[Federal Register: November 16, 2007 (Volume 72, Number 221)]
[Notices]
[Page 64614-64616]
[DOCID:fr16no07-62]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0047; FRL-8496-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NSPS for Onshore Natural Gas
Processing Plants (Renewal); EPA ICR Number 1086.08, OMB Control Number
2060-0120

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before December 17,
2007.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2007-0047, to (1) EPA online using http://www.regulations.gov (our preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:

EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 9, 2007 (72 FR 10735), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.

    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2007-0047, which is available for public viewing
online at http://www.regulations.gov, or in person viewing at the

Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA

receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
http://www.regulations.gov.

    Title: NSPS for Onshore Natural Gas Processing Plants (Renewal).
    ICR Numbers: EPA ICR Number 1086.08, OMB Control Number 2060-0120.
    ICR Status: This ICR is scheduled to expire on December 31, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The New Source Performance Standards (NSPS) for Equipment
Leaks of Volatile Organic Compounds (VOC) from Onshore Natural Gas
Processing Plants, published at 40 CFR part 60, subpart KKK, were
proposed on January 20, 1984, and promulgated on June 24, 1985. These
standards apply to the following affected facilities located at onshore
natural gas processing plants: compressors in VOC service or in wet gas
service, and the group of all equipment (except compressors) within a
process unit. Affected facilities commenced construction, modification
or reconstruction after the date of proposal.
    The NSPS for Onshore Natural Gas Processing: SO2
Emissions, published at 40 CFR part 60, subpart LLL, were proposed on
January 20, 1984 and promulgated on October 1, 1985. These standards
apply to the following affected facilities located at onshore natural
gas processing plants: each sweetening unit, and each sweetening unit
followed by a sulfur recovery unit. Affected facilities commenced
construction, modification or reconstruction after the date of
proposal.
    In general, all NSPS standards require initial notifications,
performance tests, and periodic reports. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. These notifications, reports, and records are essential in
determining compliance and are required of all sources subject to NSPS.
Owners or operators of affected facilities must submit notifications of
any construction/reconstruction, modification, actual date of startup,
demonstration of a continuous monitoring system, and date of a
performance test. Note that the use of control devices and continuous
monitoring is not required by subpart KKK, but is an option for
compliance.
    Owners or operators of affected facilities must submit semiannual
reports and performance test results. Note that subpart LLL requires
semiannual reporting of excess emissions. Owners or operators subject
to subpart KKK must keep various records, including records of leak
detection and repair, records of compliance tests, and records of pumps
and valves that are exempted from certain monitoring requirements.
Owners or operators subject to subpart LLL must keep records of various
calculations and measurements.
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
two years following the date of such measurements, maintenance reports,
and records. All reports are sent to the delegated state or local
authority. In the event that there is no such delegated authority, the
reports are sent directly to the EPA regional office. This information
is being collected to assure compliance with 40 CFR part 60, subparts
KKK and LLL, as authorized in section 112 and 114(a) of the Clean Air
Act. The required information consists of emissions data and other
information that have been determined to be private.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB Control Number. The OMB Control Number for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 91
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Onshore natural gas processing
plants.
    Estimated Number of Respondents: 563.
    Frequency of Response: On occasion, initially, and semiannually.
    Estimated Total Annual Hour Burden: 149,180.
    Estimated Total Annual Cost: $9,857,058, which includes $219,000
annualized Capital Startup costs, $119,700 annualized Operating and
Maintenance costs (O&M) and $9,518,358 annualized Labor costs.
    Changes in the Estimates: There is no significant change in this
ICR compared to the previous ICR. This is due to two considerations.
First, the regulations have not changed over the past three

years and are not anticipated to change over the next three years.
Secondly, the growth rate for the industry is very low, negative or
non-existent.
    There is, however, a small adjustment in the labor hour estimate.
The previous ICR shows a total of 149,174 annual hours. This renewal
ICR shows a total of 149,180 annual hours. The small labor hour
increase of six hours was caused by a mathematical error in the
previous ICR.

    Dated: November 8, 2007.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
 [FR Doc. E7-22453 Filed 11-15-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62846-62848]
[FR Doc No: 2013-24681]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70688; File No. SR-NSCC-2013-02]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing Amendment No. 3 to a Proposed Rule
Change, as Previously Modified by Amendment Nos. 1 and 2, To Institute
Supplemental Liquidity Deposits to Its Clearing Fund Designed To
Increase Liquidity Resources To Meet Its Liquidity Needs

October 15, 2013.
    On March 21, 2013, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') proposed rule change SR-NSCC-2013-02 (``Proposed Rule
Change'') pursuant to Section 19(b)(1) of the Securities Exchange Act
of 1934 (``Exchange Act'') \1\ and Rule 19b-4 thereunder.\2\ The
Proposed Rule Change was published for comment in the Federal Register
on April 10, 2013.\3\ On April 19, 2013, NSCC filed with the Commission
Amendment No. 1 to the Proposed Rule Change, which the Commission
published for comment in the Federal Register on May 29, 2013 and
designated a longer period for Commission action on the Proposed Rule
Change, as amended.\4\ On June 11, 2013, NSCC filed with the Commission
Amendment No. 2 to the Proposed Rule Change, as previously modified by
Amendment No. 1, which the Commission published for comment in the
Federal Register on July 15, 2013, with an order instituting
proceedings to determine whether to approve or disapprove the Proposed
Rule Change (``Order Instituting Proceedings'').\5\ On September 25,
2013, the Commission designated a longer period of review for
Commission action on the Order Instituting Proceedings.\6\ As of
October 15, 2013, the Commission had received 22 comment letters on the
proposal contained in the Proposed Rule Change and its related Advance
Notice,\7\ including NSCC's two responses to the comment letters
received as of August 20, 2013.\8\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4. NSCC also filed the proposal contained in
the Proposed Rule Change as advance notice SR-NSCC-2013-802
(``Advance Notice''), as modified by Amendment No. 1, pursuant to
Section 806(e)(1) of the Payment, Clearing, and Settlement
Supervision Act of 2010 and Rule 19b-4(n)(1)(i) thereunder. See
Release No. 34-69451 (Apr. 25, 2013), 78 FR 25496 (May 1, 2013). On
May 20, 2013, the Commission extended the period of review of the
Advance Notice, as modified by Amendment No. 1. Release No. 34-69605
(May 20, 2013), 78 FR 31616 (May 24, 2013). On June 11, 2013, NSCC
filed Amendment No. 2 to the Advance Notice, as previously modified
by Amendment No. 1. Release No. 34-69954 (Jul. 9, 2013), 78 FR 42127
(Jul. 15, 2013). On October 4, 2013, NSCC filed Amendment No. 3 to
the Advance Notice, as previously modified by Amendment Nos. 1 and
2. Release No. 34-70689 (Oct. 15, 2013). The proposal in the
Proposed Rule Change, as amended, and the Advance Notice, as
amended, shall not take effect until all regulatory actions required
with respect to the proposal are completed.
    \3\ Release No. 34-69313 (Apr. 4, 2013), 78 FR 21487 (Apr. 10,
2013).
    \4\ Release No. 34-69620 (May 22, 2013), 78 FR 32292 (May 29,
2013).
    \5\ Release No. 34-69951 (Jul. 9, 2013), 78 FR 42140 (Jul. 15,
2013).
    \6\ Release No. 34-70501 (Sep. 25, 2013), 78 FR 60347 (Oct. 1,
2013).
    \7\ See Comments Received on File Nos. SR-NSCC-2013-02 (http://sec.gov/comments/sr-nscc-2013-02/nscc201302.shtml) and SR-NSCC-2013-
802 (http://sec.gov/comments/sr-nscc-2013-802/nscc2013802.shtml).
Since the proposal contained in the Proposed Rule Change was also
filed as an Advance Notice, see Release No. 34-69451, supra note 2,
the Commission is considering all public comments received on the
proposal regardless of whether the comments are submitted to the
Proposed Rule Change, as amended, or the Advance Notice, as amended.
    \8\ NSCC also received a comment letter directly prior to filing
the Proposed Rule Change and related Advance Notice with the
Commission, which NSCC provided to the Commission in Amendment No. 1
to the filings. See Exhibit 2 to File No. SR-NSCC-2013-02 (http://sec.gov/rules/sro/nscc/2013/34-69620-ex2.pdf).
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    Pursuant to Section 19(b)(1) of the Exchange Act \9\ and Rule 19b-4
thereunder,\10\ notice is hereby given that on October 7, 2013, NSCC
filed with the Commission Amendment No. 3 to the Proposed Rule Change,
as previously modified by Amendment Nos. 1 and 2, as described in Items
I and II below, which Items have been prepared primarily by NSCC. The
Commission is publishing this notice to solicit comments on the
Proposed Rule Change, as modified by Amendment No. 3, from interested
persons.\11\
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    \9\ 15 U.S.C. 78s(b)(1).
    \10\ 17 CFR 240.19b-4.
    \11\ Defined terms that are not defined in this notice are
defined in Amended Exhibit 5 to the Proposed Rule Change, available
at http://sec.gov/rules/sro/nscc.shtml, under File No. SR-NSCC-2013-
02, Additional Materials.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The Proposed Rule Change, as modified by Amendments No. 1, No. 2,
and No. 3, is a proposal by NSCC to amend its Rules & Procedures (the
``NSCC Rules'') to provide for supplemental liquidity deposits to its
Clearing Fund (the ``NSCC Clearing Fund'') to ensure that NSCC has
adequate liquidity resources to meet its liquidity needs (the ``SLD
Proposal'' or sometimes the ``Proposal''), as described below. NSCC
filed Amendment No. 3 (this ``Amendment'') to the Proposed Rule Change,
as previously modified by Amendment No. 1 and No. 2, in order to delete
the provisions in the proposed Rule relating to Regular Activity
Liquidity Obligations (as defined), to respond to concerns raised by
Members. As a result the Proposal, as revised, would impose
supplemental liquidity obligations on affected Members only with
respect to activity relating to monthly options expiry periods (defined
in the proposed Rule as ``Special Activity Liquidity Obligations'').

