[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4956-4958]
[FR Doc No: 2015-01646]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74127; File No. SR-NYSEMKT-2015-06]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Establishing the NYSE
MKT Integrated Feed Data Feed

January 23, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on January 21, 2015, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to establish the NYSE MKT Integrated Feed
(``NYSE MKT Integrated Feed'') data feed. The text of the proposed rule
change is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to establish the NYSE MKT Integrated Feed.
The NYSE MKT Integrated Feed would provide real-time market data in a
unified view of events, in sequence, as they appear on the NYSE MKT
matching engines. The NYSE MKT Integrated Feed would include depth of
book order data, last sale data, and opening and closing imbalance
data. The NYSE MKT Integrated Feed would also include security status
updates (e.g., trade corrections and trading halts) and stock summary
messages. The stock summary message updates every minute and includes
NYSE MKT's opening price, high price, low price, closing price, and
cumulative volume for the security. The NYSE MKT Integrated Feed would
include information currently available from three existing NYSE MKT
real-time market data feeds:

NYSE MKT OpenBook,\4\ which provides a compilation of all limit orders
resident in the NYSE MKT limit order book; NYSE MKT Trades,\5\ which
provides NYSE MKT last sale information on a real-time basis; and NYSE
MKT Order Imbalances,\6\ which publishes order imbalance information
prior to the opening and closing of trading.\7\
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    \4\ See Securities Exchange Act Release No. 60123 (June 17,
2009), 74 FR 30192 (June 24, 2009) (SR-NYSEAmex-2009-28).
    \5\ See Securities Exchange Act Release No. 62187 (May 27,
2010), 75 FR 31500 (June 3, 2010)(NYSEAmex-2010-35).
    \6\ See Securities Exchange Act Release Nos. 59743 (April 9,
2009), 74 FR 17699 (April 16, 2009) (SR-NYSEAmex-2009-11); 60151
(June 19, 2009), 74 FR 30653 (June 26, 2009)(SR-NYSEAmex-29).
    \7\ Neither this filing nor the later filing establishing fees
for the NYSE MKT Integrated Feed will have any effect on the filings
for NYSE MKT Openbook, NYSE MKT Trades, or NYSE MKT Order
Imbalances.
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    The Exchange proposes to offer the NYSE MKT Integrated Feed through
the Exchange's Liquidity Center Network (``LCN''), a local area network
in the Exchange's Mahwah, New Jersey data center that is available to
users of the Exchange's co-location services. The Exchange also would
offer the NYSE MKT Integrated Feed through the Exchange's Secure
Financial Transaction Infrastructure (``SFTI'') network, through which
all other users and member organizations access the Exchange's trading
and execution systems and other proprietary market data products.
    Offering an integrated product addresses requests received from
vendors and subscribers that would like to receive the data described
above in an integrated fashion. An integrated data feed would provide
greater efficiencies and reduce errors for vendors and subscribers that
currently choose to integrate the data after receiving it from the
Exchange. The Exchange believes that providing vendors and subscribers
with the option of a market data product that both integrates existing
products and includes additional market data would allow vendors and
subscribers to choose the best solution for their specific businesses.
    The Exchange will file a separate rule filing to establish the fees
for the NYSE MKT Integrated Feed and will announce the date that the
NYSE MKT Integrated Feed will be available through an NYSE Market Data
Notice.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \8\ of the Act, in general, and furthers the
objectives of Section 6(b)(5) \9\ of the Act, in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest, and it is not
designed to permit unfair discrimination among customers, brokers, or
dealers. This proposal is in keeping with those principles in that it
promotes increased transparency through the dissemination of the NYSE
MKT Integrated Feed to those interested in receiving it.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes this proposal is consistent with Section
6(b)(5) of the Act because it protects investors and the public
interest and promotes just and equitable principles of trade by
providing investors with new options for receiving market data as
requested by market data vendors and purchasers. The proposed rule
change would benefit investors by facilitating their prompt access to
the real-time information contained in the NYSE MKT Integrated Feed.
    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker dealers increased authority and
flexibility to offer new and unique market data to consumers of such
data. It was believed that this authority would expand the amount of
data available to users and consumers of such data and also spur
innovation and competition for the provision of market data. The
Exchange believes that the NYSE MKT Integrated Feed is precisely the
sort of market data product that the Commission envisioned when it
adopted Regulation NMS. The Commission concluded that Regulation NMS
would itself further the Act's goals of facilitating efficiency and
competition:

    Efficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\10\
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    \10\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (``Regulation NMS Adopting
Release'').

    The Exchange further notes that the existence of alternatives to
the Exchange's product, including real-time consolidated data, free
delayed consolidated data, and proprietary data from other sources, as
well as the continued availability of the Exchange's separate data
feeds, ensures that the Exchange is not unreasonably discriminatory
because vendors and subscribers can elect these alternatives as their
individual business cases warrant.
    The NYSE MKT Integrated Feed will help to protect a free and open
market by providing additional data to the marketplace and by giving
investors greater choices. In addition, the proposal would not permit
unfair discrimination because the product will be available to all of
the Exchange's customers and broker-dealers through both the LCN and
SFTI.

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

    In accordance with Section 6(b)(8) of the Act,\11\ the Exchange
does not believe that the proposed rule change will impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act. Because other exchanges already offer similar
products, the Exchange's proposed NYSE MKT Integrated Feed will enhance
competition. The NYSE MKT Integrated Feed will foster competition by
providing an alternative to similar products offered by other
exchanges, including the NYSE Arca Integrated Feed,\12\ offered by the
Exchange's affiliate, NYSE Arca, Inc. (``NYSE Arca''), Nasdaq
TotalView-Itch,\13\ offered by The Nasdaq Stock Market, Inc., and BATS
Multicast Pitch,\14\ offered by BATS Global Markets. This proposed new
data feed provides investors with new options for receiving market
data, which was a primary goal of the market data amendments adopted by
Regulation NMS.\15\
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    \11\ 15 U.S.C. 78f(b)(8).
    \12\ See NYSE Arca Integrated Feed, http://www.nyxdata.com/page/1084 (last visited January 5, 2015) (data feed that provides a
unified view of events, in sequence as they appear on the NYSE Arca
matching engine, including depth of book, trades, order imbalance
data, and security status messages).
    \13\ See Nasdaq TotalView-ITCH, http://www.nasdaqtrader.com/Trader.aspx?id=Totalview2 (last visited January 5, 2015) (displays
the full order book depth for Nasdaq market participants and also
disseminates the Net Order Imbalance Indicator (NOII) for the Nasdaq
Opening and Closing Crosses and Nasdaq IPO/Halt Cross).
    \14\ See BATS Multicast PITCH, http://www.batstrading.com/market_data/products/ (last visited January 5, 2015) (real-time
depth of book quotations and execution information).
    \15\ See Regulation NMS Adopting Release, supra, at 37503.

