[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23086-23088]
[FR Doc No: 2020-08700]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88699; File No. SR-NYSEAMER-2020-03]

Self-Regulatory Organizations; NYSE American LLC; Order
Instituting Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change To Amend the NYSE American Rule 6800 Series, the
Exchange's Compliance Rule Regarding the National Market System Plan
Governing the Consolidated Audit Trail

April 20, 2020.

I. Introduction

    On January 3, 2020, NYSE American LLC (``NYSE American'' or ``the
Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend the Exchange's compliance rules regarding
the National Market System Plan Governing the Consolidated Audit Trail
(``CAT NMS Plan'').\3\ The proposed rule change was published for
comment in the Federal Register on January 23, 2020.\4\ On March 5,
2020, the Commission extended the time period within which to approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether to approve or disapprove the
proposed rule change, to April 22, 2020.\5\ The Commission received no
comments on the proposal. This order institutes proceedings pursuant to
Exchange Act Section 19(b)(2)(B) to determine whether to approve or
disapprove File No. SR-NYSEAMER-2020-03.\6\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The CAT NMS Plan was approved by the Commission, as
modified, on November 15, 2016. See Securities Exchange Act Release
No79318 (November 15, 2016), 81 FR 84696 (November 23, 2016).
    \4\ See Securities Exchange Act Release No. 87989 (January 16,
2020), 85 FR 3995 (``Notice'').
    \5\ See Securities Exchange Act Release No. 88331, 85 FR 14252
(March 11, 2020).
    \6\ 15 U.S.C. 78(s)(b)(2)(B).
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II. Description of the Proposed Rule Change

    The Exchange proposes to amend the NYSE American Rule 6800 Series
(``Compliance Rule''), which sets forth rules regarding Industry Member
\7\

