[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4880-4881]
[FR Doc No: 2023-01451]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2023-0004]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    Under part 235 of title 49 Code of Federal Regulations (CFR) and 49
U.S.C. 20502(a), this document provides the public notice that by
letter dated January 9, 2023, Union Pacific Railroad Company (UPRR)
petitioned the Federal Railroad Administration (FRA) seeking approval
to discontinue or modify a signal system. FRA assigned the petition
Docket Number FRA-2023-0004.
    Specifically, UPRR requests a suspension of block signals between
CP Reynard (F 417) and CP Phil (F 430) on the Winnemucca Subdivision,
near Gerlach, Nevada. UPRR explains that this suspension would be
temporary, and UPRR would later request to ``remove [Centralized
Traffic Control (CTC)] limits and replace with [Track Warrant Control
(TWC)] limits through the same area.'' In support of its request, UPRR
states that its dispatching software cannot grant track warrants
through the subject area, but when they can grant track warrants, UPRR
will notify FRA prior to implementation of TWC limits. UPRR requests
the suspension of block signals for up to six months from the date of
approval. UPRR explains that the reason for the proposed suspension is
that UPRR ``has an uncurable situation with contaminated track
conditions that will not allow the signal system to function
properly.''
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by February 24, 2023 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. FRA notes that it may consider the
application before the end of this comment period, but any final action
would be contingent on subsequent consideration of any comments that
may be received in this docket.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT)
solicits comments from the public to

better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2023-01451 Filed 1-24-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Page 6188]
[FR Doc No: 2018-02766]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6888]

Neurological Devices Panel of the Medical Devices Advisory
Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Neurological Devices Panel of
the Medical Devices Advisory Committee. This meeting was announced in
the Federal Register of December 28, 2017. The amendment is being made
to reflect a change in the Procedure portion of the document. There are
no other changes.

FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002,
[email protected],<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area) code NE. Please call the Information Line for up-to-date
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 28,
2017, 82 FR 61574, FDA announced that a meeting of the Neurological
Devices Panel of the Medical Devices Advisory Committee would be held
on March 1, 2018, from 8 a.m. to 6 p.m. On page 61574, in the 3rd
column, the Procedure portion of the document is changed to read as
follows:
    Procedure: FDA will work with affected industry organizations that
have an interest in intracranial aneurysm treatment devices and who
wish to make a presentation separate from the general Open Public
Hearing; time slots on March 1, 2018, between approximately 9:40 a.m.
and 11 a.m. Representatives from industry organizations interested in
making formal presentations to the committee should notify the contact
person on or before February 16, 2018.
    Interested persons may present data, information, or views, orally
or in writing, on issues pending before the committee. Written
submissions may be made to the contact person on or before February 16,
2018. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 noon. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before February 9, 2018. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled Open Public Hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by February 12, 2018.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02766 Filed 2-12-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Page 8601]
[FR Doc No: 2013-02567]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17Ad-16; SEC File No. 270-363, OMB Control No. 3235-0413.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
existing collection of information provided for in Rule 17Ad-16 (17 CFR
240.17Ad-16) under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.).
    Rule 17Ad-16 requires a registered transfer agent to provide
written notice to the appropriate qualified registered securities
depository when assuming or terminating transfer agent services on
behalf of an issuer or when changing its name or address. In addition,
transfer agents that provide such notice shall maintain such notice for
a period of at least two years in an easily accessible place. This rule
addresses the problem of certificate transfer delays caused by transfer
requests that are directed to the wrong transfer agent or the wrong
address.
    We estimate that the transfer agent industry submits approximately
3,700 Rule 17Ad-16 notices to appropriate qualified registered
securities depositories. The staff estimates that the average amount of
time necessary to create and submit each notice is approximately 15
minutes per notice. Accordingly, the estimated total industry burden is
925 hours per year (15 minutes multiplied by 3,700 notices filed
annually).
    Because the information needed by transfer agents to properly
notify the appropriate registered securities depository is readily
available to them and the report is simple and straightforward, the
cost is relatively minimal. The average internal compliance cost to
prepare and send a notice is approximately $7.50 (15 minutes at $30 per
hour). This yields an industry-wide internal compliance cost estimate
of $27,750 (3,700 notices multiplied by $7.50 per notice).
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid OMB control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid OMB control number.
    The public may view background documentation for this information
collection at the following Web site: www.reginfo.gov. Please direct
your written comments to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, Virginia 22312, or send an email to
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days
of this notice.