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, NSCC included statements
concerning the purpose of and basis for the Proposed Rule Change, as
modified by Amendment No. 3, 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. NSCC has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Description of Change
Existing Proposal
    As noted in the original proposal contained in the Proposed Rule
Change, as modified by Amendments No. 1 and No. 2 (the ``Rule
Filing''), the SLD Proposal would modify the NSCC Rules to add a new
Rule 4(A), to establish a supplemental liquidity funding obligation
designed to cover the liquidity exposure attributable to those Members
and families of affiliated Members (``Affiliated Families'') that
regularly incur the largest gross settlement debits over a settlement
cycle during both times of normal trading activity (``Regular Activity
Periods'') and times of increased trading and settlement activity that
arise around monthly options expiration dates (``Options Expiration
Activity Periods'').
    Under the existing Proposal, the Liquidity Obligation of a Member
or Affiliated Family with respect to a

Regular Activity Period (a ``Regular Activity Liquidity Obligation'')
or an Options Expiration Activity Period (a ``Special Activity
Liquidity Obligation'') would be imposed on the 30 Members or
Affiliated Families who generate the largest aggregate liquidity needs
over a settlement cycle that would apply in the event of a closeout
(that is, over a period from date of default through the following
three settlement days), based upon an historical look-back period. The
calculations for both the Regular Activity Liquidity Obligation and the
Special Activity Liquidity Obligation were designed so that NSCC has
adequate liquidity resources to enable it to settle transactions,
notwithstanding the default of one of these 30 largest Members or
Affiliated Families during Regular Activity Periods, as well as during
Options Expiration Activity Periods. The liquidity obligations imposed
on Members of Affiliated Families would be apportioned among the
Members in that Affiliated Family in proportion to the liquidity risk
(or peak exposure) they present to NSCC. The Regular Activity Liquidity
Obligation of an Unaffiliated Member or Affiliated Family that has a
Regular Activity Liquidity Obligation (a Regular Activity Liquidity
Provider) is satisfied by such Regular Activity Liquidity Provider
making a Regular Activity Supplemental Deposit to the Clearing Fund in
the amount of its Regular Activity Liquidity Obligation, offset by (i)
the total amount (if any) of its commitment and the commitment of its
``Designated Lender'' under NSCC's committed line of credit (the
``Credit Facility'') and (ii) a share of the unallocated commitments of
other lenders under the Credit Facility.
    The cash deposit in respect of a Special Activity Liquidity
Obligation (a ``Special Activity Supplemental Deposit'') is structured
in the existing SLD Proposal to address any additional liquidity
shortfalls (over and above NSCC's other available liquidity resources)
that arise during the heightened activity period around monthly options
expiration. As such, these additional Special Activity Supplemental
Deposits would be required to be maintained on deposit with NSCC only
through the completion of the related settlement cycle and for a few
days thereafter.
Objections From Commenters
    The key concerns raised by commenters with respect to the existing
SLD Proposal were as follows:
    First, commenters claimed that Members were not sufficiently
consulted or involved during the development of the Proposal (even
though NSCC management conducted significant Member outreach), so that
the Proposal lacked input that could have potentially resulted in a
less burdensome approach.
    Second, commenters claimed that the Proposal was anticompetitive or
discriminatory because the obligation to provide supplemental liquidity
was imposed on only the 30 largest Unaffiliated Members or Affiliated
Families (even though those Members collectively represent
approximately 85% of NSCC's total membership by peak liquidity needs),
rather than all Members of NSCC. This concern was raised in the context
of Regular Activity Supplemental Deposits.
    Third, commenters claimed that the existing Proposal was
anticompetitive or discriminatory because, with respect to Regular
Activity Supplemental Deposits, it gave a dollar for dollar credit for
commitments made by Regular Activity Liquidity Providers or their
Designated Lenders under the Credit Facility--supposedly favoring
Regular Activity Liquidity Providers with affiliated banks.
    NSCC believes that the proposed amendments and items described
below address or mitigate all of these concerns.
Proposed Amendments
    NSCC is proposing to amend the existing SLD Proposal by removing
those provisions that, collectively, deal with the imposition of
Regular Activity Liquidity Obligations, while maintaining the
provisions relating to Special Activity Liquidity Obligations. The
proposed Rule, as so revised, would thus impose only Special Activity
Liquidity Obligations with respect to the heightened activity of
Options Expiration Activity Periods (that is, the four days beginning
with the Friday that precedes the monthly expiration date for stock
options, and ending on the third settlement day following). Under the
revised Proposal, as under the existing Proposal as it relates to
Special Activity Liquidity Obligations, only those Unaffiliated Members
or Affiliated Families among the top 30 whose activity during monthly
Options Expiration Activity Periods generate liquidity needs in excess
of NSCC's then available liquidity resources will be obligated to fund
such additional amounts. That is, the allocation formula ratably
applies the additional amount needed during the relevant Options
Expiration Activity Period based upon the affected Member's Special
Activity Peak Liquidity Exposure. To the extent that a Member's Special
Activity Peak Liquidity Exposure is less than or equal to NSCC's then
available liquidity resources, its share of the Special Activity Peak
Liquidity Need will be zero.
    In addition, under the revised SLD Proposal, as under the existing
Proposal as it relates to Special Activity Liquidity Obligations,
Unaffiliated Members and Affiliated Families, will be able to manage
their exposures by making Special Activities Prefund Deposits where
they project their own activity will increase their liquidity exposure.
For example, if a Special Activity Liquidity Provider anticipates that
its Special Activity Peak Liquidity Exposure at any time during a
particular Options Expiration Activity Period will be greater than the
amount calculated by NSCC, it can make an additional cash deposit to
the Clearing Fund (in excess of its Required Deposit) that it
designates as a ``Special Activity Prefund Deposit.'' However, to the
extent that a Member fails to adequately prefund its activity, it may
be subject to a Special Activity Liquidity Call in the same manner as
provided in the existing Proposal.
    With these changes, NSCC is removing those provisions of the
existing SLD Proposal that generated most concern from commenters,
while retaining those provisions that enable NSCC to collect additional
liquidity resources to cover the heightened liquidity needs that arise
during monthly Options Expiration Activity Periods. Every Unaffiliated
Member and Affiliated Family among the top 30 whose activity causes a
liquidity need in excess of NSCC's available liquidity resources will
contribute ratably to such shortfall, so the Proposal fairly and
equitably apportions the obligation among those Unaffiliated Members
and Affiliated Families whose activity cause the need. The removal of
those provisions relating to how commitments under the Credit Facility
would be credited against the cash deposit obligations of Regular
Activity Liquidity Providers render concerns about such allocation
moot.
    As indicated in NSCC's August 20, 2013 letter to the Commission,
DTCC is separately establishing a standing member-based advisory group,
the Clearing Agency Liquidity Council (``CALC''), as a forum for the
discussion of liquidity and liquidity-related financing needs and
trends. The CALC will initially focus on liquidity initiatives
currently being considered by NSCC to address liquidity funding during
periods of normal activity, including issues raised by commenters on
the existing SLD Proposal. In response to commenters' more general
concerns regarding NSCC's reliance on

