[Federal Register: April 6, 2010 (Volume 75, Number 65)]
[Notices]
[Page 17414-17415]
[DOCID:fr06ap10-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0079]

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

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 TOVIAZ 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks 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 drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product TOVIAZ
(fesoterodine fumarate). TOVIAZ is indicated for treatment of
overactive bladder with symptoms of urge urinary incontinence, urgency,
and frequency. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for TOVIAZ (U.S.
Patent No. 6,858,650) from Schwarz Pharma AG, and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
September 29, 2009, FDA advised the Patent and Trademark

Office that this human drug product had undergone a regulatory review
period and that the approval of TOVIAZ represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
    FDA has determined that the applicable regulatory review period for
TOVIAZ is 2,395 days. Of this time, 1,445 days occurred during the
testing phase of the regulatory review period, while 950 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 (the act) (21 U.S.C. 355(i)) became effective:
April 13, 2002. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on April
13, 2002.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: March 27, 2006.
The applicant claims March 17, 2006, as the date the new drug
application (NDA) for TOVIAZ (NDA 22-030) was initially submitted.
However, FDA records indicate that NDA 22-030 was submitted on March
27, 2006.
    3. The date the application was approved: October 31, 2008. FDA has
verified the applicant's claim that NDA 22-030 was approved on October
31, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,155 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by June 7, 2010. 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 October 4,
2010. To meet its burden, the petition must 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.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-7679 Filed 4-5-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 249 (Friday, December 29, 2023)]
[Rules and Regulations]
[Pages 90094-90096]
[FR Doc No: 2023-28757]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0907]

RIN 1625-AA00 Safety Zone; Fireworks Display, Pacific Ocean,
Westport, WA

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

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain waters of the Pacific Ocean. This action is necessary to
provide for the safety of life on these navigable waters near Westport,
Washington, during a fireworks display on January 1, 2024. This
regulation prohibits persons and vessels from entering the safety zone
unless authorized by the Captain of the Port Sector Columbia River or a
designated representative.

DATES: This rule is effective from 11:30 p.m. on December 31, 2023, to
1 a.m. on January 1, 2024.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0907 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email Lieutenant Carlie Gilligan, Waterways Management
Division, Sector Columbia River, Coast Guard; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Columbia River
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On October 23, 2023, an organization notified the Coast Guard that
it will be conducting a fireworks display from 12 to 12:30 a.m. on
January 1, 2024. The fireworks are to be launched from a site in
Westport, WA, at approximate location 46[deg]54'17'' N; 124[deg]05'59''
W. Hazards from firework displays include accidental discharge of
fireworks, dangerous projectiles, and falling hot embers or other
debris. The Captain of the Port Sector Columbia River (COTP) has
determined that potential hazards associated with the fireworks to be
used in this display will be a safety concern for anyone within a 600-
foot radius of the launch site.
    In response, on December 4, 2023, the Coast Guard published a
notice of proposed rulemaking (NPRM) titled Safety Zone; Fireworks
Display, Pacific Ocean, Westport, WA (88 FR 84249). There, we stated
why we issued the NPRM and invited comments on our proposed regulatory
action related to this fireworks display. During the comment period
that ended December 20, 2023, we received one comment unrelated to the
proposed rulemaking.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential safety hazards associated with a fireworks
display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The COTP has determined that potential hazards associated with
the fireworks to be used in this January 1, 2024, display will be a
safety concern for anyone within 600 feet of the launch site. The
purpose of this rule is to ensure safety of vessels and the navigable
waters in the safety zone before, during, and after the scheduled
event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no relevant comments on our NPRM
published December 4, 2023. There are no changes in the regulatory text
of this rule from the proposed rule in the NPRM.
    This rule establishes a safety zone from 11:30 p.m. on December 31,
2023 to 1 a.m. January 1, 2024. The safety zone will cover all
navigable waters within 600 feet of the launch site in Westport, WA
located at approximate location 46[deg]54'17'' N; 124[deg]05'59'' W.
The duration of the zone is intended to ensure the safety of vessels
and these navigable waters before, during, and after the scheduled 12
to 12:30 a.m. fireworks display. No vessel or person will be permitted
to enter the safety zone without obtaining permission from the COTP or
a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, and duration of the safety zone. Vessel traffic will be able
to safely transit around this safety zone which will impact a small
designated area of the Pacific Ocean for less than 2 hours on an
evening when vessel traffic is normally low. Moreover, the Coast Guard
will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16
about the zone, and the rule allows vessels to seek permission to enter
the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting 1.5 hours that will prohibit entry within 600 feet
of a launch site on the Pacific Ocean. It is categorically excluded
from further review under paragraph L60(a) of Appendix A, Table 1 of
DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add Sec.  165.T13-0907 to read as follows:

