[Federal Register Volume 88, Number 177 (Thursday, September 14, 2023)]
[Notices]
[Pages 63180-63184]
[FR Doc No: 2023-19840]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98328; File No. SR-NSCC-2023-008]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Amend the Recovery and Wind-Down Plan

September 8, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 1, 2023, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the clearing agency.
NSCC filed the proposed rule change pursuant to section 19(b)(3)(A)

of the Act \3\ and Rule 19b-4(f)(4) thereunder.\4\ The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

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

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of amendments to the Recovery and
Wind-down Plan to reflect business and product developments that have
taken place since the time it was last amended, and make certain
changes to improve the clarity of the Plan and make other updates and
technical revisions, as described in greater detail below.\5\
---------------------------------------------------------------------------

    \5\ Capitalized terms not defined herein are defined in the
Rules and Procedures of NSCC (the ``Rules''), available at
www.dtcc.com/~/media/Files/Downloads/legal/rules/nscc_rules.pdf, or
in the Recovery & Wind-down Plan of NSCC (the ``R&W Plan'' or
``Plan'').
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
Executive Summary
    The R&W Plan was adopted in August 2018 \6\ and is maintained by
NSCC for compliance with Rule 17Ad-22(e)(3)(ii) under the Act.\7\ This
section of the Act requires registered clearing agencies to, in short,
establish, implement and maintain plans for the recovery and orderly
wind-down of the covered clearing agency necessitated by credit losses,
liquidity shortfalls, losses from general business risk, or any other
losses. The Plan is intended to be used by the Board and NSCC
management in the event NSCC encounters scenarios that could
potentially prevent it from being able to provide its critical services
to the marketplace as a going concern.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release Nos. 83974 (Aug. 28,
2018), 83 FR 44988 (Sep. 4, 2018), (SR-NSCC-2017-017); and 83955
(Aug. 27, 2018), 83 FR 44340 (Aug. 30, 2018) (SR-NSCC-2017-805).
    \7\ 17 CFR 240.17Ad-22(e)(3)(ii). NSCC is a ``covered clearing
agency'' as defined in Rule 17Ad-22(a)(5) under the Act and must
comply with paragraph (e) of Rule 17Ad-22.
---------------------------------------------------------------------------

    The R&W Plan is comprised of two primary sections: (i) the
``Recovery Plan,'' that sets out the tools and strategies to enable
NSCC to recover, in the event it experiences losses that exceed its
prefunded resources, and (ii) the ``Wind-down Plan,'' that describes
the tools and strategies to be used to conduct an orderly wind-down of
NSCC's business in a manner designed to permit the continuation of
NSCC's critical services in the event that its recovery efforts are not
successful.
    The purpose of the rule proposal is to amend the R&W Plan to
reflect business and product developments that have taken place since
the time it was last amended,\8\ make certain changes to improve the
clarity of the Plan and make other updates and technical revisions.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 91428 (Mar. 29,
2021), 86 FR 17440 Apr. 2, 2021 (SR-NSCC-2021-004).
---------------------------------------------------------------------------

    NSCC believes that by helping to ensure that the R&W Plan reflects
current business and product developments, providing additional
clarity, and making necessary grammatical corrections, that the
proposed rule change would help it continue to maintain the Plan in a
manner that supports the continuity of NSCC's critical services and
enables its Members and Limited Members to maintain access to NSCC's
services through the transfer of its membership in the event NSCC
defaults or the Wind-down Plan is ever triggered by the Board.
Background
    The R&W Plan is managed by the Office of Recovery & Resolution
Planning (referred to in the Plan as the ``R&R Team'') of NSCC's parent
company, the Depository Trust & Clearing Corporation (``DTCC''),\9\ on
behalf of NSCC, with review and oversight by the DTCC Management
Committee and the Board. In accordance with the SEC's Approval Order
covering the Plan,\10\ the Board, or such committees as may be
delegated authority by the Board from time to time, is required to
review and approve the R&W Plan biennially and would also review and
approve any changes that are proposed to the R&W Plan outside of the
biennial review. NSCC completed its most recent biennial review in
2022. The proposed rule change reflects amendments proposed to the
Plans resulting from that review, which are described in greater detail
below. None of the proposed changes modify NSCC's general objectives
and approach with respect to its recovery and wind-down strategy as set
forth under the current Plan.
---------------------------------------------------------------------------

    \9\ DTCC operates on a shared service model with respect to NSCC
and its other affiliated clearing agencies, Fixed Income Clearing
Corporation (``FICC'') and The Depository Trust Company (``DTC'').
Most corporate functions are established and managed on an
enterprise-wide basis pursuant to intercompany agreements under
which it is generally DTCC that provides relevant services to NSCC,
FICC and DTC (collectively, the ``Clearing Agencies'').
    \10\ Supra note 6.
---------------------------------------------------------------------------

A. Proposed Amendments to the R&W Plan

    NSCC is proposing the changes to the following sections of the Plan
based upon business updates and product developments that have occurred
since the Plan was last amended.\11\
---------------------------------------------------------------------------

    \11\ Supra note 8.
---------------------------------------------------------------------------

    Section 2.2 (NSCC Guaranteed Services Summary) describes those
services in which NSCC in its role as a clearing agency and a central
counterparty, provides clearing, netting, and settlement service and a
guarantee of completion for broker-to-broker equity, corporate and
municipal debt, exchange-traded products and unit investment trust
transactions executed on exchanges and other trading venues in the U.S.
NSCC proposes to update this section to add a description of a new
service, the Securities Financing Transaction (``SFT'') clearing
service, which was approved by the Commission in 2022.\12\ The SFT
service is a central clearing and settlement infrastructure for
overnight borrows and loans of equity securities (collectively,
securities financing transactions or ``SFTs''). The SFT clearing
service supports the central clearing of clients' SFTs intermediated by
Sponsoring Members or Agent Clearing Members as well as the central
clearing of SFTs between NSCC full-service Members. The SFT clearing
service also allows lenders and borrowers to submit pre-established
bilaterally-settled SFTs for clearing.
---------------------------------------------------------------------------

