[Federal Register Volume 88, Number 67 (Friday, April 7, 2023)]
[Rules and Regulations]
[Pages 20770-20772]
[FR Doc No: 2023-07361]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0258]
RIN 1625-AA00

Safety Zone; Port Los Angeles and Long Beach, San Pedro Bay, CA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving safety zone
around the M/V ZHEN HUA 26 while it transits through the Port of Los
Angeles--Long Beach, CA, to Long Beach Container Terminal (LBCT), LB
Berth E22, then to Fenix Marine Services (FMS), LA Berth 302. This
safety zone is necessary to protect personnel, vessels, and the marine
environment from potential hazards associated with oversized cargo
transfer operations of four ship-to-shore gantry cranes and one rubber
tire gantry crane, which will extend more than 200 feet out from the
transiting vessels. Entry of persons or vessels into this safety zone
is prohibited unless specifically authorized by the Captain of the Port
(COTP) Los Angeles--Long Beach, or their designated representative.

DATES: This rule is effective without actual notice from April 7, 2023,
through April 20, 2023. For the purposes of enforcement, actual notice
will be used from April 5, 2023, until April 7, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0258 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or LCDR Maria Wiener, Waterways Management, U.S. Coast Guard
Sector Los Angeles--Long Beach; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because The COTP was notified of the
impending arrival of the M/V ZHEN HUA 26 less than 30 days in advance
and immediate action is needed to respond to the potential safety
hazards associated with the transfer of large gantry cranes within the
Ports of Los Angeles and Long Beach. It is impracticable to publish an
NPRM because we must establish this safety zone by April 5, 2023.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public

interest because immediate action is needed to ensure the safety of
persons, vessels, and the marine environment in the vicinity of the M/V
ZHEN HUA 26 while conducting oversized cargo transfer operations at
LBCT, LB Berth E22, and FMS, LA Berth 302, within the Port of Los
Angeles--Long Beach, CA.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 and 70011(b)(3). The COTP Los Angeles--Long Beach has determined
that potential hazards associated with the movement of large-scale
gantry crane transfer operations will be a safety concern for anyone
within a 500-foot radius of the M/V ZHEN HUA 26 during its transit to
LBCT, LB Berth E22, and FMS, LA Berth 302, while the vessel is within
the Port of Los Angeles--Long Beach and the waters inside the Federal
breakwaters bounding San Pedro Bay or on the waters within three
nautical miles seaward of the Federal breakwaters, respectively. This
rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone while the
vessel offloads gantry cranes in the Port of Los Angeles and Long
Beach.

IV. Discussion of the Rule

    This rule establishes a safety zone from April 5, 2023, through
April 20, 2023, during the transit of the M/V ZEN HUA 26. While the M/V
ZHEN HUA 26 is within the Port of Los Angeles--Long Beach and the
waters inside the Federal breakwaters bounding San Pedro Bay or on the
waters within three nautical miles seaward of the Federal breakwaters,
respectively, the safety zone will encompass the navigable waters
around and under the vessel, form surface to bottom, within a circle
formed by connecting all points 500-feet out from the vessel. The
safety zone is needed to protect personnel, mariners, and vessels from
hazards associated with ship-to shore gantry crane arms which will
extend more than 200 feet out from the transiting vessel. The duration
of the zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters while the transfer operations are
active.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. Sector Los Angeles--Long Beach may be contacted on VHF-
FM Channel 16 or<PHONE_NUMBER>. The marine public will be notified of
the safety zone via Broadcast Notice to Mariners.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. This rule
impacts an area of 500-feet surrounding a cargo vessel while at LBCT,
LB Berth E22, for 10 days, and FMS, LA Berth 302, for 5 days during the
month of April 2023. This safety zone impacts a 500-foot-radius area of
the Port of Los Angeles--Long Beach and the waters inside the Federal
breakwaters bounding San Pedro Bay or on the waters within three
nautical miles seaward of the Federal breakwaters, respectively for a
limited duration. While the safety zone encompasses a fifteen-day
period to account for uncertain transit delays of the M/V ZHEN HUA 26,
the safety zone will only be enforced for the duration of the vessel's
inbound transit, and transit from LBCT, LB Berth E22, to FMS, LA Berth
302. Each transit is expected to last less than 24 hours, and that
period will be announced via Broadcast Notice to Mariners. Vessel
traffic will be able to safely transit around this safety zone, which
will impact a small, designated area of the San Pedro Bay, Long Beach,
and Los Angeles, CA.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A. above, this rule will not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes,

or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone encompassing an area extending 500-feet out from a cargo
vessel in vicinity of Long Beach Container Terminal and Fenix Marine
Services and will last only while transfer operations are ongoing. It
is categorically excluded from further review under paragraph L60 of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T11-123 to read as follows:

Sec.  165.T11-123  Safety Zone; Port of Los Angeles and Long Beach, San
Pedro Bay, CA.

    (a) Location. The following area is a safety zone: all navigable
waters of the port of Los Angeles--Long Beach, from surface to bottom,
within a circle formed by connecting all points 500-feet out from the
vessel, M/V ZHEN HUA 26, during the vessel's transit within the Port of
Los Angeles--Long Beach and the waters inside the Federal breakwaters
bounding San Pedro Bay or on the waters within three nautical miles
seaward of the Federal breakwaters, respectively.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard coxswain, petty officer, or other officer operating
a Coast Guard vessel designated by or assisting the Captain of the Port
Los Angeles--Long Beach (COTP) in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by hailing Coast Guard Sector Los Angeles--Long Beach on
VHF-FM Channel 16 or calling at<PHONE_NUMBER>. Those in the safety
zone must comply with all lawful orders or directions given to them by
the COTP or the COTP's designated representative.
    (d) Enforcement period. This temporary safety zone will be enforced
from April 5, 2023, through April 20, 2023, during the M/V ZHEN HUA
26's inbound transit and transit between Long Beach Container Terminal,
LB Berth E22, to Fenix Marine Services, LA Berth 302, or as announced
via Broadcast Notice to Mariners.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the enforcement date and times
for this safety zone via Local Notices to Mariners.

R.D. Manning,
Captain, U.S. Coast Guard, Captain of the Port Sector Los Angeles--Long
Beach.
[FR Doc. 2023-07361 Filed 4-6-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33278-33279]
[FR Doc No: 2021-13365]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0146; FRL-10024-82]

Certain New Chemicals or Significant New Uses; Statements of
Findings for March 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Toxic Substances Control Act (TSCA) requires EPA to
publish in the Federal Register a statement of its findings after its
review of certain TSCA notices when EPA makes a finding that a new
chemical substance or significant new use is not likely to present an
unreasonable risk of injury to health or the environment. Such
statements apply to premanufacture notices (PMNs), microbial commercial
activity notices (MCANs), and significant new use notices (SNUNs)
submitted to EPA under TSCA. This document presents statements of
findings made by EPA on such submissions during the period from March
1, 2021 to March 31, 2021.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Rebecca Edelstein, Chemical
Control Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER> email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitters of the PMNs addressed in this
action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0146, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. What action is the Agency taking?

    This document lists the statements of findings made by EPA after
review of notices submitted under TSCA section 5(a) that certain new
chemical substances or significant new uses are not likely to present
an unreasonable risk of injury to health or the environment. This
document presents statements of findings made by EPA during the period
from March 1, 2021 to March 31, 2021.