the Credit Facility and related refinancing risk, NSCC will review with
the CALC the financing options available to NSCC to supplement the
Clearing Fund as a liquidity resource, and the related costs of those
options. Any new initiatives proposed as a result of the CALC review
that require regulatory approval will be addressed in a separate
filing.
    Reporting. As noted in the previous amendment to the Rule Filing,
NSCC agrees that Members have to be able to plan for their liquidity
obligations. At the same time, NSCC also believes it is critical that
Members understand the risks that their own activity presents to NSCC,
and be prepared to monitor their activity and alter their behavior if
they want to minimize the liquidity risk they present to NSCC.
Accordingly, NSCC will make available to each Member a daily report
showing the amount of liquidity NSCC would need in the event of the
default of such Member. Separately, NSCC will provide, and continue to
discuss with Special Activity Liquidity Providers, the reports
regarding their Special Activity Liquidity Obligations as currently
provided in the proposed Rule.
    Finally, the amendment makes certain technical corrections and
clarifies the time period for when Special Activity Liquidity Calls
must be satisfied.
    Implementation Timeframe. The SLD Proposal will be implemented on
February 1, 2014. As a result, the first time that Members will be
obligated to fund any Special Activity Supplemental Deposits will be
for the Options Expiration Activity Period in February 2014. NSCC Risk
staff will provide to affected Members their Special Activity Peak
Liquidity Exposures for the relevant Special Activity Lookback Period
by no later than January 15, 2014.
2. Statutory Basis
    The revised SLD Proposal contributes to NSCC's goal of ensuring
that NSCC has adequate liquidity resources to meet its settlement
obligations notwithstanding the default of an Unaffiliated Member or
Affiliated Family that poses the largest aggregate liquidity exposure
over the relevant settlement cycle, by providing a mechanism for
satisfying the peak liquidity needs that occur during monthly Options
Expiration Activity Periods. As such, the Proposal is consistent with
the requirements of the Exchange Act, and the rules and regulations
thereunder applicable to NSCC, as well as with PFMI Principle 7 as
described in the Rule Filing.

(B) Comments on Competition

    NSCC believes that the revised SLD Proposal will not impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Exchange Act. The Special Activity
Liquidity Obligations imposed on Special Activity Liquidity Providers
will ensure that all Unaffiliated Members and Affiliated Families whose
activity present liquidity exposure to NSCC during periods of
heightened activity during Options Expiration Activity Periods fairly
and equitably contribute to NSCC's liquidity resources for settlement.
NSCC believes the changes that have been made to the existing Proposal
fully address the concerns raised by commenters, and eliminate any
impact that the SLD Proposal might have on competition. To the extent
there remains any perceived burden on competition caused by the
Proposal, NSCC believes that such burden is not unreasonable or
inappropriate to prevent systemic risk given that the Proposal
contributes to the goal of financial stability in the event of Member
default.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments on the Proposed Rule Change, including NSCC's
formal response to the written comments, have been filed with the
Commission and are available on the Commission's Web site.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the Proposed Rule
Change, as modified by Amendment No. 3, is consistent with the Section
17A \12\ or any other provision of the Exchange Act, or the rules and
regulations thereunder. Comments may be submitted by any of the
following methods:
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    \12\ 15 U.S.C. 78q-1.
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Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-NSCC-2013-02 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 No. SR-NSCC-2013-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the Proposed Rule Change, as
amended, that are filed with the Commission, and all written
communications relating to the Proposed Rule Change, as amended,
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings also will be available for inspection
and copying at the principal office of NSCC and on NSCC's Web site at
http://dtcc.com/legal/rule_filings/nscc/2013.php.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File No. SR-NSCC-2013-02 and
should be submitted on or before November 5, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(57).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-24681 Filed 10-21-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 120 (Thursday, June 21, 2012)]
[Notices]
[Page 37413]
[FR Doc No: 2012-15128]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0781]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Record Retention Requirements for
the Soy Protein and Risk of Coronary Heart Disease Health Claim

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Record Retention Requirements for
the Soy Protein and Risk of Coronary Heart Disease Health Claim'' has
been approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On May 7, 2012, the Agency submitted a
proposed collection of information entitled ``Record Retention
Requirements for the Soy Protein and Risk of Coronary Heart Disease
Health Claim'' to OMB for review and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. OMB has now approved the information
collection and has assigned OMB control number 0910-0428. The approval
expires on June 30, 2015. A copy of the supporting statement for this
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: June 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15128 Filed 6-20-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 9, 2009 (Volume 74, Number 67)]
[Notices]
[Page 16214-16217]
[DOCID:fr09ap09-70]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-M-0101]

Medical Devices; Order for Certain Class III Devices; Submission
of Safety and Effectiveness Information

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is issuing an order
requiring manufacturers of remaining preamendments class III devices
for which regulations requiring submission of premarket approval
applications (PMAs) have not been issued to submit to FDA a summary of,

and a citation to, any information known or otherwise available to them
respecting such devices, including adverse safety or effectiveness
information concerning the devices which has not been submitted under
the Federal Food, Drug, and Cosmetic Act (the act). FDA is requiring
the submission of this information in order to determine, for each
device, whether the classification of the device should be revised to
require the submission of a PMA or a notice of completion of a Product
Development Protocol (PDP), or whether the device should be
reclassified into class I or II.

DATES: Summaries and citations must be submitted by August 7, 2009.

