[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Rules and Regulations]
[Pages 52962-52963]
[FR Doc No: 2015-21695]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 740

[Docket No. 150720622-5622-01]
RIN 0694-AG63

Revisions to License Exception Availability for Consumer
Communications Devices and Licensing Policy for Civil
Telecommunications-Related Items Such as Infrastructure Regarding
Sudan; Correction

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule; correction.

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SUMMARY: The Bureau of Industry and Security publishes this rule to
correct an error in License Exception Temporary imports, exports,
reexports, and transfers (in-country) (TMP) to make certain consumer
communications devices and related software eligible for temporary
export and reexport to Sudan as ``tools of trade.'' This error was
introduced in a final rule published in February 2015 that amended the
Export Administration Regulations to authorize License Exception
Consumer Communications Devices (CCD) for use in Sudan and made changes
to License Exception TMP. BIS is publishing this rule to facilitate use
of employer-owned devices such as cell phones, Wi-Fi-equipped computers
and tablets by persons engaged in humanitarian efforts in Sudan.

DATES: The rule is effective September 2, 2015.

FOR FURTHER INFORMATION CONTACT: Theodore Curtin, telephone (202) 482-
4252, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    In general, items listed on the Commerce Control List with anti-
terrorism stated as a reason for control require a license for export
or reexport, even temporarily, to Sudan. Some limited exceptions to
this requirement exist. One such exception, License Exception Baggage
(BAG), allows travelers to Sudan to take with them for their personal
use or use by family members their personally-owned consumer
communications devices such as cell phones, Wi-Fi- enabled personal
computers, global positioning systems and related software. Another
exception, License Exception Consumer Communications Devices (CCD),
allows the export and reexport of such devices and related software for
use by non-governmental organizations or individuals in Sudan. Sudan
was added as an eligible destination under CCD in a final rule
published on February 18, 2015 (the February 2015 rule) (see ``License
Exception Availability for Consumer Communications Devices and
Licensing Policy for Civil Telecommunications-Related Items Such as
Infrastructure Regarding Sudan,'' (80 FR 8520)). For several years
prior to the February 2015 rule, a third exception, Temporary imports,
exports, reexports, and transfers (in-country) (TMP), allowed non-
governmental organizations engaged in humanitarian work in Sudan and
their individual staff members, employees, or contractors to export or
reexport temporarily to Sudan employer-owned consumer communications
devices and related software for use as ``tools of trade.'' See 70 FR
8251 (Feb. 18, 2005) (authorizing exports of such items) and 73 FR
10668 (Feb. 28, 2008) (authorizing reexports of such items).
    The February 2015 amendment to the Export Administration
Regulations (EAR) made consumer communications devices and related
software available under License Exception CCD for export and reexport
to non-governmental organizations and individuals in Sudan generally
(with no requirement that the export or reexport be temporary). That
rule was intended to foster communications to, from, and among the
people of Sudan. Because the commodities and software would be
available under License Exception CCD to all individuals in Sudan
(including persons traveling to Sudan on a temporary basis), the
February 2015 rule removed as unnecessary paragraph (a)(2) of License
Exception TMP, which had authorized the temporary export and reexport
of these items by non-governmental organizations engaged in
humanitarian work in Sudan and their individual staff members,
employees, or contractors. In addition, in an earlier rule amending
License Exception CCD, which up to that time had authorized only
donations made to individuals and non-governmental organizations Cuba,
the phrase ``either sold or donated'' was added to the paragraph
describing the authorization of the export and reexport of consumer
communications devices and related software under the license
exception. See 80 FR 2286 (Jan. 16, 2015).
    Although the intent was to state that the devices or software no
longer had to be donated, the addition of the ``either sold or
donated'' language to License Exception CCD in January 2015, in
combination with the removal of paragraph (a)(2) of license exception
TMP by the February 2015 rule on Sudan, created problems for non-
governmental organizations that send personnel to Sudan for
humanitarian activities. The employer-owned devices that such personnel
use in Sudan are neither sold nor donated in connection with the staff
member's, employee's or contractor's travel to Sudan. As an unintended
consequence of the interplay of the changes made pursuant to the two
recent rules, such travelers who seek to engage in the humanitarian
activities for which temporary exports and reexports have been
authorized by License Exception TMP since 2005 need licenses to take to
Sudan temporarily their employer-owned communication devices and
software even though the same items could be exported or reexported to
Sudan under a license exception if personally owned by the travelers or
if being sold or donated to a non-governmental organization or to any
individual in Sudan.
    This final rule amends the EAR to correct License Exception TMP to
clarify BIS's intent to authorize temporary export and reexport of
employer-owned consumer communications devices and related software as
tools of trade to Sudan under the license exception. The amended
provision refers to the list of consumer communications devices and
software that is contained in License Exception CCD (Section 740.19(b))
and notes that all other requirements and limitations found in License
Exception TMP apply to exports and reexports of such items.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). This rule
does not impose any regulatory burden on the public and is consistent
with the goals of Executive Order 13563. This rule has been determined
to be not significant for purposes of Executive Order 12866.

