[Federal Register: June 16, 2010 (Volume 75, Number 115)]
[Rules and Regulations]
[Page 34001-34004]
[DOCID:fr16jn10-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0470]
RIN 1625-AA00

Safety Zone; Grand Marais Splash-In, West Bay, Lake Superior,
Grand Marais, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in
West Bay, on Lake Superior, Grand Marais, MI. This safety zone is
intended to restrict vessel traffic from a portion of West Bay during
the Grand Marais Splash-In Sea Plane Competition.

DATES: This rule is effective from 2 p.m. to 5 p.m. on June 19, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0470 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0470 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail BMC Gregory Ford, Marine Event
Coordinator, U.S. Coast Guard Sector Sault Sainte Marie; telephone 906-
635-3222, e-mail<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final 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 permit application was not
received in time to publish an NPRM followed by a final rule before the
effective date and immediate action is necessary to prevent possible
loss of life or property due to the potential hazards associated with
the sea plane competition.
    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 this rule would be
contrary to the public interest of ensuring the safety of spectators
and vessels during this event and immediate action is necessary to
prevent possible loss of life or property.

Background and Purpose

    This temporary safety zone is necessary to ensure the safety of
vessels and spectators from hazards associated with sea planes taking-
off, flying and landing in the area. The Captain of the Port Sault
Sainte Marie has determined an aircraft competition with sea planes
flying and landing in close proximity to watercraft pose significant
risk to public safety and property. The likely combination of large
numbers of recreation vessels, congested waterways, alcohol use, and
debris falling from the sky into the water presents a significant risk
of serious injuries or fatalities. Establishing a safety zone to
control vessel movement around the location of the competition and
landing area will help ensure the safety of persons and property at
these events and help minimize the associated risks.

Discussion of Rule

    A temporary safety zone is necessary to ensure the safety of
spectators and vessels during the performance of flight maneuvers and
water landings in conjunction with the Grand Marias Splash In. This
event will occur between 2 p.m. and 5 p.m. on June 19, 2010.
    The safety zone for the Grand Marais Splash-In will encompass the
southern portion of West Bay. The zone will be bound to the north by a
line beginning 100 feet south-southeast of the Lake Street Boat Launch,
extending 5280 feet to the east on a true bearing of 080 degrees. The
eastern boundary will then be formed by a line drawn to the shoreline
on a true bearing of 170 degrees. The western and southern boundaries
of the zone will be bound by the shoreline of West Bay. The zone is
bound by the coordinates 46[deg]40'22.98'' N/ 085[deg]59'00.78'' W,
46[deg]40'32.04'' N 085[deg]57'46.14'' W and 46[deg]40'19.68'' N
085[deg]57'43.08'' W [DATUM: NAD 83], with the West Bay shoreline
forming the South and West boundaries of the zone.
    All persons and vessels shall comply with the instructions of the
Coast Guard Captain of the Port or the designated on-scene
representative. Entry into, transiting, or anchoring within the safety
zone is prohibited unless authorized by the Captain of the Port Sector
Sault Sainte Marie, or his on-scene representative. The Captain of the
Port or his on-scene representative may be contacted via VHF Channel
16.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    This determination is based on the minimal time of three hours that
vessels will be restricted from the zone. The Coast Guard expects
insignificant adverse impact to mariners from the zones' activation.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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.
    This rule will affect the following entities, some of which may be
small entities: the owners and operators of vessels intending to
transit or anchor in a portion of Lake Superior off Grand Marais,
Michigan between 2 p.m. and 5 p.m. on June 19, 2010.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: this
rule will be in effect for three hours on one day, and the majority of
marinas, piers and wharfs in the area are located on the northern
shoreline of West Bay. The Safety Zone will allow vessels to move
freely between these areas and Lake Superior. In the event that this
temporary safety zone affects shipping, commercial vessels may request
permission from the Captain of the Port Sault Sainte Marie to transit
through the safety zone. The Coast Guard will give notice to the public
via a Broadcast Notice to Mariners that the regulation is in effect.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    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.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of

compliance on them. We have analyzed this rule under that Order and
have determined that it does not have implications for federalism.

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.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
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 is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction because this rule involves the establishment of a
temporary safety zone. An environmental analysis checklist and a
categorical exclusion determination are available in the docket where
indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
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:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add new temporary Sec.  165.T09-0470 as follows:

Sec.  165.T09-0470  Safety Zone; Grand Marais Splash-In, West Bay, Lake
Superior, Grand Marais, MI.

