[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85645-85646]
[FR Doc No: 2023-27012]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-3218]

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

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 VIZIMPRO 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 must submit either electronic
or written comments and ask for a redetermination by February 6, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 5, 2024. 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. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 6, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2019-E-3218 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; VIZIMPRO.'' 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, VIZIMPRO
(dacomitinib) indicated for the first-line treatment of patients with
metastatic non-small cell lung cancer with epidermal growth factor
receptor exon 19 deletion or exon 21 L858R substitution mutations as
detected by an FDA-approved test. Subsequent to this approval, the
USPTO received a patent term restoration application for VIZIMPRO (U.S.
Patent No. 7,772,243) from Warner-Lambert Co. LLC and the USPTO
requested FDA's assistance in determining the patent's eligibility for
patent term restoration. In a letter dated November 29, 2019, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of VIZIMPRO 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
VIZIMPRO is 4,794 days. Of this time, 4,554 days occurred during the
testing phase of the regulatory review period, while 240 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:
August 14, 2005. The applicant claims August 15, 2005, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 14, 2005,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: January 31,
2018. FDA has verified the applicant's claim that the new drug
application (NDA) for VIZIMPRO (NDA 211288) was initially submitted on
January 31, 2018.
    3. The date the application was approved: September 27, 2018. FDA
has verified the applicant's claim that NDA 211288 was approved on
September 27, 2018.
    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 1,493 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: December 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27012 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Notices]
[Pages 44611-44613]
[FR Doc No: 2012-18440]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of International Meeting

    The Federal Energy Regulatory Commission hereby gives notice that
the agency will host an international meeting of the Asia Pacific
Energy Regulatory (APER) Forum on August 1-2, 2001 at its headquarters,
888 First Street NE., Washington, DC 20426. Commissioners and staff
will take part in this event. Commissioner Philip Moeller and
Commissioner John R. Norris are co-chairs of the event.
    The meetings are expected to begin at 8:30 a.m. and end at 5:00
p.m. Eastern Time on both days. An agenda of the conference is attached
to this notice.
    Those wishing to attend this event are encouraged to register using
the on-line form located at: https://www.ferc.gov/aper-forum/aper-8-1-12-form.asp.
    The APER Forum was established as a recommendation at the 3rd
Energy Regulatory and Market Development Forum, which operated under
the Asia-Pacific Partnership on Clean Development and Climate (APP).
The APP was an international partnership between the United States,
South Korea, Japan, India, Canada, China and Australia aimed at
addressing the challenges of climate change, energy security and air
pollution in a way that encouraged economic development and reduced
poverty. The APER Forum builds upon the work begun under the APP.
    The APER Forum is designed to bring together policymakers,
regulators, energy industry participants, academics, regulatory
research organizations, and grid and market operators from Asian and
Pacific countries to engage in meaningful information exchanges on
matters relating both to electricity and to natural gas. The APER Forum
is voluntary in nature and intends to provide an ongoing experience for
information exchange on the development and application of best
practices in regulatory and market arrangements. The first meeting was
sponsored by Australia and held in 2010.
    This year marks the second biennial meeting of the APER Forum. The
event will include delegations from the United States, Canada,
Australia, China, India, New Zealand, Thailand and Singapore. Other
attendees include regulators from Pakistan, Ghana and the Czech
Republic. It will focus on three major issues:

    Transitioning to a Low-Carbon Economy--examining policy,
regulatory arrangements and standards that encourage energy
efficiency and clean energy technologies and promote clean
investment/delivery (including renewable and alternative energy)
with the aim of reducing greenhouse gas emissions.
    Energy Infrastructure and Market Regulatory Arrangements--
examining challenges and reforms to the operation and design of
energy systems within the context of a market.
    Competition Reform--examining regulatory, policy and standards
matters that influence and encourage competition (wholesale and
retail) growth in the market.

