[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34173-34174]
[FR Doc No: 2019-15170]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IN14-4-000]

Vitol Inc., Federico Corteggiano; Notice of Designation of
Commission Staff as Non-Decisional

    With respect to an order issued by the Commission on July 10, 2019,
in the above-captioned docket, with the exceptions noted below, the
staff of the Office of Enforcement are designated as non-decisional in
deliberations by the Commission in this docket.\1\ Accordingly,
pursuant to 18 CFR 385.2202 (2018), they will not serve as advisors to
the Commission or take part in the Commission's review of any offer of
settlement. Likewise, as non-

decisional staff, pursuant to 18 CFR 385.2201 (2018), they are
prohibited from communicating with advisory staff concerning any
deliberations in this docket.
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    \1\ Vitol Inc. and Federico Corteggiano, 168 FERC ] 61,013
(2019).
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    Exceptions to this designation as non-decisional are:

Jeremy Medovoy
Mark Nagle
Jessica Wack
Ambrea Watts
Benjamin Jarrett
Alfred Jasins
Darice Xue
Joel Douglas

    Dated: July 11, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-15170 Filed 7-16-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 19, 2009 (Volume 74, Number 95)]
[Notices]
[Page 23459-23462]
[DOCID:fr19my09-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59908; File No. SR-BX-2009-021]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing of Proposed Rule Change To Amend the Restated Certificate of
Incorporation and By-Laws of NASDAQ OMX BX, Inc.

May 12, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on April 29, 2009, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. 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\ 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

    BX is filing this proposed rule change with regard to proposed
changes to its Restated Certificate of Incorporation and By-Laws. The
proposed rule change will be implemented as soon as practicable
following approval by the Commission. The text of the proposed rule
change is available at http://nasdaqomxbx.cchwallstreet.com, at BX's
principal office, and at the Commission's Public Reference Room.

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

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

and C below, of the most significant aspects of such statements.

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

1. Purpose
    On August 29, 2008, BX was acquired by NASDAQ OMX. Following that
acquisition, BX--together with The NASDAQ Stock Market LLC (the
``NASDAQ Exchange'') and NASDAQ OMX PHLX, Inc. (formerly the
Philadelphia Stock Exchange, Inc. and also an exchange subsidiary of
NASDAQ OMX, and referred to herein as ``PHLX'')--has been evaluating
means to realize synergies in the operations of these three exchanges
while maintaining the separate identity and member representation
structures of each.
    In making this evaluation, BX and its sister exchanges have given
consideration to the experiences of their respective boards and have
reviewed the governance documents of other exchanges. In particular, BX
and the other exchanges have reviewed the board structures established
by NYSE Euronext and its exchange subsidiaries. In Securities Exchange
Act Release No. 55293,\3\ the Commission approved a structure in which
certain committees of the board of directors of NYSE Euronext, the
public holding company, perform functions for exchange subsidiaries,
which do not themselves have these committees. Specifically, the
Commission's approval order states that ``the NYSE Euronext board of
directors will have an audit committee, a human resource and
compensation committee, and a nominating and governance committee. Each
of the audit committee, human resource and compensation committee, and
nominating and governance committee of the NYSE Euronext board of
directors will consist solely of directors meeting the independence
requirements of NYSE Euronext. These committees also will perform
relevant functions for NYSE Group,\4\ the Exchange,\5\ NYSE Market,\6\
NYSE Regulation,\7\ Archipelago,\8\ NYSE Arca,\9\ and NYSE Arca
Equities,\10\ as well as other subsidiaries of NYSE Euronext, except
that the board of directors of NYSE Regulation will continue to have
its own compensation committee and nominating and governance
committee.''
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    \3\ Securities Exchange Act Release No. 55293 (February 14,
2007), 72 FR 8033 (February 22, 2007) (SR-NYSE-2006-120).
    \4\ NYSE Group, Inc., the former public holding company of NYSE
Euronext's U.S. exchanges.
    \5\ New York Stock Exchange LLC (``NYSE''), a registered
national securities exchange.
    \6\ NYSE Market, Inc., a subsidiary of NYSE to which it has
delegated certain operational authority.
    \7\ NYSE Regulation, Inc., a subsidiary of NYSE to which it has
delegated certain operational authority.
    \8\ Archipelago Holdings, Inc., formerly the public holding
company of the entities now known as NYSE Arca, Inc. and NYSE Arca
Equities, Inc.
    \9\ NYSE Arca, Inc., a registered national securities exchange.
    \10\ NYSE Arca Equities, Inc., a subsidiary of NYSE Arca to
which it has delegated certain operational authority.
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    BX and the other exchanges owned by NASDAQ OMX have also considered
the experience of the NASDAQ Exchange in operating as a subsidiary of a
public company since 2006. During the period, the board of each of the
NASDAQ Exchange and its parent corporation (currently NASDAQ OMX, and
formerly The Nasdaq Stock Market, Inc.) has appointed its own audit
committee and management compensation committee. However, these
committees at the NASDAQ Exchange level have generally found themselves
duplicating the work of other committees at the exchange or holding
company level. The NASDAQ OMX audit committee has broad authority to
review the financial information that will be provided to shareholders
and others, systems of internal controls, and audit, financial
reporting and legal and compliance processes. Because NASDAQ OMX's
financial statements are prepared on a consolidated basis that includes
the financial results of NASDAQ OMX's subsidiaries, including BX and
the other exchange subsidiaries, the NASDAQ OMX audit committee's
purview necessarily includes these subsidiaries. The committee is
composed of four or five directors, all of whom must be independent
under the standards established by Section 10A(m) of the Act \11\ and
Rule 4200(a) of the NASDAQ Exchange. All committee members must be able
to read and understand financial statements, and at least one member
must have past employment experience in finance or accounting,
requisite professional certification in accounting, or any other
comparable experience or background that results in the individual's
financial sophistication.
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    \11\ 15 U.S.C. 78j-1(m).
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    By contrast, the audit committee of the NASDAQ Exchange has a more
limited role, focused solely on the exchange entity and its
subsidiaries that operate as facilities of the NASDAQ Exchange. As
described in the current By-Laws of the NASDAQ Exchange (which are, in
this respect, virtually identical to the current By-Laws of BX), the
primary functions of the audit committee are (i) Oversight over
financial reporting, (ii) oversight over the systems of internal
controls established by management and the Board and the legal and
compliance process, (iii) selection and evaluation of independent
auditors, and (iv) direction and oversight of the internal audit
function. However, to the extent that the committee reviews financial
and accounting matters, its activities are duplicative of the
activities of the NASDAQ OMX audit committee, which is also charged
with providing oversight over financial reporting and independent
auditor selection for NASDAQ OMX and all of its subsidiaries, including
the NASDAQ Exchange, BX, and PHLX and their subsidiaries. Similarly,
the NASDAQ OMX audit committee has general responsibility for oversight
over internal controls and direction and oversight over the internal
audit function for NASDAQ OMX and all of its subsidiaries. Thus, the
responsibilities of the exchanges' audit committees are fully
duplicated by the responsibilities of the NASDAQ OMX audit committee.
Accordingly, the NASDAQ Exchange is proposing to allow the elimination
of its audit committee by amending Article III, Section 5 of the By-
Laws.\12\ Similarly, drawing upon the model established by NYSE
Euronext and the experience of the NASDAQ Exchange, BX is likewise
proposing to allow the elimination of its audit committee by amending
Section 4.13 of its By-Laws.
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    \12\ SR-NASDAQ-2009-042 (April 29, 2009). PHLX expects to file a
similar proposed rule change in the near future.
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    BX believes, however, that even in light of the NASDAQ OMX audit
committee's overall responsibilities for internal controls and the
internal audit function, it is nevertheless important for the BX Board
to maintain its own independent oversight over BX's controls and
internal audit matters relating to BX's operations. In this regard, BX
notes that its regulatory oversight committee currently has broad
authority to oversee the adequacy and effectiveness of BX's regulatory
and self-regulatory organization responsibilities, and is therefore
able to maintain oversight over controls in tandem with the NASDAQ OMX
audit committee's overall control oversight responsibilities.
Similarly, it is already the practice of NASDAQ OMX's Internal

