[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59735-59738]
[FR Doc No: 2021-23507]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1050]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Targeted Mechanism of Action Presentations in
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 and
to allow 60 days for public comment in response to the notice. This
notice

solicits comments on a proposed study entitled ``Targeted Mechanism of
Action Presentations in Prescription Drug Promotion.''

DATES: Submit either electronic or written comments on the collection
of information by December 27, 2021.

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 December 27, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 27, 2021. 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-2021-N-1050 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Targeted Mechanism of Action
Presentations in Prescription Drug Promotion.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].
    For copies of the questionnaire: Office of Prescription Drug
Promotion (OPDP) Research Team, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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.

Targeted Mechanism of Action Presentations in Prescription Drug
Promotion

OMB Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to

protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: Advertising features, including
content and format; target populations; and research quality. Through
the evaluation of advertising features, we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform the first two topic areas, advertising features and
target populations.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings are improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other scientific sources,
and this larger body of knowledge collectively informs our policies as
well as our research program. Our research is documented on our home
page, which can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
    In 2014, OPDP conducted focus groups designed to provide insights
on how consumers and healthcare providers (HCP), including physicians,
nurse practitioners, and physician assistants, interpret the term
``targeted'' in prescription drug promotional materials. Although
diverse views were voiced, there appeared to be some tendency toward
the impression that products with promotional materials using this term
would be safer and more effective than other similar treatments. OPDP
is also now conducting a nationally representative survey regarding the
ways in which consumers and primary care physicians (PCPs) interpret
terms and phrases commonly used in prescription drug promotional
materials, including assessment of impressions of the terms
``targeted'' and ``targeted mechanism of action'' (targeted MoA) (May
10, 2021, 86 FR 24867). Building upon this line of research, the
proposed study will investigate the influence of targeted MoA claims,
graphics, and disclosures that provide context about a drug's targeted
MoA, utilizing an experimental design with both consumer and HCP
samples. The experimental approach described here is intended to
complement and augment the prior research by facilitating assessment of
causality. Specifically, the proposed study will explore how varied
targeted MoA presentations affect consumer and HCP understanding of the
MoA of a drug, perception of drug benefits and risks, attention to risk
information, and interest in the drug.
    Table 1 depicts the study design. Participants will be randomly
assigned to 1 of 12 experimental conditions in which the presence
versus absence of: (1) A targeted MoA claim, (2) a graphic depicting a
targeted MoA, and (3) a disclosure that provides context about the
targeted MoA of the drug are varied in a branded website for a
fictitious prescription drug indicated to treat bladder cancer and
cancers of the urinary tract (renal pelvis, ureter, or urethra) that
have spread or cannot be removed by surgery. We selected cancer as the
medical condition for study given the prevalence of targeted MoA
presentations in promotional materials for prescription drugs indicated
to treat various forms of cancer. Notably, there will be three
variations related to the targeted MoA graphic: (1) No graphic, (2) an
inaccurate graphic (graphic 1) showing only the effect of the drug on
cancerous cells but not on healthy cells, and (3) an accurate graphic
(graphic 2) that will show the effect of the drug on both cancerous and
healthy cells. The design will be replicated in both the consumer and
HCP samples with stimuli specifically created for each audience. Draft
stimuli were informed by, but not identical to, actual targeted MoA
presentations from a marketplace evaluation conducted under FDA
guidance. Draft stimuli were also informed by an FDA subject matter
expert's review. Following exposure to the stimuli, the participants
will complete a questionnaire designed to assess relevant outcome
measures. A copy of the questionnaire is available upon request. All
aspects of this study will be completed online. Participation is
estimated to take approximately 20 minutes, excluding the screener's
time.

                                                                  Table 1--Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Targeted MoA graphic \1\
                                                                                --------------------------------------------------
                  Sample                            Disclosure                Targeted MoA claim           Present          Present
                                                                                (graphic 1--     (graphic 2--        Absent
                                                                                inaccurate)       accurate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCP......................................  Present.....................  Present.....................         [ssquf]          [ssquf]          [ssquf]
                                                                         Absent......................         [ssquf]          [ssquf]          [ssquf]
                                           Absent......................  Present.....................         [ssquf]          [ssquf]          [ssquf]
                                                                         Absent......................         [ssquf]          [ssquf]          [ssquf]
Consumer.................................  Present.....................  Present.....................         [ssquf]          [ssquf]          [ssquf]
                                                                         Absent......................         [ssquf]          [ssquf]          [ssquf]
                                           Absent......................  Present.....................         [ssquf]          [ssquf]          [ssquf]
                                                                         Absent......................         [ssquf]          [ssquf]          [ssquf]
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Each [ssquf] symbol represents an experimental condition.

