[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80428-80430]
[FR Doc No: 2015-32384]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76688; File No. SR-BATS-2015-114]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
ALLB Routing and Other Fees for Use of BATS Exchange, Inc.

December 18, 2015.
    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 December 15, 2015, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') 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
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change 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)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to BATS Rules
15.1(a) and (c) (``Fee Schedule'') to adopt fees for the recently
adopted ALLB routing strategy. The Exchange also proposes to amend the
Fee Codes and Associated Fees table of the Fee Schedule to indicate the
amount of the fees and rebates as five decimal points, rather than four
decimal points, by adding a zero to the end of each fee and rebate.
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    \5\ The term ``Member'' is defined as ``any registered broker or
dealer that has been admitted to membership in the Exchange. A
Member will have the status of a ``member'' of the Exchange as that
term is defined in Section 3(a)(3) of the Act.'' See Exchange Rule
1.5(n).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 parts of such
statements.

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

1. Purpose
ALLB Routing Fees
    The Exchange proposes to adopt fees for the ALLB routing strategy.
In sum, ALLB is a routing option under which the order checks the
System \6\ for available shares and is then sent to the BATS Y-
Exchange, Inc. (``BYX''), EDGA Exchange, Inc. (``EDGA''), and the EDGX
Exchange, Inc. (``EDGX'' collectively with the Exchange, BYX, and EDGA,
the ``BGM Affiliated Exchanges'').\7\ Specifically, an order subject to
the ALLB routing option would execute first against liquidity on the
BATS Book.\8\ Any remainder would then be routed to BYX, EDGA, and/or
EDGX in accordance with the System routing table.\9\
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    \6\ The term ``System'' is defined as ``the electronic
communications and trading facility designated by the Board through
which securities orders of Users are consolidated for ranking,
execution and, when applicable, routing away.'' See Exchange Rule
1.5(aa).
    \7\ See Exchange Rule 11.13(b)(3)(O). See also Securities
Exchange Act Release No. 76455 (November 17, 2015), 80 FR 73009
(November 23, 2015) (SR-BATS-2015-97).
    \8\ The term ``BATS Book'' is defined as ``the System's
electronic file of orders.'' See Exchange Rule 1.5(e).
    \9\ The term ``System routing table'' refers to the proprietary
process for determining the specific trading venues to which the
System routes orders and the order in which it routes them. See
Exchange Rule 11.13(b)(3).
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    The Exchange now proposes to adopt three new fee codes, AA, AX, and
AY and related fees for the ALLB routing strategy. These fee codes
would enable the Exchange to pass through the rate that BATS Trading,
Inc. (``BATS Trading''), the Exchange's affiliated routing broker-
dealer, would be charged for routing orders to BYX, EDGA, and EDGX.\10\
Each of the proposed fee codes are described as follows:
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    \10\ Orders using the ALLB routing option that execute on the
Exchange would be subject to the Exchange's standard fees and
rebates, unless the Member achieves a volume tiered reduced fee or
enhanced rebate.
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     Fee Code AA. Order routed to EDGA using the ALLB routing
strategy would yield fee code AA and receive a rebate of $0.00200 per
share in securities priced at or above $1.00. Under proposed footnote
15, orders yielding fee code AA in securities priced below $1.00 would
be charged no fee nor would they receive a rebate.
     Fee Code AX. Order routed to EDGX using the ALLB routing
strategy would yield fee code AY and be charged a fee of $0.00290 per
share in securities priced at or above $1.00. Under proposed footnote
16, orders yielding fee code AX in securities priced below $1.00 would
be charged a fee of 0.30% of the transaction's dollar value.
     Fee Code AY. Order routed to BYX using the ALLB routing
strategy would yield fee code AY and receive a rebate of $0.00150 per
share in securities priced at or above $1.00. Under proposed footnote
17, orders yielding fee code AY in securities priced below $1.00 would
be charged a fee of 0.10% of the transaction's dollar value.
    BATS Trading will pass through the above rates to the Exchange and
the Exchange, in turn, will pass through that exact rate to its
Members. The proposed rates would enable the Exchange to equitably
allocate its costs among all Members utilizing the ALLB routing
strategy.
Fee Codes and Associated Fees Table
    The Exchange also proposes to amend the Fee Codes and Associated
Fees table to indicate the amount of the fees and rebates as five
decimal points, rather than four decimal points, by adding a zero to
the end of each fee and rebate, to reflect the order pricing format on
the Exchange's Web site.\11\ The Exchange notes that none of these
changes amend any fee or rebate, nor do they alter the manner in which
it assesses fees or calculates rebates.
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    \11\ The Exchange notes that fee code D already indicates its
related fee as five decimal points.
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Implementation Date
    The Exchange proposes to implement this amendment to its Fee
Schedule on January 4, 2016, but the proposed fee codes and their
associated rates will not be available until January 8, 2016, the date
upon which it announced to Members that it would implement the ALLB
routing strategy.\12\
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    \12\ See BATS Announces ALLB Routing Option, available at http://cdn.batstrading.com/resources/release_notes/2015/BATS-ALL-BATS-Routing-Strategy-Release-Schedule-Updated.pdf. The Exchange notes
that the Fee Schedule's date was amended to January 4, 2016 in file
no. SR-BATS-2015-115 (December 8, 2015).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\13\ in general, and
furthers the objectives of Section 6(b)(4),\14\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities. The Exchange believes that its proposed rates represent an
equitable allocation of reasonable dues, fees, and other charges among
Members and other persons using its facilities because the Exchange
does not levy additional fees or offer additional rebates for orders
that it routes to BYX, EDGA, and EDGX through BATS Trading. The
Exchange believes that its proposed pass through rate for orders that
yield fee codes AA, AX or AY is equitable and reasonable because it
accounts for the rate that BATS Trading would be subject to for orders
it routes and are executed on BYX, EDGA, and EDGX. In addition, the
proposal allows the Exchange to pass-through to its Members the rate
for orders that are routed to BYX, EDGA, and EDGX using the ALLB
routing strategy. Furthermore, the Exchange notes that routing through
BATS Trading is voluntary. Lastly, the Exchange also believes that the
proposed amendment is non-discriminatory because it applies uniformly
to all Members.
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    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that the changes to the Fee Codes and
Associated Fees table of the Fee Schedule are reasonable because they
are designed to provide greater transparency to Members with regard to
how the Exchange assesses fees and calculates rebates. The Exchange
notes that none of the proposed changes are designed to amend any fee,
nor alter the manner in which it assesses fees or calculates rebates.
These changes to the Fee Schedule are intended to make the Fee Schedule
clearer and less confusing for investors and eliminate potential
investor confusion, thereby removing impediments to and perfecting the
mechanism of a free and open market and a national market system, and,
in general, protecting investors and the public interest.