    \12\ See Securities Exchange Act Release No. 95011 (May 31,
2022), 87 FR 34339 (Jun. 6, 2022) (SR-NSCC-2022-003) (Order
Approving Proposed Rule Change to Introduce Central Clearing for
Securities Financing Transaction Clearing Service). NSCC also filed
the proposal as advance notice SR-NSCC-2022-801. See Securities
Exchange Act Release No. 94998 (May 27, 2022), 87 FR 33528 (Jun. 2,
2022) (SR-NSCC-2022-801) (Notice of No Objection to Advance Notice
to Introduce Central Clearing for Securities Financing Transaction
Clearing Service). (Securities Exchange Release No. 34-95011 (May
31, 2022), 87 FR 34339 (Jun. 6, 2022) (SR-NSCC-2022-003).
---------------------------------------------------------------------------

    Section 2.4 (Intercompany Arrangements) describes how corporate
support services are provided to NSCC

from DTCC and DTCC's other subsidiaries, through intercompany
agreements under a shared services model. This section includes a
table, (Facilities, Table 2-B), that lists each of the DTCC facilities
utilized by the Clearing Agencies and indicates whether the facility is
owned or leased. NSCC proposes to update this table to add Washington
DC, London, UK, and McLean, Virginia as additional DTCC facility
locations.
    Section 2.5 (FMI Links) \13\ describes some of the key financial
market infrastructures (``FMIs''), both domestic and foreign, that NSCC
has identified as critical ``links.'' \14\ As set out in this section
of the Plan, the inventory of NSCC's links is maintained by DTCC's
Systemic Risk Office (``SRO'') and the SRO has set forth a set of
practices and protocols for managing and reviewing the various risks
and controls associated with clearing agency links. Based on a change
to the SRO Clearing Agency Links-Risk Review Procedures, the proposal
would clarify that in addition to approval by the Chief Systemic Risk
Officer, the inventory of clearing agency links is also subject to the
approval of a Deputy General Counsel of the General Counsel's Office.
In addition, for purposes of completeness, the proposed rule change
would add a footnote to the table included in this section of the Plan,
(Table 2-C, Links), making clear that under SRO's Clearing Agency
Links-Risk Review Procedures, trading market links, such as equity
alternative trading systems and regulated securities exchanges are also
subject to the links risk review process; however, given the large
number of these links, they have not been separately delineated in
Table 2-C, Links.
---------------------------------------------------------------------------

    \13\ For purposes of consistency, under the proposed rule change
all references to ``FMI Links'' would be revised to refer to these
as ``Clearing Agency Links.''
    \14\ As defined in Rule 17Ad-22(a)(8) under the Act, a link
``means, for purposes of paragraph (e)(20) of Rule 17Ad-22, a set of
contractual and operational arrangements between two or more
clearing agencies, financial market utilities, or trading markets
that connect them directly or indirectly for the purposes of
participating in settlement, cross margining, expanding their
services to additional instruments or participants, or for any other
purposes material to their business.'' 17 CFR 240.17Ad-22(a)(8).
---------------------------------------------------------------------------

    Section 3 (Critical Services) defines the criteria for classifying
certain of NSCC's services as ``critical,'' \15\ and identifies such
critical services and the rationale for their classification. The
identification of NSCC's critical services is important for evaluating
how the recovery tools and the wind-down strategy would facilitate and
provide for the continuation of NSCC's critical services to the markets
it serves. There is also a table (Table 3-B: NSCC Critical Services)
that lists each of the services, functions or activities that NSCC has
identified as ``critical'' based on the applicability of the criteria.
In addition, there is a table (Table 3-C: Indicative Non-Critical NSCC
Services) that identifies indicative non-critical services of NSCC,
which list is not exhaustive. The proposed rule change would clarify
the description of the Account Information Transmission (``AIT'')
service \16\ by making clear that AIT can support transmissions for the
bulk account transfer initiative, which is an industry effort to
prepare carrying broker-dealers for an emergency mass transfer of large
quantities of customer accounts and assets from a distressed broker to
a financially secure broker-dealer and that in the absence of this
service, Members/Limited Members can process and settle their
investments manually, as transaction volumes are currently low enough
to handle manually, or outside of AIP.
---------------------------------------------------------------------------

    \15\ The criteria that is used to identify an NSCC service or
function as critical includes consideration as to whether (1) there
is a lack of alternative providers or products; (2) failure of the
service could impact NSCC's ability to perform its central
counterparty services; (3) failure of the service could impact
NSCC's ability to perform its netting services, and, as such, the
availability of market liquidity; and (4) the service is
interconnected with other participants and processes within the U.S.
financial system (for example, with other FMIs, settlement banks,
broker-dealers, and exchanges).
    \16\ As set forth in NSCC Rule 59 (Account Information
Transmission Service), AIT enables Members to transmit account
related information between themselves on an automated basis in
respect of the movement of correspondent accounts between Members,
or other material events that result in the bulk movement of
accounts between Members.
---------------------------------------------------------------------------