    Dated: January 31, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-02567 Filed 2-5-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Proposed Rules]
[Pages 31541-31542]
[FR Doc No: 2019-13372]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2019-0328; FRL-9995-32-Region 7]

Air Plan Approval; Missouri; Rescission of Information on Sales
of Fuels To Be Provided and Maintained and Certain Coals To Be Washed

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve two State Implementation Plan (SIP) revision submissions from
the State of Missouri. In these submissions, the State requested that
two rules relating to the sales of fuel and coal washing be rescinded
from the Missouri SIP. The EPA received both submissions on December 4,
2018, and received supplemental information for both submissions on May
6, 2019. The EPA reviewed the submissions and supplemental information
and determined that rescission of these rules from the SIP does not
impact the stringency of the SIP or air quality and is proposing to
rescind the rules from the Missouri SIP. Approval of the submissions
will ensure consistency between state and federally approved rules and
is being done in accordance with the requirements of the Clean Air Act
(CAA).

DATES: Comments must be received on or before August 1, 2019.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R07-
OAR-2019-0328 to https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Written
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.

FOR FURTHER INFORMATION CONTACT: Tracey Casburn, Environmental
Protection Agency, Region 7 Office, Air Quality Development Branch,
11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number (913)
551-7016; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. Written Comments
II. What is being addressed in this document?
III. Have the requirements for approval of a SIP revision been met?
IV. What action is the EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2019-
0328, at https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. What is being addressed in this document?

    The EPA is proposing to approve two submissions requesting revision
of the Missouri SIP, received on December 4, 2018. Supplemental
information for both submissions was received on May 6, 2019. In the
submissions, the State requested that two rules, found at Title 10,
Division 10 of the code of state regulations (CSR)-10 CSR 10-5.120
Information on Sales of Fuels to be Provided and Maintained and 10 CSR
10-5.130 Certain Coals to be Washed- be rescinded from the Missouri
SIP.

This document and the technical support document (TSD) that is a part
of this docket describes the EPA's rational to approve the state's
submissions.

III. Have the requirements for approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
state provided public notice of the revisions from June 15, 2018, to
September 6, 2018, and held a public hearing on August 30, 2018. The
State received and addressed one comment. The comment was from the EPA
and was general in nature. No changes were made to the proposal to
rescind the rules in response to the EPA's comment. As explained in
more detail in the TSD which is part of this docket, the SIP revision
submission meets the substantive requirements of the CAA, including
section 110 and implementing regulations.

IV. What action is the EPA taking?

    The EPA is proposing to amend the Missouri SIP by rescinding 10 CSR
10-5.120 Information on Sales of Fuels to be Provided and Maintained
and 10 CSR 10-5.130 Certain Coals to be Washed.
    Approval of these revisions will ensure consistency between state
and federally-approved rules. These rescissions will not impact air
quality since the rules do not effectively limit emissions or the
amount of fuel that can be burned and do not function to achieve
attainment or maintenance of the National Ambient Air Quality Standards
(NAAQS).
    The EPA is processing this as a proposed action because we are
soliciting comments on the action. Final rulemaking will occur after
consideration of any comments.

V. Incorporation by Reference

    In this document, the EPA is proposing to amend regulatory text
that includes incorporation by reference. As described in the proposed
amendments to 40 CFR part 52 set forth below, the EPA is proposing to
remove provisions of the EPA-Approved Missouri Regulations from the
Missouri State Implementation Plan, which is incorporated by reference
in accordance with the requirements of 1 CFR part 51. The EPA has made,
and will continue to make the State Implementation Plan generally
available through www.regulations.gov and at the EPA Region 7 Office
(please contact the person identified in the ``For Further Information
Contact'' section of this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Certain coals to
be washed, Incorporation by reference, Information on fuel sales,
Particulate matter, Rescission, Sulfur dioxide.

    Dated: June 18, 2019.
James Gulliford,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA proposes to amend
40 CFR part 52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart AA--Missouri

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by removing
entries ``10-5.120'' and ``10-5.130'' under the heading ``Chapter 5--
Air Quality Standards and Air Pollution Control Regulations for the St.
Louis Metropolitan Area''.
[FR Doc. 2019-13372 Filed 7-1-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Page 16384]
[FR Doc No: 2017-06607]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-1315-000]

Meadow Lake Wind Farm V 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
Meadow Lake Wind Farm V 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 April 18, 2017.
    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 should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 29, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-06607 Filed 4-3-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: February 25, 2008 (Volume 73, Number 37)]
[Rules and Regulations]
[Page 9955-9957]
[DOCID:fr25fe08-8]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 578

[Docket No. NHTSA-2007-28445; Notice 2]
RIN 2127-AK07

Civil Penalties

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Final rule.