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \16\ and Rule 19b-4(f)(6) thereunder.\17\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, provided that the self-regulatory
organization has given the Commission written notice of its intent to
file the proposed rule change at least five business days prior to the
date of filing of the proposed rule change or such shorter time as
designated by the Commission,\18\ the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \19\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \19\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2015-06 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2015-06. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Section, 100 F Street
NE., Washington, DC 20549-1090, on official business days between the
hours of 10:00 a.m. and 3:00 p.m. Copies of the filing will also be
available for inspection and copying at the NYSE's principal office and
on its Internet Web site at www.nyse.com. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEMKT-2015-06 and should be submitted
on or before February 19, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-01646 Filed 1-28-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Rules and Regulations]
[Page 47482-47487]
[DOCID:fr06au10-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2000-0006; FRL-9185-4]

National Oil and Hazardous Substance Pollution Contingency Plan;
National Priorities List: Deletion of the Peter Cooper Corporation
(Markhams) Superfund Site

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA), Region 2 is
publishing a direct final notice of deletion of the Peter Cooper
Corporation (Markhams) Superfund Site (Markhams Site) located in the
Town of Dayton, Cattaraugus County, New York from the National
Priorities List (NPL).
    The NPL, promulgated pursuant to section 105 of the Comprehensive
Environmental Response,

Compensation, and Liability Act (CERCLA) of 1980, as amended, is an
appendix of the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). This direct final deletion is being published
by EPA with the concurrence of the State of New York, through the
Department of Environmental Conservation (NYSDEC), because EPA has
determined that all appropriate response actions under CERCLA, other
than operation, maintenance, and five-year reviews, have been
completed. However, this deletion does not preclude future actions
under Superfund.

DATES: This direct final rule will be effective September 20, 2010
unless EPA receives adverse comments by September 7, 2010. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final deletion in the Federal Register informing the public that
the deletion will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-2000-0006, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Sherrel Henry, Remedial Project Manager, U.S.
Environmental Protection Agency, Region 2, 290 Broadway, 20th Floor,
New York, New York 10007-1866
     Hand delivery: Superfund Records Center, 290 Broadway,
18th Floor, New York, NY 10007-1866 (telephone:<PHONE_NUMBER>). Such
deliveries are only accepted during the Docket's normal hours of
operation (Monday to Friday from 9 a.m. to 5 p.m.) and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
2000-0006. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.

Docket

    All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at:

U.S. Environmental Protection Agency, Region 2, Superfund Records
Center, 290 Broadway, Room 1828, New York, New York 10007-1866. (212)
637-4308.
Hours: Monday through Friday: 9 a.m. through 5 p.m.
 or
Town of Dayton, Town Building, 9100 Route 62, South Dayton, New York
14138.<PHONE_NUMBER>.
Hours: Monday through Friday: 9 a.m. through 5 p.m.

FOR FURTHER INFORMATION CONTACT: Ms. Sherrel D. Henry, Remedial Project
Manager, U.S. Environmental Protection Agency, Region 2, 290 Broadway,
20th Floor, NY, NY 10007-1866,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Site Deletion
V. Deletion Action

I. Introduction

    EPA Region 2 is publishing this direct final Notice of Deletion of
the Peter Cooper Corporation (Markhams) Superfund Site (Markhams Site)
from the NPL. The NPL constitutes Appendix B of 40 CFR part 300, which
is the National Oil and Hazardous Substances Pollution Contingency Plan
(NCP), which EPA promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA) of 1980, as amended. EPA maintains the NPL as the list of
sites that appear to present a significant risk to public health,
welfare or the environment. Sites on the NPL may be the subject of
remedial actions financed by the Hazardous Substance Superfund (Fund).
As described in 300.425(e) (3) of the NCP, sites deleted from the NPL
remain eligible for Fund-financed remedial actions if future conditions
warrant such actions.
    Because EPA considers this action to be noncontroversial and
routine, this action will be effective September 20, 2010 unless EPA
receives adverse comments by September 7, 2010. Along with this direct
final Notice of Deletion, EPA is co-publishing a Notice of Intent to
Delete in the ``Proposed Rules'' section of the Federal Register. If
adverse comments are received within the 30-day public comment period
on this deletion action, EPA will publish a timely withdrawal of this
direct final Notice of Deletion before the effective date of the
deletion, and the deletion will not take effect. EPA will, as
appropriate, prepare a response to comments and continue with the
deletion process on the basis of the Notice of Intent to Delete and the
comments already received. There will be no additional opportunity to
comment.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III discusses procedures that EPA is using
for this action. Section IV discusses the Markhams Site and
demonstrates how it meets the deletion criteria. Section V discusses
EPA's action to delete the Site from the NPL unless adverse comments
are received during the public comment period.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the State, whether any of the following criteria have
been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed response under CERCLA has been
implemented, and no further response

action by responsible parties is appropriate; or
    iii. The remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-
year reviews to ensure the continued protectiveness of remedial actions
where hazardous substances, pollutants, or contaminants remain at a
site above levels that allow for unlimited use and unrestricted
exposure. EPA conducts such five-year reviews even if a site is deleted
from the NPL. EPA may initiate further action to ensure continued
protectiveness at a deleted site if new information becomes available
that indicates it is appropriate. Whenever there is a significant
release from a site deleted from the NPL, the deleted site may be
restored to the NPL without application of the hazard ranking system.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    (1) EPA consulted with the State of New York prior to developing
this direct final Notice of Deletion and the Notice of Intent to Delete
co-published today in the ``Proposed Rules'' section of the Federal
Register.
    (2) EPA has provided New York State 30 working days for review of
this notice and the parallel Notice of Intent to Delete prior to their
publication today, and the State, through the NYSDEC, has concurred on
the deletion of the Site from the NPL.
    (3) Concurrently with the publication of this direct final Notice
of Deletion, a notice of the availability of the parallel Notice of
Intent to Delete is being published in a major local newspaper, Dunkirk
Observer. The newspaper notice announces the 30-day public comment
period concerning the Notice of Intent to Delete the Site from the NPL.
    (4) The EPA placed copies of documents supporting the proposed
deletion in the deletion docket and made these items available for
public inspection and copying at the Site information repositories
identified above.
    (5) If adverse comments are received within the 30-day public
comment period on this deletion action, EPA will publish a timely
notice of withdrawal of this direct final Notice of Deletion before its
effective date and will prepare a response to comments and continue
with the deletion process on the basis of the Notice of Intent to
Delete and the comments already received.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion of a site from
the NPL does not in any way alter EPA's right to take enforcement
actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist EPA management. Section
300.425(e)(3) of the NCP states that the deletion of a site from the
NPL does not preclude eligibility for future response actions, should
future conditions warrant such actions.

