[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27321-27322]
[FR Doc No: 2015-11528]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0611]

Biosimilars: Additional Questions and Answers Regarding
Implementation of the Biologics Price Competition and Innovation Act of
2009; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Biosimilars: Additional Questions and Answers Regarding
Implementation of the Biologics Price Competition and Innovation Act of
2009.'' This draft guidance is intended to provide answers to common
questions from sponsors interested in developing proposed biosimilar
products, biologics license application (BLA) holders, and other
interested parties regarding FDA's interpretation of the Biologics
Price Competition and Innovation Act of 2009 (BPCI Act). This guidance
revises the draft guidance entitled ``Biosimilars: Questions and
Answers Regarding Implementation of the Biologics Price Competition and
Innovation Act of 2009,'' issued February 15, 2012, to provide new and
revised questions and answers (Q&As).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 13, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002, or Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042, or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Biosimilars: Additional Questions and Answers
Regarding Implementation of the Biologics Price Competition and
Innovation Act of 2009.'' This draft guidance provides answers to
common questions from sponsors interested in developing proposed
biosimilar products, BLA holders, and other interested parties
regarding FDA's interpretation of the BPCI Act. This guidance revises
the draft guidance entitled ``Biosimilars: Questions and Answers
Regarding Implementation of the Biologics Price Competition and
Innovation Act of 2009,'' issued February 15, 2012, to provide new and
revised Q&As. It also includes certain original Q&As that have not yet
been finalized.
    The BPCI Act, enacted as part of the Patient Protection and
Affordable Care Act (Pub. L. 111-148) on March 23, 2010, created an
abbreviated licensure pathway under section 351(k) of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262(k)) for biological products
demonstrated to be biosimilar to, or interchangeable with, an FDA-
licensed reference product. This draft guidance describes FDA's current
interpretation of certain statutory requirements added by the BPCI Act
and includes Q&As in the following categories:
     Biosimilarity or Interchangeability
     Provisions Related to Requirement to Submit a BLA for a
``Biological Product''

     Exclusivity

The Q&A format is intended to promote transparency and facilitate
development programs for proposed biosimilar products by addressing
questions that may arise in the early stages of development. In
addition, these Q&As respond to questions the Agency has received from
prospective BLA and new drug application (NDA) applicants regarding the
appropriate statutory authority under which certain products will be
regulated.
    In the Federal Register of February 15, 2012 (77 FR 8885), FDA
published a notice announcing the availability of a draft guidance
entitled ``Biosimilars: Questions and Answers Regarding Implementation
of the Biologics Price Competition and Innovation Act of 2009.''
Although interested parties can comment on any guidance at any time, to
ensure that the Agency considered comments on the draft guidance before
beginning work on the final version of the guidance, FDA requested that
interested parties submit comments by April 16, 2012. FDA's
consideration of these comments, among other things, is reflected in
this revised draft guidance (which provides new and revised Q&As) and
the final guidance. This revised draft guidance describes the status of
the draft guidance Q&As provided in this revised draft guidance and the
status of the final guidance Q&As that are included in the guidance
entitled ``Biosimilars: Questions and Answers Regarding Implementation
of the Biologics Price Competition and Innovation Act of 2009.'' FDA
intends to update these guidances to include additional Q&As as
appropriate.
    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 this topic. 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. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This draft guidance refers to information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The submission of an investigational new drug application is
covered under 21 CFR part 312 and approved under OMB Control No. 0910-
0014. The submission of an NDA is covered under 21 CFR 314.50 and
approved under OMB Control No. 0910-0001. The submission of a BLA under
section 351(a) of the PHS Act is covered under part 601 (21 CFR part
601) and approved under OMB Control No. 0910-0338. The submission of a
BLA under section 351(k) of the PHS Act is covered under part 601 and
approved under OMB control number 0910-0719.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: May 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11528 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Notices]
[Pages 38992-38993]
[FR Doc No: 2013-15468]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0723]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reports of Corrections and Removals of Medical Devices
and Radiation Emitting Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed revision of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on an electronic process for
submitting reports of corrections and removals (806 reports) that are
associated with medical and radiation emitting products regulated by
FDA's Center for Devices and Radiological Health (CDRH). The electronic
process is expected to both enhance consistency of submission data and
speed submission processing.

DATES: Submit either electronic or written comments on the collection
of information by August 27, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the collection of information: Daniel Gittleson, Office
of Information Management, Food and Drug Administration, 1350 Piccard
Dr., PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Regarding reports of corrections and removals: Ronny D. Brown,
Division of Risk Management Operations, Office of Compliance, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2611,
Silver Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Reports of Corrections and Removals--21 CFR Part 806 (OMB Control
Number 0910-0359)--Revision

I. Reports of Corrections and Removals

    Under Sec.  806.10 (21 CFR 806.10), each device manufacturer or
importer shall submit a written report to FDA of any action initiated
to correct or remove a device to reduce a risk to health posed by the
device or to remedy a violation of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) caused by the device which may present a risk to
health within 10-working days of initiating the correction or removal.
    Under Sec.  806.20(a) (21 CFR 806.20(a)), each device manufacturer
or importer of a device who initiates a correction or removal of a
device that is not required to be reported to FDA, shall keep a record
of the correction or removal.
    FDA currently accepts by mail reports of corrections and removals
(806 reports) associated with medical and radiation emitting products
regulated by CDRH under part 806 (21 CFR part 806).
    For general information and assistance with 806 reports, contact
the CDRH Division of Small Manufacturers, International and Consumer
Assistance (DSMICA) by telephone: 1-800-638-2041 or<PHONE_NUMBER>; or by
email<EMAIL_ADDRESS>
II. Proposed Electronic Submission Process

    FDA is now proposing to make available, as a voluntary alternative
to paper submissions, an electronic process for submitting 806 reports.
The electronic process is expected to enhance consistency of submission
data and to speed submission processing. Submission by mail will remain
available and will be augmented by the new electronic submission
process.
    Establishing a process for using electronic submissions does
necessitate some preparation by reporters, which includes obtaining
both: (1) A WebTrader account and (2) a digital verification
certificate. Many other FDA applications also utilize WebTrader. If an
applicant already has an account with the WebTrader Electronic
Submission Gateway and a digital verification certificate (certificate
must be valid for 1 to 3 years), no additional burden or cost will be
incurred outside of the time it takes to make the submission of
corrections and removals. However, for calculating the burden for this
collection, FDA is assuming that all respondents will be establishing a
new WebTrader account and purchasing a digital verification
certificate.
    Establishing a new account for sending electronic submissions may
take up to 2 weeks. During that time, new reporters are advised to
submit paper reports to avoid inadvertently missing the 10-day
timeframes associated with submission of reports under part 806.
    Upon approval of the information collection, a submitter would go
to http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm to submit
an 806 report via the electronic portal. Additional information about
FDA's Electronic Submission Gateway is posted at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. You can also
email questions about the system to FDA's Electronic Submissions
Gateway Help Desk<EMAIL_ADDRESS>

    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Total
                                                             Number of       Number of     Total annual   Average burden    Total hours     operating &
                 Activity (21 CFR Part)                     respondents    responses per     responses     per response         \2\         maintenance
                                                                            respondent                                                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic process set-up (one time)....................           1,022               1           1,022            9.25           9,454         $30,660
Submission of corrections and removals (part 806).......           1,033               1           1,033           10             10,330  ..............
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\1\ There are no capital costs associated with this collection of information.
\2\ Totals may not sum due to rounding.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                Number of                       Average burden
                       Activity (21 CFR Part)                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records of corrections and removals (part 806).....................              93                1               93               10              930
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of the reporting and recordkeeping burden is based
on our experience with this program and similar programs that utilize
the Electronic Submission Gateway. For respondents who use the
electronic process, the operating and maintenance costs associated with
this information collection are approximately $30 per year to purchase
a digital verification certificate (certificate must be valid for 1 to
3 years). This burden may be minimized if the respondent has already
purchased a verification certificate for other electronic submissions
to FDA. However, FDA is assuming that all respondents who submit
corrections and removals using the electronic process will be
establishing a new WebTrader account and purchasing a digital
verification certificate.