    For the HCP sample, we will recruit oncologists, PCPs with oncology
experience, and nurse practitioners and physician assistants who
specialize in oncology. We will also recruit a general population
sample of adult volunteers 18 years or older for the consumer sample. A
general population, rather than a diagnosed consumer sample, was

selected because of concerns about being able to recruit a sufficient
number of participants for this particular study if we selected a
cancer-specific sample.
    We will ask consumers to consider a hypothetical scenario in which
they have recently been diagnosed with cancer and are actively looking
for available treatments. HCPs will be asked to consider a scenario in
which they are actively looking for available treatments for a patient
who has been diagnosed with cancer. We will also ask consumers if they
have ever been diagnosed with cancer. HCP participants will be drawn
from online HCP panels and general population consumer participants
will be drawn from online consumer panels. Informed by power analyses,
we will recruit a sample of 540 HCPs and 540 consumers for the main
study.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                     Number of       Number of                    Average burden
            Activity                respondents    responses per   Total annual    per response     Total hours
                                        \2\         respondent       responses          \3\
----------------------------------------------------------------------------------------------------------------
                                                     Pretest
----------------------------------------------------------------------------------------------------------------
General population: Pretest                  528               1             528         0.08 (5            42.2
 screener completes (assumes 75%                                                        minutes)
 eligible)......................
General population: Number of                396               1             396        0.33 (20           130.7
 completes, pretest.............                                                        minutes)
HCP: Pretest screener completes              660               1             660         0.08 (5            52.8
 (assumes 60% eligible).........                                                        minutes)
HCP: Number of completes,                    396               1             396        0.33 (20           130.7
 pretest........................                                                        minutes)
----------------------------------------------------------------------------------------------------------------
                                                   Main Study
----------------------------------------------------------------------------------------------------------------
General population: Number of                792               1             792         0.08 (5            63.4
 main study screener completes                                                          minutes)
 (assumes 75% eligible).........
General population: Number of                594               1             594        0.33 (20           196.0
 completes, main study..........                                                        minutes)
HCP: Number of main study                    990               1             990         0.08 (5            79.2
 screener completes (assumes 60%                                                        minutes)
 eligible)......................
HCP: Number of completes, main               594               1             594        0.33 (20           196.0
 study..........................                                                        minutes)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             891
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ As with most online and mail surveys, it is always possible that some participants are in the process of
  completing the survey when the target number is reached and that those surveys will be completed and received
  before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for
  both samples in the study.
\3\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23507 Filed 10-27-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Rules and Regulations]
[Pages 74516-74517]
[FR Doc No: 2022-26377]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0078; Airspace Docket No. 22-AAL-2]
RIN 2120-AA66

Revocation of Colored Federal Airway Amber 4 (A-4); Anaktuvuk
Pass, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action revokes Colored Federal airway Amber 4 (A-4) in
the vicinity of Anaktuvuk Pass, AK, due to the pending decommissioning
of the Anaktuvuk Pass, AK (AKP), Non-Directional Beacon (NDB).

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

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

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

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the route structure as necessary to preserve
the safe and efficient flow of air traffic within the National Airspace
System (NAS).

History

    The FAA published a notice of proposed rulemaking (NPRM) for Docket
No. FAA-2022-0078 in the Federal Register (87 FR 10991; February 28,
2022), revoking Colored Federal airway A-4 due to the planned
decommissioning of the Anaktuvuk Pass, AK, NDB. Interested parties were
invited to participate in this rulemaking effort by submitting comments
on the proposal. No comments were received.
    Amber Federal airways are published in paragraph 6009(c) of FAA
Order JO 7400.11G, dated August 19, 2022, and effective September 15,
2022, which is incorporated by reference in 14 CFR 71.1. The Colored
Federal airway listed in this document will be published subsequently
in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11G, Airspace Designations
and Reporting Points, dated August 19, 2022, and effective September
15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11G lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by revoking Colored Federal
airway A-4 due to the decommissioning of the Anaktuvuk Pass, AK, NDB.
The amendment is described below.
    A-4: A-4 extends between the Evansville, AK, NDB and the Anaktuvuk
Pass, AK, NDB. The airway is removed in its entirety.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this airspace action of revoking
Colored Federal airway A-4, due to the planned decommissioning of the
Anaktuvuk Pass, AK, NDB, qualifies for categorical exclusion under the
National Environmental Policy Act (42 U.S.C. 4321 et seq.) and its
implementing regulations at 40 CFR part 1500, and in accordance with
FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points), and paragraph 5-
6.5k, which categorically excludes from further environmental review
the publication of existing air traffic control procedures that do not
essentially change existing tracks, create new tracks, change altitude,
or change concentration of aircraft on these tracks. As such, this
action is not expected to result in any potentially significant
environmental impacts. In accordance with FAA Order 1050.1F, paragraph
5-2 regarding Extraordinary Circumstances, the FAA has reviewed this
action for factors and circumstances in which a normally categorically
excluded action may have a significant environmental impact requiring
further analysis. Accordingly, the FAA has determined that no
extraordinary circumstances exist that warrant preparation of an
environmental assessment or environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

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

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6009(c) Amber Federal airways.