Audit Department (``Department''),\13\ which performs internal audit
functions for all NASDAQ OMX subsidiaries, to report to the BX
regulatory oversight committee on all internal audit matters relating
to BX. This practice will be formally reflected in the Department's
written procedures. In addition, to ensure that the BX Board retains
authority to direct the Department's activities with respect to BX, the
Department's written procedures will be amended to stipulate that the
BX regulatory oversight committee may, at any time, direct the
Department to conduct an audit of a matter of concern to it and report
the results of the audit both to the BX regulatory oversight committee
and the NASDAQ OMX audit committee.
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    \13\ See e-mail from John Yetter, Vice President and Deputy
General Counsel, NASDAQ OMX Group, Inc., to Christopher W. Chow,
Special Counsel, Commission, dated May 5, 2009.
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    BX also proposes to amend Section 4.13 of the By-Laws in order to
follow the NYSE Euronext model with respect to allowing the elimination
of its compensation committee and the performance of its function by
the NASDAQ OMX compensation committee and/or subsidiary boards. The
NASDAQ OMX By-Laws provide that its compensation committee considers
and recommends compensation policies, programs, and practices for
employees of NASDAQ OMX. Because many employees performing work for BX
are also employees of NASDAQ OMX, its compensation committee already
performs these functions for such employees. Moreover, certain of its
senior officers are also officers of NASDAQ OMX and other NASDAQ OMX
subsidiaries because their responsibilities relate to multiple entities
within the NASDAQ OMX corporate structure. Accordingly, NASDAQ OMX pays
these individuals and establishes compensation policy for them. Most
notably, the former Chief Executive Officer of BX was also an
``executive officer'' of NASDAQ OMX within the meaning of NASDAQ
Exchange Rule 4350.\14\ Under that rule, the compensation of executive
officers of an issuer of securities, such as the common stock of NASDAQ
OMX, that is listed on the NASDAQ Exchange, must be determined by, or
recommended to the board of directors for determination by, a majority
of independent directors or a compensation committee comprised solely
of independent directors. Accordingly, the NASDAQ OMX board of
directors and/or its compensation committee was legally required to
establish the compensation for this individual. Although the individual
recently resigned his positions with NASDAQ OMX and its subsidiaries in
order to pursue another opportunity, it is likely that his successor as
Chief Executive Officer of BX will serve in a similar position at
NASDAQ OMX and therefore be subject to comparable compensation
requirements.
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    \14\ The position of Chief Executive Officer of BX is currently
vacant, pending selection of a successor.
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    To the extent that policies, programs, and practices must also be
established for any BX officers or employees who are not also NASDAQ
OMX officers or employees, the BX Board will perform such actions
without the use of a compensation committee (but subject to the recusal
of Staff Directors) \15\ unless the persons in question are also
employees of Boston Options Exchange Regulation LLC (``BOXR''). BOXR is
the subsidiary of BX that has been delegated responsibility to regulate
the market operated by Boston Options Exchange Group LLC (``BOX''), an
options exchange that is a facility of BX but in which neither BX nor
any of its affiliates has a financial interest. Section 17 of the By-
Laws of BOXR (which are part of its Limited Liability Company
Agreement) provides that the compensation of BOXR's officers shall be
determined by the BOXR Board. Because of BOXR's special status as a
regulatory subsidiary, this provision will remain operative following
the implementation of the rule change proposed by this filing. Finally,
it should be noted that as already provided in the By-Laws, the
regulatory oversight committee of the BX Board must be informed about
the compensation and promotion or termination of the BX chief
regulatory officer and the reasons therefor, to allow it to provide
oversight over decisions affecting this key officer.\16\
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    \15\ Staff Directors are directors of BX that are also serving
as officers. Since the BX Board would not be responsible for setting
the compensation of any Staff Directors who are also officers of
NASDAQ OMX, they would be permitted to participate in discussions
concerning compensation of BX employees, but would recuse themselves
from a vote on the subject to allow the determination to be made by
directors that are not officers or employees of BX. If a Staff
Director was not also an employee of NASDAQ OMX, that Staff Director
would also absent himself or herself from any deliberations
regarding his or her compensation.
    \16\ In this filing, BX is also amending its Restated
Certificate of Incorporation and By-laws to reflect the name change
of The Nasdaq Stock Market, Inc. to The NASDAQ OMX Group, Inc. See
Article Fourth of Restated Certificate of Incorporation; Section 9.4
of the By-Laws.
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2. Statutory Basis
    BX believes that its proposal is consistent with Section 6(b) of
the Act \17\ in general, and furthers the objectives of: (1) Section
6(b)(1) of the Act,\18\ which requires a national securities exchange
to be so organized and have the capacity to carry out purposes of the
Act and to enforce compliance by its members and persons associated
with its members with the provisions of the Act; and (2) Section
6(b)(5) of the Act,\19\ in that it is designed, among other things, to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest.
Specifically, the proposed rule change will allow BX to eliminate two
Board committees whose roles are limited by BX's status as a wholly
owned subsidiary of NASDAQ OMX, thereby allowing directors to focus
greater attention on matters falling directly within the purview of the
Board, including regulatory quality, market structure, new product
initiatives, and review of proposed rule changes. The filing also
updates the corporate name of NASDAQ OMX in the Restated Certificate of
Incorporation and By-Laws.
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    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78(b)(1).
    \19\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    BX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:

    (A) By order approve the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2009-021 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2009-021. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2009-021 and should be
submitted on or before June 8, 2009.
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    \20\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-11609 Filed 5-18-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Notices]
[Page 53427]
[FR Doc No: 2011-21796]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12845-003; Project No. 14092-000]

Free Flow Power Corporation; Northland Power Mississippi River
LLC; Notice of Competing Preliminary Permit Applications Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

    On January 11, 2011, Free Flow Power Corporation (Free Flow) and
Northland Power Mississippi River LLC (Northland) filed preliminary
permit applications, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of developing hydropower projects
hydropower on the Mississippi River, near the town of Killona, in St.
Charles Parish, Louisiana. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed projects are described as follows:

    Free Flow's hydrokinetic Project, Project No. 12845-003 would
consist of: (1) Up to 1,200 SmartTurbine generating units installed
in arrays on the bottom of the river; (2) the total capacity of the
installation would be up to 48,000 kilowatts; (3) flexible cables
would convey each arrays power to a metering station; and (4) a
transmission line would interconnect with the power grid. The
proposed project would have an average annual generation of
109,162,800 kilowatt-hours (kWh), which would be sold to a local
utility.
    Northland's hydrokinetic Project, Project No. 14092-000 would
consist of: (1) Up to 180 TREK generating units installed in a
matrix on the bottom of the river; (2) the total capacity of the
installation would be up to 45,000 kilowatts; (3) shielded
underwater cables would convey each matrix power to a substation;
and (4) a transmission line would interconnect with the power grid.
The proposed project would have an average annual generation of
394,000,000 kWh, which would be sold to a local utility.
    Applicants Contact: For Free Flow: Ramya Swaminathan, Free Flow
Power Corporation, 239 Causeway Street, Boston, MA 02114; phone
(978) 283-2822. For Northland: Tim Richardson, 30 St. Clair Avenue
West, 17th Floor, Toronto, Ontario, Canada; phone<PHONE_NUMBER>.
    FERC Contact: Michael Spencer,<PHONE_NUMBER>.

    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text-only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and eight copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-12845-003, or P-14092-000) in the docket
number field to access the document. For assistance, contact FERC
Online Support.

    Dated: August 18, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-21796 Filed 8-25-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Rules and Regulations]
[Page 29947]
[FR Doc No: E9-14768]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0440]

Drawbridge Operation Regulations; Long Island, New York Inland
Waterway From East Rockaway Inlet to Shinnecock Canal, Nassau County,
NY, Public Event

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Meadowbrook State Parkway Bridge across Sloop Channel, mile 12.8, and
the Long Beach Bridge, mile 4.7, across Reynolds Channel, Nassau
County, New York. This deviation is necessary to facilitate the Salute
to Veterans Fireworks Display. The deviation allows the bridges to
remain in the closed position during the Salute to Veterans event to
facilitate public safety.

DATES: This deviation is effective from 9:30 p.m. on June 27, 2009
through midnight on June 28, 2009.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2009-0440 and are available online
by going to www.regulations.gov, selecting the Advanced Docket Search
option on the right side of the screen, inserting USCG-2009-0440 in the
docket ID box, pressing Enter, and then clicking on the item in the
Docket ID column. This material is also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Ms. Judy Leung-Yee, Project Officer, First Coast Guard
District, telephone<PHONE_NUMBER><EMAIL_ADDRESS>If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Town of Hempstead, Department of Public
Safety, requested this temporary deviation to facilitate a public
event, the Salute to Veterans Fireworks Display. The Meadowbrook State
Parkway Bridge, mile 12.8 across the Sloop Channel and the Long Beach
Bridge, mile 4.7, across Reynolds Channel must remain in the closed
position for two and one half hours to help facilitate public safety
during the fireworks event.
    The Meadowbrook Parkway Bridge, across Sloop Channel at mile 12.8,
at Nassau County, New York, has a vertical clearance in the closed
position of 22 feet at mean high water and 25 feet at mean low water.
The Long Beach Bridge at mile 4.7 across Reynolds Channel has a
vertical clearance of 20 feet at mean high water and 24 feet at mean
low water. The drawbridge operation regulations are listed at 33 CFR
117.799.
    Under this temporary deviation the Meadowbrook State Parkway Bridge
may remain in the closed position from 9:30 p.m. through midnight and
the Long Beach Bridge may remain in the closed position from 10 p.m. to
midnight on June 27, 2009, with a rain date of June 28, 2009. Vessels
that can pass under the draw in the closed position may do so at all
times.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: June 3, 2009.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. E9-14768 Filed 6-23-09; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register Volume 86, Number 79 (Tuesday, April 27, 2021)]
[Notices]
[Page 22294]
[FR Doc No: 2021-08730]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No 270-581, OMB Control No. 3235-0649]