III. Online Support and Information

    CDRH intends to establish a Web site for online support and
information about electronic submissions of 806 reports. The Web site
will provide the following information:
 Introduction
 Tracking information
 Contact information
    [cir] Submitter identification
    [cir] Manufacturer information
    [cir] Recalling firm information
    [cir] Importer information
 Correction and removal report information
    [cir] Event
    [cir] Correction and removal product data
    [cir] Domestic consignee information
    [cir] Foreign consignee information
    [cir] Communication documentation
    [cir] Additional documentation (which allows for attaching
WordTM, ExcelTM, and PDFTM documents)

Within the online help provided by FDA, users will find yellow light
bulb icons. These icons indicate supplemental tips and information.

    Dated: June 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15468 Filed 6-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 159 (Thursday, August 18, 2022)]
[Notices]
[Pages 50891-50894]
[FR Doc No: 2022-17723]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95488; File No. PCAOB-2022-001]

Public Company Accounting Oversight Board; Order Granting
Approval of Amendments to Auditing Standards Governing the Planning and
Supervision of Audits Involving Other Auditors and Dividing
Responsibility for the Audit With Another Accounting Firm

August 12, 2022.

I. Introduction

    On June 24, 2022, the Public Company Accounting Oversight Board
(the ``Board'' or the ``PCAOB'') filed with the Securities and Exchange
Commission (the ``Commission''), pursuant to Section 107(b) \1\ of the
Sarbanes-Oxley Act of 2002 (the ``Sarbanes-Oxley Act'') and Section
19(b) \2\ of the Securities Exchange Act of 1934 (the ``Exchange
Act''), a proposal to adopt Auditing Standard (``AS'') 1206, Dividing
Responsibility for the Audit with Another Accounting Firm (AS 1206);
rescind AS 1205, Part of the Audit Performed by Other Independent
Auditors (AS 1205), and AI 10, Part of the Audit Performed by Other
Independent Auditors: Auditing Interpretations of AS 1205 (AI 10); and
amend several other existing auditing standards, interpretations,
rules, and forms (collectively, the ``Amendments''). The Amendments
were published for comment in the Federal Register on July 1, 2022.\3\
We received three comment letters in response to the notice.\4\ This
order approves the Amendments, which we find to be consistent with the
requirements of the Sarbanes-Oxley Act and the securities laws and
necessary or appropriate in the public interest or for the protection
of investors.
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    \1\ 15 U.S.C. 7217(b).
    \2\ 15 U.S.C. 78s(b).
    \3\ See Public Company Accounting Oversight Board; Notice of
Filing of Proposed Rules on Planning and Supervision of Audits
Involving Other Auditors and Dividing Responsibility for the Audit
with Another Accounting Firm, Release No. 34-95159 (June 24, 2022)
[87 FR 39680 (July 1, 2022)] (the ``Notice of Filing of Proposed
Rules''), available at https://www.sec.gov/rules/pcaob/2022/34-95159.pdf.
    \4\ We received comment letters from Deloitte & Touche LLP (July
21, 2022); PricewaterhouseCoopers LLP (July 22, 2022); and KPMG LLP
(July 22, 2022). Copies of the comment letters received on the
Commission order noticing the Proposed Rules are available on the
Commission's website at https://www.sec.gov/comments/pcaob-2022-01/pcaob202201.htm.
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II. Description of the Amendments

    On June 21, 2022, the Board adopted the Amendments.\5\ The
Amendments would (i) strengthen requirements for audits involving
accounting firms and individual accountants other than the accounting
firm that issues the auditor's report (``other auditors'' and the
``lead auditor,'' respectively), and (ii) update requirements to
address relatively uncommon situations in which the lead auditor
divides responsibility for the audit with another accounting firm (the
``referred-to auditor''). The Amendments are intended to increase and
improve the lead auditor's involvement in,

supervision of, and evaluation of the other auditors' work, which will
improve communication among auditors and the lead auditor's ability to
prevent or detect deficiencies in that work. This should promote
investor protection by enhancing the quality of audits involving other
auditors. The requirements contained within the Amendments are
discussed further below.
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    \5\ See Planning and Supervision of Audits Involving Other
Auditors and Dividing Responsibility for the Audit with Another
Accounting Firm, PCAOB Release No. 2022-002 (June 21, 2022) (``PCAOB
Adopting Release''), available at https://pcaob-assets.azureedge.net/pcaob-dev/docs/default-source/rulemaking/docket042/pcaob-other-auditors-adopting-release-6-21-2022.pdf?sfvrsn=c3712668_4.
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A. Changes to PCAOB Standards

    The Amendments are intended to improve the PCAOB's standards
principally by (i) applying a risk-based supervisory approach to the
lead auditor's oversight of other auditors whose work the lead auditor
assumes responsibility for, and (ii) requiring that the lead auditor
perform certain procedures when planning and supervising an audit that
involves other auditors. The Amendments take into account recent
professional practice developments in the lead auditor's oversight of
other auditors' work, including the greater use of communication
technology. The Amendments build on existing communication requirements
and increase those communication requirements between the lead auditor
and other auditor. Whether or not the lead auditor is leveraging
technology for those communications, audit documentation supporting the
lead auditor's conclusions will need to contain a record that the lead
auditor fulfilled its responsibilities under PCAOB standards, including
regarding matters such as determinations related to other auditors'
work \6\ and audit documentation.\7\
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    \6\ See, e.g., AS 1201, Supervision of the Audit Engagement,
paragraph .13 (requiring the lead auditor to make certain
determinations based on a review of the documentation provided by
the other auditor, discussions with the other auditor, and other
information obtained by the lead auditor).
    \7\ See, e.g., AS 1215, Audit Documentation, paragraphs .06 and
.18, as amended.
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    In summary, the Amendments:
     Require that the engagement partner \8\ determine whether
their firm's participation in the audit is sufficient for the firm to
carry out the responsibilities of a lead auditor and report as such.\9\
The Amendments include considerations for the engagement partner to use
in making this determination \10\ and require that the audit's
engagement quality reviewer review the determination.\11\
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    \8\ The term ``engagement partner'' means the member of the
engagement team with primary responsibility for the audit. See AS
1201, Appendix A, as amended.
    \9\ See AS 2101, Audit Planning, paragraph .06A, as amended.
    \10\ See id.
    \11\ See AS 1220, Engagement Quality Review, paragraph .10a, as
amended.
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     Require that the lead auditor, when determining the
engagement's compliance with independence and ethics requirements,
understand the other auditor's knowledge of those requirements and
experience in applying them.\12\ The lead auditor is required to obtain
and review written affirmations regarding the other auditor's policies
and procedures related to those requirements and regarding its
compliance with the requirements, and a description of certain auditor-
client relationships related to independence.\13\ In addition, the
Amendments require the sharing of information about changes in
circumstances and the updating of affirmations and descriptions in
light of those changes.\14\
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    \12\ See AS 2101.06Da, as amended.
    \13\ See AS 2101.06Db, as amended.
    \14\ See AS 2101.06Dc(1) and .06Dc(2), as amended.
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     Require that the lead auditor understand the knowledge,
skill, and ability of other auditors' engagement team members who
assist the lead auditor with planning and supervision,\15\ and obtain a
written affirmation from the other auditor that its engagement team
members possess the knowledge, skill, and ability to perform assigned
tasks.\16\
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    \15\ See AS 2101.06Ha, as amended.
    \16\ See AS 2101.06Hb, as amended.
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     Require that the lead auditor supervise other auditors
under the Board's standard on audit supervision and inform other
auditors about the scope of their work, identified risks of material
misstatement, and certain other key matters.\17\ The Amendments also
require that the lead auditor and other auditors communicate about the
audit procedures to be performed, and any changes needed to the
procedures.\18\ In addition, the lead auditor is required to obtain and
review a written affirmation from the other auditor about its
performance of work in accordance with the lead auditor's instructions,
and to direct other auditors to provide certain documentation about
their work.\19\
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    \17\ See AS 1201.08, as amended.
    \18\ See AS 1201.09 and .10, as amended.
    \19\ See AS 1201.11 and .12, as amended.
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     Provide that, in multi-tiered audits, a first other
auditor may assist the lead auditor in performing certain required
procedures with respect to second other auditors.\20\
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    \20\ See AS 1201.14, and AS 2101.06E and .06I, as amended.
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    In addition, this rulemaking rescinds AS 1205 and AI 10 but carries
forward and strengthens certain existing requirements in new AS 1206
that apply to infrequent situations where the lead auditor divides
responsibility for a portion of the audit with the referred-to auditor
and therefore does not supervise the work performed by that firm. In
those situations, the lead auditor refers to the work of that auditor
in the audit report.\21\
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    \21\ Rule 2-05 of Regulation S-X, 17 CFR 210.2-05, requires that
the auditor's report of the referred-to auditor be filed with the
SEC. See also AS 1206.08.
---------------------------------------------------------------------------

    AS 1206 requires that in these situations the lead auditor
determine that audit procedures were performed regarding the
consolidation or combination of financial statements of the business
units audited by the referred-to auditor into the company's financial
statements. The standard also requires that the lead auditor obtain the
referred-to auditor's written representation that it is independent and
duly licensed to practice, and that the lead auditor disclose in the
audit report the magnitude of the portion of the financial statements,
and, if applicable, of internal controls audited by the referred-to
auditor.

