[Federal Register: May 8, 2008 (Volume 73, Number 90)]
[Notices]
[Page 26170-26174]
[DOCID:fr08my08-135]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57762; File No. SR-BSE-2008-25]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing of a Proposed Rule Change Relating to Proposal to
Transfer Boston Stock Exchange, Inc.'s Ownership Interest in Boston
Options Exchange Group, LLC

May 1, 2008.
    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 April 23, 2008, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the BSE. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to transfer its 21.87% ownership interest in
the Boston Options Exchange Group, LLC (``BOX''), the operator of its
Boston Options Exchange facility (``BOX Market'') \3\ to MX US 2, Inc.
(``MX US''), a wholly-owned U.S. subsidiary of the Montr[eacute]al
Exchange Inc. (``MX''), such that, following the transfer, the
Exchange's aggregate Percentage Interest will be 0% and MX US's
Percentage Interest will increase to 53.24%.\4\ The Exchange will
remain the Regulatory Authority \5\ for the BOX Market and is
submitting the proposed rule change to the Commission to approve the
transfer of interests to MX US and to amend the Fifth Amended and
Restated Operating Agreement (the ``5th BOX LLC Agreement'') of BOX
accordingly (such agreement, as amended, the ``6th BOX LLC
Agreement'').\6\ The Exchange is requesting confidential treatment of
the sections of the 6th BOX LLC Agreement, which contain confidential
business information and do not relate to the control and governance of
BOX.
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    \3\ 15 U.S.C. 78c(a)(2).
    \4\ MX US currently has a 31.37% ownership interest in BOX. The
BSE notes that in SR-BSE-2008-06, MX US's ownership interest in BOX
was rounded up to 31.4%. See Securities Exchange Act Release No.
57260 (February 1, 2008), 73 FR 7617 (February 8, 2008) (SR-BSE-
2008-06).
    \5\ The ``Regulatory Authority'' is defined as the BSE as the
non-equity, non-Member authority of BOX and, together with and
pursuant to delegated authority from BSE, the Boston Options
Exchange Regulation LLC (``BOXR''), as approved by the SEC. See
Section 1.1, 6th BOX LLC Agreement.
    \6\ Capitalized terms not otherwise defined herein shall have
the meanings set forth in the 6th BOX LLC Agreement.
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    The text of the proposed rule change is available at the BSE, the
Commission's Public Reference Room, and http://www.bostonstock.com. The
text of Exhibits 3A and 3B of the proposed rule change are also
available on the Exchange's Web site and on the Commission's Web site
(http://www.sec.gov/rules/sro/bse.shtml).

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

    In its filing with the Commission, the BSE 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 BSE 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On January 13, 2004, the Commission approved four BSE proposals
that together established the BOX Market as a facility of the
Exchange.\7\ This

proposal relates to Section 8.4(f) of the 5th BOX LLC Agreement, which
requires that any Transfer \8\ that results in the acquisition and
holding by any Person, alone or together with any Affiliate of such
Person, of an aggregate Percentage Interest level which meets or
crosses the threshold level of 20% or any successive 5% Percentage
Interest level \9\ be subject to the rule filing process pursuant to
Section 19(b)(1) of the Act \10\ and Rule 19b-4 thereunder.\11\
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    \7\ See Securities Exchange Act Release Nos. 49066 (January 13,
2004), 69 FR 2773 (January 20, 2004) (SR-BSE-2003-17) (establishing
a fee schedule for the proposed BOX Market); 49065 (January 13,
2004), 69 FR 2768 (January 20, 2004) (SR-BSE-2003-04) (creating BOXR
to which the BSE would delegate its self-regulatory functions with
respect to the BOX Market); 49068 (January 13, 2004), 69 FR 2775
(January 20, 2004) (SR-BSE-2002-15) (approving trading rules for the
BOX Market); and 49067 (January 13, 2004), 69 FR 2761 (January 20,
2004) (SR-BSE-2003-19) (approving certain regulatory provisions of
the operating agreement of BOX).
    \8\ A ``Transfer'' occurs when any member of BOX (``Member'')
disposes of, sells, alienates, assigns, exchanges, participates,
subparticipates, encumbers, or otherwise transfers in any manner all
or any portion of its Units. See Section 8.1(a), 5th BOX LLC
Agreement.
    \9\ See Section 8.4(f), 5th BOX LLC Agreement.
    \10\ 15 U.S.C. 78s(b)(1).
    \11\ 17 CFR 240.19b-4.
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BSE Transfer of BOX Units
    The NASDAQ OMX Group, Inc. (``Nasdaq'') has entered into an
agreement to purchase the BSE but not the BSE's BOX Units. In
conjunction therewith, the BSE proposes to Transfer such BOX Units to
MX US. The BSE is proposing to Transfer all of its BOX Units to MX US,
which would result in the BSE's Percentage Interest falling to 0% and
MX US's Percentage Interest increasing from 31.37% to 53.24%. Since MX
US already holds an ownership interest in BOX in excess of 20% and the
BSE's proposed Transfer of its BOX Units to MX US would cross the 5%
threshold specified in Section 8.4(f) of the 5th BOX LLC Agreement,
such Transfer necessitates SEC approval.\12\ MX US, as a current Member
of BOX, is already a party to, and is therefore bound by the provisions
of, the 5th BOX LLC Agreement.\13\
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    \12\ See Section 8.4(f), 5th BOX LLC Agreement.
    \13\ Although MX has transferred its BOX Units to MX US, MX has
signed an Instrument of Accession through which MX has agreed to
abide by all of the provisions of the 5th BOX LLC Agreement, as
amended and in effect from time to time, including those provisions
requiring submission to the jurisdiction of the Commission. See SR-
BSE-2008-28.
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    The BSE states that the Act does not require that a self-regulatory
organization (``SRO'') have any ownership interest in the operator of
one of its facilities. The Commission has stated in a similar case
involving the establishment of Archipelago Exchange (``ArcaEx'') as a
facility of the Pacific Exchange, Inc. (``PCX''), that a national
securities exchange need not have a significant ownership interest in
the operator of one of its facilities.\14\ Although the BSE will no
longer hold an ownership interest in BOX, the BSE will continue to act
as the SRO and regulatory services provider for the BOX Market. The BSE
and BOXR, by delegated authority, will act as the Regulatory Authority
for the BOX Market. Furthermore, the BOX Market will remain a facility
of the BSE pursuant to Section 3(a)(2) of the Act.\15\
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    \14\ See Securities Exchange Act Release No. 44983 (October 25,
2001), 66 FR 55225 (November 1, 2001) (SR-PCX-00-25). ArcaEx was
operated by Archipelago Exchange LLC (``Arca LLC''). At the time of
its approval, PCX's ownership interest in Arca LLC consisted solely
of a 10% interest in Archipelago Holdings, LLC, the parent company
of Arca LLC.
    \15\ 15 U.S.C. 78c(a)(2).
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Amendments to BOX LLC Agreement
    In conjunction with the BSE's Transfer of its BOX Units to MX US,
the BSE is proposing to amend the 5th BOX LLC Agreement to reflect
modifications to the BSE's role as Regulatory Authority of the BOX
Market. Below is a description of certain proposed amendments to the
5th BOX LLC Agreement.
Regulatory Director
    Since the BSE's Percentage Interest in BOX will be less than 8%,
the BSE will no longer be entitled to maintain two directors on the BOX
Board, but the BSE will have the right to designate one non-voting
Regulatory Director \16\ to the BOX Board, pursuant to Section
4.1(a)(i) of the 6th BOX LLC Agreement.\17\
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    \16\ The ``Regulatory Director'' is defined as the individual
designated as such by the BSE pursuant to Section 4.1(b) of the 6th
BOX LLC Agreement. The Regulatory Director must be a member of the
senior management of the regulation staff of the Regulatory
Authority, who is separated from the business operations of the BSE
via effective information barriers. The Regulatory Director shall
not be an employee, officer, or director of Nasdaq or its
Affiliates, other than the BSE and the BSE's subsidiaries. See
Section 1.1, 6th BOX LLC Agreement.
    \17\ As long as BOX Market remains a facility of the BSE
pursuant to Section 3(a)(2) of the Act, the BSE shall have the right
to retain/designate one Regulatory Director, whether or not the BSE
is admitted as a Member of BOX. See Section 4.1(a)(i), 6th BOX LLC
Agreement.
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Regulatory Veto
    Under the provisions of the 5th BOX LLC Agreement, the BSE holds
veto power over certain ``Major Actions,'' which relate to both
commercial and regulatory actions.\18\ After the sale of the BSE's BOX
Units to MX US, the BSE will continue to have a regulatory interest in
the BOX Market but will no longer have a commercial interest in BOX.
Consequently, the BSE will no longer hold veto power over Major Actions
of BOX but will instead hold veto power over all regulatory actions
(``Regulatory Veto''). The terms of the Regulatory Veto provide that
the Regulatory Authority shall receive notice of planned or proposed
changes to BOX (except certain Non-Market Matters) \19\ or the BOX
Market (including, but not limited to, the System) pursuant to
procedures established by the mutual agreement of BOX and the
Regulatory Authority, which will require an affirmative approval of
such changes by the Regulatory Authority prior to implementation.\20\
The planned or proposed changes subject to the Regulatory Veto shall
include, without limitation: (A) Planned or proposed changes to the
System; (B) the sale by BOX of any material portion of its assets; (C)
taking any action to effect a voluntary, or which would precipitate an
involuntary, dissolution or winding up of BOX; or (D) obtaining
regulatory services from a regulatory services provider other than the
Regulatory Authority.\21\ The Regulatory Authority, in its sole
discretion, may direct BOX, subject to approval of the BOXR Board, to
modify a proposal as necessary to ensure that it does not cause a
Regulatory Deficiency if the Regulatory Authority, in its sole
discretion, determines that the proposed or planned changes to BOX or
the BOX Market (including, but not limited to, the System) could cause
a Regulatory Deficiency if implemented.\22\ The Regulatory Authority
will also have the authority to direct BOX, subject to the approval of
the BOXR Board, to undertake modifications to BOX (but not to include
Non-Market Matters) or the BOX Market as are necessary or appropriate
to eliminate or prevent a Regulatory Deficiency in the event that the
Regulatory Authority, in its sole discretion, determines that a
Regulatory Deficiency exists or is planned.\23\
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    \18\ See Section 4.4(b), 5th BOX LLC Agreement.
    \19\ ``Non-Market Matters'' include changes relating solely to
one or more of the following: Marketing, administrative matters,
personnel matters, social or team-building events, meetings of
Members, communication with Members, finance, location and timing of
BOX Board meetings, market research, real property, equipment,
furnishings, personal property, intellectual property, insurance,
contracts unrelated to the operation of the BOX Market, and de
minimis items. See Section 3.2(a)(ii), 6th BOX LLC Agreement.
    \20\ See Section 3.2(a)(ii), 6th BOX LLC Agreement.
    \21\ Id.
    \22\ See Section 3.2(a)(iii), 6th BOX LLC Agreement. A
``Regulatory Deficiency'' is defined as ``the operation of the BOX
(in connection with matters that are not Non-Market Matters) or the
BOX Market (including, but not limited to, the System) in a manner
that is not consistent with the Regulatory Authority Rules and/or
the SEC Rules governing the BOX Market or BOX Options Participants,
or that otherwise impedes the Regulatory Authority's ability to
regulate the BOX Market or BOX Options Participants or to fulfill
its obligations under the Exchange Act as an SRO.'' See Section 1.1,
6th BOX LLC Agreement.
    \23\ See Section 3.2(a)(iv), 6th BOX LLC Agreement.