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SUMMARY: This document increases the maximum civil penalties for
violations of the odometer tampering and disclosure requirements and
certain administrative provisions of the Energy Policy and Conservation
Act. This action is taken pursuant to the Federal Civil Monetary
Penalty Inflation Adjustment Act of 1990, as amended by the Debt
Collection Improvement Act of 1996, which requires us to review and, as
warranted, adjust penalties based on inflation at least every four
years.

DATES: This final rule is effective March 26, 2008.

ADDRESSES: Petitions for reconsideration should refer to the docket
number and be submitted to: Administrator, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue, SE., West Building,
Fourth Floor, Washington, DC 20590, with a copy to the DOT docket.
Copies to the docket may be submitted electronically through the
Federal E-Rulemaking Portal at http://www.regulations.gov. Follow the
online instructions for submitting comments.
    You may call Docket Management at<PHONE_NUMBER>. The Docket room
(Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.), hours are
from 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the Supplementary Information section of this
document. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets 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 (65 FR 19477-78).

FOR FURTHER INFORMATION CONTACT: Michael Kido, Office of Chief Counsel,
NHTSA, telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>, 1200 New
Jersey Avenue, SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION: This rule adjusts for inflation certain
maximum available penalty amounts and codifies the new amounts in 49
CFR part 578 Civil and Criminal Penalties. In order to preserve the
remedial impact of civil penalties and to foster compliance with the
law, the Federal Civil Monetary Penalty Inflation Adjustment Act of
1990 (28 U.S.C. 2461 Notes, Pub. L. 101-410), as amended by the Debt
Collection Improvement Act of 1996, (Pub. L. 104-134) (referred to
collectively as the ``Adjustment Act'' or, in context, the ``Act''),
requires us and other Federal agencies to regularly adjust civil
penalties for inflation. Under the Adjustment Act, following an initial
adjustment that was capped by the Act, these agencies must make further
adjustments, as warranted, to the amounts of penalties in statutes they
administer at least once every four years.\1\
---------------------------------------------------------------------------

    \1\ As we indicated in our September 2007 notice of proposed
rulemaking, since this rule will become effective in 2008, we used
the 2007 consumer price index (CPI) rather than the 2006 CPI in
calculating the projected adjustment. Applying the 2007 CPI to our
calculations did not alter the final increased amounts that we
previously proposed.
---------------------------------------------------------------------------

    The changes to certain maximum penalties for violations of the
odometer laws, regulations and orders and for violations of certain
administrative procedures of the Energy Policy and Conservation Act of
1975 as amended and recodified (EPCA) in today's rule were proposed and
explained in our September 26, 2007 Notice of Proposed Rulemaking
(NPRM). 72 FR 54635. The discussion in that notice is incorporated by
reference. We received no comments to that notice.
    NHTSA is adjusting the maximum penalty for a single violation of
the odometer tampering and disclosure requirements in 49 U.S.C. Chapter
327 or a regulation or order thereunder. The maximum penalty is
codified at 49 CFR 578.6(f)(1). The agency last published a rule
adjusting the maximum civil penalty for a single violation under 49
U.S.C. Chapter 327 in a rule published on February 4, 1997. 62 FR 5167.
In today's rule, NHTSA is adjusting this amount from $2,200 to $3,200
based on the Adjustment Act, for the reasons set forth in the NPRM.
    Additionally, the agency is adjusting the maximum penalty amount
for a single violation of certain administrative provisions of the EPCA
found at 49 U.S.C. 32911(a). The maximum penalty is codified at 49 CFR
578.6(h)(1). This amount was last adjusted in a rule published on
February 4, 1997. 62 FR 5167. After applying the statutory formulation
described in the NPRM, the maximum civil penalty amount for a single
violation is being adjusted from $11,000 to $16,000. The basis for this
adjustment is set forth in the NPRM.

Rulemaking Analyses and Notices

Executive Order 12866 and DOT Regulatory Policies and Procedures

    We have considered the impact of this rulemaking action under
Executive Order 12866 and the Department of Transportation's regulatory
policies and procedures. This rulemaking document was not reviewed
under Executive Order 12866, ``Regulatory Planning and Review.'' This
action is limited to the adoption of adjustments of civil penalties
under statutes that the agency enforces, and has been determined to be
not ``significant'' under the Department of Transportation's regulatory
policies and procedures.