III. What is the Agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a)
notice and make one of the following specific findings:
     The chemical substance or significant new use presents an
unreasonable risk of injury to health or the environment;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects of the
chemical substance or significant new use;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects and the
chemical substance or significant new use may present an unreasonable
risk of injury to health or the environment;
     The chemical substance is or will be produced in
substantial quantities, and such substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities or there is or may be significant or substantial human
exposure to the substance; or
     The chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment.
    Unreasonable risk findings must be made without consideration of
costs or other non-risk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
under the conditions of use. The term ``conditions of use'' is defined
in TSCA section 3 to mean ``the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.''
    EPA is required under TSCA section 5(g) to publish in the Federal
Register a statement of its findings after its review of a TSCA section
5(a) notice when EPA makes a finding that a new chemical substance or
significant new use is not likely to present an unreasonable risk of
injury to health or the environment. Such statements apply to PMNs,
MCANs, and SNUNs submitted to EPA under TSCA section 5.
    Anyone who plans to manufacture (which includes import) a new
chemical substance for a non-exempt commercial purpose and any
manufacturer or processor wishing to engage in a use of a chemical
substance designated by EPA

as a significant new use must submit a notice to EPA at least 90 days
before commencing manufacture of the new chemical substance or before
engaging in the significant new use.
    The submitter of a notice to EPA for which EPA has made a finding
of ``not likely to present an unreasonable risk of injury to health or
the environment'' may commence manufacture of the chemical substance or
manufacture or processing for the significant new use notwithstanding
any remaining portion of the applicable review period.

IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent
that such information is not claimed as Confidential Business
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this
period, EPA has made findings under TSCA section 5(a)(3)(C) that the
new chemical substances or significant new uses are not likely to
present an unreasonable risk of injury to health or the environment:
     EPA case number assigned to the TSCA section 5(a) notice.
     Chemical identity (generic name, if the specific name is
claimed as CBI).
     Website link to EPA's decision document describing the
basis of the ``not likely to present an unreasonable risk'' finding
made by EPA under TSCA section 5(a)(3)(C).

------------------------------------------------------------------------
        EPA Case No.            Chemical identity       Website link
------------------------------------------------------------------------
J-20-0019, J-20-0020, J-20-   Saccharomyces         https://www.epa.gov/
 0021, J-20-0022, J-20-0023,   cerevisiae modified   reviewing-new-
 J-20-0024.                    (Generic Name).       chemicals-under-
                                                     toxic-substances-
                                                     control-act-tsca/
                                                     tsca-section-5a3c-
                                                     determination-506.
P-20-0167...................  Phenylene, alkyl and  https://www.epa.gov/
                               polycarbomonocycle    reviewing-new-
                               substituted, 1,2-     chemicals-under-
                               dicarboxylate         toxic-substances-
                               (Generic Name).       control-act-tsca/
                                                     tsca-section-5a3c-
                                                     determination-503.
J-21-0007, J-21-0008, J-21-   Biofuel producing     https://www.epa.gov/
 0009.                         Saccharomyces         reviewing-new-
                               cerevisiae            chemicals-under-
                               modified,             toxic-substances-
                               genetically stable    control-act-tsca/
                               (Generic Name).       tsca-section-5a3c-
                                                     determination-502.
P-21-0051...................  Fatty Acids, C18-     https://www.epa.gov/
                               unsatd., dimers,      reviewing-new-
                               hydrogenated,         chemicals-under-
                               polymers with 2-      toxic-substances-
                               hydroxyethyl-         control-act-tsca/
                               terminated            tsca-section-5a3c-
                               hydrogenated          determination-500.
                               polybutadiene,
                               bis(2,5-dihydro-2,5-
                               dioxo-1H-pyrrole-1-
                               hexanoate); CASRN:
                               2506146-94-5.
P-20-0025...................  Octadecanoic acid,    https://www.epa.gov/
                               12-(acetoxy)-, 2-     reviewing-new-
                               ethylhexyl ester;     chemicals-under-
                               CASRN 61800-40-6.     toxic-substances-
                                                     control-act-tsca/
                                                     tsca-section-5a3c-
                                                     determination-499.
------------------------------------------------------------------------

    Authority: 15 U.S.C. 2601 et seq.

    Dated: June 11, 2021.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2021-13365 Filed 6-23-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76121-76127]
[FR Doc No: 2012-31016]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68476; File No. SR-NYSEArca-2012-138]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change To List and Trade PIMCO Foreign Currency
Strategy Exchange-Traded Fund Under NYSE Arca Equities Rule 8.600

December 19, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'')\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that, on December 6, 2012, NYSE Arca, Inc.
(``Exchange'' or ``NYSE Arca'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to list and trade the following under NYSE
Arca Equities Rule 8.600 (``Managed Fund Shares''): PIMCO Foreign
Currency Strategy Exchange-Traded Fund. The text of the proposed rule
change is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to list and trade shares (``Shares'') of the
PIMCO Foreign Currency Strategy Exchange-Traded Fund (``Fund'') under
NYSE Arca Equities Rule 8.600,\3\ which governs the listing and trading
of Managed Fund Shares.\4\ The Shares will be offered by PIMCO ETF
Trust (``Trust''), a statutory trust organized under the laws of the
State of Delaware and registered with the Commission as an open-end
management investment company.\5\
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    \3\ The Commission has previously approved the listing and
trading on the Exchange of other actively managed funds under Rule
8.600. See, e.g., Securities Exchange Act Release Nos. 60981
(November 10, 2009), 74 FR 59594 (November 18, 2009) (SR-NYSEArca-
2009-79) (order approving Exchange listing and trading of five fixed
income funds of the PIMCO ETF Trust); 66321 (February 3, 2012), 77
FR 6850 (February 9, 2012) (SR-NYSEArca-2011-95) (order approving
listing and trading of PIMCO Total Return Exchange Traded Fund); and
66670 (March 28, 2012), 77 FR 20087 (April 3, 2012) (SR-NYSEArca-
2012-09) (order approving listing and trading of PIMCO Global
Advantage Inflation-Linked Bond Strategy Fund).
    \4\ A Managed Fund Share is a security that represents an
interest in an investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a-1) (``1940 Act'') organized as an
open-end investment company or similar entity that invests in a
portfolio of securities selected by its investment adviser
consistent with its investment objectives and policies. In contrast,
an open-end investment company that issues Investment Company Units,
listed and traded on the Exchange under NYSE Arca Equities Rule
5.2(j)(3), seeks to provide investment results that correspond
generally to the price and yield performance of a specific foreign
or domestic stock index, fixed income securities index, or
combination thereof.
    \5\ The Trust is registered under the 1940 Act. On October 28,
2011, the Trust filed an amendment to its registration statement on
Form N-1A under the Securities Act of 1933 (15 U.S.C. 77a) (``1933
Act'') and the 1940 Act relating to the Fund (File Nos. 333-155395
and 811-22250) (``Registration Statement''). The description of the
operation of the Trust and the Fund herein is based, in part, on the
Registration Statement. In addition, the Commission has issued an
order granting certain exemptive relief to the Trust under the 1940
Act. See Investment Company Act Release No. 28993 (November 10,
2009) (File No. 812-13571) (``Exemptive Order'').
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    The investment manager to the Fund is Pacific Investment Management
Company LLC (``PIMCO'' or ``Adviser''). PIMCO Investments LLC serves as
the distributor for the Fund (``Distributor''). State Street Bank &
Trust Co. serves as the custodian and transfer agent for the Fund
(``Custodian'' or ``Transfer Agent'').
    Commentary .06 to Rule 8.600 provides that, if the investment
adviser to the investment company issuing Managed Fund Shares is
affiliated with a broker-dealer, such investment adviser shall erect a
``fire wall'' between the investment adviser and the broker-dealer with
respect to access to information concerning the composition and/or
changes to such investment company portfolio.\6\ In addition,
Commentary .06 further requires that personnel who make decisions on
the open-end fund's portfolio composition must be subject to procedures
designed to prevent the use and dissemination of material nonpublic
information regarding the open-end fund's portfolio. The Adviser is
affiliated with a broker-dealer and has implemented a ``fire wall''
with respect to such broker-dealer regarding access to information
concerning the composition and/or changes to the Fund's portfolio. If
PIMCO elects to hire a sub-adviser for the Fund that is also affiliated
with a broker-dealer, such sub-adviser will implement a fire wall with
respect to such broker-dealer regarding access to information
concerning the composition and/or changes to the portfolio. In the
event (a) the Adviser or any sub-adviser becomes newly affiliated with
a broker-dealer, or (b) any new manager, adviser, or sub-adviser
becomes affiliated with a broker-dealer, it will implement a fire wall
with respect to such broker-dealer regarding access to information
concerning the composition and/or changes to the portfolio, and will be
subject to procedures designed to prevent the use and dissemination of
material, non-public information regarding such portfolio.
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    \6\ An investment adviser to an open-end fund is required to be
registered under the Investment Advisers Act of 1940 (``Advisers
Act''). As a result, the Adviser and its related personnel are
subject to the provisions of Rule 204A-1 under the Advisers Act
relating to codes of ethics. This Rule requires investment advisers
to adopt a code of ethics that reflects the fiduciary nature of the
relationship to clients as well as compliance with other applicable
securities laws. Accordingly, procedures designed to prevent the
communication and misuse of non-public information by an investment
adviser must be consistent with Rule 204A-1 under the Advisers Act.
In addition, Rule 206(4)-7 under the Advisers Act makes it unlawful
for an investment adviser to provide investment advice to clients
unless such investment adviser has (i) adopted and implemented
written policies and procedures reasonably designed to prevent
violation, by the investment adviser and its supervised persons, of
the Advisers Act and the Commission rules adopted thereunder; (ii)
implemented, at a minimum, an annual review regarding the adequacy
of the policies and procedures established pursuant to subparagraph
(i) above and the effectiveness of their implementation; and (iii)
designated an individual (who is a supervised person) responsible
for administering the policies and procedures adopted under
subparagraph (i) above.
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Principal Investment Strategies
    According to the Registration Statement, the Fund will seek maximum