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

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. The Exchange does not believe that this change represents a
significant departure from previous pricing offered by the Exchange or
pricing offered by the Exchange's competitors. Additionally, Members
may opt to disfavor the Exchange's pricing if they believe that
alternatives offer them better value. Accordingly, the Exchange does
not believe that the proposed changes will impair the ability of
Members or competing venues to maintain their competitive standing in
the financial markets. The Exchange believes that its proposal to pass
through the rates that BATS Trading

would be subject to for orders routing to BYX, EDGA, and EDGX using the
ALLB routing strategy to Members would increase intermarket competition
because it offers customers an alternative means to route orders to
those venues. In addition, the proposed pricing would not provide any
advantage to Users when routing to BYX, EDGA, and EDGX as compared to
other methods of routing or connectivity available to Users by the
Exchange because the proposed rates are identical to what the Member
would be subject to if it routed to those venues directly. The Exchange
believes that its proposal would not burden intramarket competition
because the proposed rate would apply uniformly to all Members.
    The Exchange believes that the changes to the Fee Codes and
Associated Fees table of the Fee Schedule would not affect intermarket
nor intramarket competition because none of these changes are designed
to amend any fee or alter the manner in which the Exchange assesses
fees or calculates rebates. These changes are intended to provide
greater clarity to Members with regard to how the Exchange access fees
and calculates rebates.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from Members or other interested
parties.

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) of the Act \15\ and paragraph (f) of Rule 19b-4
thereunder.\16\ 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.
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f).
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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 No. SR-BATS-2015-114 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 No. SR-BATS-2015-114. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BATS-2015-114 and should be
submitted on or before January 14, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-32384 Filed 12-23-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27332-27335]
[FR Doc No: 2011-11539]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0621]

Proposal To Withdraw Approval for the Breast Cancer Indication
for Bevacizumab; Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of hearing.

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SUMMARY: The Food and Drug Administration (FDA) is granting a hearing
to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and
Research's (CDER's) proposal to withdraw approval of the breast cancer
indication for bevacizumab (Avastin). Genentech is the sponsor for
Avastin. Genentech and CDER are the parties to the hearing. The issues
to be discussed and resolved at the hearing relate directly to the
statutory and regulatory standard for FDA to withdraw accelerated
approval of the metastatic

breast cancer (MBC or breast cancer) indication for Avastin.

DATES:  Date and Time: The hearing will be held on June 28 and 29,
2011, from 8 a.m. to 5 p.m.

ADDRESSES: The hearing will be held at FDA's White Oak Campus, 10903
New Hampshire Ave., Bldg 31, Rm. 1503 (Great Room), Silver Spring, MD
20993.