Regulatory Flexibility Act

    We have also considered the impacts of this notice under the
Regulatory Flexibility Act. I certify that this final rule will not
have a significant economic impact on a substantial number of small
entities. The following

provides the factual basis for this certification under 5 U.S.C.
605(b). The amendments potentially affect entities involved with
odometers and manufacturers of motor vehicles.
    The Small Business Administration's regulations define a small
business in part as a business entity ``which operates primarily within
the United States.'' 13 CFR 121.105(a). SBA's size standards were
previously organized according to Standard Industrial Classification
(SIC) Codes. SIC Code 336211 ``Motor Vehicle Body Manufacturing''
applied a small business size standard of 1,000 employees or fewer. SBA
now uses size standards based on the North American Industry
Classification System (NAICS), Subsector 336--Transportation Equipment
Manufacturing, which provides a small business size standard of 1,000
employees or fewer for automobile manufacturing businesses. Other motor
vehicle-related industries have lower size requirements that range
between 500 and 750 employees.
    Many small businesses are subject to the penalty provisions of the
odometer laws in 49 U.S.C. Chapter 327. Some small businesses are
subject to the EPCA provisions in 49 U.S.C. 32911(a) and therefore may
be affected by the adjustments that this final rule makes. As noted in
this preamble, this rule increases only the maximum penalty amounts
that the agency could obtain for a single violation of the odometer
tampering and disclosure provisions and administrative provisions of
EPCA. The rule does not set the amount of penalties for any particular
violation or series of violations. Under the odometer laws, the
applicable penalty provision requires the agency to take into account
the ability to pay and any effect on the ability to continue doing
business when determining the appropriate civil penalty in an
individual case. See 49 U.S.C. 32709(a)(3)(B). Although EPCA does not
provide for consideration of business size, it contains a provision for
the compromise or remittitur of penalties for violations of 49 U.S.C.
32911(a). See 49 U.S.C. 32912(a) and 32913(a). The agency would also
consider the size of a business under its civil penalty policy when
determining the appropriate civil penalty amount for violations of 49
U.S.C. 32701 et seq. or 49 U.S.C. 32911(a). See 62 FR 37115 (July 10,
1997) (NHTSA's civil penalty policy under the Small Business Regulatory
Enforcement Fairness Act (SBREFA)). The penalty adjustments that are
promulgated by this rule do not affect our civil penalty policy under
SBREFA.
    Since this regulation does not establish penalty amounts, this rule
will not have a significant economic impact on small businesses.
    Small organizations and governmental jurisdictions are not
significantly affected as the price of motor vehicles and equipment
ought not to change as a result of this rule. As explained above, this
action is limited to the adoption of a statutory directive, and has
been determined to be not ``significant'' under the Department of
Transportation's regulatory policies and procedures.

Executive Order 13132 (Federalism)

    Executive Order 13132 requires NHTSA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects 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.'' Under Executive Order 13132, the agency may not issue a
regulation with Federalism implications that imposes substantial direct
compliance costs, and that is not required by statute, unless the
Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, the agency
consults with State and local governments, or the agency consults with
State and local officials early in the process of developing the
regulation.
    This rule will not have substantial direct effects 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, as specified in Executive Order 13132. The reason
is that this rule applies to motor vehicle manufacturers, and not to
the States or local governments. Thus, the requirements of Section 6 of
the Executive Order do not apply.

Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995, Public Law 104-4,
requires agencies to prepare a written assessment of the cost, benefits
and other effects of proposed or final rules that include a Federal
mandate likely to result in the expenditure by State, local, or tribal
governments, in the aggregate, or by the private sector, of more than
$100 million annually. Because this rule will not have a $100 million
effect, no Unfunded Mandates assessment will be prepared.

National Environmental Policy Act

    We have also analyzed this rulemaking action under the National
Environmental Policy Act and determined that it will have no
significant impact on the human environment.

Executive Order 12778 (Civil Justice Reform)

    This rule does not have a retroactive or preemptive effect.
Judicial review of this rule may be obtained pursuant to 5 U.S.C. 702.
That section does not require that a petition for reconsideration be
filed prior to seeking judicial review.

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1980, we state
that there are no requirements for information collection associated
with this rulemaking action.

List of Subjects in 49 CFR Part 578

    Motor vehicle safety, Penalties.

0
In consideration of the foregoing, 49 CFR part 578 is amended as set
forth below.

PART 578--CIVIL AND CRIMINAL PENALTIES

0
1. The authority citation for part 578 continues to read as follows:

    Authority: Pub. L. 101-410, Pub. L. 104-134, Pub. L. 106-414,
Pub. L. 109-59, 49 U.S.C. 30165, 30170, 30505, 32308, 32309, 32507,
32709, 32710, 32912, and 33115; delegation of authority at 49 CFR
1.50.