total return,\7\ consistent with prudent investment management. The
Fund will invest under normal circumstances\8\ at least 80% of its
assets in currencies of, or Fixed Income Instruments\9\ denominated in
the currencies of, foreign (non-U.S.) countries, including, but not
limited to, a combination of short-term Fixed Income Instruments, money
market securities, and currency forwards\10\ backed by high-quality,
low duration securities (``80% Holdings'').\11\ The Fund will seek
exposure to foreign (non-U.S.) currencies likely to outperform the U.S.
dollar over the long-term. Assets not invested in the 80% Holdings may
be invested in other types of Fixed Income Instruments (e.g., Fixed
Income Instruments denominated in U.S. dollars).
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    \7\ The ``total return'' sought by the Fund will consist of
income and capital appreciation, if any, which generally arises from
decreases in interest rates, foreign currency appreciation, or
improving credit fundamentals for a particular sector or security.
    \8\ The term ``under normal circumstances'' includes, but is not
limited to, the absence of extreme volatility or trading halts in
the fixed income markets or the financial markets generally;
operational issues causing dissemination of inaccurate market
information; or force majeure type events such as systems failure,
natural or man-made disaster, act of God, armed conflict, act of
terrorism, riot or labor disruption, or any similar intervening
circumstance.
    \9\ ``Fixed Income Instruments,'' as used generally in the
Registration Statement, includes:
     Debt securities issued or guaranteed by the U.S.
Government, its agencies or government-sponsored enterprises (``U.S.
Government Securities'');
     Corporate debt securities of U.S. and non-U.S. issuers,
including convertible securities and corporate commercial paper;
     Mortgage-backed and other asset-backed securities;
     Inflation-indexed bonds issued both by governments and
corporations;
     Structured notes, including hybrid or ``indexed''
securities and event-linked bonds;
     Bank capital and trust preferred securities;
     Loan participations and assignments;
     Delayed funding loans and revolving credit facilities;
     Bank certificates of deposit, fixed time deposits and
bankers' acceptances;
     Repurchase agreements on Fixed Income Instruments and
reverse repurchase agreements on Fixed Income Instruments;
     Debt securities issued by states or local governments
and their agencies, authorities and other government-sponsored
enterprises;
     Obligations of non-U.S. governments or their
subdivisions, agencies and government-sponsored enterprises; and
     Obligations of international agencies or supranational
entities.
    Only those Fixed Income Instruments that are denominated in
foreign (non-U.S.) currencies count towards the 80% Holdings (as
defined above).
    \10\ A forward foreign currency exchange contract involves an
obligation to purchase or sell a specific currency at a future date
at a price set at the time of the contract.
    \11\ In connection with its holdings in Fixed Income
Instruments, the Fund will seek, where possible, to use
counterparties, as applicable, whose financial status is such that
the risk of default is reduced; however, the risk of losses
resulting from default is still possible. PIMCO's Counterparty Risk
Committee evaluates the creditworthiness of counterparties on an
ongoing basis. In addition to information provided by credit
agencies, PIMCO credit analysts evaluate each approved counterparty
using various methods of analysis, including company visits,
earnings updates, the broker-dealer's reputation, PIMCO's past
experience with the broker-dealer, market levels for the
counterparty's debt and equity, the counterparty's liquidity and its
share of market participation.
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    According to the Registration Statement, the Fund may invest up to
50% of its total assets in securities and instruments that are
economically tied to emerging market countries, which may include
assets comprising the 80% Holdings.\12\ PIMCO will select the Fund's
country and currency composition based on its evaluation of relative
interest rates, inflation rates, exchange rates, monetary and fiscal
policies, trade and current account balances, legal and political
developments, and other specific factors PIMCO believes to be relevant.
The Fund will normally limit its exposure to a single non-U.S. currency
(from currency holdings or investments in securities denominated in
that currency) to 20% of its total assets.
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    \12\ PIMCO generally considers an instrument to be economically
tied to an emerging market country if the issuer or guarantor is a
government of an emerging market country (or any political
subdivision, agency, authority or instrumentality of such
government), if the issuer or guarantor is organized under the laws
of an emerging market country, or if the currency of settlement is a
currency of an emerging market country. PIMCO has broad discretion
to identify countries that it considers to qualify as emerging
markets. In making investments in emerging market instruments, the
Fund emphasizes those countries with relatively low gross national
product per capita and with the potential for rapid economic growth.
Emerging market countries are generally located in Asia, Africa, the
Middle East, Latin America, and Eastern Europe.
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    According to the Registration Statement, the average portfolio
duration of the Fund will vary based on PIMCO's forecast for interest
rates and, under normal market conditions, will vary from zero to three
years.\13\ The Fund may invest in both high yield securities (``junk
bonds'') rated Ba, or investment grade securities rated Baa or higher,
by Moody's Investors Service, Inc. (``Moody's''), or equivalently rated
by Standard & Poor's Ratings Services (``S&P'') or Fitch, Inc.
(``Fitch''), or, if unrated, determined by PIMCO to be of comparable
quality.\14\ The Fund currently anticipates that at least 50% of issues
of Fixed Income Instruments held by the Fund will be rated investment
grade or determined by PIMCO to be of comparable quality.\15\ The Fund
is non-diversified, which means that it may invest its assets in a
smaller number of issuers than a diversified fund.\16\
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    \13\ Duration is a measure used to determine the sensitivity of
a security's price to changes in interest rates. The longer a
security's duration, the more sensitive it will be to changes in
interest rates.
    \14\ Securities rated Ba or lower by Moody's, or equivalently
rated by S&P or Fitch, are sometimes referred to as ``high yield
securities'' or ``junk bonds,'' while securities rated Baa or higher
are referred to as ``investment grade.'' Unrated securities may be
less liquid than comparably rated securities and involve the risk
that the portfolio manager may not accurately evaluate the
security's comparative credit rating. To the extent that the Fund
invests in unrated securities, the Fund's success in achieving its
investment objective may depend more heavily on the portfolio
manager's creditworthiness analysis than if the Fund invested
exclusively in rated securities. See note 15, infra.
    \15\ PIMCO utilizes sophisticated proprietary techniques in its
creditworthiness analysis of unrated securities similar to the
processes utilized by Moody's, S&P, and Fitch in their respective
analyses of rated securities. For example, in making a ``comparable
quality'' determination for an unrated security, PIMCO may evaluate
the likelihood of payment by the obligor, the nature and provisions
of the debt obligation, and/or the protection afforded by, and
relative position of, the debt obligation in the event of
bankruptcy, reorganization, or other arrangement under laws
affecting creditors' rights. Upon consideration of these and other
factors, PIMCO may determine that an unrated security is of
comparable quality to rated securities in which the Fund may invest
consistent with the Fund's credit quality guidelines described
above.
    \16\ The diversification standard is set forth in Section
5(b)(1) of the 1940 Act (15 U.S.C. 80e).
---------------------------------------------------------------------------