FOR FURTHER INFORMATION CONTACT: Talisha Williams, Office of the
Ombudsman, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Registration and Requests to Make Oral
Presentations: On June 28, 2011, up to 2 hours of the hearing have been
reserved for oral presentations by persons other than the parties.
    If you wish to make an oral presentation during the hearing, you
must register by submitting an electronic or written request by May 27,
2011, to Talisha Williams (see FOR FURTHER INFORMATION CONTACT).
Depending on the number of requests, FDA may not be able to honor all
such requests. You must provide your name, title, business affiliation
(if applicable), address, telephone and fax numbers, e-mail address,
and (if applicable) type of organization you represent (e.g., industry,
consumer organization). You also should submit a brief summary of the
presentation, including the discussion topic(s) that will be addressed
and the approximate time requested for your presentation. We encourage
individuals and organizations with common interests to consolidate or
coordinate their presentations to allow adequate time for each request
for presentation. If there are many requests to present during the 2-
hour period, the amount of time that can be allotted to each presenter
may be limited to provide an opportunity to as many persons wishing to
present as possible. Persons registered to make an oral presentation
should check in with Talisha Williams before the hearing. Participants
should submit a copy of each presentation to Talisha Williams.
    We will file the hearing schedule, indicating the order of
presentation and the time allotted to each person, with the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852 and it will be posted on
http://www.regulations.gov. We will mail, e-mail, or telephone the
schedule to each participant before the hearing. In anticipation of the
hearing presentations moving ahead of schedule, participants are
encouraged to arrive early to ensure their designated order of
presentation. Participants who are not present when called risk
forfeiting their scheduled time.
    If you need special accommodations due to a disability, please
contact Talisha Williams at least 7 days in advance.
    Registration and Requests to Attend the Hearing: The public hearing
is free, but all persons wishing to attend the hearing, who have not
registered to make an oral presentation, must register with FDA in
advance of the hearing. By May 20, 2011, FDA will post further details
regarding the registration process for attendees to its Web site at
http://www.fda.gov. Beginning May 27, 2011, you will be able to
register to attend the hearing via FDA's Web site at http://www.fda.gov. Space in the Great Room, where the hearing is to be held,
will be limited to 300 persons from the general public, and thus
registration will be first-come, first-served.
    Web cast: The hearing will also be available to be viewed online
via a Web cast. Availability of the Web cast to the public will also be
limited to a certain number of persons, and registration will be
required to access the Web cast. By May 20, 2011, FDA will post further
details regarding the Web cast and the registration process for the Web
cast to the Agency's Web site at http://www.fda.gov. Beginning May 27,
2011, you will be able to register to access the Web cast via FDA's Web
site at http://www.fda.gov.
    Comments: Regardless of participation in the public hearing,
interested persons may submit electronic or written comments on CDER's
proposal to withdraw approval of the MBC indication. Submit electronic
comments to http://www.regulations.gov. Submit written comments to the
Division of Dockets Management (see Registration and Requests to Make
Oral Presentations). Comments must be submitted by July 14, 2011. It is
only necessary to send one set of comments. It is no longer necessary
to send two copies of mailed comments. Identify comments with the
docket number found in brackets in the heading of this document.
Submission of comments prior to the meeting is strongly encouraged.
    All documents filed or posted in this matter are available for
public review under Docket No. FDA-2010-N-0621 in the Division of
Dockets Management (see Registration and Requests to Make Oral
Presentations) between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain documents at http://www.regulations.gov.

I. Background

    Section 506 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 356), which was added to the statute with the passage of the
Food and Drug Modernization Act of 1997, provides for the accelerated,
or fast track, approval of a drug product when FDA determines that the
``* * * product has an effect on a clinical endpoint or on a surrogate
endpoint that is reasonably likely to predict clinical benefit''
(section 506(b)(1)). Section 506 of the FDC&C Act also provides
explicit authority for FDA to use expedited procedures to withdraw
accelerated approval of a product under certain circumstances.
    FDA's regulations regarding the accelerated approval of biological
products (Sec. Sec.  601.40 through 601.46; part 601, subpart E) (21
CFR 601.40 through 601.46; 21 CFR part 601, subpart E)) set forth the
procedures that FDA uses to withdraw accelerated approval for a
biological product. Under Sec.  601.43(b), FDA notifies the sponsor of
the biological product of an opportunity for a hearing on a proposal to
withdraw approval of the product. FDA conducts such hearings in
accordance with the procedures set forth in part 15 (21 CFR part 15),
with some specific modifications, including the presence of an advisory
committee duly constituted under 21 CFR part 14, which provides advice
and recommendations to the Agency (Sec.  601.43(e)).
    On February 22, 2008, under section 506 of the FD&C Act and FDA's
implementing regulations for accelerated approval of biological
products, CDER approved supplemental biological license application
125085/91 (the sBLA), which was submitted by Genentech. The sBLA sought
approval of Avastin for use in combination with the chemotherapy drug
paclitaxel for the treatment of patients who have not received
chemotherapy for metastatic HER2 negative breast cancer. Consistent
with the regulations requiring postmarket studies for accelerated
approval (see CFR 601.41 and 601.43), CDER's approval of the MBC
indication for Avastin was subject to the requirement that the product
be studied further to verify and describe clinical benefit. The two
specific ongoing clinical trials identified to verify and describe
clinical benefit were: Trial BO17708 (AVADO) (NCT 00333775) and Trial
AVF 3694g (RIBBON1) (NCT 00262067). On November 16, 2009, Genentech
submitted the results of the AVADO and RIBBON1 trials to CDER.

    On December 16, 2010, CDER issued a notice for opportunity for a
hearing (NOOH) on a proposal to withdraw approval of the MBC indication
for Avastin. The NOOH stated CDER's conclusions that AVADO and RIBBON1
failed to verify clinical benefit with respect to the MBC indication
for Avastin and that, because of that failure, the risk/benefit
assessment that supported the initial approval of the MBC indication
had changed significantly such that Avastin no longer met the safety
and effectiveness requirements for continued marketing for that
indication. On January 16, 2011, Genentech requested a hearing and
submitted the data and information on which it intends to rely at the
hearing.
    By letter dated February 23, 2011, Karen Midthun (the Presiding
Officer), advised the parties that FDA was granting the hearing request
and that the Commissioner of Food and Drugs (the Commissioner) had
appointed her as presiding officer. The letter stated that, although
not required by FDA's regulations (see Sec.  601.43(d)), the Agency
would be observing separation of functions for purposes of the hearing.
The letter further communicated FDA's conclusion that FDA's regulations
require that the Agency's Oncologic Drugs Advisory Committee (ODAC)
serve as the advisory committee for the hearing and to provide advice
and recommendations to the Commissioner under Sec.  601.43(e)(1).
Finally, the Presiding Officer directed Genentech and CDER to submit a
joint statement of undisputed facts and disputed issues.
    On April 7, 2011, Genentech and CDER submitted a ``Joint Statement
of Undisputed Facts and Select Issues in Dispute'' (Joint Statement).
On April 8, 2011, Genentech and CDER submitted separate statements of
questions to be presented at the hearing.

II. Hearing Issues and Process

    FDA hereby grants Genentech's request for a hearing under Sec.
601.43 and part 15 on CDER's proposal to withdraw approval of the MBC
indication for Avastin.

