[Federal Register Volume 86, Number 109 (Wednesday, June 9, 2021)]
[Notices]
[Pages 30632-30635]
[FR Doc No: 2021-12031]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92098; File No. SR-FINRA-2021-013]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the Supplemental Inventory Schedule
Pursuant to FINRA Rule 4524 (Supplemental FOCUS Information)

June 3, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 26, 2021, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).

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

    FINRA is proposing to amend the Supplemental Inventory Schedule
(``SIS'') pursuant to FINRA Rule 4524 (Supplemental FOCUS Information)
so that members that are filers of FOCUS Report Part II will not be
required to file the SIS. The proposed rule change does not make any
other change to the SIS or the instructions thereto.
    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    FINRA Rule 4524 provides in part that, as a supplement to filing
FOCUS Reports required pursuant to SEA Rule 17a-5 \4\ and FINRA Rule
2010, each member, as FINRA shall designate, shall file such additional
financial or operational schedules or reports as FINRA may deem
necessary or appropriate for the protection of investors or in the
public interest. In general, members with a FOCUS filing requirement
must either file a FOCUS Report Part II if they clear transactions or
carry customer accounts \5\ or file a FOCUS Report Part IIA if they do
not.\6\ Members that are government securities broker-dealers
registered under SEA Section 15C \7\ do not file a FOCUS Report and
instead are required to file reports concerning their financial and
operational status using the Report on Finances and Operations of
Government Securities Brokers and Dealers (``FOGS Report'').\8\ FINRA
established the SIS requirement pursuant to Rule 4524 in 2014.\9\
Pursuant to this requirement, the SIS must be filed by a member that is
required to file FOCUS Report Part II, FOCUS Report Part IIA or the
FOGS Report Part I, with inventory positions as of the end of the FOCUS
or FOGS reporting period, unless the member has (1) a minimum dollar
net capital or liquid capital requirement of less than $100,000; or (2)
inventory positions consisting only of money market mutual funds. A
member with inventory positions consisting only of money market mutual
funds must affirmatively indicate through the eFOCUS system that no SIS
filing is required for the reporting period. As FINRA noted in
establishing the SIS, the purpose of the SIS requirement is to provide
more detailed information of inventory positions held by members.\10\
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    \4\ 17 CFR 240.17a-5 (hereinafter cited as SEA ``Rule 17a-5'').
SEA Rule 17a-5 governs financial and operational reporting by
brokers and dealers. Members are required to file with FINRA,
through the eFOCUS System, reports concerning their financial and
operational status using SEC Form X-17A-5 (the ``FOCUS Report'').
See, e.g., Information Notice, November 23, 2020 (2021 and First
Quarter of 2022 Report Filing Due Dates); Regulatory Notice 18-38
(November 2018) (Amendments to the SEC's Financial Reporting
Requirements--eFOCUS System Updates and Annual Audit Requirements).
``FOCUS'' stands for Financial and Operational Combined Uniform
Single.
    \5\ Currently, members that calculate net capital using Appendix
E to SEA Rule 15c3-1 file FOCUS Report Part II CSE, rather than
FOCUS Report Part II. Such members are referred to as ``alternative
net capital'' or ``ANC'' broker-dealers.
    \6\ SEA Rule 17a-5.
    \7\ 15 U.S.C. 78o-5.
    \8\ Department of the Treasury Form G-405.
    \9\ See Securities Exchange Act Release No. 73192 (September 23,
2014), 79 FR 58390 (September 29, 2014) (Order Approving Proposed
Rule Change; File No. SR-FINRA-2014-025); see also Regulatory Notice