0
2. Section 578.6 of title 49, Code of Federal Regulations, is amended
by revising paragraphs (f)(1) as (h)(1) to read as follows:

Sec.  578.6  Civil penalties for violations of specified provisions of
Title 49 of the United States Code.

* * * * *
    (f) Odometer tampering and disclosure. (1) A person that violates
49 U.S.C. Chapter 327 or a regulation prescribed or order issued
thereunder is liable to the United States Government for a civil
penalty of not more than $3,200 for each violation. A separate
violation occurs for each motor vehicle or device involved in the
violation. The maximum civil penalty under this paragraph for a related
series of violations is $130,000.
* * * * *
    (h) Automobile fuel economy. (1) A person that violates 49 U.S.C.
32911(a)

is liable to the United States Government for a civil penalty of not
more than $16,000 for each violation. A separate violation occurs for
each day the violation continues.
* * * * *

     Issued on: February 7, 2008.
Nicole R. Nason,
Administrator.
 [FR Doc. E8-3518 Filed 2-22-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Pages 17349-17350]
[FR Doc No: 2022-06386]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94487; File No. SR-NYSEAMER-2022-15]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing of Proposed Rule Change To Amend Rule 7.31E(h)(3)

March 22, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on March 9, 2022, NYSE American LLC (``NYSE American'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 7.31E(h)(3). The proposed rule
change is available on the Exchange's website at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 7.31E(h)(3) to modify certain
factors relevant to the quote instability calculation for Discretionary
Pegged Orders. Specifically, the Exchange proposes to amend Rule
7.31E(h)(3)(D)(i)(D)(1)(a), which sets forth the quote stability
coefficients. Under Rule 7.31E(h)(3)(D)(i)(D)(3), the Exchange may
modify the quote stability coefficients at any time, subject to a
filing of a proposed rule change. The Exchange proposes such changes in
this rule filing.
Discretionary Pegged Orders
    Rule 7.31E(h)(3) provides for Discretionary Pegged Orders, which
are Pegged Orders \4\ that may exercise price discretion from their
working price to a discretionary price in order to trade with contra-
side orders on the Exchange Book, except during periods of quote
instability as defined in Rule 7.31E(h)(3)(D).
---------------------------------------------------------------------------

    \4\ A Pegged Order is a Limit Order that does not route with a
working price that is pegged to a dynamic reference price. If the
designated reference price is higher (lower) than the limit price of
a Pegged Order to buy (sell), the working price will be the limit
price of the order. See Rule 7.31E(h).
---------------------------------------------------------------------------

    Rule 7.31E(h)(3)(D) provides that the Exchange uses a quote
instability calculation to assess a security's ``quote instability
factor,'' or the probability of an imminent change to the current PBB
to a lower price or PBO to a higher price.\5\ When quoting activity in
a security meets predefined criteria and the quote instability factor
calculated is greater than the Exchange's defined ``quote instability
threshold,'' the Exchange treats the quote as unstable (``quote
instability'' or a ``crumbling quote'').
---------------------------------------------------------------------------

    \5\ NYSE American Rule 1.1E(dd) defines PBB as the highest
Protected Bid and PBO as the lowest Protected Offer. Rule 1.1E(dd)
also provides that ``PBBO'' means the Best Protected Bid and the
Best Protected Offer.
---------------------------------------------------------------------------

    Rule 7.31E(h)(3)(D)(i) provides that the Exchange determines a
quote to be unstable when, among other factors, the quote instability
factor result from the quote stability calculation is greater than the
quote instability threshold. To perform the quote stability calculation
and determine the quote instability factor, the Exchange employs a
fixed formula utilizing the quote stability coefficients and quote
stability variables set forth in Rule 7.31E(h)(3)(D)(i)(D)(1)(a) and
Rule 7.31E(h)(3)(D)(i)(D)(1)(b), respectively.
Proposed Rule Change
    The Exchange proposes to update the quote stability coefficients
used in the quote instability calculation, which have not been modified
since Rule 7.31E(h)(3) was adopted. The proposed changes are intended
to update the quote stability coefficients to be based on more current
market data and activity on the Exchange, including to reflect the
Exchange's elimination of a delay mechanism that previously added
latency to certain order processing (the ``Delay Mechanism'').\6\
---------------------------------------------------------------------------

    \6\ The Exchange eliminated the Delay Mechanism, which added a
delay of 350 microseconds of latency to specified order processing,
in 2019. See Securities Exchange Act Release No. 87550 (November 15,
2019), 84 FR 64359 (November 21, 2019) (SR-NYSEAMER-2019-48) (Notice
of Filing and Immediate Effectiveness of Proposed Rule Change to
Amend Exchange Rules 1.1E and 7.29E to Eliminate the Delay Mechanism
and Amend Exchange Rule 7.31E and Related Exchange Rules to Re-
Introduce Previously-Approved Order Types and Modifiers).
---------------------------------------------------------------------------