    (a) Location. The following area is a temporary safety zone: all
U.S. navigable waters of West Bay, Lake Superior, Grand Marais, MI
bound to the north by a line beginning 100 feet south-southeast of the
Lake Street Boat Launch, extending 5280 feet to the east on a true
bearing of 080 degrees. The eastern boundary will then be formed by a
line drawn to the shoreline on a true bearing of 170 degrees. The
western and southern boundaries of the zone will be bound by the
shoreline of West Bay. The zone is bound by the coordinates
46[deg]40'22.98'' N 085[deg]59'00.78'' W, 46[deg]40'32.04'' N
085[deg]57'46.14'' W, and 46[deg]40'19.68'' N 085[deg]57'43.08'' W
[DATUM: NAD 83], with the West Bay shoreline forming the South and West
boundaries of the zone.
    (b) Effective period. This regulation will be enforced from 2 p.m.
to 5 p.m. on June 19, 2010.
    (1) The Captain of the Port, Sector Sault Sainte Marie may suspend
at any time the enforcement of any safety zone established under this
section.
    (2) The Captain of the Port, Sector Sault Sainte Marie, will notify
the public of the enforcement and suspension of enforcement of a safety
zone established by this section via any means that will provide as
much notice as possible to the public. These means might include some
or all of those listed in 33 CFR 165.7(a). The primary method of
notification, however, will be through Broadcast Notice to Mariners and
Local Notice to Mariners.
    (c) Regulations.
    (1) In accordance with the general regulations in Sec.  165.23 of
this part, entry into, transiting, or anchoring within an enforced
safety zone established by this section is prohibited unless authorized
by the Captain of the Port, Sector Sault Sainte Marie, or his on-scene
representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port, Sector Sault Sainte Marie, or
his on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port,
Sector Sault Sainte Marie, is any Coast Guard commissioned, warrant or
petty officer who has been designated by the Captain

of the Port, Sector Sault Sainte Marie, to act on his behalf. The on-
scene representative of the Captain of the Port, Sector Sault Sainte
Marie, is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port to act on his behalf.
    (4) Vessel operators desiring to enter or operate within an
enforced safety zone shall contact the Captain of the Port, Sector
Sault Sainte Marie, or his on-scene representative to obtain permission
to do so. The Captain of the Port, Sector Sault Sainte Marie, or his
on-scene representative may be contacted via VHF Channel 16. Vessel
operators given permission to enter or operate in the safety zone must
comply with all directions given to them by the Captain of the Port,
Sector Sault Sainte Marie, or his on-scene representative.

    Dated: June 2, 2010.
M.J. Huebschman,
Captain, U.S. Coast Guard, Captain of the Port Sault Sainte Marie.
[FR Doc. 2010-14486 Filed 6-15-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54295-54296]
[FR Doc No: 2015-22683]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1039]

Nonclinical Evaluation of Endocrine-Related Drug Toxicity;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Nonclinical
Evaluation of Endocrine-Related Drug Toxicity.'' The purpose of this
guidance is to clarify when additional studies are warranted after the
standard toxicology tests have been conducted and there is a signal for
potential adverse endocrine-related toxicity. This guidance finalizes
the draft guidance entitled ``Endocrine Disruption Potential of Drugs:
Nonclinical Evaluation'' issued on September 20, 2013.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

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

FOR FURTHER INFORMATION CONTACT: Abby Jacobs, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg., 22, Rm. 6474, Silver Spring, MD 20993-0002, 301-
796-0174.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Nonclinical Evaluation of Endocrine-Related Drug Toxicity.''
This guidance focuses on nonclinical testing designed to assess the
potential for a drug to cause endocrine effects that are

unintentional and adverse. The standard comprehensive test battery is
generally sufficient to identify endocrine-related toxicity. Depending
on the outcome of a standard battery of nonclinical tests, additional
nonclinical studies may be warranted to more fully characterize the
endocrine-related toxicity potential of a drug.
    This guidance finalizes the draft guidance entitled ``Endocrine
Disruption Potential of Drugs: Nonclinical Evaluation'' issued on
September 20, 2013 (78 FR 57859). Revisions to the draft guidance
address public comments and try to give more clarity regarding when
additional studies could be appropriate.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on nonclinical evaluation of endocrine-related
drug toxicity. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Comments

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

IV. Electronic Access

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

    Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22683 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Notices]
[Page 9802-9805]
[DOCID:fr05mr07-88]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55353; File No. SR-NASDAQ-2007-011]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change To Permit Trading Pursuant to Unlisted Trading Privileges
of Shares of 93 Funds of the Proshares Trust

February 26, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 21, 2007, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
This order provides notice of the proposed rule change and approves the
proposal on an accelerated basis.
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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

