[Federal Register Volume 84, Number 110 (Friday, June 7, 2019)]
[Notices]
[Pages 26685-26687]
[FR Doc No: 2019-11951]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1516]

Nonalcoholic Steatohepatitis With Compensated Cirrhosis:
Developing Drugs for Treatment; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Nonalcoholic Steatohepatitis with

Compensated Cirrhosis: Developing Drugs for Treatment.'' The purpose of
this draft guidance is to provide the Agency's current recommendations
regarding the important components of a drug development program for
nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. This
draft guidance focuses on the enrollment criteria, trial design,
efficacy endpoints, and safety considerations for phase 3 trials.

DATES: Submit either electronic or written comments on the draft
guidance by August 6, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-1516 for ``Nonalcoholic Steatohepatitis with Compensated
Cirrhosis: Developing Drugs for Treatment.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Frank A. Anania, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5387, Silver Spring, MD 20993, 240-402-
9725.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Nonalcoholic Steatohepatitis with Compensated Cirrhosis:
Developing Drugs for Treatment.''
    This draft guidance focuses on the design of clinical trials to
study patients who have compensated cirrhosis secondary to NASH. This
draft guidance is in addition to a draft guidance published in 2018
which discusses the Agency's thinking for the design of clinical trials
for patients who have NASH but do not have cirrhosis (see the draft
guidance for industry entitled ``Noncirrhotic Nonalcoholic
Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment''
available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm627376.pdf).
    NASH is the hepatic manifestation of insulin resistance syndrome
and is associated with type 2 diabetes, hypertension,
hypertriglyceridemia, and obesity, among other diseases. NASH-related
cirrhosis is becoming a major public health problem and is anticipated
to be the leading indication for orthotopic liver transplantation
within a decade.
    This draft guidance applies only to compensated cirrhosis and
specifically excludes patients with decompensated cirrhosis, i.e.
patients who have already experienced any of several clinical events
(e.g., variceal bleeding, ascites, hepatic encephalopathy) that are
associated with high morbidity and significantly reduce their life
expectancies. This draft guidance describes the criteria for enrolling
patients with compensated cirrhosis in clinical trials, including the
histologic criteria to establish the pathological diagnosis of
cirrhosis.
    This draft guidance provides recommendations on the selection of
primary efficacy endpoints in clinical trials intended to study
pharmacological treatments for compensated NASH

cirrhosis. Finally, the Agency discusses the rationale for recommending
that sponsors conduct clinical outcome trials for drugs treating
compensated NASH cirrhosis. The Agency also provides recommendations to
help ensure safety in patients with hepatic impairment and strategies
to deal with drug-induced liver injury during a compensated NASH
cirrhosis clinical trial.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Nonalcoholic
Steatohepatitis with Compensated Cirrhosis: Developing Drugs for
Treatment.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information under 21 CFR part 312 (Investigational New
Drug Application) have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR parts 50 and 56
(Protection of Human Subjects: Documentation of Informed Consent;
Institutional Review Boards) have been approved under OMB control
number 0910-0755. The collection of information under 21 CFR part 314,
including the submission of information under subpart H (``Accelerated
Approval of New Drugs for Serious or Life-Threatening Illnesses''), has
been approved under OMB control number 0910-0001. The collection of
information under the guidance for industry entitled ``Expedited
Programs for Serious Conditions--Drugs and Biologics'' (available at
<EMAIL_ADDRESS>has been approved under OMB control
number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: June 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11951 Filed 6-6-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 138 (Wednesday, July 20, 2022)]
[Notices]
[Page 43354]
[FR Doc No: 2022-15447]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95282; File No. SR-DTC-2022-006]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Designation of Longer Period for Commission Action on a
Proposed Rule Change To Amend the Stress Testing Framework and
Liquidity Risk Management Framework