Proposed Collection; Comment Request

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

Extension:
    Rule 17g-5.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 17g-5 (17 CFR 240.17g-5)
under the Securities Exchange Act of 1934 (15 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 17g-5 requires the disclosure of and establishment of
procedures to manage certain NRSRO conflicts of interest, prohibits
certain other NRSRO conflicts of interest, and contains requirements
regarding the disclosure of information in the case of the conflict of
interest of an NRSRO issuing or maintaining a credit rating on an
asset-backed security that was paid for by the issuer, sponsor, or
underwriter of the security. The Commission estimates that the total
annual burden for respondents to comply with Rule 17g-5 is 262,185
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 on
respondents; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid Office of Management and Budget (OMB) control number.
    Please direct your written comments to: Dave Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F St NE, Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>
    Dated: April 22. 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-08730 Filed 4-26-21; 8:45 am]
BILLING CODE 8011-01-P


Proposed Information Collection Request; Water Quality Standards Program (Renewal): Response to Public Comments
      This document provides EPA's response to comments on the Federal Register notice Proposed Information Collection Request: Water Quality Standards Program (Renewal), 86 FR 15665, March 24, 2021. The comments received are available individually in the docket for the notice. To access the docket, go to www.regulations.gov and enter "EPA-HQ-OW-2011-0465" in the Search box.

EPA-HQ-OW-2011-0465-0028: Anonymous public comment
Comment: We support cleaner water standards.
EPA response: EPA acknowledges and appreciates the comment and its support for water quality standards. Because the comment does not provide views or information directly relevant to the proposed Information Collection Request (ICR), however, it was not considered in developing the ICR.

EPA-HQ-OW-2011-0465-0029: Comment submitted by Kim D (no surname provided)
Comment: I support clean water standards and the effort the EPA needs to take in order to collect information to review and assess Water Quality Standards. Understanding that it can be a significant burden to states and authorized tribes associated with the information collections, I believe it is important to maintain clean water sources for all individuals and this is not the place to cut corners.
EPA response: EPA acknowledges and appreciates the comment and its support for water quality standards and the collections described in the ICR. As described in the supporting statement for the ICR, EPA will continue to work with state and tribal respondents to minimize the burden of collections as appropriate.

EPA-HQ-OW-2011-0465-0030: Anonymous public comment
Comment: I support cleaner water standards. I believe we should have tools and processes in place to enhance the quality and clarity of information collected. These rules should be standardized across the board.
EPA response: EPA acknowledges and appreciates the comment and its support for water quality standards. EPA agrees with the need to enhance information quality and clarity and will continue to work with state and tribal co-regulators to that end, including providing guidance and tools and exercising its oversight role as necessary.

EPA-HQ-OW-2011-0465-0031: Anonymous public comment, postmarked May 24, 2021
Comment: As a Florida resident, I support cleaner water standards.
EPA response: EPA acknowledges and appreciates the comment and its support for water quality standards. Because the comment does not provide views or information directly relevant to the proposed ICR, however, it was not considered in developing the ICR.

EPA-HQ-OW-2011-0465-0032: Anonymous public comment, postmarked May 24, 2021
Comment: We support cleaner water standards!
EPA response: EPA acknowledges and appreciates the comment and its support for water quality standards. Because the comment does not provide views or information directly relevant to the proposed ICR, however, it was not considered in developing the ICR.


[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Proposed Rules]
[Pages 27165-27168]
[FR Doc No: 2013-10934]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2012-0746; FRL-9810-9]

Approval and Promulgation of Implementation Plans; Utah;
Revisions to Utah Rule R307-107; General Requirements; Breakdowns

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve changes to Utah's rule R307-107,
which pertains to source emissions during breakdowns. On April 18,
2011, EPA finalized a rulemaking which found that the Utah State
Implementation Plan

(SIP) was substantially inadequate to attain or maintain the national
ambient air quality standards (NAAQS) or to otherwise comply with the
requirements of the Clean Air Act (CAA) because it included rule R307-
107. Concurrent with this finding, EPA issued a SIP call that required
the State to revise its SIP by either removing R307-107 or correcting
its deficiencies, and to submit the revised SIP to EPA by November 18,
2012. On August 16, 2012, the State submitted to EPA revisions to R307-
107. EPA is proposing that these revisions correct the rule's
deficiencies and, therefore, satisfy EPA's April 18, 2011 SIP call. If
EPA finalizes its proposed approval, all sanctions clocks and the clock
for EPA to promulgate a federal implementation plan (FIP) will end.

DATES: Comments must be received on or before June 10, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2012-0746, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Carl Daly, Director, Air Program, U.S. Environmental
Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street,
Denver, Colorado 80202-1129.
     Hand Delivery: Carl Daly, Director, Air Program, U.S.
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129. Such deliveries are only
accepted Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding
Federal holidays. Special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2012-0746. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
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 www.regulations.gov or email. The
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 email comment
directly to EPA, without going through www.regulations.gov, your email
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. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm. For additional
instructions on submitting comments, go to Section I. General
Information of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the
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 hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air Program, U.S.
Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129. EPA requests that if at all possible, you
contact the individual listed in the FOR FURTHER INFORMATION CONTACT
section to view the hard copy of the docket. You may view the hard copy
of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Adam Clark, U.S. Environmental
Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street,
Denver, Colorado 80202-1129,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
II. Background
III. Revised Utah Rule R307-107 and EPA Analysis
IV. EPA's Proposed Action
V. Statutory and Executive Order Reviews

