[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Pages 58192-58193]
[FR Doc No: 2021-22612]

Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 /
Notices

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1380]

Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products.'' The FDA Reauthorization Act of 2017 (FDARA) directed FDA to
update and finalize the draft guidance entitled ``Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products,'' issued on November 7, 2013. Therefore, FDA is issuing this
updated draft guidance, which supersedes the November 7, 2013, draft
guidance. This updated draft guidance is intended to describe hearing
aids, personal sound amplification products (PSAPs), their respective
intended uses, and the regulatory requirements that apply to these
products. This draft guidance is not final nor is it in effect at this
time.

DATES: Submit either electronic or written comments on the draft
guidance by January 18, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1380 for ``Regulatory Requirements for Hearing Aid Devices
and Personal Sound Amplification Products.'' Received comments 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,<PHONE_NUMBER>.
     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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the draft guidance. Submit
written requests for a single hard copy of the draft guidance document
entitled ``Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Shu-Chen Peng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52)
directs FDA to establish a category of over-the-counter (OTC) hearing
aids through rulemaking, and mandates that FDA establish various
requirements for this category of devices. FDA has issued a proposed
rule to establish the OTC category of hearing aids and to implement the
requirements of FDARA (``Proposed Rule'') as published elsewhere in
this edition of the Federal Register. In the proposed rule, FDA has
also proposed multiple related changes to the overall regulatory
framework for hearing aids to harmonize existing regulations with the
proposed OTC category while continuing to provide a reasonable
assurance of safety and effectiveness.

    FDARA also directed FDA to update and finalize the draft guidance
entitled ``Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products,'' issued on November 7, 2013. To fulfill
this requirement of FDARA, FDA is issuing this updated draft guidance,
which supersedes the November 7, 2013, draft guidance. This updated
draft guidance reflects the current regulatory framework for hearing
aids and summarizes the new regulatory framework for hearing aids in
the proposed rule. After the proposed rule is finalized, this guidance
will be updated accordingly so that it only reflects the final
regulatory framework for hearing aids.
    This guidance identifies current applicable legal requirements
under the Federal Food, Drug, and Cosmetic Act for hearing aids and for
PSAPs. This guidance is intended to describe hearing aids, PSAPs, their
respective intended uses, and the regulatory requirements that apply to
both types of products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance is also
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Regulatory Requirements for Hearing
Aid Devices and Personal Sound Amplification Products'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1832 and complete
title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations have been approved by
OMB as listed in the following table:

----------------------------------------------------------------------------------------------------------------
                    21 CFR part(s)                                      Topic                    OMB control No.
----------------------------------------------------------------------------------------------------------------
800, 801, and 809....................................  Medical Device Labeling Regulations....         0910-0485
803..................................................  Medical Devices; Medical Device                 0910-0437
                                                        Reporting; Manufacturer reporting,
                                                        importer reporting, user facility
                                                        reporting, distributor reporting.
807, subpart E.......................................  Premarket notification.................         0910-0120
814..................................................  Premarket Approval Application.........         0910-0231
1000 through 1050....................................  Electronic Products....................         0910-0025
----------------------------------------------------------------------------------------------------------------

    This draft guidance also refers to proposed collections of
information described in FDA's proposed rule on ``Medical Devices; Ear,
Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.''
The proposed collections of information in the proposed rule are
subject to review by OMB under the PRA (44 U.S.C. 3501-3521). As
required by the PRA, FDA has published an analysis of the information
collection provisions of the proposed rule as published elsewhere in
this edition of the Federal Register and has submitted it for OMB
approval.

    Dated: October 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22612 Filed 10-19-21; 8:45 am]
BILLING CODE 4164-01-P


Department                                               Statutes (2005).
                                    concerning                                               See 40 CFR
                                    registration and                                         52.1490(c)(71)(i)(A
                                    licensing.                                               )(1).
482.171..........................  List of registered        5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    owners to be                                             Statutes (2005).
                                    provided for                                             See 40 CFR
                                    selection of jury;                                       52.1490(c)(71)(i)(A
                                    reimbursement of                                         )(1).
                                    Department.
482.173..........................  Schedule for              5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    retention and                                            Statutes (2005).
                                    disposition of                                           See 40 CFR
                                    certain records of                                       52.1490(c)(71)(i)(A
                                    Department.                                              )(1).
482.175..........................  Validity of               5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    registration:                                            Statutes (2005).
                                    Powers and duties                                        See 40 CFR
                                    of Department and                                        52.1490(c)(71)(i)(A
                                    registered dealers.                                      )(1).
482.180..........................  Motor Vehicle Fund:       5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Creation: deposits;                                      Statutes (2005).
                                    interest and                                             See 40 CFR
                                    income; dishonored                                       52.1490(c)(71)(i)(A
                                    payments;                                                )(1).
                                    distribution of
                                    money collected for
                                    basic governmental
                                    services tax;
                                    transfers.
482.1805.........................  Revolving Account         5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    for Issuance of                                          Statutes (2005).
                                    Special License                                          See 40 CFR
                                    Plates: Creation;                                        52.1490(c)(71)(i)(A
                                    deposit of certain                                       )(1).
                                    fees; use of money
                                    in Account;
                                    transfer of excess
                                    balance to State
                                    Highway Fund.
482.181..........................  Governmental              5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    services taxes:                                          Statutes (2005).
                                    Certification of                                         See 40 CFR
                                    amount collected                                         52.1490(c)(71)(i)(A
                                    each month;                                              )(1).
                                    distribution.
482.183..........................  Motor Vehicle             5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Revolving Account:                                       Statutes (2005).
                                    Creation; use;                                           See 40 CFR
                                    deposits.                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.186..........................  Certain odometers         5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    deemed to register                                       Statutes (2005).
                                    mileage reflected                                        See 40 CFR
                                    on odometer plus                                         52.1490(c)(71)(i)(A
                                    100,000 miles.                                           )(1).
482.187..........................  Department                5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    authorized to enter                                      Statutes (2005).
                                    into written                                             See 40 CFR
                                    agreements for                                           52.1490(c)(71)(i)(A
                                    periodic payment of                                      )(1).
                                    delinquent taxes or
                                    fees; regulations.
482.188..........................  Waiver of penalty or      5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    interest for                                             Statutes (2005).
                                    failure timely to                                        See 40 CFR
                                    file return or pay                                       52.1490(c)(71)(i)(A
                                    tax, penalty or fee                                      )(1).
                                    in certain
                                    circumstances.
----------------------------------------------------------------------------------------------------------------
     Nevada Revised Statutes, Title 43, Public Safety; Vehicles; Watercraft; Chapter 482, Motor Vehicles and
           Trailers: Licensing, Registration, Sales and Leases--Original and Renewal of Registration
----------------------------------------------------------------------------------------------------------------
482.205..........................  Registration              5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    required for                                             Statutes (2005).
                                    certain vehicles.                                        See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.206..........................  Periods of                5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    registration for                                         Statutes (2005).
                                    motor vehicles;                                          See 40 CFR
                                    exceptions.                                              52.1490(c)(71)(i)(A
                                                                                )(1).
482.208..........................  Registration of           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    leased vehicles by                                       Statutes (2005).
                                    long-term lessor or                                      See 40 CFR
                                    long-term lessee.                                        52.1490(c)(71)(i)(A
                                                                                )(1).