    While corporate debt securities and debt securities economically
tied to an emerging market country generally must have $200 million or
more par amount outstanding and significant par value traded to be
considered as an eligible investment for the Fund, at least 80% of
issues of such securities held by the Fund must have $200 million or
more par amount outstanding. The Fund may invest up to 10% of its
assets in mortgage-backed securities or in other asset-backed
securities, although this limitation does not apply to securities
issued or guaranteed by Federal agencies and/or U.S. government
sponsored instrumentalities.
    According to the Registration Statement, the Fund may purchase or
sell securities on a when-issued, delayed delivery, or forward
commitment basis and may engage in short sales. The Fund may, without
limitation, seek to obtain market exposure to the securities in which
it primarily invests by entering into a series of purchase and sale
contracts or by using other investment techniques (such as buy backs or
dollar rolls).
Investment Selection Techniques
    According to the Registration Statement, in selecting investments
for the Fund, PIMCO will develop an outlook for interest rates,
currency exchange rates and the economy,

analyze credit and call risks, and use other asset selection
techniques. The proportion of the Fund's investments in securities with
particular characteristics (such as quality, sector, interest rate, or
maturity) will vary based on PIMCO's outlook for the U.S. economy and
the economies of other countries in the world, the financial markets,
and other factors. In seeking to identify undervalued currencies, PIMCO
may consider many factors, including but not limited to longer-term
analysis of relative interest rates, inflation rates, real exchange
rates, purchasing power parity, trade account balances, and current
account balances, as well as other factors that influence exchange
rates such as flows, market technical trends, and government policies.
With respect to fixed income investing, PIMCO will attempt to identify
areas of the bond market that are undervalued relative to the rest of
the market. PIMCO identifies these areas by grouping Fixed Income
Instruments into sectors such as money markets, governments,
corporates, mortgages, asset-backed, and international. Sophisticated
proprietary software then will assist in evaluating sectors and pricing
specific investments. Once investment opportunities are identified,
PIMCO will shift assets among sectors depending upon changes in
relative valuations, credit spreads, and other factors.
Additional Information Regarding Principal Investment Strategies\17\
---------------------------------------------------------------------------

    \17\ Many of the investment strategies of the Fund are
discretionary, which means that PIMCO can decide from time to time
whether to use them or not.
---------------------------------------------------------------------------

    The Fund will invest in currencies and Fixed Income Instruments
that are economically tied to foreign (non-U.S.) countries. PIMCO
generally considers an instrument to be economically tied to a non-U.S.
country if the issuer is a foreign government (or any political
subdivision, agency, authority, or instrumentality of such government),
or if the issuer is organized under the laws of a non-U.S. country. In
the case of certain money market instruments, such instruments will be
considered economically tied to a non-U.S. country if either the issuer
or the guarantor of such money market instrument is organized under the
laws of a non-U.S. country.
    The Fund will invest in foreign currencies and may invest in Fixed
Income Instruments denominated in foreign (non-U.S.) currencies or
receive revenues in foreign currencies, and may engage in foreign
currency transactions on a spot (cash) basis and enter into forward
foreign currency exchange contracts.\18\ A forward foreign currency
exchange contract, which involves an obligation to purchase or sell a
specific currency at a future date at a price set at the time of the
contract, reduces the Fund's exposure to changes in the value of the
currency it will deliver and increases its exposure to changes in the
value of the currency it will receive for the duration of the contract.
Certain foreign currency transactions may also be settled in cash
rather than the actual delivery of the relevant currency. The effect on
the value of the Fund is similar to selling securities denominated in
one currency and purchasing securities denominated in another currency.
A contract to sell foreign currency would limit any potential gain
which might be realized if the value of the hedged currency increases.
The Fund may enter into these contracts to hedge against foreign
exchange risk, to increase exposure to a foreign currency, or to shift
exposure to foreign currency fluctuations from one currency to another.
Suitable hedging transactions may not be available in all circumstances
and there can be no assurance that the Fund will engage in such
transactions at any given time or from time to time.
---------------------------------------------------------------------------

    \18\ The Fund will limit its investments in currencies to those
currencies with a minimum average daily foreign exchange turnover of
USD $1 billion, as determined by the Bank for International
Settlements (``BIS'') Triennial Central Bank Survey. As of the most
recent BIS Triennial Central Bank Survey, at least 52 separate
currencies had minimum average daily foreign exchange turnover of
USD $1 billion. For a list of eligible BIS currencies, see
www.bis.org.
---------------------------------------------------------------------------