    Section 5.2.4 (Recovery Corridor and Recovery Phase) outlines the
early warning indicators to be used by NSCC to evaluate its options and
potentially prepare to enter the ``Recovery Phase,'' which phase refers
to the actions to be taken by NSCC to restore its financial resources
and avoid a wind-down of its business. This section contains
descriptions of potential stress events that could lead to recovery,
and several early warning indicators and metrics that NSCC has
established to evaluate its options and potentially prepare to enter
the Recovery Phase. These indicators, which are referred to in the
Recovery Plan as recovery corridor indicators (``Corridor Indicators''
or ``Indicator(s)''),\17\ are calibrated against NSCC's financial
resources and are designed to give NSCC the ability to replenish
financial resources, typically through business-as-usual tools applied
prior to entering the Recovery Phase. Included in this section is a
table (Table 5-A: Corridor Indicators) that identifies for each
Indicator (i) how it is measured, (ii) the basis for the evaluation of
the status of the Indicator, (iii) the type of metrics used for
determining the status of the deterioration or improvement of the
Indicator, and (iv) ``Corridor Actions & Escalation,'' which are those
steps that may be taken to improve the status of the Indicator and the
management escalations required to authorize those steps. The proposed
rule change would provide the following clarifications to Table 5-A.
---------------------------------------------------------------------------

    \17\ The majority of the Corridor Indicators, as identified in
the Recovery Plan, relate directly to conditions that may require
NSCC to adjust its strategy for hedging and liquidating a defaulting
Member's portfolio, and any such changes would include an assessment
of the status of the Corridor Indicators.
---------------------------------------------------------------------------

    First, for purposes of providing additional context on the
applicable measurement, the proposed rule change would clarify the
entry for the ``Hedge Effectiveness'' Indicator \18\ set out in Table
5-A. Specifically, the language in the measurement column for this
Indicator would be revised to clarify that if the hedge effectiveness
measures are outside of the designated metrics due to certain types of
factors (e.g., mismatch in portfolio profit and loss (``P&L'') and
hedge P&L due to timing of initiating the hedge or the portfolio),
management would document the performance and only escalate to the
Board Risk Committee and Management Risk Committee if the measurement
status deteriorates in a material respect.
---------------------------------------------------------------------------

    \18\ Hedging is a risk management strategy that would be
employed when executing the liquidation of a defaulting Member's
portfolio to potentially help reduce the risk of loss of an existing
position.
---------------------------------------------------------------------------

    Second, regarding ``Commercial Paper/Extendible Notes,'' \19\ the
description of when the applicable metrics for this Indicator reflect a
deterioration would be revised to remove the specific dollar threshold
(currently, the inability to source at least $1.0 billion) and replace
it with a general statement regarding NSCC's inability to source
additional funding via issuance of commercial paper when needed. The
description of the improvement metric would be revised similarly to
remove the specific dollar threshold (currently, an ability to source
at least $2.5 billion) and replace it with a general statement of
NSCC's ability to source additional funding via issuance of commercial
paper. The dollar thresholds would be removed to provide

discretion and flexibility to evaluate this indicator and take actions,
as needed. Additionally, under ``Corridor Actions'' for purposes of
consistency with the language formulation used for the other
Indicators, the statement that currently reads ``If this indicator has
been triggered, and if less than 50% of overall liquidity resources are
available, NSCC would evaluate the liquidation speeds and potential
price impacts of increased liquidation speeds--particularly for large
positions,'' would be revised to remove the phrase, ``and if less than
50% of overall liquidity resources are available.''
---------------------------------------------------------------------------

    \19\ The Commercial Paper/Extendible Notes indicator measures
the ability of NSCC to roll-over and potentially increase issuance
of its commercial paper.
---------------------------------------------------------------------------

    Third, for the ``Retirements/Trade Volume Reductions''
Indicator,\20\ a clarification would be made to identify Client Account
Management and NSCC Global Business Operations as the internal groups
responsible for measurement of the applicable deterioration and
improvement Indicator metrics.
---------------------------------------------------------------------------

    \20\ The Retirements/Transaction Reductions indicator measures
Member terminations or curtailment of transactions that impact the
financial viability of NSCC.
---------------------------------------------------------------------------

    Section 5.3 (Liquidity Shortfalls) identifies tools that may be
used to address foreseeable shortfalls in NSCC's liquidity resources
following a Member default. The goal in managing NSCC's qualifying
liquidity resources is to maximize resource availability in an evolving
stress situation, to maintain flexibility in the order and use of
sources of liquidity, and to repay any third-party lenders of liquidity
in a timely manner. This section includes a table (Table 5-C) that
lists NSCC liquidity tools and resources.\21\ The proposed rule change
would make the following clarifications to Table 5-C: (i) under the
entry for the ``Unissued Commercial Paper'' liquidity resource, the
language would be revised to clarify that unissued commercial paper
capacity could be deployed, but remove the existing language that it
could be increased within 2 weeks depending on market conditions, since
this timeframe could be adjusted depending on the overall
circumstances, and (ii) under the description of the NSCC's ``Non-
Qualifying Liquid Resources,'' for the current language specifying a
one-to two week timeframe for NSCC to enter into new Master Repurchase
Agreements would be removed because more flexibility of time is needed
for NSCC to establish new agreements. Thus, the updated language would
state that ``NSCC would utilize existing Master Repurchase Agreements
or establish new Master Repurchase Agreements utilizing standard
agreements.''
---------------------------------------------------------------------------

    \21\ Table 5-C lists the following NSCC liquidity tools: Utilize
short-settling liquidating trades, Increase the speed of portfolio
asset sales, Credit Facility, Unissued Commercial Paper, Non-
Qualifying Liquid Resources, and Uncommitted stock loan and equity
repos.
---------------------------------------------------------------------------