482.210..........................  Exemptions from           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    registration.                                            Statutes (2005).
                                                                                See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.215..........................  Application for           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    registration.                                            Statutes (2005).
                                                                                See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.216..........................  Department may            5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    authorize new                                            Statutes (2005).
                                    vehicle dealer to                                        See 40 CFR
                                    accept applications                                      52.1490(c)(71)(i)(A
                                    for registration                                         )(1).
                                    and transfer of
                                    registration of new
                                    motor vehicles and
                                    to issue
                                    certificates of
                                    registration;
                                    duties of dealer;
                                    prohibited acts;
                                    regulations.
482.220..........................  Application for           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    specially                                                Statutes (2005).
                                    constructed,                                             See 40 CFR
                                    reconstructed,                                           52.1490(c)(71)(i)(A
                                    rebuilt or foreign                                       )(1).
                                    vehicle;
                                    certificate of
                                    inspection; charge
                                    for inspection.
482.225..........................  Collection of sales       5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    or use tax upon                                          Statutes (2005).
                                    application for                                          See 40 CFR
                                    registration of                                          52.1490(c)(71)(i)(A
                                    certain vehicles                                         )(1).
                                    purchased outside
                                    this State; payment
                                    of all applicable
                                    taxes and fees
                                    required for
                                    registration;
                                    refund of tax
                                    erroneously or
                                    illegally collected.
482.230..........................  Grounds requiring         5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    refusal of                                               Statutes (2005).
                                    registration.                                            See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.235..........................  Registration indexes      5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    and records;                                             Statutes (2005).
                                    assignment of                                            See 40 CFR
                                    registration number                                      52.1490(c)(71)(i)(A
                                    by registered                                            )(1).
                                    dealer.
482.240..........................  Issuance of               5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    certificates of                                          Statutes (2005).
                                    registration and                                         See 40 CFR
                                    title by Department                                      52.1490(c)(71)(i)(A
                                    or registered                                            )(1).
                                    dealer; period of
                                    validity of
                                    certificate.
482.245..........................  Contents of               5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    certificates of                                          Statutes (2005).
                                    registration and                                         See 40 CFR
                                    title.                                                   52.1490(c)(71)(i)(A
                                                                                )(1).
482.255..........................  Placement of              5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    certificate of                                           Statutes (2005).
                                    registration;                                            See 40 CFR
                                    surrender upon                                           52.1490(c)(71)(i)(A
                                    demand of peace                                          )(1).
                                    officer, justice of
                                    the peace or deputy
                                    of Department;
                                    limitation on
                                    conviction.
482.260..........................  Duties of Department      5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    of Motor Vehicles                                        Statutes (2005).
                                    and its agents                                           See 40 CFR
                                    relative to                                              52.1490(c)(71)(i)(A
                                    registration of                                          )(1).
                                    vehicle; issuance
                                    of certificate of
                                    title; fees and
                                    taxes.
482.265..........................  License plates            5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    issued upon                                              Statutes (2005).
                                    registration;                                            See 40 CFR
                                    stickers, tabs or                                        52.1490(c)(71)(i)(A
                                    other devices                                            )(1).
                                    issued upon renewal
                                    of registration;
                                    return of plates;
                                    fee for and
                                    limitations on
                                    issuance of special
                                    license plates.