    The Fund may invest in variable and floating rate debt securities,
which are securities that pay interest at rates that adjust whenever a
specified interest rate changes and/or that reset on predetermined
dates (such as the last day of a month or calendar quarter). To the
extent the Fund invests in variable and floating rate debt securities
that are deemed illiquid, the Fund will limit such holdings to an
amount consistent with the 15% limitation on illiquid securities
discussed below. The Fund may invest in floating rate debt instruments
(``floaters'') and engage in credit spread trades. Variable and
floating rate securities generally are less sensitive to interest rate
changes, but may decline in value if their interest rates do not rise
as much, or as quickly, as interest rates in general. Conversely,
floating rate securities will not generally increase in value if
interest rates decline.
    The Fund may invest in bank capital securities. Bank capital
securities are issued by banks to help fulfill their regulatory capital
requirements. There are two common types of bank capital: Tier I and
Tier II. Bank capital is generally, but not always, of investment grade
quality. Tier I securities are typically exchange-traded and often take
the form of trust preferred securities. Tier II securities are commonly
thought of as hybrids of debt and preferred stock. Tier II securities
are typically traded over-the-counter, are often perpetual (with no
maturity date), callable, and have a cumulative interest deferral
feature. This means that under certain conditions, the issuer bank can
withhold payment of interest until a later date. However, such deferred
interest payments generally earn interest.
    The Fund may make short sales as part of its overall portfolio
management strategies or to offset a potential decline in value of a
security.
Other Portfolio Holdings and Non-Principal Investment Strategies
    For the purpose of achieving income, the Fund may lend its
portfolio securities to brokers, dealers, and other financial
institutions, provided a number of conditions are satisfied, including
that the loan is fully collateralized. When the Fund lends portfolio
securities, its investment performance will continue to reflect changes
in the value of the securities loaned, and the Fund will also receive a
fee or interest on the collateral. Cash collateral received by the Fund
in securities lending transactions may be invested in short-term liquid
Fixed Income Instruments or in money market or short-term mutual funds
or similar investment vehicles, including affiliated money market or
short-term mutual funds.
    The Fund may invest in, to the extent permitted by Section
12(d)(1)(A) of the 1940 Act, other affiliated and unaffiliated funds,
such as open-end or closed-end management investment companies,
including other exchange traded funds, provided that the Fund's
investment in units or shares of investment companies and other open-
end collective investment vehicles will not exceed 10% of the Fund's
total assets. The Fund may invest securities lending collateral in one
or more money market funds to the extent permitted by Rule 12d1-1 under
the 1940 Act, including series of PIMCO Funds, an affiliated open-end
management investment company managed by PIMCO.
    Subject to the restrictions and limitations of the 1940 Act, the
Fund may elect to pursue its investment objective either by investing
directly in

securities or instruments, or by investing in one or more underlying
investment vehicles or companies that have substantially similar
investment objectives and policies as the Fund.
    The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid securities (calculated at the time of investment).
Certain financial instruments, including, but not limited to, Rule 144A
securities, loan participations and assignments, delayed funding loans,
revolving credit facilities,\19\ and fixed- and floating-rate loans
\20\ will be included in the 15% limitation on illiquid securities. The
Fund will monitor its portfolio liquidity on an ongoing basis to
determine whether, in light of current circumstances, an adequate level
of liquidity is being maintained, and will consider taking appropriate
steps in order to maintain adequate liquidity if, through a change in
values, net assets, or other circumstances, more than 15% of the Fund's
net assets are held in illiquid securities. Illiquid securities include
securities subject to contractual or other restrictions on resale and
other instruments that lack readily available markets as determined in
accordance with Commission staff guidance.\21\
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    \19\ The Fund may enter into, or acquire participations in,
delayed funding loans and revolving credit facilities, in which a
lender agrees to make loans up to a maximum amount upon demand by
the borrower during a specified term. These commitments may have the
effect of requiring the Fund to increase its investments in a
company at a time when it might not otherwise decide to do so
(including at a time when the company's financial condition makes it
unlikely that such amounts will be repaid). To the extent that the
Fund is committed to advance additional funds, it will segregate or
``earmark'' assets determined to be liquid by PIMCO in accordance
with procedures established by the Fund's Board of Trustees in an
amount sufficient to meet such commitments.
    \20\ The Fund may invest in fixed- and floating-rate loans,
which investments generally will be in the form of loan
participations and assignments of portions of such loans.
Participations and assignments involve special types of risk,
including credit risk, interest rate risk, liquidity risk, and the
risks of being a lender.
    \21\ The Commission has stated that long-standing Commission
guidelines have required open-end funds to hold no more than 15% of
their net assets in illiquid securities and other illiquid assets.
See Investment Company Act Release No. 28193 (March 11, 2008), 73 FR
14618 (March 18, 2008), footnote 34. See also Investment Company Act
Release No. 5847 (October 21, 1969), 35 FR 19989 (December 31, 1970)
(Statement Regarding ``Restricted Securities''); Investment Company
Act Release No. 18612 (March 12, 1992), 57 FR 9828 (March 20, 1992)
(Revisions of Guidelines to Form N-1A). A fund's portfolio security
is illiquid if it cannot be disposed of in the ordinary course of
business within seven days at approximately the value ascribed to it
by the fund. See Investment Company Act Release No. 14983 (March 12,
1986), 51 FR 9773 (March 21, 1986) (adopting amendments to Rule 2a-7
under the 1940 Act); and Investment Company Act Release No. 17452
(April 23, 1990), 55 FR 17933 (April 30, 1990) (adopting Rule 144A
under the 1933 Act).
---------------------------------------------------------------------------

    The Fund intends to qualify annually and elect to be treated as a
regulated investment company under Subchapter M of the Internal Revenue
Code.\22\
---------------------------------------------------------------------------

    \22\ 26 U.S.C. 851.
---------------------------------------------------------------------------

    The Fund may not concentrate its investments in a particular
industry, as that term is used in the 1940 Act, and as interpreted,
modified, or otherwise permitted by regulatory authority having
jurisdiction from time to time.\23\
---------------------------------------------------------------------------

    \23\ See Form N-1A, Item 9. The Commission has taken the
position that a fund is concentrated if it invests more than 25% of
the value of its total assets in any one industry. See, e.g.,
Investment Company Act Release No. 9011 (October 30, 1975), 40 FR
54241 (November 21, 1975).
---------------------------------------------------------------------------

    If PIMCO believes that economic or market conditions are
unfavorable to investors, PIMCO may temporarily invest up to 100% of
the Fund's assets in certain defensive strategies, including holding a
substantial portion of the Fund's assets in cash, cash equivalents, or
other highly rated short-term securities, including securities issued
or guaranteed by the U.S. government, its agencies, or
instrumentalities.
    The Fund will not invest in any non-U.S registered equity
securities, except if such securities are traded on exchanges that are
members of the Intermarket Surveillance Group (``ISG'').
    The Fund's investments will be consistent with the Fund's
investment objective and will not be used to enhance leverage. That is,
while the Fund will be permitted to borrow as permitted under the 1940
Act, the Fund's investments will not be used to seek performance that
is the multiple or inverse multiple (i.e., 2Xs and 3Xs) of the Fund's
broad-based securities market index (as defined in Form N-1A).\24\
---------------------------------------------------------------------------

    \24\ The Fund's broad-based securities market index will be
identified in a future amendment to the Registration Statement
following the Fund's first full calendar year of performance.
---------------------------------------------------------------------------

    The Fund will not invest in options contracts, futures contracts,
or swap agreements, in accordance with the Trust's Exemptive Order.
    The Shares will conform to the initial and continued listing
criteria under NYSE Arca Equities Rule 8.600. Consistent with NYSE Arca
Equities Rule 8.600(d)(2)(B)(ii), the Fund's Reporting Authority will
implement and maintain, or be subject to, procedures designed to
prevent the use and dissemination of material, non-public information
regarding the actual components of the Fund's portfolio. The Exchange
represents that, for initial and/or continued listing, the Fund will be
in compliance with Rule 10A-3 under the Exchange Act,\25\ as provided
by NYSE Arca Equities Rule 5.3. A minimum of 100,000 Shares will be
outstanding at the commencement of trading on the Exchange. The
Exchange will obtain a representation from the issuer of the Shares
that the net asset value (``NAV'') per Share will be calculated daily
and that the NAV and the Disclosed Portfolio will be made available to
all market participants at the same time.
---------------------------------------------------------------------------