14-43 (October 2014) (SEC Approves Supplemental Inventory Schedule).
    \10\ See note 9 supra.
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    The Commission, as part of its rulemakings pursuant to Title VII of
the Dodd-Frank Wall Street Reform and Consumer Protection Act (``Dodd-
Frank Act'') \11\ to establish a regulatory framework for security-
based swaps (``SBS''), has adopted among other things amendments to the
FOCUS reporting requirements, including amendments to FOCUS Report Part
II \12\ designed to elicit additional information about the SBS
activities of broker-dealers that file FOCUS Report Part II, including
broker-dealers that will also be registered as SBS dealers and major
SBS participants.\13\
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    \11\ Public Law 111-203, 124 Stat. 1376 (2010).
    \12\ See Securities Exchange Act Release No. 87005 (September
19, 2019), 84 FR 68550 (December 16, 2019) (Final Rule:
Recordkeeping and Reporting Requirements for Security-Based Swap
Dealers, Major Security-Based Swap Participants, and Broker-Dealers)
(``Reporting Requirements Release'').
    \13\ See Reporting Requirements Release, 84 FR at 68573.
Pursuant to the SEC's rule change, ANC broker-dealers that currently
file FOCUS Report Part II CSE will file new FOCUS Report Part II.
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    FINRA believes that Schedule 1--Aggregate Securities, Commodities,
and Swaps Positions (``Schedule 1'') to FOCUS Report Part II, as
amended, includes substantially all the information that is required by
the SIS, including, among other things, information on the following
types of positions:
     U.S. Treasury securities;
     U.S. government agency and U.S. government-sponsored
enterprise securities;
     securities issued by states and political subdivisions in
the U.S.;
     foreign securities;
     money market instruments;
     private label mortgage backed securities;
     other asset-backed securities;
     corporate obligations;
     stocks and warrants (other than arbitrage positions);
     arbitrage positions;
     spot commodities;
     other securities and commodities; and
     securities with no ready market.
    Further, line 11 of the SIS requires specified information on
``derivatives including options,'' based on whether the positions are
centrally cleared or not. On Schedule 1 this information will be
reported based on whether the position is a cleared or non-cleared SBS,
mixed swap or swap, or will be reported under the category ``other
derivatives and options.'' \14\ Schedule 1 will also require
information on counterparty netting and cash collateral netting.
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    \14\ Schedule 1 requires the information for cleared and non-
cleared SBS, mixed swaps and swaps in separate categories on Lines,
15, 16 and 17 of Schedule 1, while the SIS requires that SBS and
swaps be reported in aggregate under ``centrally cleared'' and ``all
other'' under Line 11 of the SIS. Further, Schedule 1 requires that
other derivatives or options be reported in aggregate on Line 18 of
Schedule 1, while the SIS specifies separate categories for
``centrally cleared'' and ``all other'' options, ``forward settling
and delayed delivery transactions,'' ``futures'' and ``other''
products under Line 11 of the SIS. Also, under Line 13 of the SIS
(``securities with no ready market''), the category for ``other
(include limited partnership interests)'' is reflected as ``other''
under Line 13 of Schedule 1.
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    Given that substantially all the information required by the SIS is
covered by Schedule 1 of FOCUS Report Part II, as amended, FINRA
believes that it would be an unnecessary duplication of reporting to
require members that file FOCUS Report Part II to continue to submit
the SIS after the compliance date \15\ for certain of the SEC's SBS