    The conference will not be transcribed. However, there will be a
free webcast. Anyone with Internet access who desires to watch the
conference and download presentations can do so by going to the
calendar of events on the FERC Web site (www.ferc.gov). The Capitol
Connection provides technical support for webcasts and offers the
option of listening to the meeting via phone-bridge for a fee. If you
have any questions, visit www.CapitolConnection.org or call 703-993-
3100.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information, please contact:

Sarah McKinley, Secretariat, APER Forum, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426,<PHONE_NUMBER>
or 8368<EMAIL_ADDRESS>
    Dated: July 20, 2012.
Kimberly D. Bose,
Secretary.

Asia Pacific Energy Regulatory (APER) Forum, Meeting Agenda, Sponsored
by the Federal Energy Regulatory Commission

August 1-2, 2012

Day 1, Wednesday, August 1, 2012--Morning

8:30 a.m. Opening Remarks
    Philip Moeller, Commissioner, U.S. Federal Energy Regulatory
Commission
    John R. Norris, Commissioner, U.S. Federal Energy Regulatory
Commission
    Joseph T. Kelliher, Executive Vice President, Federal Regulatory
Affairs, NextEra Energy, former Chairman, U.S. Federal Energy
Regulatory Commission and Head of U.S. Delegation, 2010 APER Forum
Meeting

Theme--Overview of Energy and Regulatory Structures/APER Members

9:00 a.m. Energy and Regulatory Overview of the United States: Philip
Moeller, Commissioner, U.S. Federal Energy Regulatory Commission
9:20 a.m. Energy and Regulatory Overview of Australia: Brendan Morling,
Head of Energy and Environment Division, Department of Resources,
Energy and Tourism, Australia
9:40 a.m. Energy and Regulatory Overview of China: HE Yang, Director,
Department of Power Market Regulation, State Electricity Regulatory
Commission, China
10:00 a.m. Break
10:20 a.m. Energy and Regulatory Overview of Canada: John Foran,
Director, Natural Resources Canada
10:40 a.m. Energy/Electricity Regulatory Overview of India: Dr. Pramod
Deo, Chairman, Central Electricity Regulatory Commission, India
11:00 a.m. Energy and Regulatory Overview of Thailand: Dr. Pallapa
Ruanrong, Commissioner, Energy Regulatory Commission
11:20 a.m. Energy and Regulatory Overview of New Zealand: Carl Hansen,
Chief Executive, Electricity Authority of New Zealand
12:15 noon Lunch Break

Day 1, Wednesday, August 1, 2012--Afternoon

Theme--Transitioning to a Low-Carbon Economy

2:00 p.m. Carbon Trading and Policies for Low-Carbon Consumption
    Panel Moderator: Brendan Morling, Head of Energy and Environment
Division, Department of Resources, Energy and Tourism, Australia
    [cir] Presentation on regional carbon trading in California and the
U.S. Northeast: Dallas Burtraw, Darius Gaskins Senior Fellow, Resources
for the Future, United States
    [cir] Guided discussion about carbon policies with the heads of all
the delegations
3:00 p.m. Break
3:15 p.m. Smart Grid Technologies that Enhance Efficiency
    Panel Moderator: W. Terry Boston, President and Chief Executive
Officer, PJM Interconnection, L.L.C., U.S.
    [cir] Presentation: Working toward industry standards for
interoperability--David Wollman, Deputy Director, Smart Grid and Cyber-
Physical Systems Programs Office, U.S. National Institute of Standards
and Technology
    [cir] Presentation: Canada smart grid roadmap standards--Michel
Fernand Girard, Vice-President, Policy and Stakeholder Relations,
Standards Council of Canada
    [cir] Presentation: Impacts of new technologies on security of
supply--Dr. Brian Spalding, Commissioner, Australian Energy Market
Commission (AEMC)
    [cir] Discussion with heads of delegation
5:00 p.m. Adjourn

Day 2, Thursday, August 2, 2012--Morning

8:30 a.m. Opening Remarks--Day 2
    Philip Moeller, Commissioner, U.S. Federal Energy Regulatory
Commission
    John R. Norris, Commissioner, U.S. Federal Energy Regulatory
Commission
    David A. Wright, President, South Carolina Public Service
Commission and President of the National Association of Regulatory
Utility Commissioners (NARUC)