    \25\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

Net Asset Value
    The NAV of the Fund's Shares will be determined by dividing the
total value of the Fund's portfolio investments and other assets, less
any liabilities, by the total number of Shares outstanding.
    Fund Shares will be valued as of the close of trading (normally
4:00 p.m. Eastern time (``E.T.'')) on each business day. Information
that becomes known to the Fund or its agents after the NAV has been
calculated on a particular day will not generally be used to
retroactively adjust the price of a security or the NAV determined
earlier that day. The Fund reserves the right to change the time its
NAV is calculated if the Fund closes earlier, or as permitted by the
Commission.
    For purposes of calculating NAV, portfolio securities and other
assets for which market quotes are readily available will be valued at
market value. Market value is generally determined on the basis of last
reported sales prices, or if no sales are reported, based on quotes
obtained from a quotation reporting system, established market makers,
or pricing services. Domestic and foreign fixed income securities will
normally be valued on the basis of quotes obtained from brokers and
dealers or pricing services using data reflecting the earlier closing
of the principal markets for those securities. Prices obtained from
independent pricing services use information provided by market makers
or estimates of market values obtained from yield data relating to
investments or securities with similar characteristics.
Creations and Redemptions of Shares
    According to the Registration Statement, Shares of the Fund that
trade in the secondary market will be ``created'' at NAV \26\ by
Authorized

Participants only in block-size Creation Units of 100,000 Shares or
multiples thereof. The Fund will offer and issue Shares at their NAV
per Share generally in exchange for a basket of debt securities held by
the Fund (``Deposit Securities'') together with a deposit of a
specified cash payment (``Cash Component''). Alternatively, the Fund
may issue Creation Units in exchange for a specified all-cash payment
(``Cash Deposit''). Similarly, Shares can be redeemed only in Creation
Units, generally in-kind for a portfolio of debt securities held by the
Fund and/or for a specified amount of cash.
---------------------------------------------------------------------------

    \26\ The NAV of the Fund's Shares generally will be calculated
once daily Monday through Friday as of the close of trading on the
New York Stock Exchange (``NYSE''), generally 4:00 p.m. E.T. (``NAV
Calculation Time'') on any business day. NAV per Share is calculated
by dividing the Fund's net assets by the number of Fund Shares
outstanding. For more information regarding the valuation of Fund
investments in calculating the Fund's NAV, see the Registration
Statement.
---------------------------------------------------------------------------

    Except when aggregated in Creation Units, Shares will not be
redeemable by the Fund. The prices at which creations and redemptions
occur are based on the next calculation of NAV after an order is
received. Requirements as to the timing and form of orders are
described in the Authorized Participant agreement. PIMCO will make
available on each business day via the National Securities Clearing
Corporation (``NSCC''), prior to the opening of business (subject to
amendments) on the Exchange (currently 9:30 a.m. E.T.), the identity
and the required amount of each Deposit Security and the amount of the
Cash Component (or Cash Deposit) to be included in the current Fund
Deposit \27\ (based on information at the end of the previous business
day). Creations and redemptions must be made by an Authorized
Participant or through a firm that is either a participant in the
Continuous Net Settlement System of the NSCC or a DTC participant, and
in each case, must have executed an agreement with the Distributor and
Transfer Agent with respect to creations and redemptions of Creation
Unit aggregations.
---------------------------------------------------------------------------

    \27\ The Deposit Securities and Cash Component or,
alternatively, the Cash Deposit, constitute the ``Fund Deposit,''
which represents the investment amount for a Creation Unit of the
Fund.
---------------------------------------------------------------------------

    Additional information regarding the Trust, the Fund and the
Shares, including investment strategies, risks, creation and redemption
procedures, fees, portfolio holdings, disclosure policies,
distributions, and taxes is included in the Registration Statement. All
terms relating to the Fund that are referred to but not defined in this
proposed rule change are defined in the Registration Statement.
Availability of Information
    The Trust's Web site (www.pimcoetfs.com), which is publicly
available prior to the public offering of Shares, will include a form
of the prospectus for the Fund that may be downloaded. The Trust's Web
site will include additional quantitative information updated on a
daily basis, including, for the Fund, (1) daily trading volume, the
prior business day's reported closing price, NAV and mid-point of the
bid/ask spread at the time of calculation of such NAV (``Bid/Ask
Price''),\28\ and a calculation of the premium and discount of the Bid/
Ask Price against the NAV, and (2) data in chart format displaying the
frequency distribution of discounts and premiums of the daily Bid/Ask
Price against the NAV, within appropriate ranges, for each of the four
previous calendar quarters. On each business day, before commencement
of trading in Shares in the Core Trading Session (9:30 a.m. E.T. to
4:00 p.m. E.T.) on the Exchange, the Fund will disclose on the Trust's
Web site the Disclosed Portfolio as defined in NYSE Arca Equities Rule
8.600(c)(2) that will form the basis for the Fund's calculation of NAV
at the end of the business day.\29\
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    \28\ The Bid/Ask Price of the Fund will be determined using the
mid-point of the highest bid and the lowest offer on the Exchange as
of the time of calculation of the Fund's NAV. The records relating
to Bid/Ask Prices will be retained by the Fund and its service
providers.
    \29\ Under accounting procedures followed by the Fund, trades
made on the prior business day (``T'') will be booked and reflected
in NAV on the current business day (``T+1''). Accordingly, the Fund
will be able to disclose at the beginning of the business day the
portfolio that will form the basis for the NAV calculation at the
end of the business day.
---------------------------------------------------------------------------

    On a daily basis, the Adviser will disclose for each portfolio
security or other financial instrument of the Fund the following
information: ticker symbol (if applicable), name of security and
financial instrument, number of shares or dollar value of securities
and financial instruments held in the portfolio, and percentage
weighting of the security and financial instrument in the portfolio.
The Web site information will be publicly available at no charge. In
addition, price information for the debt securities and other financial
instruments held by the Fund will be available through major market
data vendors.
    In addition, a basket composition file, which includes the security
names and share quantities, if applicable, required to be delivered in
exchange for Fund Shares, together with estimates and actual cash
components, will be publicly disseminated daily prior to the opening of
the NYSE via the NSCC. The basket represents one Creation Unit of the
Fund. The NAV of the Fund will normally be determined as of the close
of the regular trading session on the NYSE (ordinarily 4:00 p.m. E.T.)
on each business day.
    Investors can also obtain the Trust's Statement of Additional
Information (``SAI''), the Fund's Shareholder Reports, and its Form N-
CSR and Form N-SAR, filed twice a year. The Trust's SAI and Shareholder
Reports are available free upon request from the Trust, and those
documents and the Form N-CSR and Form N-SAR may be viewed on-screen or
downloaded from the Commission's Web site at www.sec.gov. Information
regarding market price and trading volume of the Shares will be
continually available on a real-time basis throughout the day on
brokers' computer screens and other electronic services. Information
regarding the previous day's closing price and trading volume
information for the Shares will be published daily in the financial
section of newspapers. Quotation and last-sale information for the
Shares will be available via the Consolidated Tape Association
(``CTA'') high-speed line. In addition, the Portfolio Indicative Value,
as defined in NYSE Arca Equities Rule 8.600 (c)(3), will be widely
disseminated by one or more major market data vendors at least every 15
seconds during the Core Trading Session.\30\ The dissemination of the
Portfolio Indicative Value, together with the Disclosed Portfolio, will
allow investors to determine the value of the underlying portfolio of
the Fund on a daily basis and to provide a close estimate of that value
throughout the trading day.
---------------------------------------------------------------------------