rulemakings, including the new FOCUS reporting requirements pursuant to
the Reporting Requirements Release. As such, in the interest of
avoiding unnecessary duplication, FINRA believes it is appropriate to
remove FOCUS Report Part II filers from the scope of members required
to file the SIS.\16\ Accordingly, the proposed rule change would revise
the first paragraph under the General Instructions to the SIS so as to
provide, in relevant part, that: ``The Supplemental Inventory Schedule
(SIS) is to be filed within 20 business days after the end of each
firm's FOCUS reporting period by all FOCUS Part IIA and FOGS Part I
filers . . .'' \17\ FINRA believes it is appropriate to implement this
revision in alignment with the reporting cycle that coincides with the
SEC's SBS compliance date. FINRA is not proposing any other change to
the SIS.
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    \15\ The Commission has broadly coordinated the compliance date
for certain SBS rulemakings by setting October 6, 2021, as the
compliance date (the ``compliance date'' or ``SBS compliance date'')
for the registration requirements that the Commission adopted for
SBS dealers and major SBS participants. See Reporting Requirements
Release, 84 FR at 68600; see also Key Dates for Registration of
Security-Based Swap Dealers and Major Security-Based Swap
Participants, available on the Commission website at: <https://www.sec.gov/page/key-dates-registration-security-based-swap-dealers-and-major-security-based-swap-participants.
    \16\ FINRA notes that members that have elected to be treated as
capital acquisition brokers (``CABs'') would be subject to the
proposed rule change to the extent that FINRA Rule 4524, pursuant to
CAB Rule 452(b), applies to CABs. To the extent any CABs are FOCUS
Report Part II filers, then, pursuant to the rule change, such firms
would no longer need to file the SIS.
    The proposed rule change would not impact funding portal members
because such members are not subject to Rule 4524 and are not
subject to the FOCUS reporting requirements.
    \17\ The SIS, as proposed to be revised pursuant to the rule
change, is included as Exhibit 3 to this rule filing.
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    FINRA has filed the proposed rule change for immediate
effectiveness. FINRA is proposing that the implementation date of the
proposed rule change will be October 31, 2021, for SIS filings that
report on the month ending October 31, 2021, and are due by November
30, 2021. Thus, SISs filed on or after October 31, 2021, would reflect
the proposed rule change.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\18\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. Consistent with the provisions of the Act, FINRA
believes that eliminating the SIS filing requirement for members that
file FOCUS Report Part II, as amended by the Reporting Requirements
Release, will avoid unnecessary duplication of reporting for such
members while ensuring that regulators continue to receive the needed
information reflected on these forms, given that Schedule 1 of FOCUS
Report Part II, as amended, includes substantially all the information
required by the SIS. The proposed rule change will thereby reduce
unnecessary burdens while also helping to protect investors and serve
the public interest.
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    \18\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. Schedule 1 of FOCUS Report Part
II, as amended, requires substantially all the information required by
the SIS. Eliminating the SIS filing requirement for members that file
FOCUS Report Part II, as amended, would avoid unnecessary duplication
of reporting, thereby reducing burdens for such members, while ensuring
that regulators continue to receive the needed information reflected on
these forms.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \19\ and Rule 19b-
4(f)(6) thereunder.\20\
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2021-013 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2021-013. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of FINRA. All comments received will be
posted without change. Persons submitting comments are cautioned that
we do not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
FINRA-2021-013 and should be submitted on or before June 30, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-12031 Filed 6-8-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47498-47499]
[FR Doc No: 2017-21999]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP17-56-000, CP17-57-000]