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Board Composition
    Although BOX itself will not carry out any regulatory functions,
all of its activities must be consistent with the Act. For example,
provisions set forth in Sections 4.2(a) and 5.3 of the 6th BOX LLC
Agreement state that each unit holder and director of BOX agrees to
cooperate with the Commission and the BSE in carrying out their
regulatory responsibilities. The BOX Market, as a facility of an
exchange, is not solely a commercial enterprise; it is an integral part
of an SRO registered pursuant to the Act and is subject to the
obligations imposed by the Act. These obligations endure so long as the
BOX Market is a facility of the Exchange, regardless of whether the BSE
has an ownership interest in BOX. In recognition of these obligations,
the BSE has agreed that for so long as the BOX Market remains a
facility of the BSE pursuant to Section 3(a)(2) of the Act, BOX shall
have the right to recommend at least 10% of the BOXR Board (but no
fewer than one director) for election to the BOXR Board.\24\ The BOXR
director recommended by BOX shall: (1) Have the right to attend all
BOXR Board meetings and committees thereof; (2) receive equivalent
notice of BOXR Board meetings and committees thereof as other BOXR
directors; and (3) receive a copy of the meeting materials provided to
other BOXR directors, including, without limitation, agendas, action
items, and minutes.\25\
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    \24\ See Section 4.1(f), 6th BOX LLC Agreement. The BOXR Board
shall also include at least two BOX Options Participant directors
(but not less than 20% of all directors on the BOXR Board) selected
in accordance with the BOXR Limited Liability Company Agreement and
By-Laws and at least four directors who do not have a material
direct or indirect relationship with Nasdaq, its Affiliates, or any
Regulatory Outsourcing provider (other than service solely as a
director of BOXR and/or BSE). Id.
    ``Regulatory Outsourcing'' is defined as all BOX-related
regulatory functions that are outsourced by the BSE to the Financial
Industry Regulatory Authority or other service provider that is an
SRO. See Section 1.1, 6th BOX LLC Agreement.
    \25\ See Section 4.1(f), 6th BOX LLC Agreement.
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    The BSE has also agreed to delegate all actions and decisions
relating to the Regulatory Authority Rules,\26\ regulation of the BOX
Market (except regulatory actions and decisions delegated to the BSE
Regulatory Oversight Committee) and appeals from regulatory decisions
of the BOXR Board to a committee of the BSE Board (the ``BOX
Committee'').\27\ The resolutions to be adopted by the BSE Board to
establish the BOX Committee are being filed herein as proposed rules of
the Exchange. The resolutions reflect the compositional requirements
for the BOX Committee that are also required by the 6th BOX LLC
Agreement.\28\ In addition, the resolutions provide that the BOX
Committee may not be dissolved, and the resolutions and the powers of
the BOX Committee established thereby may not be altered, amended,
removed, or abridged, without the express written consent of BOX. In
addition, any resolution or other action that would have the effect of
dissolving the BOX Committee or altering, amending, removing, or
abridging the resolutions or the powers of the BOX Committee
established thereby must be submitted to the BSE Board, and if the same
must be filed with, or filed with and approved by, the SEC under
Section 19 of the Act, then it shall not be effective until filed with,
or filed with and approved by, the SEC, as the case may be.
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    \26\ ``Regulatory Authority Rules'' are defined as the rules of
the Regulatory Authority, including for the avoidance of doubt, the
BOX Rules, that constitute ``rules of an exchange,'' within the
meaning of Section 3 of the Act, and that pertain to the BOX Market.
See Section 1.1, 6th BOX LLC Agreement.
    \27\ See Section 4.1(f), 6th BOX LLC Agreement.
    \28\ The BOX Committee of the BSE Board shall include a BOX
Options Participant representative, in accordance with the BSE's By-
Laws, to serve as a representative of BOX Options Participants and
four other directors who do not have a material direct or indirect
relationship with Nasdaq, its Affiliates, or any Regulatory
Outsourcing provider (other than service as directors of the BSE
and/or BOXR). Furthermore, at least 50% of the BOX Committee must be
Public Directors, as defined in the BSE's By-Laws. Id.
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    The BSE has also agreed that for so long as the BOX Market remains
a facility of the BSE pursuant to Section 3(a)(2) of the Act, BOX shall
have the right to designate one non-voting participant (``Non-Voting
Participant'') to the BSE Board.\29\ The Non-Voting Participant shall:
(1) Have the right to attend all meetings of the BOX Committee and all
BOX-related deliberations of the BSE Board and committees thereof
(collectively, ``BOX-Related Meetings''); (2) receive equivalent notice
of BOX-Related Meetings as BSE directors; and (3) receive a copy of the
meeting minutes provided to BSE directors, including agendas, action
items, and minutes for all BOX-Related Meetings.\30\
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    \29\ Id.
    \30\ Id.
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    The BSE has agreed that the directors sitting on the BOXR Board or
any committees thereof or the BOX Committee or otherwise engaged in
BOX-Related Meetings (other than by membership on the BSE Regulatory
Oversight Committee) shall not have a material direct or indirect
relationship with Nasdaq or its Affiliates or any Regulatory
Outsourcing provider (other than service as directors of the BSE and/or
BOXR).\31\ Furthermore, all other persons permitted to attend meetings
of the BOXR Board or any committees thereof or the BOX Committee or
otherwise engaged in BOX-Related Meetings shall not have a material
direct or indirect relationship with Nasdaq or its Affiliates or any
Regulatory Outsourcing provider unless they are: (i) Permitted
Recipients; \32\ (ii) BOXR directors, officers, or employees; (iii)
other parties making presentations to directors of the BSE Board
engaged in BOX-Related Meetings, the BOXR Board, BOX Committee, or BSE
Regulatory Oversight Committee, if such parties' participation is only
to the extent necessary to make such presentations; or (iv) consented
to by BOX.\33\
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    \31\ See Section 4.1(f), 6th BOX LLC Agreement. Material direct
or indirect relationship includes, without limitation, any of the
following: Being an Affiliate; serving as a board member, employee,
officer, consultant, advisor, or any Regulatory Outsourcing
provider; being a party to any contractual or other relationship
pursuant to which more than $50,000 is paid; reporting to,
controlling, being controlled by, or holding an investment greater
than 5% in any such Person; and being a parent, child, sibling,
spouse, or in-law of such Person. Id.
    \32\ ``Permitted Recipients'' are defined as: (A) The BSE's
Chief Regulatory Officer and only those members of his regulatory
staff responsible for regulatory technology and budget, counsel to
the BSE's Chief Regulatory Officer, or staff of the BSE's internal
audit department (it being agreed and understood, for purposes of
this definition that these roles may be performed for the BSE by
Nasdaq employees serving comparable regulatory functions for
Nasdaq), (B) any member of the BSE Board serving on the BOX
Committee or the BSE Regulatory Oversight Committee, (C) Nasdaq's
Chief Regulatory Officer and his staff in the Office of General
Counsel, (D) any member of the Nasdaq Board of Directors serving on
the Nasdaq Regulatory Oversight Committee, and (E) any Professional
Services provider. See Section 1.1, 6th BOX LLC Agreement.
    ``Professional Services'' is defined as services performed by
outside counsel, consultants, Regulatory Outsourcing, or
subcontractors for the benefit of BOX or the BOX Market. Id.
    \33\ See Section 4.1(f), 6th BOX LLC Agreement.
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Books and Records
    In accordance with the BSE's obligations as the SRO for the BOX
Market, the books, records, premises, officers, directors, agents, and
employees of BOX shall be deemed to be the books, premises, officers,
directors, agents, and employees of the Regulatory Authority for the
purpose of, and subject to, oversight pursuant to the Act.\34\
Furthermore, the books and records of BOX shall be subject at all times
to inspection and copying by the Regulatory Authority and the SEC.\35\