Theme--Energy Infrastructure and Market Regulations

9:00 a.m. Grid Reliability
    Panel Moderator: John R. Norris, Commissioner, U.S. Federal Energy
Regulatory Commission
    [cir] Enhancing grid reliability: Cheryl LaFleur, Commissioner,
U.S. Federal Energy Regulatory Commission
    [cir] Presentation: Network Investments for the Long-Term Interests
of Consumers--Andrew Reeves, Chairman, Australian Energy Regulator
    [cir] Discussion with heads of delegation
10:00 a.m. Break
10:15 a.m. Renewables in the New Markets
    Panel Moderator: John Pierce, Chairman, Australian Energy Market
Commission
    [cir] Presentation: Integrating variable energy resources into
existing grids--Jon Wellinghoff, Chairman, U.S. Federal Energy
Regulatory Commission
    [cir] Presentation: Integrating renewables from a reliability
perspective--Darren Finkbeiner, Manager, Market Development, Ontario
Independent Electricity System Operator (IESO), Canada
    [cir] Presentation: Incorporating new technologies onto the grid--
Kai

XIE, President, New York Office, State Grid Corporation of China (SGCC)
    [cir] Discussion with heads of delegation
11:45 p.m. Lunch Break

Day 2, Thursday, August 2, 2012--Afternoon

Theme--Competition Reform

1:30 p.m. Market Regulation--Oil and Gas Developments
    Panel Moderator: S. Krishnan, Chairperson, Petroleum and Natural
Gas Regulatory Board (PNGRB), India
    [cir] Oil Developments in Canada: John Foran, Director, Natural
Resources Canada
    [cir] Presentation: Regulatory Framework in Oil & Natural Gas
Sector in India--Challenges & Opportunities: Konedana Rajeswara Rao,
Petroleum & Natural Gas Regulatory Board (PNGRB), India
    [cir] Impacts of the Shale Gas Revolution Mike McGehee, Director,
Division of Pipeline Certificates, Office of Energy Projects, U.S.
Federal Energy Regulatory Commission
    [cir] Discussion with heads of delegation
3:00 p.m. Break
3:15 p.m. Impact of Competition on Reliability of Supply
    Panel Moderator: Carl Hansen, Chief Executive, Electricity
Authority of New Zealand
    [cir] Presentation: Energy network regulation policy and consumer
prices--Mr. Brendan Morling, Head of Energy and Environment Division,
Department of Resources, Energy and Tourism, Australia
    [cir] Presentation: Building efficient wholesale markets, the RTO/
ISO model--Andrew L. Ott, Senior Vice President for Markets, PJM
Interconnection L.L.C., United States
    [cir] Discussion with heads of delegation
4:45 p.m. Concluding Remarks
    Philip Moeller, Commissioner, U.S. Federal Energy Regulatory
Commission
    John R. Norris, Commissioner, U.S. Federal Energy Regulatory
Commission

[FR Doc. 2012-18440 Filed 7-27-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 9, 2007 (Volume 72, Number 153)]
[Notices]
[Page 44891-44892]
[DOCID:fr09au07-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56194; File No. SR-BSE-2007-32]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
and Amendment No. 1 Thereto to Amend the Existing Fee Schedule

August 2, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 5, 2007, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. The BSE has designated this proposal as one changing a due,
fee, or other charge under section 19(b)(3)(A)(ii) of the Act \3\ and
Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal effective
upon filing with the Commission. On July 20, 2007, BSE filed Amendment
No. 1 to the proposed rule change.\5\ The Commission is publishing this
notice to solicit comments on the proposed rule change, as amended,
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
    \5\ In Amendment No. 1, the Exchange replaced the term
Intermarket Sweep Order (``ISO'') with the phrase ``order routed as
a part of an NMS Cross Order'' and the term ``Reg NMS cross'' with
the phrase ``NMS Cross Order''. In addition, the Exchange updated
the BeX fee schedule to reflect these changes.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The BSE proposes to amend certain transaction fees set forth in the
Boston Equities Exchange (``BeX'') fee schedule. The text of the
proposed rule change is available at http://www.bostonstock.com, at the