Texas Eastern Transmission, L.P.; Brazoria Interconnector Gas
Pipeline, LLC; Notice of Availability of the Environmental Assessment
for the Proposed Stratton Ridge Expansion Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the
Stratton Ridge Expansion Project (Project), proposed by Texas Eastern
Transmission, L.P. and Brazoria Interconnector Gas Pipeline, LLC
(together referred to as Applicants) in the above-referenced dockets.
The Applicants request authorization to construct certain facilities
designed to transport up to 322 million cubic feet per day of natural
gas on a firm basis from Texas Eastern Transmission, L.P.'s existing
interconnections to a delivery point on the Brazoria Interconnector Gas
Pipeline near Stratton Ridge, Texas.
    The EA assesses the potential environmental effects of the

construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the proposed project, with appropriate
mitigating measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    The proposed Project includes the following facilities:
     A 0.5-mile-long new pipeline lateral (BIG Interconnect)
connecting the proposed new Angleton Compressor Station to the existing
BIG Pipeline in Brazoria County, Texas;
     the new Angleton Compressor Station, a 12,500 horsepower
electrically-powered compressor station in Brazoria County, Texas;
     pressure regulation modifications at the existing Joaquin
Compressor Station in Shelby County, Texas;
     installation of Clean Burn technologies at the existing
Mont Belvieu Compressor Station in Chambers County, Texas;
     modifications to existing pig \1\ launchers at the
existing Huntsville Compressor Station, in San Jacinto County, Texas;
and Hempstead Compressor Station in Waller County, Texas;
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    \1\ A pig is an internal pipeline device used to clean or
inspect the pipeline.
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     modifications to an existing pig launcher/receiver,
facility crossover piping and a valve at the existing Provident City
Station in Lavaca County, Texas:
     a new aboveground wire-line launcher/receiver assembly
site and interconnect valve site near milepost 0.5 of the BIG
Interconnect Pipeline in Brazoria County, Texas; and
     replacement of existing 16-inch-diameter crossover piping
and valve with new 24-inch-diameter crossover piping and valve at an
existing facility in Lavaca County, Texas.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; and newspapers and libraries in the project area. In addition,
the EA is available for public viewing on the FERC's Web site
(www.ferc.gov) using the eLibrary link. A limited number of copies of
the EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street
NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this project, it is important
that we receive your comments in Washington, DC on or before November
4, 2017.
    For your convenience, there are three methods you can use to file
your comments to the Commission. In all instances, please reference the
project docket numbers (CP17-56-000 and CP17-57-000) with your
submission. The Commission encourages electronic filing of comments and
has expert staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on eRegister. You must select the type of filing you are making. If you
are filing a comment on a particular project, please select Comment on
a Filing; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\2\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
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    \2\ See the previous discussion on the methods for filing
comments.
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    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on General Search, and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP17-
56 or CP17-57). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: October 5, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-21999 Filed 10-11-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Page 58676]
[FR Doc No: 2018-25305]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Flight and
Duty Limitations and Rest Requirements--Flightcrew Members

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on July 31, 2018. The collection involves reporting exceeded
flight duty periods and flight times, including scheduled maximum and
actual flight duty periods and flight times, basic flight information
(e.g., city pairs, departure times, flight number), and reason for
exceedance. Reporting and recordkeeping are required any time a
certificated air carrier has exceeded a maximum daily flight time limit
or a maximum daily Flight Duty Period (FDP) limit. It is also required
for the voluntary development of a Fatigue Risk Management System
(FRMS), and for fatigue training. The information is necessary to
monitor trends in exceedance and possible underlying systemic causes
requiring operator action, and to determine whether operator is
scheduling realistically.

DATES: Written comments should be submitted by December 20, 2018.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
[email protected], or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Barbara Hall at<PHONE_NUMBER>, or by
email at: [email protected].

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0751.
    Title: Flight and Duty Limitations and Rest Requirements--
Flightcrew Members.
    Form Numbers: There are no forms associated with this collection.
    Type of Review: This is a renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on July 31, 2018 (83 FR 37041). The FAA collects reports
from air carriers conducting passenger operations certificated under 14
CFR part 121 as prescribed in 14 CFR part 117 Flightcrew Member Duty
and Rest Requirements, Sec. Sec.  117.11 and 117.19. Air carriers are
required to submit a report of exceeded flight duty periods and flight
times, including scheduled maximum and actual flight duty periods and
flight times, basic flight information (e.g., city pairs, departure
times, flight number), and reason for exceedance. The purpose for the
reports is to notify the FAA that the certificate holder has extended a
flight time and/or FDP limitation. This information enables FAA to
monitor trends in exceedance and possible underlying systemic causes
requiring operator action as well as determine whether operators are
scheduling realistically. Additionally, if air carriers choose to
develop a Fatigue Risk Management System (FRMS) they are required to
collect data specific to the need of the operation for which they will
seek an FRMS authorization. It results in an annual recordkeeping and
reporting burden when carriers adopt the system because they need to
report the related activities to the FAA. Each air carrier is also
required to develop specific elements and incorporate these elements
into their training program. Once the elements have been incorporated,
the air carrier must submit the revised training program for approval.
    Respondents: 67 Certificated Air Carriers.
    Frequency: On Occasion.
    Estimated Average Burden per Response: 20 Hours.
    Estimated Total Annual Burden: 3,178 Hours.

    Issued in Washington, DC, on November 14, 2018.
Barbara Hall,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2018-25305 Filed 11-19-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Notices]
[Pages 36193-36194]
[FR Doc No: 2013-14299]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0662]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Applications for Food and Drug Administration Approval
To Market a New Drug: Patent Submission and Listing Requirements

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 extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements for
submission and listing of patent information associated with a new drug
application (NDA), an amendment, or a supplement.