B. Applicability and Effective Date

    The Amendments would be effective for audits of financial
statements for fiscal years ending on or after December 15, 2024. The
PCAOB has proposed application of the Amendments to include audits of
emerging growth companies (``EGCs''),\22\ as discussed in Section IV
below, and audits of brokers and dealers under Exchange Act Rule 17a-5.
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    \22\ The term ``emerging growth company'' is defined in Section
3(a)(80) of the Exchange Act (15 U.S.C. 78c(a)(80)). See also
Inflation Adjustments and Other Technical Amendments Under Titles I
and III of the JOBS Act, Release No. 33-10332 (Mar. 31, 2017) [82 FR
17545 (Apr. 12, 2017)], available at https://www.sec.gov/rules/final/2017/33-10332.pdf.
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III. Comment Letters

    The comment period on the Amendments ended on July 22, 2022. We
received three comment letters from accounting firms.\23\ The
commenters generally supported the Amendments and encouraged us to
support the PCAOB's plans to monitor implementation, conduct post-
implementation review, and monitor advancements in technology that may
affect application of the Amendments.\24\

Additionally, one commenter encouraged the PCAOB to consider the
intersection of a firm's system of quality control with the
requirements in the PCAOB standards and that questions may arise about
compliance with the principles-based requirements, to actively engage
with stakeholders to promote an understanding of the Amendments, and to
be available for consultation.\25\ We agree with the Board that the
Amendments are sufficiently principles-based to accommodate a variety
of scenarios in practice and to allow the lead auditor to adjust its
procedures according to the circumstances of the audit.\26\ We
acknowledge the importance of monitoring the implementation of the
Amendments and the Commission staff works closely with the PCAOB as
part of our general oversight mandate.\27\ As part of that oversight,
Commission staff will keep itself apprised of the PCAOB's activities
for monitoring the implementation of the Amendments and update the
Commission, as necessary.
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    \23\ We received comment letters from Deloitte & Touche LLP
(July 21, 2022); PricewaterhouseCoopers LLP (July 22, 2022) (``PWC
Letter''); and KPMG LLP (July 22, 2022). Copies of the comment
letters are available on the Commission's website at https://www.sec.gov/comments/pcaob-2022-01/pcaob202201.htm.
    \24\ See id.
    \25\ See PWC Letter available at https://www.sec.gov/comments/pcaob-2022-01/pcaob202201-20134692-305861.pdf.
    \26\ See, e.g., PCAOB Adopting Release, at A4-22, A4-28.
    \27\ See Section 107 of the Sarbanes-Oxley Act.
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    The Sarbanes-Oxley Act requires us to determine whether the
Amendments are consistent with the requirements of the Sarbanes-Oxley
Act and the securities laws or are necessary or appropriate in the
public interest or for the protection of investors.\28\ In making this
determination, we have considered the comments we received, as well as
the feedback received and modifications made by the PCAOB throughout
its rulemaking process.
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    \28\ See Section 107(b)(3) of the Sarbanes-Oxley Act. The
Sarbanes-Oxley Act also specifies that the provisions of Section
19(b) of the Exchange Act shall govern the proposed rules of the
Board. See Section 107(b)(4) of the Sarbanes-Oxley Act. Section 19
of the Exchange Act covers the registration, responsibilities, and
oversight of self-regulatory organizations. Under the procedures
prescribed by the Sarbanes-Oxley Act and Section 19(b)(2) of the
Exchange Act, the Commission must either approve or disapprove, or
institute proceedings to determine whether the proposed rules of the
Board should be disapproved; and these procedures do not expressly
permit the Commission to amend or supplement the proposed rules of
the Board.
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IV. Effect on Emerging Growth Companies

    In the notice of filing of the Amendments, the Board recommended
that the Commission determine that the Amendments apply to audits of
EGCs.\29\ Section 103(a)(3)(C) of the Sarbanes-Oxley Act, as amended by
Section 104 of the Jumpstart Our Business Startups Act of 2012,
requires that any rules of the Board requiring mandatory audit firm
rotation or a supplement to the auditor's report in which the auditor
would be required to provide additional information about the audit and
the financial statements of the issuer (auditor discussion and
analysis) shall not apply to an audit of an EGC. The provisions of the
Amendments do not fall into these categories.\30\
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    \29\ See the Notice of Filing of Proposed Rules, supra note 3,
at 191.
    \30\ While the precise scope of this category of rules under
Section 103(a)(3)(C) is not entirely clear, we do not interpret this
statutory language as precluding the application of Board rules
requiring inclusion of additional factual information about
referred-to auditors and the scope of their work in connection with
the audits of EGCs. In our view, this approach reflects an
appropriate interpretation of the statutory language and is
consistent with our understanding of the Congressional purpose
underlying this provision.
---------------------------------------------------------------------------

    Section 103(a)(3)(C) further provides that ``[a]ny additional
rules'' adopted by the PCAOB after April 5, 2012 do not apply to audits
of EGCs ``unless the Commission determines that the application of such
additional requirements is necessary or appropriate in the public
interest, after considering the protection of investors and whether the
action will promote efficiency, competition, and capital formation.''
The Amendments fall within this category. Having considered those
statutory factors, we find that applying the Amendments to the audits
of EGCs is necessary or appropriate in the public interest.
    With respect to the Commission's determination of whether the
Amendments will apply to audits of EGCs, the PCAOB provided data and
analysis of EGCs identified by the Board's staff from public sources
that sets forth its views as to why the Amendments should apply to
audits of EGCs. Analysis of Form AP filings in 2021 suggests that, when
compared to issuer audits overall, audits of EGCs are less likely to
involve the use of other firms and, even when they do, they typically
involve fewer other firms and those other firms account for a smaller
share of total audit hours.\31\ Thus, because the use of other firms is
less prevalent in audits of EGCs than in audits of non-EGCs, audits of
EGCs generally are less likely than those of non-EGCs to be affected by
the amendments.\32\ EGCs are also likely to be newer companies, which
may increase the importance to investors of the external audit to
enhance the credibility of management disclosures.\33\ Investors in
newer companies may require a larger risk premium that increases the
cost of capital for those companies. Therefore, the improved audit
quality resulting from applying the Amendments to EGC audits could
reduce the cost of capital to those EGCs.\34\ When considering these
and other factors addressed in the PCAOB's analysis, the benefits of
the higher audit quality resulting from the amendment may be greater
for EGCs than for non-EGCs.
---------------------------------------------------------------------------