BSE, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    On November 20, 2006, the BSE filed File No. SR-BSE-2006-44,\6\ a
rule filing that amended the existing BSE fee schedule and established
a fee schedule for the BeX, a facility of the Exchange. On March 5,
2007, a subsequent filing, SR-BSE-2007-13,\7\ was made to add a new
Smart Order Routing fee. On June 28, 2007, the Exchange filed an
additional fee filing, SR-BSE-2007-29 \8\ to lower the rate for this
service.
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    \6\ See Securities Exchange Act Release No. 54795 (November 20,
2006), 71 FR 68850 (November 28, 2007).
    \7\ See Securities Exchange Act Release No. 55529 (March 26,
2007), 72 FR 15734 (April 2, 2007).
    \8\ See Securities Exchange Act Release No. 56129 (July 25,
2007), 72 FR 42157 (August 1, 2007).
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    In this filing, the Exchange is proposing to implement a fee for
orders routed as a part of an NMS Cross Order,\9\ which the Exchange
has developed to help firms comply with the trade-through requirements
of Regulation NMS. An NMS Cross Order consists of a priced cross with
two quantities: (i) The quantity that the customer wants to cross; and
(ii) the ``disinterest'' quantity, which is the additional single-sided
amount that the customer is willing to add in order to fulfill
Regulation NMS obligations.
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    \9\ See Securities Exchange Act Release No. 55903 (June 13,
2007), 72 FR 33792 (June 19, 2007) (SR-BSE-2007-24).
---------------------------------------------------------------------------

    When this new order type is received, the Exchange will look at the
best bids and offers at all Regulation NMS venues and route orders, as
needed, up to the disinterest quantity. The cross will then be executed
and reported back to the customer, along with any executions from the
routed orders. If the disinterest quantity is not large enough to
satisfy the size of the total trade-through on all markets, no orders
will be routed and the entire cross will be rejected.

    The orders routed as a result of an NMS Cross Order will be added
to the Exchange's other order routing products and will be charged at a
rate of $0.0020 per share if a firm uses its own give-up on another
market center and $0.0060 per share if a firm used a BeX provided give-
up on another market center.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of section 6(b) of the Act,\10\ in general, and
furthers the objectives of section 6(b)(4) of the Act,\11\ in
particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees and other charges among Exchange
members and issuers and other persons using Exchange facilities.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition 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

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

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to section 19(b)(3)(A)(ii) of the Act \12\ and Rule
19b-4(f)(2) thereunder,\13\ because it establishes or changes a due,
fee, or other charge imposed by the Exchange. Accordingly, the proposal
will take effect upon filing with the Commission.
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    \12\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \13\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-BSE-2007-32 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-BSE-2007-32. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the BSE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BSE-2007-32 and should be
submitted on or before August 30, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
 Deputy Secretary.
[FR Doc. E7-15545 Filed 8-8-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 33 (Monday, February 22, 2021)]
[Proposed Rules]
[Pages 10522-10524]
[FR Doc No: 2021-02906]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2020-0238; FRL-10015-85-Region 9]

Air Plan Approval; California; San Joaquin Valley Air Pollution
Control District; Stationary Source Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the San Joaquin Valley Air Pollution Control
District (SJVAPCD or ``the District'') portion of the California State
Implementation Plan (SIP). This revision concerns the District's New
Source Review (NSR) permitting program for new and modified sources of
air pollution under section 110(a)(2)(C) of the Clean Air Act (CAA);
specifically our proposal to approve Rule 2021: Experimental Research
Operations. We are taking comments on this proposal and plan to follow
with a final action.