Definitions

    For the purpose of this document, the following definitions
apply:
    i. The words or initials Act or CAA mean or refer to the Clean
Air Act, unless the context indicates otherwise.
    ii. The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    iii. The initials FIP mean or refer to federal implementation
plan.
    iv. The initials NAAQS mean or refer to National Ambient Air
Quality Standards.
    v. The initials NESHAPS mean or refer to National Emission
Standards for Hazardous Air Pollutants.
    vi. The initials NSPS mean or refer to New Source Performance
Standards.
    vii. The initials SIP mean or refer to state implementation
plan.
    viii. The initials SSM mean or refer to startup, shutdown, and
malfunction.
    ix. The words State or Utah mean the State of Utah, unless the
context indicates otherwise.
    x. The initials UAQB mean or refer to the Utah Air Quality
Board.
    xi. The initials UDAQ mean or refer to the Utah Division of Air
Quality, Utah Department of Environmental Quality.
    xii. The words 1999 Policy mean or refer to the September 20,
1999 EPA Memorandum signed by Steven A. Herman, Assistant
Administrator for Enforcement and Compliance Assurance, and Robert
Perciasepe, Assistant Administrator for Air and Radiation, titled
``State Implementation Plans: Policy Regarding Excess Emissions
During Malfunctions, Startup, and Shutdown.''

I. General Information

What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments.
    When submitting comments, remember to:
    a. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).

    b. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    c. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    h. Make sure to submit your comments by the comment period deadline
identified.

II. Background

    On April 18, 2011, EPA published a final rulemaking in the Federal
Register (76 FR 21639) that found that the Utah SIP was substantially
inadequate to attain or maintain the NAAQS or to otherwise comply with
the requirements of the CAA because it included rule R307-107. In
particular, we explained that R307-107: (1) Did not treat all
exceedances of SIP and permit limits as violations; (2) could have been
interpreted to grant the Utah executive secretary exclusive authority
to decide whether excess emissions constituted a violation; and (3)
improperly applied to Federal technology-based standards such as New
Source Performance Standards (NSPS) and National Emission Standards for
Hazardous Air Pollutants (NESHAPS). We concluded that R307-107
undermined EPA's, Utah's, and citizens' ability to enforce emission
limitations that have been relied on in the SIP to ensure attainment
and maintenance of the NAAQS or meet other CAA requirements. 76 FR
21640.
    Accordingly, we issued a SIP call which required the State to
revise its SIP by either removing R307-107 or correcting its
deficiencies, and to submit the revised SIP to us by November 18, 2012.
Id. We also explained that if the State failed to submit a complete SIP
revision by November 18, 2012, or if we disapproved a submitted SIP
revision, clocks would be triggered for mandatory sanctions and for EPA
to promulgate a FIP. Id. at 21640-41.
    On June 17, 2011, U.S. Magnesium challenged our SIP call in the
United States Court of Appeals for the 10th Circuit. On August 6, 2012,
the 10th Circuit upheld EPA's SIP call.
    On August 16, 2012, the State submitted to EPA revisions to R307-
107 for the purpose of correcting the deficiencies described in the SIP
call.

III. Revised Utah Rule R307-107 and EPA Analysis

A. The Revised Rule

    The State substantially revised and simplified R307-107 in response
to our SIP call. The rule now contains three sections--R307-107-1,
``Applicability and Timing,'' R307-107-2, ``Reporting,'' and R307-107-
3, ``Enforcement Discretion.''
    R307-107-1 requires the owner or operator of a source to report
breakdowns to the director within 24 hours of the incident (R307-107-
1(1)), to be followed by a detailed written description of the incident
and corrective program within 14 days of the start of the incident
(R307-107-1(2)). Alternative reporting deadlines apply where emissions
are monitored by continuous monitoring systems under R307-170, but even
where these alternative deadlines apply, the reports must still contain
the information required by R307-107-1(2) and R307-107-2.
    R307-107-2 requires breakdown incident reports to include the cause
and nature of the event, estimated quantity of emissions, time of
emissions, and other relevant evidence, including evidence that:
    1. There was an equipment malfunction beyond the reasonable control
of the owner or operator;
    2. The excess emissions could not have been avoided by better
operation, maintenance or improved design of the malfunctioning
component;
    3. To the maximum extent practicable, the source maintained and
operated the air pollution control equipment and process equipment in a
manner consistent with good practice for minimizing emissions,
including minimizing any bypass emissions;
    4. Any necessary repairs were made as quickly as practicable, using
off-shift labor and overtime as needed and as possible;
    5. All practicable steps were taken to minimize the potential
impact of the excess emissions on ambient air quality; and
    6. The excess emissions are not part of a recurring pattern that
may have been caused by inadequate operation or maintenance, or
inadequate design of the malfunctioning component.
    R307-107-2 also states that the owner or operator has the burden of
proof to demonstrate the above elements.
    R307-107-3 states that the director will evaluate, on a case-by-
case basis, the information the owner or operator submits pursuant to
R307-107-1 and 2 ``to determine whether to pursue enforcement action.''
    The version of R307-107 that was the subject of our SIP call stated
that ``emissions resulting from unavoidable breakdown will not be
deemed a violation of these regulations.'' This exemption, which was
part of the reason for our SIP call, has been eliminated in the revised
rule. The revised rule does not exempt exceedances of emissions limits
caused by breakdowns.
    The version of R307-107 that was the subject of our SIP call
required the source to submit information regarding an unavoidable
breakdown to the executive secretary of Utah's Air Quality Board and
indicated that the information would be used by the executive secretary
to determine ``whether a violation has occurred . . .'' This provision
was another reason for our SIP call because it appeared to give the
executive secretary exclusive authority to determine whether excess
emissions constituted a violation and thus to preclude independent
enforcement action by EPA and citizens when the executive secretary
made a non-violation determination. This problematic language,
indicating that the State would determine whether a violation had
occurred, has been eliminated in the revised rule. Instead, as
expressed in R307-107-3, the director will use the submitted
information to determine whether to pursue an enforcement action. The
director's decision not to pursue an enforcement action does not impact
EPA's or citizens' ability to independently pursue an enforcement
action in response to a given violation.