Inspection, copying, and review of the books and records of BOX by the
Regulatory Authority at the premises of BOX, and access to any copied
books and records removed from the premises of BOX or produced to the
Regulatory Authority at its request, shall in all cases be conducted
by, or limited to, BSE employees who are Permitted Recipients and/or
directors or employees of BOXR.\36\
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    \34\ See Section 12.1, 6th BOX LLC Agreement.
    \35\ Id. BOX shall not be entitled to refuse the inspection,
review, or copying of its books and records by the Regulatory
Authority as provided in Section 12.1 of the 6th BOX LLC Agreement
but shall be entitled to damages in the event any inspection,
copying, or review of BOX books and records by the Regulatory
Authority is, in whole or in part, used by the Regulatory Authority
or any of its Affiliates for any purpose other than to fulfill the
Regulatory Authority's regulatory obligations. Id.
    \36\ Id.
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Confidential Information
    All Members of BOX and the Regulatory Authority are prohibited from
using BOX Confidential Information \37\ otherwise than in connection
with its respective activities contemplated by the 6th BOX LLC
Agreement and other related agreements (the ``Agreements'') or pursuant
to the Act and the rules and regulations thereunder.\38\ All Members of
BOX and the Regulatory Authority are prohibited from disclosing any BOX
Confidential Information to any Person except as expressly permitted by
the Agreements and pursuant to the Act and the rules and regulations
thereunder.\39\ The Commission and the Regulatory Authority, however,
are not limited or impeded in their right to access and examine BOX
Confidential Information. In addition, the 6th BOX LLC Agreement does
not limit or impede the ability of a Member, officer, director, agent,
or employee of a Member to disclose BOX Confidential Information to the
SEC or the Regulatory Authority.\40\
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    \37\ ``BOX Confidential Information'' includes any financial,
scientific, technical, trade, or business secrets of BOX and any
financial, scientific, technical, trade, or business materials that
BOX treats, or is obligated to treat, as confidential or
proprietary, including, but not limited to, innovations or
inventions belonging to BOX and confidential information obtained by
or given to BOX about or belonging to its suppliers, licensors,
licensees, partners, affiliates, customers, potential customers, or
others. The definition of BOX Confidential Information, with respect
to any Person, shall not include information which: (i) Is publicly
known through publication or otherwise through no wrongful act of
such Person; or (ii) is received by such Person from a third Party
who rightfully discloses it to such Person without restriction on
its subsequent disclosure. See Section 1.1, 6th BOX LLC Agreement.
    \38\ See Section 16.2, 6th BOX LLC Agreement.
    \39\ Id. No Member or Regulatory Authority shall share BOX
Confidential Information with Nasdaq or its Affiliates, other than
BSE and BOXR, or as permitted in the Regulatory Services Agreement.
Id.
    \40\ See Section 16.5, 6th BOX LLC Agreement.
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    Furthermore, all confidential information, including BOX
Confidential Information, pertaining to regulatory matters of BOX and
the BOX Market (including, but not limited to, disciplinary matters,
trading data, trading practices, and audit information) contained in
the books and records of BOX shall: (i) Not be made available to any
persons other than to those officers, directors, employees, and agents
of BOX that have a reasonable need to know the contents thereof; (ii)
be retained in confidence by BOX and the officers, directors,
employees, and agents of BOX; and (iii) not be used for any commercial
purposes.\41\
Future Amendments to BOX LLC Agreement
    When BOX formally presents any amendments, modifications, waivers,
or supplements to the 6th BOX LLC Agreement or any future amended BOX
LLC Agreement (``BOX LLC Agreement'') to the BOX Board for approval,
BOX represents that it will provide prompt notice to the Regulatory
Authority and the Regulatory Director and submit any proposed
amendments to the BOX Committee for its review and filing with the SEC
if deemed necessary under Section 19 of the Act and the rules
promulgated thereunder.\42\ BOX, however, shall not be required to
obtain the approval of the Regulatory Authority for any amendment to
the BOX LLC Agreement pursuant to which the BOX Market would cease to
be a facility of the BSE within the meaning of Section 3 of the Act,
provided that such amendment shall be filed with, or filed with and
approved by, the SEC, as the case may be, before such amendment may be
effective.\43\ In the event the BSE ceases to be the Regulatory
Authority, the BSE shall no longer be a party to the BOX LLC Agreement
and thereafter the provisions of the BOX LLC Agreement shall not apply
to the BSE or BOXR except for certain delineated provisions, which
shall survive.\44\
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    \41\ See Section 16.6, 6th BOX LLC Agreement.
    \42\ See Section 19.1, 6th BOX LLC Agreement.
    \43\ Id.
    \44\ Id.
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Jurisdiction
    Each Member of BOX acknowledges that, to the extent that they are
related to BOX activities, the books, records, premises, officers,
directors, agents, and employees of the Members shall be deemed to be
the books, records, premises, officers, directors, agents, and
employees of the Regulatory Authority for the purpose of and subject to
oversight pursuant to the Act.\45\ BOX, the Members and the officers,
directors, agents, and employees of each, irrevocably submit to the
exclusive jurisdiction of the U.S. federal courts, the SEC, and the
Regulatory Authority for the purposes of any suit, action, or
proceeding pursuant to the U.S. federal securities laws and the rules
or regulations thereunder, arising out of, or relating to, BOX
activities or Section 19.6(a) of the 6th BOX LLC Agreement.\46\
Furthermore, BOX, the Regulatory Authority, and each Member are
required to take necessary action to ensure that the officers,
directors, and employees of BOX, the Regulatory Authority, and each
Member consent to the applicability of certain of the provisions in the
6th BOX LLC Agreement, including provisions relating to
confidentiality, books and records, and jurisdiction.\47\
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    \45\ See Section 19.6(a), 6th BOX LLC Agreement.
    \46\ See Section 19.6(b), 6th BOX LLC Agreement.
    \47\ See Section 19.6(c), 6th BOX LLC Agreement.
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Conclusion
    The BSE will remain the SRO for the BOX Market, and the BSE will
continue to provide the regulatory services for the BOX Market in order
for BOX to conduct BOX's business in a manner consistent with the
regulatory and oversight responsibilities of the BSE, even though the
BSE will no longer have an ownership interest in BOX. The BSE proposes
to amend the 5th BOX LLC Agreement to make the aforementioned changes
and reflect the BSE's status as the Regulatory Authority.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of Section 6(b) of the Act,\48\ in general, and
furthers the objectives of Section 6(b)(1) of the Act,\49\ in
particular, in that it ensures that the Exchange is so organized and
has the capacity to carry out the purposes of the Act and to comply and
to enforce compliance by the Exchange's members with the Act, the rules
and regulations of the Act, and the rules of the Exchange. The Exchange
also believes that the proposal is consistent with the requirements of
Section 6(b)(5) of the Act,\50\ in particular, in that it is designed
to facilitate transactions in securities, to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with

persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to, and perfect the mechanism of a
free and open market and a national market system, and in general, to
protect investors and the public interest.
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    \48\ 15 U.S.C. 78f(b).
    \49\ 15 U.S.C. 78f(b)(1).
    \50\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml ); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BSE-2008-25 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BSE-2008-25. This file
number should be included on the subject line if e-mail 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 Web site (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 inspection and copying 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 the BSE. All comments received will
be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BSE-2008-25 and should be submitted on
or before May 29, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\51\
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    \51\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-10094 Filed 5-7-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62381-62383]
[FR Doc No: 2023-19502]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2396]

Chemistry, Manufacturing, and Controls Development and Readiness
Pilot Program; Program Announcement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the year
two opportunity for a limited number of applicants to participate in a
Chemistry, Manufacturing, and Controls (CMC) Development and Readiness
Pilot (CDRP) program to facilitate the expedited CMC development of
products under an investigational new drug application (IND), where
warranted, based on the anticipated clinical benefit of earlier patient
access to the products. FDA has implemented this pilot program to
facilitate CMC readiness for selected Center for Biologics Evaluation
and Research (CBER)- and Center for Drug Evaluation and Research
(CDER)-regulated products with accelerated clinical development
timelines. To accelerate CMC development and facilitate CMC readiness,
the pilot features increased communication between FDA and sponsors and
explores the use of science- and risk-based regulatory approaches, such
as those described in FDA guidance, as applicable. This notice outlines
the eligibility criteria and process for submitting a request to
participate in the pilot.