    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid Office of Management and Budget (OMB) control number. This rule
involves a collection of information approved under OMB control number
0694-0088, Simplified Network Application Processing+ System (SNAP+)
and the Multipurpose Export License Application, which carries an
annual estimated burden of 31,833 hours. BIS believes that this rule
will have no material impact on that burden. To the extent that it has
any impact at all, the impact would be to reduce the burden because
this rule makes some transactions that would otherwise require a
license eligible for a license exception.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. BIS finds good cause under 5 U.S.C. 553(b)(B) to waive prior
notice of proposed rulemaking and the opportunity for public comment
because it is impracticable and contrary to the public interest. This
rule corrects an error in License Exception TMP to make certain
consumer communications devices and related software eligible for
temporary export and reexport to Sudan as ``tools of trade.'' Due to a
drafting error in the February 2015 rule, license exception
availability under the EAR was eliminated for employer-owned consumer
communications devices and related software being exported or
reexported temporarily to Sudan for use by staff members, employees,
and contractors of non-governmental organizations engaged in
humanitarian activities. Those same devices may be exported or
reexported temporarily to Sudan under a license exception if they are
owned personally by the traveler. They may also be exported or
reexported permanently to Sudan under a license exception if they are
to be sold or donated to a non-governmental organization or individual
in Sudan. This rule is necessary in order to ensure that persons
traveling to Sudan benefit from clarity on the point addressed by this
rule, as it would enable them to bring certain items with them for use
in their humanitarian activities in the country without having to apply
for a license. Maintaining a license requirement for this limited
category of exports and reexports is contrary to the public interest as
it would hamper the activities of non-governmental organizations
engaged in humanitarian work without providing any corresponding
benefit to the foreign policy goals that export controls are intended
to meet. It would be impracticable to delay this rule to allow for
notice and comment, as there is an urgent need for timely clarification
consistent with the purpose of the February 2015 rule, which sought to
expand the scope of exports and reexports to Sudan that may occur
without the need to obtain a license.
    BIS also finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-
day delay in effectiveness. This rule does not impose any new
regulatory burden on any person. It merely makes clear that certain
employer-owned consumer communications devices and software may be
exported or reexported temporarily to Sudan as tools of trade by
persons traveling to Sudan. No person would be required to change any
of its existing practices as a result of this rule. However, persons
traveling to Sudan would benefit from clarity on the point addressed by
this rule, as it would enable them to bring certain items with them for
use in their humanitarian activities in the country without having to
apply for a license. Because this rule imposes no new burden while
providing a benefit to some persons, delaying implementation would be
contrary to the public interest.

List of Subjects in 15 CFR Part 740

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

    For the reasons set forth in the preamble, the Export
Administration Regulations (15 CFR parts 730-774) are amended as
follows:

PART 740--[AMENDED]

0
1. The authority citation for 15 CFR part 740 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp.,
p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice
of August 7, 2015, 80 FR 48233 (August 11, 2015).

0
2. In Sec.  740.9, paragraph (a)(2) is added to read as follows:

Sec.  740.9  Temporary imports, exports, reexports, and transfers (in-
country) (TMP).

* * * * *
    (a) * * *
    (2) Sudan. Notwithstanding the exclusion of destinations in Country
Group E:1 in paragraphs (a)(1) and (3) of this section, items listed in
Sec.  740.19(b) of the EAR may be exported or reexported as tools of
trade to Sudan. All other requirements and limitations of this
paragraph (a) apply to such exports and reexports.
* * * * *

    Dated: August 25, 2015.
Kevin J. Wolf,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2015-21695 Filed 9-1-15; 8:45 am]
 BILLING CODE 3510-33-P


[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12925-12926]
[FR Doc No: 2023-04194]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1417-278]

Central Nebraska Public Power and Irrigation District; Notice of
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Revised Land and Shoreline Management Plan.
    b. Project No: 1417-278.
    c. Date Filed: December 29, 2022.
    d. Applicant: Central Nebraska Public Power and Irrigation
District.
    e. Name of Project: Kingsley Dam Hydroelectric Project.
    f. Location: The project is located on the North Platte and Platte
Rivers in Garden, Keith, Lincoln, Dawson, and Gosper counties, in
south-central Nebraska.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mike Drain, Central Nebraska Public Power and
Irrigation District, P.O. Box 740, Holdrege, Nebraska 68949, (308) 995-
8601 or [email protected].
    i. FERC Contact: Jon Cofrancesco,<PHONE_NUMBER> or
[email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: March 27, 2023.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy. Submissions sent via the U.S. Postal Service must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include docket numbers P-1417-278.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: Pursuant to License Article 421, Central
Nebraska Public Power and Irrigation District (Central) filed, for
Commission approval, a revised Land and Shoreline Management Plan
(LSMP) for the Kingsley Dam Project. The revised LSMP is a
comprehensive plan to manage the multiple resources and uses of the
project's shoreline in a manner that is consistent with license
requirements and project purposes, and protect environmental resources.
The revised LSMP supersedes and updates the project's current LSMP
approved by the Commission in 2014 and was prepared in consultation
with resource agencies and with input from interested stakeholders.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE, Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's website at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', ``MOTION TO
INTERVENE'', ``RECOMMENDATIONS'', or ``TERMS AND CONDITIONS'' as
applicable; (2) set forth in the heading the name of the applicant and
the project number of the

application to which the filing responds; (3) furnish the name,
address, and telephone number of the person commenting, protesting or
intervening; and (4) otherwise comply with the requirements of 18 CFR
385.2001 through 385.2005. All comments, motions to intervene, or
protests must set forth their evidentiary basis. Any filing made by an
intervenor must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 385.2010.

    Dated: February 23, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-04194 Filed 2-28-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 153 (Thursday, August 8, 2013)]
[Notices]
[Pages 48510-48513]
[FR Doc No: 2013-19149]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70102; File No. SR-C2-2013-028]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Exchange Order Handling

August 2, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 25, 2013, C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items and II 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

    The Exchange proposes to modify its rules to address certain option
order handling procedures on the Exchange in connection with the
implementation of the market wide equity Plan to Address Extraordinary
Market Volatility (the ``Plan''). The text of the proposed rule change
is available at the Exchange's Office of the Secretary, on the
Exchange's Web site at http://www.c2exchange.com/Legal/, at the
Commission's Public Reference Room, and on the Commission's Web site at
http://www.sec.gov.