B. EPA's Analysis

    EPA's interpretation is that the CAA requires that all periods of
excess emissions, regardless of cause, be treated as violations and
that automatic exemptions from emissions limits are not appropriate.
This interpretation has been expressed in several documents. Most
relevant to this action are the following: memorandum dated September
28, 1982, from Kathleen M. Bennett, Assistant Administrator for Air,
Noise, and Radiation, entitled, ``Policy on Excess Emissions During
Startup, Shutdown, Maintenance, and Malfunctions'' (the 1982
Memorandum); a clarification to that memorandum from Kathleen M.
Bennett issued on February 15, 1983 (the 1983 Memorandum); and a
memorandum dated September 20, 1999 entitled, ``State Implementation
Plans: Policy Regarding Excess Emissions During

Malfunctions, Startup, and Shutdown,'' from Steven A. Herman, Assistant
Administrator for Enforcement and Compliance Assurance, and Robert
Perciasepe, Assistant Administrator for Air and Radiation (the 1999
Memorandum).
    As explained in these memoranda, because excess emissions might
aggravate air quality so as to prevent attainment and maintenance of
the NAAQS and compliance with other CAA requirements, EPA views all
periods of excess emissions as violations of the applicable emission
limitation. Therefore, EPA will disapprove SIP revisions that
automatically exempt from enforcement excess emissions claimed to
result from an equipment malfunction. In addition, as made explicit in
the 1999 Memorandum, EPA will disapprove SIP revisions that give
discretion to a state director to determine whether an instance of
excess emissions is a violation of an emission limitation, because such
a determination could bar EPA and citizens from enforcing applicable
requirements.
    Under EPA's interpretations of the CAA as set forth in the 1982,
1983, and 1999 Memoranda, if a state chooses to address in its SIP
violations that occur as a result of claimed malfunctions, the state
may take two approaches. The first, the ``enforcement discretion''
approach, allows a state director to refrain from taking an enforcement
action for a violation if certain criteria are met. The second, the
``affirmative defense'' approach, allows a source to avoid civil
penalties if it can prove that certain conditions are met. Utah's
revised R307-107 follows the enforcement discretion approach.
    We have evaluated Utah's enforcement discretion provisions in
revised R307-107 and find that they are consistent with EPA's
interpretations of the CAA as described in the memoranda above. In
particular, the revised rule contains no automatic exemption from
emission limits, and the criteria specified in R307-107-2 that the
State will consider in deciding whether to pursue an enforcement action
generally parallel the criteria outlined in the 1982 and 1983
Memoranda. In addition, revised R307-107 only addresses the State's
exercise of its enforcement discretion and contains no language that
suggests that a State decision not to pursue an enforcement action for
a particular violation bars EPA or citizens from taking an enforcement
action. Therefore, EPA interprets the rule, consistent with EPA's
interpretations of the CAA, as not barring EPA and citizen enforcement
of violations of applicable requirements when the State declines
enforcement.

IV. EPA's Proposed Action

    We are proposing to approve the revisions to rule R307-107 of the
Utah SIP that the State submitted to us on August 16, 2012. We are
proposing that these revisions correct the deficiencies outlined in our
April 18, 2011 SIP call. If we finalize this proposed approval, the
mandatory sanctions clocks described in our SIP call and the clock for
EPA to promulgate a FIP will end.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: April 23, 2013.
Judith Wong,
Acting Regional Administrator, EPA Region 8.
[FR Doc. 2013-10934 Filed 5-8-13; 8:45 am]
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[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60832-60834]
[FR Doc No: 2021-24074]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-1326]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 3, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 3, 2022. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2020-E-1326 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; SCENESSE.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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, 240-
402-7500.
     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 Sec.  10.20 (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,<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, SCENESSE
(afamelanotide acetate) indicated to increase pain-free light exposure
in adult patients with a history of phototoxic reactions from
erythropoietic protoporpyria. Subsequent to this approval, the USPTO
received a patent term restoration application for SCENESSE (U.S.
Patent No. 8,334,265) from Clinuvel Pharmaceuticals Limited, and the
USPTO requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated May 26,
2020, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of SCENESSE
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
SCENESSE is 3,914 days. Of this time, 3,579 days occurred during the
testing phase of the regulatory review period, while 335 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 21, 2009. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
January 21, 2009.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: November 8,
2018. The applicant claims June 21, 2018, as the date the new drug
application (NDA) for SCENESSE (NDA 210797) was initially submitted.
However, FDA records indicate that NDA 210797, submitted on June 21,
2018, was incomplete. The completed NDA was then submitted on November
8, 2018, which is considered to be the initially submitted date.
    3. The date the application was approved: October 8, 2019. FDA has
verified the applicant's claim that NDA 210797 was approved on October
8, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,481 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may

petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24074 Filed 11-3-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Proposed Rules]
[Pages 17778-17780]
[FR Doc No: 2017-07378]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0184; Airspace Docket No. 17-ASW-5]

Proposed Amendment of Class E Airspace; Pauls Valley, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to modify Class E airspace extending up
to 700 feet above the surface at Pauls Valley Municipal Airport, Pauls
Valley, OK. Airspace reconfiguration is necessary due to the
decommissioning of the Pauls Valley non-directional radio beacon (NDB),
and cancellation of the NDB approach. This proposed action would
enhance the safety and management of standard instrument approach
procedures for instrument flight rules (IFR) operations at the airport.

DATES: Comments must be received on or before May 30, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone
(202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No.
FAA-2017-0184; Airspace Docket No. 17-ASW-5, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://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:<PHONE_NUMBER>. The Order is also available for inspection at
the National Archives and Records Administration (NARA). For
information on the availability of FAA Order 7400.11A at NARA, call
202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html. FAA Order 7400.11,
Airspace Designations and Reporting Points, is published yearly and
effective on September 15.

FOR FURTHER INFORMATION CONTACT: Ron Laster, Federal Aviation
Administration, Contract Support, Operations Support Group, Central
Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone
(817) 222-5879.

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 modify Class E airspace extending up to and including 700
feet above the surface area at Pauls Valley Municipal Airport, Pauls
Valley, OK.