Sec.  165.T13-0907  Safety Zone; Fireworks Display, Pacific Ocean,
Westport, WA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Pacific Ocean, surface to bottom, 600 feet from the
fireworks display site at approximately 46[deg]54'17'' N;
124[deg]05'59'' W. These coordinates are based on the launch site
located on the Pacific Ocean near Firecracker Point, Westport, WA.
    (b) Definitions. As used in this section--
    Designated representative means a commissioned, warrant, or petty
officer of the U.S. Coast Guard assigned to a unit under the
operational control of the U.S. Coast Guard Sector Columbia River and
designated by or assisting the Captain of the Port Columbia River
(COTP) in the enforcement of the regulations in this section.
    (c) Regulations.
    (1) Under the general safety zone regulations in subpart C of this
part, you may not enter the safety zone described in paragraph (a) of
this section unless authorized by the COTP or the COTP's designated
representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by calling<PHONE_NUMBER> or the Sector Columbia River
Command Center on Channel 16 VHF-FM. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the COTP's designated representative.
    (d) Enforcement period. This section will be enforced from 11:30
p.m. on December 31, 2023, through 1 a.m. on January 1, 2024.

    Dated: December 22, 2023.
J.W. Noggle,
Captain, U.S. Coast Guard, Captain of the Port Columbia River.
[FR Doc. 2023-28757 Filed 12-28-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Rules and Regulations]
[Page 20727]
[FR Doc No: C1-2011-33772]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 65

[Docket ID FEMA-2011-0002]

Changes in Flood Elevation Determinations

Correction

    In rule document 2011-33772 appearing on pages 423-425 in the issue
of Thursday, January 5, 2012 make the following correction:

Sec.  65.4  [Corrected]

    On page 425, in the table, in the column ``Chief executive officer
of community'', on the 10th line, ``Mr. Robert Hyatt Davidson, County
Manager'' should read ``Mr. Robert Hyatt, Davidson County Manager''.

[FR Doc. C1-2011-33772 Filed 4-5-12; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Notices]
[Page 6628-6630]
[DOCID:fr12fe07-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55235; File No. SR-BSE-2007-05]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Remove All References to a Specific Regulation NMS Trading Phase Date

February 2, 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 January 31, 2007, the Boston Stock Exchange (``BSE'' or
``Exchange'') 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 substantially prepared by the
Exchange. The Exchange has designated the proposed rule change as one
constituting a stated policy, practice, or interpretation with respect
to the meaning, administration, or enforcement of an existing rule
under Section 19(b)(3)(A) of the Act,\3\ and Rule 19b-4(f)(1)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(1).