482.266..........................  Manufacture of            5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    license plates                                           Statutes (2005).
                                    substantially                                            See 40 CFR
                                    similar to license                                       52.1490(c)(71)(i)(A
                                    plates issued                                            )(1).
                                    before January 1,
                                    1982: Written
                                    request; fee;
                                    delivery; duties of
                                    Department;
                                    retention of old
                                    plates authorized
                                    if requested plates
                                    contain same
                                    letters and numbers.
482.267..........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Production at                                            Statutes (2005).
                                    facility of                                              See 40 CFR
                                    Department of                                            52.1490(c)(71)(i)(A
                                    Corrections.                                             )(1).
482.268..........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Additional fee for                                       Statutes (2005).
                                    issuance; deposit                                        See 40 CFR
                                    of fee.                                                  52.1490(c)(71)(i)(A
                                                                                )(1).
482.270..........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    General                                                  Statutes (2005).
                                    specifications;                                          See 40 CFR
                                    redesign;                                                52.1490(c)(71)(i)(A
                                    configuration of                                         )(1).
                                    special license
                                    plates designed,
                                    prepared and issued
                                    pursuant to process
                                    of direct
                                    application and
                                    petition.
482.2703.........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Samples; form; fee;                                      Statutes (2005).
                                    penalty.                                                 See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.2705.........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Passenger cars and                                       Statutes (2005).
                                    trucks.                                                  See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.271..........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Decals; fees.                                            Statutes (2005).
                                                                                See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.2715.........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Registrant entitled                                      Statutes (2005).
                                    to maintain code if                                      See 40 CFR
                                    continuously                                             52.1490(c)(71)(i)(A
                                    renewed;                                                 )(1).
                                    exceptions;
                                    issuance of
                                    replacement plates
                                    with same code
                                    after expiration of
                                    registration; fee.
482.2717.........................  License plates to be      5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    issued to                                                Statutes (2005).
                                    automobile wreckers                                      See 40 CFR
                                    and operators of                                         52.1490(c)(71)(i)(A
                                    salvage pools.                                           )(1).
482.272..........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Motorcycles.                                             Statutes (2005).
                                                                                See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.274..........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Trailers.                                                Statutes (2005).
                                                                                See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.275..........................  License plates:           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Display.                                                 Statutes (2005).
                                                                                See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.280..........................  Expiration and            5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    renewal of                                               Statutes (2005).
                                    registration.                                            See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
482.2805.........................  Department not to         5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    renew registration                                       Statutes (2005).
                                    if local authority                                       See 40 CFR
                                    has filed notice of                                      52.1490(c)(71)(i)(A
                                    nonpayment pursuant                                      )(1).
                                    to NRS 484.444; fee
                                    for service
                                    performed by
                                    Department.
482.2807.........................  Requirements for          5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    registration if                                          Statutes (2005).
                                    local government                                         See 40 CFR
                                    has filed notice of                                      52.1490(c)(71)(i)(A
                                    nonpayment pursuant                                      )(1).
                                    to NRS 484.444.
482.281..........................  Authority of              5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    Department of Motor                                      Statutes (2005).
                                    Vehicles to allow                                        See 40 CFR
                                    authorized                                               52.1490(c)(71)(i)(A
                                    inspection station                                       )(1).
                                    or authorized
                                    station to renew
                                    certificates of
                                    registration;
                                    adoption of
                                    regulations.

482.283..........................  Change of name or         5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    place of residence:                                      Statutes (2005).
                                    Notice to                                                See 40 CFR
                                    Department                                               52.1490(c)(71)(i)(A
                                    required; timing                                         )(1).
                                    and contents of
                                    notice.
482.285..........................  Certificates, decals      5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    and number plates:                                       Statutes (2005).
                                    Illegibility, loss,                                      See 40 CFR
                                    mutilation or                                            52.1490(c)(71)(i)(A
                                    theft; obtaining of                                      )(1).
                                    duplicates or
                                    substitutes; fees
                                    and taxes.
482.290..........................  Assignment and            5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    recording of new                                         Statutes (2005).
                                    number for                                               See 40 CFR
                                    identification of                                        52.1490(c)(71)(i)(A
                                    vehicle if old                                           )(1).
                                    number destroyed or
                                    obliterated; fee;
                                    penalty for willful
                                    defacement,
                                    alteration,
                                    substitution or
                                    removal of number
                                    with intent to
                                    defraud.
----------------------------------------------------------------------------------------------------------------
     Nevada Revised Statutes, Title 43, Public Safety; Vehicles; Watercraft; Chapter 482, Motor Vehicles and
          Trailers: Licensing, Registration, Sales and Leases--Permits for Unregistered Motor Vehicles
----------------------------------------------------------------------------------------------------------------
482.385..........................  Registration of           5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    vehicle of                                               Statutes (2005).
                                    nonresident owner                                        See 40 CFR
                                    not required;                                            52.1490(c)(71)(i)(A
                                    exceptions;                                              )(1).
                                    registration of
                                    vehicle by person
                                    upon becoming
                                    resident of this
                                    State; penalty;
                                    taxes and fees;
                                    surrender or
                                    nonresident license
                                    plates and
                                    registration
                                    certificate;
                                    citation for
                                    violation.
----------------------------------------------------------------------------------------------------------------
     Nevada Revised Statutes, Title 43, Public Safety; Vehicles; Watercraft; Chapter 482, Motor Vehicles and
               Trailers: Licensing, Registration, Sales and Leases--Cancellation of Registration
----------------------------------------------------------------------------------------------------------------
482.461..........................  Failure of mandatory      5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    test of emissions                                        Statutes (2005).
                                    from engines;                                            See 40 CFR
                                    notification; cost                                       52.1490(c)(71)(i)(A
                                    of inspection.                                           )(1).
----------------------------------------------------------------------------------------------------------------
     Nevada Revised Statutes, Title 43, Public Safety; Vehicles; Watercraft; Chapter 482, Motor Vehicles and
                         Trailers: Licensing, Registration, Sales and Leases--Penalties
----------------------------------------------------------------------------------------------------------------
482.565..........................  Administrative fines      5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    for violations                                           Statutes (2005).
                                    other than                                               See 40 CFR
                                    deceptive trade                                          52.1490(c)(71)(i)(A
                                    practices;                                               )(1).
                                    injunction or other
                                    appropriate remedy;
                                    enforcement
                                    proceedings.
----------------------------------------------------------------------------------------------------------------
 Nevada Revised Statutes (2005), Title 43, Public Safety; Vehicles; Watercraft; Chapter 484, Traffic Laws--Other
                                                   Equipment
----------------------------------------------------------------------------------------------------------------
484.101..........................  Passenger car             5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    defined.                                                 Statutes (2005).
                                                                                See 40 CFR
                                                                                52.1490(c)(71)(i)(A
                                                                                )(1).
484.644..........................  Device for control        5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    of pollution: Use                                        Statutes (2005).
                                    required;                                                See 40 CFR
                                    disconnection or                                         52.1490(c)(71)(i)(A
                                    alteration                                               )(1).
                                    prohibited;
                                    exceptions.
484.6441.........................  Device for control        5/11/07  73 FR 38124 (7/3/08)  Nevada Revised
                                    of pollution:                                            Statutes (2005).
                                    Penalty; proof of                                        See 40 CFR
                                    conformity may be                                        52.1490(c)(71)(i)(A
                                    required.                                                )(1).
----------------------------------------------------------------------------------------------------------------
\*\ Not applicable.
\1\ The organization of this table generally follows from the organization of the State of Nevada's original
  1972 SIP, which was divided into 12 sections. Nonattainment and maintenance plans, among other types of plans,
  are listed under Section 5 (Control Strategy). Lead SIPs and Small Business Stationary Source Technical and
  Environmental Compliance Assistance SIPs are listed after Section 12 followed by nonregulatory or quasi-
  regulatory statutory provisions approved into the SIP. Regulatory statutory provisions are listed in 40 CFR
  52.1470(c).