Comments Invited

    Interested parties are invited to participate in 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 and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-0184/
Airspace Docket No. 17-ASW-5.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.regulations.gov.
    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 the 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 during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.
    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 notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by modifying Class E airspace extending
upward from 700 feet above the surface within a 6.6-mile radius of
Pauls Valley Municipal Airport, Pauls Valley, OK. The segment 2.6 miles
each side of the 169[deg] bearing from the Pauls Valley NDB extending
from the 6.6-mile radius to 7.6 miles south of the airport would be
removed due to the decommissioning of the NDB, and cancellation of NDB
approach. This action would enhance the safety and management of the
standard instrument approach procedures for IFR operations at the
airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, 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.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. 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 rule, when promulgated, would 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.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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 FAA Order
7400.11A, Airspace Designations and Reporting

Points, dated August 3, 2016, and effective September 15, 2016, is
amended as follows:

Paragraph 6005 Class E Airspace Areas.

* * * * *

ASW OK E5 Pauls Valley, OK

Pauls Valley Municipal Airport, OK

    (Lat. 34[deg] 42'34'' N., long. 97[deg] 13'24'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Pauls Valley Municipal Airport, and
within 4 miles each side of the 000[deg] bearing from the airport
extending from the 6.6-mile radius to 11.6 miles north of the
airport.

    Issued in Fort Worth, Texas, on April 4, 2017.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-07378 Filed 4-12-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Rules and Regulations]
[Pages 24429-24431]
[FR Doc No: 2022-08867]

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

40 CFR Part 52

[EPA-R04-OAR-2021-0395; FRL-9563-02-R4]

Air Plan Approval; Kentucky; Emissions Statement Requirements for
the 2015 8-Hour Ozone Standard Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the Kentucky State Implementation Plan (SIP) submitted to
EPA by the Commonwealth of Kentucky through the Kentucky Division for
Air Quality (KDAQ) on October 15, 2020. The SIP revision was submitted
by KDAQ to address the emissions statement requirements for the 2015 8-
hour ozone national ambient air quality standards (NAAQS) for Kentucky
counties in the Cincinnati, Ohio-Kentucky 2015 8-hour ozone NAAQS
nonattainment area (Cincinnati, OH-KY Area), and for some of the
Kentucky counties in the Louisville, Kentucky-Indiana 2015 8-hour ozone
NAAQS nonattainment area (Louisville, KY-IN Area). Specifically, EPA is
approving the emissions statement requirements for portions of Boone,
Campbell, and Kenton Counties in the Cincinnati, OH-KY Area, and
Bullitt and Oldham Counties in the Louisville, KY-IN Area. EPA will
consider and take action, or has considered and taken action, on
submissions addressing the emissions statement requirements for the
remaining counties in these two nonattainment areas, including the
Jefferson County, Kentucky portion of the Louisville, KY-IN Area, in a
separate rulemaking. This action is being taken pursuant to the Clean
Air Act (CAA or Act).

DATES: This rule is effective May 26, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2021-0395. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that, if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tiereny Bell, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, Region 4, U.S. Environmental Protection Agency, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9088. Ms. Bell can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On October 1, 2015, EPA promulgated a revised 8-hour primary and
secondary ozone NAAQS, strengthening both from 0.075 parts per million
(ppm) to 0.070 ppm. See 80 FR 65292 (October 26, 2015).\1\ Upon
promulgation of a new or revised ozone NAAQS, the CAA requires EPA to
designate as nonattainment any area that is violating the NAAQS based
on the three most recent years of ambient air quality data at the
conclusion of the designation process. On June 4, 2018 (effective
August 3, 2018), EPA designated the 7-county Cincinnati, OH-KY Area as
a Marginal ozone nonattainment area for the 2015 8-hour ozone NAAQS.\2\
Also on June 4, 2018 (effective August 3, 2018), EPA designated the 5-
county Louisville, KY-IN Area as a Marginal ozone nonattainment area
for the 2015 8-hour ozone NAAQS.\3\ The Cincinnati, OH-KY Area and the
Louisville, KY-IN Area were designated nonattainment for the 2015 8-
hour Ozone NAAQS using 2014-2016 ambient air quality data. See 83 FR
25776.
---------------------------------------------------------------------------

    \1\ The 2015 8-hour Ozone NAAQS was promulgated on October 1,
2015, published on October 26, 2015, and effective December 28,
2015.
    \2\ The Cincinnati, OH-KY Area consists of the following
counties: Boone (Partial), Campbell (Partial), Kenton (Partial), in
Kentucky and the entire counties of Butler, Clermont, Hamilton, and
Warren in Ohio. EPA has taken action on the 2015 8-hour ozone NAAQS
nonattainment area emissions statement requirements for the entire
counties of Butler, Clermont, Hamilton, and Warren in Ohio in a
separate action. See 86 FR 12270 (March 3, 2021).
    \3\ The Louisville, KY-IN Area consists of Bullitt, Jefferson,
and Oldham Counties in Kentucky and Clark and Floyd Counties in
Indiana. EPA took final action on the 2015 8-hour ozone NAAQS
emissions statement requirements for the Jefferson County, Kentucky
portion of the Louisville, KY-IN Area in a separate rulemaking, see
87 FR 13177 (March 9, 2022), and will take action on the emissions
statement requirements for Clark and Floyd Counties in Indiana in a
separate rulemaking.
---------------------------------------------------------------------------

    Based on the nonattainment designation, Kentucky was required to
develop a SIP revision addressing certain CAA requirements for an area
designated nonattainment, including, pursuant to satisfying, among
other things, CAA section 182(a)(3)(B). On October 15, 2020,\4\
Kentucky submitted a SIP revision addressing the emissions statement
requirements related to the 2015 8-hour ozone NAAQS for the Kentucky
portion of the Cincinnati, OH-KY Area and for Bullitt and Oldham
Counties in the Kentucky portion of the Louisville, KY-IN Area.
---------------------------------------------------------------------------

    \4\ KDAQ's transmittal letter for the October 15, 2020, SIP
revision was dated October 15, 2020, and submitted to EPA on October
16, 2020.
---------------------------------------------------------------------------