DATES: Submit either electronic or written comments on the collection
of information by August 16, 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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Applications for FDA Approval To Market a New Drug: Patent Submission
and Listing Requirements and Application of 30-Month Stays on Approval
of Abbreviated New Drug Applications Certifying That a Patent Claiming
a Drug Is Invalid or Will Not Be Infringed--(OMB Control Number 0910-
0513)--Extension

    Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355(b)(1)) requires all NDA applicants to file, as
part of the NDA, ``the patent number and the expiration date of any
patent which claims the drug for which the applicant submitted the
application or which claims a method of using such drug and with
respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug.'' Section 505(c)(2) of the FD&C
Act (21 U.S.C. 355(c)(2)) imposes a similar patent submission
obligation on holders of approved NDAs when the NDA holder could not
have submitted the patent information with its application. Under
section 505(b)(1) of the FD&C Act, we publish patent information after
approval of an NDA in the list entitled ``Approved Drug Products With
Therapeutic Equivalence Evaluations'' (the Orange Book). If patent
information is submitted after NDA approval, section 505(c)(2) of the
FD&C Act directs us to publish the information upon its submission.
    FDA regulations at Sec. Sec.  314.50(h) (21 CFR 314.50(h)) and
314.53 (21 CFR 314.53) clarify the types of patent information that
must and must not be submitted to FDA as part of an NDA, an amendment,
or a supplement, and require persons submitting an NDA, an amendment,
or a supplement, or submitting information on a patent after NDA
approval, to make a detailed patent declaration using Forms FDA 3542
and 3542a.
    The reporting burden for submitting an NDA, an amendment, or a
supplement in accordance with Sec.  314.50

(a) through (f) and (k) has been estimated by FDA and the collection of
information has been approved by OMB under OMB control number 0910-
0001. We are not reestimating these approved burdens in this document.
Only the reporting burdens associated with patent submission and
listing, as explained in the following paragraphs, are estimated in
this document.
    The information collection reporting requirements are as follows:
    Section 314.50(h) requires that an NDA, an amendment, or a
supplement contain patent information described under Sec.  314.53.
    Section 314.53 requires that an applicant submitting an NDA, an
amendment, or a supplement, except as provided in Sec.  314.53(d)(2),
submit on Forms FDA 3542 and 3542a, the required patent information
described in this section.
    Compliance with the information collection burdens under Sec. Sec.
314.50(h) and 314.53 consists of submitting with an NDA, an amendment,
or a supplement (collectively referred to as ``application'') the
required patent declaration(s) on Form FDA 3542a for each ``patent that
claims the drug or a method of using the drug that is the subject of
the new drug application or amendment or supplement to it and with
respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner of the patent engaged in
the manufacture, use, or sale of the drug product'' (Sec.  314.53(b)).
Such patents claim the drug substance (active ingredient), drug product
(formulation and composition), or method of use. If a patent is issued
after the application is filed with FDA, but before the application is
approved, the applicant must submit the required patent information on
Form FDA 3542a as an amendment to the application, within 30 days of
the date of issuance of the patent.
    Within 30 days after the date of approval of an application, the
applicant must submit Form FDA 3542 for each patent that claims the
drug substance (active ingredient), drug product (formulation and
composition), or approved method of use for listing in the Orange Book.
In addition, for patents issued after the date of approval of an
application, Form FDA 3542 must be submitted within 30 days of the date
of issuance of the patent.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   21 CFR 314.50  (citing Sec.       Number of     responses per   Total annual     burden per      Total hours
             314.53)                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Form FDA 3542...................             183             2.8             512               5           2,560
Form FDA 3542a..................             201             2.8             563              20          11,260
    Total.......................          13,820
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The numbers of patents submitted to FDA for listing in the Orange
Book in 2010, 2011, and 2012 were 351, 329, and 458, respectively, for
an annual average of 379 (351 patents + 329 patents + 458 patents)/3
years = 379 patents/year). Because many of these individual patents are
included in multiple NDA submissions, there could be multiple
declarations for a single patent. From our previous review of
submissions, we believe that approximately 14 percent of the patents
submitted are included in multiple NDA submissions, and thus require
multiple patent declarations. Therefore, we estimate that 53 (379
patents x 14 percent) patents will be multiple listings, and there will
be a total of 432 patents (379 patents + 53 patents = 432 patents)
declared on Form FDA 3542. We approved 84, 93, and 86 NDAs in 2010,
2011, and 2012, respectively, of which approximately 71 percent
submitted patent information for listing in the Orange Book. The
remaining NDAs submitted Form FDA 3542 as required and declared that
there were no relevant patents. We also approved approximately 101, 83,
and 101 NDA supplements in 2010, 2011, and 2012, respectively, for
which submission of a patent declaration would be required. We estimate
there will be 183 instances (based on an average of 88 NDA approvals
and 95 supplement approvals per year) where an NDA holder would be
affected by the patent declaration requirements, and that each of these
NDA holders would, on average, submit 2.8 declarations (432 patent
declarations + 76 no relevant patent declarations)/183 instances = 2.8
declarations per instance) on Form FDA 3542. We filed 96, 91, and 112
NDAs in 2010, 2011, and 2012, respectively, and 100, 91, and 112 NDA
supplements in 2010, 2011, and 2012, respectively, for which submission
of a patent declaration would be required. We estimate there will be
201 instances (based on an average of 100 NDAs filed and 101 NDA
supplements filed per year) where an NDA holder would be affected by
the patent declaration requirements. We estimate, based on a
proportional increase from the number of declarations for approved
NDAs, that there will be an annual total of 563 declarations (201
instances x 2.8 declarations per instance = 563 declarations) on Form
FDA 3542a submitted with these applications. Based upon information
provided by regulated entities and other information, we previously
estimated that the information collection burden associated with Sec.
314.50(h) (citing Sec.  314.53) and Forms FDA 3542 and 3542a will be
approximately 5 hours and 20 hours per response, respectively.