* * * * *

A-4 [Removed]

* * * * *

    Issued in Washington, DC, on November 29, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-26377 Filed 12-5-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Notices]
[Pages 27937-27940]
[FR Doc No: 2023-09334]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97392; File No. SR-CboeBZX-2023-026]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fee Schedule

April 27, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 17, 2023, Cboe BZX Exchange, Inc. (``Exchange'' or ``BZX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \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

    Cboe BZX Exchange, Inc. (the ``Exchange'' or ``BZX'' or ``BZX
Equities'') proposes to amend its Fee Schedule. The text of the
proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the

places specified in Item IV below. The Exchange has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

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

1. Purpose
    The Exchange proposes to amend its Fee Schedule applicable to its
equities trading platform (``BZX Equities'') as follows: (1) modify
Step-Up Tier 1; and (2) modify the Non-Displayed Step-Up Tier. The
Exchange proposes to implement the proposed changes to its fee schedule
on April 3, 2023.\3\
---------------------------------------------------------------------------

    \3\ The Exchange initially filed the proposed fee changes on
April 3, 2023 (SR-CboeBZX-2023-022). On April 17, 2023, the Exchange
withdrew that filing and submitted SR-CboeBZX-2023-025. On April 17,
2023, the Exchange withdrew SR-CboeBZX-2023-025 and submitted this
proposal.
---------------------------------------------------------------------------

    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 registered equities exchanges, as well as a
number of alternative trading systems and other off-exchange venues
that do not have similar self-regulatory responsibilities under the
Exchange Act, to which market participants may direct their order flow.
Based on publicly available information,\4\ no single registered
equities exchange has more than 17% of the market share. Thus, in such
a low-concentrated and highly competitive market, no single equities
exchange possesses significant pricing power in the execution of order
flow. The Exchange in particular operates a ``Maker-Taker'' model
whereby it pays credits to Members that add liquidity and assesses fees
to those that remove liquidity. The Exchange's fee schedule sets forth
the standard rebates and rates applied per share for orders that
provide and remove liquidity, respectively. Currently, for orders in
securities priced at or above $1.00, the Exchange provides a standard
rebate of $0.00160 per share for orders that add liquidity and assesses
a fee of $0.0030 per share for orders that remove liquidity.\5\ For
orders in securities priced below $1.00, the Exchange does not provide
a rebate or assess a fee for orders that add liquidity and assesses a
fee of 0.30% of total dollar value for orders that remove liquidity.\6\
Additionally, in response to the competitive environment, the Exchange
also offers tiered pricing which provides Members opportunities to
qualify for higher rebates or reduced fees where certain volume
criteria and thresholds are met. Tiered pricing provides an incremental
incentive for Members to strive for higher tier levels, which provides
increasingly higher benefits or discounts for satisfying increasingly
more stringent criteria.
---------------------------------------------------------------------------

    \4\ See Cboe Global Markets, U.S. Equities Market Volume
Summary, Month-to-Date (March 24, 2023), available at https://www.cboe.com//equities/market_statistics/.
    \5\ See BZX Equities Fee Schedule, Standard Rates.
    \6\ Id.
---------------------------------------------------------------------------

Step-Up Tiers
    Pursuant to footnote 2 of the Fee Schedule, the Exchange currently
offers Step Up Tiers (tiers 1 through 4) that provide Members an
opportunity to receive an enhanced rebate from the standard rebate for
liquidity adding orders that yield fee codes B,\7\ V,\8\ and Y \9\
where they increase their relative liquidity each month over a
predetermined baseline. The Exchange now proposes to modify the
criteria of Step-Up Tier 1. The current criteria for Step-Up Tier 1 is
as follows:
---------------------------------------------------------------------------

    \7\ Orders yielding Fee Code ``B'' are displayed orders adding
liquidity to BZX (Tape B).
    \8\ Orders yielding Fee Code ``V'' are displayed orders adding
liquidity to BZX (Tape A).
    \9\ Orders yielding Fee Code ``Y'' are displayed orders adding
liquidity to BZX (Tape C).
---------------------------------------------------------------------------

     Tier 1 offers an enhanced rebate of $0.0031 per share for
qualifying orders (i.e., orders yielding fee codes B, V, or Y) where 1)
Member has a Step-Up ADAV \10\ from January 2023 >=10,000,000 or Member
has a Step-Up Add TCV \11\ from January 2023 >=0.10%; and 2) Member has
an ADV \12\ >=0.60% of the TCV.
---------------------------------------------------------------------------

    \10\ ``Step-Up ADAV'' means ADAV in the relevant baseline month
subtracted from current ADAV. ADAV means average daily added volume
calculated as the number of shares added per day. ADAV is calculated
on a monthly basis.
    \11\ ``Step-Up Add TCV'' means ADAV as a percentage of TCV in
the relevant baseline month subtracted from current ADAV as a
percentage of TCV. TCV means total consolidated volume calculated as
the volume reported by all exchanges and trade reporting facilities
to a consolidated transaction reporting plan for the month for which
the fees apply.
    \12\ ``ADV'' means average daily volume calculated as the number
of shares added or removed, combined, per day. ADV is calculated on
a monthly basis.
---------------------------------------------------------------------------

    The Exchange proposes to modify the criteria for Step-Up Tier 1 to
the following:
     Proposed Tier 1 would offer an enhanced rebate of $0.0031
per share for qualifying orders (i.e., orders yielding fee codes B, V,
or Y) where (1) Member has a Step-Up Add TCV from January 2023 >=0.09%;
and (2) Member has an ADV >=0.60% of the TCV; and (3) Member adds an
ADV >=5,000,000 for Non-Displayed orders \13\ that yield fee codes
HB,\14\ HI,\15\ HV,\16\ or HY.\17\
---------------------------------------------------------------------------