ADDRESSES:  Submit paper copies of summaries and citations to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
copies of summaries and citations to http://www.regulations.gov.
Identify summaries and citations with the docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sarah K. Morabito, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The act (21 U.S.C. 301 et seq.), as amended by the Medical Device
Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe
Medical Devices Act (SMDA) (Public Law 101-629), the Food and Drug
Administration Modernization Act of 1997 (Public Law 105-115), the
Medical Device User Fee and Modernization Act of 2002 (Public Law 107-
250), the Medical Devices Technical Corrections Act (Public Law 108-
214), and the Food and Drug Administration Amendments Act of 2007
(Public Law 110-85), establishes a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the act (21 U.S.C. 360c) requires the classification of medical devices
into one of three regulatory classes: Class I (general controls), class
II (special controls), or class III (premarket approval). Generally,
devices that were on the market before May 28, 1976, the date of
enactment of the 1976 amendments, and devices marketed on or after that
date that are substantially equivalent to such devices, have been
classified by FDA. This order refers to both the class III devices that
were on the market before May 28, 1976, and the devices found to be
substantially equivalent to them that were marketed on or after that
date, as ``preamendments devices.''
    Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes the
requirement that a preamendments device that FDA has classified into
class III is subject to premarket approval. However, submission of a
PMA (or a notice of completion of a PDP) is not required until 90 days
after FDA promulgates a final rule requiring premarket approval for the
device, or 30 months after final classification of the device,
whichever is later. See section 501(f)(2)(B) of the act (21 U.S.C.
351(f)(2)(B)). The device may, however, be distributed only for
investigational use if the manufacturer, importer, or other sponsor of
the device complies with the investigational device exemption (IDE)
requirements.
    The SMDA changed the definition of class II devices from those for
which a performance standard is necessary to provide reasonable
assurance of safety and effectiveness to those for which there is
sufficient information to establish special controls to provide such
assurance. Special controls include performance standards, postmarket
surveillance, patient registries, guidelines (including guidelines for
the submission of clinical data in premarket notification submissions
in accordance with section 510(k) of the act (21 U.S.C. 360(k))),
recommendations, and other appropriate actions the agency deems
necessary to provide such assurance. Thus, the SMDA modified the
definition of class II devices to permit reliance on special controls,
rather than performance standards alone, to provide reasonable
assurance of safety and effectiveness.
    The SMDA also added section 515(i) (21 U.S.C. 360e(i)) to the act.
This section requires FDA to order manufacturers of preamendments class
III devices for which no final regulation has been issued requiring the
submission of PMAs to submit to the agency a summary of, and a citation
to, any information known or otherwise available to them respecting
such devices, including adverse safety and effectiveness information
that has not been submitted under section 519 of the act (21 U.S.C.
360i). Section 519 of the act requires manufacturers, importers, and
distributors to maintain records and to report information that
reasonably suggests that one of its marketed devices may have caused or
contributed to a death or serious injury or that a malfunction of the
device is likely to cause death or serious injury on recurrence.
Section 515(i) of the act also directs FDA to either revise the
classification of the device into class I or class II or require the
device to remain in class III; and for devices remaining in class III,
to establish a schedule for the promulgation of a rule requiring the
submission of PMAs for the device.
    In the Federal Register of May 6, 1994 (59 FR 23731), FDA announced
the availability of a notice setting forth its strategy for addressing
the remaining class III preamendments devices. Of the approximately 149
preamendments devices FDA initially classified or proposed to classify
into class III (48 FR 40272, September 6, 1983), FDA has either
reclassified into class I or II, or issued regulations requiring the
submission of PMAs for, all but 27 devices. Of the 27 devices, 25 are
the subject of this notice. The two remaining devices, Herpes simplex
virus serological assays (21 CFR 866.3305) and Topical oxygen chamber
for extremities (21 CFR 878.5650), will be addressed in separate
orders.

II. Statutory Authority and Enforcement

    In addition to the provisions of section 515(i) of the act
described in section I of this document, this order is issued under
section 519 of the act, as implemented by Sec.  860.7(g)(2) (21 CFR
860.7(g)(2)). Section 860.7(g)(2) authorizes FDA to require reports or
other information bearing on the classification of a device. Section
519 of the act also requires the reporting of any death or serious
injury caused by a device or by its malfunction.
    Failure to comply with this order results in the device being
misbranded under section 502(t) of the act (21 U.S.C. 352(t)) and is a
prohibited act under sections 301(a) and (q) of the act (21 U.S.C.
331(a) and (q)). The agency will use its enforcement powers to deter
noncompliance. Violations of section 301 of the act may be subject to
seizure or injunction under sections 302(a) and 304(a) of the act (21
U.S.C. 332(a) and 334(a)). In addition, violations under section 301 of
the act may be subject to civil penalties under section 303(f) of the
act (21 U.S.C. 333(f)) and criminal prosecution under section 303(a) of
the act (21 U.S.C. 333(a)).

III. Order

    The agency is hereby issuing this order under sections 515(i) and
519 of the act and Sec.  860.7(g)(1) of the regulations. Under the
order, the required information must be submitted by the date set forth
in this document (see DATES) so that FDA may begin the process
established by section 515(i) of

the act to either reclassify these devices into class I or II or
initiate rulemaking to require submission of PMAs or PDPs for them. FDA
does not anticipate extending the time for submitting the required
information.
    For the following 25 devices, the required information must be
submitted by August 7, 2009.
    1. 21 CFR 868.5610 Membrane lung for long-term pulmonary support.
    2. 21 CFR 870.3535 Intra-aortic balloon and control system.
    3. 21 CFR 870.3545 Ventricular bypass (assist) device.
    4. 21 CFR 870.3600 External pacemaker pulse generator.
    5. 21 CFR 870.3610 Implantable pacemaker pulse generator.
    6. 21 CFR 870.3680(b) Cardiovascular permanent pacemaker electrode.
    7. 21 CFR 870.3700 Pacemaker programmers.
    8. 21 CFR 870.3710 Pacemaker repair or replacement material.
    9. 21 CFR 870.4360 Nonroller-type cardiopulmonary bypass blood
pump.
    10. 21 CFR 870.5200 External cardiac compressor.
    11. 21 CFR 870.5225 External counter-pulsating device.
    12. 21 CFR 870.5310 Automated external defibrillator.
    13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form).
    14. 21 CFR 872.3960 Mandibular condyle prosthesis (temporary
implant).
    15. 21 CFR 876.5540(b)(1) Implanted blood access device.
    16. 21 CFR 876.5870 Sorbent hemoperfusion system.
    17. 21 CFR 882.5800 Cranial electrotherapy stimulator.
    18. 21 CFR 882.5940 Electroconvulsive therapy device.
    19. 21 CFR 884.5330 Female condom.
    20. 21 CFR 888.3070(b)(2) Pedicle screw spinal system (certain
uses).
    21. 21 CFR 888.3320 Hip joint metal/metal semi-constrained, with a
cemented acetabular component, prosthesis.
    22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an
uncemented acetabular component, prosthesis.
    23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses).
    24. 21 CFR 890.5525(b) Iontophoresis device (certain uses).
    25. 892.1990 Transilluminator for breast evaluation.