compliance with the CAT NMS Plan. Specifically, the proposed rule
change would make the following changes to the Compliance Rule to be
consistent with certain proposed amendments to and exemption requests
submitted by the Participants \8\ of the CAT NMS Plan: (1) Revise data
reporting requirements for the Firm Designated ID \9\ based on a
proposed amendment to the CAT NMS Plan filed with the Commission; \10\
(2) amend the dates for required testing and reporting in the
Compliance Rule for Industry Member reporting; \11\ (3) amend the rules
to require Industry Members to submit trade reports for executions and
cancellations for cancelled trades to the FINRA's Trade Reporting
Facilities, FINRA's OTC Reporting Facility or FINRA's Alternative
Display Facility; \12\ (4) revise the timestamp granularity requirement
to require Industry Members with order handling or execution systems
that utilize time stamps in increments finer than milliseconds to
report timestamps up to nanoseconds when reporting Industry Member data
\13\ to the Central Repository; \14\ (5) revise the reporting
requirements for circumstances in which an Industry Member uses an
established trading relationship for an individual Customer, instead of
an account, on the order reported to CAT; \15\ and (6) revise the CAT
reporting requirements so Industry Members would not be required to
report to the Central Repository dates of birth, social security
numbers, or account numbers for individuals.\16\
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    \7\ Industry Member means a member of a national securities
exchange or a member of a national securities association. See CAT
NMS Plan, supra note 3, at Section 1.1. See also proposed NYSE
American Rule 6810(s).
    \8\ The Participants include BOX Exchange LLC, Cboe BYX
Exchange, Inc., Cboe BZX Exchange, Inc., Cboe C2 Exchange, Inc.,
Cboe EDGA Exchange, Inc., Cboe EDGX Exchange, Inc., Cboe Exchange,
Inc., Financial Industry Regulatory Authority, Inc., Investors'
Exchange LLC, Long-Term Stock Exchange, Inc., Miami International
Securities Exchange LLC, MIAX Emerald, LLC, MIAX PEARL, LLC, Nasdaq
BX, Inc., Nasdaq GEMX, LLC, Nasdaq ISE, LLC, Nasdaq MRX, LLC, Nasdaq
PHLX LLC, The Nasdaq Stock Market LLC, New York Stock Exchange LLC,
NYSE American LLC, NYSE Arca, Inc., NYSE Chicago, Inc., and NYSE
National, Inc.
    \9\ As proposed, ``Firm Designated ID'' would mean a unique and
persistent identifier for each trading account designated by
Industry Members for purposes of providing data to the Central
Repository, where each such identifier is unique among all
identifiers from any given Industry Member; provided, however, such
identifier may not be the account number for such trading account if
the trading account is not a proprietary account. See proposed NYSE
American Rule 6810(r).
    \10\ See Notice, supra note 4, at 3995. See also Letter to
Vanessa Countryman, Secretary, SEC, from Michael Simon, CAT NMS Plan
Operating Committee Chair re: Notice of Filing of Amendment to the
National Market System Plan Governing the Consolidated Audit Trail
(April 14, 2020). The Commission has not approved or disapproved the
changes proposed in this amendment.
    \11\ See Notice, supra note 4, at 3999-4003. On February 19,
2020, the Participants submitted a request for exemptive relief from
the reporting dates required by the CAT NMS Plan. See Letter to
Vanessa Countryman, Secretary, SEC, from Michael Simon, CAT NMS Plan
Operating Committee Chair, re: Request for Exemption from Provisions
of the National Market System Plan Governing the Consolidated Audit
Trail related to Industry Member Reporting Dates (Feb. 19, 2020).
    \12\ See Notice, supra note 4, at 4003. On February 12, 2020,
the Participants submitted a request for exemptive relief from the
requirement in Sections 6.4(d)(ii)(A)(2) and (B) of the CAT NMS Plan
to require Industry Members to record and report, if an order is
executed, the SRO-Assigned Market Participant Identifier of the
clearing broker, and if a trade is cancelled, the cancelled trade
indicator. See Letter to Vanessa Countryman, Secretary, SEC, from
Michael Simon, CAT NMS Plan Operating Committee Chair, re: Request
for Exemption from Certain Provisions of the National Market System
Plan Governing the Consolidated Audit Trail related to FINRA
Facility Data Linkage (Feb. 12, 2020). If granted, the exemptive
relief would revise CAT reporting requirements regarding cancelled
trades and SRO-Assigned Market Participant Identifiers of clearing
brokers, if applicable, in connection with order executions, as such
information would be available from FINRA's trade reports submitted
to CAT.
    \13\ See Notice, supra note 4, at 4004. On February 3, 2020, the
Participants filed a request for exemptive relief from the current
CAT NMS Plan requirement to record and report Industry Member Data
with time stamps consistent with their system, a requirement from
which the Exchange requests an exemption. See Letter to Vanessa
Countryman, Secretary, SEC, from Michael Simon, CAT NMS Plan
Operating Committee Chair, re: Request for Exemption from Certain
Provisions of the National Market System Plan Governing the
Consolidated Audit Trail related to Granularity of Timestamps and
Relationship Identifiers (Feb. 3, 2020). On April 8, 2020, the
Commission granted the exemptive relief for timestamp granularity.
See Securities Exchange Act Release No. 88608 (April 8, 2020), 85 FR
20743 (April 14, 2020).
    \14\ The Central Repository, as defined in the CAT NMS Plan,
means ``the repository responsible for the receipt, consolidation,
and retention of all information reported to the CAT pursuant to SEC
Rule 613 and this Agreement.'' See CAT NMS Plan, supra note 3, at
Section 1.1.
    \15\ See Notice, supra note 4, at 4004. On February 3, 2020, the
Participants filed a request for exemptive relief from the CAT NMS
Plan requirement that Participants, through their Compliance Rules,
require Industry Members to record and report to the Central
Repository the account number, the date account opened, and the
account type for individual customers in circumstances in which an
Industry Member uses an established trading relationship for the
individual customer. Instead, the Participant would require Industry
Members to record and report to the Central Repository for the
original receipt or origination of an order: (i) The relationship
identifier instead of the account number, (ii) the ``account type''
as a ``relationship'', and (3) the account effective date instead of
the ``date account opened.'' See Letter to Vanessa Countryman,
Secretary, SEC, from Michael Simon, CAT NMS Plan Operating Committee
Chair, re: Request for Exemption from Certain Provisions of the
National Market System Plan Governing the Consolidated Audit Trail
related to Granularity of Timestamps and Relationship Identifiers
(Feb. 3, 2020).
    \16\ See Notice, supra note 4, at 4005. The Participants
requested and have received exemptive relief from the requirement of
Section 6.4(d)(ii)(C) of the CAT NMS Plan for the Participants, in
their Compliance Rules, to require their members to provide dates of
birth, account numbers and social security numbers for individuals
to the CAT. See Securities Exchange Act Release No. 88393 (March 17,
2020), 85 FR 16152 (March 20, 2020). See also Letter to Vanessa
Countryman, Secretary, SEC, from Michael Simon, CAT NMS Plan
Operating Committee Chair, re: Request for Exemptive Relief from
Certain Provisions of the CAT NMS Plan related to Social Security
Numbers, Dates of Birth and Account Numbers (Jan. 29, 2020).
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    The Exchange also proposes to amend the Exchange's Compliance Rule
to facilitate the retirement of certain existing regulatory systems,
specifically the Financial Industry Regulatory Authority, Inc.'s
(``FINRA'') Order Audit Trail System, by adding additional data
elements to the CAT reporting requirements for Industry Members,\17\
additional reporting requirements for alternative trading systems,\18\
and additional data elements related to OTC Equity Securities \19\ that
FINRA currently receives from alternative trading systems that trade
OTC Equity Securities.\20\
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    \17\ See Notice, supra note 4, at 3996.
    \18\ See Notice, supra note 4, at 3996-99.
    \19\ OTC Equity Security, as defined in the CAT NMS Plan, means
any equity security, other than an NMS Security, subject to prompt
last sale reporting rules of a registered national securities
association and reported to one of such association's equity trade
reporting facilities. See CAT NMS Plan, supra note 3, at Section
1.1.
    \20\ See Notice, supra note 4, at 3999.
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III. Proceedings To Determine Whether To Approve or Disapprove the
Proposed Rule Change

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \21\ to determine whether the proposed rule
change should be approved or disapproved. Institution of proceedings
does not indicate that the Commission has reached any conclusions with
respect to any of the issues involved. Rather, the Commission seeks and
encourages interested persons to provide additional comment on the
proposed rule change to inform the Commission's analysis of whether to
approve or disapprove the proposed rule change.
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    \21\ 15 U.S.C. 78s(b)(2)(B).
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    Pursuant to Section 19(b)(2)(B) of the Act,\22\ the Commission is
providing notice of the grounds for possible disapproval under
consideration. The Commission is instituting proceedings to allow for
additional analysis of the proposed rule change's consistency with
Section 6(b)(5) of the Act,\23\ which requires, among other things,
that the rules of a national securities exchange be ``designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade,'' and ``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.'' \24\ The Commission believes that
several of the proposed rule changes are not consistent with the CAT
NMS Plan or exemptive relief that has been granted as of the date of
this Order.
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    \22\ 15 U.S.C. 78s(b)(2)(B).
    \23\ 15 U.S.C. 78f(b)(5).
    \24\ 15 U.S.C. 78f(b)(5).
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IV. Commission's Solicitation of Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) \25\ or any other provision of the Act,
or the rules and regulations thereunder. Although there do not appear
to be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4 under the Act,\26\ any
request for an opportunity to make an oral presentation.\27\
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    \25\ 15 U.S.C. 78f(b)(5).
    \26\ 17 CFR 240.19b-4.
    \27\ Section 19(b)(2) of the Exchange Act, as amended by the
Securities Act Amendments of 1975, Public Law 94-29 (June 4, 1975),
grants the Commission flexibility to determine what type of
proceeding--either oral or notice and opportunity for written
comments--is appropriate for consideration of a particular proposal
by a self-regulatory organization. See Securities Act Amendments of
1975, Senate Comm. on Banking, Housing & Urban Affairs, S. Rep. No.
75, 94th Cong., 1st Sess. 30 (1975).
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    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposal should be approved or
disapproved by May 15, 2020. Any person who wishes to file a rebuttal
to any other person's submission must file that rebuttal by May 29,
2020. Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Numbers SR-NYSEAMER-2020-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAMER-2020-03. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2020-03 and should be submitted
on or before May 15, 2020. Rebuttal comments should be submitted by May
29, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
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    \28\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-08700 Filed 4-23-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 95 (Wednesday, May 17, 2023)]
[Notices]
[Pages 31532-31533]
[FR Doc No: 2023-10464]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34915; File No. 812-15304]

Hartford Schroders Private Opportunities Fund, et al.