    \31\ For example, only 14 percent of audits of EGCs involved
other firms compared to 27 percent of issuer audit overall; in
audits involving other firms, EGC audits involve two or more other
firms in about 35 percent of audits compared to about 61 percent in
audits of issuers overall; and other accounting firms perform 10
percent or more of the audit hours in about 40 percent of audits of
EGCs compared to about 52 percent of audits of issues overall. See
PCAOB Adopting Release, at 54, Figure 6.
    \32\ See PCAOB Adopting Release, at 54.
    \33\ See PCAOB Adopting Release, at 55, footnote 115.
    \34\ See PCAOB Adopting Release, at 55.
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    In addition, the Board sought public input on the application of
the Amendments to the audits of EGCs. Commenters on the Board's
proposal generally supported applying the Amendments to audits of EGCs,
citing benefits to the users of EGC financial statements and the
importance of consistent audit requirements for all audits. In the
Board's filing of the Amendments, the Board expressed the view that the
benefits of the higher audit quality resulting from the amendments may
be larger for EGCs than for non-EGCs and that, overall, the Amendments
are expected to enhance audit quality and contribute to an increase in
the credibility of financial reporting by EGCs.
    We agree with the Board's analysis and note that the potential
increase in audit quality from the Amendments would strengthen investor
protection and increase informational efficiency of the capital
markets, thus enhancing capital formation. Additionally, improvements
in the quality of the audit may also increase price efficiency by
providing investors with more accurate information. Price efficiency
helps investors make more informed investment decisions facilitative
issuers', including EGCs', access to capital thus enhancing capital
formation. With respect to competition, we note that due to the
additional supervisory requirements, smaller firms may be less able to
compete with larger firms in the audit market for audit involving other
auditors. However, Form AP data shows that smaller firms perform
relatively fewer audits that involve other accounting firms, and, as
noted above, that audits of EGCs are less likely to involve the use of
other firms. Therefore, any impact on competition in

the overall audit market and for audits of EGCs is likely to be
relatively small. As such, after considering the protection of
investors and whether the action will promote efficiency, competition,
and capital formation, we believe there is a sufficient basis to
determine that applying the Amendments to the audits of EGCs is
necessary or appropriate in the public interest.

V. Conclusion

    The Commission has carefully reviewed and considered the
Amendments, the information submitted therewith by the PCAOB, and the
comment letters received. In connection with the PCAOB's filing and the
Commission's review,
    A. The Commission finds that the Amendments are consistent with the
requirements of the Sarbanes-Oxley Act and the securities laws and are
necessary or appropriate in the public interest or for the protection
of investors; and
    B. Separately, the Commission finds that the application of the
Amendments to the audits of EGCs is necessary or appropriate in the
public interest, after considering the protection of investors and
whether the action will promote efficiency, competition, and capital
formation.
    It is therefore ordered, pursuant to Section 107 of the Sarbanes-
Oxley Act and Section 19(b)(2) of the Exchange Act, that the Amendments
(File No. PCAOB-2022-002) be and hereby are approved.

    By the Commission.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-17723 Filed 8-17-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Proposed Rules]
[Pages 3732-3739]
[FR Doc No: 2019-00758]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 107

[Docket No.: 2018-1086; Notice No. 18-08]
RIN 2120-AL26

Safe and Secure Operations of Small Unmanned Aircraft Systems

AGENCY: Federal Aviation Administration (FAA).

ACTION: Advance notice of proposed rulemaking (ANPRM).

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SUMMARY: The FAA is considering additional rulemaking in response to
public safety and national security concerns associated with the
ongoing integration of unmanned aircraft systems (UAS) into the
National Airspace System (NAS). The FAA is seeking information from the
public in response to the questions contained in this ANPRM.
Specifically, the FAA seeks comment on whether and in what
circumstances the FAA should promulgate new rulemaking to require
stand-off distances, additional operating and performance restrictions,
the use of UAS Traffic Management (UTM), and additional payload
restrictions. The FAA also seeks comment on whether it should prescribe
design requirements and require that unmanned aircraft be equipped with
critical safety systems.

DATES: Send comments on or before April 15, 2019.

ADDRESSES: Send comments identified by docket number FAA-2018-1086
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For small UAS policy questions
concerning this ANPRM, contact Ben Walsh, Flight Technologies and
Procedures Division, Federal Aviation Administration, 470 L'Enfant
Plaza SW, Suite 4102, Washington, DC 20024; telephone 1-844-FLY-MY-UA;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Tips for Preparing Your Comments. The FAA seeks public comment on
the areas outlined within this ANPRM. The FAA also seeks comments on
how this rulemaking could be implemented to meet the objective of the
proposal in a manner that maximizes benefits without imposing
excessive, unjustified, or unnecessary costs.
    Specific questions are included in this ANPRM immediately following
the discussion of the relevant issues. The FAA asks that commenters
provide as much information as possible on any questions of interest to
the commenter. In some areas, the FAA requests very specific
information. Whenever possible, please provide citations and copies of
any relevant studies or reports on which you rely, including cost data
as well as any additional data which supports your comment. It is also
helpful to explain the basis and reasoning underlying your comment.
Each commenting party should include the identifying number of the
specific question(s) to which it is responding.
    The FAA will use comments to make decisions regarding the content
and direction of potential notices of proposed rulemaking (NPRM) or
other future rulemakings. Some proposals for addressing national
security and other concerns may exceed the FAA's authority to regulate
independently and may necessitate a broader Federal Executive or
Legislative action. Comments, including proposals for rulemaking, will
be considered within the context of the FAA's existing statutory
authority.

I. Authority for This Rulemaking

    This ANPRM is promulgated pursuant to 49 U.S.C. 40103(b)(1) and
(2), which charge the FAA with issuing regulations: (1) To ensure the
safety of aircraft and the efficient use of airspace; and (2) to govern
the flight of aircraft for purposes of navigating, protecting and
identifying aircraft, and protecting individuals and property on the
ground. In addition, 49 U.S.C. 44701(a)(5) charges the FAA with
prescribing regulations that the FAA finds necessary for safety in air
commerce and national security.
    The primary authority for this ANPRM is 49 U.S.C. 44807, which
directs the Secretary of Transportation to determine whether ``certain
unmanned aircraft systems may operate safely in the national airspace
system [NAS].'' Section 44807 directs the Secretary to use a risk-based
approach in making such determinations and provides such determinations
may occur notwithstanding the completion of the comprehensive plan and
rulemaking required in other sections of the statute. Section 44807(b)
directs the Secretary to consider a specific list of factors in
determining which types of UAS may operate safely: The Secretary must
consider size, weight, speed, operational capability, proximity to
airports and populated areas, operation over people, and operation
within or beyond the visual line of sight, or operation during the day
or night. The Secretary must determine, based on these factors, whether
operations of the UAS do not create a hazard to users of the NAS or the
public.
    This action also relies on other DOT and FAA statutory authorities.

II. Executive Summary

    The purpose of this advance notice of proposed rulemaking (ANPRM)
is to seek comment regarding proposals for FAA rulemaking to reduce
risks to public safety and national security as UAS are integrated into
the NAS.
    Consistent with its statutory authority, the FAA seeks to ensure
that

small UAS \1\ operations will not create a hazard to users of the NAS
or the public or pose a threat to national security. This ANPRM is
intended to gather information from the public to help inform the FAA's
efforts to assess options for reducing risks to public safety and
national security associated with further integration of UAS into the
NAS. The FAA may consider initiating one or more rulemaking efforts
based on the comments received in response to this ANPRM.
---------------------------------------------------------------------------

    \1\ A small UAS is defined as a small unmanned aircraft and its
associated elements (including communication links and the
components that control the small unmanned aircraft) that are
required for the safe and efficient operation of the small unmanned
aircraft in the national airspace system (NAS). A small unmanned
aircraft is defined as an unmanned aircraft weighing less than 55
pounds on takeoff, including everything that is on board or
otherwise attached to the aircraft. 14 CFR 107.3.
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    In a separate but related rulemaking action published elsewhere in
this issue of the Federal Register, the Operation of Small Unmanned
Aircraft Systems over People NPRM, the FAA is proposing to amend part
107 to allow small UAS operations at night and over people. Because
these operations have a potential impact on public safety and national
security, the FAA does not intend to promulgate a final rule to allow
these operations until a regulation finalizes the requirements
regarding remote identification of small UAS, as discussed further in
Related Agency Actions.