A. Issues

    The issues to be decided at the hearing relate directly to the
statutory and regulatory standard for FDA to withdraw accelerated
approval of the MBC indication for Avastin. On April 7, 2011, in
response to direction from the Presiding Officer to consult with each
other and submit an agreed statement of the issues in dispute in this
hearing, counsel for Genentech and CDER reported that they were unable
to reach agreement on how to frame the issues to be resolved. The
issues for decision will thus be stated in accordance with the statute
and regulations.
    The applicable regulation is Sec.  601.43. This regulation was
finalized in 1992 (57 FR 58942, December 11, 1992). In 1997, Congress
enacted section 506 of the FD&C Act, which sets out criteria for
expedited approval and withdrawal of approval of ``fast-track
products.'' It is FDA's position that section 506(b) of the FD&C Act,
while enacted after the finalization of the regulation, essentially
codifies in the statute FDA's accelerated approval regulations. Section
506(b)(3) of the FD&C Act sets out four bases for expedited withdrawal
of approval of a product approved under the accelerated procedures.
Section 601.43(a) sets out six bases. In this matter, there appears to
be agreement that two of the bases will be at issue in this hearing.
These two bases appear in both the regulations and the statute.
    One basis for withdrawal of approval of a product approved under
the accelerated procedures, set out in nearly identical language in
Sec.  601.43(a)(1) and section 506(b)(3)(B) of the FD&C Act, is that
FDA may withdraw approval if, in the words of the regulation: ``A
postmarketing clinical study fails to verify clinical benefit'', or, in
the words of the statute, if: ``[A] post-approval study of the fast
track product fails to verify clinical benefit of the product.''
    In this case, the parties agree that ``During CDER's review of [the
sBLA], Genentech proposed and CDER agreed that the AVADO and RIBBON1
trials could serve as the required trial(s) to verify and describe the
clinical benefit'' (Joint Statement, paragraph 31). Thus, one ultimate
issue in this hearing is:
    Issue 1. Do the AVADO and RIBBON1 trials fail to verify the
clinical benefit of Avastin for the breast cancer indication for which
it was approved?
    If, after the hearing, the Commissioner concludes that these
studies fail to verify the clinical benefit of Avastin for that
indication, FDA may withdraw the approval.
    CDER also seeks to base the withdrawal of approval on an
alternative ground. This ground is set forth in the regulation and in
the statute. Section 601.43(a)(6) states that FDA may withdraw approval
if: ``Other evidence demonstrates that the biological product is not
shown to be safe or effective under its conditions of use.''
    Section 506(b)(3)(C) of the FD&C Act states that withdrawal is
authorized if: ``[O]ther evidence demonstrates that the fast track
product is not safe or effective under the conditions of use.''
    In this case, the parties have agreed that the FDA-approved
prescribing information for Avastin ``is a fair and accurate
description of the safety profile of Avastin,'' and that ``[t]he safety
data observed in the E2100, AVADO, and RIBBON1 studies were consistent
with the safety profile of Avastin described in its approved
prescribing information'' (Joint Statement, paragraphs 22 and 23). In
light of this agreement, the dispute with respect to this issue centers
on the effectiveness information for the breast cancer indication, and
on the appropriate risk-benefit analysis to be made in light of that
information as compared to the agreed risk of the product. Thus, FDA
does not anticipate that the hearing will involve any dispute about the
safety information in the clinical studies.
    The safety profile of Avastin described in its approved prescribing
information includes a black box warning concerning gastrointestinal
perforation, surgery and wound healing complications, and severe or
fatal hemorrhage. Genentech does not state that the use of this drug in
the treatment of breast cancer is safe in the abstract. Instead, it
states that the drug should be found to be safe because its use
provides benefits to patients that outweigh its risks. Applying the
standard in the regulation and statute to the facts presented,
therefore, the issue for resolution will be:
    Issue 2.A. Does the available evidence on Avastin demonstrate that
the drug has not been shown to be effective for the breast cancer
indication for which it was approved?
    Issue 2.B. Does the available evidence on Avastin demonstrate that
the drug has not been shown to be safe for the breast cancer indication
for which it was approved, in that Avastin has not been shown to
present a clinical benefit that justifies the risks associated with use
of the product for this indication?
    A third issue is presented by the fact that both section 506(b)(3)
of the FD&C Act and Sec.  601.43(a) do not by their terms require the
withdrawal of an accelerated approval even if the bases for withdrawal
they describe are present. Instead, in each case, the statute and
regulation state that FDA ``may'' withdraw approval in those
circumstances. This standard reflects the fact that decisions on
withdrawals of approval of products necessarily reflect judgment on
FDA's part as to what actions are appropriate to protect the public
with respect to approved products, and what uses of those products
should be stated on the labels of those products.
    Genentech has stated that the ``core issue presented in this
proceeding [is] whether FDA should maintain or