    \30\ Currently, it is the Exchange's understanding that several
major market data vendors display and/or make widely available
Portfolio Indicative Values taken from the CTA or other data feeds.
---------------------------------------------------------------------------

Trading Halts
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares of the Fund.\31\ Trading in Shares of the Fund
will be halted if the circuit breaker parameters in NYSE Arca Equities
Rule 7.12 have been reached. Trading also may be halted because of
market conditions or for reasons that, in the view of the Exchange,
make trading in the Shares inadvisable. These may include: (1) the
extent to which trading is not occurring in the securities and/or the
financial instruments comprising the Disclosed Portfolio of the Fund;
or (2) whether other unusual conditions or circumstances detrimental to
the maintenance of a fair and orderly market are present. Trading in
the Shares will be subject to NYSE Arca Equities Rule 8.600(d)(2)(D),
which sets

forth circumstances under which Shares of the Fund may be halted.
---------------------------------------------------------------------------

    \31\ See NYSE Arca Equities Rule 7.12, Commentary .04.
---------------------------------------------------------------------------

Trading Rules
    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. Shares will trade on
the NYSE Arca Marketplace from 4:00 a.m. to 8:00 p.m. E.T. in
accordance with NYSE Arca Equities Rule 7.34 (Opening, Core, and Late
Trading Sessions). The Exchange has appropriate rules to facilitate
transactions in the Shares during all trading sessions. As provided in
NYSE Arca Equities Rule 7.6, Commentary .03, the minimum price
variation (``MPV'') for quoting and entry of orders in equity
securities traded on the NYSE Arca Marketplace is $0.01, with the
exception of securities that are priced less than $1.00 for which the
MPV for order entry is $0.0001.
Surveillance
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products (which include Managed
Fund Shares) to monitor trading in the Shares. The Exchange represents
that these procedures are adequate to properly monitor Exchange trading
of the Shares in all trading sessions and to deter and detect
violations of Exchange rules and applicable federal securities laws.
    The Exchange's current trading surveillance focuses on detecting
securities trading outside their normal patterns. When such situations
are detected, surveillance analysis follows and investigations are
opened, where appropriate, to review the behavior of all relevant
parties for all relevant trading violations.
    The Exchange may obtain information via the ISG from other
exchanges that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.\32\
---------------------------------------------------------------------------

    \32\ For a list of the current members of ISG, see http://www.isgportal.org. The Exchange notes that not all components of the
Disclosed Portfolio for the Fund may trade on markets that are
members of ISG or with which the Exchange has in place a
comprehensive surveillance sharing agreement.
---------------------------------------------------------------------------

    In addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
Equity Trading Permit (``ETP'') Holders in an Information Bulletin
(``Bulletin'') of the special characteristics and risks associated with
trading the Shares. Specifically, the Bulletin will discuss the
following: (1) The procedures for purchases and redemptions of Shares
in Creation Unit aggregations (and that Shares are not individually
redeemable); (2) NYSE Arca Equities Rule 9.2(a), which imposes a duty
of due diligence on its ETP Holders to learn the essential facts
relating to every customer prior to trading the Shares; (3) the risks
involved in trading the Shares during the Opening and Late Trading
Sessions when an updated Portfolio Indicative Value will not be
calculated or publicly disseminated; (4) how information regarding the
Portfolio Indicative Value is disseminated; (5) the requirement that
ETP Holders deliver a prospectus to investors purchasing newly issued
Shares prior to or concurrently with the confirmation of a transaction;
and (6) trading information.
    In addition, the Bulletin will reference that the Fund is subject
to various fees and expenses described in the Registration Statement.
The Bulletin will discuss any exemptive, no-action, and interpretive
relief granted by the Commission from any rules under the Exchange Act.
The Bulletin will also disclose that the NAV for the Shares will be
calculated after 4:00 p.m. E.T. each trading day.
2. Statutory Basis
    The basis under the Exchange Act for this proposed rule change is
the requirement under Section 6(b)(5) \33\ that an exchange have rules
that are designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to, and perfect the mechanism of a free and open market
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares will be listed and traded on the Exchange pursuant to the
initial and continued listing criteria in NYSE Arca Equities Rule
8.600. The Exchange has in place surveillance procedures that are
adequate to properly monitor trading in the Shares in all trading
sessions and to deter and detect violations of Exchange rules and
applicable federal securities laws. The Exchange may obtain information
via ISG from other exchanges that are members of ISG or with which the
Exchange has entered into a comprehensive surveillance sharing
agreement. The Fund will not invest in any non-U.S registered equity
securities, except if such securities are traded on exchanges that are
members of the ISG. The Fund's investments will be consistent with the
Fund's investment objective and will not be used to enhance leverage;
that is, the Fund's investments will not be used to seek performance
that is the multiple or inverse multiple (i.e., 2Xs and 3Xs) of the
Fund's broad-based securities market index (as defined in Form N-1A).
According to the Registration Statement, the Fund will invest under
normal circumstances at least 80% of its assets in currencies of, or
Fixed Income Instruments denominated in the currencies of, foreign
countries, including, but not limited to, a combination of short-term
Fixed Income Instruments, money market securities, and currency
forwards backed by high-quality, low duration securities. The Fund may
invest up to 50% of its total assets in securities and instruments
(including currencies and Fixed Income Instruments) that are
economically tied to emerging market countries. The Fund currently
anticipates that at least 50% of issues of Fixed Income Instruments
held by the Fund will be rated investment grade or determined by PIMCO
to be of comparable quality. The Fund will normally limit its exposure
to a single non-U.S. currency (from currency holdings or investments in
securities denominated in that currency) to 20% of its total assets.
Further, the Fund will limit its investments in currencies to those
currencies with a minimum average daily foreign exchange turnover of
USD $1 billion as determined by the BIS Triennial Central Bank Survey.
The Fund may invest in corporate debt securities. While corporate debt
securities and debt securities economically tied to an emerging market
country generally must have $200 million or more par amount outstanding
and significant par value traded to be considered as an eligible
investment for the Fund, at least 80% of issues of such securities held
by the Fund must have $200 million or more par amount outstanding. The
Fund may invest up to 10% of its assets in mortgage-backed securities
or in other asset-backed securities, although this limitation does not
apply to securities issued or guaranteed by Federal agencies and/or
U.S. government sponsored instrumentalities. The Fund may hold up to
15% of its net assets in illiquid securities. The Fund will not invest
in options contracts, futures contracts, or swap agreements.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the