May 11, 2023
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice.

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    Notice of application for an order (``Order'') under section 17(d)
of the Investment Company Act of 1940 (the ``Act'') and rule 17d-1
under the Act to permit certain joint transactions otherwise prohibited
by section 17(d) of the Act and rule 17d-1 under the Act.

Summary of Application:  Applicants request an order to permit certain
closed-end management investment companies to co-invest in portfolio
companies with each other and with certain affiliated investment
entities.

Applicants:  Hartford Schroders Private Opportunities Fund, Hartford
Funds Management Company, LLC, Schroder Investment Management North
America Inc., Schroders Capital Management

(US) Inc., Cresta III S.C.S., GPEP V S.C.S., IST3 Manesse PE3 Impact
S.C.S., KVT PE S.C.S., Malatrex S.C.S., Marmolata PE Impact S.C.S.,
Marmolata S.C.S., PSY Private Equity S.C.S., SA-EL II S.C.S., SA-EL
Opportunity S.C.S., Sal[egrave]ve 2022 S.C.S., SC Global Opportunities
S.L.P., Schroder British Opportunities Trust PLC, Schroder UK Public
Private Trust PLC, Schroders Capital cPl Global 2023-2025 S.C.S.,
Schroders Capital Private Equity Asia VI S.C.S., Schroders Capital
Private Equity Europe Direct III S.C.S., Schroders Capital Private
Equity Europe VIII S.C.S., Schroders Capital Private Equity Global
Direct III S.C.S., Schroders Capital Private Equity Global III S.C.S.,
Schroders Capital Private Equity Global Innovation X S.C.S., Schroders
Capital Private Equity Global Innovation XI S.C.S., Schroders Capital
Private Equity Healthcare S.C.S., Schroders Capital Private Equity
Secondaries IV S.C.S., Schroders Capital Private Equity US V S.C.S.,
Schroders Capital Private Equity US VI S.C.S., Schroders Capital Semi-
Liquid--Circular Economy Private Plus, Schroders Capital Semi-Liquid--
Global Innovation Private Plus, Schroders Capital Semi-Liquid Global
Private Equity Holding S.C.S., Schroders Capital Taft-Hartley Ventures
S.C.S. and Wollstonecraft L.P.

Filing Dates:  The application was filed on January 27, 2022 and
amended on August 19, 2022, December 16, 2022 and April 11, 2023.

Hearing or Notification of Hearing:  An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the SEC's Secretary at [email protected] and serving the
Applicants with a copy of the request by email, if an email address is
listed for the relevant Applicant below, or personally or by mail, if a
physical address is listed for the relevant Applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on June 5,
2023, and should be accompanied by proof of service on Applicants, in
the form of an affidavit or, for lawyers, a certificate of service.
Pursuant to rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary at
[email protected].

ADDRESSES: The Commission: [email protected]. Applicants: John
V. O'Hanlon, Esquire, Dechert LLP, One International Place, 40th Floor,
100 Oliver Street, Boston, Massachusetts 02110-2605, and Thomas R.
Phillips, Hartford Funds Management Company, LLC, 690 Lee Road, Wayne,
Pennsylvania 19087.

FOR FURTHER INFORMATION CONTACT: Christopher D. Carlson, Senior
Counsel, or Daniele Marchesani, Assistant Chief Counsel, at (202) 551-
6825 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal
analysis, and conditions, please refer to Applicants' third amended and
restated application, dated April 11, 2023, which may be obtained via
the Commission's website by searching for the file number at the top of
this document, or for an Applicant using the Company name search field,
on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
http://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may
also call the SEC's Public Reference Room at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-10464 Filed 5-16-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Rules and Regulations]
[Pages 78612-78614]
[FR Doc No: 2022-27295]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1643; Project Identifier MCAI-2022-00799-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2020-21-07, which applies to all Airbus SAS Model A350-941 and -1041
airplanes. AD 2020-21-07 requires replacement of affected passenger
oxygen masks (which includes re-identifying the parts). Since the FAA
issued AD 2020-21-07, it was determined that additional parts are
subject to the unsafe condition. This proposed AD would continue to
require the actions in AD 2020-21-07, and would require replacing
additional affected parts, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is proposed for incorporation by
reference (IBR). This proposed AD would also prohibit installation of
affected parts. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by February 6,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1643; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For material that is proposed for IBR in this NPRM,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at ad.easa.europa.eu. It is
also available at regulations.gov under Docket No. FAA-2022-1643.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dat Le, Aerospace Engineer, Large
Aircraft Section, FAA, International Validation Branch, 2200 South
216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-1643; Project Identifier
MCAI-2022-00799-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dat
Le, Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected]. Any commentary that the
FAA receives which is not specifically designated as CBI will be placed
in the public docket for this rulemaking.