withdraw the accelerated approval of Avastin for [the MBC indication],
subject to Genentech's conduct of a new confirmatory study of Avastin
with paclitaxel'' (Letter from Michael Labson to the Presiding Officer,
April 8, 2011, page 1). CDER has stated the issue, ``Whether CDER has
appropriately exercised its authority by proposing to withdraw approval
of the MBC indication, rather than allowing the indication to remain on
the label while the sponsor designs and conducts additional studies
intended to verify the drug's clinical benefit'' (CDER's Statement of
Questions Presented, page 3). Ultimately, while stated differently, the
parties seem to agree that there is an issue of the propriety of CDER's
proposed withdrawal of this indication now as opposed to the
alternative of continuing the approval of the breast cancer indication
while Genentech performs new clinical studies of Avastin with
paclitaxel to verify the clinical benefit of the MBC indication. This
statement of the issue raises the question of why, to confirm an
indication for combination use with paclitaxel, Genentech proposed, and
CDER agreed, that Genentech could rely on studies of Avastin in
combination with chemotherapeutic agents other than paclitaxel. It
appears that the explanation is that these studies were already ongoing
at the time of the initial approval and both CDER and Genentech
believed, at that time, that the results of these studies could provide
evidence to verify the claim that Avastin, combined with paclitaxel,
would have the effect indicated in the approved labeling.
    FDA is addressing the issue of whether to maintain the accelerated
approval while additional studies are conducted as the third issue for
this hearing as follows:
    Issue 3. If the Commissioner agrees with the grounds for withdrawal
set out in issue 1, issue 2.A, or issue 2.B, should FDA nevertheless
continue the approval of the breast cancer indication while the sponsor
designs and conducts additional studies intended to verify the drug's
clinical benefit?

While the parties would state the issues differently, the three issues
stated in this notice will be those upon which the Commissioner expects
to decide this matter. If Genentech prevails on issues 1, 2.A, and 2.B,
the approval will be continued. If CDER prevails on issue 1, 2.A, or
2.B, the question of withdrawal will depend on issue 3.
    In addition to the issues 1, 2.A, 2.B, and 3, Genentech has
proposed to raise issues concerning the consistency of CDER's position
here with CDER's decisions with respect to other products for the
treatment of MBC or of other products approved under the accelerated
approval program. Issues with respect to FDA action on other products
are not relevant to this proceeding. Each decision to withdraw or not
to withdraw the approval of a product must be made on its own merits.
If the decision with respect to another product is in error, that would
not justify continuing that error with respect to the MBC indication
for Avastin. Moreover, as a practical matter, it would not be possible
to evaluate the different circumstances associated with decisions with
respect to other products in the context of this or any hearing. FDA
has consistently rejected attempts to bring evidence with respect to
decisions on other products into hearings on approval or withdrawal of
approval of products and will not deviate from that position here.

B. Process

    As further specified previously in this document, the hearing will
be held in the Agency's White Oak Conference Center on June 28 and 29,
2011. Although no statute or regulation requires that separation of
functions be applied to this proceeding, the Agency is observing
separation of functions as a matter of policy in this matter. As the
Center responsible for the proposed action, CDER, like Genentech, will
be a party to the hearing and will be responsible for presenting its
position at the hearing in accordance with Sec.  601.43 and part 15.
    In accordance with Sec.  601.43(e)(2), no person other than the
Presiding Officer, the three designated representatives for each party,
and the members of the advisory committee may question witnesses
present at the hearing.
    Because this is a public hearing, it is subject to our regulations
concerning the policy and procedures for electronic media coverage of
public agency administrative proceedings (Sec. Sec.  10.200 through
10.206 (21 CFR 10.200 through 10.206)). These procedures are primarily
intended to expedite media access to our public proceedings.
Representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record our public
administrative proceedings, including the testimony of witnesses in the
proceedings. Accordingly, the parties and nonparty participants to this
hearing, and all other interested persons, are directed to Sec. Sec.
10.200 through 10.206, for a more complete explanation of those
regulations' effect on this hearing.

III. Transcripts

    Please be advised that, as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see Registration and Requests to
Make Oral Presentation). A transcript will also be available in either
hardcopy or on CD-ROM, after submission of a Freedom of Information
request. Written requests are to be sent to the Division of Freedom of
Information (HFI-35), Office of Management Programs, Food and Drug
Administration, 5600 Fishers Lane, Rm. 6-30, Rockville, MD 20857.

    Dated: May 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11539 Filed 5-6-11; 4:15 pm]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)]
[Notices]
[Pages 33276-33277]
[FR Doc No: 2018-15292]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Thursday, July 19, 2018.

PLACE: Closed Commission Hearing Room 10800.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed;
please contact Brent J. Fields from the Office of the Secretary at
(202) 551-5400.

    Dated: July 12, 2018.
Lynn M. Powalski,
Deputy Secretary.
[FR Doc. 2018-15292 Filed 7-13-18; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 198 (Thursday, October 13, 2011)]
[Notices]
[Pages 63626-63627]
[FR Doc No: 2011-26412]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2011-0955]

Information Collection Requests to Office of Management and
Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit Information Collection Requests
(ICRs) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of
revisions to the following collections of information: 1625-0034,
Ships' Stores Certification for Hazardous Materials Aboard Ships; and
1625-0043, Ports and Waterways Safety--Title 33 CFR Subchapter P. Our
ICRs describe the information we seek to collect from the public.
Before submitting these ICRs to OIRA, the Coast Guard is inviting
comments as described below.

DATES: Comments must reach the Coast Guard on or before December 12,
2011.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2011-0955] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT). To avoid duplicate
submissions, please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: DMF (M-30), DOT, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, to attention Desk Officer for the Coast
Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-611), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2100 2nd St., SW., Stop 7101, Washington, DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Ms. Kenlinishia Tyler, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Renee V.