III. Background

A. Integration of UAS Into the NAS

    The FAA is working to safely integrate small UAS operations into
the NAS using a phased, incremental, and risk-based approach to
rulemaking within the FAA's existing statutory authority.\2\ In 2012,
Congress passed the FAA Modernization and Reform Act of 2012 (Pub. L.
112-95). Section 333 of Public Law 112-95 \3\ directed the Secretary to
determine which types of UAS do not create a hazard to users of the NAS
or the public or pose a threat to national security. Based on such
findings, Congress directed the Secretary to establish requirements for
the safe operation of UAS. On June 28, 2016, the FAA published the
final rule for Operation and Certification of Small Unmanned Aircraft
Systems (sUAS Operation and Certification final rule) (part 107 final
rule),\4\ which was a first step in integrating civil small UAS
operations that were not model aircraft under the statute in effect at
the time of publication.\5\
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    \2\ For more information regarding the operation of small
unmanned aircraft, see http://www.faa.gov/uas.
    \3\ Section 347 of Public Law 115-254 repealed Section 333, but
replaced the relevant substantive provisions, codified at 49 U.S.C.
44807.
    \4\ 81 FR 42063.
    \5\ Public Law 112-95, section 336 (Feb. 14, 2012). Section 336
was repealed by Section 349 of Public Law 115-254 (Oct. 5, 2018) and
replaced with 49 U.S.C. 44809. Section 44809 provides an exception
for limited recreational UAS operations, provided the operations
satisfy eight specific conditions. See 49 U.S.C. 44809(a)(1)-(8).
---------------------------------------------------------------------------

    As the next step, the FAA's regulatory plan calls for the agency to
issue an NPRM that would propose to allow small UAS operations at night
and over people without a waiver issued under Sec.  107.200. During the
development process, the FAA heard from a number of government and
industry stakeholders expressing support for the potential increase in
commercial viability of UAS operations, but also concerns over the
potential impacts on public safety, national security, and law
enforcement.

B. Public Safety and National Security Concerns

    As technology continues to improve and new uses for small UAS are
identified, the FAA anticipates an increased demand for flexibility in
operational restrictions under part 107. These new types of operations
may have public safety and national security risks that were not
anticipated or envisioned. This ANPRM seeks public comment on existing
and future operational requirements and limitations in part 107 that
may be necessary to reduce risks to the public and users of the NAS in
accordance with 49 U.S.C. 44807.
    In addition, public safety and national security entities have
expressed a need to distinguish between small UAS that may pose a
threat and those that do not, especially when operating in close
proximity to large public gatherings, critical infrastructure or
certain other facilities and assets.\6\ In light of this, the FAA is
constantly assessing the ability of the regulations to ensure that
small UAS operations do not pose a threat to public safety or national
security.
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    \6\ The Departments of Defense, Energy, Homeland Security, and
Justice have authority to address threats posed by UAS under certain
circumstances to certain facilities and assets identified by
statute. 10 U.S.C. 130i; 50 U.S.C. 2661; and section 1602 of Public
Law 115-254 (to be codified at 6 U.S.C. 124n).
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C. Related Agency Actions

1. Operation of Small Unmanned Aircraft Systems Over People NPRM
    The Operations of Small UAS over People rulemaking would promulgate
performance-based standards applicable to manufacturers of small UAS,
as well as some requirements applicable to operators. The rule proposes
three operational categories.\7\ Category 1 would limit the weight of
the small unmanned aircraft. Categories 2 and 3 would limit the
severity of potential injuries based on impact kinetic energy
thresholds and exposed rotating parts limitations. For operations of
small UAS at night, the rule would require the remote pilot in command
to complete a knowledge test or the appropriate training prior to
operating at night and would require that the small UAS be equipped
with anti-collision lighting visible for at least 3 statute miles.
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    \7\ The 3 categories proposed for civil small UAS operations
over people are unrelated to the Department of Defense UAS
categories which are divided into 5 groups that distinguish UAS by
weight and other characteristics.
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2. Remote Identification and Tracking Aviation Rulemaking Committee
    Section 2202 of the FAA Extension, Safety, and Security Act of 2016
(FESSA) required the FAA Administrator, in consultation with the
Secretary of Transportation, the President of RTCA, Inc., and the
Director of the National Institute of Standards and Technology, to
convene industry stakeholders to facilitate the development of
consensus standards for remotely identifying operators and owners of
unmanned aircraft systems and associated unmanned aircraft.
    FESSA required that, as part of any standards developed, the
Administrator shall consider requirements for remote identification of
unmanned aircraft systems; appropriate requirements for different
classifications of unmanned aircraft systems operations, including
public and civil; and the feasibility of the development and operation
of a publicly accessible online database of unmanned aircraft and the
operators thereof, and any criteria for exclusion from the database.
    The FAA convened the UAS Identification and Tracking Aviation
Rulemaking Committee (ARC) to make recommendations for the
identification and tracking of small UAS. The FAA has reviewed the ARC
recommendations and initiated a separate rulemaking (RIN 2120-AL31) to
propose remote identification requirements for UAS, but has not yet
published any proposals in the Federal Register.\8\ As previously
explained, the FAA does not intend to promulgate the Operations of
Small UAS over People final rule until the

remote identification rulemaking is finalized.
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    \8\ A copy of the report is available at https://www.faa.gov/regulations_policies/rulemaking/committees/documents/media/UAS%20ID%20ARC%20Final%20Report%20with%20Appendices.pdf.
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3. Section 2209 Process for UAS-Specific Airspace Restrictions
    Section 2209 of FESSA requires the Secretary of Transportation to
establish a process to allow certain fixed-site facility owners or
operators to petition the FAA to prohibit or restrict the operation of
unmanned aircraft in close proximity to certain facilities, such as
national security sites, critical infrastructure, amusement parks and
other locations that warrant such a restriction. That process is
currently under development.\9\
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    \9\ See RIN 2120-AL33.
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IV. Discussion and Questions Concerning Proposal Under Consideration

    This ANPRM is intended to gather information from the public to
help inform the FAA's efforts to assess options for reducing risks to
public safety and national security associated with further integration
of UAS into the NAS, including options for additional rulemaking.
Examples of subjects for additional rulemaking may include operating
limitations, such as stand-off distances, payload restrictions,
altitude, airspeed and performance limitations.

A. Stand-Off Distances

    Small UAS have the capability to operate in locations that are
inaccessible to manned aircraft as well as operate at reduced
horizontal and vertical stand-off distances from people and structures
compared to manned aircraft. This capability is a major benefit of
small UAS operations to both the public and private sectors, but also
presents unique safety and security concerns. Because small UAS can
operate in places that manned aircraft cannot, such as in confined
locations, under bridges, or close to buildings, they are capable of
capturing useful information for inspection, investigation, and other
purposes. In certain cases, small UAS may be able to observe people,
structures, and areas on the ground from a vantage point that cannot be
achieved by manned aircraft or by persons on the ground. On the other
hand, when small UAS are operated too close to sensitive locations;
critical infrastructure; certain mobile assets, including vessels and
ground vehicle convoys; government activities, such as firefighting,
search and rescue operations; certain law enforcement activities; over
large gatherings of people; or near manned aircraft, it raises safety
and security concerns within the NAS.
    Stand-off distances are the amount of space between a small UAS and
the closest person or object. They can have a horizontal component, a
vertical component, or be measured directly using a slant range. Stand-
off distances are sometimes referred to as minimums, such as in a
minimum separation or minimum stand-off distance, and are typically
measured in feet. They may help to ensure a small UAS does not pose a
hazard to people on the ground or assess whether a UAS poses a threat
to national security.
    Currently, small UAS operated under part 107 do not have any
prescriptive horizontal or vertical stand-off distances from people or
structures. Rather, remote pilots must comply with performance-based
rules that reduce risk by ensuring that small UAS will pose no undue
hazard to people, aircraft, or property in the event of a loss of
control of the small unmanned aircraft for any reason (Sec.  107.19(c))
and avoiding operations over any person who is not directly involved in
the flight operation unless that person is under an appropriate covered
structure or inside a vehicle (Sec.  107.39).
    In a separate rulemaking action, specifically the Operation of
Small Unmanned Aircraft Systems over People NPRM, the FAA is proposing
to amend Sec.  107.39 to allow certain small UAS to operate over people
under specific conditions. Those small UAS would be required to meet
safety thresholds that ensure the small UAS will not cause a serious
injury to people if an impact occurs, and while the subject of stand-
off distances is addressed, the rule does not propose to establish any
specific stand-off requirements.
    As discussed in the part 107 final rule, the FAA considered
requiring minimum stand-off distances, but ultimately determined that,
due to the wide range of possible small unmanned aircraft and small UAS
operations, a prescriptive numerical stand-off distance requirement
would be more burdensome than necessary for some operations while not
being stringent enough for other operations. This decision by the FAA
provided flexibility to small UAS operators to determine the
appropriate stand-off distance, if any, for low-risk operations, but
the FAA notes that as UAS operations continue to expand and the FAA
works to integrate them into the NAS, stand-off distances may be
considered to reduce public safety and national security hazards
presented by higher-risk UAS operations.
    While part 107 currently does not contain any prescriptive stand-
off distances, there are examples of small UAS regulations from other
countries that include stand-off distances. For example, in the United
Kingdom, small UAS must be operated at least 150 feet away from people
and property and 500 feet away from large crowds and built-up areas,
unless given special permission.\10\ In addition, proposed rules from
Canada and EASA both include prescriptive stand-off distances for small
UAS operations.
---------------------------------------------------------------------------