Background

    The FAA issued AD 2020-21-07, Amendment 39-21280 (85 FR 64949,
October 14, 2020) (AD 2020-21-07), for all Airbus SAS Model A350-941
and -1041 airplanes. FAA AD 2020-21-07 was prompted by an MCAI
originated by EASA, which is the Technical Agent for the Member States
of the European Union. EASA issued AD 2020-0031, dated February 18,
2020 (EASA AD 2020-0031), to correct an unsafe condition identified as
sticking of the breathing bag on certain passenger oxygen masks, which
could prevent the breathing bag from fully inflating, and possibly
injure cabin occupants following a depressurization event.
    AD 2020-21-07 requires replacement of affected passenger oxygen
masks (which includes re-identifying the parts).

Actions Since AD 2020-21-07 Was Issued

    Since the FAA issued AD 2020-21-07, EASA superseded EASA AD 2020-
0031 and issued EASA AD 2022-0112, dated June 17, 2022 (EASA AD 2022-
0112) (also referred to as the MCAI), to

correct an unsafe condition for all Airbus SAS Model A350-941 and -1041
airplanes. The MCAI states that additional affected parts (emergency
passenger oxygen container assembly having serial number BEHJ-XXXX)
have been identified as being subject to the same unsafe condition.
    The FAA is issuing this AD to address sticking of the breathing bag
on certain passenger oxygen masks. The unsafe condition, if not
addressed, could prevent the breathing bag from fully inflating, and
possibly injure cabin occupants following a depressurization event. You
may examine the MCAI in the AD docket at regulations.gov under Docket
No. FAA-2022-1643.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2020-21-07, this proposed AD would retain all of the
requirements of AD 2020-21-07. Those requirements are referenced in
EASA AD 2022-0112, which, in turn, is referenced in paragraph (g) of
this proposed AD.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0112 specifies procedures for replacing the affected
passenger oxygen masks (those passenger oxygen masks contained in each
affected emergency passenger oxygen container assembly), and re-
identifying each affected part. EASA AD 2022-0112 also prohibits the
installation of affected parts.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would retain all of the requirements of AD 2020-
21-07. This proposed AD would require accomplishing the actions
specified in EASA AD 2022-0112 described previously, except for any
differences identified as exceptions in the regulatory text of this
proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2022-0112 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2022-0112 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2022-0112 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA 2022-0112.
Service information required by EASA 2022-0112 for compliance will be
available at regulations.gov under Docket No. FAA-2022-1643 after the
FAA final rule is published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 30 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per    Cost on U.S.
                  Action                            Labor cost           Parts cost    product       operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2020-21-07 (13    6 work-hours x $85 per hour         * $0         $510          $6,630
 airplanes).                                = $510.
New proposed actions.....................  6 work-hours x $85 per hour          * 0          510          15,300
                                            = $510.
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable the FAA to provide cost estimates of the parts cost
  for the replacement specified in this proposed AD.

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2020-21-07, Amendment 39-21280
(85 FR 64949, October 14, 2020); and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2022-1643; Project Identifier MCAI-2022-
00799-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by February 6, 2023.

(b) Affected ADs

    This AD replaces AD 2020-21-07, Amendment 39-21280 (85 FR 64949,
October 14, 2020) (AD 2020-21-07).

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Unsafe Condition

    This AD was prompted by a report that sticking effects have been
observed affecting the breathing bag on certain passenger oxygen
masks, and by a determination that additional parts are subject to
the unsafe condition. The FAA is issuing this AD to address sticking
of the breathing bag on certain passenger oxygen masks. The unsafe
condition, if not addressed, could prevent the breathing bag from
fully inflating, and possibly injure cabin occupants following a
depressurization event.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0112, dated June 17, 2022 (EASA AD 2022-0112).

(h) Exceptions to EASA AD 2022-0112

    (1) Where EASA AD 2022-0112 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2022-0112 does not apply
to this AD.
    (3) Where EASA AD 2022-0112 specifies to do the replacement and
re-identification specified in Airbus Service Bulletin A350-35-P013,
Revision 02, dated March 8, 2022, which specifies to inspect for the
part number and serial number and then do a replacement; this AD
only requires the replacement and re-identification.
    (4) Where service information identified in EASA AD 2022-0112
specifies to do an inspection for the date of manufacture of the
affected part, this AD does not require that inspection.
    (5) Where Table 3 of EASA AD 2022-0112 specifies a compliance
time for airplanes on which ``the SB'' has not been embodied, for
this AD the compliance time for those airplanes is ``before
exceeding 72 months since airplane date of manufacture or within 30
days after the effective date of this AD, whichever occurs later.''

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to International
Validation Branch, send it to the attention of the person identified
in paragraph (j) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (i)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(j) Additional Information

    For more information about this AD, contact Dat Le, Aerospace
Engineer, Large Aircraft Section, FAA, International Validation
Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 516-
228-7317; email [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0112,
dated June 17, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0112, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on December 12, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-27295 Filed 12-21-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44418-44419]
[FR Doc No: 2023-14814]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97851; File No. SR-ICEEU-2023-010]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Amendment No. 2 to Proposed Rule Change, as Modified by
Amendment No. 1, Relating to Amendments to the Clearing Rules

July 7, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 21, 2023, ICE Clear Europe Limited (``ICE Clear Europe'' or
the ``Clearing House'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change to amend the ICE
Clear Europe Clearing Rules regarding the treatment of non-default
losses. On May 2, 2023, ICE Clear Europe filed Amendment No. 1 to the
proposed rule change.\3\ Notice of the proposed rule change, as
modified by Amendment No. 1, was published for comment in the Federal
Register on May 10, 2023.\4\ On June 21, 2023, the Commission
designated a longer period for Commission action on the proposed rule
change until August 8, 2023.\5\ On June 30, 2023, ICE Clear Europe
filed Amendment No. 2 to the proposed rule change.\6\ The Commission is
publishing this notice to solicit comments on the proposed rule change,
as modified by Amendment No. 1 and No. 2 (the ``proposed rule
change''), from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 amended and restated in its entirety the
Form 19b-4 and Exhibit 1A in order to correct the narrative
description of the proposed rule change.
    \4\ Self-Regulatory Organizations; ICE Clear Europe Limited;
Notice of Filing of Proposed Rule Change, as Modified by Amendment
No. 1, Relating to Amendments to the Clearing Rules, Exchange Act
Release No. 97429 (May 4, 2023); 88 FR 30187 (May 10, 2023) (SR-
ICEEU-2023-010).
    \5\ Self-Regulatory Organizations; ICE Clear Europe Limited;
Notice of Designation of Longer Period for Commission Action on
Proposed Rule Change, as Modified by Amendment No. 1, Relating to
Amendments to the Clearing Rules; Exchange Act Release No. 97780
(June 21, 2023), 88 FR 41711 (June 27, 2023) (File No. SR-ICEEU-
2023-010).
    \6\ In Amendment No. 2, ICE Clear Europe provided additional
clarifications as to funds available to the Clearing House to be
applied in accordance with the Rules as proposed to be amended.
---------------------------------------------------------------------------