Required Contents of Submissions

    By the date listed in the DATES section of this document, all
manufacturers currently marketing the preamendments class III devices
subject to this order shall provide a summary of, and citation to, any
information known or otherwise available to them respecting the
devices, including adverse safety and effectiveness data that has not
been submitted under section 519 of the act. FDA suggests that it may
be in the best interest of submitters to summarize the information
submitted under section 519 of the act to facilitate FDA's
decisionmaking.
    The information should be submitted in one of the two following
formats depending on whether the manufacturer is aware of information
that would support the reclassification of the device into class I
(general controls) or class II (special controls). Information that
would support the reclassification of the device must consist of
adequate, valid scientific evidence showing that general controls
alone, or general controls along with special controls, will provide a
reasonable assurance of the safety and effectiveness of the device.
    If a manufacturer is not aware of information that would support
the reclassification of its device into class I or class II, the
information should be submitted in the following format:
    1. Indications for use. A general description of the disease or
condition to be diagnosed, treated, cured, mitigated, or prevented,
including a description of the patient population for which the device
is intended.
    2. Device description. An explanation of how the device functions,
significant physical and performance characteristics of the device, and
basic scientific concepts that form the basis for the device.
    3. Other device labeling. Other device labeling that includes
contraindications, warnings and precautions and/or promotional
materials.
    4. Risks. A summary of all adverse safety and effectiveness
information and identification of the risks presented by the device as
well as any mechanisms or procedures which will control the risk.
    5. Alternative practices and procedures. A description of
alternative practices or procedures for diagnosing, treating,
preventing, curing, or mitigating the disease or condition for which
the device is intended.
    6. Summary of preclinical and clinical data. The summary of
preclinical and clinical data should include the conclusions drawn from
the studies that support the safety and effectiveness of the device,
and that address the adverse effects of the device on health. The
summary should include a brief description of the objective of the
studies, the experimental design, how the data were collected and
analyzed, and a brief description of the results of the studies,
whether positive, negative, or inconclusive. The summary of the
clinical study should also include a discussion of the subject
inclusion and exclusion criteria, the study population, reasons for
patient discontinuations, and results of statistical analyses.
    7. Bibliography. A copy of each key reference, a brief summary of
the salient features of each key reference, and a brief discussion of
why the reference is relevant to an evaluation of the safety and
effectiveness of the device.
    Any manufacturer who is aware of information that would support the
reclassification of its device into class I or class II may either
submit information using the format described below or may submit a
formal reclassification petition, which as described in 21 CFR
860.123(a)(3) and (a)(4), should include:
    1. Identification. A brief narrative identification of the device.
This identification should be specific enough to distinguish a
particular device from a generic type of device. Where appropriate,
this identification should include a listing of the materials, and the
component parts, and a description of the intended use of the device.
    2. Risks to health. An identification of the risks to health. This
section should summarize all adverse safety and effectiveness
information that has not been submitted under section 519 of the act,
particularly the most significant information. The mechanisms or
procedures that will control the risk should be described. A list of
the general hazards associated with the device and a bibliography with
copies of the referenced material should be provided.
    3. Recommendation. A statement whether the manufacturer believes
the device should be reclassified into class I or class II.
    4. Summary of reasons for recommendation. Each manufacturer should
include a summary of the reasons for requesting reclassification of its
device and an explanation of why it believes the device meets the
statutory criteria for reclassification into class I or class II. Each
manufacturer should also identify the special controls that it believes
would be sufficient to provide reasonable assurance of the safety and
effectiveness of its device if it believes the device should be
reclassified into class II.
    5. Summary of valid scientific evidence on which the recommendation
is based. Manufacturers are advised that, when considering a formal
reclassification petition, FDA will rely

only upon valid scientific evidence to determine whether there is
reasonable assurance of the safety and effectiveness of the device, if
regulated by general controls alone (class I) or by general controls
and special controls (class II). Valid scientific evidence consists of
evidence from well-controlled investigations, partially controlled
studies, studies and objective trials without matched controls, well-
documented case histories conducted by qualified experts, and reports
of significant human experience with a marketed device, from which it
can fairly and responsibly be concluded by qualified experts that there
is reasonable assurance of the safety and effectiveness of a device
under its conditions of use. The evidence required may vary according
to the characteristics of the device, its conditions of use, the
existence and adequacy of warnings and other restrictions, and the
extent of experience with its use. Isolated case reports, random
experience, reports lacking sufficient details to permit scientific
evaluation, and unsubstantiated opinions are not regarded as valid
scientific evidence to show safety or effectiveness (see Sec.
860.7(c)(2)).
    According to Sec.  860.7(d)(1), there is reasonable assurance that
a device is safe when it can be determined, based upon valid scientific
evidence, that the probable benefits to health from use of the device
for its intended uses and conditions of use, when accompanied by
adequate directions and warnings against unsafe use, outweigh any
probable risks. The valid scientific evidence used to determine the
safety of a device shall adequately demonstrate the absence of
unreasonable risk of illness or injury associated with the use of the
device for its intended uses and conditions for use. Moreover, under
Sec.  860.7(e)(1), there is reasonable assurance that a device is
effective when it can be determined, based upon valid scientific
evidence, that in a significant portion of the target population, the
use of the device for its intended uses and conditions of use, when
accompanied by adequate directions for use and warnings against unsafe
use, will provide clinically significant results.

IV. Submission of Required Information

    The summary of, and citation to, any information required by the
act must be submitted by the dates listed in the DATES section of this
document to the Division of Dockets Management (see ADDRESSES).

V. Paperwork Reduction Act of 1995

    This order refers to collections of information necessary to comply
with the requirements found in sections 510(k) of the act (21 U.S.C.
360(k)) and 21 CFR part 807, subpart E or the requirements of 515(b) of
the act (21 U.S.C. 360e(b)), 21 CFR part 860, and 21 CFR part 814.
These collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR 860.123
have been approved under OMB control number 0910-0138; the collections
of information in 21 CFR part 814, have been approved under OMB control
number 0910-0231; and the collections of information in 21 CFR part
807, subpart E have been approved under OMB control number 0910-0120.

    Dated: April 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8022 Filed 4-8-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 41 (Friday, March 3, 2017)]
[Proposed Rules]
[Pages 12424-12426]
[FR Doc No: 2017-04116]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-5019; Directorate Identifier 2015-SW-079-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Airbus Helicopters Model AS332C, AS332C1, AS332L, AS332L1, AS332L2, and
EC225LP helicopters. This proposed AD would require inspecting the
sliding cabin doors. This proposed AD is prompted by the failure of the
sliding door's jettison mechanism due to corrosion. The proposed
actions are intended to address the unsafe condition in these products.

DATES: We must receive comments on this proposed AD by May 2, 2017.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
5019; 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 proposed AD, the European Aviation Safety Agency (EASA)
AD, the economic evaluation, any comments received, and other
information. The street address for the Docket Operations Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.airbushelicopters.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety

Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2015-0156, dated July 29, 2015,
and corrected July 30, 2015, to correct an unsafe condition for Airbus
Helicopters Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2
helicopters manufactured before July 14, 2014, and equipped with cabin
sliding plug doors (sliding doors) modified in accordance with Airbus
Helicopters modification (MOD) AL25612 or 0725870. EASA AD No. 2015-
0156 also applies to Airbus Helicopters Model EC225LP helicopters
manufactured before July 14, 2014, and equipped with sliding doors.
    EASA advises that the sliding door's emergency jettisoning
mechanism failed during a scheduled inspection and that a subsequent
investigation found significant corrosion damage caused by water that
accumulated after a plastic-rubber compound obstructed the water drain
of the door's jettison mechanism system. This condition, if not
detected and corrected, could lead to jamming of the jettisoning
mechanism, possibly preventing the jettisoning of the door during an
emergency and jeopardizing the safe evacuation of occupants, EASA
advises.
    To address this unsafe condition, EASA AD No. 2015-0156 requires a
one-time inspection of the left hand and right hand sliding doors for
corrosion.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other products of the same type design.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters Alert Service Bulletin No. AS332-
53.01.86, Revision 1, dated June 29, 2015 (ASB AS332-53.01.86), for
Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2 helicopters and
military model AS332B, B1, F1, M, and M1 helicopters; and Alert Service
Bulletin No. EC225-53A048, Revision 0, dated August 18, 2014 (ASB
EC225-53A048), for Model EC225LP helicopters. ASB AS332-53.01.86 and
ASB EC225-53A048 specify checking areas of the emergency jettisoning
system of the sliding doors for the absence of sealing compound, for
corrosion on the visible surfaces of the bracket, for the absence of
interference between the stainless steel pipe and the aluminum bracket,
and for non-obstruction of the drain.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements

    This proposed AD would require, within 30 days, visually inspecting
the left-hand and right-hand sliding doors for sealing compound and
removing any sealing compound.
    This proposed AD also would require inspecting all visible bracket
surfaces for corrosion. If there is any corrosion, this proposed AD
would require removing the corrosion, measuring the corrosion depth,
and performing a jettisoning test. If the measured corrosion depth is
less than 0.5 mm and the door passes the test, this proposed AD would
require applying corrosion protectant. If the measured corrosion depth
is 0.5 mm or more and the door passes the test, this proposed AD would
require applying corrosion protectant, retesting at intervals not to
exceed two months, and then replacing the jettisoning system within 6
months. If the door does not pass the test, this proposed AD would
require replacing the jettisoning system before further flight.
    This proposed AD would also require measuring the clearance between
the bracket and stainless steel pipe. If the clearance is less than 3
mm, this proposed AD would require removing the lockwire from the
union, loosening the unions of the air vent pipe, positioning the
support and the air vent pipe to ensure a minimum clearance of 3 mm.
This proposed AD would then require tightening the support and unions
of the pipe and safety the union using lockwire.
    For Model EC225LP helicopters and Model AS332-series helicopters
with modification AL25612, this proposed AD would require inspecting
for drain obstruction and, if the drain is obstructed, removing the
sealing compound and adhesive from the gutter in the bracket area and
unclogging the drain and gutter. This proposed AD would then require
cleaning the gutter, applying adhesive to the gutter, and applying
sealing compound.

