[Federal Register Volume 77, Number 127 (Monday, July 2, 2012)]
[Rules and Regulations]
[Pages 39172-39174]
[FR Doc No: 2012-16117]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0512]
RIN 1625-AA00

Safety Zone: Skagway Harbor, Skagway, AK for 4th of July
Fireworks

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard has established a temporary safety zone on the
navigable waters within a 1,000 foot radius of the fireworks launching
point located on the White Pass and Yukon Railway Dock in position
59[deg]26.70' north and 135[deg]19.58' west in the vicinity of the
mouth of the Small Boat Harbor, Skagway, Alaska, to limit access for
the duration of the 4th of July Fireworks display. Persons desiring to
transit within this safety zone must contact the Captain of the Port
Southeast Alaska, or the designated on scene representative via VHF
radio channel 16 or 13 (156.650 MHz) to receive permission.

DATES: This rule is effective on July 3, 2012 from 9:00 p.m. local time
through July 10, 2012, 1:00 a.m. local time.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2012-0512 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0512 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 9:00
a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email LT Patrick Drayer, Chief of Waterways
Management, U.S. Coast Guard Sector Juneau; telephone<PHONE_NUMBER>,
email<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)(3)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because publishing an NPRM would be
impracticable and contrary to the public interest since immediate
action is needed to minimize potential danger to the public during the
event. Any delay in the effective date of this rule would prevent this
community event from occurring safely. The Coast Guard will issue a
broadcast notice to mariners to advise mariners of the temporary safety
zone and on-scene Coast Guard assets will provide notice to mariners
during the event.
    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 because immediate action is needed
to minimize potential danger to the public during the event. Any delay
in the effective date of this rule would prevent this community event
from occurring safely.

Basis and Purpose

    The legal basis for this temporary rule is 33 U.S.C. 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; Public Law 107-295, 116 Stat. 2064; and
Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to define regulatory safety
zones.
    The temporary safety zone is necessary for the safety of mariners
in the vicinity of the fireworks display. The impact of this rule on
commercial and recreational traffic is expected to be minimal because
of the limited area and time of the safety zone.

Discussion of Rule

    The Coast Guard is establishing a safety zone in the waters in the
immediate vicinity of the location where the fireworks will be launched
in Taiya Inlet for the City of Skagway, Alaska, sponsored 4th of July
fireworks display. A no-action alternative was considered, but not
employed because of the increased safety hazards posed to mariners
during the fireworks display.

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 rule is not a significant regulatory
action because the rule is applicable to a one-time event, and also
because the temporary safety zone is limited in location and duration.
The small size of the safety zone allows for mariners to safely
navigate around the safety zone.

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. However, this rule may affect the following entities, some of
which may be small entities: the owners or operators of vessels
intending to transit, anchor, or fish in a portion of the Taiya Inlet
from 9:00 p.m. local time, July 3, 2012, to 1:00 a.m. local time on
July 4, 2012. 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 enforced for only a four hour period and
mariners will be able to easily navigate safely around the zone by
staying outside of the 1,000-foot radius of the position from which
fireworks will be launched. During the effective period, we will issue
maritime advisories widely available to the mariners that transit Taiya
Inlet.

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 or more in any
one year. Though this rule will not result in such expenditure, we do
discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not affect 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 which 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.

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: 33 U.S.C. 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; Public
Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add temporary Sec.  165.T17-0512, to read as follows:

Sec.  165.T17-0512  Safety Zone: Taiya Inlet, City of Skagway, Alaska,
for 4th of July Fireworks Display.