Wright, Program Manager, Docket Operations,<PHONE_NUMBER>, for questions
on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collections; (2) the accuracy of the estimated burden of the
Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of information
technology. In response to your comments, we may revise these ICRs or
decide not to seek approval for the Collections. We will consider all
comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2011-0955], and
must be received by December 12, 2011. We will post all comments
received, without change, to http://www.regulations.gov. They will
include any personal information you provide. We have an agreement with
DOT to use their DMF. Please see the ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2011-0955], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via http://www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an e-mail address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit your comments and material by electronic means,
mail, fax, or delivery to the DMF at the address under ADDRESSES; but
please submit them by only one means. To submit your comment online, go
to http://www.regulations.gov, and type ``USCG-2011-0955'' in the
``Keyword'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\; by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.
    Viewing comments and documents: To view comments, as well as
documents mentioned in this Notice as being available in the docket, go
to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Keyword'' box
insert ``USCG-2011-0955'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. You may also visit the DMF in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Requests

    1. Title: Ships' Stores Certification for Hazardous Materials
Aboard Ships.
    OMB Control Number: 1625-0034.
    Summary: The information is used by the Coast Guard to ensure that
personnel aboard ships are made aware of the proper usage and stowage
instructions for certain hazardous materials. Provisions are made for
waivers of products in special Department of Transportation (DOT)
hazard classes.
    Need: Section 3306 of 46 U.S.C. authorizes the Coast Guard to
prescribe regulations for the transportation, stowage, and use of
ships' stores and supplies of a dangerous nature. Part 147 of 46 CFR
prescribes the regulations for hazardous ships' stores.
    Forms: None.
    Respondents: Owners and operators of ships, and suppliers and
manufacturers of hazardous materials used on ships.
    Frequency: On occasion.
    Burden Estimate: The estimated burden has decreased from 12 hours
to 8 hours a year.
    2. Title: Ports and Waterways Safety--Title 33 CFR Subchapter P.
    OMB Control Number: 1625-0043.
    Summary: This collection of information allows the master, owner,
or agent of a vessel affected by these rules to request a deviation
from the requirements governing navigation safety equipment to the
extent that there is no reduction in safety.
    Need: Provisions in 33 CFR chapter I, subchapter P, allow any
person directly affected by the rules in that subchapter to request a
deviation from any of the requirements as long as it does not
compromise safety. This collection enables the Coast Guard to evaluate
the information the respondent supplies, to determine whether it
justifies the request for a deviation.
    Forms: None.
    Respondents: Master, owner, or agent of a vessel.
    Frequency: On occasion.
    Burden Estimate: The estimated burden has decreased from 2,865
hours to 2,447 hours a year.

    Dated: October 5, 2011.
R.E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2011-26412 Filed 10-12-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23802-23803]
[FR Doc No: 2015-09869]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1213]

Environmental Assessment: Questions and Answers Regarding Drugs
With Estrogenic, Androgenic, or Thyroid Activity; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Environmental Assessment: Questions and Answers Regarding Drugs With
Estrogenic, Androgenic, or Thyroid Activity.'' This guidance is
intended to supplement CDER's guidance for industry on ``Environmental
Assessment of Human Drug and Biologics Applications,'' issued July
1998, by addressing specific considerations for drugs that have
potential estrogenic, androgenic, or thyroid pathway activity (E, A, or
T activity) in environmental organisms. It is intended to help sponsors
of such drugs determine whether they should submit environmental
assessments (EA) for new drug applications (NDAs) and certain NDA
supplements, and to clarify what information such sponsors should
include if they submit a claim of categorical exclusion instead of an
EA.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 29, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Raanan A. Bloom, Environmental
Assessment Team, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-2185<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Environmental Assessment: Questions and Answers Regarding
Drugs With Estrogenic, Androgenic, or Thyroid Activity.'' The National
Environmental Policy Act of 1969 (Pub. L. 91-190) requires all Federal
agencies to assess the environmental impact of their actions and to
ensure that the interested and affected public is informed of the
environmental analyses. FDA regulations at 21 CFR part 25 specify that
EAs must be submitted as part of certain NDAs, abbreviated new drug
applications (ANDAs), biologic license applications (BLAs), supplements
to such applications, and investigational new drug applications (INDs),
and for various other actions, unless the action qualifies for a
categorical exclusion. Failure to submit either an EA or a claim of
categorical exclusion is sufficient grounds for FDA to refuse to file
or approve an application (Sec.  25.15(a), 21 CFR 314.101(d)(4), and
601.2(a) and (c)).
    Categorical exclusions for actions related to human drugs and
biologics are listed at Sec.  25.31. This draft guidance focuses on the
categorical exclusion for actions on NDAs and NDA supplements that
would increase the use of an active moiety, but the estimated
concentration of the substance at the point of entry into the aquatic
environment would be below 1 part per billion (1 ppb) (Sec.  25.31(b)).
Although an action that qualifies for this exclusion ordinarily does
not require an EA, FDA will require ``at least an EA'' if
``extraordinary circumstances'' indicate that the specific proposed
action (e.g., the approval of the NDA) may significantly affect the
quality of the human environment (Sec.  25.21). Research indicates that
drugs with endocrine-related activity and, more specifically, drugs
with E, A, or T activity have the potential to cause developmental or
reproductive effects when present in the aquatic environment at
concentrations below 1 ppb.\1\
---------------------------------------------------------------------------

    \1\ For example, see Section II.C (pp. 7-13) of USFDA, 2013,
``Response to Citizen Petition to the FDA Commissioner under the
National Environmental Policy Act and Administrative Procedure Act
Requesting an Amendment to an FDA Rule Regarding Human Drugs and
Biologics,'' Docket No. FDA-2010-P-0377; U.S. Environmental
Protection Agency (USEPA), Endocrine Disruptor Screening Program
(EDSP), last accessed February 17, 2015, at http://www.epa.gov/endo;
and Organisation for Economic Co-operation and Development (OECD),
OECD Work Related to Endocrine Disrupters, last accessed February
17, 2015, at http://www.oecd.org/env/ehs/testing/oecdworkrelatedtoendocrinedisrupters.htm.
---------------------------------------------------------------------------