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

    The BSE is proposing to remove references in Chapters XXXVII and
XXXVIII of the BSE Rules to February 5, 2007, which was the Regulation
NMS Trading Phase Date as of the date of Commission approval of the
proposed rule change relating to the second phase of the BeX trading
system, and replace all such references with the phrase ``Regulation
NMS Trading Phase Date.'' The Regulation NMS Trading Phase Date is the
final date for full operation of Regulation NMS-compliant trading
systems of all automated trading centers (both SRO trading facilities
and ADF participants) that intend to qualify their quotations for
trade-through protection under Rule 611 of Regulation NMS, as
determined by the Commission. The text of the proposed rule change is
available at http://www.bostonstock.com, at the BSE, 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 BSE 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. BSE 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
    On June 13, 2006 the Exchange filed Amendment No. 3 to SR-BSE-2006-
22 (the ``BeX Facility Filing''), a rule filing submitted in connection
with the implementation of the first of two phases of BeX, a fully
automated electronic book for the display and execution of orders in
securities. On August 25, 2006 SR-BSE-2006-22 was approved by the
Commission.\5\ On August 3, 2006 the BSE filed, in connection with the
implementation of the second phase of the BeX trading system and in
connection with satisfying the requirements of Regulation NMS, SR-BSE-
2006-30. On September 29, 2006 the Commission approved SR-BSE-2006-
30.\6\
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    \5\ See Securities Exchange Act Release No. 54365 (August 25,
2006), 71 FR 52192 (September 1, 2006).
    \6\ See Securities Exchange Act Release No. 54546 (September 29,
2006), 71 FR 59161 (October 6, 2006).
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    The purpose of this filing is to remove references in Chapters
XXXVII and XXXVIII of the BSE Rules to February 5, 2007 as the
Regulation NMS Trading Phase Date and to replace all references to that
specific date with the phrase ``Regulation NMS Trading Phase Date.''
The Regulation NMS Trading Phase Date is the final date for full
operation of Regulation NMS-compliant trading systems of all automated
trading centers (both SRO trading facilities and ADF participants) that
intend to qualify their quotations for trade-through protection under
Rule 611 of Regulation NMS, as determined by the Commission. In other
words, the BSE Rules will no longer reference a date certain for the
Regulation NMS Trading Phase Date and any occurrence that could have
taken place or that would have been triggered on February 5, 2007, such
as the ability for certain order types to be submitted on the BeX, will
be postponed to coincide with the revised Regulation NMS Trading Phase
Date scheduled by the Commission. Further, this filing replaces all
specific references to the February 5, 2007 date contained in BSE-2006-
30 as modified by Amendment 2 to that filing with the phrase Regulation
NMS Trading Phase Date.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of Section 6(b) of the Act,\7\ in general, and
furthers the objectives of Section 6(b)(5) of the Act,\8\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and to protect investors and the public interest
in that it is designed to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism for a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing rule change constitutes a stated policy,
practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(1) thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(1).
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    At any time within 60 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 Exchange Act.

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-BSE-2007-05 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-BSE-2007-05. 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 BSE.
    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-BSE-2007-05
and should be submitted on or before March 5, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon
Deputy Secretary
 [FR Doc. E7-2251 Filed 2-9-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Rules and Regulations]
[Pages 67009-67011]
[FR Doc No: 2013-26043]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0514; Directorate Identifier 2012-SW-068-AD;
Amendment 39-17647; AD 2013-22-15]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
(Sikorsky) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for
Sikorsky Model S-76A, B, and C helicopters to require certain
inspections of each spindle cuff assembly or blade fold cuff assembly
for a crack. If there is a crack, this AD requires replacing the
cracked part. If there is no crack, this AD requires applying white
paint to the inspection area to enhance the existing inspection
procedure. This AD was prompted by discovery of cracks in the spindle
cuffs. The actions are intended to prevent failure of a spindle cuff
assembly or blade fold cuff assembly, loss of a rotor blade, and
subsequent loss of control of the helicopter.

DATES: This AD is effective December 13, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of December 13,
2013.

ADDRESSES: For service information identified in this AD, contact
Sikorsky Aircraft Corporation, Attn: Manager, Commercial Technical
Support, mailstop s581a, 6900 Main Street, Stratford, CT 06614;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>or at http://www.sikorsky.com.http://www.eurocopter.com/techpub. You may

review a copy of the referenced service information at the FAA, Office
of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room
663, Fort Worth, Texas 76137.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, any incorporated-by-reference
service information, the economic evaluation, any comments received,
and other information. The street address for the Docket Operations
Office (phone:<PHONE_NUMBER>) is U.S. Department of Transportation,
Docket Operations Office, M-30, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Nicholas Faust, Aviation Safety
Engineer, Boston Aircraft Certification Office, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, Massachusetts
01803; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On June 20, 2013, at 78 FR 37160, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 to include an AD that would apply to Sikorsky Model S-76A,
B, and C helicopters. The NPRM proposed either a one-time
nondestructive inspection (NDI) or a visual inspection of each spindle
cuff assembly or blade fold cuff assembly for a crack and replacing any
cracked part. If there was no crack in the part, the NPRM proposed
applying white paint to a portion of each spindle cuff assembly or
blade fold cuff assembly lower cuff plate to enhance the existing
inspection procedure. The NPRM was prompted by the discovery of five
cracked spindle cuffs found during aircraft overhaul. The proposed
requirements were intended to prevent failure of a spindle cuff
assembly or blade fold cuff assembly, loss of a rotor blade, and
subsequent loss of control of the helicopter.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM (78 FR 37160,
June 20, 2013).

FAA's Determination

    We have reviewed the relevant information and determined that an
unsafe condition exists and is likely to exist or develop on other
products of these same type designs and that air safety and the public
interest require adopting the AD requirements as proposed.