    The Exchange reviewed NYSE American market data from randomly
selected days in the fourth quarter of 2021 to analyze the
effectiveness of the quote stability coefficients in predicting changes
to the PBBO. Specifically, the Exchange reviewed PBBO data, on a
nanosecond level, for certain intervals throughout each randomly
selected day to track changes to quotes on NYSE American and away
markets. The Exchange used this data to generate and test the proposed
quote stability coefficients, and based on its analysis, believes that
modifying the quote stability coefficients would enable the Exchange to
evaluate the quality of the PBBO more effectively.
    The Exchange proposes to modify the quote stability coefficients
set forth in Rule 7.31E(h)(3)(D)(i)(D)(1)(a)(i) through (v) as follows:

------------------------------------------------------------------------
                                                  Current      Proposed
          Quote stability coefficient              value        value
------------------------------------------------------------------------
C0............................................     -2.39515    -2.174901

C1............................................     -0.76504    -0.561555
C2............................................      0.07599     0.077739
C3............................................      0.38374    0.4860265
C4............................................      0.14466    0.1627735
------------------------------------------------------------------------

    The Exchange believes that its proposed modification of the quote
stability coefficients, based on the market data analysis described
above, would improve the accuracy of the fixed formula used to perform
the quote instability calculation. Specifically, the Exchange believes
that the proposed quote stability coefficients, which have been
adjusted to reflect more recent activity on the Exchange (including the
elimination of the Delay Mechanism), would improve the calibration of
the quote instability calculation to activity on the Exchange, thereby
enhancing the Exchange's ability to predict whether there is quote
instability and protect Discretionary Pegged Orders from exercising
discretion when the PBBO is unstable.
    Because of the technology changes associated with this proposed
rule change, the Exchange will announce the implementation date by
Trader Update.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\7\ in general, and furthers the objectives of Section 6(b)(5),\8\
in particular, because it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system and, in general, to protect investors and
the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed change would promote just
and equitable principles of trade, remove impediments to, and perfect
the mechanism of, a free and open market and a national market system,
and protect investors and the public interest because it is designed to
increase the effectiveness of the quote instability calculation used to
determine whether a crumbling quote exists. As discussed above, the
proposed change is based on the Exchange's analysis of market data,
which supports that the proposed change would improve the accuracy of
the Exchange's quote instability calculation. Accordingly, the Exchange
believes that the proposed change would remove impediments to, and
perfect the mechanism of, a free and open market and a national market
system, as well as protect investors and the public interest, by
enhancing the Exchange's protection of Discretionary Pegged Orders.
Specifically, because the proposed quote stability coefficients were
derived through an analysis of more recent market data and are
calibrated to reflect current activity on the Exchange (including to
account for the fact that the Exchange no longer operates with the
Delay Mechanism), the Exchange believes that the proposed change would
improve the effectiveness of the quote instability calculation in
predicting periods of quote instability and thus enhance the extent to
which Discretionary Pegged Orders would be protected from unfavorable
executions.

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. The Exchange believes that
the proposed change would promote competition by improving the accuracy
of the quote instability calculation, thereby enhancing the protection
of Discretionary Pegged Orders from unfavorable executions during
periods of quote instability.

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

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

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

    Within 45 days of the date of publication of this notice in the
Federal Register or such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEAMER-2022-15 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-NYSEAMER-2022-15. 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 (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 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. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2022-15 and should be submitted
on or before April 18, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-06386 Filed 3-25-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Rules and Regulations]
[Pages 57610-57612]
[FR Doc No: 2019-23464]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2019-N-4328]

Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Self-Fitting Air-Conduction Hearing Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the self-fitting air-conduction hearing aid into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the self-fitting air-conduction hearing aid's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.

DATES: This order is effective October 28, 2019. The classification was
applicable on October 5, 2018.