Differences Between This Proposed AD and the EASA AD

    The EASA AD requires compliance within various times, depending on
the helicopter model and modifications. This proposed AD would require
compliance within 30 days.

Costs of Compliance

    We estimate that this proposed AD would affect 24 helicopters of
U.S. Registry and that labor costs average $85 per work-hour. Based on
these estimates, we expect that visually inspecting for corrosion would
require 1 work-hour and no parts for a total cost of $85 per
helicopter, and $2,040 for the U.S. fleet. Replacing corroded parts
would require 8 work-hours and parts would cost $500 for a total cost
of $1,180 per helicopter. Replacing the door jettisoning system would
require 16 work-hours and parts would cost $4,500 for a total cost of
$5,860 per 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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the 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 proposed 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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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):

Airbus Helicopters: Docket No. FAA-2016-5019; Directorate Identifier
2015-SW-079-AD.

(a) Applicability

    This AD applies to the following Airbus Helicopters,
certificated in any category:
    (1) Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2
helicopters with a date of manufacture on or before July 14, 2014,
and with a sliding cabin plug door (sliding door) with Airbus
Helicopters modification AL25612 or 0725870 installed; and
    (2) Model EC225LP helicopters with a date of manufacture on or
before July 14, 2014.

(b) Unsafe Condition

    This AD defines the unsafe condition as corrosion of a
jettisoning mechanism which, if not detected and corrected, could
result in failure of a sliding door to jettison, preventing
occupants from exiting the helicopter during an emergency.

(c) Comments Due Date

    We must receive comments by May 2, 2017.

(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 30 days:
    (1) Visually inspect the left-hand and right-hand sliding doors
for sealing compound as shown in Figure 1 of Airbus Helicopters
Alert Service Bulletin No. AS332-53.01.86, Revision 1, dated June
29, 2015 (ASB AS332-53.01.86), or Airbus Helicopters Alert Service
Bulletin No. EC225-53A048, Revision 0, dated August 18, 2014 (ASB
EC225-53A048), as applicable for your model helicopter. Remove any
sealing compound.
    (2) Inspect all visible bracket surfaces for corrosion. If there
is any corrosion, remove the corrosion and measure the corrosion
depth.
    (i) If the measured corrosion depth is less than 0.5 mm, perform
a jettisoning test. If the door passes the test, apply corrosion
protectant. If the door does not pass the test, replace the
jettisoning system before further flight.
    (ii) If the measured corrosion depth is 0.5 mm or more, perform
a jettisoning test. If the door passes the test, apply corrosion
protectant, perform a jettisoning test at intervals not to exceed
two months for not more than six months, and replace the jettisoning
system within six months. If the door does not pass the test,
replace the jettisoning system before further flight.
    (3) Measure the clearance between the bracket and stainless
steel pipe. If the clearance is less than 3 mm, remove the lockwire
from the union and loosen the unions of the air vent pipe. Position
the support and the air vent pipe to ensure a minimum clearance of 3
mm. Tighten the support and unions of the pipe and safety the union
using lockwire.
    (4) For Model EC225LP helicopters and Model AS332-series
helicopters with modification AL25612, inspect for drain obstruction
by compressing the middle rail roller well piston and injecting
distilled water through the roller well to determine if the water
drains. If the drain is obstructed, remove the sealing compound and
adhesive from the gutter in the bracket area. Remove the drain from
the gutter and unclog the drain and gutter using a spatula or brush.
Clean the gutter on the bracket side and the drain. Apply adhesive
to the gutter and then slide in the drain. Allow the adhesive to dry
and then apply sealing compound.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: David Hatfield, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-
5116; 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.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2015-0156, dated July 29, 2015, and corrected
July 30, 2015. You may view the EASA AD on the Internet at http://www.regulations.gov in the AD Docket.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 5220, Emergency
Exits.

    Issued in Fort Worth, Texas, on February 23, 2017.
Lance T. Gant,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2017-04116 Filed 3-2-17; 8:45 am]
BILLING CODE 4910-13-P


 Rock Creek John Day River North Fork John Day R iver Long Creek Camas Creek Hay Creek Middle Fork John Day River Butte Creek Thirtymile Creek South Fork John Day River Bridge Creek Ditch Cree k Pass Creek Grass Valley Canyon Murderers Creek Muddy Creek Rudio Creek Sc ott Canyon Canyon Creek Mountain Creek Ferry Canyon Desolation Creek Cherry Creek Big Wall Creek Alder Cree k Big Creek Fivemile C ree k Potamus Creek Clear Creek Flat Creek Girds Creek Pine Hollow Mallory Creek Owens Creek Pine Creek Hidaway Creek Deer Cre ek Bear Creek Rowe Creek Lake Creek Juniper Creek Parrish Creek Riley Creek Cottonwood Creek Kahler Creek Shoofly Creek Basin Creek Patill Canyon Birch Creek Currant Creek Dixie Creek Lewis Creek Fields Cree k Beech Creek Little W all C ree k Dry Creek Swale Creek Jackk nife Creek Camp Creek Service C reek Johnson Creek Grub Cree k Indian Creek Slide Creek Lone Rock Creek Laycock Creek Roseb ush Creek Squaw Creek Corral Creek Crane Creek Skookum Creek Lost Valley Creek Brown Creek Meadow Creek Horsesho e Creek Long Hollow Creek Sn ipe Cr eek Fall Creek Tex Cr eek Ferris Cree k Cable C ree k Battle Creek Rail Creek Sixm ile Creek Kelsay Creek Buckhorn Creek Big Pine Hollow Vinegar Creek Lob Fork Reynolds Creek Slyfe Creek Bull Run Creek Deep Creek Papers ack Canyon Eightmile Creek D og Creek Wind Creek Fort Creek Juniper Canyon Dans Creek Sorefoot Creek Sunflower Creek Winom Creek Wilson Creek East Fork Dry Creek Hoover Creek Harper Cre ek Rabbit Creek Little Potamus Creek Bacon Creek Olive Creek Dick Creek Tenmile Canyon Venator C reek Spring Hollow Dry Fork Hay Creek Rush Creek Elk Creek Haystack Creek Cummings Creek West Fork Dry Creek Granite Cree k Lick Creek Chapin Creek Rosebud Creek Little Pine Hollow Strawberry Creek Stockdale Creek Junkens Creek Wiley Creek Sixmile Canyon Smoky Creek Be rry Creek Wick Cree k Smith Creek Baldy Creek Idaho Creek Morgan Creek Stony Cree k Fred Creek Tama rack Butte Jonas Creek Cole Canyon Crawford Creek Branson Creek Horse Creek Hinton Creek Tubb Creek Corral Canyon Picnic Creek Marshal l Creek Tamarack Cree k Heidtmann Canyon Little Fe rry Can yon Dodds Creek Onion Creek Wildca t Creek Rancheria Creek Sugarb owl Creek Robinson Canyon Little Indian Creek Jericho Creek Cove Creek Stephenson Creek Silver Creek Cougar Gul ch Straw Fork Wyman Creek Vester Creek Mosquito Creek North Reynolds Creek Gallag her Canyon Brisbois G ulch Bologna Canyon Pine Creek Rock Creek Bridge Creek Pine Creek Clear Creek Lick Creek Indian Creek Birch Creek Canyon Cre ek Dry Creek Pi ne Cre ek Pin e Creek Bear Creek Alder Cree k Bear Creek Dee r Creek Lake Creek Harper Creek Legend Salmon & Steelhead Spawning Through Fry Emergence: 13C/ 55F Unassigned Sept. 1  June 15 Oct. 15  May 15 Oct. 15  June 15 Bull Trout Juvenile Rearing and Spawning: 12C/ 54F Subbasins ( HUCs) Salmon, Steelhead & Bull Trout Spawning Through Fry Emergence Use Designations, John Day Basin, Oregon DRAFT, September 24, 2003 Map produced by Bill Bogue, EPA Region 10, September 24, 2003 Mainstem John Day R. & it's forks are shown in bolder lines UPPER JOHN DAY MIDDLE FORK JOHN DAY LOWER JOHN DAY NORTH FORK JOHN DAY John Day River John Day River John Day River John Day River N. F.