Related Service Information

    Sikorsky issued S-76 Alert Service Bulletin ASB 76-65-67A, Revision
A, dated July 18, 2012 (ASB), which specifies performing an NDI of the
upper and lower cuff plate on each spindle cuff assembly or blade fold
cuff assembly for a crack, either by eddy current, fluorescent
penetrant, or ultrasonic inspection. If a crack indication is detected
and not verified, the ASB specifies performing a different NDI to
verify a crack. If there is a crack, the ASB specifies removing the
spindle cuff assembly or blade fold cuff assembly from service. If a
crack cannot be verified, the ASB specifies contacting Sikorsky for
further instruction. Finally, if no crack is found, the ASB specifies
applying white paint to a portion of the spindle cuff assembly or blade
fold cuff assembly lower cuff plate to enhance the existing inspection
procedure.

Differences Between This AD and the Service Information

    The ASB specifies contacting the manufacturer if suspect cracks are
not confirmed in the spindle cuff assembly or blade fold cuff assembly;
this AD does not require contacting the manufacturer. This AD applies
to spindle cuff assembly, part number (P/N) 76102-08001-043, which was
inadvertently omitted in the ASB. The manufacturer has since revised
the ASB to apply to this spindle cuff assembly. The ASB applies to
spare parts; this AD does not.

Costs of Compliance

    We estimate that this AD will affect 181 helicopters of U.S.
Registry.
    We estimate that operators may incur the following costs in order
to comply with this AD, based on an average labor cost of $85 per work
hour: It will take 2.5 work hours to do an NDI and 2 work hours to
apply the white paint. It will cost $15 in materials for the paint for
each helicopter. Based on these estimates, it will cost a total of $398
per helicopter and $72,038 for the fleet.
    If it is necessary to replace a spindle cuff assembly or a blade
cuff assembly, it will take 2.5 work hours and an estimated parts cost
of $54,000, for a total cost of $54,212 for each helicopter.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-22-15 Sikorsky Aircraft Corporation: Amendment 39-17647; FAA-
2013-0514; Directorate Identifier 2012-SW-068-AD.

(a) Applicability

    This AD applies to Model S-76A, S-76B, and S-76C helicopters
with a serial number up to and including 760822 and with a spindle
cuff assembly, part number (P/N) 76102-08001-043, -045 or -046, or a
blade fold cuff assembly, P/N 76150-09601-041, installed,
certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a spindle
cuff assembly or blade fold cuff assembly. This condition could
result in failure of a spindle cuff assembly or blade fold cuff
assembly, loss of a rotor blade, and subsequent loss of control of
the helicopter.

(c) Effective Date

    This AD becomes effective December 13, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 150 hours time-in-service (TIS):
    (1) For each spindle cuff assembly or blade cuff assembly with
1,900 or more hours TIS, conduct a nondestructive inspection (NDI)
by following the Accomplishment Instructions, paragraph 3.B., of
Sikorsky S-76 Alert Service Bulletin ASB 76-65-67A, Revision A,
dated July 18, 2012 (ASB), except this AD does not require you to
contact Sikorsky Aircraft Corporation. This inspection must be done
by a level 2 or higher technician with National Aerospace Standard
410 or equivalent certification.
    (2) For each spindle cuff assembly or blade cuff assembly with
less than 1,900 hours TIS, visually inspect the area indicated in
Figure 4 of the ASB as ``white paint application area'' for a crack
by using a 5x or higher power magnifying glass.
    (3) If there is a crack, before further flight, replace the
cracked part.
    (4) If there is no crack, apply white paint by following the
Accomplishment Instructions, paragraph 3.D., of the ASB.
    (5) Do not install an affected spindle cuff assembly or blade
fold cuff assembly on any helicopter unless it has been inspected in
accordance with paragraphs (e)(1) through (e)(4) of this AD.

(f) Special Flight Permit

    Special flight permits will not be issued.

(g) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Boston Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Send your proposal to: Nicholas Faust,
Aviation Safety Engineer, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, Massachusetts 01803; telephone
(781) 238-7763; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6220 Main Rotor
Head.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Sikorsky S-76 Alert Service Bulletin ASB 76-65-67A, Revision
A, dated July 18, 2012.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Sikorsky Aircraft Corporation, Attn: Manager, Commercial Technical
Support, mailstop s581a, 6900 Main Street, Stratford, CT 06614;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>or at
http://www.sikorsky.com.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on October 24, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-26043 Filed 11-7-13; 8:45 am]
BILLING CODE 4910-13-P