DATES: Comments must be received on or before March 24, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2020-0238 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, or if you need assistance
in a language other than English or if you are a person with a
disability who needs a reasonable accommodation at no cost to you,
please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section. For the full EPA public comment policy, information
about CBI or multimedia

submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, Air-3-
1, 75 Hawthorne St., San Francisco, CA 94105,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule?
II. The EPA's Evaluation
    A. How is the EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
III. Proposed Action and Public Comment
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the dates
that it was adopted by the local air agency and submitted to the EPA by
the California Air Resources Board (CARB or ``the State'').

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
         Local agency                  Rule No.                Rule title           Adopted on     Submitted on
----------------------------------------------------------------------------------------------------------------
SJVAPCD.......................  2021..................  Experimental Research           12/17/92        11/18/93
                                                         Operations.
----------------------------------------------------------------------------------------------------------------

    On May 18, 1994, the submittal of SJVAPCD Rule 2021 was deemed by
operation of law to meet the completeness criteria in 40 CFR part 51
Appendix V, which must be met before formal EPA review.

B. Are there other versions of this rule?

    There is no previous version of Rule 2021 in the SIP. SJVAPCD
submitted Rule 2021 on November 18, 1993 as part of the District's
revised NSR program. The District has not submitted any revised
versions since the most recent submittal. On October 3, 2017, the
District provided additional information in support of Rule 2021. The
rule provides limited exemptions to the SJVAPCD's current program for
preconstruction review and permitting of new or modified stationary
sources under its jurisdiction.

C. What is the purpose of the submitted rule?

    Rule 2021 exempts experimental research operations from Authority
to Construct and Permit to Operate requirements as long as the facility
meets all other rule requirements. Otherwise the source would be
required to comply with Rule 2010--Permits Required. The District
defines Experimental Research Operations as ``any air pollution control
device or technology or any industrial process or technology with
reduced emissions which is: Innovative, not in common use for a
particular process, not readily available from a commercial supplier,
or funded as original research by a public agency.'' The District
determined that emissions from Experimental Research Operations
exempted from permitting requirements pursuant to Rule 2021 will not
adversely affect progress toward attainment or maintenance of any
NAAQS.

II. The EPA's Evaluation

A. How is the EPA evaluating the rule?

    The EPA reviewed Rule 2021 for compliance with the applicable
requirements of section 110(a)(2)(C) and associated regulations at 40
CFR 51.160-164. We also reviewed the rule for consistency with other
CAA general requirements for SIP submittals, including requirements at
section 110(a)(2)(A) regarding rule enforceability, and requirements at
sections 110(l) and 193 for SIP revisions.
    Section 110(a)(2)(C) of the Act requires each SIP to include a
program to regulate the modification and construction of any stationary
source within the areas covered by the SIP as necessary to assure
attainment and maintenance of the NAAQS. The EPA's regulations at 40
CFR 51.160-51.164 provide specific programmatic requirements to
implement this statutory mandate.
    Section 110(a)(2)(A) of the Act requires that regulations submitted
to the EPA for SIP approval must be clear and legally enforceable.
Section 110(l) of the Act prohibits the EPA from approving any SIP
revisions that would interfere with any applicable requirement
concerning attainment and reasonable further progress (RFP) or any
other applicable requirement of the CAA. Section 193 of the Act
prohibits the modification of a SIP-approved control requirement in
effect before November 15, 1990 in a nonattainment area, unless the
modification ensures equivalent or greater emission reductions of the
relevant pollutant(s). With respect to procedures, CAA sections 110(a)
and 110(l) require that a state conduct reasonable notice and hearing
before adopting a SIP revision.