B. Other Updates, Clarifications and Technical Revisions
    NSCC is also proposing to make other updates and technical
revisions to the Plan. These technical revisions would, for example,
make grammatical corrections, update the names of certain NSCC internal
groups, and clarify the description of internal organizations, without
changing the substantive statements being revised.
    For example, in Section 2.4, Table 2-A (SIFMU Legal Entity
Structure and Intercompany Agreements), for purposes of clarifying the
full scope of services provided by NSCC's affiliate, DTC, the
description of DTC's services would be revised from ``Underwriting,
Securities Processing, Corporate Actions,'' to ``Asset Services.'' Some
other examples include: (i) a revision would be made throughout the
Plan to reflect an internal name change from DTCC's ``Operational Risk
Management'' to ``Operational Risk,'' and add a new internal
organization, ``Embedded Risk Management,'' \22\ (ii) all references to
``FMI Links'' would be revised to refer to these as ``Clearing Agency
Links,'' (iii) in the table listing NSCC's liquidity tools (Table 5-C)
replacing the terms ``medium-term notes'' and ``term debt'' with
``senior debt'' to more accurately identify the instrument consistent
with how DTCC Treasury identifies these, and (iv) in the section
covering DTCC facilities, the name of the DTCC legal entity that is the
holder of the lease for the Manila location would be changed from
``DTCC'' to ``DTCC Manila.''
---------------------------------------------------------------------------

    \22\ The Embedded Risk Management group supports the R&R Team.
For example, they may assist in the identification of new
initiatives, processes, or product developments that may impact
NSCC's R&W Plan.
---------------------------------------------------------------------------

    NSCC believes the proposed updates and technical revisions would
improve the clarity and accuracy of the Plan and, therefore, would help
facilitate the execution of Plan, if necessary.
2. Statutory Basis
    NSCC believes that the proposal is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
registered clearing agency. In particular, NSCC believes that the
amendments to the R&W Plan are consistent with section 17A(b)(3)(F) of
the Act \23\ and Rule 17Ad-22(e)(3)(ii) under the Act,\24\ for the
reasons described below.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78q-1(b)(3)(F).
    \24\ 17 CFR 240.17Ad-22(e)(3)(ii).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of NSCC be designed to promote the prompt and accurate clearance and
settlement of securities transactions. As described above, the proposed
rule change would update the R&W Plan to reflect business and product
developments and make certain technical corrections. By helping to
ensure that the R&W Plan reflects current business and product
developments, and providing additional clarity, NSCC believes that the
proposed rule change would help it continue to maintain the Plan in a
manner that supports the continuity of NSCC's critical services and
enables its Members and Limited Members to maintain access to NSCC's
services through the transfer of its membership in the event NSCC
defaults or the Wind-down Plan is ever triggered by the Board. Further,
by facilitating the continuity of its critical clearance and settlement
services, NSCC believes the Plan and the proposed rule change would
continue to promote the prompt and accurate clearance and settlement of
securities transactions. Therefore, NSCC believes the proposed
amendments to the R&W Plan are consistent with the requirements of
section 17A(b)(3)(F) of the Act.
    Rule 17Ad-22(e)(3)(ii) under the Act requires NSCC to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to maintain a sound risk management framework for
comprehensively managing legal, credit, liquidity, operational, general
business, investment, custody, and other risks that arise in or are
borne by the covered clearing agency, which includes plans for the
recovery and orderly wind-down of the covered clearing agency
necessitated by credit losses, liquidity shortfalls, losses from
general business risk, or any other losses.\25\
---------------------------------------------------------------------------

    \25\ Id.
---------------------------------------------------------------------------

    Specifically, the Recovery Plan defines the risk management
activities, stress conditions and indicators, and tools that NSCC may
use to address stress scenarios that could eventually prevent it from
being able to provide its critical services as a going concern. Through
the framework of the Crisis Continuum, the Recovery Plan addresses
measures that NSCC may take to address risks of credit losses and
liquidity shortfalls, and other losses that could arise from a
Participant default. The Recovery Plan also addresses the management of
general business risks

and other non-default risks that could lead to losses. The Wind-down
Plan would be triggered by a determination by the Board that recovery
efforts have not been, or are unlikely to be, successful in returning
NSCC to viability as a going concern. Once triggered, the Wind-down
Plan sets forth clear mechanisms for the transfer of NSCC's membership
and business and is designed to facilitate continued access to NSCC's
critical services and to minimize market impact of the transfer. By
establishing the framework and strategy for the execution of the
transfer and wind-down of NSCC in order to facilitate continuous access
to its critical services, the Wind-down Plan establishes a plan for the
orderly wind-down of NSCC.
    As described above, the proposed rule change would update the R&W
Plan to reflect business and product developments and make certain
technical corrections. By ensuring that material provisions of the Plan
are current, clear, and technically correct, NSCC believes that the
proposed amendments are designed to support the maintenance of the Plan
for the recovery and orderly wind-down of the covered clearing agency
necessitated by credit losses, liquidity shortfalls, losses from
general business risk, or any other losses, and, as such, meets the
requirements of Rule 17Ad-22(e)(3)(ii) under the Act.\26\ Therefore,
the proposed changes would help NSCC to maintain the Plan in a way that
continues to be consistent with the requirements of Rule 17Ad-
22(e)(3)(ii).
---------------------------------------------------------------------------

    \26\ Id.
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    NSCC does not believe that the proposed rule change would have any
impact, or impose any burden, on competition. NSCC does not anticipate
that the proposal would affect its day-to-day operations under normal
circumstances, or in the management of a typical Member default
scenario or non-default event. The R&W Plan was developed and
documented to satisfy applicable regulatory requirements, as discussed
above. The proposal is intended to enhance and update the Plan to
ensure it is clear and remains current in the event it is ever
necessary to be implemented. The proposed revisions would not affect
any changes to the overall structure or operation of the Plan or NSCC's
recovery and wind-down strategy as set forth under the current Plan. As
such, NSCC believes the proposal would not have any impact, or impose
any burden, on competition.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    NSCC has not received or solicited any written comments relating to
this proposal. If any written comments are received, NSCC will amend
this filing to publicly file such comments as an Exhibit 2 to this
filing, as required by Form 19b-4 and the General Instructions thereto.
    Persons submitting written comments are cautioned that, according
to Section IV (Solicitation of Comments) of the Exhibit 1A in the
General Instructions to Form 19b-4, the Commission does not edit
personal identifying information from comment submissions. Commenters
should submit only information that they wish to make available
publicly, including their name, email address, and any other
identifying information.
    All prospective commenters should follow the Commission's
instructions on How to Submit Comments, available at www.sec.gov/regulatory-actions/how-to-submit-comments.
    General questions regarding the rule filing process or logistical
questions regarding this filing should be directed to the Main Office
of the Commission's Division of Trading and Markets at
[email protected] or<PHONE_NUMBER>.
    NSCC reserves the right to not respond to any comments received.