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

    ICE Clear Europe Limited (``ICE Clear Europe'' or the ``Clearing
House'') submits this partial amendment (``Amendment No. 2'') to its
previously submitted proposed rule amendments, as amended by Amendment
No. 1 thereto (as so amended, the ``Prior Filing'') to its Clearing
Rules (the ``Rules'') \7\ to address more consistently the treatment of
certain losses that do not result from Clearing Member default,
including certain investment losses and custodial losses. Amendment No.
2 sets forth certain additional clarifications as to funds available to
the Clearing House to be applied in accordance with the Rules as
proposed to be amended.
---------------------------------------------------------------------------

    \7\ Capitalized terms used but not defined herein have the
meanings specified in the Rules.
---------------------------------------------------------------------------

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

    In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

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

(a) Purpose
    ICE Clear Europe is proposing to make certain additional changes to
the proposed amendments to the Rules as described in the Prior Filing.
In general, these changes would clarify that certain obligations of the
Clearing House to use funds would only apply to the extent that the
relevant assets are available to the Clearing House ``in cleared
funds.''
    The proposed amendments to Rule 919(b) would be further revised to
state that the obligations in the subsection only apply to the extent
the relevant Loss Assets remain available to the Clearing House ``in
cleared funds'' and have not themselves been subject to an event
similar to a Custodial Loss, Investment Loss, Pledged Collateral Loss
or Title Transfer Collateral Loss.
    Rule 919(h) (as described in the Prior Filing), which addresses the
allocation by the Clearing House of recoveries in respect of Investment
Losses, would be further modified to state that the Clearing House's
obligation to reimburse for recoveries only applies to the extent the
relevant assets remain available ``in cleared funds'' to the Clearing
House. Similarly, Rule 919(j), which provides for return of excess
Collateral Offset Obligations, would be further revised to clarify that
the obligation to return only applies to the extent the relevant
amounts remain available to the Clearing House ``in cleared funds.''
    In Rule 919(p), a reference to ``Non-Default Loss'' would be
removed as the limitation on liability under Rule 919(p) does not apply
to Non-Default Losses.
    In various other locations in the Rules, further clarifications
would be made that obligations of the Clearing House to return or
provide certain funds or property to Clearing Members apply only to the
extent such assets are received by and remain available to the Clearing
House in cleared funds and are not themselves subject to an event
similar to a Custodial Loss, Investment Loss, Pledged Collateral Loss
or Title Transfer Collateral Loss, reflecting the consequences of Rule
919. This includes Rules 301(f), 908(b)(iii), 908(c)(iii), 908(d)(iii),
908(g)(iii), 913(a)(iv), 914(j) and 916(n). The changes in this
Amendment No. 2 correct certain inconsistent drafting across these
provisions. In Rules 908(c)(iii), (d)(iii) and (g)(iii), a further
drafting clarification would be made that the relevant claims under any
default insurance policies (and not the received funds) arise as a
result of the Event of Default.
    The proposed amendments to Rule 1103(e), which address the
potential situation where amounts received in respect of default
insurance may themselves be subject to losses similar to a Custodial
Loss, Investment Loss, Pledged Collateral Loss or Title Transfer
Collateral Loss, would be further revised to provide that application
of such amounts could only be made to the extent that such amounts
remain available to the Clearing House in cleared funds and such
amounts are not subject to an event similar to a Custodial Loss,
Investment Loss, Pledged Collateral Loss or Title Transfer Collateral
Loss.
    The purpose of the proposed rule changes as set out in Item 3(a) of
the Prior Filing is otherwise unchanged.
(b) Statutory Basis
    The description of the statutory basis for the amendments set forth
in the Prior Filing is unchanged.

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

    The statement on burden on competition in the Prior Filing is
unchanged.

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

    The statement on comments on the proposed rule change in the Prior
Filing is unchanged.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove 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 (https://www.sec.gov/rules/sro.shtml) or
     Send an email to [email protected]. Please include
file number SR-ICEEU-2023-010 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-ICEEU-2023-010. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filings will also be available for
inspection and copying at the principal office of ICE Clear Europe and
on ICE Clear Europe's website at https://www.theice.com/clear-europe/regulation. Do not include personal identifiable information in
submissions; you should submit only information that you wish to make
available publicly. We may redact in part or withhold entirely from
publication submitted material that is obscene or subject to copyright
protection. All submissions should refer to file number SR-ICEEU-2023-
010 and should be submitted on or before August 2, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-14814 Filed 7-11-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27328-27331]
[FR Doc No: 2011-11540]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0042]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational New
Drug Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June
10, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0014.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Investigational New Drug (IND) Regulations--21 CFR Part 312--(OMB
Control Number 0910-0014)--Extension