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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In an attempt to address extraordinary market volatility in NMS
Stock, and, in particular, events like the severe volatility on May 6,
2010, the Exchange, in conjunction with the other national securities
exchanges and the Financial Industry Regulatory Authority, Inc.
(collectively, ``Participants'') drafted the Plan pursuant to Rule 608
of Regulation NMS and under the Securities Exchange Act of 1934 (the
``Act'').\3\ The Plan is primarily designed to, among other things,
address extraordinary market volatility in NMS stocks, protect
investors, and promote fair and orderly markets. The Plan provides for
market-wide limit up-limit down requirements that prevent trades in
individual NMS Stocks from occurring outside of specified price bands,
as defined in Section I(N) of the Plan. These requirements are coupled
with trading pauses, as defined in Section I(Y) of the Plan, to
accommodate more fundamental price moves (as opposed to erroneous
trades or monetary gaps of liquidity).
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    \3\ See Securities Exchange Act Release No. 64547 (May 25,
2011), 76 FR 31647 (June 1, 2011) (File No. 4-631).
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    The Plan was filed on April 5, 2011 by the Participants for
publication and comment.\4\ The Participants requested the Commission
approve the Plan as a one-year pilot. On May 24, 2012, the Participants
filed an amendment to the Plan which clarified, among other things, the
calculation of the reference price, as defined in Section I(T) of the
Plan, potential for order type exemption, and the creation of an
Advisory Committee.\5\ On May 31, 2012, the Commission approved the
Plan, as amended, on a one-year pilot basis.\6\ The Plan was
implemented on April 8, 2013.
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    \4\ Id.
    \5\ See Securities and Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (File No. 4-631).
    \6\ See Securities and Exchange Act Release No. 67091 (May 31,
2012) 77 FR 33498 (June 6, 2012).
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    Though the Plan was primarily designed for equity markets, the
Exchange believed it would impact the options markets as well. Thus,
the Exchange filed rule changes to amend the Exchange rules to ensure
the option markets are not compromised as a result of the Plan's
implementation.\7\ The Exchange is proposing to amend these rules to
clarify how the openings will operate on the Exchange in the event of a
limit up-limit down state.
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    \7\ See Securities and Exchange Act Release No. 34-69345 (April
8, 2013), 78 FR 21985 (April 11, 2013) (SR-C2-2013-013).
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    The current rule 6.11, as recently amended, states that is an
underlying security for an option class enters into a limit up-limit
down state when the class moves to opening rotation, ``all market
orders in the system will be cancelled.''\8\ The Exchange is proposing
to: (1) Correct the reference to Exchange Rule 6.3A, (2) add an
exception to this general rule, and (3) provide greater clarity on the
effect of a limit up-limit down state on an underlying security after
the Rotation Period has begun.
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    \8\ See Exchange Rule 6.11.03.
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    First, the Exchange is proposing to clarify an incorrect reference
in Rule 6.11.03 to Rule 6.3A. The correct reference should be made to
Rule 6.39 which was a recently added rule to address the Plan. The
Exchange believes that by updating the reference, Permit Holders will
have greater clarity of which rule is applicable.
    Next the Exchange is proposing to make an exception to the general
rule that all market orders will be cancelled during the Rotation
Period if the underlying security is in a limit up-limit down state.
The Exchange is proposing to add language stating that the type of
order described in Exchange Rule 6.12(h), ``No-Bid Series'' orders,
from a previous day will not cancelled. The Exchange is proposing to
allow such market orders to remain in the Exchange Book because these
essentially act as limit orders at the minimum increment. Cancelling
such orders could potentially cause such orders to lose their priority
with respect to other market orders in the Exchange Book. The Exchange
believes that though these orders are essentially treated as limit
orders, because they may have a ``market'' distinction, alerting Permit
Holders of the behavior of such orders when the underlying security
enters a limit up-limit down state will provide more clarity. In
addition, this behavior is consistent with how limit orders are treated
in the same situation.
    Finally, the Exchange is proposing to add further clarity to the
recently amended rule to clarify that if a limit up-limit down state
commences after the Rotation Period has begun for a class of options,
the Rotation Period will continue normally. More specifically, the
Exchange is proposing to add language to state that market and limit
orders will continue through the Rotation Period as they would if there
was not a limit up-limit down state. Once the Rotation Period has begun
for a class of options, due to how the Exchange System operates, the
process will not be interrupted to modify the order handling mid-
process.
    Market orders will continue to process even though they are
normally returned during a limit up-limit down state,\9\ limit orders
will process normally,\10\ and the Exchange will open normally if there
is a presence of Opening Conditions.\11\ Market orders, though normally
returned during a limit up-limit down state to avoid executions at
unfavorable or unreliable prices, do not face the same risks when they
are part of the opening process. This is because preopening orders are
matched with each other and with other interest during the Rotation
Period. Thus, market orders will trade at the calculated opening price.
Preopening limit orders will also be filled at the opening price and
cannot be filled through their limit prices.
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    \9\ See Exchange Rule 6.10(a) which describes how market orders
process.
    \10\ See Exchange Rule 6.10(b) which describes how limit orders
process.
    \11\ See Exchange Rule 6.11(f) which describes how the Exchange
will open in the presence of Opening Conditions. If a limit up-limit
down state commences after the Rotation Period has begun for a class
of options, options to buy and sell will be paired to the extent
possible. If another market is displaying a more favorable price,
then the Exchange will open as described in 6.11(f). Consistent with
Rule 6.11(f), the Exchange will link any unmatched portion of the
market order to an away trading venue. Any portion of a market order
that is unfilled and returned to the Exchange will be cancelled.
Thus, markets orders will not be filled at an unreliable price
because they will either be paired with other resting orders at the
open or linked to an away trading venue displaying a more favorable
price. The Exchange believes this is consistent with the treatment
of market orders and ensures they will not be given an unreliable
price despite the limit up-limit down state. Additionally, because
limit orders have a limit price, these orders will also not fill at
an unreliable price.
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    The Exchange believes this clarity is necessary to ensure Permit
Holders are fully aware of special order handling during limit up-limit
down states. Though the rule currently specifies what happens to orders
on the Exchange if the limit up-limit down state commences prior to the
Rotation Period beginning for a class of options, the Exchange believes
it is necessary to additionally state what would happen if the Rotation
Period had already begun and the limit up-limit down state triggers
during the time of that process. The Exchange believes that including
pre-opening market order interest in the Rotation Period will enhance
the liquidity available during the rotation, and that the nature of the
opening match process will protect market orders against anomalous
opening prices that could otherwise be caused by market conditions
associated with a limit-up limit-down state. This will also