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A) \27\ of the Act and paragraph (f) \28\ of Rule 19b-4
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78s(b)(3)(A).
    \28\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NSCC-2023-008 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-NSCC-2023-008. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549 on official business days between the hours of 10
and 3 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of NSCC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). Do not include personal
identifiable information in submissions; you should submit only
information that you wish to make available publicly. We may redact in
part or withhold entirely from publication submitted material that is
obscene or subject to copyright protection. All submissions should
refer to File Number SR-NSCC-2023-008 and should be submitted on or
before October 5, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-19840 Filed 9-13-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Rules and Regulations]
[Pages 35538-35539]
[FR Doc No: 2018-15980]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0286; Product Identifier 2018-CE-008-AD; Amendment
39-19340; AD 2018-15-08]
RIN 2120-AA64

Airworthiness Directives; Pacific Aerospace Limited Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for Pacific
Aerospace Limited Model 750XL airplanes. This AD results from mandatory
continuing airworthiness information (MCAI) issued by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as airplane sound insulation materials attached to the aft
face of the firewall not complying with the applicable burn testing
criteria for materials on the cabin side of the firewall. We are
issuing this AD to require actions to address the unsafe condition on
these products.

DATES: This AD is effective August 31, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of August 31,
2018.

ADDRESSES: You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0286; or in person at Docket Operations, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
    For service information identified in this AD, contact Pacific
Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton
3240, New Zealand; phone: +64 7843 6144; fax: +64 843 6134; email:
[email protected]; internet: www.aerospace.co.nz. You may view
this referenced service information at the FAA, Policy and Innovation
Division, 901 Locust, Kansas City, Missouri 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the internet at http://www.regulations.gov by
searching for Docket No. FAA-2018-0286.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to Pacific Aerospace Limited
Model 750XL airplanes. The NPRM was published in the Federal Register
on April 11, 2018 (83 FR 15517). The NPRM proposed to correct an unsafe
condition for the specified products and was based on mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country. The MCAI states:

    The sound insulation material on the aft face of the firewall
must comply with the applicable burn test criteria specified in FAR
[14 CFR] 23.853(f). [As of August 30, 2017, Sec.  23.853 was
replaced by Sec.  23.2325 (81 FR 96572, December 30, 2016).]
    Inspect the aft face of the firewall and determine if sound
insulation material is installed per the instructions in Pacific
Aerospace Mandatory Service Bulletin (MSB) PACSB/XL/095 issue 1,
dated 21 December 2017, or later approved revision.
    If a layer of black foam insulating material is found covering
the firewall, then remove the material per the instructions in MSB
PACSB/XL/095 before further flight.

    The MCAI can be found in the AD docket on the internet at: https://www.regulations.gov/document?D=FAA-2018-0286-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed.

Related Service Information Under 1 CFR Part 51

    We reviewed Pacific Aerospace Service Bulletin PACSB/XL/095, Issue
1, dated December 21, 2017. The service information describes
procedures for inspection of the airplane sound insulation attached to
the aft face of the firewall and removal if necessary. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD will affect 22 products of U.S. registry.
We also estimate that it would take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of this AD on U.S.
operators to be $1,870, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 8 work-hours, for a cost of $680 per product. We have no way
of determining the number of products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C.

In accordance with that order, issuance of ADs is normally a function
of the Compliance and Airworthiness Division, but during this
transition period, the Executive Director has delegated the authority
to issue ADs applicable to small airplanes, gliders, balloons,
airships, domestic business jet transport airplanes, and associated
appliances to the Director of the Policy and Innovation Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0286; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
the NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (telephone (800)
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-15-08 Pacific Aerospace Limited: Amendment 39-19340; Docket No.
FAA-2018-0286; Product Identifier 2018-CE-008-AD.

(a) Effective Date

    This AD becomes effective August 31, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pacific Aerospace Limited Model 750XL
airplanes, all serial numbers up to and including 215, certificated
in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 54: Nacelles/
Pylons.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and address an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as airplane sound
insulation materials attached to the aft face of the firewall not
complying with the applicable burn testing criteria for materials on
the cabin side of the firewall. We are issuing this AD to prevent
the spread of fire into the cabin in case of an engine fire.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) and (2) of this AD:
    (1) Within 90 days after August 31, 2018 (the effective date of
this AD), inspect the aft face of the firewall and determine if the
sound insulation material is installed per the Inspection
Instructions in Pacific Aerospace Service Bulletin PACSB/XL/095,
Issue 1, dated December 21, 2017.
    (2) If a layer of black foam insulating material is found
covering the firewall during the inspection required in paragraph
(f)(1) of this AD, before further flight, remove the material per
the Accomplishment Instructions in Pacific Aerospace Service
Bulletin PACSB/XL/095, Issue 1, dated December 21, 2017.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Small Airplane Standards Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Mike Kiesov, Aerospace Engineer,
FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816) 329-
4090; email: [email protected]. Before using any approved AMOC on
any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, Small Airplane
Standards Branch, FAA; or the Civil Aviation Authority of New
Zealand (CAA).