    FDA is requesting OMB approval for the reporting and recordkeeping
requirements contained in the FDA regulations ``Investigational New
Drug Application'' in part 312 (21 CFR part 312). Part 312 implements
provisions of section 505(i) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 355(i)) to issue regulations under which
the clinical investigation of the safety and effectiveness of
unapproved new drugs and biological products can be conducted.
    FDA is charged with implementing statutory requirements that drug
products marketed in the United States be shown to be safe and
effective, properly manufactured, and properly labeled for their
intended uses. Section 505(a) of the FD&C Act provides that a new drug
may not be introduced or delivered for introduction into interstate
commerce in the United States unless FDA has previously approved a new
drug application (NDA). FDA approves an NDA only if the sponsor of the
application first demonstrates that the drug is safe and effective for
the conditions prescribed, recommended, or suggested in the product's
labeling. Proof must consist, in part, of adequate and well-controlled
studies, including studies in humans, that are conducted by qualified
experts. The IND regulations establish reporting requirements that
include an initial application as well as amendments to that
application, reports on significant revisions of clinical investigation
plans, and information on a drug's safety or effectiveness. In
addition, the sponsor is required to give FDA an annual summary of the
previous year's clinical experience. Submissions are reviewed by
medical officers and other Agency scientific reviewers assigned
responsibility for overseeing the specific study. The IND regulations
also contain recordkeeping requirements that pertain to the
responsibilities of sponsors and investigators. The detail and
complexity of these requirements are dictated by the scientific
procedures and human subject safeguards that must be followed in the
clinical tests of INDs.
    The IND information collection requirements provide the means by
which FDA can do the following: (1) Monitor the safety of ongoing
clinical investigations; (2) determine whether the clinical testing of
a drug should be authorized; (3) ensure production of reliable data on
the metabolism and pharmacological action of the drug in humans; (4)
obtain timely information on adverse reactions to the drug; (5) obtain
information on side effects associated with increasing doses; (6)
obtain information on the drug's effectiveness; (7) ensure the design
of well-controlled, scientifically valid studies; and (8) obtain other
information pertinent to determining whether clinical testing should be
continued and information related to the protection of human subjects.
Without the information provided by industry in response to the IND
regulations, FDA cannot authorize or monitor the clinical
investigations which must be conducted prior to authorizing the sale
and general use of new drugs. These reports enable FDA to monitor a
study's progress, to assure subject safety, to assure that a study will
be conducted ethically, and to increase the likelihood that the sponsor
will conduct studies that will be useful in determining whether the
drug should be marketed and available for use in medical practice.
    There are two forms that are required under part 312:
    Form FDA-1571--``Investigational New Drug Application''--A person
who intends to conduct a clinical investigation submits this form to
FDA. It includes the following information: (1) A cover sheet
containing background information on the sponsor and investigator; (2)
a table of contents; (3) an introductory statement and general
investigational plan; (4) an investigator's brochure describing the
drug substance; (5) a protocol for each planned study; (6) chemistry,
manufacturing, and control information for each investigation; (7)
pharmacology and toxicology information for each investigation; and (8)
previous human experience with the investigational drug.
    Form FDA-1572--``Investigator Statement''--Before permitting an
investigator to begin participation in an investigation, the sponsor
must obtain and record this form. It includes background information on
the investigator and the investigation, and a general outline of the
planned investigation and the study protocol.
    FDA is requesting OMB approval for the following reporting and
recordkeeping requirements in part 312:

Reporting Requirements

21 CFR 312.2(e)--Requests for FDA advice on the applicability of part
312 to a planned clinical investigation.
21 CFR 312.8--Charging for investigational drugs under an IND.
21 CFR 312.10--Applications for waiver of requirements under part 312.
As indicated in Sec.  312.10(a), estimates for this requirement are
included under Sec. Sec.  312.23 and 312.31. In addition, separate
requests under Sec.  312.10 are estimated in Table 1.
21 CFR 312.20(c)--Applications for investigations involving an
exception from informed consent under Sec.  50.24 (21 CFR 50.24).
Estimates for this requirement are included under Sec.  312.23.
21 CFR 312.23--INDs (content and format).
21 CFR 312.23(a)(1)--Cover sheet FDA-1571.
21 CFR 312.23(a)(2)--Table of Contents.
21 CFR 312.23(a)(3)--Investigational plan for each planned study.
21 CFR 312.23(a)(5)--Investigator's brochure.
21 CFR 312.23(a)(6)--Protocols--Phases 1, 2, and 3.
21 CFR 312.23(a)(7)--Chemistry, manufacturing, and control information.
21 CFR 312.23(a)(7)(iv)(a),(b),(c)--A description of the drug
substance, a list of all components, and any placebo used.
21 CFR 312.23(a)(7)(iv)(d)--Labeling: Copies of labels and labeling to
be provided each investigator.
21 CFR 312.23(a)(7)(iv)(e)--Environmental impact analysis regarding
drug manufacturing and use.
21 CFR 312.23(a)(8)--Pharmacological and toxicology information.
21 CFR 312.23(a)(9)--Previous human experience with the investigational
drug.
21 CFR 312.23(a)(10)--Additional information.
21 CFR 312.23(a)(11)--Relevant information.
21 CFR 312.23(f)--Identification of exception from informed consent.
21 CFR 312.30--Protocol amendments.
21 CFR 312.30(a)--New protocol.
21 CFR 312.30(b)--Change in protocol.
21 CFR 312.30(c)--New investigator.
21 CFR 312.30(d)--Content and format.
21CFR 312.30(e)--Frequency.
21 CFR 312.31--Information amendments.
21CFR 312.31(b)--Content and format.
    --Chemistry, toxicology, or technical information.
21 CFR 312.32--Safety reports.
21 CFR 312.32(c)(1)--Written reports to FDA and to investigators.
21 CFR 312.32(c)(2)--Telephone reports to FDA for fatal or life-
threatening experience.
21 CFR 312.32(c)(3)--Format or frequency.
21 CFR 312.32(d)--Follow up submissions.
21 CFR 312.33--Annual reports.
21 CFR 312.33(a)--Individual study information.
21 CFR 312.33(b)--Summary information.
21 CFR 312.33(b)(1)--Adverse experiences.
21 CFR 312.33(b)(2)--Safety report summary.
21 CFR 312.33(b)(3)--List of fatalities and causes of death.
21 CFR 312.33(b)(4)--List of discontinuing subjects.
21 CFR 312.33(b)(5)--Drug action.
21 CFR 312.33(b)(6)--Preclinical studies and findings.
21 CFR 312.33(b)(7)--Significant changes.
21 CFR 312.33(c)--Next year general investigational plan.
21 CFR 312.33(d)--Brochure revision.
21 CFR.312.33(e)--Phase I protocol modifications.
21 CFR.312.33(f)--Foreign marketing developments.
21 CFR 312.38(b) and (c)--Notification of withdrawal of an IND.
21 CFR 312.42(e)--Sponsor requests that a clinical hold be removed and
submits a complete response to the issues identified in the clinical
hold order.
21 CFR 312.44(c) and (d)--Opportunity for sponsor response to FDA when
IND is terminated.
21 CFR 312.45(a) and (b)--Sponsor request for, or response to, inactive
status determination of an IND.
21 CFR 312.47(b)--``End-of-Phase 2'' meetings and ``Pre-NDA'' meetings.
21 CFR 312.53(c)--Investigator information.
Investigator report (Form FDA-1572) and narrative; Investigator's
background information; Phase 1 outline of planned investigation and
Phase 2 outline of study protocol.
21 CFR 312.54(a) and (b)--Sponsor submissions concerning investigations
involving an exception from informed consent under Sec.  50.24.
21 CFR 312.55(b)--Sponsor reports to investigators on new observations,
especially adverse reactions and safe use. Only ``new observations''
are estimated under this section; investigator brochures are included
under Sec.  312.23.
21 CFR 312.56(b), (c), and (d)--Sponsor monitoring of all clinical
investigations, investigators, and drug safety; notification to FDA.
21 CFR 312.58(a)--Sponsor's submission of records to FDA on request.
21 CFR 312.64--Investigator reports to the sponsor.
21 CFR 312.64(a)--Progress reports.
21 CFR 312.64(b)--Safety reports.
21 CFR 312.64(c)--Final reports.
21 CFR 312.66--Investigator reports to Institutional Review Board.
Estimates for this requirement are included under Sec.  312.53.
21 CFR 312.70(a)--Investigator disqualification; opportunity to respond
to FDA.
21 CFR 312.83--Sponsor submission of treatment protocol. Estimates for
this requirement are included under Sec.  312.320.
21 CFR 312.85--Sponsors conducting phase 4 studies. Estimates for this
requirement are included under Sec.  312.23 in 0910-0014, and
Sec. Sec.  314.50, 314.70, and 314.81 in 0910-0001.
21 CFR 312.110(b)--Request to export an investigational drug.
21 CFR 312.120--Submissions related to foreign clinical studies not
conducted under an IND.
21 CFR 312.130(d)--Request for disclosable information for
investigations involving an exception from informed consent under Sec.
50.24.
21 CFR 312.310(b); 312.305(b)--Submissions related to expanded access
and treatment of an individual patient.
21 CFR 312.310(d)--Submissions related to emergency use of an
investigational new drug.
21 CFR 312.315(c); 312.305(b)--Submissions related to expanded access
and treatment of an intermediate size patient population.
21 CFR 312.320--Submissions related to treatment IND or treatment
protocol.

Recordkeeping Requirements

21 CFR 312.52(a)--Transfer of obligations to a contract research
organization.
21 CFR 312.57--Sponsor recordkeeping.
21 CFR 312.59--Sponsor recordkeeping of disposition of unused supply of
drugs. Estimates for this requirement are included under Sec.  312.57.
21 CFR 312.62(a)--Investigator recordkeeping of disposition of drugs.

21 CFR 312.62(b)--Investigator recordkeeping of case histories of
individuals.
21 CFR 312.120(d)--Recordkeeping requirements for submissions related
to foreign clinical studies not conducted under an IND. Estimates for
this requirement are included under Sec.  312.57.
21 CFR 312.160(a)(3)--Records maintenance: shipment of drugs for
investigational use in laboratory research animals or in vitro tests.
21 CFR 312.160(c)--Shipper records of alternative disposition of unused
drugs.
    In the tables below, the estimates for ``No. of Respondents,''
``Annual Frequency per Response,'' and ``Total Annual Responses'' were
obtained from the Center for Drug Evaluation and Research (CDER) and
the Center for Biologics Evaluation and Research (CBER) reports and
data management systems for submissions received in 2007 and from other
sources familiar with the number of submissions received under part
312. The estimates for ``Hours per Response'' were made by CDER and
CBER individuals familiar with the burden associated with these reports
and from estimates received from the pharmaceutical industry.
    In the Federal Register of January 27, 2011 (76 FR 4914), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                         Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
         21 CFR Section             respondents    responses per     responses     response  (in    Total hours
                                                    respondent                      hours) \2\
----------------------------------------------------------------------------------------------------------------
312.2(e)........................             455            1.03             469              24          11,256
312.8...........................              30            1.13              34              48           1,632
312.10..........................               4            1                  4              10              40
312.23(a) through (f)...........           2,496            1.26           3,145           1,600       5,032,000
312.30(a) through (e)...........           2,030            8.91          18,087             284       5,136,708
312.31(b).......................             153            2.97             454             100          45,400
312.32(c) and (d)...............             985           23.06          22,714              32         726,848
312.33(a) through (f)...........           2,564            2.34           6,000             360       2,160,000
312.38(b) and (c)...............             654            1.34             876              28          24,528
312.42(e).......................             149            1.10             164             284          46,576
312.44(c) and (d)...............              44            1                 45              16             704
312.45(a) and (b)...............             254            1.43             363              12           4,356
312.47(b).......................             281            1.8              506             160          80,960
312.53(c).......................          21,194            1             21,194              80       1,695,520
312.54(a) and (b)...............               0            0                  0              48               0
312.55(b).......................             985        2,306          2,271,410              48     109,027,680
312.56(b), (c), and (d).........              18            1                 18              80           1,440
312.58(a).......................              91            4.10             373               8           2,984
312.64..........................          31,791            1             31,791              24         762,984
312.70(a).......................               4            1                  4              40             160
312.110(b)......................              23           18.26             420              75          31,500
312.120.........................             115            5                575              32          18,400
312.130(d)......................               3            1                  3               8              24
312.310(b) and 312.305(b).......             988            1                988               8           7,904
312.310(d)......................             525            1.23             646              16          10,336
312.315(c) and 312.305(b).......              68            1                 68             120           8,160
312.320.........................               9            1.11              10             300           3,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............     124,841,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