    (a) Location. The following area is a safety zone: All navigable
waters, from surface to bottom, of Taiya Inlet within a 1000 foot
radius of position of 59[deg]26.70' N and 135[deg]19.58' W.
    (b) Definitions. The following definition applies to this section:
``Designated representative'' means any commissioned, warrant, and
petty officer of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port
Southeast Alaska.
    (c) Regulations. (1) Under the general regulations contained in
Sec.  165.23 of this title, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Southeast Alaska or his designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the Coast Guard Captain of the Port Southeast Alaska or
his designated representative.
    (3) Upon being hailed by a U.S. Coast Guard vessel or designated
representative by siren, radio, flashing light or other means, the
operator of the vessel shall proceed as directed.
    (4) Persons desiring to enter the safety zone may request
permission from the Captain of the Port Southeast Alaska via VHF
Channel 16 or 13 (156.650 MHz), or via telephone at<PHONE_NUMBER>.
    (5) The Coast Guard will issue a broadcast notice to mariners to
advise mariners of the temporary safety zone and on-scene Coast Guard
representatives will provide notice to mariners during the event.
    (d) Enforcement Period. This rule will be enforced from 9:00 p.m.
local time on July 3, 2012, to 1:00 a.m. local time on July 4, 2012. If
the event is postponed due to weather, the rule may be enforced on a
succeeding date between July 5, 2012, and July 10, 2012. The Coast
Guard will issue a broadcast notice to mariners to advise mariners of
the date change for the temporary safety zone and on-scene Coast Guard
representatives will provide notice to mariners during the event.

    Dated: June 7, 2012.
S.W. Bornemann,
Captain, U.S. Coast Guard, Captain of the Port Southeast Alaska.
[FR Doc. 2012-16117 Filed 6-29-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 7, 2009 (Volume 74, Number 65)]
[Notices]
[Page 15789-15792]
[DOCID:fr07ap09-127]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59664; File No. SR-OCC-2009-04]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Commodity Options

March 31, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on March 20, 2009, The
Options Clearing Corporation (``OCC'') 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
primarily by OCC. OCC filed the proposed rule change pursuant to
Section 19(b)(3)(A)(iii) of the Act \2\ and Rule 19b-4(f)(4) \3\
thereunder so that the proposal was effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s-1(b)(3)(A)(iii).
    \3\ 17 CFR 240.19b-4(f)(4).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change would revise OCC's By-Laws and Rules to
accommodate conventional cash-settled commodity options, binary
commodity options, and event options.

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

    In its filing with the Commission, OCC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of such
statements.\4\
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    \4\ The Commission has modified parts of these statements.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The primary purpose of the proposed rule change is to revise OCC's
By-Laws and Rules to accommodate conventional