    \13\ See Exchange Rule 11.9(c)(11).
    \14\ Orders yielding Fee Code ``HB'' are non-displayed orders
adding liquidity to BZX (Tape B).
    \15\ Orders yielding Fee Code ``HI'' are non-displayed orders
that receive price improvement while adding liquidity to BZX .
    \16\ Orders yielding Fee Code ``HV'' are non-displayed orders
adding liquidity to BZX (Tape A).
    \17\ Orders yielding Fee Code ``HY'' are non-displayed orders
adding liquidity to BZX (Tape C).
---------------------------------------------------------------------------

    Also pursuant to footnote 2 of the Fee Schedule, the Exchange
currently offers a Non-Displayed Step-Up Tier, which provides Members
an opportunity to receive an enhanced rebate from the standard rebate
\18\ for liquidity adding non-displayed orders that yield fee codes HB,
HV, and HY and meet certain required volume-based criteria. The
criteria for the Non-Displayed Step-Up Tier is as follows:
---------------------------------------------------------------------------

    \18\ Currently, the Exchange provides a standard rebate of
$0.00100 per share for liquidity adding non-displayed orders that
yield fee codes HB, HV, or HY.
---------------------------------------------------------------------------

     The Non-Displayed Step-Up Tier offers an enhanced rebate
of $0.0025 per share for qualifying orders (i.e., orders yielding fee
codes HB, HV, or HY) where (1) Member has a Step-Up ADAV from January
2023 >=10,000,000 or Member has a Step-Up Add TCV from January 2023
>=0.10%; and (2) Member has an ADV >=0.60% of the TCV.
    The Exchange proposes to modify the criteria of the Non-Displayed
Step-Up Tier to the following:
     The Non-Displayed Step-Up Tier offers an enhanced rebate
of $0.0025 per share for qualifying orders (i.e., orders yielding fee
codes HB, HV, or HY) where (1) Member has a Step-Up Add TCV from
January 2023 >=0.09%; and (2) Member has an ADV >=0.60% of the TCV; and
(3) Member adds an ADV >=5,000,000 for Non-Displayed Orders that yield
fee codes HB, HI, HV, or HY.
    The Exchange notes that the Step-Up Tiers in general are designed
to provide Members with additional opportunities to receive enhanced
rebates by increasing their order flow to the Exchange, which further
contributes to a deeper, more liquid market and provides even more
execution opportunities for active market participants. The proposed
modifications to the criteria of Step-Up Tier 1 and the Non-Displayed
Step-Up Tier are designed to increase the Members' provision of
liquidity to the Exchange, which increases execution opportunities and
provides for overall enhanced price discovery and price improvement
opportunities on the Exchange. Increased overall order flow benefits
all Members by contributing

towards a robust and well-balanced market ecosystem.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of section 6(b) of the
Act.\19\ Specifically, the Exchange believes the proposed rule change
is consistent with the section 6(b)(5) \20\ 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) \21\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers as well as section 6(b)(4) \22\
as it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its Members and other persons using
its facilities.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(5).
    \21\ Id.
    \22\ 15 U.S.C. 78f(b)(4)
---------------------------------------------------------------------------

    As described above, the Exchange operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. The Exchange believes that
its proposed modifications to Step-Up Tier 1 and the Non-Displayed
Step-Up Tier reflects a competitive pricing structure designed to
incentivize market participants to direct their order flow to the
Exchange, which the Exchange believes would enhance market quality to
the benefit of all Members. The Exchange believes the proposed
modifications to Step-Up Tier 1 and the Non-Displayed Step-Up Tier are
reasonable as they serve to incentivize Members to increase their
liquidity-adding, displayed volume (Step-Up Tier 1) and liquidity-
adding, non-displayed volume (Non-Displayed Step-Up Tier), which
benefit all market participants by incentivizing continuous liquidity
and thus, deeper, more liquid markets as well as increased execution
opportunities. Particularly, the proposed incentives to provide
displayed liquidity are designed to incentivize continuous displayed
liquidity, which signals other market participants to take the
additional execution opportunities provided by such liquidity, while
the proposed incentives to provide non-displayed liquidity will further
contribute to a deeper, more liquid market and provide even more
execution opportunities for active market participants at improved
prices. This overall increase in activity deepens the Exchange's
liquidity pool, offers additional cost savings, supports the quality of
price discovery, promotes market transparency, and improves market
quality for all investors.
    In particular, the Exchange believes the proposed modifications to
Step-Up Tier 1 and the Non-Displayed Step-Up Tier represent an
equitable allocation of rebates and are not unfairly discriminatory
because all Members are eligible for those tiers and would have the
opportunity to meet a tier's criteria and would receive the proposed
rebate if such criteria is met. Further, the proposed rebates are
commensurate with the proposed criteria. That is, the rebates
reasonably reflect the difficulty in achieving the applicable criteria
as proposed. Without having a view of activity on other markets and
off-exchange venues, the Exchange has no way of knowing whether this
proposed rule change would definitely result in any Members qualifying
for the proposed tier. While the Exchange has no way of predicting with
certainty how the proposed tiers will impact Member activity, the
Exchange anticipates that at least one Member will be able to satisfy
the criteria proposed under Step-Up Tier 1 and the Non-Displayed Step-
Up Tier. The Exchange also notes that proposed tier/rebate will not
adversely impact any Member's ability to qualify for other reduced fee
or enhanced rebate tiers. Should a Member not meet the proposed
criteria under the modified tier, the Member will merely not receive
that corresponding enhanced rebate.
    Additionally, the Exchange notes that relative volume-based
incentives and discounts have been widely adopted by exchanges,\23\
including the Exchange,\24\ and are reasonable, equitable and non-
discriminatory because they are open to all Members on an equal basis
and provide additional benefits or discounts that are reasonably
related to (i) the value to an exchange's market quality and (ii)
associated higher levels of market activity, such as higher levels of
liquidity provision and/or growth patterns. Competing equity exchanges
offer similar tiered pricing structures, including schedules of rebates
and fees that apply based upon members achieving certain volume and/or
growth thresholds, as well as assess similar fees or rebates for
similar types of orders, to that of the Exchange.
---------------------------------------------------------------------------