0
4. In newly redesignated Sec.  52.1490, the section heading and
paragraph (a) are revised to read as follows:

Sec.  52.1490  Original identification of plan.

    (a) This section identified the original ``Air Quality
Implementation Plan for the State of Nevada'' and all revisions
submitted by the State of Nevada that

were federally approved prior to September 28, 2010.
* * * * *
[FR Doc. 2012-5554 Filed 3-12-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 223 (Tuesday, November 21, 2023)]
[Notices]
[Pages 81121-81122]
[FR Doc No: 2023-25723]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-574, OMB Control No. 3235-0648]

Proposed Collection; Comment Request; Extension: Rule 498

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

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') is soliciting
comments on the collection of information summarized below. The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 498 (17 CFR 230.498) under the Securities Act of 1933 (15
U.S.C. 77a et seq.) (``Securities Act'') permits open-end management
investment companies (``funds'') to satisfy their prospectus delivery
obligations under the Securities Act by sending or giving key
information directly to investors in the form of a summary prospectus
(``Summary Prospectus'') and providing the statutory prospectus on a
website. Upon an investor's request, funds are also required to send
the statutory prospectus to the investor. In addition, under rule 498,
a fund that relies on the rule to meet its statutory prospectus
delivery obligations must make available, free of charge, the fund's
current Summary Prospectus, statutory prospectus, statement of
additional information, and most recent annual and semi-annual reports
to shareholders at the website address specified in the required
Summary Prospectus legend (17 CFR 270.498(e)(1)). A Summary Prospectus
that complies with rule 498 is deemed to be a prospectus that is
authorized under Section 10(b) of the Securities Act and Section 24(g)
of the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.).
    The purpose of rule 498 is to enable a fund to provide investors
with a

Summary Prospectus containing key information necessary to evaluate an
investment in the fund. Unlike many other federal information
collections, which are primarily for the use and benefit of the
collecting agency, this information collection is primarily for the use
and benefit of investors. The information filed with the Commission
also permits the verification of compliance with securities law
requirements and assures the public availability and dissemination of
the information.
    Based on an analysis of fund filings, the Commission estimates that
approximately 11,241 funds are using a Summary Prospectus. The
Commission estimates that the annual hourly burden per fund associated
with the compilation of the information required on the cover page or
the beginning of the Summary Prospectus is 0.5 hours, and estimates
that the annual hourly burden per fund to comply with the website
posting requirement is approximately 1 hour, requiring a total of 1.5
hours per fund per year.\1\ Thus the total annual hour burden
associated with these requirements of the rule is approximately
16,862.\2\ The Commission estimates that the annual cost burden is
approximately $21,400 per fund, for a total annual cost burden of
approximately $240,557,400.\3\
---------------------------------------------------------------------------

    \1\ 0.5 hours per fund + 1 hour per fund = 1.5 hours per fund.
    \2\ 1.5 hours per fund x 11,241 funds = 16,862 hours.
    \3\ $21,400 per fund x 11,241 funds = $240,557,400.
---------------------------------------------------------------------------

    Estimates of average burden hours are made solely for the purposes
of the Paperwork Reduction Act and are not derived from a comprehensive
or even a representative survey or study of the costs of Commission
rules and forms. Under rule 498, use of the Summary Prospectus is
voluntary, but the rule's requirements regarding provision of the
statutory prospectus upon investor request are mandatory for funds that
elect to send or give a Summary Prospectus in reliance upon rule 498.
The information provided under rule 498 will not be kept confidential.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted by January 22, 2024.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John Pezzullo, 100 F Street NE, Washington, DC 20549 or send an
email to: [email protected].