    Nasdaq is proposing to trade shares of the 93 funds identified
below (collectively, the ``Funds'') of the ProShares Trust (``Trust'')
pursuant to unlisted trading privileges (``UTP'').
    The text of the proposed rule change is available from Nasdaq's Web
site at nasdaq.complinet.com, at Nasdaq's principal office, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to trade, pursuant to UTP, the Shares of 93
Funds, which are exchange-traded funds (``ETFs''). The Commission has
approved exchange rules for the original listing and trading of the
Shares on the American Stock Exchange (``Amex''). Nasdaq is submitting
this filing because its current generic listing standards for ETFs do
not extend to ETFs with the investment objective of corresponding to a
specified multiple of the performance, or the inverse performance, of
an index that underlies each Fund (each such index is referred to below
as an ``Underlying Index''), rather than merely mirroring the
performance of the index. Systems operated by Nasdaq and its affiliates
currently trade on an over-the-counter basis (as facilities of the
NASD) those Shares that have already commenced trading on Amex; some of
the Shares were approved for listing and trading only recently, and
actual trading has not yet commenced. This filing will allow Nasdaq to
trade the Shares as an exchange.
Ultra Funds
    Certain Funds seek daily investment results, before fees and
expenses, that correspond to twice (200%) the daily performance of the
Underlying Indexes (``Ultra Funds''). If such Funds meet their
objective, the net asset value (the ``NAV'') \3\ of the Shares of each
Fund should increase (on a percentage basis) approximately twice as
much as the Fund's Underlying Index when the prices of the securities
in such Index increase on a given day, and should lose approximately
twice as much when such prices decline on a given day. This filing
applies to the following Ultra Funds:
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    \3\ NAV per Share of each Fund is computed by dividing the value
of the net assets of such Fund (i.e., the value of its total assets
less total liabilities) by its total number of Shares outstanding.
Expenses and fees are accrued daily and taken into account for
purposes of determining NAV.
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    4 Ultra Funds listed and traded on Amex pursuant to Commission
order on May 10, 2006 \4\: (1) Ultra S&P 500, (2) Ultra Nasdaq-100, (3)
Ultra Dow 30, and (4) Ultra S&P Mid-Cap 400; and
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    \4\ Securities Exchange Act Release No. 53784 (May 10, 2006), 71
FR 28721 (May 17, 2006). These Funds were subsequently approved for
UTP trading on NYSE Arca. See Securities Exchange Act Release No.
54026 (June 21, 2006), 71 FR 36850 (June 28, 2006).
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    27 Ultra Funds listed and traded on Amex pursuant to Commission
order on January 17, 2007 \5\: (1) Ultra Russell 2000, (2) Ultra S&P
SmallCap 600, (3) Ultra S&P500/Citigroup Value, (4) Ultra S&P500/
Citigroup Growth, (5) Ultra S&P MidCap 400/Citigroup Value, (6) Ultra
S&P MidCap 400/Citigroup Growth, (7) Ultra S&P SmallCap 600/Citigroup
Value, (8) Ultra S&P SmallCap 600/Citigroup Growth, (9) Ultra Basic
Materials, (10) Ultra Consumer Goods, (11) Ultra Consumer Services,
(12) Ultra Financials, (13) Ultra Health Care, (14) Ultra Industrials,
(15) Ultra Oil & Gas, (16) Ultra Real Estate, (17) Ultra
Semiconductors, (18) Ultra Technology, (19) Ultra Utilities, (20) Ultra
Russell Midcap Index, (21) Ultra Russell Midcap Growth Index, (22)
Ultra Russell Midcap Value Index, (23) Ultra Russell 1000 Index, (24)
Ultra Russell 1000 Growth Index, (25) Ultra Russell 1000 Value Index,
(26) Ultra Russell 2000 Growth Index, and (27) Ultra Russell 2000 Value
Index.
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    \5\ Securities Exchange Act Release No. 55117 (January 17,
2007), 72 FR 3442 (January 25, 2007). These Funds were subsequently
approved for UTP trading on NYSE Arca. See Securities Exchange Act
Release No. 55125 (January 18, 2007), 72 FR 3462 (January 25, 2007).
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Short Funds
    Nasdaq also proposes to trade Shares of certain Funds that seek
daily investment results, before fees and expenses, that correspond to
the inverse or opposite of the daily performance (-100%) of the
Underlying Indexes (``Short Funds''). If such a Fund is successful in
meeting its objective, the NAV of the corresponding Shares should
increase approximately as much (on a percentage basis) as the
respective Underlying Index loses when the prices of the securities in
the Index decline on a given day, or should decrease approximately as
much as the respective Index gains when prices in the Index rise on a
given day. This filing applies to the following Short Funds:
    4 Short Funds listed and traded on Amex pursuant to Commission
order on May 10, 2006 \6\: (1) Short S&P 500, (2) Short Nasdaq-100, (3)
Short Dow 30, and (4) Short S&P Mid-Cap 400; and
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    \6\ See supra note 4.
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    27 Short Funds listed and traded on Amex pursuant to Commission
order on January 17, 2007 \7\: (1) Short Russell 2000, (2) Short S&P
SmallCap 600, (3) Short S&P500/Citigroup Value, (4) Short S&P500/
Citigroup Growth, (5) Short S&P MidCap 400/Citigroup Value, (6) Short
S&P MidCap 400/Citigroup Growth, (7) Short S&P SmallCap 600/Citigroup
Value, (8) Short S&P

SmallCap 600/Citigroup Growth, (9) Short Basic Materials, (10) Short
Consumer Goods, (11) Short Consumer Services, (12) Short Financials,
(13) Short Health Care, (14) Short Industrials, (15) Short Oil & Gas,
(16) Short Real Estate, (17) Short Semiconductors, (18) Short
Technology, (19) Short Utilities, (20) Short Russell Midcap Index, (21)
Short Russell Midcap Growth Index, (22) Short Russell Midcap Value
Index, (23) Short Russell 1000 Index, (24) Short Russell 1000 Growth
Index, (25) Short Russell 1000 Value Index, (26) Short Russell 2000
Growth Index, and (27) Short Russell 2000 Value Index.
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    \7\ See supra note 5.
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UltraShort Funds