John Day R.


[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30791-30792]
[FR Doc No: 2018-13975]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83510; File Nos. SR-DTC-2017-022; SR-FICC-2017-022; SR-
NSCC-2017-018]

Self-Regulatory Organizations; The Depository Trust Company;
Fixed Income Clearing Corporation; National Securities Clearing
Corporation; Notice of Designation of Longer Period for Commission
Action on Proceedings To Determine Whether To Approve or Disapprove
Proposed Rule Changes To Amend the Loss Allocation Rules and Make Other
Changes

June 25, 2018.
    On December 18, 2017, The Depository Trust Company (``DTC''), Fixed
Income Clearing Corporation (``FICC''), and National Securities
Clearing Corporation (``NSCC'') (collectively, ``Clearing Agencies''),
each filed with the Securities and Exchange Commission (``Commission'')
a proposed rule change to amend the loss allocation rules and make
other changes (SR-DTC-2017-022, SR-FICC-2017-022, and SR-NSCC-2017-
018), respectively (``Proposed Rule Changes''), pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule
19b-4 thereunder.\2\ The Proposed Rule Changes were published for
comment in the Federal Register on January 8, 2018.\3\ On February 8,
2018, the Commission designated a longer period within which to
approve, disapprove, or institute proceedings to determine whether to
approve or disapprove the Proposed Rule Changes.\4\ On March 20, 2018,
the Commission instituted proceedings pursuant to Section 19(b)(2)(B)
of the Act \5\ to determine whether to approve or disapprove the
Proposed Rule Changes.\6\ The Commission did not receive any comments
on the Proposed Rule Changes.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4. On December 18, 2018, the Clearing
Agencies each filed these proposals as advance notices (SR-DTC-2017-
804, SR-FICC-2017-806, SR-NSCC-2017-806) with the Commission
pursuant to Section 806(e)(1) of the Payment, Clearing, and
Settlement Supervision Act of 2010 (``Clearing Supervision Act'')
and Rule 19b-4(n)(1)(i) of the Act (``Advance Notices''). On January
30, 2018, the Commission published in the Federal Register notices
of filing of the Advance Notices. These notices also extended the
review periods for the Advance Notices pursuant to Section
806(e)(1)(H) of the Clearing Supervision Act. (12 U.S.C.
5465(e)(1)(H).) See Securities Exchange Act Release Nos. 82582
(January 24, 2018), 83 FR 4297 (January 30, 2018) (SR-DTC-2017-804);
82583 (January 24, 2018), 83 FR 4358 (January 30, 2018) (SR-FICC-
2017-806); 82584 (January 24, 2018), 83 FR 4377 (January 30, 2018)
(SR-NSCC-2017-806). On April 10, 2018, the Commission required
further information for consideration of the Advance Notices,
pursuant to Section 806(e)(1)(D) of the Clearing Supervision Act,
which provided the Commission with a renewed 60-day review period
beginning on the date that the information requested is received by
the Commission. (12 U.S.C. 5465(e)(1)(D).) As of the date of this
release, the Commission has not yet received the requested
information.
    \3\ Securities Exchange Act Release Nos. 82426 (January 2,
2018), 83 FR 913 (January 8, 2018) (SR-DTC-2017-022); 82427 (January
2, 2018), 83 FR 854 (January 8, 2018) (SR-FICC-2017-022); 82428
(January 2, 2018), 83 FR 897 (January 8, 2018) (SR-NSCC-2017-018).
    \4\ Securities Exchange Act Release No. 82670 (February 8,
2018), 83 FR 6626 (February 14, 2018) (SR-DTC-2017-022; SR-FICC-
2017-022; SR-NSCC-2017-018).
    \5\ 15 U.S.C. 78s(b)(2)(B).
    \6\ Securities Exchange Act Release Nos. 82914 (March 20, 2018),
83 FR 12978 (March 26, 2018) (SR-DTC-2017-022); 82909 (March 20,
2018), 83 FR 12990 (March 26, 2018) (SR-FICC-2017-022); 82910 (March
20, 2018), 83 FR 12968 (March 26, 2018) (SR-NSCC-2017-018).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \7\ provides that proceedings to
determine whether to approve or disapprove a proposed rule change must
be concluded within 180 days of the date of publication of notice of
filing of the proposed rule change. The time for conclusion of the
proceedings may be extended for up to 60 days if the Commission
determines that a longer period is appropriate and publishes the
reasons for such determination.\8\ The 180th day for the Proposed Rule
Changes is July 7, 2018.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).
    \8\ 15 U.S.C. 78s(b)(2)(B)(ii)(II).
---------------------------------------------------------------------------

    The Commission is extending the period for Commission action on the
Proposed Rule Changes. The Commission finds that it is appropriate to
designate a longer period within which to take action on the Proposed
Rule Changes so that the Commission has sufficient time to consider the
issues raised by the Proposed Rule Changes and to take action on the
Proposed Rule Changes. The proposal shall not take effect until all
regulatory actions required with respect to the proposal are
completed.\9\
---------------------------------------------------------------------------

    \9\ See supra note 2.
---------------------------------------------------------------------------

    Accordingly, pursuant to Section 19(b)(2)(B)(ii)(II) of the Act
\10\ and for the reasons stated above, the Commission designates
September 5, 2018, as the date by which the Commission should either
approve or disapprove proposed rule changes SR-DTC-2017-022, SR-FICC-
2017-022, and SR-NSCC-2017-018.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2)(B)(ii)(II).

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-13975 Filed 6-28-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Rules and Regulations]
[Pages 44234-44236]
[FR Doc No: 2018-18850]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0707]
RIN 1625-AA00

Safety Zone; Lake Michigan, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Lake Michigan, near Chicago, IL. This zone is necessary to protect
spectators and vessels from potential hazards associated with a
competition involving motorized personal vehicles on Lake Michigan.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Lake Michigan.

DATES: This rule is effective from 7 a.m. on September 1, 2018 through
5:30 p.m. on September 2, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-

0707 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open Docket
Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email LT John Ramos, Marine Safety Unit Chicago, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. The details of the event were not
provided to the Coast Guard in sufficient time to publish an NPRM.
Delaying the effective date of this rule to wait for a comment period
to run would be impracticable and contrary to the public interest by
inhibiting the Coast Guard's ability to protect the public, mariners,
vessels, and property from the hazards associated with this 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. Delaying the effective date of
this rule would inhibit the Coast Guard's ability to protect
participants, mariners and vessels from the hazards associated with
this event.