July 14, 2022.
    On May 26, 2022, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') proposed rule
change SR-DTC-2022-006 (the ``Proposed Rule Change'') pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder.\2\ The Proposed Rule Change was published
for comment in the Federal Register on June 15, 2022,\3\ and the
Commission has received comments regarding the changes proposed in the
Proposed Rule Change.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 95080 (June 9,
2022), 87 FR 36191 (June 15, 2022) (File No. SR-DTC-2022-006).
    \4\ Comments are available at https://www.sec.gov/comments/sr-dtc-2022-006/srdtc2022006.htm.
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    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for the Proposed Rule Change
is July 30, 2022.
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    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day period for Commission action
on the Proposed Rule Change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the Proposed Rule Change so that it has sufficient time to consider and
take action on the Proposed Rule Change.
    Accordingly, pursuant to Section 19(b)(2) of the Act \6\ and for
the reasons stated above, the Commission designates September 13, 2022,
as the date by which the Commission shall either approve, disapprove,
or institute proceedings to determine whether to disapprove proposed
rule change SR-DTC-2022-006.
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    \6\ Id.
    \7\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-15447 Filed 7-19-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Notices]
[Pages 88905-88906]
[FR Doc No: 2023-28434]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e) (1) (v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. This filing may be viewed
on the Commission's website at http://www.ferc.gov using the eLibrary
link. Enter the docket number, excluding the last three digits, in the
docket number field to access the document. For assistance, please
contact FERC Online Support at [email protected] or toll free
at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
              Docket Nos.                     File date                     Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited
    1. CP22-2-000......................         12-12-2023  FERC Staff \1\
    2. CP22-2-000......................         12-12-2023  FERC Staff \2\
    3. CP22-2-000......................         12-13-2023  FERC Staff \3\
    4. CP22-2-000......................         12-15-2023  FERC Staff \4\

Exempt
    None...............................
----------------------------------------------------------------------------------------------------------------
\1\ Emailed comments from Nathalie Bouville and 15 other individuals.
\2\ Emailed comments from Paul Snodgrass and 13 other individuals.
\3\ Emailed comments from Alan Unell and 22 other individuals.
\4\ Emailed comments from Harry Moody.

    Dated: December 19, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-28434 Filed 12-22-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Notices]
[Page 16024-16025]
[DOCID:fr26mr08-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0178]

International Conference on Harmonisation; Draft Guidance on
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals
Intended for Human Use; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``S2(R1) Genotoxicity Testing
and Data Interpretation for Pharmaceuticals Intended for Human Use.''
The draft guidance was prepared under the auspices of the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH). The draft guidance updates and
combines information from two ICH guidances, ``S2A Specific Aspects of
Regulatory Genotoxicity Tests for Pharmaceuticals'' and ``S2B
Genotoxicity: A Standard Battery for Genotoxicity Testing of
Pharmaceuticals.'' The draft guidance is intended to help facilitate
drug development programs, ensure patient safety, and reduce animal
usage.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 12, 2008.

ADDRESSES:  Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. Submit written requests for
single copies of the draft guidance to the Division of Drug Information
(HFD-240), Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver
Spring, MD 20993-0002; or the Office of Communication, Training and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. Send two self-
addressed adhesive labels to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: David
Jacobson-Kram, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6488, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese

Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In February 2008, the ICH Steering Committee agreed that a draft
guidance entitled ``S2(R1) Genotoxicity Testing and Data Interpretation
for Pharmaceuticals Intended for Human Use'' should be made available
for public comment. The draft guidance is the product of the Safety
Expert Working Group of the ICH. Comments about this draft will be
considered by FDA and the Safety Expert Working Group.
    The draft guidance provides guidance on optimizing the standard
genetic toxicology battery for the prediction of potential human risks,
and on interpreting the results. The ultimate goal of this guidance is
to improve risk characterization for carcinogenic effects induced by
changes in the genetic material. The draft guidance is intended to help
facilitate drug development programs, ensure patient safety, and reduce
animal usage.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/
guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: March 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1076 Filed 3-21-08; 3:05 pm]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Notices]
[Pages 15659-15661]
[FR Doc No: 2019-07505]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85588; File No. SR-ICC-2019-003]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
ICC's Cash Investment Yield Schedule

April 10, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 26, 2019, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission the proposed rule change as
described in Items I, II and III below, which Items have been prepared
by ICC. ICC filed the proposed rule change pursuant Section 19(b)(3)(A)
of the Act \3\ and rule 19b-4(f)(2) thereunder,\4\ such that the
proposed rule change was immediately effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The principal purpose of the proposed rule change is to revise
ICC's cash investment yield schedule.