DATES: Starting October 2, 2023, FDA will accept requests to
participate in the CDRP program. See the ``Participation'' section of
this document for eligibility criteria, instructions on how to submit a
request to participate, and selection criteria and process.

FOR FURTHER INFORMATION CONTACT: Tanya Clayton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4506, Silver Spring, MD 20993-0002, 301-
796-0871; or Anne Taylor, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7256, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    For general questions about the CDRP Program for CBER:
[email protected].
    For general questions about the CDRP Program for CDER: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Development programs for CBER- and CDER-regulated drugs and
biologics intended to diagnose, treat, or prevent a serious disease or
condition where there is an unmet medical need may have accelerated
clinical development timelines. Yet, marketing applications for
products in expedited development programs still need to meet FDA's
approval standards, including manufacturing facility compliance with
current good manufacturing practice (CGMP). Products with accelerated
clinical development activities may face challenges in expediting CMC
development activities to align with the accelerated clinical
timelines. Successfully expediting CMC readiness may require additional
interactions with FDA during product development and, if applicable,
warrant the use of science- and risk-based regulatory approaches
allowing streamlining of CMC development activities so that clinical
benefits of earlier patient access to these products can be realized.
    As described in the FDA Prescription Drug User Fee Act (PDUFA) VII
Commitment Letter for fiscal years (FYs) 2023 Through 2027 (Ref. 1),
FDA implemented the CDRP program to facilitate CMC readiness for
selected CBER- and CDER-regulated products with accelerated clinical
development timelines in FY 2023. To accelerate CMC development and
facilitate CMC readiness, the pilot features increased communication
between FDA and sponsors and explores the use of science- and risk-
based regulatory approaches, such as those described in the FDA
guidance for industry entitled ``Expedited Programs for Serious
Conditions--Drugs and Biologics'' (May 2014) (Ref. 2), as applicable.
    FDA (CBER and CDER) is continuing to conduct a CDRP to facilitate
the CMC development of selected products under INDs that have expedited
clinical development timeframes, based on the anticipated clinical
benefits of earlier patient access to the products. This includes
products with Breakthrough Therapy (BT), Fast Track (FT), and
Regenerative Medicine Advance Therapy (RMAT) designations. For sponsors
participating in the pilot, FDA will provide product-specific CMC
advice during product development, to include two additional CMC-
focused Type B meetings, as well as a limited number of additional CMC-
focused discussions, based on readiness and defined CMC milestones. The
increased communication between FDA review staff and sponsors is
intended to ensure a mutual understanding of approaches to completing
CMC activities, including what information should be provided at the
appropriate timepoint (i.e., at the time of new drug application (NDA)
or biologics license application (BLA) submission, prior to the end of
the review cycle, or post-approval) to ensure CMC readiness for a
marketing application.

II. Participation

    FDA will continuously accept requests to participate in the CDRP
program. FDA will select no more than nine proposals per fiscal year,
with

approximately two-thirds being CBER-regulated products and one-third
CDER-regulated products. Taking into consideration lessons learned from
the prior year, FDA will publish in the Federal Register a notice to
announce pilot programs for each of the remaining FYs of the CDRP
program. Sponsors who are interested in participating in the pilot
program should submit a request to participate in the pilot as an
amendment to their IND. The cover letter should state ``Request to
participate in the CMC Development and Readiness Pilot.''
    To promote innovation and understanding in this area, lessons
learned through the pilot may be presented by FDA (e.g., in a public
workshop) as case studies, including when the product studied in the
pilot has not yet been approved by FDA. FDA intends to conduct a public
workshop and issue a strategy document focused on CMC aspects of
expedited development incorporating lessons from the CDRP. To be
eligible for the pilot, the sponsor and FDA will reach an agreement on
the information to be publicly disclosed. Generally, FDA does not
anticipate that the case studies will need to include information, such
as the sponsor's name or product information, that can specifically
identify a unique product.
    Participation in the pilot program, including such agreement on
information disclosure, is voluntary and at the discretion of the
sponsor. Where feasible, FDA will notify a sponsor in advance when it
plans to include some aspect of their experience in the program in a
public discussion (e.g., a slide presentation, a white paper).

A. Eligibility Criteria

    To be considered for the pilot program, participants must meet the
following eligibility criteria:
1. Joint CBER and CDER Eligibility Criteria
     Participant must have an active commercial IND (see the
definitions of commercial INDs at https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/research-investigational-new-drug-applications-what-you-need-know).
     IND has been submitted in, or converted to, Electronic
Common Technical Document (eCTD) format, unless the IND is of a type
granted a waiver from eCTD format as per FDA's guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related
Submissions Using the eCTD Specifications'' (February 2020) (Ref. 3).
     INDs for combination products (21 CFR 3.2(e)(1)) are
eligible; products that require significant cross-Center interactions
(e.g., complex combination products) may be less likely to be selected
for the pilot.
     In general, at the time of application to the pilot, the
IND clinical program has not yet reached the end of Phase 2 to allow
the pilot to have sufficient time to have an impact on CMC readiness
(e.g., 2 years from anticipated marketing application submission).
However, in extenuating circumstances, requests for exceptions may be
considered, where the development programs would still benefit from the
pilot--examples of what could constitute such circumstances include:
    [cir] Cases where the clinical development is following an
innovative trial design
    [cir] The product is intended to treat a rare disease
     CMC-related information is provided to demonstrate a
commitment to pursue a CMC development plan that aligns with the
expedited clinical development program (see ``CMC Development Plan''
under What To Submit in a Request To Participate in the Pilot for
details).
    Due to the differences in product complexity between CBER- and
CDER-regulated products, the following eligibility and selection
criteria differ between the Centers.
2. CBER-Specific Eligibility Criteria
     IND is an existing, CBER-regulated IND intended for
submission as an application for licensure of a biological product
under section 351(a) of the Public Health Service Act (PHS Act) (42
U.S.C. 262(a)) for cellular therapies, gene therapies, and other
products regulated by the Office of Therapeutic Products/CBER or
vaccines regulated by the Office of Vaccines Research and Review/CBER.
     IND has a BT or RMAT designation.
3. CDER-Specific Eligibility Criteria
     IND is an existing, CDER-regulated IND for a product
intended for submission as an application for (1) approval of a new
drug submitted under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)), or (2) licensure of a biological
product under section 351(a) of the PHS Act.
     IND has an expedited clinical timeframe warranted based on
the anticipated clinical benefits of earlier patient access. This would
include INDs for products with a BT or FT designation; IND sponsors of
other products that meet this criterion may also apply to the pilot,
with their eligibility to be determined by FDA.

B. What To Submit in a Request To Participate in the Pilot

    To participate in the CDRP, sponsors should submit a written
request as an amendment to the IND. In addition to providing a point of
contact and noting any expedited program designations the IND has
received to date, the request should include the following information.
1. CMC Development Plan
    To focus pilot resources where they should be most useful and have
an impact on the timeliness with which CMC readiness is achieved,
prospective applicants to the pilot program should include in their
Request to Participate a description of their CMC development plan that
includes a timeline for CMC development aligned with when the clinical
development program is expected to be complete:
    (1) The plan should describe the current state of CMC development,
including any ongoing activities not already included in the IND.
    (2) The plan should include a projected timeline for product
development that aligns with the anticipated clinical development
timeline, showing the CMC tasks and activities intended to yield
complete CMC data and information to be included in the marketing
application. This part of the plan should cover the following CMC-
related areas:
     Available product characterization and preliminary
identification of critical quality attributes.
     Description of the current drug substance and drug product
manufacturing process and control strategy (including identification
and development of assays), and a description of and plan for the
proposed commercial scale manufacturing and control strategy, including
any necessary microbial control strategy.
     Identification of manufacturing facilities, including any
contract facilities, along with the facilities' recent inspection
history (including foreign regulatory inspections, where applicable).
     Plans for ensuring product availability for commercial
launch.
     Drug substance and drug product stability assessment plan.
     Overall plan for process validation (e.g., stage 1 and
stage 2 as described in FDA's guidance for industry entitled ``Process
Validation: General Principles and Practices'' (Ref. 4)).