    On February 28, 2022, EPA published a Notice of Proposed Rulemaking
(NPRM) proposing to approve the October 15, 2020, SIP revision as
meeting the emissions statement requirements of section 182(a)(3)(B) of
the CAA and EPA's SIP Requirements Rule.\5\ See 87 FR 10998. The
February 28, 2022, NPRM provides additional detail regarding the
background and rationale for EPA's action. Comments on the February 28,
2022, NPRM were due on or before March 30, 2022. EPA received no
comments on the February 28, 2022, NPRM.
---------------------------------------------------------------------------

    \5\ On December 6, 2018, EPA finalized a rule titled
``Implementation of the 2015 National Ambient Air Quality Standards
for Ozone: Nonattainment Area State Implementation Plan
Requirements'' (SIP Requirements Rule) that establishes the
requirements that state, tribal, and local air quality management
agencies must meet as they develop implementation plans for areas
where air quality exceeds the 2015 8-hour ozone NAAQS. See 83 FR
62998.
---------------------------------------------------------------------------

II. Final Action

    EPA is approving the aforementioned October 15, 2020, Kentucky SIP
revision addressing the emissions statement requirements for the 2015
8-hour Ozone NAAQS for portions of Boone, Campbell, and Kenton Counties
in the Cincinnati, OH-KY Area, and Bullitt and Oldham Counties in the
Louisville, KY-IN Area. EPA has determined that Kentucky's SIP revision
meets the requirements of CAA sections 110 and 182.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 27, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it

extend the time within which a petition for judicial review may be
filed and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: April 19, 2022.
Daniel Blackman,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart S--Kentucky

0
2. In Sec.  52.920(e), amend the table by adding a new entry for
``Emissions Statement Requirements for the 2015 Ozone 8-hour NAAQS'' at
the end of the table.
    The addition reads as follows:

Sec.  52.920   Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Kentucky Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                     Applicable       State submittal
   Name of non-regulatory SIP       geographic or      date/effective    EPA approval date      Explanations
           provision             nonattainment area         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Emissions Statement              Boone, Campbell,           10/15/2020  4/26/2022, [Insert
 Requirements for the 2015 8-     and Kenton                             citation of
 hour Ozone NAAQS.                Counties                               publication].
                                  (partial) in
                                  Kentucky portion
                                  of Cincinnati, OH-
                                  KY Area, and
                                  Bullitt and
                                  Oldham Counties
                                  (entire) in
                                  Kentucky portion
                                  of Louisville, KY-
                                  IN Area.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-08867 Filed 4-25-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 7, 2007 (Volume 72, Number 235)]
[Notices]
[Page 69209]
[DOCID:fr07de07-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12607-001]

Town of Massena; Notice of Dispute Resolution Panel Meeting and
Technical Conference

November 30, 2007.
    On November 26, 2007, Commission staff, in response to the filing
of a notice of study dispute by the New York State Department of
Environmental Conservation on November 8, 2007, convened two three-
person Dispute Resolution Panels pursuant to 18 CFR 5.14(d).
    The Panels will hold a two-session technical conference at the
times and place noted below. The morning session (Session 1) will
address study disputes regarding impacts related to floodplain, ice
management, municipal combined sewer overflows and infrastructure. The
afternoon session (Session 2) will address study disputes regarding
sampling for sturgeon movement and spawning and the Phase II ASTM
environmental site assessment. The focus of the technical session is
for the disputing agency, applicant, and Commission to provide the
Panels with additional information necessary to evaluate the disputed
studies. All local, state, and federal agencies, Indian tribes, and
other interested parties are invited to attend the meeting as
observers. The Panels may also request information or clarification on
written submissions as necessary to understand the matters in dispute.
The Panels will limit all input that it receives to the specific
studies or information in dispute and will focus on the applicability
of such studies or information to the study criteria stipulated in 18
CFR 5.9(b). If the number of participants wishing to speak creates time
constraints, the Panels may, at their discretion, limit the speaking
time for each participant.
Technical Conference
    Date: December 12, 2007.
    Session 1: 9 a.m.-11:30 a.m. (EST).
    Session 2: 1 p.m.-4 p.m.
    Place: Doubletree Hotel Syracuse, 6301 State Route 298, East
Syracuse, New York 13057.
    Phone:<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E7-23751 Filed 12-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Proposed Rules]
[Pages 13512-13513]
[FR Doc No: 2015-05808]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0851; FRL-9923-06-Region 9]

Revisions to the California State Implementation Plan, South
Coast Air Quality Management District and Sacramento Metropolitan Air
Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the South Coast Air Quality Management District
(SCAQMD) and Sacramento Metropolitan Air Quality Management District
(SMAQMD) portions of the California State Implementation Plan (SIP).
These revisions concern particulate matter (PM) emissions from
particulate matter air pollution control devices and residential wood
burning. We are proposing to approve these local rules that regulate
these emission sources under the Clean Air Act (CAA or the Act).

DATES:  Any comments on this proposal must arrive by April 15, 2015.

ADDRESSES: Submit comments, identified by docket number EPA-09-OAR-
2014, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. 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: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location

(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Christine Vineyard, EPA Region IX,
(415) 947-4125<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses the following local
rules: SCAQMD Rule 1155, Particulate Matter (PM) Control Devices and
SMAQMD Rule 421 Mandatory Episodic Curtailment of Wood and Other Solid
Fuel Burning (except section 402). In the Rules and Regulations section
of this Federal Register, we are approving these local rules in a
direct final action without prior proposal because we believe these SIP
revisions are not controversial. If we receive adverse comments,
however, we will publish a timely withdrawal of the direct final rule
and address the comments in subsequent action based on this proposed
rule. Please note that if we receive adverse comment on an amendment,
paragraph, or section of these rules and if that provision may be
severed from the remainder of the rules, we may adopt as final those
provisions of the rules that are not the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: January 23, 2015.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2015-05808 Filed 3-13-15; 8:45 am]
 BILLING CODE 6560-50-P