IV. Basis for Site Deletion

    The following information provides EPA's rationale for deleting the
Site from the NPL:

Site Background and History

    The Markhams Site, EPA ID No. NYD980592547, is located off Bentley
Road, in the Town of Dayton, Cattaraugus County, New York. The Site is
approximately 103 acres in size and is bordered to the northwest by
Bentley Road; to the northeast by a wooded property and farm field; to
the southeast by a railroad right-of-way; and to the southwest by
hardwood forest. Site access is restricted by a locked cable gate at
the Bentley Road entrance. Surrounding property is rural, consisting of
small farm fields, open meadow and forests.
    The Site was used for the disposal of wastes remaining after the
manufacturing process from the Peter Cooper Corporation (PCC), a former
animal glue and adhesives plant located in Gowanda, New York. Materials
disposed at the Site were reported to consist of ``cookhouse sludge,''
residue pile material and vacuum filter sludge. Cookhouse sludge was so
named because of a cooking cycle that occurred just prior to extraction
of the glue. It was derived primarily from chrome-tanned hides obtained
from tanneries and leather finishers. Residue pile material is
described as air-dried cookhouse sludge, which was stabilized to a dry,
granular form. Vacuum filter sludge reportedly was produced during
dewatering of cookhouse sludge. The waste material has been shown to
contain elevated levels of chromium, arsenic, zinc, and several organic
compounds.
    PCC purchased the Site in 1955 and sold the Site, among other
assets including its corporate name, in 1976 to a foreign company,
Rousselot Gelatin Corporation, and its parent, Rousselot, S.A. of
Paris, France. Rousellot Gelatin subsequently changed its name to the
Peter Cooper Corporation. From approximately 1955 until September 1971,
it was reported that approximately 9,600 tons of waste material from
the Gowanda plant were placed at the Site over an approximately 15-acre
area.
    In addition, PCC transferred approximately 38,600 additional tons
of waste materials from the Gowanda plant to the Site pursuant to a New
York State Supreme Court Order (8th J.D. Cattaraugus County) dated June
1971. PCC arranged the material into several waste piles approximately
20 feet high and covering a total of approximately seven acres, mostly
in the original disposal area.
    The NYSDEC completed preliminary site investigations in 1983 and
1985 and identified the presence of arsenic, chromium and zinc in soil
samples.
    At that time, the Site did not meet the New York State statutory
definition for an inactive hazardous waste disposal site and NYSDEC
could not use State funds to implement a remedial program.
Consequently, the NYSDEC removed the Site from its Registry of Inactive
Hazardous Waste Disposal Sites and transferred the Site to EPA for
further evaluation.
    In 1993, EPA conducted a Site Sampling Inspection, which included
the collection and analysis of soil and surface water samples from the
Site. Chromium and arsenic were detected in soils above background
concentrations within the waste piles. In 1999, EPA determined a Hazard
Ranking System score for the Site so that it could be evaluated for
potential listing on the National Priorities List (NPL). The Site was
proposed to the NPL on April 23, 1999 (64 FR 19968) and subsequently
added on February 4, 2000 (65 FR 5435).

Remedial Investigation and Feasibility Study (RI/FS)

    On September 29, 2000, EPA issued a Unilateral Administrative Order
(UAO) to several potentially responsible parties (PRPs) to perform the
RI/FS for the Site, subject to EPA oversight. The RI characterized the
physical properties of the soil fill piles, soils around the perimeter
of the fill piles (perimeter surface soils), native subsurface soils,
wetland sediments, groundwater, and soil gas.
    The PRPs, through their consultants, Benchmark Environmental
Engineering and Science PLLC (Benchmark) and Geomatrix Consultants,
performed the Remedial Investigation (RI) from November 2000 to
December 2003 and the final RI report was submitted to EPA in February
2005. The chemicals of concern (COCs) in site media included: arsenic,
total chromium and hexavalent

chromium (metal COCs). The results of the RI suggest that low
concentrations of metal COCs can leach from the waste fill. However,
the data from native soil samples (non-waste fill) collected below the
waste fill indicate that metals have not migrated substantially in
native soil. Arsenic and total chromium concentration detected in the
surface soil samples from the cover of the fill piles were above soil
criteria. Soil testing below the fill piles identified decreasing
concentrations of metal COCs with depth. Metal COCs were reported to
exceed the NYS Groundwater Quality Standards and Guidance Values (GWQS/
GVs) in one groundwater monitoring well MW-2S for arsenic, chromium,
zinc and benzene (with benzene only slightly above the GWQS/GVs). In
the RI report, difficulties in obtaining representative samples from
monitoring well MW-2S were identified. Suggested possible explanations
for these difficulties were the age of the well and construction
materials. The report concluded that the groundwater analytical results
collected from well MW-2S during the first and second sampling events
might not be representative of Site groundwater. To address the
limitations of the sampling from monitoring well MW-2S, the ROD
required that any groundwater monitoring program at the Site include
replacing well MW-2S and conducting analytical sampling for metals.
Monitoring well MW-2S was decommissioned by the PRPs contractor in
September 2008. MW-2S was found to be constructed of steel casing and
screen, and was found to be visibly rusted/rotted on removal. MW-2S was
replaced with a new PVC replacement well (MW-2SR). Site data indicate
that transport of metal COCs and organic compounds is not considered
significant at the Site.
    The RI concluded that all groundwater from the Site ultimately
discharges to Wetland F before reaching the southwestern property
boundary located more that 500 feet across the wetland. Site-related
chemicals in the overburden groundwater are transported beneath the
Site to the southwest in the direction of Wetland F. Water quality data
indicate subsurface conditions are not conducive to transport of metal
COCs. Although chromium was widely detected in soils across the Site,
chromium concentrations were not elevated in groundwater (except in
monitoring well MW-2S). Hexavalent chromium was detected at a low
concentration in one of 18 samples analyzed: the detection was not
confirmed in the second sampling event. The lack of hexavalent chromium
in groundwater suggests conditions are not suitable for the oxidation
of chromium (Cr+3) to hexavalent chromium (Cr+6).
The slightly alkaline subsurface soil conditions and relatively low
concentrations of manganese inhibit reactions that can produce
hexavalent chromium. These results are indicative that the area of
groundwater contamination is limited to a relatively small area, under
the waste piles.
    Based on the results of the RI report a risk assessment was
performed for the Site. The risk assessment determined that if
infiltration of rainwater through the waste/fill material is not
curtailed, then the quality of Site groundwater would continue to
degrade, resulting in a potential future risk from groundwater
ingestion.
    A Feasibility Study (FS) was then completed by the PRPs and
submitted to EPA in August 2006. The FS Report identified and evaluated
effective remedial alternatives for the Site, consistent with the
guidelines presented in ``Guidance for Conducting Remedial
Investigations and Feasibility Studies under CERCLA.'' The FS evaluated
five alternatives, including no action, institutional controls, two
containment alternatives and an excavation/off-site disposal remedies.
The remedial alternatives were developed to satisfy the Remedial Action
Objectives (RAO) for the Site:
     Minimize or eliminate contaminant migration from
contaminated soils to the groundwater.
     Prevent direct contact with waste fill materials.
     Mitigate erosion and migration of waste material from the
exposed surface.