III. Legal Authority and Need for Rule

    The legal basis for the rule is the Coast Guard's authority to
establish safety zones: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1,
6.04-1, 6.04-6 and 160.5; Department of Homeland Security Delegation
No. 0170.1. The Coast Guard will enforce a safety zone from 7 a.m.
through 5:30 p.m. on September 1, 2018 and September 2, 2018 in the
vicinity 31st Street Harbor, Chicago IL, for a competition utilizing
motorized personal watercraft. The Captain of the Port Lake Michigan
has determined that a competition of this nature proximate to a
gathering of watercraft proses a significant risk to public safety and
property. Such hazards include potential for collision with spectators
and participants. This rule is needed to protect personnel, vessels,
and the marine environment in the navigable waters within the safety
zone while the competition takes place.

IV. Discussion of the Rule

    This rule establishes a safety zone from 7 a.m. on September 1,
2018 through 5:30 p.m. on September 2, 2018. The safety zone will
encompass all navigable waters of Lake Michigan bounded by a line drawn
from the position 41[deg]49.903' N, 087[deg]36.161' W, then northeast
to 41[deg]50.029' N, 087[deg]35.863' W, then southeast to
41[deg]49.576' N, 087[deg]35.503' W, then southwest to 41[deg]49.484'
N, 087[deg]35.850' W, then along the shoreline back to the point of
origin (NAD 83).
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the Captain of the Port Lake Michigan
or a designated on-scene representative. The Captain of the Port or a
designated on-scene representative may be contacted via VHF Channel 16
or at<PHONE_NUMBER>.

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. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    We conclude that this rule is not a significant regulatory action
because we anticipate that it will have minimal impact on the economy,
will not interfere with other agencies, will not adversely alter the
budget of any grant or loan recipients, and will not raise any novel
legal or policy issues.
    The safety zone created by this rule will be relatively small and
enforced from 7 a.m. through 5:30 p.m. on September 1, 2018 and
September 2, 2018. Moreover, the Coast Guard will issue Broadcast
Notice to Mariners (BNM) via VHF-FM marine channel 16 about the zone
and the rule allows vessels to seek permission to enter the zone. Under
certain conditions, moreover, vessels may still transit through the
safety zone when permitted by the Captain of the Port.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

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, which guides 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 establishment of a safety zone on
Lake Michigan in Chicago, IL. 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. 01. A Record of Environmental Consideration
supporting this determination is available in the docket where
indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact 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 parts 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; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T09-0707 to read as follows:

Sec.  165.T09-0707  Safety zone; Lake Michigan, Chicago, Illinois.

    (a) Location. All navigable waters of Lake Michigan near Chicago,
Illinois, bounded by a line drawn position 41[deg]49.903' N,
087[deg]36.161' W, then northeast to 41[deg]50.029' N, 087[deg]35.863'
W, then southeast to 41[deg]49.576' N, 087[deg]35.503' W, then
southwest to 41[deg]49.484' N, 087[deg]35.850' W, then along the
shoreline back to the point of origin (NAD 83).
    (b) Enforcement period. This rule will be enforced from 7 a.m.
through 5:30 p.m. on September 1, 2018 and September 2, 2018.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into, transiting, or anchoring within this safety
zone is prohibited unless authorized by the Captain of the Port Lake
Michigan or a designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Lake Michigan or a designated
on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port Lake
Michigan is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Lake Michigan to act on
his or her behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Lake Michigan or an on-scene
representative to obtain permission to do so. The Captain of the Port
Lake Michigan or an on-scene representative may be contacted via VHF
Channel 16 or at<PHONE_NUMBER>. Vessel operators given permission to
enter or operate in the safety zone must comply with all directions
given to them by the Captain of the Port Lake Michigan, or an on-scene
representative.

    Dated: August 6, 2018.
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2018-18850 Filed 8-29-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Page 57940]
[FR Doc No: 2014-22951]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0031]

Draft Informed Consent Information Sheet: Guidance for
Institutional Review Boards, Clinical Investigators, and Sponsors;
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the draft guidance document entitled ``Informed
Consent Information Sheet.'' A notice of availability requesting
comments on the draft guidance document appeared in the Federal
Register of July 15, 2014. The Agency is reopening the comment period
to update comments and to receive any new information.

DATES: Submit either electronic or written comments by October 27,
2014.

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

FOR FURTHER INFORMATION CONTACT: Marsha Melvin, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave.,
Building 32, Silver Spring, MD 20993<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 15, 2014 (79 FR 41291), FDA
published a notice of availability with a 60-day comment period to
request comments on the draft guidance document entitled ``Informed
Consent Information Sheet.''
    The Agency has received a request for a 30-day extension of the
comment period for the draft guidance. The request conveyed concern
that the current 60-day comment period does not allow sufficient time
to develop a meaningful or thoughtful response to the draft guidance.
    FDA is reopening the comment period for 30 days. The Agency
believes that a 30-day extension allows adequate time for interested
persons to submit comments without significantly delaying finalizing
the guidance on these important issues.

II. Request for Comments

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

    Dated: September 19, 2014
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22951 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Rules and Regulations]
[Page 78849]
[FR Doc No: 2022-27928]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-1472; Airspace Docket No. 22-AWA-8]
RIN 2120-AA66

Amendment of Class C Airspace; Manchester, NH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting a final rule published in the Federal
Register on December 6, 2022, that amended the Manchester, NH Class C
airspace description to update the Manchester Airport name and airport
reference point (ARP) geographic coordinates. In the description of the
Class C airspace area, the final rule contained an error in the
longitude coordinate of the ARP. This action makes an editorial
correction to insert the correct longitude coordinate in references to
the ARP.

DATES: Effective date 0901 UTC, February 23, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule for Docket No. FAA-2022-1472 in the
Federal Register (87 FR 74505; December 6, 2022), to update the ARP for
the Manchester, NH airport. Subsequent to publication, the FAA
determined that the ARP longitude geographic coordinate was in error.
This rule corrects that error by changing the references from ``long.
71[deg]45'39'' W'' to ``long. 71[deg]26'09'' W''. This is an editorial
change only to match the FAA's National Airspace System Resource
database information.
    Class C airspace areas are published in paragraph 4000 of FAA Order
7400.11G, dated August 19, 2022, and effective September 15, 2022,
which is incorporated by reference in 14 CFR 71.1. The Class C airspace
listed in this document will be published subsequently in FAA Order JO
7400.11.

Correction to Final Rule

    The reference to the Manchester ARP longitude coordinate published
in the Federal Register of December 6, 2022 (87 FR 74505), FR Doc.
2022-26458, is corrected as follows:
    1. On page 74506, in column 2, under the heading ``The Rule''
revise ``The ``Manchester Airport'' name is changed to ``Manchester
Boston Regional Airport'', to match the Airport Master Record database,
and the ARP geographic coordinates are updated from ``lat.
42[deg]56'00'' N, long. 71[deg]26'16'' W'' to ``at. 42[deg]55'58'' N,
long. 71[deg]45'39'' W'' to read ``The ``Manchester Airport'' name is
changed to ``Manchester Boston Regional Airport'', to match the Airport
Master Record database, and the ARP geographic coordinates are updated
from ``lat. 42[deg]56'00'' N, long. 71[deg]26'16'' W'' to ``lat.
42[deg]55'58'' N, long. 71[deg]26'09'' W.''
    2. On page 74506, in column 3, under the heading ``ANE NH C
Manchester, NH [Amended]'' revise ``Manchester Boston Regional Airport,
NH (Lat. 42[deg]55'58'' N, long. 71[deg]45'39'' W)'' to read
``Manchester Boston Regional Airport, NH (Lat. 42[deg]55'58'' N, long.
71[deg]26'09'' W)''.

    Issued in Washington, DC, on December 19, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-27928 Filed 12-22-22; 8:45 am]
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