    \10\ https://www.caa.co.uk/Consumers/Unmanned-aircraft-and-drones/.
---------------------------------------------------------------------------

    Questions for the Public: The FAA is considering rulemaking to
address public safety and national security concerns associated with
small UAS and invites input from the public as follows--
    A1. If the FAA were to establish specific horizontal or vertical
stand-off distances for all small UAS operations, what should those
stand-off distances be and why?
    A2. If the FAA were to establish horizontal or vertical stand-off
distances for only certain types of small UAS operations, what types of
operations should require a stand-off distance, what should the stand-
off distance be, and why? Examples of types of operations include, but
are not limited to, night operations, operations in controlled airspace
under an ATC authorization, and beyond-visual-line-of-sight operations.
    A3. What types of operations, if any, should be excluded from a
proposed stand-off distance requirement and why?
    A4. How would a horizontal or vertical stand-off distance
requirement help reduce hazards to public safety and national security?
    A5. What are the incremental costs \11\ of introducing a stand-off
distance requirement compared to how operations are conducted today?
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    \11\ For the purposes of this ANPRM, the FAA is requesting
incremental costs, which is the difference between current and
future operations.
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    A6. Does requiring a minimum stand-off distance necessitate
additional instrumentation? If yes, provide costs and other relevant
information.
    A7. If minimum stand-off distances are required, would training or
testing be necessary? If yes, provide estimate of time and cost.

B. Altitude, Airspeed, and Other Performance Limitations

    Due to their potential small size, light weight, and propulsion
capabilities, small UAS can have relative performance that far exceeds
that of conventional manned aircraft. These capabilities allow for
operations that manned aircraft are not capable of or

cannot conduct safely. Some small UAS are capable of speeds in excess
of 150 knots (172 mph), altitudes of 10,000 feet or more, and climb
rates in excess of 6,000 feet per minute. Some can accelerate from 0 to
60 mph in less than 1 second. They can have extreme maneuverability and
the capability to hover for extended periods of time. These performance
capabilities provide considerable benefits and advantages to UAS
operations but also create unique safety and security concerns.
    Because of their performance capabilities, small UAS can operate in
confined areas with speed and agility and, with their maneuverability,
are capable of operating in close proximity to buildings, vehicles, and
people, which allows for the gathering of imagery and data that cannot
otherwise be obtained from the air or ground. However, with their
capability for speed, maneuverability, and extreme acceleration, both
horizontally and vertically, they can pose a hazard to other aircraft
or persons on the ground. Also, those performance capabilities could
lead to risks when operating in close proximity to sensitive government
locations, large gatherings of people, law enforcement activities,
search and rescue operations, and other aircraft.
    Currently, small UAS operated under part 107 are limited to a
maximum groundspeed of 87 knots (100 mph) and a maximum altitude of 400
feet above ground level, unless operated within a 400-foot radius of a
structure, in which case the limit is 400 feet above the structure's
uppermost limit. As discussed in the part 107 final rule, a small UAS
travelling at high speed poses a higher risk to persons, property, and
other aircraft than one traveling at a lower speed. The rule also noted
that a speed limit would have safety benefits outside of a loss-of-
positive-control scenario because a small unmanned aircraft traveling
at a lower speed is generally easier to control. Also, the rule states
that the speed and altitude limitations reduce the risk of collision
with other aircraft. As stated in the part 107 final rule, a maximum
speed limit of 87 knots is appropriate because the remote pilot in
command will have to implement mitigations commensurate with the risk
posed by his or her specific small UAS operation, such as operating at
a speed less than 87 knots. Section 107.51 also includes limitations on
flight visibility and cloud clearances, but does not have any operating
limitations for vertical climb or descent rates or rates of
acceleration.
    As new uses for small UAS are identified and new types of
operations are introduced into the NAS, the FAA continues to assess
possible performance limitations, such as airspeed and altitude, to
mitigate potential hazards.
    Questions for the Public: The FAA is considering rulemaking to
address public safety and national security concerns associated with
small UAS and invites input from the public as follows--
    B1. If the FAA were to establish additional operating or
performance limitations for small UAS, what should those operating or
performance limitations be and why?
    B2. If the FAA were to establish additional operating or
performance limitations for only certain types of small UAS operations,
what types of small UAS operations should require additional operating
or performance limitations, what should they be, and why?
    B3. How would additional operating or performance limitations help
to reduce risks to public safety or national security?
    B4. What types of current small UAS operations would be impacted by
establishing additional operating or performance limitations?
    B5. What are the incremental costs of altitude, airspeed, and other
performance limitations?

C. Unmanned Traffic Management (UTM) Operations

    Small UAS pose a unique public safety and security risk to other
aircraft and persons and property on the ground because they can
operate more readily in sensitive areas and it can be difficult to
identify non-compliant operations. Applying more structure to the
airspace and operations may reduce public safety or national security
risks in the NAS by removing the anonymity of the operations and
establishing operating norms, which can then be used to highlight
anomalous activity that may indicate malicious intent.
    Many entities in both the public and private sector are developing
a decentralized communication architecture identified as UAS Traffic
Management (UTM), which could support more structured airspace and
operations for small UAS without active control from the FAA's Air
Traffic Organization. Increased communication between operators on
planned and actual flight paths, deconfliction capability, additional
information sources, and new service suppliers are intended to allow
for optimized flight paths with increased safety. While UTM is focused
on managing the safe and efficient operation of an increasing number of
UAS operating in the NAS, especially beyond visual line of sight
(BVLOS), there may be opportunities to mitigate public safety and
national security risks at the same time.
    Section 2208 of the FESSA directed the FAA to conduct research and
establish a pilot program with NASA regarding UTM, both of which are
currently underway with the ultimate goal of informing future
rulemaking. Further, in conjunction with completing the pilot program
required by FESSA, Section 376 of Public Law 115-254 requires the FAA,
in coordination with NASA and industry stakeholders, to develop an
implementation plan for UTM services that expand operations beyond
visual line of sight, have full operational capability, and ensure the
safety and security of all aircraft. The UTM implementation plan, which
must address safety standards among other matters and delineate the
roles and responsibilities of public and private actors, is to be
completed within one year of the conclusion of the UTM pilot program.
    In the part 107 rulemaking, the FAA found the risk to public safety
and national security acceptable without requiring any type of UTM
coordination, even considering the inherent structure it would provide.
Because operations under part 107 (conducted without a waiver) are
limited to visual line of sight and small UAS must yield the right-of-
way to all other aircraft, the FAA determined that a certificated
remote pilot can operate a small UAS safely without the need to
coordinate its flight path with other operators. Consistent with the
direction in Section 376, however, as UAS operations in the NAS
continue to evolve and increase in number, the FAA anticipates there
will be a need for additional airspace coordination and management to
ensure those operations do not pose a risk to public safety or national
security.
    Questions for the Public: The FAA is considering rulemaking to
address public safety and national security concerns associated with
small UAS and invites input from the public as follows--
    C1. How can additional information sharing (e.g., intended flight
path, operational boundary) via UTM help reduce risks to public safety
and national security? What suite of capabilities should UTM have?
    C2. What types of small UAS operations should be subject to UTM
requirements? Should any be excluded? Should the requirement be based
on geographical location, the type of operation, or other factors?
Please

provide data or explanations to justify your response.
    C3. For small UAS subject to UTM requirements, what type of
information should be available to the general public? What type of
information should be available to security personnel?
    C4. What are the initial nonrecurring investment costs associated
with establishing a UTM architecture? Once implemented, what are the
annual recurring operation and maintenance costs?
    C5. For questions C.1., C.2., and C.3., please include information
in your response identifying the costs that would be necessary to equip
small UAS to comply with UTM requirements.
    C6. Would additional testing or training be required for a remote
pilot to safely operate a small unmanned aircraft subject to UTM
requirements? Please explain.
    C7. What would be the costs for information sharing if UAS
operations are subject to UTM requirements?