cash-settled commodity options, binary commodity options, and event
options. A general description of each option product follows below.
Additionally, OCC is proposing to simplify the By-Laws and Rules by
amending the definition of the term ``Exchange'' to refer to any
exchange, futures market, security futures market, or international
market for which OCC clears transactions and by revising the language
of numerous provisions of its By-Laws and Rules to reflect this amended
definition.
Conventional Cash-Settled Commodity Options
    Conventional cash-settled commodity options are cash-settled
options on the spot price of physical commodities such as precious
metals, energy-related commodities such as oil or natural gas, or other
physical commodities. Conventional cash-settled commodity options will
settle upon exercise based on some specified benchmark price for the
underlying commodity. The exercise settlement amount for an in-the-
money option will be the product of the multiplier and the difference
between the final underlying interest value and the strike price. The
listing exchange or other reporting authority will report the final
underlying interest value of the underlying commodity to OCC for the
purpose of determining the exercise settlement amount.
Binary Commodity Options
    Binary commodity options are binary cash-settled options on the
spot price of physical commodities. Binary commodity options will be
automatically exercised and will pay a fixed exercise settlement amount
if the spot price of the underlying commodity on the expiration date is
greater than or equal to the specified strike price and will otherwise
expire unexercised. Other kinds of binary commodity options may be
structured such that call options pay only if the price of the
underlying commodity is above and not merely equal to the underlying
benchmark price and that put options pay if the price of the underlying
commodity is less than or equal to the underlying benchmark price.
Event Options
    Event options are a type of binary option that pay a fixed cash
settlement amount upon the occurrence of a specified event such as a
positive change in U.S. gross domestic product for a particular time
period. Event options are automatically exercised immediately upon
confirmation of the occurrence of a defined event. The listing exchange
or other reporting authority will monitor data reported by the official
sources and will notify OCC when the underlying event is determined to
have occurred. Event options may be referred to in Exchange rules as
``capped-style'' event options but are referred to in OCC's rules
simply as ``event options.''
    Exchange rules may also provide for ``European-style'' event
options. An example would be a trade deficit option for which
settlement is based upon U.S. trade deficit data. A trade deficit call
option would pay a fixed exercise settlement amount if the trade
deficit for a specified month is greater than or greater than or equal
to the specified strike price, and a trade deficit put option would pay
a fixed exercise settlement amount if the trade deficit for a specified
month is less than or less than or equal to the specified strike price.
In-the-money trade deficit options would be automatically exercised on
the expiration date. ``European-style event options'' are referred to
in OCC's rules simply as ``binary options'' because they are based on
the level of an underlying measure or metric at a specified point in
time rather than an event that can occur at any time during the life of
the option.
Changes in General Terminology
    To accommodate conventional commodity options and binary commodity
options, OCC proposes to introduce the term ``commodity option'' and to
add references to commodity options where the By-Laws and Rules now
refer to ``futures options'' where appropriate. The definitions of
``Call'' and ``Put'' in Article I of the By-Laws would be amended to
clarify their meanings with regard to futures options. In connection
with the introduction of commodity options, the term ``underlying
interest'' would be amended to include commodities as possible
underlying interests. Commodity options are not ``securities.''
Therefore, OCC proposes to replace ``underlying security'' and
``cleared securities'' with ``underlying interest'' and ``cleared
contracts,'' respectively, in the definitions of certain terms related
to options, such as ``call'' and ``opening purchase transaction.''
    OCC also proposes to simplify its By-Laws and Rules by revising the
term ``Exchange.'' Currently, the term includes only national
securities exchanges. Accordingly, in numerous places in the By-Laws
and Rules, where the intended reference is to any market for which OCC
clears transactions, the term ``Exchange'' is accompanied by
``international market, futures market or security futures market,'' or
a similar phase. OCC proposes to revise the definition of Exchange to
include all such markets and to eliminate the numerous references to
each type of market for which OCC clears transactions. The revised
definition of Exchange will be more consistent with the definitions of
``Exchange transaction'' and ``Exchange rules'' because the scope of
each of these latter terms includes non-securities exchanges or markets
for which OCC clears transactions. In addition, OCC proposes to
introduce the term ``Securities Exchange'' to refer to national
security exchanges. In instances in which the reference to ``Exchange''
in the By-Laws and Rules is necessarily limited to a specific type of
market, such as a Securities Exchange or ``Equity Exchange'' as defined
in the By-Laws, OCC proposes to replace the term ``Exchange'' with the
appropriate term.
    Finally, OCC proposes to amend the definition of ``multiplier'' to
address the use of this term in connection with cash-settled options
other than index options.
Changes With Respect to Cash-Settled Commodity Options Generally
    Section 1 of Article XII sets forth conditions for OCC to clear
futures and futures options for an Exchange. Because the same
conditions would apply for OCC to clear commodity options for an
Exchange, OCC proposes to make Section 1 applicable to commodity
options. Rule 1303 pertains to OCC's arrangement with an associate
clearinghouse to enable members of the associate clearinghouse to clear
futures and futures options through the facilities of OCC. OCC proposes
that Rule 1303 would potentially apply to all commodity options
although the contracts to be included in any particular such
arrangement are agreed upon by OCC and the other clearing organization
on a case-by-case basis.
    Existing provisions in By-Law Article XII and Rule Chapter XIII
already provide for clearance of futures options. As discussed below,
OCC proposes to address cash-settled commodity options separately in
other Articles of its By-Law Articles and Chapters of its Rules. The
introductions to By-Laws Articles XII, XIV and XVII and Rules Chapters
XIII, XV and XVIII would be amended to reflect their proposed scope.
    OCC is proposing to amend the definitions of ``Call'' and ``Put''
in Article I of the By-Laws to clarify their meanings with respect to
futures options. In addition, for purposes of clarification, OCC
proposes to update Interpretation and Policy .01 to Article VI, Section
9 to state that general rights