B. Do the rules meet the evaluation criteria?

    With respect to procedural requirements, CAA sections 110(a)(2) and
110(l) require that revisions to a SIP be adopted by the state after
reasonable notice and public hearing. Based on our review of the public
process documentation included in the November 18, 1993 submittal of
Rule 2021, we find that the SJVAPCD has provided sufficient evidence of
public notice, opportunity for comment and a public hearing prior to
adoption and submittal of these rules to the EPA.
    With respect to the substantive requirements found in CAA sections
110(a)(2)(A) and (C), 110(l), 193, and 40 CFR 51.160-51.164, we
evaluated Rule 2021 in accordance with the applicable CAA and
regulatory requirements that apply to new source review permit
programs. The permit exemption provided for experimental research
operations is extremely narrow in scope, such that the emissions not
subject to permit requirements are not expected to interfere with
attainment or RFP. Therefore we find that Rule 2021 satisfies these
requirements.
    Our Technical Support Document, which can be found in the docket
for this rulemaking, contains a more detailed discussion of our
analysis.

III. Proposed Action and Public Comment

    As authorized in section 110(k)(3) of the Act, the EPA is proposing
to approve the submitted rule because it fulfills all relevant CAA
requirements. We have concluded that our approval of the submitted rule
would comply with the relevant provisions of CAA sections 110(a)(2),
110(l), and 193, and 40 CFR 51.160-51.164.
    If we finalize this action as proposed, our action will be codified
through

revisions to 40 CFR 52.220a (Identification of plan-in part).
    We will accept comments from the public on this proposal until
March 24, 2021.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the rule listed in Table 1 of this preamble. The EPA has
made, and will continue to make, this document available through
https://www.regulations.gov and in hard copy at the EPA Region IX
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

IV. 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, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve 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 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 Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the 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 and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

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

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

    Dated: February 5, 2021.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2021-02906 Filed 2-19-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 56 (Friday, March 24, 2017)]
[Notices]
[Pages 15054-15055]
[FR Doc No: 2017-05876]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR17-20-001.
    Applicants: Atmos Pipeline-Texas.
    Description: Tariff filing per 284.123(b), (e): Atmos Pipeline--
Texas, Further Revisions to Statement of Operating Conditions to be
effective 12/21/2016; Filing Type: 1000.
    Filed Date: 3/10/17.
    Accession Number:<PHONE_NUMBER>88.
    Comments/Protests Due: 5 p.m. ET 3/31/17.

    Docket Numbers: RP17-529-001.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System, L.P. submits tariff
filing per 154.205(b): 03/14/17 Negotiated Rates--Consolidated Edison
Energy Inc. (HUB) 2275-89 to be effective 3/11/2017.
    Filed Date: 03/15/2017.
    Accession Number: 20170315-5062.
    Comment Date: 5:00 p.m. Eastern Time on Monday, March 27, 2017.

    Docket Numbers: RP17-536-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
tariff filing per 154.204: North Shore Gas Negotiated Rate to be
effective 4/1/2017.
    Filed Date: 03/15/2017.
    Accession Number: 20170315-5106.
    Comment Date: 5:00 p.m. Eastern Time on Monday, March 27, 2017.

    Docket Numbers: RP17-537-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
tariff filing per 154.204: Enstor Energy Services Negotiated Rate to be
effective 4/1/2017.
    Filed Date: 03/15/2017.
    Accession Number: 20170315-5137.
    Comment Date: 5:00 p.m. Eastern Time on Monday, March 27, 2017.

    Docket Numbers: RP17-538-000.
    Applicants: Golden Triangle Storage, Inc.
    Description: Golden Triangle Storage, Inc. submits tariff filing
per 154.204: GTS Capacity Release Revisions to be effective 4/17/2017.
    Filed Date: 03/15/2017.
    Accession Number: 20170315-5142.
    Comment Date: 5:00 p.m. Eastern Time on Monday, March 27, 2017.

    Docket Numbers: RP17-350-001.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Eastern Shore Natural Gas Company submits tariff
filing per 154.206: Motion to Place Suspended Tariff Record Into Effect
to be effective 3/16/2017.
    Filed Date: 03/16/2017.
    Accession Number: 20170316-5158.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, March 28, 2017.

    Docket Numbers: RP17-539-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System, L.P. submits tariff
filing per 154.204: 03/16/17 Negotiated Rates--Consolidated Edison
Energy Inc. (HUB) 2275-89 to be effective 3/15/2017.
    Filed Date: 03/16/2017.
    Accession Number: 20170316-5075.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, March 28, 2017.