    (3) Given the expedited clinical timeframe, mapping out a plan for
manufacturing readiness within the same overall timespan may reveal
potential challenges in accomplishing CMC activities within the
allotted time that is typically needed during CMC development to
prepare a marketing application that can support approval. The plan
should highlight these areas (exemplified in the bulleted list above,
and any additional CMC challenges that may require FDA input), to
facilitate FDA engagement regarding the types of supportive data and
information that might be used to address these challenges.
Participants in the pilot should plan to discuss these challenges with
FDA during the pilot (for CDER-regulated products, see MAPP 5015.13,
Quality Assessment for Products in Expedited Programs (Ref. 5)).
2. Proposed Plan and Timing for Meetings With FDA
    The CMC Development Plan should include proposed timing (i.e.,
month and year) for the two additional CMC-specific Type B meetings
afforded by the pilot, as well as any other meetings and discussions
foreseen.

C. Selection Criteria and Process

    FDA intends to select participant CBER and CDER INDs based on the
criteria outlined below. Review of requests is planned to occur
quarterly, or as needed, depending on the requests to participate in
the pilot that are received during the period. FDA intends to issue a
letter to notify each sponsor of FDA's decision on their request to
participate within 180 days of receipt.
    In selecting INDs for the pilot program, FDA intends to consider
factors such as (1) anticipated clinical benefits of facilitating
earlier patient access to the product, (2) novelty of the product, (3)
complexity of the product or its manufacturing process, including
technology, (4) sponsor's overall manufacturing experience, and (5)
sponsor's experience with the particular product type, class, or the
type of manufacturing process. FDA may give additional consideration to
less-experienced sponsors. Overall, FDA intends to seek balance and
diversity in product types, sponsors, and therapeutic indications to
obtain a variety of relevant experience and learnings from the pilot.

D. FDA-Sponsor Interactions During the Pilot

    During this CDRP program, sponsors will be able to discuss their
product development strategies and goals with FDA review staff during
predesignated Type B meetings and a limited number of additional CMC-
focused discussions. As part of the CMC readiness pilot, two dedicated
CMC meetings will be granted, and sponsors will have an opportunity for
followup discussions to address questions arising from the meeting or
meeting minutes, or if additional clarifications are needed.
    In preparation for a meeting, sponsors should submit written
questions along with a background information package clearly marked as
a ``PDUFA VII CDRP meeting'' as part of the cover letter to enable FDA
review staff to address the questions. The briefing package should be
submitted to the corresponding IND. Meetings associated with the pilot
should be requested by sponsors. For additional information on meetings
and other communications between the sponsors and FDA, see the FDA
draft guidance for industry entitled ``Formal Meetings Between the FDA
and Sponsors or Applicants of PDUFA Products'' (December 2017) (Ref.
6), CDER MAPP 6025.6: Good Review Practice: Management of Breakthrough
Therapy-Designated Drugs and Biologics (July 2014) (Ref. 7), CBER SOPP
8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and
Biological Products (March 2023) (Ref. 8), and CBER SOPP 8212:
Breakthrough Therapy Products--Designation and Management (August 2023)
(Ref. 9).

III. Paperwork Reduction Act of 1995

    Collections of information from fewer than 10 respondents within
any 12-month period are not subject to the Paperwork Reduction Act of
1995 (PRA) (5 CFR 1320.3(c)(4)). To the extent this information
collection involves 10 or more respondents within any 12-month period,
the collections of information are subject to the PRA. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the PRA (44 U.S.C. 3501-3521). The
collections of information for NDAs, formal meetings with sponsors and
applicants for PDUFA products, and the PDUFA VII Commitment Letter have
been approved under OMB control number 0910-0001. The collections of
information for INDs have been approved under OMB control number 0910-
0014. The collections of information for BLAs have been approved under
OMB control number 0910-0338. The collections of information pertaining
to CGMP requirements have been approved under OMB control number 0910-
0139. The collections of information pertaining to expedited programs
for serious conditions for drugs and biologics and breakthrough
therapy-designation for drugs and biologics have been approved under
OMB control number 0910-0765.

IV. References

    The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852,<PHONE_NUMBER>, and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at https://www.regulations.gov.
FDA has verified the website addresses, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

1. PDUFA Reauthorization Performance Goals and Procedures Fiscal
Years 2023 Through 2027 at https://www.fda.gov/media/151712/download.
2. FDA guidance for industry ``Expedited Programs for Serious
Conditions--Drugs and Biologics'' (May 2014): https://www.fda.gov/media/86377/download.
3. FDA guidance for industry ``Providing Regulatory Submissions in
Electronic Format--Certain Human Pharmaceutical Product Applications
and Related Submissions Using the eCTD Specifications'' (February
2020): https://www.fda.gov/media/135373/download.
4. FDA guidance for industry ``Process Validation: General
Principles and Practices'' (January 2011): https://www.fda.gov/
files/drugs/published/Process-Validation_General-Principles-and-
Practices.pdf.
5. CDER MAPP 5015.13: Quality Assessment for Products in Expedited
Programs: https://www.fda.gov/media/162786/download?attachment.
6. FDA draft guidance for industry ``Formal Meetings Between the FDA
and Sponsors or Applicants of PDUFA Products'' (December 2017):
https://www.fda.gov/media/109951/download.
7. CDER MAPP 6025.6: Good Review Practice: Management of
Breakthrough Therapy-Designated Drugs and Biologics (July 2014):
https://www.fda.gov/media/89155/download.
8. CBER SOPP 8101.1: Regulatory Meetings with Sponsors and
Applicants for Drugs and Biological Products (March 2023).
9. CBER SOPP 8212: Breakthrough Therapy Products--Designation and
Management (August 2023).

    Dated: September 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19502 Filed 9-8-23; 8:45 am]
BILLING CODE 4164-01-P


SF-83 SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Benzene Waste Operations (40 CFR part 61, subpart FF) (Renewal)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Benzene Waste Operations (40 CFR part 61, subpart FF).

1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for the regulations published at 40 CFR part 61, subpart FF were proposed on September 14, 1989, and promulgated on March 7, 1990.  These regulations apply to facilities that generate waste containing benzene, such as chemical manufacturing plants, coke by-product recovery plants, petroleum refineries, and those owners and operators of hazardous waste treatment, storage, and disposal facilities (TSDF) which receive wastes from the above facilities, commencing construction, modification or reconstruction after the date of the proposal.  This information is being collected to assure compliance with 40 CFR part 61, subpart FF.

In general, all NESHAP standards require initial notifications, performance tests, and periodic reports.  Owners, or operators also are required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative.  These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NESHAP.

Any owner, or operator subject to the provisions of this part will maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records.  Facilities managing waste containing less than 1 megagram (Mg) of benzene must certify to that effect and maintain documentation to support their finding.  Facilities managing more than 1 Mg and less than 10 Mg of benzene-containing waste must prepare an initial certification, test annually to verify that their waste stream still falls within this range, and maintain documentation to support these findings.  Finally, facilities managing more than 10 Mg of waste must submit quarterly and annual reports documenting the results of continuous monitoring.  All reports are sent to the delegated state, or local authority.  In the event that there is no such delegated authority, the reports are sent directly to the appropriate United States Environmental Protection Agency (EPA) Regional Office.

Approximately 234 sources are currently subject to the regulation and 117 of those are estimated to have more than 10 Mg/yr of benzene in the waste.  It is estimated that no additional sources will become subject to the regulation in the next three years. To determine the size of the regulated universe subject to NESHAP subpart FF, EPA contacted the National Petroleum Refiners Association (NPRA) for any changes that may have occurred since the last ICR was issued, and if any new sources subject to NESHAP subpart FF were anticipated to come on-line over the next three years.  NPRA confirmed that the regulated universe of facilities subject to NESHAP subpart FF was expected to remain unchanged over the next three years and that no new sources subject to these standards are anticipated to come on-line in the next three years.  EPA also conducted a search of the Integrated Data for Enforcement Analysis system (IDEA) and the AIRS (Aerometric Information Retrieval System) Air Facility Subsystem (AFS) to determine the number of sources subject to this regulation and found that EPA data matched the information received from the NPRA.  The respondent cost of this ICR will be $949,677.  OMB approved the currently active ICR without any “Terms of Clearance.”

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The Clean Air Act (Act) provides authority to the Agency to establish standards to control air pollution and to ensure compliance with promulgated regulations through adequate recordkeeping and reporting by the affected industries (i.e., respondents).  The regulations include the New Source Performance Standards (NSPS) under section 111 of the Act, the National Emission Standards for Hazardous Air Pollutants ( NESHAP), which includes the original NESHAP standards and the more recent Maximum Achievable Control Technology (MACT), or NESHAP-MACT standards under section 112 of the Act, and emission guidelines for the designated types of incinerators under section 129 of the Act.

2(b)  Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard are used by regulatory agencies, the public and the regulated community for a variety of reasons, including the determination of the respondent’s compliance status, analytical studies to demonstrate compliance trends, and evaluations regarding the efficacy of the promulgated regulations.