and obligations of holders and writers of cleared contracts other than
stock options are governed by the provisions of those Articles of the
By-Laws pertaining to such products and not by Subsections (a) and (b)
Section 9 of Article VI.
Changes With Respect to Event Options and Binary Commodity Options
    To accommodate event options and binary commodity options, OCC
proposes to broaden By-Law Article XIV and Rule Chapter XV, which
currently apply only to binary options and range options for which the
underlying interest is a security or securities index. Credit default
options (``CDOs'') and credit default basket options (``CDBOs'') are
the only types of event options currently addressed by these provisions
of the By-Laws and Rules. OCC proposes to modify the existing framework
of rules governing CDOs and CDBOs to support clearance of event options
in general while retaining certain definitions and provisions that are
applicable only to CDOs and/or CDBOs.
    Article XIV of the By-Laws, which presently applies to CDOs and
CDBOs as well as to other binary options and range options, is proposed
to be amended to apply to the event options and other binary options
proposed by CFE. Section 1 would be amended to add a definition of
``event option,'' which in OCC's lexicon would be confined to binary
options that are automatically exercised upon the occurrence of a
specified event. CDOs and CDBOs would be defined as specific kinds of
event options. Event options, in turn, would be a subcategory of binary
options. Certain terms applicable to CDOs and CDBOs would be made more
generic so as to apply to all event options. Other definitions would be
amended to accommodate event options, and to provide that underlying
interests for binary options and range options may include commodities.
Other sections of Article XIV are amended to, among other things,
specify which provisions are unique to CDOs and CDBOs and which apply
to event options generally. Although no market has yet proposed to
trade range options on underlying commodities, the proposed rule
amendments are broad enough to accommodate such trading.
    Existing adjustment provisions in Section 3 of Article XIV, which
defer entirely to the listing market to determine adjustments for CDOs
and CDBOs, will be made to apply to all event options. This is
appropriate because OCC anticipates that the definitions of underlying
events and other terms of these products will be unique to the listing
market. Existing Section 3A will apply to binary options other than
event options and range options where the underlying interest is a
security or an index of securities, and OCC is proposing a new Section
3B to provide for adjustments to binary options other than event
options and range options where the underlying interest is a commodity
rather than a security or index of securities. Adjustments under
Section 3B will be made by OCC rather than through an adjustment panel
as is the case for securities products under Section 3A.
    Rules in Chapter V are being amended to provide for event options,
other binary options and range options on underlying commodities. The
changes intended to accommodate the new contracts govern among other
things the automatic exercise of event options and binary options and
exercise settlement. They also provide that binary options and event
options on commodities that when carried for the accounts of customers,
must be carried in the customers' segregated funds account in
accordance with CFTC regulations.
Changes With Respect to Cash-Settled Conventional Commodity Options
    OCC proposes to provide for clearance of cash-settled conventional
commodity options by expanding the scope of By-Law Article XVII and
Rule Chapter XVIII, which currently cover only index options.
Article XVII
    OCC proposes to amend the definitions of numerous terms to apply to
cash-settled options generally. Other provisions of Article VII are
also amended to make them more generic to cash-settled options
generally. Provisions limited to index options are retained where
appropriate and in many cases are made applicable to options on
commodity indexes as well as securities indexes. OCC proposes to
substitute the term ``cash-settled option'' for the term ``index
option'' in Article XVII, Section 2 so that it will apply to cash-
settled options generally. Section 3 of Article XVII will govern
adjustments to cash-settled options generally. A new proposed paragraph
(b) would address adjustments to cash-settled options overlying a
single commodity. Under the proposed amendments, OCC rather than an
adjustment panel will decide when and what adjustments may be necessary
in light of various policy considerations. Existing paragraph (b),
which governs adjustments of index options, would be renumbered as
paragraph (c) and amended to reflect the inclusion of commodities as
possible components of an underlying index.
    Similarly, existing Section 4 of Article XVII, which defines OCC's
rights and obligations in situations in which the current index value
of an index option is unavailable or otherwise determined to be
inaccurate will be amended to expand its application to cover
unavailability or inaccuracy of values for any underlying interest.
Chapter XVIII, Rules 1802-1806
    OCC proposes to amend Rules 1802-1806 so that they will apply to
cash-settled options generally. The term ``cash-settled option'' would
be substituted for the term ``index option'' and the term ``current
interest value'' would be substituted for the term ``current index
value'' in Rules 1802-1806. In addition, OCC proposes to amend
paragraphs 1801(a)(1) and (a)(2) to specify the conditions under which
Clearing Member will pay the exercise settlement to or receive the
exercise settlement from OCC with respect to an exercised cash-settled
option other than an index option. OCC also proposes to substitute the
term ``cash-settled option'' for the term ``index option'' and make a
small number of other corrections to certain defined terms in Rules
1802, 1803, 1804, and 1805 so that they will apply to cash-settled
options generally.
Chapter XVIII, Rules 1807
    Cash-settled commodity options will be carried in a Clearing
Member's segregated futures account(s). Therefore, to maintain
consistency with Rule 1104, OCC proposes to amend Rule 1807 so that the
net settlement amount with respect to exercised cash-settled commodity
options is paid from or credited to a suspended Clearing Member's
Segregated Liquidating Settlement Account.
    In several other places in the By-Laws and Rules where references
are made to index options, OCC proposes to substitute the term ``cash-
settled option'' for the term ``index option'' and the term ``current
underlying interest value'' for the term ``current index value.''
    Finally, OCC proposes to amend the terms of Article VI, Section 2
of the By-Laws, which concerns the initial clearing fund contribution
of clearing members, to be consistent with the terms of Rule 1001. Rule
1001 provides that affiliates of existing Clearing Members that become
Clearing Members of OCC solely for the purpose of clearing transactions
in security futures, commodity futures, and/or futures options need not
put up an additional