    \23\ See e.g., EDGX Equities Fee Schedule, Footnote 1, Add/
Remove Volume Tiers.
    \24\ See e.g., BZX Equities Fee Schedule, Footnote 1, Add/Remove
Volume Tiers.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Rather, as discussed above,
the Exchange believes that the proposed changes would encourage the
submission of additional order flow to a public exchange, thereby
promoting market depth, execution incentives and enhanced execution
opportunities, as well as price discovery and transparency for all
Members. As a result, the Exchange believes that the proposed changes
further the Commission's goal in adopting Regulation NMS of fostering
competition among orders, which promotes ``more efficient pricing of
individual stocks for all types of orders, large and small.'' \25\
---------------------------------------------------------------------------

    \25\ Securities Exchange Act Release No. 51808, 70 FR 37495,
37498-99 (June 29, 2005) (S7-10-04) (Final Rule).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule changes do not impose any
burden on intramarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Particularly, the proposed
tier changes apply to all Members equally in that all Members continue
to be eligible for Step-Up Tier 1 and the Non-Displayed Step-Up Tier,
have a reasonable opportunity to meet the tiers' criteria and will
receive the corresponding additional rebates if such criteria are met.
Additionally, the proposed tier changes are designed to attract
additional order flow to the Exchange. The Exchange believes that the
proposed tier criteria would incentivize market participants to direct
liquidity adding displayed and non-displayed order flow to the
Exchange, bringing with it additional execution opportunities for
market participants and improved price transparency. Greater overall
order flow, trading opportunities, and pricing transparency benefits
all market participants on the Exchange by enhancing market quality and
continuing to encourage Members to send orders, thereby contributing

towards a robust and well-balanced market ecosystem.
    Next, the Exchange believes the proposed rule change does not
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market.
Members have numerous alternative venues that they may participate on
and direct their order flow, including 15 other equities exchanges and
off exchange venues and alternative trading systems. Additionally, the
Exchange represents a small percentage of the overall market. Based on
publicly available information, no single equities exchange has more
than 17% \26\ of the market share. Therefore, no exchange possesses
significant pricing power in the execution of order flow. Indeed,
participants can readily choose to send their orders to other exchange
and off-exchange venues if they deem fee levels at those other venues
to be more favorable. Moreover, the Commission has repeatedly expressed
its preference for competition over regulatory intervention in
determining prices, products, and services in the securities markets.
Specifically, in Regulation NMS, the Commission highlighted the
importance of market forces in determining prices and SRO revenues and,
also, recognized that current regulation of the market system ``has
been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' \27\ The fact that this market is competitive has also
long been recognized by the courts. In NetCoalition v. Securities and
Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .''.\28\ Accordingly, the Exchange does not believe its
proposed fee change imposes any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \26\ Supra note 3.
    \27\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \28\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

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 foregoing rule change has become effective pursuant to section
19(b)(3)(A) of the Act \29\ and paragraph (f) of Rule 19b-4 \30\
thereunder. At any time within 60 days of the filing of the 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 will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78s(b)(3)(A).
    \30\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeBZX-2023-026 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeBZX-2023-026. 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 website (https://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 website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. Do
not include personal identifiable information in submissions; you
should submit only information that you wish to make available
publicly. We may redact in part or withhold entirely from publication
submitted material that is obscene or subject to copyright protection.
All submissions should refer to File Number SR-CboeBZX-2023-026, and
should be submitted on or before May 24, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-09334 Filed 5-2-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Proposed Rules]
[Page 58266]
[FR Doc No: 2013-22871]

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

40 CFR Part 81

[EPA-R09-OAR-2008-0467; FRL-9901-12-Region 9]

Designation of Areas for Air Quality Planning Purposes;
California; San Joaquin Valley, South Coast Air Basin, Coachella
Valley, and Sacramento Metro Ozone Nonattainment Areas;
Reclassification

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of proposed rule.

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

SUMMARY: EPA is withdrawing a proposed action to reclassify the Indian
country pertaining to the Morongo Band of Mission Indians (Morongo
Reservation) from ``severe-17'' to ``extreme'' for the 1997 eight-hour
ozone standard.

DATES: The proposed rule published on August 27, 2009 (74 FR 43654) is
withdrawn with respect to the Morongo Reservation on September 23,
2013.

