1.
    \5\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\6\ for approving the proposed rule change prior to the
thirtieth day after the date of publication of notice in the Federal
Register. The Commission believes that accelerating approval of this
proposal should benefit OCC's members and investors by permitting OCC
to update its margin requirements without undue delay and in a manner
that will expand the securities that members may deposit as margin
collateral while it implements the Collateral in Margin project without
compromising OCC's ability to safeguard the funds and securities in its
custody or control.
---------------------------------------------------------------------------

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

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 No. SR-OCC-2009-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File No. SR-OCC-2009-08. 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, 100 F Street, NE.,
Washington, DC 20549, on official business days

between the hours of 10:00 a.m. to 3:00 p.m. Copies of such filing also
will be available for inspection and copying at OCC's principal office
and on OCC's Web site at http://www.theocc.com/publications/rules/
proposed_changes/proposed_changes.jsp. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File No. OCC-2009-08 and should be submitted on or
before May 27, 2009.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\7\ that the proposed rule change (SR-OCC-2009-08) be, and it hereby
is, approved on an accelerated basis.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).
    \8\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-10448 Filed 5-5-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18298-18299]
[FR Doc No: 2017-07772]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1063]

Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

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

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

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Oncologic Drugs
Advisory Committee. The general function of the committee is to provide
advice and recommendations to the Agency on FDA's regulatory issues.
The meeting will be open to the public. FDA is establishing a docket
for public comment on this document.

DATES: The public meeting will be held on May 25, 2017, from 8 a.m. to
1:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-1063. The docket will close on May 23,
2017. Submit either electronic or written comments on this public
meeting by May 23, 2017. Late untimely filed comments will not be
considered. Electronic comments must be submitted on or before May 23,
2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of May 23, 2017.
Comments received by mail/hand delivery/courier (for written/paper
submissions: Will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
    Comments received on or before May 10, 2017, will be provided to
the committee. Comments received after that date will be taken into
consideration by the Agency.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA--305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-1063 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down
to the appropriate advisory committee meeting link, or call the
advisory committee information line to learn about possible
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss biologics license application
(BLA) 125545, for a proposed biosimilar to Amgen Inc.'s Epogen/Procrit
(epoetin alfa), submitted by Hospira Inc., a Pfizer company. The
proposed indications/uses for this product are: (1) For the treatment
of anemia due to chronic kidney disease, including patients on dialysis
and not on dialysis, to decrease the need for red blood cell (RBC)
transfusion; (2) for the treatment of anemia due to zidovudine
administered at <=4,200 mg/week in HIV-infected patients with
endogenous serum erythropoietin levels of <=500 m units/mL; (3) for the
treatment of anemia in patients with non-myeloid malignancies where
anemia is due to the effect of concomitant myelosuppresive
chemotherapy, and upon initiation, there is a minimum of 2 additional
months of planned chemotherapy; and (4) to reduce the need for
allogeneic RBC transfusions among patients with perioperative
hemoglobin >10 to <=13 g/dL who are at high risk for perioperative
blood loss from elective, noncardiac, and nonvascular surgery.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before May 10, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 11:15 a.m. and 12:15 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before May 2, 2017. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by May 3, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require special accommodations due to a
disability, please contact Lauren D. Tesh at least 7 days in advance of
the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07772 Filed 4-17-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 165 (Monday, August 28, 2017)]
[Rules and Regulations]
[Pages 40696-40697]
[FR Doc No: 2017-17886]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0722; Airspace Docket No. 17-AGL-16]

Amendment of Class E Airspace; Mason, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the airspace description of Class E
airspace extending upward from 700 feet or more above the surface at
Mason Jewett Field, Mason, MI, removing the exclusionary language
contained in the airspace description referencing Skyway Estates
Airport, Eaton Rapids, MI, and to bring the airspace description in
compliance with FAA Order 7400.2L, Procedures for Handling Airspace
Matters.

DATES: Effective 0901 UTC, December 7, 2017. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the airspace description of Class E airspace extending
upward from 700 feet or more above the surface at Mason Jewett Field,
Mason, MI.

History

    The FAA published in the Federal Register (82 FR 19007, April 25,
2017) a notice of proposed rulemaking to remove Class E airspace at
Skyway Estates Airport, Eaton Rapids, MI, as standard instrument
approach procedures have been cancelled and controlled airspace is no
longer required. The exclusionary language referencing Eaton Rapids,
MI, is being removed from the airspace description for Mason Jewett
Field, Mason, MI. This is an administrative change to bring the
airspace description into compliance with FAA Order 7400.2L.
    Class E airspace designations are published in paragraph 6005 of
FAA

Order 7400.11A dated August 3, 2016, and effective September 15, 2016,
which is incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14, Code of Federal Regulations (14 CFR)
part 71 by removing the exclusionary language that reads ``excluding
that airspace within the Eaton Rapids, MI, Class E airspace area'' from
the regulatory text of the Class E airspace extending upward from 700
feet or more above the surface at Mason Jewett Field, Mason, MI.
    Section 553(b)(3)(B) of the Administrative Procedures Act (5
U.S.C.) authorizes agencies to dispense with notice and comment
procedure when the agency for ``good cause'' finds that these
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' This is an administrative change amending the description
for Mason Jewett Field, Mason, MI, by removing the exclusionary
language from the description and does not affect the boundaries, or
operating requirements of the airspace; therefore, notice and public
procedure under 5 U.S.C. 553(b) are unnecessary.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016,
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL MI E5 Mason, MI [Amended]

Mason Jewett Field, MI
    (Lat. 42[deg]33'57'' N., long. 84[deg]25'24'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of the Mason Jewett Field.

    Issued in Fort Worth, Texas, on August 16, 2017.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-17886 Filed 8-25-17; 8:45 am]
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[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Notices]
[Page 35385]
[DOCID:fr23jn08-37]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-69-000]

New England Conference of Public Utilities Commissioners,
Inc.,Complainants v. Bangor Hydro-Electric Company, Central Maine Power
Company, National Grid, USA, NSTAR Electric & Gas Corporation,
Northeast Utilities Service Company, The United Illuminating Company,
Vermont Electric Power Company, Respondents; Notice of Complaint

June 16, 2008.
    Take notice that on June 12, 2008, the New England Conference of
Public Utilities Commissioners, Inc. (NECPUC) filed a complaint against
Bangor Hydro-Electric Company, Central Maine Power Company, National
Grid, USA, NSTAR Electric & Gas Corporation, Northeast Utilities
Service Company, The United Illuminating Company, and Vermont Electric
Power Company. Among other things, NECPUC states that it seeks to limit
application of the return on equity cost adder for certain qualified
projects.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions or protests must be filed on or before the
comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of Respondent's
answer, protests and interventions in lieu of paper using the
``eFiling'' link at http://www.ferc.gov. Persons unable to file
electronically should submit an original and 14 copies of the protest
or intervention to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 2, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-14065 Filed 6-20-08; 8:45 am]

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