D. Payload Restrictions

    Small UAS are readily available for purchase in home electronic and
general merchandise stores by individuals who may have little or no
familiarity with the civil aviation regulations that are applicable to
them. Some of these small UAS have very small visual, radar, and
acoustic signatures, which may make them more difficult to detect,
identify, and track compared to manned aircraft. On the other hand,
small UAS that weigh close to 55 pounds could carry a significant
amount of internal or external payload. If a small UAS is determined to
present a threat to public safety or national security, currently there
are limited ways to mitigate the threat. As a result, the increased
integration of UAS operations in the NAS poses unique public safety and
national security concerns.
    Given their size, propulsion systems, and navigational
capabilities, small UAS can operate in close proximity to buildings,
persons, vehicles and other objects without anyone's awareness. With
the current and expected improvements in technical capabilities
available on small UAS, they can circumvent measures used to protect
security-sensitive sites and operations, which, if accessed or damaged,
could threaten national security or introduce hazards to public safety.
The FAA is aware of situations where small UAS have been used to
conduct illegal surveillance and industrial espionage; to deliver
contraband to prison inmates; to deliver incendiary, explosive,
chemical and radiological payloads; to damage or disrupt critical
infrastructure, including communications networks; and to conduct
malicious cyber activity. There have been instances in which small UAS
were used in ways that interfere with law enforcement, firefighting,
and aviation operations.
    Recently, Congress enacted section 363 of Public Law 115-254,
responding to several payload and installed equipment concerns. Unless
authorized by the Administrator, section 363 prohibits a person from
operating a UAS equipped or armed with a dangerous weapon as defined in
18 U.S.C. 930(g)(2).\12\
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    \12\ The term ``dangerous weapon'' as defined in 18 U.S.C.
930(g)(2) means a weapon, device, instrument, material, or
substance, animate or inanimate, that is used for, or is readily
capable of, causing death or serious bodily injury, except that such
term does not include a pocket knife with a blade of less than 2\1/
2\ inches in length.
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    Further, Sec.  107.36 prohibits the carriage of hazardous materials
as defined in 49 CFR 171.8. This definition includes many types of
hazardous substances, such as chemicals or hazardous waste, but does
not address all types of payloads or sensors that could pose a threat
to public safety or national security. Part 107 does allow for the
transportation of property for compensation or hire, but only if the
aircraft, including its attached systems, payload, and cargo weigh less
than 55 pounds total; the flight is conducted within visual line of
sight and not from a moving vehicle or aircraft; and the flight occurs
wholly within the bounds of a State and does not involve transport
between (1) Hawaii and another place in Hawaii through airspace outside
Hawaii; (2) the District of Columbia and another place in the District
of Columbia; or (3) a territory or possession of the United States and
another place in the same territory or possession.
    Questions for the Public: The FAA is considering rulemaking to
address public safety and national security concerns associated with
small UAS and invites input from the public as follows--
    D1. Should the prohibition from carrying hazardous materials in
Sec.  107.36 be expanded to include other types of payloads or
installed equipment that could pose a threat to public safety or
national security? If yes, what types of payloads should be prohibited
and why?
    D2. Should the FAA consider rulemaking to restrict the use of
certain types of small UAS payloads or installed equipment? If yes,
what types of payloads should be restricted, under what conditions
should they be restricted? Should there be exceptions or special
provisions applicable to certain conditions or other factors such as
location, time, population density, or purpose? Please provide data or
explanations to justify your response.
    D3. What types of operations would be affected if additional
restrictions are placed on the type of payloads and equipment that can
be installed on a small UAS? Would there be any costs or lost revenues
associated with those restrictions?

E. Small UAS Critical System Design Requirements

    Public safety and national security concerns have been raised
regarding the potential failure of critical systems on small UAS, which
could result in the loss of control of the aircraft and increase the
risk to persons and property on the ground and other users of the
airspace. One way of designing critical systems on small UAS that has
the potential to address these concerns from both a public safety and
national security perspective is the use of redundancy. From a safety
standpoint, redundancy helps to mitigate the risk of critical single-
point system failures. For example, a battery failure on a UA with only
one battery might result in a crash landing. If the UA was built with a
redundant power system (multiple batteries or a backup), the UA could
switch to the alternate power source and maintain safe flight. Another
approach to increase safety is the use of fail-safe design features. A
small UAS that has a fail-safe command and control (C2) link would
improve the safety of the small UAS if a lost-link event occurs.
    From a national security standpoint, redundancy of critical systems
plays a more indirect role. Failure of some functions on an unmanned
aircraft may lead to unplanned airspace or security violations. For
example, a loss of navigation or lost-link could lead to an unmanned
aircraft entering unauthorized airspace. Having a redundant navigation
system or a fail-safe C2 system could reduce the risk of this
happening. Additionally, critical systems could be a piece of a larger
security strategy ensuring a robust capability to strengthen the
overall security of the system. An example would be having redundant
positioning solutions (e.g., GPS, inertial) to ensure a high
availability to broadcast the unmanned aircraft's position, if
required.
    Currently, small UAS operated under 14 CFR part 107 are not
required to have an airworthiness certificate. Furthermore, they do not
have any prescribed design standards or required

system redundancies. As a result, many small UAS operating today,
especially those with relatively small size, do not have redundancies
in their design. However, the FAA, through policy, may condition the
grant of waiver from certain operational limitations in part 107 on
equipage with redundant systems. For example, Sec.  107.31--Visual line
of sight aircraft operations and Sec.  107.39--Operation over people,
are both subject to waiver as prescribed in Sec. Sec.  107.200 and
107.205. In evaluating waiver requests for Sec. Sec.  107.31 and
107.39, the FAA may consider the need for design requirements,
including redundancy, for critical UAS systems based upon the nature of
the request and the need to mitigate any risks associated with the
proposed operation.
    In a related rulemaking action, specifically the Operation of Small
Unmanned Aircraft Systems over People NPRM, the FAA is proposing to
amend Sec.  107.39 to allow small UAS to operate over people if they
are tested and shown to fulfill certain safety standards intended to
limit the severity of injuries to people on the ground. While
manufacturers of small UAS qualified to operate over people may choose
to have redundancy for critical systems in their designs, it is not
required by the proposed rule.
    Questions for the Public: The FAA is considering rulemaking to
address public safety and national security concerns associated with
small UAS and invites input from the public as follows--
    E1. For small UAS operations beyond the visual line of sight of the
remote pilot, should the FAA establish design requirements, such as
redundancy, for systems critical to safety of flight? If yes, what
should these requirements be and why? Are there other means the FAA
should consider to address public safety and national security risk for
BVLOS operations?
    E2. For small UAS operations over people that exceed the NPRM
safety thresholds indicated above and therefore still must seek a
waiver to Sec.  107.39 to operate over people, should the FAA establish
design requirements, such as redundancy, for systems critical to safety
of flight? If yes, what should these requirements be and why? Are there
other means the FAA should consider to address public safety and
national security risk for operations over people?
    E3. Are there other types of small UAS operations besides BVLOS and
operations over people that the FAA should establish design
requirements for, such as redundancy, to address public safety and
national security risk?
    E4. What are the costs and benefits to incorporate redundant
systems critical to safety of flight for BVLOS operations or operations
over people that exceed the NPRM safety thresholds indicated above?

V. Regulatory Requirements and Executive Order Determinations

    The FAA will address the following requirements in future small UAS
safety and security rulemakings. Please provide comments that would
assist the FAA in its consideration and analyses of these requirements.