The required recordkeeping and reporting also are used to: 1) certify compliance with the regulations; 2) determine the respondent’s compliance with the designated emission limitation(s); 3) notify regulatory agencies when a standard is violated; 4) evaluate continuous compliance through the use of emission, or operational parameter monitors; and 5) ensure that plant personnel are following the required procedures and are periodically trained, as indicated.

3.  Nonduplication, Consultations, and Other Collection Criteria

3(a)  Nonduplication

The standards do not require the duplication in the collection and reporting of information.  If the subject standards have not been delegated, the information is sent directly to the appropriate Environmental Protection Agency (EPA) regional office.  Otherwise, the information is sent directly to the delegated state or local agency.  If a state or local agency has adopted its own similar standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards.

3(b)  Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR was published in the Federal Register (70 FR 24020) on May 6, 2005).  No comments were received on the burden published in the Federal Register.

3(c)  Consultations

It is our policy to carefully review any comments received since the last ICR renewal including those submitted in response to the first federal register notice and respond appropriately. In this case, no comments were received.  The Agency’s internal industry experts have been consulted.  The Agency’s internal data sources and any projections of industry growth over the next three years also have been considered.

The primary source of information as reported by industry, in compliance with the recordkeeping and reporting provisions in the standard, is the Air Facility Subsystem (AFS), which is operated and maintained by EPA's Office of Compliance.  AFS is EPA’s database for the collection, maintenance, and retrieval of all compliance data.  Approximately 234 respondents currently are subject to the regulation, and our consultations with Agency industry experts regarding the growth rate for the industry indicated that no additional respondents per year will become subject to the regulation over the next three years.

It should be noted that the respondents, the industry trade association(s) and other interested parties were provided an opportunity to comment on the burden associated with the standard as it was being developed and the standard has been previously reviewed to determine the minimum information needed for compliance purposes.

3(d)  Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards.  Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met.  If the information required by these standards was collected less frequently, the proper operation and maintenance of control equipment and the possibility of detecting violations would be less likely.

3(e)  General Guidelines

Neither the reporting, nor the recordkeeping requirements violate the regulations established by Office of Management and Budget (OMB) at 5 CFR Part 1320, Section 1320.5.  However, most NESHAP standards and a few NSPS standards require records to be kept more than three years.  In general, these standards require the respondents to maintain all records, including reports and notifications, for five years.  The five-year record retention requirement is consistent with the permit program at 40 CFR part 70, and the five-year statute of limitations on which the permit program is based.

The retention of records for five years allows EPA to establish the compliance history of the respondent for purposes of determining the appropriate level of enforcement action.  Historically, EPA notes that the most flagrant violations have extended beyond a five-year period.  If records are retained for less than five years, EPA would be deterred from pursuing the most flagrant violations due to the destruction of records documenting noncompliance.

3(f)  Confidentiality

Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B - Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

The recordkeeping and reporting requirements do not contain sensitive questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are facilities which generate waste that contains benzene.  The SIC codes for the respondents affected by the standards are the SIC (United States Standard Industrial Classification) codes listed in the table below, which correspond to the NAICS (The North American Industry Classification System) codes also listed below.

Category	SIC code	NAICS code	Examples of regulated entities

Chemical manufacturing, Plastic product manufacturing	2800	325, 3261 Chemical products manufacturing

Petroleum refineries	2911	32411	Petroleum refineries

Integrated iron and steel mills	3312	331111	Steel Works, Blast Furnaces (Including Coke Ovens), and Rolling Mills (except coke ovens not integrated with steel mills

Sanitary and waste management services	4959	56291, 562998	Remediation services and all other miscellaneous waste management services

Administration of Air and Water Resource and Solid Waste Management Programs	9511	92411	Air, water, solid waste management

This table is not meant to be exhaustive, but rather provides a guide for readers regarding the entities likely to be regulated by this standard.  To determine whether the standard applies to a particular entity, review the applicability provisions in the standard.

4(b)  Information Requested

(i)  Data Items

All data in this ICR that are recorded and/or reported are required by 40 CFR part 61, subpart FF- benzene waste operations.

A source must make the following reports:

Reports for 40 CFR part 61, subpart FF

Construction or modification application 	61.07

Anticipated startup 	61.09(a)(1)

Actual startup	61.09(a)(2)

Source reporting and request for waiver of compliance	61.10

Emission test and waiver of emission tests for flares and some waste   incinerators	61.13

Initial performance test results	61.13(f)

Initial performance test	61.13(c)

Demonstration of continuous monitoring system	61.354(c)

Physical or operational change	61.15

Report that summarizes the regulatory status of each waste stream that contain benzene 	61.357 (a)

Initial certification of necessary equipment and inspection tests	61.357 (d)(1)

Annual certification of benzene waste steams, benzene concentration, and benzene quantity determination	61.357 (b), (c), (d)(2)

Notification of election to comply with alternative requirements and certification of benzene waste steams, benzene concentration, and benzene quantity determination	61.357(d)(4)-(5)

Quarterly reports certifying required inspections	61.357(d)(6)

Quarterly reports when monitored parameters are exceeded	61.357 (d)(7)

Initial and quarterly reports for inspections during which detectable emissions or a problem is identified	61.357(d)(8)

Notification of election to comply with standard	61.357(e)

Initial and quarterly reports identifying all seal gap measurements that are outside limits 	61.357(g)

A source must maintain the following records:

Monitoring and Recordkeeping for 40 CFR part 61, subpart FF

Monitoring requirements	61.14

Monitoring of operation of treatment process or wastewater treatment  61.354(a),(b)

Monitoring of alternative operational or process parameters	61.354(e)

Monitoring of affected facilities	61.343-349

Startups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative	61.356

Emission test results and other data needed to determine emissions 61.13(g)

All reports and notifications	63.10(b)

Record of applicability	63.10(b)(3)

Records for sources with continuous monitoring systems	63.10(3)

Records of off-site shipment of waste	61.356(c)

Record of control equipment engineering design	61.356(d)

Records of engineering calculations, operating conditions, and performance tests	61.356(e)

Records of detectable emissions from closed vent systems and control devices	61.356(f)

Records of location, date, and corrective actions for problems found during visual inspections	61.356(g)(l)

Records of location, date, and corrective actions for problems found during visual inspections	61.356(g)(l)

Records for each test of no detectable emissions	61.356(h)

Operational records for each control device, treatment process, and wastewater treatment system	61.356(i), (j)

Records are required to be retained for two years and they must be retained at the facility	61.356(a)

Measurements and determinations of annual waste quantity, water content, and benzene concentration	61.356(b)

Electronic Reporting

Some respondents use monitoring equipment that automatically records parameter data.  Although personnel at the affected facility must evaluate the data, internal automation has significantly reduced the burden associated with monitoring and recordkeeping at the plant site.

Regulatory agencies, in cooperation with the respondents, also continue to create reporting systems to transmit data electronically.  However, electronic reporting systems still are not widely used.  At this time, it is estimated that approximately 10 percent of the respondents use electronic reporting.

(ii)  Respondent Activities

Respondent Activities

Read instructions.

Perform initial performance test, Reference Method 21 tests, and repeat performance tests as necessary.

Write the notifications and reports listed above.

Enter information required to be recorded listed above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

5.  The Information Collected: Agency Activities, Collection Methodology, and Information Management

5(a)  Agency Activities

EPA conducts one or more of the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities

Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS (Aerometric Information Retrieval System) Air Facility Subsystem (AFS) database.

5(b)  Collection Methodology and Management

The required data and reports can be evaluated on-site by conducting a partial compliance evaluation, full compliance evaluation, or inspection, or thru an off-site review of compliance monitoring records and reports.  Evaluation reports and inspection results are maintained by the Agency or delegated authority.

The results of these evaluations are entered into the Air Facility Subsystem (AFS), which is operated and maintained by EPA's Office of Compliance.  AFS is EPA’s database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government-owned facilities.  EPA uses the AFS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters.  EPA and delegated authorities can retrieve and analyze the data.

5(c)  Small Entity Flexibility

There are no small businesses affected by this regulation.

5(d)  Collection Schedule

The specific frequency for each information collection activity within this request is shown in Table 1, attached.

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry.  The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act.  Where appropriate, specific tasks and major assumptions have been identified.  Responses to this information collection are mandatory.

6(a)  Estimating Respondent Burden

The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 16,626 hours ( Total Labor Hours from Table 1).  These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs

This ICR uses a Technical Labor Rate of $57.12 per hour.  This rate is from the United States Department of Labor, Bureau of Labor Statistics, March 2001, “Table 10. Private industry, by occupational and industry group.”  The rates are from column 1, “Total compensation.”  The wage rate of $27.20 has been increased by 110% to account for the benefit packages available to those employed by private industry for a labor rate of $57.12 per hour.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

The only type of industry costs associated with the information collection activity in the regulations is labor costs.  There are no capital/startup, or operation and maintenance costs.  The capital/startup costs are one-time costs when a facility becomes subject to the regulation.  The annual operation and maintenance costs are the ongoing costs to maintain the monitor and other costs, such as photocopying and postage.