    Nasdaq also proposes to trade Shares of certain Funds that seek
daily investment results, before fees and expenses, that correspond to
twice the inverse (-200%) of the daily performance of the Underlying
Indexes (``UltraShort Funds''). If such a Fund is successful in meeting
its objective, the NAV of the corresponding Shares should increase
approximately twice as much (on a percentage basis) as the respective
Underlying Index loses when the prices of the securities in the Index
decline on a given day, or should decrease approximately twice as much
as the respective Underlying Index gains when such prices rise on a
given day. This filing applies to the following UltraShort Funds:
    4 UltraShort Funds listed and traded on Amex pursuant to Commission
order on June 23, 2006 \8\: (1) UltraShort S&P 500, (2) UltraShort
Nasdaq-100, (3) UltraShort Dow 30, and (4) UltraShort S&P Mid-Cap 400;
and
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    \8\ Securities Exchange Act Release No. 54040 (June 23, 2006),
71 FR 37629 (June 30, 2006). These Funds were subsequently approved
for UTP trading on NYSE Arca. See Securities Exchange Act Release
No. 54045 (June 26, 2006), 71 FR 37971 (July 3, 2006).
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    27 UltraShort funds listed and traded on Amex pursuant to
Commission order on January 17, 2007 \9\: (1) UltraShort Russell 2000,
(2) UltraShort S&P SmallCap 600, (3) UltraShort S&P500/Citigroup Value,
(4) UltraShort S&P500/Citigroup Growth, (5) UltraShort S&P MidCap 400/
Citigroup Value, (6) UltraShort S&P MidCap 400/Citigroup Growth, (7)
UltraShort S&P SmallCap 600/Citigroup Value, (8) UltraShort S&P
SmallCap 600/Citigroup Growth, (9) UltraShort Basic Materials, (10)
UltraShort Consumer Goods, (11) UltraShort Consumer Services, (12)
UltraShort Financials, (13) UltraShort Health Care, (14) UltraShort
Industrials, (15) UltraShort Oil & Gas, (16) UltraShort Real Estate,
(17) UltraShort Semiconductors, (18) UltraShort Technology, (19)
UltraShort Utilities, (20) UltraShort Russell Midcap Index, (21)
UltraShort Russell Midcap Growth Index, (22) UltraShort Russell Midcap
Value Index, (23) UltraShort Russell 1000 Index, (24) UltraShort
Russell 1000 Growth Index, (25) UltraShort Russell 1000 Value Index,
(26) UltraShort Russell 2000 Growth Index, and (27) UltraShort Russell
2000 Value Index.
---------------------------------------------------------------------------

    \9\ See supra note 5.
---------------------------------------------------------------------------

    Access to the current portfolio composition of each Fund is
currently available through the Trust's Web site (http://www.proshares.com
).\10\ The Underlying Indexes are identified in Amex's

proposed rule changes to list the Funds (the ``Original Filings'').\11\
The Original Filings state that Amex would disseminate for each Fund on
a daily basis by means of Consolidated Tape Association (``CTA'') and
CQ High Speed Lines information with respect to an Indicative Intra-Day
Value (``IIV''), the daily trading volume, closing price, NAV, and
final dividend amounts, if any, to be paid for each Fund.\12\
---------------------------------------------------------------------------

    \10\ The Trust's Web site is publicly accessible at no charge
and contains the following information for each Fund's Shares: (1)
The prior business day's closing NAV, the reported closing price,
and a calculation of the premium or discount of such price in
relation to the closing NAV; (2) data for a period covering at least
the current and three immediately preceding calendar quarters (or
the life of a Fund, if shorter) indicating how frequently each
Fund's Shares traded at a premium or discount to NAV based on the
daily closing price and the closing NAV, and the magnitude of such
premiums and discounts; (3) its prospectus and product description;
and (4) other quantitative information such as daily trading volume.
The prospectus and/or product description for each Fund would inform
investors that the Trust's Web site has information about the
premiums and discounts at which the Fund's Shares have traded.
    \11\ See supra notes 4, 5 and 8.
    \12\ The Original Filings explain that, if the IIV is not
disseminated as required, Amex would halt trading in the shares of
the Funds. If Amex halts trading for this reason, then Nasdaq would
do so as well.
---------------------------------------------------------------------------

    The Original Filings state that the daily closing index value and
the percentage change in the daily closing index value for each
Underlying Index would be publicly available on various Web sites such
as http://www.bloomberg.com. The Original Filings further state that

data regarding each Underlying Index are also available from the
respective index provider to subscribers. According to the Original
Filings, several independent data vendors package and disseminate index
data in various value-added formats (including vendors displaying both
securities and index levels and vendors displaying index levels only).
    The Original Filings state that the value of each Underlying Index
is updated intra-day on a real-time basis as its individual component
securities change in price, and the intra-day values of each Underlying
Index are disseminated at least every 15 seconds throughout Amex's
trading day by Amex or another organization authorized by the relevant
Underlying Index provider.
    To provide updated information relating to each Fund for use by
investors, professionals, and persons wishing to create or redeem
Shares, Amex disseminates through the facilities of the CTA: (1)
Continuously throughout Amex's trading day, the market value of a
Share; and (2) at least every 15 seconds throughout Amex's trading day,
the IIV as calculated by Amex.
    Shares would trade on Nasdaq from 9:30 a.m. ET until 8 p.m. ET,
even if the IIV is not disseminated from 4:15 p.m. ET to 8 p.m. ET.\13\
Nasdaq has appropriate rules to facilitate transactions in the Shares
during these trading sessions.
---------------------------------------------------------------------------

    \13\ Because NSCC does not disseminate the new basket amount to
market participants until approximately 6 p.m. to 7 p.m. ET, an
updated IIV is not possible to calculate from 4:15 p.m. to 8 p.m.
ET. It is also Nasdaq's understanding that the official index
sponsors for the Underlying Indexes currently do not calculate
updated index values during those times. However, if the index
sponsors calculated an Underlying Index for a Fund during those
times in the future, Nasdaq would not trade that Fund during those
times unless the official index value were widely disseminated.
---------------------------------------------------------------------------