public interest in that the Exchange will obtain a representation from
the issuer of the Shares that the NAV per Share will be calculated
daily and that the NAV and the Disclosed Portfolio will be made
available to all market participants at the same time. In addition, a
large amount of information is publicly available regarding the Fund
and the Shares, thereby promoting market transparency. Moreover, the
Portfolio Indicative Value will be widely disseminated by one or more
major market data vendors at least every 15 seconds during the
Exchange's Core Trading Session. On each business day, before
commencement of trading in Shares in the Core Trading Session on the
Exchange, the Fund will disclose on the Trust's Web site the Disclosed
Portfolio that will form the basis for the Fund's calculation of NAV at
the end of the business day. Information regarding market price and
trading volume of the Shares will be continually available on a real-
time basis throughout the day on brokers' computer screens and other
electronic services, and quotation and last sale information will be
available via the CTA high-speed line. The Trust's Web site will
include a form of the prospectus for the Fund and additional data
relating to NAV and other applicable quantitative information.
Moreover, prior to the commencement of trading, the Exchange will
inform its ETP Holders in an Information Bulletin of the special
characteristics and risks associated with trading the Shares. In
connection with its holdings in Fixed Income Instruments, the Fund will
seek, where possible, to use counterparties, as applicable, whose
financial status is such that the risk of default is reduced. Trading
in Shares of the Fund will be halted if the circuit breaker parameters
in NYSE Arca Equities Rule 7.12 have been reached or because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable, and trading in the Shares will be
subject to NYSE Arca Equities Rule 8.600(d)(2)(D), which sets forth
circumstances under which Shares of the Fund may be halted. In
addition, as noted above, investors will have ready access to
information regarding the Fund's holdings, the Portfolio Indicative
Value, the Disclosed Portfolio, and quotation and last-sale information
for the Shares.
    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that it will facilitate the listing and trading of
an additional type of actively-managed exchange-traded product that
will enhance competition among market participants, to the benefit of
investors and the marketplace. As noted above, the Exchange has in
place surveillance procedures relating to trading in the Shares and may
obtain information via ISG from other exchanges that are members of ISG
or with which the Exchange has entered into a comprehensive
surveillance sharing agreement. The Adviser is affiliated with a
broker-dealer and has implemented a ``fire wall'' with respect to such
broker-dealer regarding access to information concerning the
composition and/or changes to the Fund's portfolio. In addition, the
Fund's Reporting Authority will implement and maintain, or be subject
to, procedures designed to prevent the use and dissemination of
material, non-public information regarding the actual components of the
Fund's portfolio.

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

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

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

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

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be 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-NYSEArca-2012-138 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NYSEArca-2012-138.
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 Section, 100
F Street, NE., Washington, DC 20549 on official business days between
10:00 a.m. and 3:00 p.m. Copies of the filing will also be available
for inspection and copying at the NYSE's principal office and on its
Internet Web site at www.nyse.com. 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-NYSEArca-2012-138 and should be submitted on or before
January 16, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-31016 Filed 12-21-12; 4:15 pm]
BILLING CODE 8011-01-P


"Shah PhD., Hasmukh C."<EMAIL_ADDRESS>
08/12/2008 10:35 PM

To

Jeanne Kasai/DC/USEPA/US@EPA, Nancy Fitz/DC/USEPA/US@EPA

cc

Subject

Example of pesticide-impregnated objects

Hello Jeanne Kasai:  The Panel believes it is important for the
Container Regulation to take into account that there is likely to be a
growing trend toward the registration of pesticidal articles and
objects.  There are currently few examples of articles that are
registered as pesticides.  For example, there are
insecticide-impregnated garments, mosquito nets, etc. that are
registered because they make claims of pesticidal activity.  In the
antimicrobial area, a number of copper alloys were recently registered
that can be fabricated into objects, for example, railing for hospital
beds.  This is merely one example of the types of registered articles
that may be developed in the antimicrobial area.  It is expected  that
the antimicrobial area will see growth in the number of articles or
objects registered because they make claims of pesticidal activity.
Because of the pesticidal claims these articles are not  "exempt
treated articles"  and are subject to registration requirements.

Because this is a foreseeable trend, the Panel submitted comments that
the final container regulation with regard to exemption of "if not
packaged" should not be limited to registered "pesticide-impregnated"
articles, but instead should be applicable to objects generally that
must be registered pursuant to FIFRA.  We believe that the copper
alloy registrations are good examples of the trend in the antimicrobial
area.  Again, the articles made from the copper alloys are not
"impregnated".  Nevertheless, they should be considered in the same
category as "pesticide-impregnated" articles with regard to exemption
from the container regulation.

Thank you for your consideration of the Biocides Panel comments.

Has Shah

American Chemistry Council

1300 Wilson Boulevard

Arlington, VA 22209

Tel.: 703/741-5637

Fax: 703/741-6080

e-mail<EMAIL_ADDRESS>
-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS>

Sent: Monday, August 04, 2008 12:49 PM

To: Shah PhD., Hasmukh C.

Cc<EMAIL_ADDRESS>
Subject: To Mr. Shah regarding comments on changes to
Container-Containment rule

Hello, Mr. Shah-

Thank you for the comment you submitted on July 11th concerning the

proposed changes to the pesticide Container-Containment rule.

We are in the process of working through the public comments in our

internal-EPA work group.

To help with our discussions and understanding of your comments, I am

wondering if you would be able to send us examples (photos, if possible)

of:  1)  pesticide-impregnated objects, and 2) other registered

pesticidal objects not packaged in containers.

Thank you for your time and consideration.

Sincerely,

Jeanne Kasai

EPA - Office of Pesticide Programs

tel.<PHONE_NUMBER>   fax<PHONE_NUMBER>

http://www.epa.gov/pesticides/regulating/containers.htm


[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39790-39792]
[FR Doc No: 2017-17726]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4885]

Pediatric 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 the Agency) announces
a forthcoming public advisory committee meeting of the Pediatric
Advisory Committee (PAC). 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 comments.

DATES: The meeting will be held on September 11, 2017, from 8:30 a.m.
to 5:30 p.m. and September 12, 2017, from 8:30 a.m. to 1 p.m.

ADDRESSES: Hilton Washington DC/Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville, MD 20852. The hotel's telephone
number is<PHONE_NUMBER>. Answers to commonly asked questions including
information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html.
    FDA is establishing a docket for public comment on this document.
The docket number is FDA-2017-N-4885. The docket will close on
September 13, 2017. Submit either electronic or written comments on
this public meeting by that date. Late, untimely comments will not be
considered. Electronic comments must be submitted on or before
September 13, 2017. The https://www.regulations.gov electronic filing
system will accept comments until midnight Eastern Time at the end of
September 13, 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 August 28, 2017, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.

    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 make 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-4885 for ``Pediatric 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 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5154, Silver Spring, MD 20993,<PHONE_NUMBER>,
<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. 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 PAC will meet to discuss pediatric-focused safety
reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub.
L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155).
Comments about the upcoming September advisory committee meeting should
be submitted to Docket No. FDA-2017-N-4885.
    On September 11, 2017, the PAC will discuss the use of prescription
opioid products containing hydrocodone or codeine for the treatment of
cough in pediatric patients. The discussion will include current
practice for the treatment of cough in children and benefit-risk
considerations regarding the use of prescription opioid products in
pediatric patients.
    On September 12, 2017, the PAC will meet to discuss the following
products (listed by FDA Center):

(1) Center for Drug Evaluation and Research
    a. ABILIFY (aripiprazole)
    b. KEPPRA/KEPPRA XR (levetiracetam)
(2) Center for Devices and Radiological Health
    a. CONTEGRA Pulmonary Valved Conduit (humanitarian device exemption
(HDE)
    b. ENTERRA Therapy System (HDE)
    c. PLEXIMMUNE (HDE)
    d. ELANA Surgical Kit (HDE)

    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 will be
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
September 5, 2017. Oral presentations from the public will be scheduled
on September 11, 2017, between approximately 1 p.m. and 2 p.m. and on
September 12, 2017, between approximately 9 a.m. and 10 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 August 25, 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 August 28, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    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 accommodations due to a disability, please
contact Marieann Brill 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: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17726 Filed 8-21-17; 8:45 am]
 BILLING CODE 4164-01-P