$150,000 minimum Clearing Fund contribution. OCC would expand this
exemption to also apply to commodity options.
    The proposed rule change is consistent with the purposes and
requirements of Section 17A of the Act because it provides for the
clearance of various commodity futures and options products without
adversely affecting the prompt and accurate clearance and settlement of
transactions in securities options, the prompt and accurate clearance
and settlement of securities transactions, or the protection of
securities investors and the public interest. The proposed rule change
accomplishes this purpose by applying substantially the same rules and
procedures to transactions in futures products that OCC applies to
transactions in securities options. The proposed rule change is not
inconsistent with any rules of OCC, including any rules proposed to be
amended.

(B) Self-Regulatory Organization's Statement on Burden on Competition

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

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

    Written comments were not and are not intended to be solicited with
respect to the proposed rule change, and none have been received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(iii) of the Act \5\ and Rule 19b-4(f)(4) \6\ promulgated
thereunder because the proposal changes effects a change in an existing
service of a registered clearing agency that (i) does not adversely
affect the safeguarding of securities or funds in the custody or
control of the clearing agency or for which it is responsible and (ii)
does not significantly affect the respective rights or obligations of
the clearing agency or persons using the service. At any time within
sixty days of the filing of the proposed rule change, the Commission
may summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \6\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2009-04 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-OCC-2009-04. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of OCC. 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-OCC-2009-04 and should be
submitted on or before April 28, 2009.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
Florence E. Harmon,
Deputy Secretary.
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    \7\ 17 CFR 200.30-3(a)(12).
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[FR Doc. E9-7710 Filed 4-6-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Pages 91938-91939]
[FR Doc No: 2016-30399]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-3157]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TRULICITY

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TRULICITY and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 17, 2017. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 19,
2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows: June 19, 2017