FOR FURTHER INFORMATION CONTACT: Cherish Giusto, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2432, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the self-fitting air-conduction
hearing aid as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug
Administration Modernization Act of 1997 established the first
procedure for De Novo classification (Pub. L. 105-115). Section 607 of
the Food and Drug Administration Safety and Innovation Act modified the
De Novo application process by adding a second procedure (Pub. L. 112-
144). A device sponsor may utilize either procedure for De Novo
classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a

determination of substantial equivalence, that person requests a
classification under section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On May 11, 2018, Bose Corp. submitted a request for De Novo
classification of the Bose Hearing Aid. FDA reviewed the request in
order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on October 5, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 874.3325. We have named
the generic type of device self-fitting air-conduction hearing aid, and
it is identified as a wearable sound amplifying device that is intended
to compensate for impaired hearing and incorporates technology,
including software, that allows users to program their hearing aids.
This technology integrates user input with a self-fitting strategy and
enables users to independently derive and customize their hearing aid
fitting and settings.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Self-Fitting Air-Conduction Hearing Aid Risks and Mitigation
                                Measures
------------------------------------------------------------------------
             Identified risks                    Mitigation measures
------------------------------------------------------------------------
Diminished hearing due to over-             Software verification,
 amplification caused by:                    validation, and hazard
 Excessively high sound output       analysis;
 levels in the ear canal                    Electroacoustic performance
 Device malfunction                  testing; and
 Interference with or from other    Electromagnetic
 devices                                     compatibility (EMC)
                                             testing.
Listening fatigue or failure to provide     Clinical data;
 sound awareness due to over- or under-     Usability testing;
 amplification caused by:                   Software verification,
 Poor fitting                        validation, and hazard
 Device malfunction                  analysis;
 Use error                          Electroacoustic performance
 Interference with or from other     testing;
 devices                                    EMC testing; and
                                            Labeling
Tissue heating due to exposure to non-      Wireless technology
 ionizing radiation emitted by wireless      evaluation; and
 technology                                 Labeling.
Tissue trauma/damage in the ear canal or    Usability testing;
 other patient contacting areas due to:     Electrical and thermal
                                             safety testing; and
                                             Labeling.
     Excessively long ear piece
     Device malfunction
     Use error
Missed or delayed medical diagnosis or      Labeling.
 treatment due to failure to self-identify
 correct population and condition
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 814, subparts A through E, regarding

premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for part 874 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  874.3325 to subpart D to read as follows:

Sec.  874.3325   Self-fitting air-conduction hearing aid.

    (a) Identification. A self-fitting air-conduction hearing aid is a
wearable sound amplifying device that is intended to compensate for
impaired hearing and incorporates technology, including software, that
allows users to program their hearing aids. This technology integrates
user input with a self-fitting strategy and enables users to
independently derive and customize their hearing aid fitting and
settings.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical data must evaluate the effectiveness of the self-
fitting strategy.
    (2) Electroacoustic parameters, including maximum output limits,
distortion levels, self-generated noise levels, latency, and frequency
response, must be specified and tested.
    (3) Performance data must demonstrate the electromagnetic
compatibility (EMC), electrical safety, and thermal safety of the
device.
    (4) Software verification, validation, and hazard analysis must be
performed.
    (5) If the device incorporates wireless technology:
    (i) Performance testing must validate safety of exposure to non-
ionizing radiation;
    (ii) Performance data must validate wireless technology functions;
and
    (iii) Labeling must specify instructions, warnings, and information
relating to wireless technology and human exposure to non-ionizing
radiation.
    (6) Usability testing must demonstrate that users can correctly use
the device as intended under anticipated conditions of use.
    (7) Patient labeling must include the following:
    (i) Information on how a patient can self-identify as a candidate
for the device;
    (ii) Information about when to seek professional help;
    (iii) A warning about using hearing protection in loud
environments;
    (iv) A warning about staying alert to sounds around the user of the
device;
    (v) Technical information about the device, including information
about EMC; and
    (vi) Information on how to correctly use and maintain the device.

    Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23464 Filed 10-25-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 93 (Friday, May 13, 2022)]
[Notices]
[Page 29310]
[FR Doc No: 2022-10352]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2021-0103: FRL-9856-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Asphalt Processing and Asphalt
Roofing Manufacturing (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Asphalt Processing and
Asphalt Roofing Manufacturing (EPA ICR Number 2029.09, OMB Control
Number 2060-0520), to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through May 31, 2022. Public comments were previously requested via the
Federal Register on April 13, 2021 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may nether conduct nor sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before June 13, 2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2021-0103,, online using https://www.regulations.gov/ (our
preferred method), by email to [email protected], or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI), or other information whose disclosure is
restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Muntasir Ali, Sector Policies and
Program Division (D243-05), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina, 27711; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov, or in person at the EPA Docket Center, WJC
West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC.
The telephone number for the Docket Center is<PHONE_NUMBER>. For
additional information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: Owners and operators of existing and new facilities that
are engaged in asphalt processing or asphalt roofing manufacturing are
required to comply with reporting and record keeping requirements for
the General Provisions (40 CFR part 63, subpart A), as well as for the
applicable specific standards in 40 CFR part 63 subpart LLLLL. This
includes submitting initial notifications, performance tests and
periodic reports and results, and any period during which the add-on
control system is inoperative. These reports are used by EPA to
determine compliance with these standards.
    Form Numbers: 5900-567.
    Respondents/affected entities: Owners or operators of asphalt
processing or asphalt roofing manufacturing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart LLLLL).
    Estimated number of respondents: 8 (total).
    Frequency of response: Initially, semiannually, periodically.
    Total estimated burden: 4,000 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $558,000 (per year), which includes $84,900
in annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is an increase in burden from the
most-recently approved ICR as currently identified in the OMB Inventory
of Approved Burdens. This increase is not due to any program changes.
This ICR merges the `burdens' from EPA ICR Number 2029.08 and EPA ICR
No. 2598.02 (OMB No. 2060-0724), and from the ICR that the RTR
amendments finalized on March 12, 2020 at 85 FR 14526. The prior RTR
amendments revised the rule to add periodic testing requirements which
increased burden, and resulted in an increase in periodic testing costs
and an increase in operation and maintenance (O&M) costs for control
devices. The regulations are not anticipated to change over the next
three years. The growth rate for this industry is very low or non-
existent. There are no changes in the capital/startup costs as no new
sources have been constructed.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-10352 Filed 5-12-22; 8:45 am]
BILLING CODE 6560-50-P


Dear Mr.______________: This letter provides notice under 40 CFR 82.169 of the impending suspension and revocation of the approval of ___________to certify technicians under 40 CFR 82.161.  Accordingly, the U.S. Environmental Protection Agency (EPA) is suspending approval for ________to offer the Section 608 technician certification test. Additionally, EPA is suspending __________approval to newly issue Section 608 technician certification cards. We are sending this notice because _________did not comply with the requirements for approved 608 technician certification programs under 40 CFR Part 82, Subpart F.  As explained below, the suspension of the program approval will take effect 30 calendar days after the date of this notice and the program approval will be revoked 60 calendar days after the date of this notice.  In accordance with the recordkeeping and reporting requirements specified in Section (g)(2) of Appendix D of 40 CFR Part 82, Subpart F, approved technician certification programs must submit activity reports to EPA by January 30 and June 30 of each calendar year. EPA has not received the required reports from _________ for the first half of 2012 and the first half of 2013. An EPA employee also contacted you by phone on September 25, 2014 to inform you that EPA had not received these reports and requested that you submit the activity reports. EPA has not received the reports.   ___________________may choose to submit a request for a hearing in accordance with the regulations published at 40 CFR 82.169.  Any request for a hearing must be filed in writing within 30 calendar days from the date of this notice and must set forth any objections you have to the revocation or suspension and data to support those objections.  If EPA does not receive a written request for a hearing within 30 calendar days of the date of this notice, the suspension of your program approval will automatically take effect, and your program approval will be revoked 60 calendar days from the date of this notice.

As a reminder, during the suspension, ________________must continue to maintain all records.

_________may also voluntarily withdraw from the technician certification program. Please send a voluntary withdrawal request in writing and provide the information required under Section (g)(4), Appendix D of 40 CFR Part 82, Subpart F.   Please send any hearing request and voluntary withdrawal requests to one of the following addresses:   via U.S. Postal Service				via Private Courier

608 Technician Certification Program	608 Technician Certification Program Manager 	Manager Attention: Robert Burchard				Attention: Robert Burchard Stratospheric Protection Division 			Stratospheric Protection Division U.S. Environmental Protection Agency 		U.S. Environmental Protection Mailcode 6205T					WJCE Connection Wing (4355EE) 1200 Pennsylvania Avenue, NW			1201 Constitution Avenue, NW Washington, DC  20460				Washington, DC 20460

If you have any questions about this letter, please contact Robert Burchard of my staff at<PHONE_NUMBER> or<EMAIL_ADDRESS>                         Regards,

                        David Donaldson, Chief                         Stratospheric Program Implementation Branch                         Stratospheric Protection Division


[Federal Register Volume 76, Number 151 (Friday, August 5, 2011)]
[Notices]
[Page 47577]
[FR Doc No: 2011-19939]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR11-121-000]

Rocky Mountain Natural Gas LLC; Notice of Filing

    Take notice that on July 28, 2011, Rocky Mountain Natural Gas LLC
filed a revised Statement of Operating Conditions to comply with an
unpublished Delegated letter order issued on July 13, 2011, in Docket
No. PR10-130-000.
    Any person desiring to participate in this rate filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 9, 2011.

    Dated: August 1, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-19939 Filed 8-4-11; 8:45 am]
BILLING CODE 6717-01-P