6(c)  Estimating Agency Burden and Costs

The only costs to the Agency are those associated with analysis of the reported information.  EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $50,939 (see Table 1 attached).  This cost is based on the average hourly labor rate at a GS-12, Step 1, multiplied by a 1.6 benefits factor to account for government overhead expenses for a total of $38.30.  These rates are from the Office of Planning and Management (OPM) “2002 General Schedule”, which excludes locality rates of pay.  Details upon which this estimate is based appear in Table 2, attached.

6(d)  Estimating the Respondent Universe and Total Burden and Costs

Number of Respondents

	Respondents That Submit Reports	Respondents That Do Not Submit Any Reports

	Year	(A)

Number of New Respondents 1	(B)

Number of Existing Respondents	(C)

Number of Existing Respondents That Keep Records but Do Not Submit Reports	(D)

Number of         Existing Respondents That Are Also New Respondents	(E)

Number of Respondents

(E=A+B+C-D)

1	0	234	0	0	234

2	0	234	0	0	234

3	0	234	0	0	234

Average	0	234	0	0	234

1 New respondents include sources with constructed, reconstructed and modified affected facilities.  [In this standard existing respondents submit initial notifications.]

Column D is subtracted to avoid double-counting the number of respondents.  The average Number of Respondents over the three-year period of this ICR is shown in column D.  This number appears on the OMB 83-I form in block 13(a), Number of respondents.

The number of total respondents is 234.  This represents the number of existing sources plus the number of new sources averaged over the three-year period (i.e., number of new respondents per year multiplied by three years divided by two).  It is shown in block 13(a), Number of respondents, on the OMB 83-I form.

The total number of annual responses per year is calculated using the following table:

Total Annual Responses

(A)

Information Collection Activity	(B)

Number of Respondents	(C)

Number of Responses	(D)

Number of Existing Respondents That Keep Records But   Do Not Submit Reports	(E)

Total Annual Responses

E=(BxC)+D

Periodic reports	234	1	0	234

	Total	234

The number of Total Annual Responses is 234.  This is the number in column E of the Respondent Universe and Number of Responses Per Year table.  This number is shown in block 13(b), Total Annual Responses, on the OMB 83-I form.

The total annual labor cost may be found in Table 1, Annual Respondent Burden and Cost:  NESHAP for Benzene Waste Operations (40 CFR part 61, subpart FF).  The total annual labor hours are 16,626.  This number is not shown on the OMB 83-I form in block 13(c), Total hours requested.  Only the burden hours are reflected in block 13(c).

There are no total annual capital and O&M costs to the regulated entity.  This number is shown on the OMB 83-I form in block 14(c), “Total annualized cost requested.”  These costs are detailed in section 6(b)(iii), Capital/Startup vs. Operating and Maintenance (O&M) Costs.

The average annual Agency burden and cost over next three years is shown in Table 2, Annual Burden and Cost for The Federal Government: NESHAP for Benzene Waste Operations (40 CFR part 61, subpart FF).

6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the respondents and the Agency are shown in Tables 1 and 2, respectively.

(i) Respondent Tally

The Total Hours Requested is shown on the OMB 83-I form in block 13(c).  The annual labor cost is not shown on the OMB 83-I form.  Details regarding these estimates may be found in Table 1.  Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 71 hours per response.

The total annual capital/startup and O&M costs to the regulated entity are shown on the OMB 83-I form in block 14(c), Total annualized cost requested.  The cost calculations are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Cost.

(ii) The Agency Tally

The average annual Agency burden hours and cost over next three years is shown in Table 2.

6(f)  Reasons for Change in Burden

There are no changes in the burden calculation for the renewal of this ICR since we have assumed that there has been no change in the industry burden since the last ICR was approved.

 6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 71 hours per response.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to, or for a Federal agency.  This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to adjust the existing ways to comply with any previously applicable instructions and requirements; to train personnel to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit, or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number.  The OMB Control Numbers for EPA’s regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OECA-2005-0020, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, N.W., Washington, D.C.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Enforcement and Compliance Docket and Information Center is<PHONE_NUMBER>.  An electronic version of the public docket is available through Federal Docket Management System (FDMS) at http://www.regulations.gov.  Use FDMS to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select “search,” then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N.W., Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OECA-2005-0020 and OMB Control Number 2060-0183 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in collecting this information.

TABLE 1.  AVERAGE ANNUAL EPA RESOURCE REQUIREMENT  NESHAP Subpart FF

	A	B	C	D	E	F

	EPA hours per occurrence	Occurrences per plant/yr	EPA                 hours/plant/yr     (A x B)	Plants/year	EPA           hours/year    (C x D)	Total annual cost (E x $38.30)

Initial Performance Tests	............................not applicable.........................

Report Review	............................not applicable.........................

     New Plant

          Notification of construction	None expected

          Notification of anticipated startup ............................not applicable.........................

          Notification of actual startup	............................not applicable.........................

          Initial Report (b)	............................not applicable.........................

          Notification of performance test ............................not applicable.........................

     Existing Plant

          Quarterly reports	2	4	8	137	1,096	$41,977

          Annual Recertification	1	1	1	234	234	$8,962

TOTAL ANNUAL HOURS

	1,330	$50,939

Travel Expenses (d) (1 person x 0 plants/yr x 1 d/plant x $50 per diem) + ($250 round trip/plant x 0 plants/yr) = $0/yr

TOTAL ANNUAL COST	$50,939

a) A X B = C

b) C X D = E

d) Assume that as there will be no new sources, no new affected facilities will be visited.

	e) Assume an hourly wage of a GS12, Step 1 employee rate times a 1.6 benefits multiplication factor to account for government overhead expenses for a total of $38.30. This amount was multiplied by the hours in each line of Column E to estimate the total annual cost per year.

TABLE 2.  ANNUAL BURDEN OF REPORTING AND RECORD KEEPING REQUIREMENTS AS A RESULT OF THE STANDARDS NESHAP SUBPART FF

	A	B	C	D	E	F

Reporting and recordkeeping requirements	Person hours per occurrence Annual occurrences per    respondent	Annual person hours/respondent     (A x B)	Total number of respondents	Total annual person hours    (C x D)	Total annual cost (E x $57.12)

1. APPLICATIONS	............................not applicable.........................

2. SURVEYS AND STUDIES	............................not applicable.........................

3. REPORTING REQUIREMENTS

    a. Read instructions	Included in 3C

     b. Required activites

	    c. Create information

	       i. Determine quantity of benzene in waste	done initially

       ii. Initial waste determination	done initially

      iii. Treatment performance evaluation	done initially

      iv. Annual waste determination (c)	2	1	2	234 (d)	468	$26,732

      v. Monthly treated waste analysis	1 (e)	12	12	13 (f)	156	$8,911

      vi.Treatment/control device monitoring	included in 4C

     vii. Initial visual inspection	done initially

    viii. Quarterly visual inspection	2	4	8	137 (g)	1,096	$62,604

     ix. Annual method 21 monitoring	6	1	6	137 (g) 	822	$46,953

D. Gather Existing Information

	E. Write report

       New Sources

          Notification of const/reconstruction  ........................not applicable.........................

          Notification of ant/ act.startup	........................not applicable.........................

          Notification/Report of perf.test	........................not applicable.........................

       Existing sources

	          Initial report	........................not applicable.........................

          Quarterly emission report	4	4	16	137 (g) 	2,192	$125,207

          Annual report	1	1	1	234 (d)	234	$13,366

          Notification of offsite facility	2	12	24	13 (h)	312	$17,821

4. RECORD KEEPING REQUIREMENTS

    a. Read instructions	Included in 3A

     b. Plan Activites	Included in 4C

    c. Implement Activities

	        i. Filling and maintain records	78	1	78	137 (i)	10,686	$610,384

       ii. Concentration data	0.5	12	6	97 (k)	582	$33,244

      iii. Concentration data	0.5	12	6	13	78	$4,455

      iv. Waste quantity data	Done initially

    d. Develop Record System	Included in 4C

    e. Time to Enter Information	Included in 4C

    f. Train Personnel	........................not applicable.........................

    g. Audits	........................not applicable.........................

Total

	16,626	$949,677

(a) estimate that there are 234 affected sources. No new sources are expected over the next three years. Estimate that 117 sources have a TAB between 1 Mg/yr and 10 Mg/yr and file an annual report of TAB. Estimate that 117 sources have a TAB greater than 10 Mg/yr and have complied with the control requirements and file quarterly reports.

A total of 56 facilities has over 50 Mg/yr and are expected to have installed controls without applying for exemptions.

(b) Estimate an hourly wage of $57.12 ($27.20 x 110% to account for the benefit packages available to those employed by private industry). This amount was multiplied by the hours in each line of Column E to estimate the total annual cost.

(c) Based upon of knowledge of waste and initial tests for determination.

	(d) All facilities above 1 Mg/yr must evaluate waste streams annually TAB report (97+137 = 234).