help to ensure the options markets remain just and equitable with the
implementation of the Plan.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\12\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \13\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5)\14\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ Id.
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    In particular, the Exchange believes the proposed changes will be
in accordance with the Act as they are merely intended to ensure the
options markets will continue to remain just and equitable with the
implementation of the Plan which is intended to reduce the negative
impacts of a sudden, unanticipated price movement in NMS stocks. The
proposed rule changes would promote this intention in the options
markets while protecting investors participating there. More
specifically, the currently proposed changes will correct and clarify
current Exchange rules promoting the interest of investors. Finally,
creating a more orderly market will promote just and equitable
principles of trade by allowing investors to feel more secure in their
participation in the national market system after the implementation of
the Plan. In addition, the Exchange is proposing to provide a more
robust rule text by clarifying what occurs if a limit up-limit down
states initiates after the beginning of the Exchange's opening
rotation. The Exchange believes that not cancelling the pre-opening
interest will ensure investors can execute more interest despite the
change in the market conditions after the opening process has begun.
This will also help to ensure the options markets remain just and
equitable with the implementation of the Plan.

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

    C2 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. Specifically, the Exchange
believes the proposed changes will not impose any burden on intramarket
competition because it applies to all Permit Holders equally. The
Exchange does not believe the proposed changes will impose any burden
on intermarket competition as the changes are merely being made to
protect investors with the implementation of the Plan. In addition, the
proposed changes will provide certainty of treatment and execution of
options orders during periods of extraordinary market volatility.

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

    The Exchange 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 Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \15\ and Rule 19b-4(f)(6) thereunder.\16\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \15\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \16\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-C2-2013-028 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-C2-2013-028. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Section, 100 F Street
NE., Washington, DC 20549-1090 on official business days between the
hours of 10:00 a.m. and 3:00 p.m. Copies of the filing will also be
available for inspection and copying at the 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-C2-2013-028 and should be submitted on
or before August 29, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19149 Filed 8-7-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 21, 2008 (Volume 73, Number 163)]
[Rules and Regulations]
[Page 49354-49355]
[DOCID:fr21au08-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1989-0008, Notice 4; FRL-8706-2]

National Oil and Hazardous Substance Pollution Contingency Plan
National Priorities List

AGENCY: Environmental Protection Agency.

ACTION: Notice of Deletion of the Fourth Street Abandoned Refinery
Superfund Site from the National Priorities List.

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

SUMMARY: The Environmental Protection Agency (EPA) Region 6 announces
the deletion of the Fourth Street Abandoned Refinery Superfund Site
(Site) located in Oklahoma City, Oklahoma, from the National Priorities
List (NPL). The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is found at Appendix B of 40 CFR part 300
which is the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). The EPA and the State of Oklahoma, through the
Oklahoma Department of Environmental Quality, have determined that all
appropriate response actions under CERCLA, other than operation,
maintenance, and five-year reviews, have been completed. However, this
deletion does not preclude future actions under Superfund.

DATES: Effective Date: This action is effective August 21, 2008.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-HQ-SFUND-1989-0008, Notice 4. All documents in
the docket are listed on the http://www.regulations.gov Web site.
Although listed in the index, some information is not 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 http://
www.regulations.gov or in hard copy at the site information
repositories. Locations, contacts, phone numbers and viewing hours are:

U.S. EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-
2733,<PHONE_NUMBER>, by appointment only Monday through Friday 9 a.m.
to 12 p.m. and 1 p.m. to 4 p.m.
Ralph Ellison Library, 2000 Northeast 23, Oklahoma City, OK 73111,
(409) 643-5979, Monday through Wednesday 9 a.m. to 9 p.m., Thursday and
Friday 9 a.m. to 6 p.m., Saturday 10 a.m. to 4 p.m.
Oklahoma Department of Environmental Quality (ODEQ), 707 North
Robinson, Oklahoma City, Oklahoma 73101,<PHONE_NUMBER>, Monday through
Friday 8 a.m. to 5 p.m.