    Docket Numbers: RP17-540-000.
    Applicants: Panhandle Eastern Pipe Line Company, LP.
    Description: Panhandle Eastern Pipe Line Company, LP submits tariff
filing per 154.203: Flow Through of Penalty Revenues Report filed on 3-
16-17.
    Filed Date: 03/16/2017.
    Accession Number: 20170316-5076.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, March 28, 2017.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings

can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 20, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-05876 Filed 3-23-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 222 (Tuesday, November 18, 2014)]
[Notices]
[Page 68676]
[FR Doc No: 2014-27242]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-18-000]

Consolidated Edison Company of New York, Inc. (Complainant) v.
PJM Interconnection, L.L.C., (Respondent); Notice of Complaint

    Take notice that on November 7, 2014, pursuant to Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206 and sections 206 and 306 of the Federal
Power Act, 16 U.S.C. 824(e) and (825(e), Consolidated Edison Company of
New York, Inc. (Con Edison or Complainant), filed a complaint against
the PJM Interconnection, L.L.C (PJM or Respondent). Con Edison requests
that the Commission order PJM to revise its allocation of costs to Con
Edison with respect to the PSE&G Sewaren and PSE&G Upgrade projects and
to modify the PJM allocation method, as more fully explained in the
complaint.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on December 1, 2014.

    Dated: November 10, 2014.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-27242 Filed 11-17-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 93 (Wednesday, May 14, 2014)]
[Rules and Regulations]
[Pages 27489-27490]
[FR Doc No: 2014-10972]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2014-0198]

Safety Zone; Big Bay Boom Fourth of July Fireworks, San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Big Bay Boom Fourth of July
Fireworks safety zones on July 4, 2014. This recurring marine event
occurs on the navigable waters of San Diego Bay in San Diego,
California. This action is necessary to provide for the safety of the
participants, crew, spectators, safety vessels, and general users of
the waterway. During the enforcement period, persons and vessels are
prohibited from entering into, transiting through, or anchoring within
this regulated area unless authorized by the

Captain of the Port, or his designated representative.

DATES: This rule is effective from 8:30 p.m. to 10:00 p.m. on July 4,
2014.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Commander John Bannon, Waterways Management,
U.S. Coast Guard Sector San Diego, CA; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones in San Diego Bay for the Big Bay Boom Fourth of July Fireworks
Display in 33 CFR 165.1123, Table 1, Item 5 from 8:30 p.m. to 10:00
p.m.
    Under the provisions of 33 CFR 165.1123, persons and vessels are
prohibited from entering into, transiting through, or anchoring within
the 1,000 foot regulated area safety zone around each tug and barge
unless authorized by the Captain of the Port, or his designated
representative. Persons or vessels desiring to enter into or pass
through the safety zones may request permission from the Captain of the
Port or a designated representative. If permission is granted, all
persons and vessels shall comply with the instructions of the Captain
of the Port or designated representative. Spectator vessels may safely
transit outside the regulated area, but may not anchor, block, loiter,
or impede the transit of participants or official patrol vessels. The
Coast Guard may be assisted by other Federal, State, or local law
enforcement agencies in enforcing this regulation.
    This notice is issued under authority of 5 U.S.C. 552(a) and 33 CFR
165.1123. In addition to this notice in the Federal Register, the Coast
Guard will provide the maritime community with advance notification of
this enforcement period via the Local Notice to Mariners, Broadcast
Notice to Mariners, and local advertising by the event sponsor.
    If the Captain of the Port Sector San Diego or his designated
representative determines that the regulated area need not be enforced
for the full duration stated on this notice, he or she may use a
Broadcast Notice to Mariners or other communications coordinated with
the event sponsor to grant general permission to enter the regulated
area.

    Dated: April 28, 2014.
S.M. Mahoney,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2014-10972 Filed 5-13-14; 8:45 am]
BILLING CODE 9110-04-P