    FDA has, on a case-by-case basis, requested additional information
from sponsors of NDAs and NDA supplements for drugs with E, A, or T
activity to help it determine whether extraordinary circumstances
exist. However, late cycle requests for additional environmental
information have the potential to delay approval of applications.
Accordingly, this guidance is intended to clarify that sponsors of
drugs with potential E, A, or T activity should consult with the Agency
early in product development concerning the information FDA may need to
determine whether an EA will be required or whether a claim of
categorical exclusion will be acceptable, and what information should
be included in the EA or claim of categorical exclusion.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

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

III. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in part 25 have been approved
under OMB control number 0910-0322 and the collections of information
in part 314 have been approved under OMB control number 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 23, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-09869 Filed 4-28-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Rules and Regulations]
[Pages 72383-72384]
[FR Doc No: 2022-25638]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31456; Amdt. No. 4033]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums
and Obstacle Departure procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective November 25, 2022. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of November 25, 2022.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30. 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Information Services, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected] or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73169. Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by
establishing, amending, suspending, or removes SIAPS, Takeoff Minimums
and/or ODPS. The complete regulatory description of each SIAP and its
associated Takeoff Minimums or ODP for an identified airport is listed
on FAA form documents which are incorporated by reference in this
amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20.
The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B,
when required by an entry on 8260-15A, and 8260-15C.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers or
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the typed of SIAPS, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPs as identified in the amendatory language for Part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flights safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C. 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under 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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial

number of small entities under the criteria of the Regulatory
Flexibility Act.

Lists of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on October 28, 2022.
Thomas J. Nichols,
Aviation Safety, Flight Standards Service, Manager, Standards Section,
Flight Procedures & Airspace Group, Flight Technologies & Procedures
Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 1 December 2022

West Palm Beach, FL, KPBI, ILS OR LOC RWY 28R, Amdt 4A
West Palm Beach, FL, KPBI, RNAV (GPS) Y RWY 14, Amdt 4
West Palm Beach, FL, KPBI, RNAV (GPS) Y RWY 28R, Amdt 3A
West Palm Beach, FL, KPBI, RNAV (RNP) Z RWY 32, Amdt 2
Mansfield, MA, 1B9, COPTER RNAV (GPS) Y RWY 14, Orig
Mansfield, MA, 1B9, RNAV (GPS) RWY 32, Amdt 1
Mansfield, MA, 1B9, RNAV (GPS) Z RWY 14, Orig
Rochester, NH, KDAW, RNAV (GPS) RWY 15, Orig
East Hampton, NY, KJPX, RNAV (GPS) Z RWY 28, Orig-A

Effective 29 December 2022

Weed, CA, O46, RNAV (GPS) RWY 14, Orig-A
Orlando, FL, KMCO, ILS OR LOC RWY 17L, ILS RWY 17L (SA CAT I), ILS
RWY 17L (CAT II), ILS RWY 17L (CAT III), Amdt 4B
Orlando, FL, KMCO, ILS OR LOC RWY 17R, ILS RWY 17R (CAT II), Amdt 5F
Orlando, FL, KMCO, ILS OR LOC RWY 35L, ILS RWY 35L (SA CAT I), ILS
RWY 35L (CAT II), ILS RWY 35L (CAT III), Amdt 8A
Orlando, FL, KMCO, ILS OR LOC RWY 35R, ILS RWY 35R (SA CAT I), ILS
RWY 35R (CAT II), ILS RWY 35R (CAT III), Amdt 5B
Orlando, FL, KMCO, ILS OR LOC RWY 36R, ILS RWY 36R (SA CAT I), ILS
RWY 36R (CAT II), ILS RWY 36R (CAT III), Amdt 11A
Swainsboro, GA, KSBO, ILS OR LOC RWY 14, Amdt 2
Swainsboro, GA, KSBO, NDB RWY 14, Amdt 2B, CANCELLED
Danville, KY, KDVK, Takeoff Minimums and Obstacle DP, Amdt 1A
Lake Charles, LA, KCWF, ILS OR LOC RWY 15, Amdt 7
Lake Charles, LA, KCWF, RNAV (GPS) RWY 15, Amdt 1A
Lake Charles, LA, KCWF, RNAV (GPS) RWY 33, Amdt 1B
Rangeley, ME, 8B0, RNAV (GPS) RWY 14, Orig
Rangeley, ME, 8B0, RNAV (GPS) RWY 32, Orig
Stanley, ND, 08D, RNAV (GPS) RWY 28, Amdt 2
Stanley, ND, 08D, Takeoff Minimums and Obstacle DP, Orig-A
Reno, NV, KRNO, SPARKS ONE, Graphic DP
Reno, NV, KRNO, Takeoff Minimums and Obstacle DP, Amdt 5
Tulsa, OK, KTUL, RNAV (GPS) RWY 36L, Amdt 1A
Greenville, SC, KGMU, ILS OR LOC RWY 1, Amdt 31
Greenville, SC, KGMU, ILS Y OR LOC Y RWY 1, Orig-B, CANCELLED
Rosebud, SD, KSUO, RNAV (GPS) RWY 34, Orig-A
Commerce, TX, 2F7, VOR-A, Amdt 3B, CANCELLED
Blanding, UT, KBDG, Takeoff Minimums and Obstacle DP, Amdt 2