FOR FURTHER INFORMATION CONTACT: Ken Israels, Grants and Program
Integration Office (AIR-8), U.S. Environmental Protection Agency,
Region IX,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 27, 2009 (74 FR 43654), EPA
published a proposed rule to grant requests by the State of California
to reclassify four nonattainment areas for the 1997 8-hour ozone
standards and to reclassify Indian country in keeping with the
classifications of nonattainment areas within which they are located.
On May 5, 2010 (75 FR 24409), EPA finalized the action as proposed
except that EPA deferred reclassification of Indian country pertaining
to the Morongo Band of Mission Indians (Morongo Reservation) and the
Pechanga Band of Luiseno Mission Indians (Pechanga Reservation) in
keeping with the state's request for the South Coast Air Basin. On
January 2, 2013 (78 FR 51), EPA proposed to revise the boundaries of
the South Coast Air Basin nonattainment area to designate the Morongo
Reservation as a separate air quality planning area for the 1997 8-hour
ozone standards. In the January 2, 2013 proposed rule, EPA indicated
that, if the Agency finalizes the January 2, 2013 proposed rule, as
proposed, EPA would withdraw the August 27, 2009 proposed rule to the
extent that the 2009 proposed rule relates to the Morongo Reservation.
In the Rules section of this Federal Register, EPA is finalizing its
January 2, 2013 proposed rule, as proposed. In light of final Agency
action on the January 2, 2013 proposal, EPA is withdrawing the August
27, 2009 proposed reclassification of the Morongo Reservation for the
1997 8-hour ozone standard. This withdrawal is being taken under Clean
Air Act sections 301(a) and 301(d)(4).

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, Intergovernmental
relations, National parks, Ozone, Wilderness areas.

    Dated: September 4, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2013-22871 Filed 9-20-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Rules and Regulations]
[Pages 47293-47295]
[FR Doc No: 2016-17332]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0648]
RIN 1625-AA00

Safety Zone; Hudson River, Edgewater, NJ.

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone in the
waters of the Hudson River in the vicinity of Edgewater, NJ. This zone
is intended to restrict vessels from a portion of the Hudson River due
to the presence of a dielectric oil leak from a submerged power cable,
and the hazards associated with the cable repair vessels. This
temporary safety zone is necessary to protect people and vessels from
the hazards associated with this event. Entry of vessels or persons
into this zone is prohibited unless specifically authorized by the
Captain of the Port New York.

DATES: This rule is effective without actual notice from July 21, 2016
through July 10, 2017. For the purposes of enforcement, actual notice
will be used from July 10, 2016 through July 21, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0648 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST1 Kristina Pundt, Waterways Management Division, U.S.
Coast Guard Sector New York; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NAD 83 North American Datum of 1983
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On January 2, 2016, the Coast Guard received notification of a
dielectric oil release from a submerged power cable in the Hudson River
in the vicinity Edgewater, NJ. In response, on February 5, 2016, the
Coast Guard published a temporary final rule at 33 CFR 165-T01.0028 (81
FR 246181) establishing a safety zone to be enforced until July 9, 2016
or until completion of cleanup and cable repairs. On May 29, 2016, the
Coast Guard received notification that cleanup operations and cable
repairs were completed. The Coast Guard received notification of
another dielectric oil release from a submerged power cable in the
Hudson River in the vicinity of Edgewater, NJ on June 28, 2016.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable.
Waiting for a notice and comment period to run would inhibit the Coast
Guard from protecting the public and vessels from the possible hazards
associated with this dielectric oil leak and the hazards associated
with the cable repairs.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register. For the same reasons as
discussed in the preceding paragraph, waiting for a 30 day notice and
comment period to run would be impracticable.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port New York (COTP) has determined that a
temporary safety zone is necessary to ensure the safety of vessels from
the hazards associated with this dielectric oil leak and power cable
repairs.

IV. Discussion of the Rule

    This rule establishes a safety zone from July 10, 2016 through July
10, 2017. The safety zone will cover all navigable waters of the Hudson
River extending 1700 feet from the New Jersey shoreline and
approximately 460 feet on either side of the charted power cable
between Edgewater, NJ and W 110th Street, Manhattan, NY.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the COTP or a designated
representative. Vessel operators must contact the COTP or an on-scene
representative to obtain permission to transit through this safety
zone. The COTP or an on-scene representative may be contacted by VHF
Channel 16.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    We conclude that this rule is not a significant regulatory action
because we anticipate that it will have minimal impact on the economy,
will not interfere with other agencies, and will not adversely alter
the budget of any grant or loan recipients. Vessel traffic will be able
to safely transit around this safety zone. This safety zone only
affects a small-designated area of the Hudson River waterway. Moreover,
the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM
marine channel 16 and publish the information in the Local Notice to
Mariners.

B. Impact on Small Entities

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

compliance, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, 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 the establishment of a safety zone that will prohibit
entry within the dielectric oil spill, cleanup, and power cable repair
area, and is therefore categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination will be available in the docket
where indicated under ADDRESSES. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this rule.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR 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 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T01-0648 to read as follows:

Sec.  165.T01-0648  Safety Zone: Hudson River, Edgewater, NJ.