Selected Remedy

    Based upon the results of the RI/FS, a Proposed Plan, and a Public
Meeting, a Record of Decision (ROD) was signed in December 2006. The
major components of the selected remedy included consolidation of
various waste/fill piles into a single waste/fill area, followed by
capping with a low-permeability soil cover. Specifically, the ROD
called for:
     Consolidating the waste/fill piles into seven acres or
less, followed by capping the consolidated wastes with a low
permeability soil cover, consistent with the requirements of 6 NYCRR
Part 360, including seeding with a seed mixture to foster natural
habitat, and replacement of waste piles moved during consolidation with
native soil.
     Imposing institutional controls in the form of an
environmental easement/restrictive covenant filed in the property
records of Cattaraugus County that will at a minimum require: (a)
Restricting activities on the Site that could compromise the integrity
of the cap; and (b) restricting the use of groundwater as a source of
potable or process water unless groundwater quality standards are met.
     Developing a site management plan that provides for the
proper management of all remedy components post-construction, such as
institutional controls, and also includes: (a) Monitoring of
groundwater to ensure that, following the soil consolidation and
capping, the contamination is attenuating and groundwater quality
continues to improve; (b) an inventory of any site use restrictions;
(c) necessary provisions for ensuring the easement/covenant remains in
place and is effective; (d) provision for any operation and maintenance
required of the components of the remedy; and (e) the owner/operator or
entity responsible for maintenance of the Site to complete and submit
periodic certifications concerning the status of the institutional and
engineering controls for the Site.
     Evaluating site conditions at least once every five years
to ensure that the remedy continues to protect public health and the
environment.

Response Actions

    In 2008, EPA concluded Consent Decree negotiations with the PRPs
related to the performance of the design and implementation of the
remedy called for in the ROD. On February 19, 2008, the Consent Decree
was entered in United States District Court (approved by the Judge). On
March 12, 2008 Benchmark Environmental Engineering and Science PLLC
(Benchmark) was approved as the supervising contractor to conduct the
remedial design and construction work at the Site.
    The PRPs prepared a Remedial Design (RD) Report which was approved
by EPA on July 3, 2008. The RD report outlined the following remedial
construction measures: mobilization, site preparation, waste/fill
consolidation and grading, and cover system (barrier layer material
placement and compaction, topsoil and seeding, and passive gas
venting).
    Zoladz Construction Company, Inc. was approved as the subcontractor
for the Remedial Action (RA) and mobilized to the site on July 30,
2008. Site preparation work included clearing, grubbing and access
improvements required for consolidation and covering work. Vegetation
was stripped from the surface of the waste fill where cover soils were
placed.

    Waste/fill consolidation involved relocation of the various waste/
fill piles located at various areas across the center of the site into
a single area. Regraded and consolidated waste/fill were placed in
maximum 12-inch lifts and compacted with rollers to 90% modified
density.
    A total of approximately 40,000 cubic yards of waste/fill were
consolidated and compacted. The waste fill consolidated area has a
footprint of approximately four acres, with an average peak elevation
(including cover soil) of 14 feet above surrounding grade.
Landfill Cap Construction
    The final landfill cap meets the grading requirements of 6 NYCCR
Part 360-2.13(q)2(ii) which requires that the barrier component of the
cap have a slope of no less than 4 percent to promote positive drainage
and no more than 33 percent to minimize erosion.
Cover System
    The final cover system was constructed to function with minimum
maintenance, promote drainage, and minimize erosion. The cover system
was designed with an 18-inch thick recompacted low permeability (less
than 1 x 10-6 cm/sec) soil barrier layer and 6 inches of
topsoil.
Barrier Layer
    Barrier soil was placed and compacted to provide a thickness of 18
inches across the final waste surface. Barrier layer soil was compacted
with rollers. Smooth drum rollers were used for temporary sealing of
the lifts and for the stockpiled soils.
Topsoil, Seeding and Tree Planting
    Following the final grading and compaction of the barrier layer,
topsoil was placed to a depth of six inches (after placement and
rolling). Topsoil was placed and graded to a smooth, even surface and
was rolled and raked to remove ridges and fill in depressions, ruts and
low spots. A conservation seed mixture was used to foster a natural
habitat and minimize maintenance requirements. Fifty trees, including
25 hardwood trees, 13 poplars and 12 birch trees were replanted at
various locations across the Site to provide shelter for the wildlife
and stimulate repopulation of the wooded areas outside of the
consolidated area.

Cleanup Goals

    Results of subsurface soil data indicated that metal COCs have not
migrated into native soils beneath the waste fill piles. The
consolidated waste piles were removed and underlying native soils were
scraped and consolidated into one central area. As a result,
contaminated-specific soil cleanup values for the Site were not
developed. Groundwater is being monitored through post-remedial
groundwater and surface water sampling. The primary objectives of the
remedy are to reduce or eliminate any direct contact threat associated
with the contaminated soils/fill and minimize or eliminate contaminant
migration from contaminated soils to the groundwater.