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-E-3157 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TRULICITY.'' 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and

an approval phase. For human biological products, the testing phase
begins when the exemption to permit the clinical investigations of the
biological becomes effective and runs until the approval phase begins.
The approval phase starts with the initial submission of an application
to market the human biological product and continues until FDA grants
permission to market the biological product. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (for example, half the
testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a human biological product
will include all of the testing phase and approval phase as specified
in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product TRULICITY
(dulaglutide). TRULICITY is indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes
mellitus. Subsequent to this approval, the USPTO received a patent term
restoration application for TRULICITY (U.S. Patent No. 7,452,966) from
Eli Lilly and Company, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated October 15, 2015, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of TRULICITY represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TRULICITY is 3,303 days. Of this time, 2,937 days occurred during the
testing phase of the regulatory review period, while 366 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September
4, 2005. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on September
4, 2005.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): September 18, 2013. The applicant claims
September 17, 2013, as the date the biologics license application (BLA)
for TRULICITY (BLA 125469) was initially submitted. However, FDA
records indicate that BLA 125469 was submitted on September 18, 2013.
    3. The date the application was approved: September 18, 2014. FDA
has verified the applicant's claim that BLA 125469 was approved on
September 18, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,249 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30399 Filed 12-16-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 17, 2010 (Volume 75, Number 180)]
[Notices]
[Page 57011-57012]
[DOCID:fr17se10-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP10-494-000]

Tallulah Gas Storage LLC; Notice of Application

September 9, 2010.
    Take notice that on August 31, 2010, Tallulah Gas Storage LLC
(Tallulah), 10370 Richmond Avenue, Suite 510, Houston, TX 77042, filed
in Docket No. CP10-494-000, an application, pursuant to section 7(c) of
the Natural Gas Act, subpart F of part 157, and subpart G of part 284
of the Commission's regulations for: (1) A certificate of public
convenience and necessity authorizing Tallulah to construct and operate
a natural gas storage facility and pipeline facilities connecting with
Midcontinent Express Pipeline LLC (Midcontinent Express), Columbia Gulf
Transmission Co. (Columbia Gulf), Gulf South Pipeline Co., LP (Gulf
South) and Southeast Supply Header, LLC (SESH) in Madison Parish
Louisiana; (2) a blanket certificate authorizing Tallulah to construct,
acquire, operate, rearrange, and abandon facilities; (3) a blanket
certificate authorizing Tallulah to provide open access firm and
interruptible gas storage services on behalf of others in interstate
commerce with pre-granted abandonment of such services; and (4) waivers
of Commission regulations, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection.
    Specifically, Tallulah proposes to construct, own, operate, and
maintain a new underground natural gas salt cavern storage facility
consisting of three caverns, each with a working gas capacity of 8
billion cubic feet (Bcf), and approximately 3.4 Bcf of base gas, having
a combined maximum daily withdrawal rate of 1,575 million cubic feet
per day (MMcf/d) and a maximum injection capability of 900 MMcf/d.
Tallulah also states that the facility will have a total capacity of
approximately 11.4 Bcf and a peak deliverability of 525 MMcf/d.
Tallulah also proposes to construct approximately 3.3 miles of dual 24-
inch diameter lateral pipeline to four new meter and regulator stations
interconnecting with Midcontinent Express, Columbia Gulf, Gulf South,
and SESH. Tallulah will also install six natural gas-fired compressors
totaling 28,410 horsepower as well as associated interconnecting piping
and appurtenant facilities. Tallulah seeks authorization to charge
market-based rates for its proposed services.
    The filing may be viewed on the web at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to Mark
Fullerton, Tallulah Gas Storage LLC, 10370 Richmond Avenue, Suite 510,
Houston, TX 77042, or by calling<PHONE_NUMBER> (telephone) or (713)
403-6461 (fax<EMAIL_ADDRESS>or to John S. Decker, Vinson &
Elkins L.L.P., 1455 Pennsylvania Avenue, NW., Suite 600, Washington, DC
20004-1008, or by calling<PHONE_NUMBER> (telephone) or<PHONE_NUMBER>
(fax<EMAIL_ADDRESS>    Pursuant to Sec.  157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all Federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be

required to serve copies of filed documents on all other parties.
However, the non-party commentors will not receive copies of all
documents filed by other parties or issued by the Commission (except
for the mailing of environmental documents issued by the Commission)
and will not have the right to seek court review of the Commission's
final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: September 30, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-23212 Filed 9-16-10; 8:45 am]
BILLING CODE 6717-01-P