    Nasdaq will halt trading in the Shares of a Fund under the
conditions specified in Nasdaq Rules 4120 and 4121. The conditions for
a halt include a regulatory halt by the listing market. UTP trading in
the Shares will also be governed by provisions of Nasdaq Rule 4120
relating to temporary interruptions in the calculation or wide
dissemination of the IOPV or the value of the Underlying Index.\14\
Additionally, Nasdaq may cease trading the Shares if other unusual
conditions or circumstances exist which, in the opinion of Nasdaq,
makes further dealings on Nasdaq detrimental to the maintenance of a
fair and orderly market. Nasdaq will also follow any procedures with
respect to trading halts as set forth in Nasdaq Rule 4120(c). Finally,
Nasdaq will stop trading the Shares of a Fund if the listing market
delists them.
---------------------------------------------------------------------------

    \14\ See Securities Exchange Act Release No. 55269 (February 9,
2007), 72 FR 7490 (February 15, 2007) (SR-NASDAQ-2006-050).
---------------------------------------------------------------------------

    In connection with the trading of the Shares, Nasdaq will inform
Nasdaq members in an Information Circular of the special
characteristics and risks associated with trading the Shares, as

well as the requirements of Nasdaq Rule 2310, which requires Nasdaq
members to determine that a particular security is suitable for a
customer before recommending a transaction in it. Nasdaq also would
require its members to deliver a prospectus or product description to
investors purchasing the Shares prior to or concurrently with a
transaction in the Shares.
    Nasdaq deems the Shares to be equity securities, thus rendering
trading in the Shares subject to Nasdaq's existing rules applicable to
UTP trading of equity securities. Nasdaq believes that its surveillance
procedures are adequate to address any concerns about the trading of
the Shares on Nasdaq. Trading of the Shares through NASD facilities
operated by Nasdaq is currently subject to NASD's surveillance
procedures for equity securities in general and ETFs in particular.
After Nasdaq begins to trade the Shares as an exchange, NASD, on behalf
of Nasdaq, will continue to monitor such trading. Nasdaq's transition
to exchange status will not result in any change in the surveillance
process with respect to the Shares.\15\
---------------------------------------------------------------------------

    \15\ Surveillance of all trading on NASD facilities operated by
Nasdaq, including the trading of Shares, is currently being
conducted by NASD. After Nasdaq begins to trade the Shares as an
exchange, NASD will continue to surveil trading, pursuant to a
regulatory services agreement. Nasdaq is responsible for NASD's
performance under this regulatory services agreement.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \16\ in general and furthers the
objectives of Section 6(b)(5) \17\ in particular in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, remove impediments to a free
and open market and a national market system, and, in general, to
protect investors and the public interest. In addition, the Exchange
believes that the proposal is consistent with Rule 12f-5 under the Act
\18\ because it deems the Shares to be equity securities, thus
rendering trading in the Shares subject to Nasdaq's existing rules
governing the trading of equity securities.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
    \18\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
proposal will promote competition with respect to trading of the Shares
by ensuring that Nasdaq can continue to trade the Shares after it
begins to operate as an exchange for non-Nasdaq securities.

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

    Written comments were neither solicited nor received.

III. Solicitation of Comments

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

Electronic Comments

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

File Number SR-NASDAQ-2007-011 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2007-011. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2007-011 and should be submitted on or before
March 26, 2007.

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

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\19\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\20\ which
requires that an exchange have rules designed, among other things, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and in general to protect investors and the public
interest. The Commission believes that this proposal should benefit
investors by increasing competition among markets that trade the
Shares.
---------------------------------------------------------------------------

    \19\ In approving this rule change, the Commission notes that it
has considered the proposal's impact on efficiency, competition, and
capital formation. See 15 U.S.C. 78c(f).
    \20\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In addition, the Commission finds that the proposal is consistent
with Section 12(f) of the Act,\21\ which permits an exchange to trade,
pursuant to UTP, a security that is listed and registered on another
exchange.\22\ The Commission notes that it previously approved the
listing and trading of the Shares on Amex and the trading of the Shares
on NYSE Arca pursuant to UTP.\23\ The Commission also finds that the
proposal is consistent with Rule 12f-5 under the Act,\24\ which
provides that an exchange shall not extend UTP to a security unless the
exchange has in effect a rule or rules providing for transactions in
the class or type of security to which the exchange extends UTP. The
Exchange has represented that it meets this requirement because it
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.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78l(f).
    \22\ Section 12(a) of the Act, 15 U.S.C. 78l(a), generally
prohibits a broker-dealer from trading a security on a national
securities exchange unless the security is registered on that
exchange pursuant to Section 12 of the Act. Section 12(f) of the Act
excludes from this restriction trading in any security to which an
exchange ``extends UTP.'' When an exchange extends UTP to a
security, it allows its members to trade the security as if it were
listed and registered on the exchange even though it is not so
listed and registered.
    \23\ See supra notes 4-9.
    \24\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