    (a) Location. The following area is a temporary safety zone: All
U.S. navigable waters of the Hudson River bound by the following
points: 40[deg]48'40.088'' N., 073[deg]58'53.026'' W.; thence to
40[deg]48'34.267'' N., 073[deg]58'37.096'' W.; thence to
40[deg]48'26.404'' N., 073[deg]58'42.270'' W.; thence to
40[deg]48'33.882'' N., 073[deg]59'01.955'' W., thence along the western
shoreline to the point of origin. All coordinates are based on the NAD
83.
    (b) Enforcement period. The safety zone described in paragraph (a)
of this section will be enforced from July 10, 2016 through July 10,
2017, unless terminated sooner by the COTP.
    (c) Regulations. (1) In accordance with the general regulations in
33 CFR 165.23, entry into, transiting, or anchoring within this safety
zone is prohibited unless authorized by the COTP or a designated on
scene representative.
    (3) An ``on-scene representative'' of the COTP is any Coast Guard
commissioned, warrant or petty officer or a Federal, State or local law
enforcement officer designated by or assisting the COTP to act on his
behalf.
    (4) Vessel operators must contact the COTP via the Command Center
to obtain permission to enter or operate within the safety zone. The
COTP may be contacted via VHF Channel 16 or at<PHONE_NUMBER>. Vessel
operators given permission to enter or operate within the safety zone
must comply with all directions given to them by the COTP, via the
Command Center or an on-scene representative.

    Dated: July 8, 2016.
M.H. Day,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2016-17332 Filed 7-20-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 77 (Thursday, April 21, 2016)]
[Notices]
[Pages 23476-23477]
[FR Doc No: 2016-09227]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-125-000]

National Fuel Gas Supply Corporation; Notice of Application

    Take notice that on April 4, 2016, National Fuel Gas Supply
Corporation (National Fuel), 6363 Main Street, Williamsville, New York
14221, filed an application pursuant to sections 7(b) and 7(c) of the
Natural Gas Act (NGA), and Part 157 of the Commission's regulations
requesting authority to construct, replace, and abandon existing
pipelines and modify compressor facilities along the T2K, TNY, and KNY
natural gas pipelines, all as more fully set forth in the application
which is on file with the Commission and open to public inspection. The
cost for the proposed project work is $29,382,602.
    Any questions concerning this application should be directed to
Laura P. Berloth, Attorney, National Fuel Gas Supply Corporation, 6363
Main Street, Williamsville, New York 14221-5887, by phone at (716) 857-
7001, by fax at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>    Specifically, National Fuel seeks to; (i) construct and operate 1.2
miles of new 20-inch-diameter pipeline, adding 2,600 dekatherms per day
(Dth/d) of new firm service capacity (Line T2K Install); (ii) replace
approximately 6.7 miles of 20-inch-diameter bare steel pipeline with
7.0 miles of new 24-inch-diameter coated pipeline (Line TNY
Replacement); and (iii) abandon approximately 14.9 miles of 20-inch-
diameter bare steel pipeline (Line KNY Abandonment), all located in
Erie County, New York.
    The filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site web 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. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify federal and state agencies of the timing for the completion of
all necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 5 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original

and 7 copies of the protest or intervention to the Federal Energy
regulatory Commission, 888 First Street NE., Washington, DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on May 6, 2016.

    Dated: April 15, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-09227 Filed 4-20-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Notices]
[Pages 2030-2031]
[FR Doc No: 2021-00197]

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DEPARTMENT OF TRANSPORTATION

[Docket No. DOT-OST-2017-0010]

Request for Extension and Revision of a Currently Approved
Information Collection: Annual Tank Car Survey

AGENCY: Bureau of Transportation Statistics (BTS), Office of the
Assistant Secretary for Research and Technology (OST-R), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: This notice announces the Bureau of Transportation Statistics
(BTS) intention to request that the Office of Management and Budget
(OMB) approve a 3-year extension of a currently approved information
collection for the ``Annual Tank Car Survey.''

DATES: Interested persons are invited to submit comments on or before
March 12, 2021.

ADDRESSES: You may submit comments identified by Docket No. DOT-OST-
2017-0010 through the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. You may also submit comments identified by DOT Docket ID
Number DOT-OST-2017-0010 to the U.S. Department of Transportation
(DOT), Dockets Management System (DMS). You may submit your comments by
mail or in person to the Docket Clerk, Docket Management System, U.S.
Department of Transportation, 1200 New Jersey Ave. SE, West Building
Room W12-140, Washington, DC 20590. Comments should identify the docket
number as indicated above. Paper comments should be submitted in
duplicate. The DMS is open for examination and copying, at the above
address, from 9 a.m. to 5 p.m., Monday through Friday, except federal
holidays. If you wish to receive confirmation of receipt of your
written comments, please include a self-addressed, stamped postcard
with the following statement: ``Comments on Docket DOT-OST-2017-0010.''
The Docket Clerk will date stamp the postcard prior to returning it to
you via the U.S. mail. Please note that due to delays in the delivery
of U.S. mail to Federal offices in Washington, DC, we recommend that
persons consider an alternative method (the internet, fax, or
professional delivery service) to submit comments to the docket and
ensure their timely receipt at U.S. DOT. You may fax your comments to
the DMS at<PHONE_NUMBER>. Comments can also be viewed and/or submitted
via the Federal Rulemaking Portal: http://www.regulations.gov.
    Please note that anyone is able to electronically search all
comments received into our docket management system by the name of the
individual submitting the comment (or signing the comment if submitted
on behalf of an association, business, labor union, etc.). You may
review DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000 (Volume 65, Number 70; pages 19475-19570)
or you may review the Privacy Act Statement at http://www.gpoaccess.gov/fr/.