FOR FURTHER INFORMATION CONTACT: Bartolome Canellas (6SF-RL), Remedial
Project Manager, U.S. Environmental Protection Agency, Region 6, U.S.
EPA, 1445 Ross Avenue, Dallas, Texas 75202,<PHONE_NUMBER> or 1-800-
533-3508 or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The site to be deleted from the NPL is:
Fourth Street Abandoned Refinery, Oklahoma City, Oklahoma. A Notice of
Intent to Delete for this Site was published in the Federal Register on
June 13, 2008.
    The closing date for comments on the Notice of Intent to Delete was
July 14, 2008. One public comment was received. The commenter
questioned the completeness of the response action based on information
found in non-EPA Internet Web sites. EPA believes the deletion is
appropriate, since the response action has been implemented, as
documented in the Deletion Docket. A responsiveness summary was
prepared and placed in the docket, EPA-HQ-SFUND-1989-0008, Notice 4, on
http://www.regulations.gov, and in the local repositories listed above.
    EPA maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment.
Deletion from the NPL does not preclude further remedial action.
Whenever there is a significant release from a site deleted from the
NPL, the deleted site may be restored to the NPL without application of
the hazard ranking system. Deletion of a site from the NPL does not
affect responsible party liability in the unlikely event that future
conditions warrant further actions.

List of Subjects in 40 CFR Part 300

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

    Dated: August 12, 2008.
Richard E. Greene,
Regional Administrator, Region 6.

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

PART 300--[AMENDED]

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

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

0
2. Table 1 of Appendix B to part 300 is amended by removing the entry
under OK for ``Fourth Street Abandoned Refinery'', ``Oklahoma City''.

[FR Doc. E8-19419 Filed 8-20-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Page 34872]
[FR Doc No: 2022-12336]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2008-000]

SEPV Sierra, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
SEPV Sierra, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 22, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: June 2, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-12336 Filed 6-7-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 43 (Tuesday, March 5, 2019)]
[Notices]
[Pages 7904-7906]
[FR Doc No: 2019-03899]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3662]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Reagents for Detection of Specific Novel
Influenza A Viruses

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with the
guidance on reagents for detection of specific novel influenza A
viruses.

DATES: Submit either electronic or written comments on the collection
of information by May 6, 2019.

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 May 6, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 6, 2019. 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-2015-N-3662 for ``Guidance on Reagents for Detection of Specific
Novel Influenza A Viruses.'' 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.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in

its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance on Reagents for Detection of Specific Novel Influenza A
Viruses--21 CFR Part 866

OMB Control Number 0910-0584--Extension

    In accordance with section 513 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360c), FDA evaluated an application
for an in vitro diagnostic device for detection of influenza subtype H5
(Asian lineage), commonly known as avian flu. FDA concluded that this
device is properly classified into class II in accordance with section
513(a)(1)(B) of the FD&C Act, because it is a device for which the
general controls by themselves are insufficient to provide reasonable
assurance of the safety and effectiveness of the device, but there is
sufficient information to establish special controls to provide such
assurance. The statute permits FDA to establish as special controls
many different things, including postmarket surveillance, development
and dissemination of guidance recommendations, and ``other appropriate
actions as the Secretary deems necessary'' (section 513(a)(1)(B) of the
FD&C Act). This information collection is a measure that FDA determined
to be necessary to provide reasonable assurance of safety and
effectiveness of reagents for detection of specific novel influenza A
viruses.
    FDA issued an order classifying the H5 (Asian lineage) diagnostic
device into class II on March 22, 2006 (71 FR 14377), establishing the
special controls necessary to provide reasonable assurance of the
safety and effectiveness of that device and similar future devices. The
new classification was codified in 21 CFR 866.3332, a regulation that
describes the new classification for reagents for detection of specific
novel influenza A viruses and sets forth the special controls that help
to provide a reasonable assurance of the safety and effectiveness of
devices classified under that regulation. The regulation refers to the
document entitled ``Class II Special Controls Guidance Document:
Reagents for Detection of Specific Novel Influenza A Viruses,'' which
provides recommendations for measures to help provide a reasonable
assurance of safety and effectiveness for these reagents. The guidance
recommends that sponsors obtain and analyze postmarket data to ensure
the continued reliability of their device in detecting the specific
novel influenza A virus that it is intended to detect, particularly
given the propensity for influenza viruses to mutate and the potential
for changes in disease prevalence over time. As updated sequences for
novel influenza A viruses become available from the World Health
Organization, National Institutes of Health, and other public health
entities, sponsors of reagents for detection of specific novel
influenza A viruses will collect this information, compare them with
the primer/probe sequences in their devices, and incorporate the result
of these analyses into their quality management system, as required by
21 CFR 820.100(a)(1). These analyses will be evaluated against the
device design validation and risk analysis required by 21 CFR 820.30(g)
to determine if any design changes may be necessary.
    FDA estimates that one respondent will be affected annually. The
respondent will collect this information twice per year; each response
is estimated to take 15 hours. This results in a total data collection
burden of 30 hours.
    The guidance also refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 801 have been approved under OMB control number 0910-0485;
the collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping regarding reagents for detection of specific novel                  1                2                2               15               30
 influenza A viruses...............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Manufactures are increasingly adopting in silico methods
(computational analysis) for the detection of specific novel Influenza
A viruses over traditional laboratory techniques. Therefore, few
manufactures are using reagents for detection of specific novel
influenza A viruses. Based on these industry trends, we estimate a
decrease in the number of total annual records and a corresponding
decrease of 270 hours in the total burden since our last OMB approval.