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

    This ANPRM is considered a significant regulatory action under
section 3(f) of Executive Order 12866 and was reviewed by the Office of
Management and Budget (OMB). It is considered a significant regulatory
action under the Regulatory Policies and Procedures order issued by the
Department of Transportation. 44 FR 11034 (Feb. 26, 1979).
    Executive Orders 12866, ``Regulatory Planning and Review,'' 58 FR
51735 (Oct. 4, 1993), and 13563, ``Improving Regulation and Regulatory
Review,'' 76 FR 3821 (Jan. 21, 2011), require agencies to regulate in
the ``most cost-effective manner,'' to make a ``reasoned determination
that the benefits of the intended regulation justify its costs,'' and
to develop regulations that ``impose the least burden on society.''
Executive Order 13610, ``Identifying and reducing Regulatory Burdens,''
77 FR 28469 (May 14, 2012), urges agencies to conduct retrospective
analyses of existing rules to examine whether they remain justified and
whether they should be modified or streamlined in light of changed
circumstances, including the rise of new technologies.
    Additionally, Executive Orders 12866, 13563, and 13610 require
agencies to provide a meaningful opportunity for public participation.
Accordingly, FAA invites comments on these considerations, including
any cost or benefit figures or factors, alternative approaches, and
relevant scientific, technical and economic data. These comments will
help FAA evaluate whether regulatory action is warranted and
appropriate.

B. Executive Order 13771

    On January 30, 2017, President Trump signed Executive Order 13771
(E.O. 13771), ``Reducing Regulation and Controlling Regulatory Costs.''
Under Section 2 of this Executive Order, unless prohibited by law,
whenever an executive department or agency publicly proposes for notice
and comment or otherwise promulgates a new regulation, it must identify
at least two existing regulations to be repealed and offset any new
incremental costs associated with new regulations by the elimination of
existing costs associated with at least two prior regulations. FAA will
need to determine if a future rulemaking is an E.O. 13771 regulatory or
deregulatory action.

C. Executive Order 13132

    Executive Order 13132, ``Federalism,'' 64 FR 43255 (Aug. 10, 1999),
requires agencies to assure meaningful and timely input by State and
local officials in the development of regulatory policies that may 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.'' FAA
invites State and local governments with an interest in this rulemaking
to comment on any effect that may result.

D. Executive Order 13175

    Consistent with Executive Order 13175, ``Consultation and
Coordination with Indian Tribal Governments,'' and FAA Order 1210.20,
``American Indian and Alaska Native Tribal Consultation Policy and
Procedures,'' the FAA ensures that Federally Recognized Tribes (Tribes)
are given the opportunity to provide meaningful and timely input
regarding proposed Federal actions that have the potential to uniquely
or significantly affect their respective Tribes. At this point, the FAA
has not identified any unique or significant effects, environmental or
otherwise, on tribes resulting from this advance notice of proposed
rulemaking. As it contemplated in the sUAS Operation and Certification
final rule, the FAA has conducted outreach to tribes and responded to
those tribes seeking information about small UAS operations conducted
within their territory to see how their concerns can be addressed
within the broader UAS integration effort.\13\
---------------------------------------------------------------------------

    \13\ 81 FR 42063 at 42189.
---------------------------------------------------------------------------

    Since publication of the sUAS Operation and Certification final
rule, the FAA has conducted outreach to tribes to ensure that they are
familiar with the rules' provisions and how they might apply in Indian
country, and that they are aware of FAA's plans for additional
rulemakings to integrate UAS into the NAS. As part of that outreach the
FAA has:

     Provided material on the sUAS Operation and Certification
final rule to participants at the mid-year conference of the National
Congress of American Indians (Spokane, WA, June 27-30, 2016);
     Presented at a workshop at the National Tribal
Transportation Conference (Anaheim, CA October 4, 2016);
     Responded to inquiries from the Shoshone-Bannock Tribes
and Muscogee (Creek) Nation regarding use of UAS;
     Presented information on UAS at a meeting of the Tribal
Transportation Self-Governance Program Negotiated Rulemaking Meeting
(Shawnee, OK October 18, 2016); and
     Provided information to The Choctaw Nation of Oklahoma,
which is participating in the UAS Integration Pilot Program.\14\
Through this program, the FAA will work with The Choctaw Nation to
ensure safe UAS operations for the purposes of agriculture, public
safety, and infrastructure inspections. Such operations may include
operations over people and operations at night.
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    \14\ Federal Aviation Administration UAS Integration Pilot
Program (May 7, 2018), available at https://www.faa.gov/uas/programs_partnership/uas_integration_pilot_program/.
---------------------------------------------------------------------------

    The FAA will continue to respond to tribes expressing interest in
or concerns about UAS operations, and will engage in government-to-
government consultation with tribes as appropriate, in accordance with
Executive Orders and FAA guidance.

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

    Under the Regulatory Flexibility Act of 1980, 5 U.S.C. 601, et
seq., FAA must consider whether a rulemaking would have a ``significant
economic impact on a substantial number of small entities.'' ``Small
entities'' include small businesses, not-for-profit organizations that
are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations under 50,000.
    Any future rulemaking would be developed in accordance with
Executive Order 13272, ``Proper Consideration of Small Entities in
Agency Rulemaking,'' 68 FR 7990 (Feb. 19, 2003), and DOT's procedures
and policies to promote compliance with the Regulatory Flexibility Act
to ensure that potential impacts on small entities of a regulatory
action are properly considered.

F. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq., 5 CFR 1320.8(d) requires that FAA provide interested members of
the public and affected agencies an opportunity to comment on
information collection and recordkeeping requests. This ANPRM does not
impose new information collection requirements. FAA would have to
consider information collection requirements for future rulemakings.

G. Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
governs the issuance of Federal regulations that require unfunded
mandates. An unfunded mandate is a regulation that requires a state,
local, or tribal government or the private sector to incur direct costs
without the Federal government's having first provided the funds to pay
those costs. The FAA will need to determine if this rulemaking would
result in costs of $155 million or more, adjusted for inflation, to
either state, local, or tribal governments, in the aggregate, or to the
private sector in any one year.

H. National Environmental Policy Act

    The National Environmental Policy Act of 1969, 42 U.S.C. 4321-4375,
requires that Federal agencies analyze proposed actions to determine
whether the action will have a significant impact on the human
environment. The Council on Environmental Quality (CEQ) regulations
require Federal agencies to conduct an environmental review considering
(1) the need for the proposed action, (2) alternatives to the proposed
action, (3) probable environmental impacts of the proposed action and
alternatives, and (4) the agencies and persons consulted during the
consideration process. See 40 CFR 1508.9(b). FAA welcomes any data or
information related to environmental impacts that may result from any
future rulemaking.

I. Privacy Act

    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, 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, see 65 FR 19477, or
you may visit http://www.regulations.gov.

J. Executive Order 13609 and International Trade Analysis

    Under Executive Order 13609, ``Promoting International Regulatory
Cooperation,'' 77 FR 26413 (May 4, 2012), 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 businesses to export and compete
internationally. In meeting shared challenges involving health, safety,
labor, security, environmental, and other issues, regulatory approaches
developed through international cooperation can provide equivalent
protection to standards developed independently while also minimizing
unnecessary differences.
    Similarly, the Trade Agreements Act of 1979, Public Law 96-39, as
amended by the Uruguay Round Agreements Act, Public Law 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. FAA welcomes any data or
information related to international impacts that may result from
future rulemaking.

K. Executive Order 13211

    Executive Order 13211, 66 FR 28355 (May 22, 2001), requires Federal
agencies to prepare a Statement of Energy Effects for any ``significant
energy action.'' Under the executive order, a ``significant energy
action'' is defined as any action by an agency (normally published in
the Federal Register) that promulgates, or is expected to lead to the
promulgation of, a final rule or regulation (including a notice of
inquiry, ANPRM, and NPRM) that (1)(i) is a significant regulatory
action under Executive Order 12866 or any successor order and (ii) is
likely to have a significant adverse effect on the supply,
distribution, or use of energy; or (2) is designated by the
Administrator of the Office of Information and Regulatory Affairs as a
significant energy action. The FAA would have to consider this
executive order for future rulemaking.

    Issued under the authority provided by 49 U.S.C. 106(f), 40101
note, and 44807, in Washington, DC, on January 28, 2019.
Daniel K. Elwell,
Acting Administrator, Federal Aviation Administration.
[FR Doc. 2019-00758 Filed 2-12-19; 8:45 am]
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