(h) Related Information

    Refer to MCAI CAA AD DCA/750XL/27A, dated March 1, 2018, for
related information. You may examine the MCAI on the internet at:
https://www.regulations.gov/document?D=FAA-2018-0286-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Pacific Aerospace Service Bulletin PACSB/XL/095, Issue 1,
dated December 21, 2017.
    (ii) Reserved.
    (3) For Pacific Aerospace Limited service information identified
in this AD, contact Pacific Aerospace Limited, Airport Road,
Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; phone: +64
7843 6144; fax: +64 843 6134; email: [email protected];
internet: www.aerospace.co.nz.
    (4) You may view this service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2018-0286.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on July 20, 2018.
Pat Mullen,
Aircraft Certification Service, Acting Deputy Director, Policy &
Innovation Division, AIR-601.
[FR Doc. 2018-15980 Filed 7-26-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49398-49399]
[FR Doc No: 2017-23167]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3395-EM; Docket ID FEMA-2017-0001]

Florida; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Florida (FEMA-3395-EM), dated October 8,
2017, and related determinations.

DATES: The declaration was issued October 8, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 8, 2017, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Florida resulting from Hurricane Nate beginning on
October 7, 2017, and continuing, are of sufficient severity and
magnitude to warrant an emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (``the Stafford Act''). Therefore, I declare that such
an emergency exists in the State of Florida.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Willie
G. Nunn, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Florida have been designated as
adversely affected by this declared emergency:

    Escambia and Santa Rosa Counties for emergency protective
measures (Category B), including direct federal assistance, under
the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-23167 Filed 10-24-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 28 (Thursday, February 10, 2011)]
[Notices]
[Pages 7594-7595]
[FR Doc No: 2011-2932]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

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

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``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 for extension and approval.

    Rule 104 of Regulation M (17 CFR 242.104)--Stabilizing and Other
Activities in Connection with an Offering permits stabilizing by a
distribution participant during a distribution so long as the
distribution participant discloses information to the market and
investors. This rule requires disclosure in offering materials of the
potential stabilizing transactions and that the distribution
participant inform the market when a stabilizing bid is made. It also
requires the distribution participants (i.e. the syndicate manager) to
maintain information regarding syndicate covering transactions and
penalty bids and disclose such information to the Self-Regulatory
Organization (SRO).
    There are approximately 745 respondents per year that require an
aggregate total of 149 hours to comply with this rule. Each respondent
makes an estimated 1 annual response. Each response takes approximately
0.20 hours (12 minutes) to complete. Thus, the total compliance burden
per year is 149 burden hours. The total internal labor compliance cost
for the respondents is approximately $9,983.00, resulting in a cost of
compliance for the respondent per response of approximately $13.40
(i.e., $9,983/745 responses).
    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
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be 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 in
writing within 60 days of this publication.
    Comments should be directed to: Thomas Bayer, Chief Information
Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon,
6432 General Green Way, Alexandria, Virginia 22312 or send an e-mail
to<EMAIL_ADDRESS>Comments must be submitted within 60 days of
this notice.

    Dated: February 3, 2011.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-2932 Filed 2-9-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Proposed Rules]
[Pages 72841-72843]
[FR Doc No: 2013-28979]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-1525]

List of Bulk Drug Substances That May Be Used in Pharmacy
Compounding; Bulk Drug Substances That May Be Used To Compound Drug
Products in Accordance With Section 503A of the Federal Food, Drug, and
Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Withdrawal of proposed rule; request for nominations.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing the proposed rule to list bulk drug substances used in
pharmacy compounding and preparing to develop a list of bulk drug
substances (bulk drugs) that may be used to compound drug products,
although they are neither the subject of a United States Pharmacopeia
(USP) or National Formulary (NF) monograph nor components of FDA-
approved drugs. To identify candidates for this bulk drugs list,
interested groups and individuals may nominate specific bulk drug
substances, and FDA is describing the information that should be
provided to the Agency in support of each nomination.

DATES: FDA is withdrawing the proposed rule published January 7, 1999
(64 FR 996), as of December 4, 2013.
    Submit written or electronic nominations for the bulk drug
substances list by March 4, 2014.

ADDRESSES: You may submit nominations, identified by Docket No. FDA-
2013-N-1525, by any of the following methods.

Electronic Submissions

    Submit electronic nominations in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting ``comments.''

Written Submissions

    Submit written nominations in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and docket number FDA-2013-N-1525 for this request for nominations. All
nominations received may be posted without change to http://www.regulations.gov, including any personal information provided. For
additional information on submitting nominations, see the ``Request for
Nominations'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
nominations received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marissa Chaet Brykman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002,
301-796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 353a) describes the conditions under which a human drug
product compounded for an identified individual patient based on a
prescription is entitled to an exemption from three sections of the
FD&C Act: (1) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice (CGMP) for drugs); (2) section
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with
adequate directions for use); and (3) section 505 (21 U.S.C. 355)
(concerning the approval of human drug products under new drug
applications (NDAs) or abbreviated new drug applications (ANDAs)).
    One of the conditions for such an exemption is that a drug product
may be compounded if the licensed pharmacist or licensed physician
compounds the drug product using bulk drug substances that: ``(I)
comply with the standards of an applicable United States Pharmacopoeia
or National Formulary monograph, if a monograph exists, and the United
States Pharmacopoeia chapter on pharmacy compounding; (II) if such a
monograph does not exist, are drug substances that are components of
drugs approved by the Secretary; or (III) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, that appear on a list developed by the Secretary through
regulations issued by the Secretary under subsection (d) [of Section
503A]'' (section 503A(b)(1)(A)(i) of the FD&C Act).
    Section 503A refers to the definition of ``bulk drug substance'' in
FDA regulations at 21 CFR 207.3(a)(4): ``any substance that is
represented for use in a drug and that, when used in the manufacturing,
processing, or packaging of a drug, becomes an active ingredient or a
finished dosage form of the drug, but the term does not include
intermediates used in the synthesis of such substances.'' See section
503A(b)(1)(A) of the FD&C Act.
    Section 503A(d)(1) of the FD&C Act requires that, before issuing
regulations to implement section 503A(b)(1)(A)(i)(III) of the FD&C Act,
an advisory committee on compounding be convened and consulted ``unless
the Secretary determines that the issuance of such regulations before
consultation is necessary to protect the public health'' (section
503A(d)(1) of the FD&C Act).
    As described in more detail below, in 1998, FDA began to develop a
list of bulk drug substances that may be used in compounding, but
before a final rule was published, the constitutionality of section
503A was challenged in court because it included restrictions on the
advertising or promotion of the compounding of any particular drug,
class of drug, or type of drug and the solicitation of prescriptions
for compounded drugs. These provisions were held unconstitutional by
the U.S. Supreme Court in 2002.\1\ After the court decision, FDA
suspended its efforts to develop the list of bulk drug substances that
could be used in compounding.
---------------------------------------------------------------------------