    Dated: February 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03899 Filed 3-4-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66994-66995]
[FR Doc No: 2020-23300]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2032]

Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral
Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other
Drug Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products if they meet relevant legal and regulatory
requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in the table are
no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                                Active                           Dosage form/
    Application No.          Drug name       ingredient(s)      Strength(s)          route          Applicant
----------------------------------------------------------------------------------------------------------------
NDA 000793.............  BUTISOL SODIUM..  Butabarbital      15 mg; 50 mg;     Tablet; Oral....  Mylan
                                            Sodium.           100 mg.                             Specialty,
                                                                                L.P.
NDA 007392.............  SECONAL SODIUM..  Secobarbital      50 mg/Milliliter  Injectable;       Eli Lilly and
                                            Sodium.           (mL).             Injection.        Co.
NDA 012665.............  VELBAN..........  Vinblastine       10 mg/Vial......  Injectable;       Eli Lilly and
                                            Sulfate.                            Injection.        Co.
NDA 017015.............  PAVULON.........  Pancuronium       1 mg/mL; 2 mg/mL  Injectable;       Schering-Plough
                                            Bromide.                            Injection.        Corp.
NDA 017919.............  ORTHO-NOVUM 1/35- Ethinyl           0.035 mg;1 mg...  Tablet; Oral-28.  Janssen
                          28.               Estradiol;                                            Pharmaceutical
                                            Norethindrone.                                        s, Inc.
NDA 018554.............  EULEXIN.........  Flutamide.......  125 mg..........  Capsule; Oral...  Schering-Plough
                                                                                Corp.
NDA 019151.............  RYTHMOL.........  Propafenone       150 mg, 225 mg,   Tablet; Oral....  GlaxoSmithKline
                                            Hydrochloride.    300 mg.                             .
NDA 019579.............  TERAZOL 7.......  Terconazole.....  0.4%............  Cream; Vaginal..  Janssen
                                                                                Pharmaceutical
                                                                                s, Inc.
NDA 019599.............  NAFTIN..........  Naftifine         1%..............  Cream; Topical..  Sebela Ireland
                                            Hydrochloride.                                        Limited.
NDA 019653.............  ORTHO CYCLEN-28.  Ethinyl           0.035 mg; 0.25    Tablet; Oral-28.  Janssen
                                            Estradiol;        mg.                                 Pharmaceutical
                                            Norgestimate.                                         s, Inc.
NDA 019716.............  DIPROLENE.......  Betamethasone     EQ 0.05% Base...  Lotion,           Merck Sharp &
                                            Dipropionate.                       Augmented;        Dohme Corp.
                                                                                Topical.
NDA 019964.............  TERAZOL 3.......  Terconazole.....  0.8%............  Cream; Vaginal..  Janssen
                                                                                Pharmaceutical
                                                                                s, Inc.
NDA 020313.............  MIACALCIN.......  Calcitonin        200               Metered Spray;    Mylan Ireland
                                            Salmon.           International     Nasal.            Limited.
                                                              Units/Spray.
NDA 020388.............  NAVELBINE.......  Vinorelbine       EQ 10 mg Base/mL  Injectable;       Pierre Fabre
                                            Tartrate.                           Injection.        Medicament.
NDA 020413.............  ZERIT...........  Stavudine.......  1 mg/mL.........  For Solution;     Bristol-Myers
                                                                                Oral.             Squibb.
NDA 020741.............  PRANDIN.........  Repaglinide.....  0.5 mg; 1 mg; 2   Tablet; Oral....  Gemini
                                                              mg.                                 Laboratories,
                                                                                LLC.
NDA 020872.............  CHILDREN'S        Fexofenadine      30 mg...........  Tablet; Oral....  Sanofi-Aventis
                          ALLEGRA ALLERGY.  Hydrochloride.                                        U.S., LLC.
NDA 021071.............  AVANDIA.........  Rosiglitazone     EQ 8 mg Base....  Tablets; Oral...  SB Pharmco
                                            Maleate.                                              Puerto Rico,
                                                                                Inc.
NDA 021235.............  PROZAC WEEKLY...  Fluoxetine        EQ 90 mg/Base...  Delayed-Release   Eli Lilly and
                                            Hydrochloride.                      Capsules; Oral.   Co.

NDA 021909.............  CHILDREN'S        Fexofenadine      30 mg...........  Tablet, Orally    Sanofi-Aventis
                          ALLEGRA HIVES.    Hydrochloride.                      Disintegrating;   U.S., LLC.
                                                                                Oral.
NDA 022246.............  METOZOLV ODT....  Metoclopramide    EQ 5 mg Base....  Tablet, Orally    Bausch Health
                                            Hydrochloride.                      Disintegrating;   US, LLC.
                                                                                Oral.
NDA 022291.............  PROMACTA........  Eltrombopag       EQ 100 mg Acid..  Tablet; Oral....  Novartis.
                                            Olamine.
NDA 022362.............  WELCHOL.........  Colesevelam       1.875 g/Packet..  For Suspension;   Daiichi Sankyo.
                                            Hydrochloride.                      Oral.
NDA 022396.............  DYLOJECT........  Diclofenac        37.5 mg/mL (37.5  Solution;         Javelin
                                            Sodium.           mg/mL).           Intravenous.      Pharmaceutical
                                                                                s, Inc.
NDA 050368.............  ILOTYCIN........  Erythromycin....  0.5%............  Ointment;         Eli Lilly and
                                                                                Ophthalmic.       Co.
NDA 050587.............  PRIMAXIN........  Cilastatin        EQ 250 mg Base/   Powder;           Merck & Co.,
                                            Sodium;           Vial; 250 mg/     Intravenous.      Inc.
                                            Imipenem.         Vial.
NDA 201373.............  CHILDREN'S        Fexofenadine      30 mg/5 mL......  Suspension; Oral  Sanofi-Aventis
                          ALLEGRA HIVES.    Hydrochloride.                                        U.S., LLC.
NDA 208411.............  NARCAN..........  Naloxone          2 mg/Spray......  Spray, Metered;   Adapt Pharma.
                                            Hydrochloride.                      Nasal.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the Agency will
continue to list the drug products in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' identifies, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed are
unaffected by the discontinued marketing of the products subject to
those NDAs and ANDAs. Additional ANDAs that refer to these products may
also be approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23300 Filed 10-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Rules and Regulations]
[Pages 52622-52625]
[FR Doc No: 2015-21690]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0800]
RIN 1625-AA87