    The Commission further believes that the proposal is consistent
with Section 11A(a)(1)(C)(iii) of the Act,\25\ which sets forth
Congress' finding that it is in the public interest and appropriate for
the protection of investors and the maintenance of fair and orderly
markets to assure the availability to brokers, dealers, and investors
of information with respect to quotations for and transactions in
securities. Quotations for and last sale information regarding the
Shares are disseminated through the facilities of the CTA and the
Consolidated Quotation System. Furthermore, the IIV, updated to reflect
changes in currency exchange rates, is calculated by Amex and published
via the facilities of the Consolidated Tape Association on a 15-second
delayed basis throughout the Exchange's Core Trading Session. In
addition, if the listing market halts trading when the IIV is not being
calculated or disseminated, the Exchange would halt trading in the
Shares.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    The Commission notes that, if the Shares should be delisted by the
listing exchange, the Exchange would no longer have authority to trade
the Shares pursuant to this order.
    In support of this proposal, the Exchange has made the following
representations:
    1. The Exchange's surveillance procedures are adequate to properly
monitor Exchange trading of the Shares in all trading sessions and to
deter and detect violations of Exchange rules.
    2. Prior to the commencement of trading, the Exchange would inform
its members in an Information Bulletin of the special characteristics
and risks associated with trading the Shares.
    3. Prior to the commencement of trading, the Exchange would inform
its members in an Information Bulletin the requirement that members
deliver a prospectus to investors purchasing newly issued Shares prior
to or concurrently with the confirmation of a transaction.

    This approval order is conditioned on the Exchange's adherence to
these representations.

    The Commission finds good cause for approving this proposal before
the thirtieth day after the publication of notice thereof in the
Federal Register. As noted previously, the Commission previously found
that the listing and trading of the Shares on Amex and the trading of
the Shares on NYSE Area pursuant to UTP are consistent with the Act.
The Commission presently is not aware of any regulatory issue that
should cause it to revisit those findings or would preclude the trading
of the Shares on the Exchange pursuant to UTP. Therefore, accelerating
approval of this proposal should benefit investors by creating, without
undue delay, additional competition in the market for the Shares.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\26\ that the proposed rule change (SR-NASDAQ-2007-011), be and it
hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\27\
Florence E. Harmon,
Deputy Secretary.
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

 [FR Doc. E7-3749 Filed 3-2-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: October 15, 2008 (Volume 73, Number 200)]
[Notices]
[Page 61176]
[DOCID:fr15oc08-146]

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

Proposed Extension of Existing Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213

Extension:
    Rule 15c2-1, SEC File No. 270-418, OMB Control No. 3235-0485.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is publishing the following summaries of
collections for public comment.
    Rule 15c2-1 (17 CFR 240.15c2-1) prohibits the commingling under the
same lien of securities of margin customers (a) with other customers
without their written consent and (b) with the broker or dealer. The
rule also prohibits the rehypothecation of customers' margin securities
for a sum in excess of the customer's aggregate indebtedness. See
Securities Exchange Act Release No. 2690 (November 15, 1940);
Securities Exchange Act Release No. 9428 (December 29, 1971). Pursuant
to Rule 15c2-1, respondents must collect information necessary to
prevent the rehypothecation of customer securities in contravention of
the rule, issue and retain copies of notices of hypothecation of
customer securities in accordance with the rule, and collect written
consents from customers in accordance with the rule. The information is
necessary to ensure compliance with the rule, and to advise customers
of the rule's protections.
    There are approximately 126 respondents (i.e., broker-dealers that
carry or clear customer accounts that also have bank loans) that
require an aggregate total of 2,835 hours to comply with the rule. Each
of these approximately 126 registered broker-dealers makes an estimated
45 annual responses. Each response takes approximately 0.5 hours to
complete. Thus, the total compliance burden per year is 2,835 burden
hours.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Please direct your written comments to Lewis W. Walker, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
C/O Shirley Martinson, 6432 General Green Way, Alexandria, Virginia
22312; or send an e-mail to<EMAIL_ADDRESS>
    Dated: October 6, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-24344 Filed 10-14-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: March 7, 2006 (Volume 71, Number 44)]
[Notices]
[Page 11457]
[DOCID:fr07mr06-97]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53390; File No. SR-ISE-2006-08]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Order Granting Accelerated Approval of a Proposed Rule Change
Establishing Fees for Historical Options Tick Market Data for Non-
Members

February 28, 2006.
    On February 1, 2006, the International Securities Exchange, Inc.
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend its Schedule of Fees to
establish non-member fees for historical options tick market data,
described below. The ISE requested the Commission grant accelerated
approval of the proposed rule change. The Commission did not
immediately grant accelerated approval. Instead, the proposed rule
change was published for comment in the Federal Register on February 9,
2006 for a 15-day comment period, which expired on February 24,
2006.\3\ The Commission received no comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 53211 (February 2,
2006), 71 FR 6801. The instant proposed rule change proposes to
establish a fee for non-ISE members only. The Exchange also filed a
separate proposed rule change, SR-ISE-2006-07, Securities Exchange
Act Release No. 53212 (February 2, 2006), 71 FR 6803 (February 9,
2006), that established fees for ISE members. The proposed fees for
both ISE members and non-ISE members are the same.
---------------------------------------------------------------------------

    Historical options tick market data is Options Price Reporting
Authority (``OPRA'') tick data, a complete file, tick-by-tick, of all
quote and transaction data of all instruments disseminated by OPRA
during a trading day. OPRA tick data includes data from all six options
exchanges. On any given trading day, OPRA tick data is publicly
available and may be stored. The OPRA tick data collected and stored by
ISE is neither exclusive nor proprietary to the Exchange. The ISE
captures the OPRA tick data and will make it available as an ``end of
day'' file \4\ or as a ``historical'' file \5\ for ISE members and non-
ISE members alike.\6\
---------------------------------------------------------------------------