    \1\ See Thompson v. Western States Med. Ctr., 535 U.S. 357
(2002).
---------------------------------------------------------------------------

    The Drug Quality and Security Act (DQSA) removes from section 503A
of the FD&C Act the provisions that had been held unconstitutional by
the U.S. Supreme Court in 2002.\2\ By removing these provisions, the
new law removes uncertainty regarding the validity of section 503A,
clarifying that it applies nationwide. Therefore, FDA is reinitiating
its efforts to develop a list of bulk drug substances that may be used
in compounding under section 503A.
---------------------------------------------------------------------------

    \2\ The DQSA also adds a new section 503B to the FD&C Act (21
U.S.C. 353b) that creates a new category of ``outsourcing
facilities.'' For additional information concerning bulk drug
substances that may be used to compound drug products in accordance
with section 503B, see the notice, ``Bulk Drug Substances That May
Be Used to Compound Drug Products in Accordance with Section 503B of
the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing
Facilities; Request for Nominations'' published in this issue of the
Federal Register.
---------------------------------------------------------------------------

II. Previous Efforts To Develop the List of Bulk Drug Substances Under
Section 503A of the FD&C Act

    In the Federal Register of April 7, 1998 (63 FR 17011), FDA invited
all interested persons to nominate bulk drug substances for inclusion
on the list of bulk drug substances that may be used in compounding
under section 503A. In total, FDA received nominations for 41 different
drug substances. After evaluating the nominated drugs and consulting
with the Pharmacy Compounding Advisory Committee as required by section
503A, FDA published a proposed rule proposing to list 20 drugs on the
section 503A bulk drugs list in January 1999 (64 FR 996, January 7,
1999). The proposed rule also discussed 10 nominated drug substances
that were still under consideration for the bulk drugs list. The
Pharmacy Compounding Advisory Committee reconvened in May 1999 to
discuss drugs included in the proposed rule, in addition to other bulk
drug substances (see 64 FR 19791 (April 22, 1999)). However, as
explained previously (see the ``Background'' section), after the 2002
U.S. Supreme Court decision, the Agency suspended its efforts to
develop the bulk drugs list under section 503A.
    FDA intends to reconsider the bulk drug substances that were
proposed for inclusion on the list and that neither have an applicable
USP or NF monograph nor are components of an FDA-approved drug due to
the time

lapse since the last proposal. Therefore, the Agency withdraws the
proposed rule, ``List of Bulk Drug Substances That May Be Used in
Pharmacy Compounding,'' published in the Federal Register of January 7,
1999 (64 FR 996).

III. Request for Nominations

    To identify candidates for this list, FDA is seeking public input
in the form of specific bulk drug nominations. All interested groups
and individuals may nominate specific bulk drug substances for
inclusion on the list. After evaluating the nominations and, as
required by section 503A, consulting with the USP and the Pharmacy
Compounding Advisory Committee, FDA will issue the list as a regulation
under notice-and-comment rulemaking procedures.
    Nominations should include the following information about the bulk
drug substance being nominated and the product(s) that will be
compounded using such substance, and any other relevant information
available. If the information requested is unknown or unavailable, that
fact should be noted accordingly.

Bulk Drug Substance

     Ingredient name;
     Chemical name;
     Common name(s);
     Chemical grade or description of the strength, quality,
and purity of the ingredient;
     Information about how the ingredient is supplied (e.g.,
powder, liquid);
     Information about recognition of the substance in foreign
pharmacopeias and the status of its registration(s) in other countries,
including whether information has been submitted to USP for
consideration of monograph development; and
     A bibliography of available safety and efficacy data,\3\
including any relevant peer-reviewed medical literature.
---------------------------------------------------------------------------

    \3\ FDA recognizes that the available safety and efficacy data
supporting consideration of a bulk drug substance for inclusion on
the list may not be of the same type, amount, or quality as is
required to support an NDA.
---------------------------------------------------------------------------

Compounded Product

     Information about the dosage form(s) into which the drug
substance will be compounded (including formulations);
     Information about the strength(s) of the compounded
product(s);
     Information about the anticipated route(s) of
administration of the compounded product(s);
     Information about the past and proposed use(s) of the
compounded product(s), including the rationale for its use or why the
compounded product(s), as opposed to an FDA-approved product, is
necessary; and
     Available stability data for the compounded product(s).
    FDA cannot guarantee that all drugs nominated during the nomination
period will be considered for inclusion on the next published bulk
drugs list. Nominations received during the nomination period that are
supported by the most complete and relevant information will likely be
evaluated first. Nominations that are not evaluated during this first
phase will receive consideration for list amendments, as the
development of this list will be an ongoing process. Individuals and
organizations also will be able to petition FDA to make additional list
amendments after the list is published.
    Interested persons may submit either electronic nominations to
http://www.regulations.gov or written nominations to the Division of
Dockets Management (see ADDRESSES). It is only necessary to send one
set of nominations. Identify nominations with the docket number found
in the brackets in the heading of this document. Received nominations
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.