Security Zone, Seward, AK

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary moving security
zone within 1000 yards of a designated vessel on the navigable waters
of the U.S. in Resurrection Bay, Seward, Alaska during the visit of the
President of the United States (POTUS) to the area. This action is
necessary to provide security for the President and first family of the
United States. Unauthorized vessels and persons will be prohibited from
entering or remaining in the security zones unless specifically
authorized by the Captain of the Port (COTP) or the COTP's designated
representative. A U.S. Coast Guard Broadcast Notice to Mariners (BNM)
will be conducted during this time to identify the vessel's name and
location in which the security zone pertains.

DATES: This rule is effective without actual notice from September 1,
2015 until 5 p.m. on September 2, 2015. For the purposes of
enforcement, actual notice will be used from 8 a.m. on August 31, 2015
until September 1, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2015-0800]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 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
temporary rule, call or email Lieutenant Eugene Chung, Coast Guard
Sector Anchorage Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER> or email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Cheryl
Collins, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because of the sensitive security issues
related to the POTUS. Providing a public notice and comment period is
contrary to national security concerns and the public interest. Under 5
U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for
making this rule effective less than 30 days after publication in the
Federal Register. Any delay encountered in this temporary rule's
effective date would be contrary to the public interest given the
immediate need to ensure the safety and security of the POTUS and first
family during their visit to Seward, Alaska from August 31, 2015
through September 02, 2015.

B. Basis and Purpose

    The legal basis for this rule is 33 U.S.C. 1231; 46 U.S.C. Chapter
701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and
160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland
Security Delegation No. 0170.1.
    The POTUS and first family are scheduled to visit Seward, Alaska,
from August 31, 2015 through September 02, 2015. It is expected that
they will reside and/or participate in activities on properties that
are adjacent to navigable waters within the Captain of the Port,
Western Alaska zone. The U.S. Secret Service has requested that the
Coast Guard provide 1000-yard moving security zone around the POTUS and
the first family. This security zone is intended to provide security
for the POTUS and first family by preventing vessels and persons from
approaching the location of the POTUS and first family without prior
authorization from the U.S. Secret Service.

C. Discussion of the Temporary Final Rule

    This temporary rule establishes a temporary moving security zone
within 1000 yards of a designated vessel on the navigable waters of the
U.S. in Resurrection Bay, Seward, Alaska from August 31, 2015 through
September 02, 2015, during the visit of the POTUS and first family to
Alaska. This rule is effective from 8 a.m. on Monday, August 31, 2015
through 5 p.m. on Wednesday, September 2, 2015. This action is intended
to prohibit unauthorized vessels or persons from entering or remaining
in navigable waters located within 1000 yards of the POTUS and/or first
family while they are in or near the navigable waters of the U.S.
during their visit to Seward, Alaska. The Captain of the Port, Western
Alaska, anticipates negligible negative impact on vessel traffic from
this temporary security zone, as they will be in effect for no more
than three days, and will only be enforced while the POTUS and/or first
family are in the vicinity of the navigable waters of the U.S. at
Seward, Alaska. It has been determined that the necessary security
enhancements provided by this rule greatly outweigh any potential
negative impacts.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13536. The Office of Management and
Budget has not reviewed it under those Orders. The rule is not a
significant regulatory action because the security zone will be in
place for a limited period, approximately three days and vessel traffic
will be able to transit around the security zone. Maritime traffic may
also request permission to transit through the zone from the Captain of
the Port, Western Alaska or a designated representative.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider potential impact on
small entities during rulemaking. The term ``small entities'' comprises
small businesses, not-for-profit organizations that are independently
owned and operated and are not dominant in their fields, and
governmental jurisdictions with populations of less than 50,000. The
Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not
have a

significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small
entities: The owners and operators of vessels intending to transit
navigable waters in the vicinity of Seward, Alaska from 8:00 a.m. on
Monday, August 31, 2015 through 5:00 p.m. on Wednesday, September 2,
2015. The security zone will not have a significant impact on a
substantial number of small entities for the following reasons: The
security zone is temporary and will be enforced only when the POTUS
and/or first family are in the vicinity of the navigable waters of the
U.S. at Seward, Alaska. Thus, the temporary nature and limited
effective period and anticipated enforcement periods of the zone,
coupled with the ability of the maritime public to maneuver around the
zone, will allow small entities to plan and conduct their business
accordingly.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking process. If you
think your small business or organization would be affected by this
rule and you have any questions concerning its provisions or options
for compliance, please call Lieutenant Eugene Chung at<PHONE_NUMBER>.
Small businesses may send comments on the actions of Federal employees
who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This rule is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Supply Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a temporary moving
security zone within 1000 yards of a designated vessel on the navigable
waters of the U.S. in Resurrection Bay, Seward, Alaska. This rule is
categorically excluded, from further review under paragraph (34)(g) of
Figure 2-1 of the Commandant Instruction. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T01-0800 to read as follows:

Sec.  165.T01-0800  Security Zone: Seward, Alaska.