[FR Doc. 2022-25638 Filed 11-23-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29721-29722]
[FR Doc No: 2015-12403]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and

recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 9, 2015, from 8
a.m. to 12:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: 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,<PHONE_NUMBER>, FAX: 301-847-
8533<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 http://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.
    Agenda: The committee will discuss biologics license application
125547, necitumumab injection, application submitted by Eli Lilly and
Company. The proposed indication (use) for this product is in
combination with gemcitabine and cisplatin for first-line treatment of
patients with locally advanced or metastatic squamous non-small cell
lung cancer.
    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 http://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.
Written submissions may be made to the contact person on or before June
24, 2015. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11:30 a.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 June 16, 2015. 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 June 17, 2014.
    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
physical disabilities or special needs. 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 http://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: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12403 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Pages 17630-17631]
[FR Doc No: 2014-06891]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71782; File No. SR-CHX-2014-04]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend a Pilot Program Related to Article 20, Rule 10 Concerning the
Handling of Clearly Erroneous Transactions

March 24, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that, on March 19, 2014, the Chicago Stock Exchange, Inc. (``CHX'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    CHX proposes to extend a pilot program related to Article 20, Rule
10, entitled ``Handling of Clearly Erroneous Transactions.'' The
Exchange has designated this proposal as non-controversial and provided
the Commission with the notice required by Rule 19b-4(f)(6)(iii) under
the Act.\3\
---------------------------------------------------------------------------

    \3\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The text of this proposed rule change is available on the
Exchange's Web site at (www.chx.com) and in the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The purpose of this filing is to extend the effectiveness of the
Exchange's current rule applicable to Clearly Erroneous Executions.
Portions of Article 20, Rule 10, explained in further detail below, are
currently operating as a pilot program set to expire on April 8,
2014.\4\ The Exchange proposes to extend the pilot program to coincide
with the pilot period for the Plan to Address Extraordinary Market
Volatility Pursuant to Rule 608 of Regulation NMS under the Act (the
``Limit Up-Limit Down Plan'' or the ``Plan''), including any extensions
to the pilot period for the Plan.\5\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 70515 (Sept. 26,
2013), 78 FR 60945 (Oct. 2, 2013) (SR-CHX-2013-17).
    \5\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
---------------------------------------------------------------------------

    On September 10, 2010, the Commission approved, on a pilot basis,
changes to Article 20, Rule 10 to provide for uniform treatment: (1) Of
clearly erroneous execution reviews in multi-stock events involving
twenty or more securities; and (2) in the event transactions occur that
result in the issuance of an individual stock trading pause by the
primary listing market and subsequent transactions that occur before
the trading pause is in effect on the Exchange.\6\ The Exchange also
adopted additional changes to Article 20, Rule 10 that reduced the
ability of the Exchange to deviate from the objective standards set
forth in Article 20, Rule 10,\7\ and in 2013, adopted a provision
designed to address the operation of the Plan.\8\
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 62886 (Sept. 10, 2010),
75 FR 56613 (Sept. 16, 2010) (SR-CHX-2010-13).
    \7\ Id.
    \8\ See Securities Exchange Act Release No. 68802 (February 1,
2013), 78 FR 9092 (February 7, 2013) (SR-CHX-2013-04); see also CHX
Article 20, Rule 10(i).
---------------------------------------------------------------------------

    The Exchange believes the benefits to market participants from the
more objective clearly erroneous executions rule should continue on a
pilot basis to coincide with the operation of the Limit Up-Limit Down
Plan. The Exchange believes that continuing the pilot will protect
against any unanticipated consequences. Thus, the Exchange believes
that the protections of the Clearly Erroneous Rule should continue
while the industry gains further experience operating the Plan.
 2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\9\ In particular, the
proposal is consistent with Section 6(b)(5) of the Act,\10\ because it
would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system. Although the Limit Up-Limit Down Plan is
operational, the Exchange believes that maintaining the pilot will help
to protect against unanticipated consequences. Thus, the Exchange
believes that the protections of the Clearly Erroneous Rule should
continue while the industry gains further experience operating the
Plan. The Exchange also believes that the pilot program promotes just
and equitable principles of trade in that it promotes transparency and
uniformity across markets concerning review of transactions as clearly
erroneous. Thus, the Exchange believes that the extension of the pilot
would help assure that the determination of whether a clearly erroneous
trade has occurred will be based on clear and objective criteria, and
that the resolution of the incident will occur promptly through a
transparent process. The proposed rule change would also help assure
consistent results in handling erroneous trades across the U.S.
markets, thus furthering fair and orderly markets, the protection of
investors and the public interest. Based on the foregoing, the Exchange
believes the benefits to market participants from the more objective
clearly erroneous executions rule should continue on a pilot basis to
coincide with the operation of the Limit Up-Limit Down Plan.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change
implicates any competitive issues. To the contrary, the Exchange
believes that the Financial Industry Regulatory Authority (``FINRA'')
and other national securities exchanges are also filing similar

proposals, and thus, that the proposal will help to ensure consistency
across market centers.

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 proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6)(iii) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Commission believes that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest,
as it will allow the clearly erroneous pilot program to continue
uninterrupted while the industry gains further experience operating
under the Limit Up-Limit Down Plan, and avoid any investor confusion
that could result from a temporary interruption in the pilot program.
For this reason, the Commission designates the proposed rule change to
be operative upon filing.\13\
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CHX-2014-04 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-CHX-2014-04. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CHX-2014-04 and should be
submitted on or before April 18, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-06891 Filed 3-27-14; 8:45 am]
BILLING CODE 8011-01-P