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

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

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

(a) Purpose
    ICC currently retains a portion of interest earned on cash
balances, net of cash management expenses. The portion of interest
retained is based on an established cash investment yield schedule,
which is set forth in the ICC Collateral Management presentation
available on the ICC website.\5\ ICC proposes changes to its cash
investment yield schedule. The proposed revisions to the cash
investment yield schedule are set forth in Exhibit 5 hereto, and
described in detail as follows.
---------------------------------------------------------------------------

    \5\ ICC Collateral Management presentation available at: https://www.theice.com/publicdocs/clear_credit/ICE_Clear_Credit_Collateral_Management.pdf.
---------------------------------------------------------------------------

    Currently, ICC retains a certain basis points (``bps'') spread for
interest rate market environments of zero bps or greater, net of
expenses. ICC proposes to retain an additional 50 bps spread for non-
customer Euro cash posted by Clearing Participants (``CPs'') in excess
of certain amounts. ICC identifies Euro House Initial Margin (``IM'')
and Euro Guaranty Fund (``GF'') requirements (collectively, the ``total
Euro requirement'') for CPs who clear Euro denominated products, and US
Dollar (``USD'') House IM and USD GF requirements (collectively, the
``total USD requirement'') for CPs who clear USD denominated products.
A CP may meet up to 100% (but no less than 45%) of its total Euro
requirement in Euro cash and up to 35% of its total USD requirement in
Euro cash.\6\ ICC proposes to retain an additional 50 bps spread for
non-customer Euro cash posted by CPs in excess of their total Euro
requirement to discourage excess Euro deposits since ICC faces
difficulty securitizing Euro deposits and is exposed to the credit and
counterparty risk of banks where Euro deposits are held.
---------------------------------------------------------------------------

    \6\ See Schedule 401 of the ICC Rules.
---------------------------------------------------------------------------

    ICC proposes to make such changes effective on or about June 1,
2019. ICC will issue a circular notification, in advance of the
effective date.
(b) Statutory Basis
    ICC believes that the proposed rule changes are consistent with the
requirements of the Act, including Section 17A of the Act.\7\ More
specifically, the proposed rule changes change a member due, fee or
other charge imposed by ICC under Section 19(b)(3)(A)(ii) \8\ of the
Act and Rule 19b-4(f)(2) \9\ thereunder. ICC believes the proposed rule
changes are consistent with the requirements of the Act and the rules
and regulations thereunder applicable to ICC, in particular, to Section
17A(b)(3)(D),\10\ because the proposed changes apply equally to all
market participants and therefore the proposed changes provide for the
equitable allocation of reasonable dues, fees and other charges among
participants. As such, the proposed changes are appropriately filed
pursuant to Section 19(b)(3)(A) \11\ of the Act and paragraph (f)(2) of
Rule 19b-4 \12\ thereunder.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q-1.
    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
    \10\ 15 U.S.C. 78q-1(b)(3)(D).
    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    ICC does not believe the proposed rule changes would have any
impact, or impose any burden, on competition. The changes to ICC's
investment yield schedule will apply uniformly across all market
participants. Therefore, ICC does not believe the proposed rule changes
impose any burden on competition that is inappropriate in furtherance
of the purposes of the Act.

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

    Written comments relating to the proposed rule change have not been
solicited or received. ICC will notify the Commission of any written
comments received by ICC.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \13\ of the Act and Rule 19b-4(f)(2) \14\ thereunder, as
the changes to ICC's investment yield schedule constitute a change to a
due, fee, or other charge applicable only to a member. At any time
within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-ICC-2019-003 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICC-2019-003. 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 such filings will also be available
for inspection and copying at the principal office of ICE Clear Credit
and on ICE Clear Credit's website at https://www.theice.com/clear-credit/regulation. 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-ICC-2019-003 and should be
submitted on or before May 7, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-07505 Filed 4-15-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Proposed Rules]
[Pages 8199-8201]
[FR Doc No: 2018-03712]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0115; Product Identifier 2017-NM-110-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 777-200, -200LR, -300, and -300ER
series airplanes. This proposed AD was prompted by reports that
additional areas of Boeing Material Specification (BMS) 8-39 flexible
urethane foam were found during a routine inspection. This proposed AD
would require an inspection for foam insulation on the dripshield above
the overhead panel support structure and replacement if necessary. For
certain airplanes, this proposed AD would also require replacement of
foam insulation on the overhead panel support structure. We are
proposing this AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by April 12, 2018.