Operation and Maintenance

    The primary components at the Site to be monitored and maintained
include groundwater and surface water quality, the waste/fill
consolidation area cover system (the Cap), and gas vents. These goals
are being met through the Operation, Maintenance and Monitoring (OM&M)
Plan that describes personnel requirements, responsibilities, duties,
and specifics post-construction sampling, analysis, and monitoring to
be conducted to monitor the effectiveness of the remedy.
    The OM&M plan requires groundwater and surface water sampling to be
conducted on a semiannual (spring and fall) basis for the first two
years of monitoring; sampling may be reduced to annually if the data
support the reduction. The semiannual samples were collected starting
in June and December 2009. Results indicate that the cover system has
minimized contaminant migration from contaminated soils to the
groundwater. In addition, the total metals concentrations reported from
both sampling events for the metal COCs arsenic, total chromium, and
hexavalent chromium were nondetectable or below NYSDEC Groundwater
Quality Standards and Guidance Values (GWQS/GVs).
    As per the OM&M plan, semiannual inspection of the landfill was
conducted concurrently with the sampling described above. Inspection
reports submitted on February 5, 2010, indicated that the final cover
system appears to be in good condition, with the gas-venting system
intact and operational. Semiannual inspections will continue as part of
the OM&M plan.
    The ROD requires the implementation of institutional controls
(ICs). The ICs involve filing of an Environmental Easement to restrict
the use of on-site groundwater as a source of potable or process water
(unless groundwater quality standards are met) and to restrict
activities on the Site that could compromise the integrity of the cap.
    The owner of record of the Site, Peter Cooper Corporation (PCC) is
an inactive Delaware Corporation. A search for potential corporate
successors was conducted and none were found. The PRPs consistent with
the obligation to use reasonable best efforts to implement the ICs:
Commenced an action in Supreme Court, Cattaraugus County, against the
Peter Cooper Corporation to secure an Order from the court to provide
the PRPs with access to the Site and to give permission to implement
the ICs by filing the Easement in the Office of the Clerk of
Cattaraugus County. The Court granted legal access to the Site on July
1, 2008. The ICs were filed with the Clerk's office on July 13, 2008
and a stamped copy was sent to EPA.

Five-Year Review

    Hazardous substances remain at this Site above levels which would
allow for unlimited use and unrestricted exposure. Pursuant to the
Comprehensive Environmental Response, Compensation, and Liability Act,
Section 121(c), EPA must conduct five-year reviews. The first Five-Year
Review Report will be completed prior to July 2013, which is five years
from the initiation of construction for the remedy.

Community Involvement

    Public participation activities for this Site have been satisfied
as required in CERCLA Sec.  113(k) and Section 117. As part of the
remedy selection process, the public was invited to comment on EPA's
proposed remedies. All other documents and information which EPA relied
on or considered in recommending this deletion are available for the
public to review at the information repositories identified above.
    Public participation activities for this Site have been satisfied
as required in CERCLA Section 113(k), 42 U.S.C. 9613(k), and Section
117, 42 U.S.C. 9617. The ROD was subject to a public review process.
All other documents and information that EPA relied on or considered in
recommending this deletion are available for the public to review at
the information repositories.

Determination That the Site Meets the Criteria for Deletion in the NCP

    One of the three criteria for site deletion is when responsible
parties or other persons have implemented all appropriate response
actions required (40 CFR 300.425(e)(1)(I)). EPA, with the concurrence
of the State of New York through NYSDEC, has determined that all
required and appropriate response actions have been implemented by the
responsible parties.

V. Deletion Action

    The EPA, with concurrence of the State of New York, has determined
that all appropriate responses under CERCLA have been completed, and
that no further response actions, under CERCLA, other than O&M and
five-year reviews, are necessary. Therefore, EPA is deleting the Site
from the NPL.
    Because EPA considers this action to be noncontroversial and
routine, EPA is taking it without prior publication. This action will
be effective September 20, 2010, unless EPA receives adverse comments
by September 7, 2010. If adverse comments are received within the 30-
day public comment period, EPA will publish a timely withdrawal of this
direct final notice of deletion before the effective date of the
deletion and it will not take effect, and EPA will prepare a response
to comments and continue with the deletion process on the basis of the
notice of intent to delete and the comments already received. There
will be no additional opportunity to comment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p. 193.

    Dated: July 25, 2010.
Judith A. Enck,
Regional Administrator, Region 2.

0
For the reasons set out in this document, 40 CFR part 300 is amended as
follows:

PART 300--[AMENDED]

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923; 3 CFR, 1987 Comp., p. 193.

0
2. Table 1 of Appendix B to part 300 is amended by removing the entry
for ``Peter Cooper Corporation (Markhams),'' ``Winslow Township,''
``NY.''

[FR Doc. 2010-19417 Filed 8-5-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43124-43125]
[FR Doc No: 2019-17836]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2014-0548; FRL-9998-52-OAR]

Proposed Information Collection Request; Comment Request;
Reformulated Gasoline and Conventional Gasoline: Requirements for
Refiners, Oxygenate Blenders, and Importers of Gasoline; Requirements
for Parties in the Gasoline Distribution Network (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Reformulated Gasoline and
Conventional Gasoline: Requirements for Refiners, Oxygenate Blenders,
and Importers of Gasoline; Requirements for Parties in the Gasoline
Distribution Network'' (EPA ICR No. 1591.27, OMB Control No. 2060-0277)
to the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Before doing so, EPA is soliciting public comments on specific aspects
of the proposed information collection as described below. This is a
proposed extension of the ICR, which is currently approved through 5/
31/2020. 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.