    Dated: November 16, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25723 Filed 11-20-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Page 21899]
[FR Doc No: 2020-08338]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

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

Extension:
    Rule 104; SEC File No. 270-411, OMB Control No. 3235-0465

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 104
of Regulation M (17 CFR 242.104), under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.).
    Rule 104 permits stabilizing by a distribution participant during a
distribution so long as the distribution participant discloses
information to the market and investors. This rule requires disclosure
in offering materials of the potential stabilizing transactions and
that the distribution participant inform the market when a stabilizing
bid is made. It also requires the distribution participants (i.e., the
syndicate manager) to maintain information regarding syndicate covering
transactions and penalty bids and disclose such information to the
Self-Regulatory Organization.
    There are approximately 805 respondents per year that require an
aggregate total of 161 hours to comply with this rule. Each respondent
makes an estimated 1 annual response. Each response takes approximately
0.20 hours (12 minutes) to complete. Thus, the total compliance burden
per year is 161 hours. The total internal labor cost of compliance for
the respondents is approximately $11,270.00 per year, resulting in an
internal cost of compliance per respondent of approximately $14.00
(i.e., $11,270.00/805 respondents).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>
    Dated: April 15, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-08338 Filed 4-17-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Rules and Regulations]
[Pages 26348-26349]
[FR Doc No: 2017-11816]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2017-N-0011]

Humanitarian Use Devices; 21st Century Cures Act; Technical
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending regulations
to reflect changes recently enacted into law by the 21st Century Cures
Act. Specifically, certain requirements related to humanitarian device
exemptions (HDEs) and institutional review boards (IRBs) for devices
have changed. This action is being taken to align the regulations with
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.

DATES: This rule is effective June 7, 2017.

FOR FURTHER INFORMATION CONTACT: Ian Ostermiller, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301
796-5678.

SUPPLEMENTARY INFORMATION: On December 13, 2016, the 21st Century Cures
Act (Pub. L. 114-255) was signed into law, amending certain provisions
of the FD&C Act. FDA is updating regulations to reflect some of those

changes that are now in effect. Specifically, section 3052 of the 21st
Century Cures Act amended section 520(m) of the FD&C Act to allow for
HDE approval for devices that, among other things, treat or diagnose a
disease or condition that affects ``not more than 8,000'' individuals
in the United States; this threshold had been ``fewer than 4,000''
individuals in the United States (amending 21 U.S.C. 360j(m), passim).
This final rule amends part 814 (21 CFR part 814) in several places to
accurately reflect the threshold recently enacted into law.
    In addition, section 3056 of the 21st Century Cures Act amended
section 520 of the FD&C Act to remove the requirement for institutional
review committees, i.e., IRBs, for devices to be ``local'', (amending
21 U.S.C. 360j, passim). This final rule amends 21 CFR 814.124(a),
``IRB approval'', to remove the term ``local'' and related language in
order to accurately reflect the requirements recently enacted into law.
    FDA finds good cause for issuing this amendment as a final rule
without notice and comment because this amendment only updates the
implementing regulation to restate the statute in light of amendments
recently enacted into law (see 5 U.S.C. 553(b)(B), relating to notice
and comment procedures): ``[W]hen regulations merely restate the
statute they implement, notice-and-comment procedures are
unnecessary''. Gray Panthers Advocacy Committee v. Sullivan, 936 F.2d
1284, 1291 (D.C. Cir. 1991); see also Komjathy v. Nat. Trans. Safety
Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (when a rule ``does no more
than repeat, virtually verbatim, the statutory grant of authority'',
notice-and-comment procedures are not required). Therefore, we are
issuing these amendments as a final rule, and publication of this
document constitutes final action on this change under the
Administrative Procedure Act (APA) (5 U.S.C. 553).
    In addition, FDA finds good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date less than 30 days after publication as ``provided by the
agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the new requirements are already effective as a matter of law.
Furthermore, this rule does not establish additional regulatory
obligations or impose additional burden on regulated entities. As a
result, affected parties do not need time to prepare before the rule
takes effect. Therefore, FDA finds good cause for these amendments to
become effective on the date of publication of this action.

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

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

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

    1. The authority citation for part 814 continues to read as
follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.

Sec.  814.3  [Amended]

0
2. Amend Sec.  814.3(n) by removing the words ``fewer than 4,000'' and
adding in their place the words ``not more than 8,000''.

Sec.  814.100  [Amended]

0
3. Amend Sec.  814.100(b) introductory text by removing the words
``fewer than 4,000'' and adding in their place the words ``not more
than 8,000''.

Sec.  814.102  [Amended]

0
4. Amend Sec.  814.102 as follows:
0
a. In paragraph (a)(5), remove the words ``fewer than 4,000'' in both
occurrences and add in their places the words ``not more than 8,000''
for both occurrences;
0
b. In paragraph (b)(3)(i), remove the words ``fewer than 4,000'' and
add in their place the words ``not more than 8,000''; and
0
c. In paragraph (b)(3)(ii), remove the words ``4,000 or more'' and add
in their place the words ``more than 8,000''.

0
5. In Sec.  814.124, revise paragraph (a) to read as follows:

Sec.  814.124  Institutional Review Board requirements.

    (a) IRB approval. The HDE holder is responsible for ensuring that a
HUD approved under this subpart is administered only in facilities
having oversight by an Institutional Review Board (IRB) constituted and
acting pursuant to part 56 of this chapter, including continuing review
of use of the device. In addition, a HUD may be administered only if
such use has been approved by an IRB. If, however, a physician in an
emergency situation determines that approval from an IRB cannot be
obtained in time to prevent serious harm or death to a patient, a HUD
may be administered without prior approval by an IRB. In such an
emergency situation, the physician shall, within 5 days after the use
of the device, provide written notification to the chairman of the IRB
of such use. Such written notification shall include the identification
of the patient involved, the date on which the device was used, and the
reason for the use.
* * * * *

Sec.  814.126   [Amended]

0
6. Amend Sec.  814.126(b)(1)(iii) by removing the number ``4,000'' and
adding in its place the number ``8,000''.

    Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11816 Filed 6-6-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)]
[Rules and Regulations]
[Pages 18397-18400]
[FR Doc No: 2017-07908]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Parts 107 and 171

[Docket No. PHMSA-2016-0041 (HM-258D)]
RIN 2137-AF23

Hazardous Materials: Revision of Maximum and Minimum Civil
Penalties

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Final rule.

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

SUMMARY: PHMSA is revising the maximum and minimum civil penalties for
a knowing violation of the Federal hazardous material transportation
law or a regulation, order, special permit, or approval issued under
that law. The Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015, which amended the Federal Civil Penalties
Inflation Adjustment Act of 1990, required Agencies to update their
civil monetary penalties in August 2016 through an interim final
rulemaking. PHMSA has elected to do the 2017 update in a final
rulemaking. Per this final rule, the maximum civil penalty for a
knowing violation is now $78,376, except for violations that result in
death, serious illness, or severe injury to any person or substantial
destruction of property, for which the maximum civil penalty is
$182,877. In addition, the minimum civil penalty amount for a violation
relating to training is now $471.

DATES: Effective Date: April 19, 2017.

FOR FURTHER INFORMATION CONTACT: Shawn Wolsey, Office of Chief Counsel,
(202) 366-4400, Pipeline and Hazardous Materials Safety Administration,
U.S. Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents:

I. Civil Penalty Amendments
II. Justification for Final Rule
III. Rulemaking Analyses and Notices
    A. Statutory/Legal Authority for This Rulemaking
    B. Executive Order 12866, Executive Order 13563, and DOT
Regulatory Policies and Procedures
    C. Executive Order 13132
    D. Executive Order 13175
    E. Regulatory Flexibility Act, Executive Order 13272, and DOT
Procedures and Policies
    F. Paperwork Reduction Act
    G. Unfunded Mandates Reform Act of 1995
    H. Environmental Assessment
    I. Executive Order 13609 and International Trade Analysis
    J. Privacy Act
    K. Regulation Identifier Number (RIN)
List of Subjects

I. Civil Penalty Amendments

    Section 701 of the Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015 (the 2015 Act), Public Law 114-74, which
amended the Federal Civil Penalties Inflation Adjustment Act of 1990
(the Inflation Adjustment Act), Public Law 101-410, required that the
Agency make an initial catch-up adjustment with subsequent annual
adjustments to the maximum and minimum civil penalties set forth in 49
U.S.C. 5123(a) for a knowing violation of the Federal hazardous
material transportation law or a regulation, order, special permit, or
approval issued under that law. These changes to the maximum and
minimum civil penalty amounts apply to violations assessed on or after
the effective date of August 1, 2016. The 2015 Act also requires that
the Agency make subsequent annual adjustments for inflation beginning
in 2017, which are to be published no later than January 15th of each
subsequent year.
    The Office of Management and Budget's (OMB) ``Memorandum for the
Heads of Executive Departments and Agencies, Implementation of the
Federal Civil Penalties Inflation Adjustment Act Improvements Act of
2015,'' M-17-11, provides guidance on how to update agencies' civil
penalties pursuant to the 2015 Act. In order to complete the 2017
annual adjustment, agencies should multiply each applicable penalty by
the multiplier (1.01636) and round to the nearest dollar. The
multiplier should be applied to the most recent penalty amount, i.e.,
the one that includes the catch-up adjustment that the 2015 Act
required agencies to issue no later than July 1, 2016.
    Accordingly, PHMSA is revising the references to the maximum and
minimum civil penalty amounts in 49 CFR 107.329, appendix A to subpart
D of 49 CFR part 107, and 49 CFR 171.1 to reflect the changes required
by the 2015 Act:

     Revising the maximum civil penalty from $77,114 to
$78,376 for a person who knowingly violates the Federal hazardous
material transportation law or a regulation, order, special permit,
or approval issued under that law.
     Revising the maximum civil penalty from $179,933 to
$182,877 for a person who knowingly violates the Federal hazardous
material transportation law or a regulation, order, special permit,
or approval issued under that law that results in death, serious

illness, or severe injury to any person or substantial destruction
of property.
     Revising the minimum penalty amount from $463 to $471
for a violation related to training.

II. Justification for Final Rule

    PHMSA is proceeding directly to a final rule without providing a
notice of proposed rulemaking (NPRM) or an opportunity for public
comment. This action is permitted, in part, because the 2015 Act
directs PHMSA to adjust the civil monetary penalties in accordance with
the schedule provided in the 2015 Act, notwithstanding the notice and
public comment procedures in the Administrative Procedure Act (APA).
However, PHMSA also notes that the APA authorizes agencies to forego
providing the opportunity for prior public notice and comment if an
agency finds good cause that notice and public comment are
``impracticable, unnecessary, or contrary to the public interest.'' See
5 U.S.C 553(b)(3)(B). In this instance, public comment is unnecessary
because, in making these technical amendments, PHMSA is not exercising
discretion in a way that could be informed by public comment. PHMSA is
required under the 2015 Act and directed by the OMB Guidance to publish
this rule by January 15, 2017, with the penalty levels stated herein to
take effect on that date. Further, PHMSA is mandated by the 2015 Act
and directed by the OMB Guidance to adjust the penalty levels pursuant
to the specific procedures also stated herein. Any public comments
received through notice and comment procedure would therefore not
affect PHMSA's obligation to comply with the 2015 Act, nor would they
affect the methods used by PHMSA to adjust the penalty levels.

III. Rulemaking Analyses and Notices

A. Statutory/Legal Authority for This Rulemaking

    This final rule is published under the authority of the Federal
hazardous materials transportation law. 49 U.S.C. 5101 et seq. Section
5123(a) of which provides civil penalties for knowing violations of
Federal hazardous material transportation law or a regulation, order,
special permit, or approval issued under that law. This rule revises
the references in PHMSA's regulations by (1) revising the maximum
penalty amount for a knowing violation and a knowing violation
resulting in death, serious illness, or severe injury to any person or
substantial destruction of property to $78,376 and $182,877,
respectively, and (2) revising the minimum penalty amount to $471 for a
violation related to training.