                       Table 2--Estimated Annual Recordkeeping Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
         21 CFR Section            recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                   (in hours) \2\
----------------------------------------------------------------------------------------------------------------
312.52(a).......................             335            1.5              503               2           1,006
312.57..........................              75          485.28          36,396             100       3,639,600
312.62(a).......................          14,732            1             14,732              40         589,280
312.62(b).......................         147,320            1            147,320              40       5,892,800
312.160(a)(3)...................             547            1.4              766           30/60             383
312.160(c)......................             547            1.4              766           30/60             383
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      10,123,452
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

                          Table 3--Estimated Annual Reporting Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                    Number of       Number of      Total annual     burden per
         21 CFR Section            respondents    responses per      responses     response  (in    Total hours
                                                    respondent                      hours) \2\
----------------------------------------------------------------------------------------------------------------
312.7(d).......................              41              1.4              57              24           1,368
312.23(a) through (f) and                   433              1.3             563           1,808       1,017,904
 312.120(b), (c)(2), and (c)(3)
312.30(a) through (e)..........             590              6.8           4,012             284       1,139,408
312.31(b)......................             263             29.3           7,706             100         770,600
312.32(c) and (d) and 312.56(c)             294             13.7           4,028              32         128,896
312.33(a) through (f) and                   647              2.3           1,488             360         535,680
 312.56(c).....................
312.35(a) and (b)..............               1              1                 1             300             300
312.36.........................               6              1                 6              16              96
312.38(b) and (c)..............             117              1.3             152              28           4,256
312.42(e)......................              74              1.5             111             284          31,524
312.44(c) and (d)..............              17              1.1              18              16             304
312.45(a) and (b)..............              60              1.8             108              12           1,296
312.47(b)......................              43              1.5              65             160          10,400
312.53(c)......................             348              6.6           2,297              80         183,760
312.54(a) and (b)..............               1              1                 1              48              48
312.55(b)......................             138              2.5             345              48          16,560
312.56(b) and (d)..............              14              1.6              22              80           1,760
312.58(a)......................               8              1                 8               8              64
312.64(a) through (d)..........           6,003              3.5          21,010              24         504,240
312.70(a)......................               6              1                 6              40             240
312.110(b).....................              21              1                21              75           1,575
312.130(d).....................               1              1                 1               8               8
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............       4,350,287
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

                        Table 4--Estimated Annual Recordkeeping Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
         21 CFR Section            recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                   (in hours) \2\
----------------------------------------------------------------------------------------------------------------
312.52(a).......................             139            1.4              195               2             390
312.57(a) and (b)...............             433            2.6            1,126             100         112,600
312.62(a).......................           5,570            1              5,570              40         222,800
312.62(b).......................           5,570           10             55,700              40       2,228,000
312.160(a)(3)...................             146            1.4              204           30/60             102
312.160(c)......................             146            1.4              204           30/60             102
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,563,994
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

    Dated: May 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11540 Filed 5-10-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 7, 2008 (Volume 73, Number 195)]
[Notices]
[Page 58698]
[DOCID:fr07oc08-123]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 58703]

Order Extending Emergency Order Pursuant to Section 12(k)(2) of
the Securities Exchange Act of 1934 Taking Temporary Action To Respond
to Market Developments

October 1, 2008.
    On September 18, 2008, the Commission issued an Emergency Order
pursuant to Section 12(k)(2) of the Securities Exchange Act of 1934
(``Exchange Act'') (the ``Order'') temporarily broadening Exchange Act
Rule 10b-18's safe harbor from liability for issuer repurchases in
order to facilitate orderly markets.\1\ That Order became effective at
12:01 a.m. E.D.T. on September 19, 2008, and is currently set to
terminate at 11:59 p.m. E.D.T. on October 2, 2008.
---------------------------------------------------------------------------

    \1\ Exchange Act Release No. 58588 (Sept. 18, 2008).
---------------------------------------------------------------------------

    Pursuant to our authority under Section 12(k)(2)(C) of the Exchange
Act, we are extending the Order. Section 12(k)(2)(C) authorizes the
Commission to extend an emergency order issued pursuant to Section
12(k)(2)(A) of the Exchange Act for a total effective period of up to
30 calendar days, if the Commission finds that the emergency still
exists and determines that an extension is necessary in the public
interest and for the protection of investors to maintain fair and
orderly securities markets.
    We have carefully reevaluated the current state of the markets and
we remain concerned about the potential of sudden and excessive
fluctuations of securities prices generally and disruption in the
functioning of the securities markets that could threaten fair and
orderly markets. Issuer repurchases can represent an important source
of liquidity during these times of market volatility. Thus, we have
determined in this environment that the standards under Section
12(k)(2) for extending the Order have been met. Accordingly, the
Commission has determined that extending the Order is in the public
interest and necessary to maintain fair and orderly securities markets
and for the protection of investors.
    Therefore, it is ordered, pursuant to Section 12(k)(2)(C) of the
Exchange Act, that the Order is extended such that it will terminate at
11:59 p.m. E.D.T. on Friday, October 17, 2008.

    By the Commission.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-23613 Filed 10-6-08; 8:45 am]

BILLING CODE 8011-01-P