DATES: Comments must be submitted on or before October 21, 2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2014-0548 online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Jose Solar, Office of Transportation
and Air Quality, (Mail Code 6405A), Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-
343-9027; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of

the methodology and assumptions used; (iii) enhance the quality,
utility, and clarity of the information to be collected; and (iv)
minimize the burden of the collection of information on those who are
to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. EPA will consider the comments received and
amend the ICR as appropriate. The final ICR package will then be
submitted to OMB for review and approval. At that time, EPA will issue
another Federal Register notice to announce the submission of the ICR
to OMB and the opportunity to submit additional comments to OMB.
    Abstract: Gasoline combustion is a major source of air pollution in
most urban areas. In the 1990 amendments to the Clean Air Act (Act),
section 211(k), Congress required that gasoline dispensed in nine areas
with severe air quality problems, and areas that opt-in, be
reformulated to reduce toxic and ozone-forming emissions. (Ozone is
also known as smog.) Congress also required that, in the process of
producing reformulated gasoline (RFG), dirty components removed in the
reformulation process not be ``dumped'' into the remainder of the
country's gasoline, known as conventional gasoline (CG). EPA
promulgated regulations at 40 CFR part 80, subpart D--Reformulated
Gasoline, subpart E--Anti-Dumping, and subpart F--Attest Engagements,
implementing the statutory requirements, which include standards for
RFG (80.41) and CG (80.101). The regulations also contain reporting and
recordkeeping requirements pertaining to the production, importation,
transport and storage of gasoline, in order for the regulated parties
to demonstrate compliance and to facilitate compliance oversight and
enforcement by the EPA. The program is run by the Compliance Division,
Office of Transportation and Air Quality, Office of Air and Radiation.
Enforcement is done by the Air Enforcement Division, Office of
Regulatory Enforcement, Office of Enforcement and Compliance Assurance.
This program excludes California, which has separate requirements for
gasoline.
    The United States has an annual gasoline consumption of about 135
billion gallons, of which about 30 percent is RFG. In 2017 EPA received
reports from 255 refineries, 500 importer facilities/facility groups,
2,068 oxygenate blending facilities, 94 independent laboratory
facilities, and the RFG Survey Association, Inc. under this program.
    Section 211(k) of the Act requires the Administrator to promulgate
regulations establishing requirements for RFG to be used in gasoline-
fueled vehicles in the nine specified nonattainment areas, and opt-in
areas. The Act specifically provides that recordkeeping, reporting, and
sampling and testing requirements are among the tools EPA may use in
enforcement of the provisions.
    Information claimed as confidential by regulated parties is handled
in accordance with EPA Freedom of Information Act regulations at 40 CFR
part 2.
    Electronic files received by the Agency are stored in a secure data
base.
    Form numbers: RFG and CG reporting is now required to be completed
electronically. The reporting is to be made through the EPA Fuels
Programs Reporting Forms which are available on the following website:
http://www.epa.gov/otaq/fuels/reporting/index.htm.
    Respondents/affected entities: Recordkeeping and, in some cases,
reporting are required by the following gasoline marketing-related
industries, Standard Industrial Classification (SIC) codes: Refiners
(2911), importers (5172), terminals (5171), pipelines (4613), truckers
and other distributors (4212), and retailers/wholesale purchaser-
consumers (5541). North American Industry Classification System (NAICS)
codes: Refiners (324110), pipelines (486910) and terminals (424710).
Not all NAICS codes for the responsible reporting parties were found.
These are, however, parties which are obligated to report: Importers,
truckers and other distributors and retailers/wholesale purchaser-
consumers. Some refiners are importers but that is not always the case.
Many of the required records are generated and maintained currently in
the normal course of business. Without the required records EPA would
be unable to enforce the Congressionally-mandated RFG and anti-dumping
requirements.
    Respondent's obligation to respond: Mandatory per 40 CFR part 80.
    Estimated number of respondents: 4,283.
    Frequency of response: Quarterly, annually, on occasion.
    Total estimated burden: 127,246 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $39,473,568 (per year), includes $24,713,032
in none-labor costs.
    Changes in estimates: Compared with the ICR currently approved by
OMB, there is no change of burden hours. There is an increase in the
total burden cost due to the update in labor salaries.

    Dated: August 13, 2019.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2019-17836 Filed 8-19-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 43 (Wednesday, March 4, 2020)]
[Notices]
[Pages 12788-12789]
[FR Doc No: 2020-04425]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4843]

Soft (Hydrophilic) Daily Wear Contact Lenses--Performance
Criteria for Safety and Performance Based Pathway; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Soft (Hydrophilic)
Daily Wear Contact Lenses--Performance Criteria for Safety and
Performance Based Pathway; Draft Guidance for Industry and Food and
Drug Administration Staff.'' The device-specific guidance identified in
this notice was developed in accordance with the final guidance
entitled ``Safety and Performance Based Pathway.'' This draft guidance
is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by May 4, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4843 for ``Soft (Hydrophilic) Daily Wear Contact Lenses--
Performance Criteria for Safety and Performance Based Pathway; Draft
Guidance for Industry and Food and Drug Administration Staff.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked

as ``confidential'' will not be disclosed except in accordance with 21
CFR 10.20 and other applicable disclosure law. For more information
about FDA's posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Soft (Hydrophilic) Daily Wear Contact Lenses--Performance Criteria
for Safety and Performance Based Pathway; Draft Guidance for Industry
and Food and Drug Administration Staff'' to the Office of Policy,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Jason Ryans, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft device-specific guidance document provides performance
criteria for premarket notification (510k) submissions to support the
optional Safety and Performance Based Pathway, as described in the
final guidance entitled ``Safety and Performance Based Pathway.'' \1\
As described in that guidance, substantial equivalence is rooted in
comparisons between new devices and predicate devices. However, the
Federal Food, Drug, and Cosmetic Act does not preclude FDA from using
performance criteria to facilitate this comparison. If a legally
marketed device performs at certain levels relevant to its safety and
effectiveness, and a new device meets those levels of performance for
the same characteristics, FDA could find the new device as safe and
effective as the legally marketed device. Instead of reviewing data
from direct comparison testing between the two devices, FDA could
support a finding of substantial equivalence with data demonstrating
the new device meets the level of performance of an appropriate
predicate device(s). Under this optional Safety and Performance Based
Pathway, a submitter could satisfy the requirement to compare its
device with a legally marketed device by, among other things,
independently demonstrating that the device's performance meets
performance criteria as established in the above-listed guidance, when
finalized, rather than using direct predicate comparison testing for
some of the performance characteristics.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
---------------------------------------------------------------------------

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on performance
criteria for the Safety and Performance Based Pathway for soft
(hydrophilic) daily wear contact lenses. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Soft (Hydrophilic)
Daily Wear Contact Lenses--Performance Criteria for Safety and
Performance Based Pathway; Draft Guidance for Industry and Food and
Drug Administration Staff'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 19022 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information. 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. 3501-3521). The collections of information have
been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
``Requests for Feedback on       Q-Submissions..........       0910-0756
 Medical Device Submissions:
 The Q-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
------------------------------------------------------------------------