(e) Based upon 0.5 hours for collection activities for all samples and 0.5 hours per sample for analysis for a total of 1 hour per sample.

(f) Assumes that 90 percent of the 137 sources (124) monitor process parameters; and 10 percent (13) must conduct monthly sampling.

(g) A total of 137 facilities are expected to be greater than 10 Mg per year and must comply with the control requirements.

(h) Assumes that 10 percent of facilities (13) choose to ship their waste offsite monthly for treatment.

(i) Recordkeeping requirements for the 137 sources which must install controls.

	(k) Recordkeeping requirements for the 97 sources which repeat the annual benzene quantity determination.

	234	sources

	0.975

0.975

136.5

234

55.575

151.125

117

 PAGE

 PAGE  10


[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]
[Page 73986]
[DOCID:fr04de08-73]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Personnel Parachute Assemblies TSO-C23e

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of cancellation.

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SUMMARY: The minimum performance standard (MPS) for Personnel Parachute
Assemblies and Components contained in Appendix 1 of technical standard
order (TSO)-C23e is substantially different from the version submitted
for public comment. As such, this notice announces the cancellation of
TSO-C23e.

DATES: TSO-C23e is cancelled as of December 4, 2008.

ADDRESSES: Send all inquiries pertaining to the cancellation of TSO-23e
to: Federal Aviation Administration, Aircraft Certification Service,
Aircraft Engineering Division, Room 815, 800 Independence Avenue, SW.,
Washington, DC 20591. ATTN: George Soteropoulos, AIR-120. You may
deliver your inquiries to: Federal Aviation Administration, Room 815,
800 Independence Avenue, SW., Washington, DC 20591. Include in the
subject line of your electronic message the following: Inquiries, FAA
TSO-23e, Personnel Parachute Assemblies.

FOR FURTHER INFORMATION CONTACT: George Soteropoulos, Aerospace
Engineer, Federal Aviation Administration, Aircraft Certification
Service, Aircraft Engineering Division, Technical Programs and
Continued Airworthiness Branch, AIR-120, Room 815, 800 Independence
Avenue, SW., Washington, DC 20591. Telephone<PHONE_NUMBER>, FAX (202)
267-5340, or e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    It is believed that the minimum performance standard (MPS)
prescribed in Appendix 1 of TSO-C23e for personnel parachute assemblies
and components thereof, differs significantly from the version
submitted for public comment. For that reason we are cancelling TSO-
C23e to allow for further review and discussions with interested
industry groups and associations to ensure safety through a coordinated
agreed-upon MPS.

    Issued in Washington, DC on November 19, 2008.
Susan J.M. Cabler,
Assistant Manager, Aircraft Engineering Division, Aircraft
Certification Service.
[FR Doc. E8-28229 Filed 12-3-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Pages 25249-25251]
[FR Doc No: 2019-11357]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC19-23-000]

Commission Information Collection Activities (FERC-725P1);
Consolidated Comment Request; Extension

AGENCY:  Federal Energy Regulatory Commission.

ACTION:  Notice of information collections and request for comments.

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SUMMARY:  In compliance with the requirements of the Paperwork
Reduction Act of 1995, the Federal Energy Regulatory Commission
(Commission or FERC) is soliciting public comment on the requirements
and burden of the information collections described below.

DATES:  Comments on the collections of information are due July 30,
2019.

ADDRESSES:  You may submit comments (identified by Docket No. IC19-23-
000) by either of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Please reference the specific collection number and/or title in
your comments.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT:  Ellen Brown may be reached by email
at<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Type of Request: Three-year extension of the information collection
requirements for all collections described below with no changes to the
current reporting requirements. Please note the three collections are
distinct.
    Comments: Comments are invited on: (1) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information will have
practical utility; (2) the accuracy of the agency's estimates of the
burden and cost of the collections of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility and clarity of the information collections; and
(4) ways to minimize the burden of the collections of information on
those who are to respond, including the use of automated collection
techniques or other forms of information technology.
    Title: FERC-725P1 (Mandatory Reliability Standards: PRC-005-6
Reliability Standard).
    OMB Control No.: 1902-0280.
    Abstract: The Commission requires the information collected by the
FERC-725P1 to Ok. implement the statutory provisions of section 215 of
the Federal Power Act (FPA).\1\ On August 8, 2005, Congress enacted
into law the Electricity Modernization Act of 2005, which is Title XII,
Subtitle A, of the Energy Policy Act of 2005 (EPAct 2005).\2\ EPAct
2005 added a new section 215 to the FPA, which required a Commission-
certified Electric Reliability Organization (ERO) to develop mandatory
and enforceable Reliability Standards, which are subject to Commission
review and approval. Once approved, the Reliability Standards may be
enforced by the ERO subject to Commission oversight, or the Commission
can independently enforce Reliability Standards.\3\
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    \1\ 16 U.S.C. 824o (2012).
    \2\ Energy Policy Act of 2005, Public Law 109-58, Title XII,
Subtitle A, 119 Stat. 594, 941 (codified at 16 U.S.C. 824o).
    \3\ 16 U.S.C. 824o(e)(3).
---------------------------------------------------------------------------

    On February 3, 2006, the Commission issued Order No. 672,
implementing section 215 of the FPA.\4\ Pursuant to Order No. 672, the
Commission certified one organization, North American Electric
Reliability Corporation (NERC), as the ERO.\5\ The Reliability
Standards developed by the ERO and approved by the Commission apply to
users, owners and operators of the Bulk-Power System as set forth in
each Reliability Standard.
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    \4\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, FERC
Stats. & Regs. ] 31,204, order on reh'g, Order No. 672-A, FERC
Stats. & Regs. ] 31,212 (2006).
    \5\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g and compliance, 117 FERC ] 61,126 (2006),
order on compliance, 118 FERC ] 61,190, order on reh'g, 119 FERC ]
61,046 (2007), aff'd sub nom. Alcoa Inc. v. FERC, 564 F.3d 1342
(D.C. Cir. 2009).
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    On November 13, 2015, the North American Electric Reliability
Corporation (NERC) filed a petition for Commission approval of proposed
Reliability Standard PRC-005-6 (Protection System, Automatic Reclosing,
and Sudden Pressure Relaying Maintenance). NERC also requested approval
of the proposed implementation plan for PRC-005-6, and the retirement
of previous versions of Reliability Standard PRC-005.
    NERC explained in its petition that Reliability Standard PRC-005-6
represents an improvement upon the most recently-approved version of
the standard, PRC-005-4. FERC approved the proposed Reliability
Standard PRC-005-6 on December 18, 2015.
    Type of Respondent: Transmission Owners (TO), Generator Owners
(GO), and Distribution Providers.
    Estimate of Annual Burden: The Commission estimates the annual
public reporting burden for the information collection as:

                                           FERC-725K--Mandatory Reliability Standards for the SERC Region \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Annual number
                                       Number of     of responses    Total number    Average burden hrs. & cost per    Total annual burden hours & total
                                      respondents   per respondent   of responses             response \7\                      annual cost \8\
                                               (1)             (2)     (1) * (2) =  (4).............................  (3) * (4) = (5)
                                                                               (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PRC-005-6 Reliability Standard....         \9\ 996               1             996  2 hrs.; $133.80.................   1,992 hrs.; $133,265.\10\
--------------------------------------------------------------------------------------------------------------------------------------------------------

    One-time reporting requirements related to the implementation of
the PRC-005-6 Reliability Standard are being removed from the FERC-
725P1 information collection. A list of those removed reporting
requirements and their related burdens follows:
---------------------------------------------------------------------------

    \6\ Entities affected by the PRC-005-6 Reliability Standard are
registered to serve any of the following roles:
     PC=Planning Coordinators;
     GO=Generator Owners.
    Some entities are registered to serve both roles.
    \7\ The estimated hourly cost (salary plus benefits) provided in
this section is based on the salary figures (http://www.bls.gov/oes/current/naics2_22.htm) and benefits (http://www.bls.gov/news.release/ecec.nr0.htm) for May 2017 posted by the Bureau of
Labor Statistics for the Utilities sector. The hourly estimates for
salary plus benefits are $66.90/hour based on the Electrical
Engineering career (Occupation Code: 17-2071).
    \8\ Total Annual Cost is rounded-up from $133,264.80 to
$133,265.
    \9\ 20 (PC role only) + 927 (GO role only) + 49 (joint role as
PC and GO) = 996 unique entities.
    \10\ This number is rounded from $133,264.80.

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     One-time review of existing plant and substation sites:
937 responses and 1,874 hours.
     One-time review and adjustment of existing programs for
reclosing relays and associated equipment: 288 responses and 2,448
hours.
     One-time review and adjustment of existing program for
sudden pressure relays: 1,287 responses and 10,296 hours.
    The previous table presents the FERC-725P1 burden estimate after
these three one-time requirements were removed and the burden was
reduced.

    Dated: May 23, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-11357 Filed 5-30-19; 8:45 am]
BILLING CODE 6717-01-P