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 http://www.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.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this service information at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2018-0115.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0115; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Scott Craig, Aerospace Engineer, Cabin
Safety and Environmental Systems Section, FAA, Seattle ACO Branch, 2200
South 216th Street, Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0115;
Product Identifier 2017-NM-110-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    We have received reports indicating additional areas of BMS 8-39
flexible urethane foam were found during the accomplishment of AD 2013-
11-04, Amendment 39-17464 (78 FR 33193, June 4, 2013) (``AD 2013-11-
04''). AD 2013-11-04 was prompted by operator or in-service reports of
burned BMS 8-39 urethane foam, and a report from the airplane
manufacturer indicating that airplanes were assembled, throughout
various areas of the airplane (including flight deck and cargo
compartments), with seals made of BMS 8-39 urethane foam, a material
with fire-retardant properties that deteriorate with age. AD 2013-11-04
requires replacing certain seals made of BMS 8-39 urethane foam.
    BMS 8-39 urethane foam fire retardants are mixed into, but are not
chemically connected with, the remaining components of the foam. Over
time, this condition will cause the fire retardant properties to have
decreased effectiveness. The concern is hidden areas where fire cannot
easily be detected and suppressed. Aged BMS 8-39 foam exposed to an
ignition source provides a potential fuel source for fire propagation.
The degradation of the foam increases the potential for an uncontrolled
fire below the passenger compartment floor and other locations outside
the areas covered by smoke detection and fire protection systems. This
condition, if not corrected, could result in loss of control of the
airplane during a fire.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Special Attention Service Bulletin 777-25-0621,
Revision 1, dated August 4, 2017. This service information describes
procedures for a general visual inspection for foam insulation on the
dripshield above the overhead panel support structure and replacement
if necessary. This service information also describes procedures for
replacement of foam insulation on the overhead panel support structure.
This service information is reasonably available because the interested
parties have access to it through their normal course

of business or by the means identified in the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the Boeing Special Attention Service Bulletin 777-25-0621, Revision
1, dated August 4, 2017, as described previously, except for any
differences identified as exceptions in the regulatory text of this
proposed AD. For information on the procedures and compliance times,
see this service information at http://www.regulations.gov by searching
for and locating Docket No. FAA-2018-0115.

Costs of Compliance

    We estimate that this proposed AD affects 132 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Action                          Labor cost          Parts cost            Cost per product                  Cost on U.S. operators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection and replacement of foam      Up to 32 work-hours x $85       $5,611  Up to $8,331.......................  Up to $1,099,692.
 insulation.                             per hour = $2,720.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    We 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) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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 adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2018-0115; Product Identifier
2017-NM-110-AD.

(a) Comments Due Date

    We must receive comments by April 12, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, and -300ER series airplanes, certificated in any category, as
identified in Boeing Special Attention Service Bulletin 777-25-0621,
Revision 1, dated August 4, 2017.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Unsafe Condition

    This AD was prompted by reports that additional areas of Boeing
Material Specification (BMS) 8-39 flexible urethane foam were found
during a routine inspection pursuant to a previously issued AD. The
degradation of the foam over time increases the potential for an
uncontrolled fire below the passenger compartment floor and other
locations outside the areas covered by smoke detection and fire
protection systems. We are issuing this AD to address BMS 8-39
flexible urethane foam found in certain areas of an airplane, which,
if exposed to an ignition source, could cause loss of control of the
airplane during a fire.

(f) Compliance

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

(g) Inspection and Replacement of Foam Installation

    Except as required by paragraph (h) of this AD: At the
applicable times specified in paragraph 1.E., ``Compliance,'' of
Boeing Special Attention Service Bulletin 777-25-0621, Revision 1,
dated August 4, 2017, do all applicable actions identified as ``RC''
(required for compliance) in, and in accordance with, the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 777-25-0621, Revision 1, dated August 4, 2017.

(h) Exception to Service Information Specifications

    For purposes of determining compliance with the requirements of
this AD: Where Boeing Special Attention Service Bulletin 777-25-
0621, Revision 1, dated August 4, 2017, uses the phrase ``the
original issue date

of this service bulletin,'' this AD requires using ``the effective
date of this AD.''

(i) Credit for Previous Actions

    This paragraph provides credit for the corresponding actions
specified in paragraph (g) of this AD, if those actions were
performed before the effective date of this AD using Boeing Special
Attention Service Bulletin 777-25-0621, dated December 10, 2014.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO 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 local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (k)(1) of this AD. Information may be
emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as RC, the provisions of paragraphs (j)(4)(i) and (j)(4)(ii) of this
AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled 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 RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(k) Related Information

    (1) For more information about this AD, contact Scott Craig,
Aerospace Engineer, Cabin Safety and Environmental Systems Section,
FAA, Seattle ACO Branch, 2200 South 216th Street, Des Moines, WA
98198; phone and fax:<PHONE_NUMBER>; email: [email protected].
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 15, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-03712 Filed 2-23-18; 8:45 am]
 BILLING CODE 4910-13-P