    Dated: February 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04425 Filed 3-3-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
[Page 38212]
[FR Doc No: 2022-13603]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-405, OMB Control No. 3235-0462]

Proposed Collection; Comment Request; Extension: Customer Account
Statements

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 604 (17 CFR 242.604)
under the Securities Exchange Act of 1934 (17 U.S.C. 78a et seq.)
(``Exchange Act''). The Commission plans to submit this existing
collection of information to the Office of Management and Budget)
(``OMB'') for extension and approval.
    Rule 604 requires specialists and market makers to publish customer
limit orders that are priced superior to the bids or offers being
displayed by each such specialist or market maker.\1\ Customer limit
orders that match the bid or offer being displayed by a specialist or
market maker must be published if the limit price also matches the
national best bid or offer (``NBBO'') and the size of the customer
limit order is more than de minimis (i.e., more than 10% of the
specialist's or market maker's displayed size).
---------------------------------------------------------------------------

    \1\ See Securities Exchange Act Release No. 37619A (September 6,
1996), 61 FR 48290 (September 12, 1996).
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    The information collected pursuant to Rule 604 is necessary to
facilitate the establishment of a national market system for
securities. The publication of trading interests that improve
specialists' and market makers' quotes presents investors with improved
execution opportunities and improved access to the best available
prices when they buy or sell securities.
    The Commission estimates that approximately 318 respondents will
respond to the collection of information requirements each time they
receive a displayable customer limit order. The Commission further
estimates that a respondent will receive a customer limit order, on
average, 15,136.767 times per trading day with an estimate average time
of 0.1 second per quote update. Accordingly, assuming 252 days in a
trading year, an average 105.957 hours per year per respondent, the
Commission estimates that the total annual burden for all respondents
is 33,694 hours.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing by August 26, 2022.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: June 21, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-13603 Filed 6-24-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 181 (Wednesday, September 22, 2021)]
[Proposed Rules]
[Pages 52622-52623]
[FR Doc No: 2021-20266]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0801; Airspace Docket No. 20-ASO-29]
RIN 2120-AA66

Proposed Establishment of Class E Airspace; Fulton, KY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace extending
upward from 700 feet above the surface for Fulton Airport, Fulton, KY,
to accommodate new area navigation (RNAV) global positioning system
(GPS) standard instrument approach procedures (SIAPs) serving this
airport. Controlled airspace is necessary for the safety and management
of instrument flight rules (IFR) operations in the area.

DATES: Comments must be received on or before November 8, 2021.

ADDRESSES: Send comments on this proposal to: U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2021-0801, Airspace Docket No. 20-ASO-29, at the
beginning of your comments. You may also submit comments through the
internet at https://www.regulations.gov.
    FAA Order JO 7400.11F Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order JO 7400.11F at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it would establish Class E airspace in Fulton, KY, to support IFR
operations in the area.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2021-0801 and Airspace Docket No. 20-ASO-29) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2021-0801; Airspace Docket No. 20-ASO-29.'' The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA proposes an amendment to 14 CFR part 71 to establish Class
E airspace extending upward from 700 feet above the surface at Fulton
Airport, Fulton, KY, to accommodate new area navigation (RNAV) global
positioning system (GPS) standard instrument

approach procedures (SIAPs) serving this airport.
    Class E airspace designations are published in Paragraph 6005, of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in the Order.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'', prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order JO 7400.11F, Airspace Designations and Reporting
Points, dated August 10, 2021, and effective September 15, 2021, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO KY E5 Fulton, KY [New]

Fulton Airport, KY
    (Lat. 36[deg]31'32'' N, long. 88[deg]55'04'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.3-mile radius of Fulton Airport.

    Issued in College Park, Georgia, on September 15, 2021.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2021-20266 Filed 9-21-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 198 (Friday, October 12, 2018)]
[Rules and Regulations]
[Pages 51623-51624]
[FR Doc No: 2018-22267]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 83, No. 198 / Friday, October 12, 2018 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 29

[Docket No.FAA-2017-1127; Notice No. 29-044-SC]

Special Conditions: Bell Helicopter Textron, Inc. (BHTI), Model
525 Helicopters; Flight Envelope Protection

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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

SUMMARY: These special conditions are issued for the BHTI Model 525
helicopter. This helicopter will have a novel or unusual design feature
associated with fly-by-wire flight control system (FBW FCS) flight
envelope protection. The applicable airworthiness regulations do not
contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: These special conditions are effective November 13, 2018.

FOR FURTHER INFORMATION CONTACT: George Harrum, Aerospace Engineer,
FAA, Rotorcraft Standards Branch, Policy and Innovation Division, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On December 15, 2011, BHTI applied for a type certificate for a new
transport category helicopter designated as the Model 525. The Model
525 is a medium twin-engine rotorcraft. The design maximum takeoff
weight is 20,500 pounds, with a maximum capacity of 19 passengers and a
crew of 2.
    The BHTI Model 525 helicopter will be equipped with a four axis
full authority digital FBW FCS that provides for aircraft control
through pilot input and coupled flight director modes. The FBW FCS will
contain an advanced flight control system that will alter the nominal
flight control laws to ensure that the aircraft remains in a
predetermined flight envelope. These Flight Envelope Protection (FEP)
features prevent the pilot or autopilot functions from making control
commands that would force the aircraft to exceed its structural,
aerodynamic, or operating limits. The design and construction
standards, specifically 14 CFR Section 29.779(a), require that movement
of the flight controls results in a corresponding sense of aircraft
motion in the same axis. The airworthiness standards for an automatic
pilot system in Section 29.1329 covers design requirements for basic
operation of the system but does not address dynamic flight envelope
limitations imposed by the automatic pilot system. Currently there are
no specific airworthiness requirements that address FBW FCS FEP in
rotorcraft. The special conditions will require the minimum safety
standard for the FEP features.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, BHTI must show that the Model
525 helicopter meets the applicable provisions of part 29, as amended
by Amendment 29-1 through 29-55 thereto. The BHTI Model 525
certification basis date is December 31, 2013, the effective date of
application to the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 29) do not contain adequate or
appropriate safety standards for the BHTI Model 525 because of a novel
or unusual design feature, special conditions are prescribed under the
provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the BHTI Model 525 helicopter must comply with the noise
certification requirements of 14 CFR part 36, and the FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The BHTI Model 525 helicopter will incorporate the following novel
or unusual design features: FBW FCS incorporating FEP features. FEP is
used to prevent the pilot or an autopilot from making control commands
that would force the rotorcraft to exceed its structural, aerodynamic,
or operating limits. To accomplish this envelope limiting, the FCS
control laws change as the limit is approached or exceeded.