B. Executive Order 12866, Executive Order 13563, and DOT Regulatory
Policies and Procedures

    This final rule has been evaluated in accordance with existing
policies and procedures and determined to be non-significant under
Executive Order 12866, ``Regulatory Planning and Review,'' 58 FR 51735
(Oct. 4, 1993), and Executive Order 13563, ``Improving Regulation and
Regulatory Review,'' 76 FR 3821 (Jan. 21, 2011). However, consistent
with OMB memorandum M-17-11, this final rule was not reviewed by OMB in
order to make a significance determination.
    Further, this rule is not a significant regulatory action under DOT
Regulatory Policies and Procedures. See 44 FR 11034 (Feb. 26, 1979). It
is a ministerial act for which the Agency has no discretion. The
economic impact of the final rule is minimal to the extent that
preparation of a regulatory evaluation is not warranted. Given the low
number of penalty actions within the scope of this final rule, the
impacts will be very limited.
    This final rule is being undertaken to address our statutory
requirements and imposes no new costs upon persons conducting hazardous
materials operations in compliance with the requirements of the
Hazardous Materials Regulations (HMR; 49 CFR parts 171-180). Those
entities not in compliance with the requirements of the HMR may
experience an increased cost based on the penalties levied against them
for non-compliance; however, this is an avoidable, variable cost and
thus is not considered in any evaluation of the significance of this
regulatory action. Moreover, as the cost is an inflationary adjustment
and the magnitude of the increase is minimal since these penalties were
recently enacted, reflected costs are nominal. The amendments in this
rule could provide safety benefits (i.e., larger penalties deterring
knowing violators). Overall, it is anticipated this rulemaking would
have minimal real costs and benefits.

C. Executive Order 13132

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13132, ``Federalism.'' See 64
FR 43255 (Aug. 10, 1999). This rule does not impose any regulation
having substantial direct effects on the States, the relationship
between the national government and the States, or the distribution of
power and responsibilities among the various levels of government.
Therefore, the consultation and funding requirements of Executive Order
13132 do not apply.

D. Executive Order 13175

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13175, ``Consultation and
Coordination with Indian Tribal Governments.'' See 65 FR 67249 (Nov. 9,
2000). Because this final rule does not have adverse tribal
implications and does not impose direct compliance costs, the funding
and consultation requirements of Executive Order 13175 do not apply and
a tribal summary impact statement is not required.

E. Regulatory Flexibility Act, Executive Order 13272, and DOT
Procedures and Policies

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-611, requires
each agency to analyze regulations and assess their impact on small
businesses and other small entities to determine whether the rule is
expected to have a significant impact on a substantial number of small
entities. The provisions of this rule apply specifically to all
businesses transporting hazardous material. Therefore, PHMSA certifies
this rule would not have a significant economic impact on a substantial
number of small entities.
    In addition, PHMSA has determined the RFA does not apply to this
rulemaking. The 2015 Act requires PHMSA to publish a final rule and
does not require PHMSA to complete notice and comment procedures under
the APA. The Small Business Administration's A Guide for Government
Agencies: How to Comply with the Regulatory Flexibility Act (2003),
provides that:

    If, under the APA or any rule of general applicability governing
Federal grants to state and local governments, the agency is
required to publish a general notice of proposed rulemaking (NPRM),
the RFA must be considered [citing 5 U.S.C. 604(a)]. . . . If an
NPRM is not required, the RFA does not apply.

    Therefore, because the 2015 Act does not require an NPRM for this
rulemaking, the RFA does not apply.

F. Paperwork Reduction Act

    There are no new information requirements in this final rule.

G. Unfunded Mandates Reform Act of 1995

    This final rule does not impose unfunded mandates under the
Unfunded Mandates Reform Act of 1995. Public Law 104-4. It does not
result in costs of $100 million or more,

adjusted for inflation, to any of the following: State, local, or
Native American tribal governments, or to the private sector.

H. Environmental Assessment

    The National Environmental Policy Act of 1969 (NEPA), as amended,
requires Federal agencies to consider the consequences of major Federal
actions and prepare a detailed statement on actions significantly
affecting the quality of the human environment. 42 U.S.C. 4321-4375.
When developing potential regulatory requirements, PHMSA evaluates
those requirements to consider the environmental impact of each
amendment. Specifically, PHMSA evaluates the following: Risk of release
and resulting environmental impact; risk to human safety, including any
risk to first responders; longevity of the packaging; and if the
proposed regulation would be carried out in a defined geographic area,
the resources, especially any sensitive areas, and how they could be
impacted by any proposed regulations. These amendments would be
generally applicable and would not be carried out in a defined
geographic area. Civil penalties may act as a deterrent to those
violating the HMR, and this can have a negligible positive
environmental impact as a result of increased compliance. Based on the
above discussion, PHMSA concludes there are no significant
environmental impacts associated with this final rule.