FOR FURTHER INFORMATION CONTACT: Clara Reschovsky, Bureau of
Transportation Statistics, Office of the Assistant Secretary for
Research and Technology, Department of Transportation 1200 New Jersey
Avenue SE, Room E36-324, Washington, DC 20590, Telephone (202) 366-
2857.

SUPPLEMENTARY INFORMATION:
    Title: Annual Tank Car Survey
    OMB Control #: 2138-0047
    Background: In accordance with the requirements of 44 U.S.C.
Section 3506(c)(2)(A) (the Paperwork Reduction Act of 1995), this
notice announces the intention of the BTS to request the Office of
Management and Budget's (OMB's) extension of the currently approved
information collection related to Section 7308 of the Fixing America's
Surface Transportation Act (Pub. L. 114-94; the ``FAST Act'').
Specifically, Section 7308(c) of the FAST ACT directs the Secretary of
Transportation to conduct a data collection of tank car facilities to
obtain an estimate of tank cars projected to be modified or built to
the new safer Department of Transportation (DOT) Specification 117 or
117R.
    On December 4, 2015, President Barack Obama signed legislation
entitled ``Fixing America's Surface Transportation Act of 2015,'' or
the ``FAST Act.'' See Public Law 114-94. The FAST Act includes the
``Hazardous Materials Transportation Safety Improvement Act of 2015''
(see Sections 7001 through 7311) and instructs the Secretary of
Transportation to make specific regulatory amendments to the Hazardous
Materials Regulations (HMR; 49 CFR parts 171-180), including
requirements for certain persons to report the progress toward
modifying rail tank cars used for the transportation of Class 3
flammable liquids in accordance with the timeline established in
Section 7304 of the FAST Act.
    In order to satisfy the FAST Act requirements, BTS has been
conducting the data collection. BTS invites comments on its intention
to continue collecting information from tank car retrofitting and
manufacturing facilities on the planned and projected number of tank
cars to be retrofitted or manufactured during the calendar year,
annually. Any facility identified with the capacity to modify or build
new tank cars to the 117 or 117R specification, as described in Section
7308(c) of the FAST Act will be included in the data collection
identified in this notice and submit the results to the Bureau of
Transportation Statistics (BTS) no later than 60 days upon request.
Individual responses to the data collection will be kept confidential
and a summary report of aggregate findings will be provided to:
    (1) The Committee on Commerce, Science, and Transportation of the
Senate; and
    (2) The Committee on Transportation and Infrastructure of the House
of Representatives.
    In addition, this summary report will also be published to the BTS
web page.
    This notice is applicable to Section 7308(c) of the FAST Act which
directs the Secretary to conduct an annual data collection of tank car
shops to acquire projections of the number of tank cars to be built or
manufactured to the new safer specifications. This includes those tank
cars modified to the DOT Specification 117R, or equivalent, as well as
any new tank cars built to the DOT Specification 117, or equivalent.
Modified tank cars will include, but may not be limited to, those
previously built to Specifications: DOT105, DOT109, DOT111, DOT112,
DOT114, DOT115, and DOT120.
    Additionally, per Executive Order 13868, issued on April 10, 2019,
BTS will ask Tank Car shops certified to build DOT-113, capable of
carrying liquified natural gas how many tank cars they anticipate
building in the calendar year. This information will be kept
confidential and a summary report of aggregate findings will be
provided to the Pipeline and Hazardous Materials Administration.
    Respondents: Across the nation there are approximately 400 tank car
facilities that are currently registered or certified to build or
modify tank cars. However, the majority of these do not have the
capacity to modify or build to the 117 or 117R specifications or the
113 specification. It is estimated that, at most, 175 tank car shops
possess the required capacity to build or modify to these new safer
requirements.
    Estimated Average Burden per Response: It is estimated that 175
facilities will provide one response each

to this request for information on an annual basis, and that it will
take approximately 30 minutes to complete, including record keeping and
reporting. This notice is intended to accurately account for the annual
burden.
    Estimated Total Annual Burden: The estimated burden is equal to 88
annual burden hours (i.e., 175 responses per year x 0.5 hour per
response). The total burden cost is estimated at $4,371 (i.e., 88
burden hours x $49.67 per hour for a manager in Transportation,
Storage, and Distribution).
    Frequency: Annually.
    Public Comments Invited: Interested parties are invited to send
comments regarding any aspect of this information collection,
including, but not limited to: (1) The necessity and utility of the
information collection for the proper performance of the functions of
the DOT; (2) the accuracy of the estimated burden; (3) ways to enhance
the quality, utility, clarity and content of the collected information;
and (4) ways to minimize the collection burden without reducing the
quality of the collected information. Comments submitted in response to
this notice will be summarized and/or included in the request for OMB's
clearance of this information collection.

    Issued in Washington, DC on January 5, 2021.
Cha-Chi Fan,
Director, Office of Data Development and Standards, Bureau of
Transportation Statistics, Office of the Assistant Secretary for
Research and Technology.
[FR Doc. 2021-00197 Filed 1-8-21; 8:45 am]
BILLING CODE 4910-9X-P