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28979 Filed 12-2-13; 11:15 am]
BILLING CODE 4160-01-P


[Federal Register: September 7, 2007 (Volume 72, Number 173)]
[Notices]
[Page 51424-51425]
[DOCID:fr07se07-49]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-615-000]

Egan Hub Storage, LLC; Notice of Proposed Changes in FERC Gas
Tariff

August 29, 2007.
    Take notice that on August 24, 2007, Egan Hub Storage, LLC (Egan
Hub) tendered for filing as part of its FERC Gas Tariff, First Revised
Volume No. 1, the tariff sheets listed in Appendix A of the filing to
be effective September 26, 2007.
    Egan Hub states that the purpose of this filing is to: (i)
Implement new enhanced park and loan services; (ii) revise the
contracting provisions in the Egan Hub Tariff to promote administrative
efficiency, further automate the process for requesting and contracting
for service, and ensure Egan Hub's continued compliance with Commission
regulations; (iii) clarify one aspect of Egan Hub's creditworthiness
provisions; and (iv) modify various exhibits to the forms of service
agreements in order to accurately reflect the specific details of each
transaction.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for

review in the Commission's Public Reference Room in Washington, DC.
There is an ``eSubscription'' link on the Web site that enables
subscribers to receive e-mail notification when a document is added to
a subscribed docket(s). For assistance with any FERC Online service,
please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll
free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-17660 Filed 9-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57252-57253]
[FR Doc No: 2020-20305]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2018-0005]

Whistleblower Stakeholder Meeting

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of public meeting.

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

SUMMARY: The Occupational Safety and Health Administration (OSHA) is
announcing a public meeting to solicit comments and suggestions from
stakeholders on issues facing the agency in the administration of the
whistleblower laws it enforces.

DATES: The public meeting will be held on October 13, 2020, from 1:00
p.m. to 4:00 p.m., ET via telephone. Persons

interested in attending the meeting must register by October 6, 2020.
In addition, comments relating to the ``Scope of Meeting'' section of
this document must be submitted in written or electronic form by
October 6, 2020.

ADDRESSES:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, which is the Federal
eRulemaking portal. Follow the on-line instructions for submissions.
All comments should be identified with Docket No. OSHA-2018-0005.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, OSHA Docket No. OSHA-2018-0005,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210.
Please note: While OSHA's Docket Office is continuing to accept and
process submissions by regular mail, due to the COVID-19 pandemic, the
Docket Office is closed to the public and not able to receive
submissions to the docket by hand, express mail, messenger, and courier
service.
    Registration to Attend and/or to Participate in the Telephonic
Meeting: If you wish to attend the public meeting, make an oral
presentation at the meeting, or participate in the meeting, you must
register using this link: https://www.eventbrite.com/e/whistleblower-stakeholder-meeting-tickets-118496465117 by close of business on
October 6, 2020. Actual times provided for presentation will depend on
the number of requests, but no more than 10 minutes per participant
will be allowed. There is no fee to register for the public meeting.
After reviewing the requests to present, OSHA will contact each
participant prior to the meeting to inform them of the speaking order.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    For general information: Mr. Anthony Rosa, Deputy Director, OSHA
Directorate of Whistleblower Protection Programs, U.S. Department of
Labor; telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. Scope of Meeting

    OSHA is interested in obtaining information from the public on key
issues facing the agency's whistleblower program. This meeting is the
sixth in a series of meetings requesting public input on this program.
The agency is seeking suggestions on how it can improve the program.
Please note that the agency does not have the authority to change the
statutory language and requirements of the laws it enforces. In
particular, the agency invites input on the following:

    1. How can OSHA deliver better whistleblower customer service?
    2. What kind of assistance can OSHA provide to help explain the
agency's whistleblower laws to employees and employers?
    3. Are there particular whistleblowing issues in the healthcare,
retail, and grocery industries that OSHA should be aware of?

B. Request for Comments

    Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments (see ADDRESSES). Submit a
single copy of electronic comments or two paper copies of any mailed
comments. To permit time for interested persons to submit data,
information, or views on the issues in the ``Scope of Meeting'' section
of this notice, please submit comments by October 6, 2020, and include
Docket No. OSHA-2018-0005.

C. Access to the Public Record

    Electronic copies of this Federal Register notice are available at:
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, also are available on the Directorate of
Whistleblower Protection Programs' web page at: http://www.whistleblowers.gov.

Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary for Occupational
Safety and Health, authorized the preparation of this notice under the
authority granted by Secretary's Order 08-2020 (May 15, 2020).

    Signed at Washington, DC, on September 9, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2020-20305 Filed 9-14-20; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: January 7, 2010 (Volume 75, Number 4)]
[Rules and Regulations]
[Page 915-916]
[DOCID:fr07ja10-6]

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

DEPARTMENT OF TRANSPORTATION

14 CFR Part 97

[Docket No. 30704; Amdt. No. 3355]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective January 7, 2010. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of January 7, 2010.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420)Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK. 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1

CFR part 51, and Sec.  97.20 of Title 14 of the Code of Federal
Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on December 25, 2009.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC date            State               City               Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
14-Jan-10............  TX.............  Longview...........  East Texas Rgnl....       9/5041     12/16/09  VOR/DME or TACAN Rwy 31, Amdt 7.
11-Feb-10............  WA.............  Seattle............  Seattle-Tacoma Intl       9/5533     12/18/09  ILS or LOC Rwy 16R, Orig-B; ILS Rwy 16R (Cat
                                                                                II), Orig-B; ILS Rwy 16R (Cat III), Orig-B.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. E9-31311 Filed 1-6-10; 8:45 am]

BILLING CODE 4910-13-P