Discussion

    These special conditions require the minimum safety standard for
the flight envelope protection features. The FEP features must meet
requirements for handling qualities, compatibility of flight parameter
limit values, response to dynamic maneuvering, and failure modes.

Discussion of Comments

    Notice of proposed special conditions No. 29-044-SC for the BHTI
Model 525 helicopter was published in the Federal Register on June 6,
2018 (83 FR 26226). No comments were received, and the special
conditions are adopted as proposed.

Applicability

    As discussed above, these special conditions are applicable to the
BHTI Model 525 helicopter. Should BHTI apply at a later date for a
change to the type certificate to include another model incorporating
the same novel or unusual design feature, the special conditions would
apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model of rotorcraft. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 29

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Bell Helicopter Textron, Inc., Model
525 helicopters:

Flight Envelope Protection

    The Flight Envelope Protection (FEP) features of the flight control
system (FCS) must meet the following requirements:
    a. Onset characteristics of each envelope protection feature must
be smooth, appropriate to the phase of flight and type of maneuver, and
not in conflict with the ability of the pilot to satisfactorily change
rotorcraft flight path, speed, or attitude within the approved flight
envelope.
    b. Limit values of protected flight parameters (and if applicable,
associated warning thresholds) must be compatible with:
    1. Rotorcraft structural limits;
    2. Safe and controllable maneuvering of the rotorcraft;
    3. Margins to critical conditions. Dynamic maneuvering, airframe
and system tolerances (both manufacturing and in-service), and non-
steady atmospheric conditions--in any appropriate combination and phase
of flight--must not result in a limited flight parameter beyond the
nominal design limit value that would cause unsafe flight
characteristics;
    4. Rotor rotational speed limits;
    5. Blade stall limits; and
    6. Engine and transmission torque limits.
    c. The aircraft must be responsive to pilot-commanded dynamic
maneuvering within a suitable range of the parameter limits that define
the approved flight envelope.
    d. The FEP system must not create unusual or adverse flight
characteristics when atmospheric conditions or unintentional pilot
action causes the approved flight envelope to be exceeded.
    e. When simultaneous envelope limiting is active, adverse coupling
or adverse priority must not result.
    f. Following a single FEP failure shown to not be extremely
improbable, the rotorcraft must:
    1. Be capable of continued safe flight and landing;
    2. Be capable of initial counteraction of malfunctions without
requiring exceptional pilot skill or strength;
    3. Be controllable and maneuverable when operated with a degraded
FCS, within a practical flight envelope identified in the Rotorcraft
Flight Manual;
    4. Be capable of prolonged instrument flight without requiring
exceptional pilot skill;
    5. Meet the controllability and maneuverability requirements of 14
CFR part 29 Subpart B throughout a practical flight envelope; and
    6. Be safely controllable following any additional failure or
malfunction shown to not be extremely improbable occurring within the
approved flight envelope.

    Issued in Fort Worth, Texas, on October 3, 2018.
Jorge Castillo,
Acting Manager, Rotorcraft Standards Branch, Policy and Innovation
Division, Aircraft Certification Services.
[FR Doc. 2018-22267 Filed 10-11-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 27, 2010 (Volume 75, Number 80)]
[Notices]
[Page 22150]
[DOCID:fr27ap10-74]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2010-0281]

Certificate of Alternative Compliance for the Ferry Boat
CHARLEVOIX

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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SUMMARY: The Coast Guard announces that a Certificate of Alternative
Compliance was issued for the ferry boat CHARLEVOIX as required by 33
U.S.C. 1605(c) and 33 CFR 81.18.

DATES: The Certificate of Alternative Compliance was issued on April 2,
2010.

ADDRESSES: The docket for this notice is available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. You may also find this
docket on the Internet by going to http://www.regulations.gov,
inserting USCG-2010-0281 in the ``Keyword'' box, and then clicking
``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call LCDR Wm. Erik Pickering, District Nine, Prevention Branch, U.S.
Coast Guard, telephone<PHONE_NUMBER>. If you have questions on viewing
or submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    A Certificate of Alternative Compliance, as allowed under Title 33
of the Code of Federal Regulations, Parts 81 and 89, has been issued
for the ferry boat CHARLEVOIX. Full compliance with 72 COLREGS and the
Inland Rules Act would hinder the vessel's ability to operate as
designed. Because of the design of the ferry boat CHARLEVOIX, operation
of its whistle at the level required in Rule 34 (g) of 72 COLREGS and
the Inland Rules Act (33 USC 2001 et. seq.) would subject passengers
and crew to dangerous and unacceptable decibel levels. The National
Institute for Occupational Safety and Health states that exposure to
sounds over 85 decibels for periods greater than eight hours will cause
permanent hearing damage. The crew on the ferry boat CHARLEVOIX works
eight hour shifts. Thus, if the ferry boat CHARLEVOIX were to comply
with Rule 34 (g) its crew would potentially suffer permanent hearing
loss.
    The Commandant, U.S. Coast Guard, certifies that full compliance
with the Inland Rules Act would interfere with the normal functions/
intent of the vessel and would not significantly enhance the safety of
the vessel's operation. Requiring the vessel to sound a prolonged
whistle/horn blast at the required decibel level prior to each
departure (approximately every 5.3 minutes, in a 16 hour period/7 days
per week operation) would subject the crew and passengers to
unacceptable decibel levels, and not improve overall vessel safety.
    The Certificate of Alternative Compliance allows for the reducing
of the intensity of the required sound signal to 85 decibel when
leaving the dock/berth during normal operations provided the following
conditions are met: A secondary whistle must be installed that meets
the requirements of Rule 34 (g) and be used when operating in
restricted visibility as per Rule 35 or to reduce the risk of collision
as per Rule 34 (d).
    This notice is issued under authority of 33 U.S.C. 1605(c), and 33
CFR 81.18.

    Dated: April 2, 2010.
L.W. Thomas,
Captain, U.S. Coast Guard, Chief, Inspections and Investigations
Branch, By Direction of the Commander, Ninth Coast Guard District.
[FR Doc. 2010-9682 Filed 4-26-10; 8:45 am]
BILLING CODE 9110-04-P