    Dated: June 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14299 Filed 6-14-13; 8:45 am]
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[Federal Register Volume 88, Number 91 (Thursday, May 11, 2023)]
[Notices]
[Pages 30361-30362]
[FR Doc No: 2023-10000]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-21, OMB Control No. 3235-0025]

Proposed Collection; Comment Request; Extension: Rule 30e-1

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

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') is soliciting
comments on the collection of information summarized below. The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 30e-1 (17 CFR 270.30e-1) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) (``Investment Company Act'') generally
requires a registered investment company (``fund'') to transmit to its
shareholders, at least semi-annually, reports containing the
information that is required to be included in such reports by the
fund's registration statement form under the Investment Company Act.
The purpose of the collection of information required by rule 30e-1 is
to provide fund shareholders with current information about the
operation of their funds in accordance with Section 30 of the
Investment Company Act.
    Approximately 11,840 funds, respond to rule 30e-1 annually.\1\ We
estimate that it takes approximately 147 hours to comply with the
collection of information associated with rule 30e-1 per fund. This
time is spent, for example, preparing, reviewing, and certifying the
reports, as well as the website availability requirements and delivery
of shareholder reports upon request requirements. Accordingly, we
calculate the total estimated annual internal burden of responding to
rule 30e-1 to be approximately 1,738,428 hours (146.8 hours x 11,840
funds). In addition to the burden hours, we estimate that the total
cost burden of compliance with the information collection requirements
of rule 30e-1 is approximately $13,105 per fund. This includes, for
example, the cost of goods and services purchased to prepare, comply
with website availability requirements, and deliver reports upon
request under the amendments to rule 30e-1, such as for the services of
independent auditors and outside counsel. Accordingly, we calculate the
total external cost burden associated with rule 30e-1 to be
approximately $155,164,791.
---------------------------------------------------------------------------

    \1\ Includes all open-end funds, including ETFs, registered on
Form N-1A.
---------------------------------------------------------------------------

    Estimates of average burden hours are made solely for the purposes
of the Paperwork Reduction Act and are not

derived from a comprehensive or even representative survey or study of
the costs of Commission rules and forms. The collection of information
under rule 30e-1 is mandatory. The information provided under rule 30e-
1 will not be kept confidential. An agency may not conduct or sponsor,
and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted by July 10, 2023.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: May 5, 2023.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-10000 Filed 5-10-23; 8:45 am]
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