I. Executive Order 13609 and International Trade Analysis

    Under Executive Order 13609, ``Promoting International Regulatory
Cooperation,'' agencies must consider whether the impacts associated
with significant variations between domestic and international
regulatory approaches are unnecessary or may impair the ability of
American business to export and compete internationally. See 77 FR
26413 (May 4, 2012). In meeting shared challenges involving health,
safety, labor, security, environmental, and other issues, international
regulatory cooperation can identify approaches that are at least as
protective as those that are or would be adopted in the absence of such
cooperation. International regulatory cooperation can also reduce,
eliminate, or prevent unnecessary differences in regulatory
requirements.
    Similarly, the Trade Agreements Act of 1979 (Pub. L. 96-39), as
amended by the Uruguay Round Agreements Act (Pub. L. 103-465),
prohibits Federal agencies from establishing any standards or engaging
in related activities that create unnecessary obstacles to the foreign
commerce of the United States. For purposes of these requirements,
Federal agencies may participate in the establishment of international
standards, so long as the standards have a legitimate domestic
objective, such as providing for safety, and do not operate to exclude
imports that meet this objective. The statute also requires
consideration of international standards and, where appropriate, that
they be the basis for U.S. standards.
    PHMSA participates in the establishment of international standards
in order to protect the safety of the American public, and we have
assessed the effects of this final rule to ensure that it does not
cause unnecessary obstacles to foreign trade. Accordingly, this
rulemaking is consistent with Executive Order 13609 and PHMSA's
obligations.

J. Privacy Act

    Anyone is able to search the electronic form of all comments
received by any of our dockets using the name of the individual
submitting the comments (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 19476), which may be viewed at http://www.gpo.gov/fdsys/pkg/FR-2000-04-11/pdf/00-8505.pdf.

K. Regulation Identifier Number (RIN)

    A regulation identifier number (RIN) is assigned to each regulatory
action listed in the Unified Agenda of Federal Regulations. The
Regulatory Information Service Center publishes the Unified Agenda in
spring and fall of each year. The RIN contained in the heading of this
document can be used to cross-reference this action with the Unified
Agenda.

List of Subjects

49 CFR Part 107

    Administrative practices and procedure, Hazardous materials
transportation, Packaging and containers, Penalties, Reporting and
recordkeeping requirements.

49 CFR Part 171

    Definitions, General information, Regulations.

    In consideration of the foregoing, 49 CFR chapter I is amended as
follows:

PART 107--HAZARDOUS MATERIALS PROGRAM PROCEDURES

0
1. The authority citation for part 107 continues to read as follows:

    Authority:  49 U.S.C. 5101-5128, 44701; Pub. L. 101-410 section
4; Pub. L. 104-121, sections 212-213; Pub. L. 104-134, section
31001; Pub. L. 114-74 section 4 (28 U.S.C. 2461 note); 49 CFR 1.81
and 1.97.

0
2. Revise Sec.  107.329 to read as follows:

Sec.  107.329   Maximum penalties.

    (a) A person who knowingly violates a requirement of the Federal
hazardous material transportation law, an order issued thereunder, this
subchapter, subchapter C of the chapter, or a special permit or
approval issued under this subchapter applicable to the transportation
of hazardous materials or the causing of them to be transported or
shipped is liable for a civil penalty of not more than $78,376 for each
violation, except the maximum civil penalty is $182,877 if the
violation results in death, serious illness, or severe injury to any
person or substantial destruction of property. There is no minimum
civil penalty, except for a minimum civil penalty of $471 for
violations relating to training. When the violation is a continuing
one, each day of the violation constitutes a separate offense.
    (b) A person who knowingly violates a requirement of the Federal
hazardous material transportation law, an order issued thereunder, this
subchapter, subchapter C of the chapter, or a special permit or
approval issued under this subchapter applicable to the design,
manufacture, fabrication, inspection, marking, maintenance,
reconditioning, repair or testing of a package, container, or packaging
component which is represented, marked, certified, or sold by that
person as qualified for use in the transportation of hazardous
materials in commerce is liable for a civil penalty of not more than
$78,376 for each violation, except the maximum civil penalty is
$182,877 if the violation results in death, serious illness, or severe
injury to any person or substantial destruction of property. There is
no minimum civil penalty, except for a minimum civil penalty of $471
for violations relating to training.
    3. In appendix A to subpart D of part 107, section II.B. (``Penalty
Increases for Multiple Counts''), the first sentence of the second
paragraph is revised to read as follows:

Appendix A to Subpart D of Part 107--Guidelines for Civil Penalties

* * * * *
    II. * * *
    B. * * *
    Under the Federal hazmat law, 49 U.S.C. 5123(a), each violation of
the HMR and each day of a continuing violation (except for violations
relating

to packaging manufacture or qualification) is subject to a civil
penalty of up to $78,376 or $182,877 for a violation occurring on or
after April 19, 2017. * * *
* * * * *

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

0
4. The authority citation for part 171 continues to read as follows:

    Authority:  49 U.S.C. 5101-5128, 44701; Pub. L. 101-410 section
4; Pub. L. 104-134, section 31001; Pub. L. 114-74 section 4 (28
U.S.C. 2461 note); 49 CFR 1.81 and 1.97.

0
5. In Sec.  171.1, paragraph (g) is revised to read as follows:

Sec.  171.1   Applicability of Hazardous Materials Regulations (HMR) to
persons and functions.

* * * * *
    (g) Penalties for noncompliance. Each person who knowingly violates
a requirement of the Federal hazardous material transportation law, an
order issued under Federal hazardous material transportation law,
subchapter A of this chapter, or a special permit or approval issued
under subchapter A or C of this chapter is liable for a civil penalty
of not more than $78,376 for each violation, except the maximum civil
penalty is $182,877 if the violation results in death, serious illness,
or severe injury to any person or substantial destruction of property.
There is no minimum civil penalty, except for a minimum civil penalty
of $471 for a violation relating to training.

    Issued in Washington, DC on April 14, 2017, under authority
delegated in 49 CFR part 1.97.
Howard W. McMillan,
Acting Deputy Administrator, Pipeline and Hazardous Materials Safety
Administration.
[FR Doc. 2017-07908 Filed 4-18-17; 8:45 am]
 BILLING CODE 4910-60-P