    (a) Location. The following areas are security zones: All navigable
waters, from surface to bottom, within 1000

yards of the POTUS and/or first family while underway in, or on shore
but within 1000 yards of, the navigable waters of the U.S. in the
coastal areas of Seward, Alaska.
    (b) Notification. Coast Guard Sector Anchorage will give actual
notice to mariners for the purpose of enforcement of this temporary
security zone.
    (c) Effective period. This rule is effective for purposes of
enforcement from 8:00 a.m. on Monday, August 31, 2015 through 5:00 p.m.
on Wednesday, September 02, 2015.
    (d) Regulations. (1) The general regulations contained in 33 CFR
165.33 apply.
    (2) In accordance with the general regulations in Sec.  165.33 of
this part, entry into or movement within this zone is prohibited unless
authorized by the Captain of the Port or his designated
representatives.
    (3) The ``designated representative'' is any Coast Guard
commissioned, warrant, or petty officer who has been designated by the
Captain of the Port to act on his behalf. The on-scene representative
may be on a Coast Guard vessel, or onboard a federal, state, or local
agency vessel that is authorized to act in support of the Coast Guard.
    (4) Upon being hailed by a U.S. Coast Guard vessel or a designated
representative, by siren, radio, flashing light or other means, the
operator of the vessel shall proceed as directed.
    (5) Vessel operators desiring to enter or operate within this
security zone shall contact the Captain of the Port or his designated
representative via VHF channel 16 to obtain permission to do so.

    Dated: August 24, 2015.
Paul Albertson,
Captain, U.S. Coast Guard, Captain of the Port, Western Alaska.
[FR Doc. 2015-21690 Filed 8-31-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 125 (Thursday, June 30, 2022)]
[Rules and Regulations]
[Pages 38989-38991]
[FR Doc No: 2022-14006]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0443]
RIN 1625-AA00

Safety Zone; SamSen Operation Fireworks, Seneca Lake, Romulus, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 840-foot radius of barge launched fireworks
over Seneca Lake in Romulus, NY. The safety zone is necessary to
protect personnel, vessels, and the marine environment from potential
hazards created by a fireworks display. Entry of vessels or persons
into this zone is prohibited unless specifically authorized by the
Captain of the Port Buffalo or a designated representative.

DATES: This rule is effective from 9:15 p.m. through 10:45 p.m. on July
3, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0443 in the ``SEARCH'' box and click ``SEARCH.'' Next, in the
Document Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST1 Anthony Urbana, Sector Buffalo, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the event sponsor did not submit
notice of the fireworks display to the Coast Guard with sufficient time
remaining before the event to publish an NPRM and immediate action is
necessary to protect spectators and vessels from the hazards associated
with this foreworks display. It is impracticable to publish an NPRM
because we must establish this safety zone by July 3, 2022.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph,

waiting for a 30-day notice period to run would be impracticable
because immediate action is necessary to protect personnel, vessels,
and the marine environment during the fireworks display over Seneca
Lake in Romulus, NY.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Buffalo
(COTP) has determined that fireworks over the water presents
significant risks to public safety and property within a 840-foot
radius of the launch point. This rule is necessary to protect
personnel, vessels, and the marine environment in the navigable waters
within the safety zone while the fireworks display is taking place.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9:15 p.m. through 10:45
p.m. on July 3, 2022. The safety zone will cover all navigable waters
within a 840-foot radius of barge launched fireworks over Seneca Lake
in Romulus, NY. The zone is intended to protect spectators, vessels,
and the marine environment in these navigable waters during the
fireworks display. No vessel or person will be permitted to enter the
safety zone without obtaining permission from the COTP Buffalo or a
designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the
characteristics of the safety zone. The safety zone will encompass a
840-foot radius from the barge-launched fireworks in the Seneca Lake in
Romulus, NY, with the event lasting approxiamately 1.5 hours during the
evening when vessel traffic is normally low. Moreover, the Coast Guard
would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16
about the zone, and the rule would allow vessels to seek permission to
enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting approximately 1.5 hours that will prohibit entry
within a 840-foot radius in Seneca Lake in Romulus, NY for a fireworks
display. It is categorically excluded from further review under
paragraph L60(a) of

Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1,
6.04-1, 6.04-6, and 160.5; Department of Homeland Security
Delegation No. 00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T09-0443 to read as follows:

Sec.  165.T09-0443   Safety Zone; SamSen Operation Fireworks; Seneca
Lake, Romulus, NY

    (a) Location. The following area is a safety zone: All waters of
the Seneca Lake, from surface to bottom, encompassed by a 840-foot
radius around 42[deg]43'39.28'' N, 076[deg]54'59.47'' W.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Buffalo (COTP) in the enforcement of the safety
zone.
    (c) Regulations. (1) In accordance with the general regulations in
section Sec.  165.23, entry into, transiting, or anchoring within the
safety zone described in paragraph (a) of this section is prohibited
unless authorized by the COTP Buffalo or a designated representative.
    (2) Vessel operators desiring to enter or operate within the safety
zone described in paragraph (a) of this section must contact the COTP
Buffalo or his designated representative to obtain permission to do so.
The COTP Buffalo or his designated representative may be contacted via
VHF Channel 16. Vessel operators given permission to enter or operate
in the safety zone must comply with all directions given to them by the
COTP Buffalo, or his designated representative.
    (d) Enforcement period. The regulated area described in paragraph
(a) is effective from 9:15 p.m. through 10:45 p.m. on July 3, 2022.

    Dated: June 23, 2022.
M.I. Kuperman,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2022-14006 Filed 6-29-22; 8:45 am]
BILLING CODE 9110-04-P