    \4\ An end of day file refers to OPRA tick data for a trading
day that is distributed prior to the opening of the next trading
day. An end of day file will be made available to subscribers as
soon as practicable at the end of each trading day on an on-going
basis pursuant to an annual subscription or through an ad-hoc
request.
    \5\ An end of day file that is distributed after the start of
the next trading day is called a historical file. A historical file
will be available to customers for a pre-determined date range by
ad-hoc requests only.
    \6\ See supra, at n.3.
---------------------------------------------------------------------------

    The Commission has reviewed carefully the proposed rule change and
finds that it is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\7\ In particular, the Commission finds that the proposed rule
change is consistent with the requirement of Section 6(b)(4) \8\ that
an exchange have an equitable allocation of reasonable dues, fees and
other charges among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(5).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Commission finds good cause for approving this proposed rule
change before the 30th day after publication of notice in the Federal
Register. On February 1, 2006, the ISE amended its rules to give its
members the opportunity to access historical options tick market
data.\9\ The ISE asked the Commission to approve the instant proposed
rule change on an accelerated basis so that the ISE could offer the
same service to non-members (at the same price) as soon as possible. As
mentioned above, the Commission received no comments on the ISE's
proposed rule change. The Commission believes that the proposed rule
change raises no new issues or novel regulatory questions, and that
non-members should have the ability to partake of this service without
unnecessary delay. Accordingly, the Commission finds good cause
pursuant to section 19(b)(2) of the Act,\10\ for approving the proposed
rule change prior to the 30th day after publication in the Federal
Register.
---------------------------------------------------------------------------

    \9\ See supra, at n.3.
    \10\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\11\ that the proposed rule change be, and hereby is approved on an
accelerated basis.
---------------------------------------------------------------------------

    \11\ Id.
    \12\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
Nancy M. Morris,
Secretary.
 [FR Doc. E6-3162 Filed 3-6-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: April 17, 2006 (Volume 71, Number 73)]
[Notices]
[Page 19759-19760]
[DOCID:fr17ap06-101]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549

Extension:
    Form ADV-E; Sec File No. 270-318; OMB Control No. 3235-0361.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget requests for extension of the previously approved
collections of information discussed below.
    Form ADV-E (17 CFR 279.8) is the cover sheet for accountant
examination certificates filed pursuant to rule 206(4)-2 under the
Investment Advisers Act of 1940 by investment advisers retaining
custody of client securities or

funds. The annual burden is approximately three minutes per respondent.
    The estimate of burden hours set forth above is made solely for the
purposes of the Paperwork Reduction Act and is not derived from a
comprehensive or even representative survey or study of the cost of SEC
rules and forms.
    The information provided on Form ADV-E is mandatory. Responses will
not be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid control number.
    General comments regarding the above information should be directed
to the following persons: (i) Desk officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or e-mail to
<EMAIL_ADDRESS>and R. Corey Booth, Director/Chief Information

Officer, Securities and Exchange Commission, c/o Shirley Martinson,
6432 General Green Way, Alexandria, Virginia 22312, or send an e-mail
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    April 7, 2006.
Nancy M. Morris,
Secretary.
 [FR Doc. E6-5670 Filed 4-14-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Page 22078]
[FR Doc No: 2023-07755]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, that the
Securities and Exchange Commission will hold an Open Meeting on Friday,
April 14, 2023 at 10 a.m.

PLACE: The meeting will be webcast on the Commission's website at
www.sec.gov.

STATUS: This meeting will begin at 10:00 a.m. (ET) and will be open to
the public via webcast on the Commission's website at www.sec.gov.

MATTERS TO BE CONSIDERED:
    1. The Commission will consider whether to reopen the comment
period for proposed amendments to Rule 3b-16 under the Securities
Exchange Act of 1934 regarding the definition of ``exchange'' as set
forth in Securities Exchange Act Release No. 94062.

CONTACT PERSON FOR MORE INFORMATION: For further information, and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Vanessa A. Countryman from the Office of the Secretary
at<PHONE_NUMBER>.
    Authority: 5 U.S.C. 552b.

    Dated: April 7, 2023.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-07755 Filed 4-10-23; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 192 (Friday, October 2, 2020)]
[Notices]
[Pages 62305-62306]
[FR Doc No: 2020-21826]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2382]

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of
Drugs for Treatment; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Opioid Use
Disorder: Endpoints for Demonstrating Effectiveness of Drugs for
Treatment.'' This guidance addresses clinical endpoints acceptable to
demonstrate effectiveness of drugs for treatment of opioid use
disorder. This guidance addresses comments received for and finalizes
the draft guidance of the same name issued August 7, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on October 2, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact

information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): 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-2018-D-2382 for ``Opioid Use Disorder: Endpoints for Demonstrating
Effectiveness of Drugs for Treatment.'' Received comments 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Silvana Borges, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3200, Silver Spring, MD 20993-0002, 301-
796-0963.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Opioid Use Disorder: Endpoints for Demonstrating
Effectiveness of Drugs for Treatment.'' This guidance addresses
clinical endpoints acceptable to demonstrate effectiveness of drugs for
treatment of opioid use disorder.
    This guidance finalizes the draft guidance of the same name issued
August 7, 2018 (83 FR 38699). All the public comments received on the
draft guidance have been considered and the guidance has been revised
as appropriate in response to such comments along with a few editorial
changes.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Opioid Use Disorder: Endpoints for
Demonstrating Effectiveness of Drugs for Treatment.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). The collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: September 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21826 Filed 10-1-20; 8:45 am]
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[Federal Register Volume 88, Number 220 (Thursday, November 16, 2023)]
[Notices]
[Page 78741]
[FR Doc No: 2023-25343]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP24-150-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: Supply Connection Service Rate
Schedule Filing to be effective 1/1/2024.
    Filed Date: 11/9/23.
    Accession Number: 20231109-5066.
    Comment Date: 5 p.m. ET 11/21/23.
    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) on or before 5:00 p.m. Eastern time on the
specified comment date. Protests may be considered, but intervention is
necessary to become a party to the proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: November 9, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-25343 Filed 11-15-23; 8:45 am]
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[Federal Register Volume 87, Number 77 (Thursday, April 21, 2022)]
[Notices]
[Page 23868]
[FR Doc No: 2022-08499]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3771]

Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the Agency's annual report entitled ``Report on the
Performance of Drug and Biologics Firms in Conducting Postmarketing
Requirements and Commitments.'' Under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), FDA is required to report annually on the
status of postmarketing requirements (PMRs) and postmarketing
commitments (PMCs) required of, or agreed upon by, application holders
of approved drug and biological products. The report on the status of
the studies and clinical trials that applicants have agreed, or are
required, to conduct is on FDA's ``Postmarketing Requirements and
Commitments: Reports'' web page (https://www.fda.gov/drugs/postmarket-requirements-and-commitments/postmarketing-requirements-and-commitments-reports).

FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5367, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 506B(c) of the FD&C Act (21 U.S.C. 356b(c)) requires FDA to
publish an annual report on the status of postmarketing studies that
applicants have committed to, or are required to conduct, and for which
annual status reports have been submitted.
    Under Sec. Sec.  314.81(b)(2)(vii) and 601.70 (21 CFR
314.81(b)(2)(vii) and 601.70), applicants of approved drugs and
licensed biological products are required to submit annually a report
on the status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study or clinical trial either
required by FDA (PMRs) or that they have committed to conduct (PMCs),
either at the time of approval or after approval of their new drug
application, abbreviated new drug application, or biologics license
application. The status of PMCs concerning chemistry, manufacturing,
and production controls and the status of other studies or clinical
trials conducted on an applicant's own initiative are not required to
be reported under Sec. Sec.  314.81(b)(2)(vii) and 601.70 and are not
addressed in this report. Furthermore, section 505(o)(3)(E) of the FD&C
Act (21 U.S.C. 355(o)(3)(E)) requires that applicants report
periodically on the status of each required study or clinical trial and
each study or clinical trial ``otherwise undertaken . . . to
investigate a safety issue . . .''
    An applicant must report on the progress of the PMR/PMC on the
anniversary of the drug product's approval \1\ until the PMR/PMC is
completed or terminated and FDA determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either no longer feasible or would no
longer provide useful information.
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    \1\ An applicant must submit an annual status report on the
progress of each open PMR/PMC within 60 days of the anniversary date
of U.S. approval of the original application or on an alternate
reporting date that was granted by FDA in writing. Some applicants
have requested and been granted by FDA alternate annual reporting
dates to facilitate harmonized reporting across multiple
applications.
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II. Fiscal Year 2020 Report

    With this notice, FDA is announcing the availability of the
Agency's annual report entitled ``Report on the Performance of Drug and
Biologics Firms in Conducting Postmarketing Requirements and
Commitments.'' \2\ Information in this report covers any PMR/PMC that
was established, in writing, at the time of approval or after approval
of an application or a supplement to an application and summarizes the
status of PMRs/PMCs in fiscal year (FY) 2020 (i.e., as of September 30,
2020). Information summarized in the report reflects combined data from
the Center for Drug Evaluation and Research and the Center for
Biologics Evaluation and Research and includes the following: (1) The
number of applicants with open PMRs/PMCs; (2) the number of open PMRs/
PMCs; (3) the timeliness of applicant submission of the annual status
reports (ASRs); (4) FDA-verified status of open PMRs/PMCs reported in
Sec.  314.81(b)(2)(vii) or Sec.  601.70 ASRs; (5) the status of closed
PMRs/PMCs; and (6) the distribution of the status by fiscal year of
establishment \3\ (FY2014 to FY2020) for PMRs and PMCs open at the end
of FY2020, or those closed within FY2020. Additional information about
PMRs/PMCs is provided on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments.
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    \2\ The ``Report on the Performance of Drug and Biologics Firms
in Conducting Postmarketing Requirements and Commitments'' can be
found on the FDA's Postmarketing Requirements and Commitments:
Reports web page: https://www.fda.gov/drugs/postmarket-requirements-and-commitments/postmarketing-requirements-and-commitments-reports.
    \3\ The establishment date is the date of the formal FDA
communication to the applicant that included the final FDA-required
(PMR) or requested (PMC) postmarketing study or clinical trial.

    Dated: April 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08499 Filed 4-20-22; 8:45 am]
BILLING CODE 4164-01-P