[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56606-56607]
[FR Doc No: 2017-25771]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6373]

Roxane Laboratories, Inc.; Withdrawal of Approval of a New Drug
Application for ROXICODONE (Oxycodone Hydrochloride) Sustained-Release
Tablets, 10 Milligrams and 30 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of new drug application (NDA) 020932 for
ROXICODONE (oxycodone hydrochloride (HCl)) Sustained-Release Tablets,
10 milligrams (mg) and 30 mg, held by Roxane Laboratories, Inc.
(Roxane). Roxane requested withdrawal of this application and waived
its opportunity for a hearing.

DATES: The approval is withdrawn as of November 29, 2017.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of
Regulatory Policy, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire

Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: NDA 020932 for ROXICODONE SR (oxycodone HCl)
Sustained-Release Tablets, 10 mg and 30 mg, was received on December
29, 1997, and approved on October 26, 1998, as safe and effective ``for
the management of moderate to severe pain where use of an opioid
analgesic is appropriate for more than a few days'' (see approval
letter, available at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20932ltr.pdf). (FDA has verified the Web site addresses
as of the date this document publishes in the Federal Register, but Web
sites are subject to change over time.) FDA later determined, however,
that this application had serious deficiencies. Accordingly, on
February 3, 2000, FDA granted Roxane's request for a stay of the
effective date of the approval of NDA 020932 until such time as: (1)
Roxane submits additional data; (2) FDA has reviewed those data; and
(3) FDA has determined that the submitted data support a finding of
safety and effectiveness without reliance on investigations to which
Roxane does not have a right of reference.\1\ Roxane has not submitted
any additional information to support approval of NDA 020932, nor has
it submitted any annual reports for this NDA since 2002. The product
has never been marketed.\2\ Roxane requested that FDA withdraw approval
of NDA 020932 for ROXICODONE (oxycodone HCl) Sustained Release Tablets,
and waived the opportunity for a hearing concerning this action.
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    \1\ February 3, 2000 FDA Response to Citizen Petition and
Petition for Stay of Action, Docket FDA-1999-P-2921, available at
https://www.regulations.gov/document?D=FDA-1999-P-2921-0014.
    \2\ Reflecting their non-marketed status, ROXICODONE (oxycodone
HCl) Sustained-Release Tablets, 10 mg and 30 mg, are on the
``Discontinued Drug Products'' list in the Orange Book, where the
drug is listed as ``Roxicodone'' and described as ``extended
release'' (see https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020932).
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    For the reasons discussed above, approval of NDA 020932, and all
amendments and supplements thereto, is withdrawn. Distribution of
ROXICODONE (oxycodone HCl) Sustained-Release Tablets, 10 mg and 30 mg,
in interstate commerce without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25771 Filed 11-28-17; 8:45 am]
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[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65262-65265]
[FR Doc No: 2022-23481]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96134; File No. SR-ICEEU-2022-010]

Self-Regulatory Organizations; ICE Clear Europe Limited; Order
Approving Proposed Rule Change Relating to Amendments to the ICE Clear
Europe Clearing Membership Procedures

October 24, 2022.

I. Introduction

    On August 30, 2022, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change
to amend its Clearing Membership Procedures (the ``Procedures''). The
proposed rule change was published for comment in the Federal Register
on September 13, 2022.\3\ The Commission did not receive comments
regarding the proposed rule change. For the reasons discussed below,
the Commission is approving the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Self-Regulatory Organizations; ICE Clear Europe Limited;
Notice of Filing of Proposed Rule Change Relating to Amendments to
the ICE Clear Europe Clearing Membership Procedures, Exchange Act
Release No. 95683 (Sep. 7, 2022); 87 FR 56110 (Sep. 13, 2022) (SR-
ICEEU-2022-010) (``Notice'').
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II. Description of the Proposed Rule Change

    The Procedures describe how ICE Clear Europe applies its policies
for reviewing applications for clearing membership, variations of
permissions for Clearing Members, ongoing monitoring of Clearing
Members, and termination of clearing membership.

The proposed rule change would amend the Procedures to: (i) correct a
typographical error and establish a new defined term; (ii) update the
names of responsible ICE Clear Europe departments and committees; (iii)
correct or remove references to material found in other ICE Clear
Europe policies or the ICE Clear Europe Clearing Rules (the ``Rules'');
and (iv) clarify certain aspects of ICE Clear Europe's process for
approving and reviewing Clearing Members.\4\
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    \4\ This description is substantially excerpted from the Notice,
87 FR at 56110. Capitalized terms not otherwise defined herein have
the meanings assigned to them in the Rules or the Procedures, as
applicable.
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i. Typographical Correction and New Defined Term

    The proposed rule change would first make minor updates to Section
1, which describes the purpose of the Procedures. First, it would make
a typographical correction, changing ``these'' to ``the'' at the
beginning of the first sentence of the section.
    Section 1 of the Procedures also states that terms used in the
document are defined in the document or in ICE Clear Europe's Clearing
Rules. The proposed rule change would retain this statement but would
add a defined term for ``the Rules'' at the end of the sentence.
Throughout the Procedures, the proposed rule change would use this new
defined term and replace references to the ``Clearing Rules'' with
references to the ``Rules.''

ii. Names of ICE Clear Europe Departments and Committees

    Next, the proposed rule change would update the names of
responsible ICE Clear Europe departments and committees. Currently, the
Procedures provide that all applications for clearing membership will
be subject to due diligence from relevant ICE Clear Europe departments,
including, among others, Operations, Risk, and Treasury. The proposed
rule change would change the reference to the ``Risk'' department to
the ``Credit and Clearing Risk'' department, to encompass both the
Credit Risk Department and the Clearing Risk Department.
    Similarly, the Procedures currently provide that all applications
are submitted to the ``Committee'' for approval. The proposed rule
change would correct this reference to the ``Executive Risk
Committee,'' which is the current and correct name of that Committee.
Throughout the Procedures, the proposed rule change also would change
references to the ``Committee'' to the ``Executive Risk Committee'' or
``ERC.''

iii. Material Found in Other ICE Clear Europe Policies or Rules

    The proposed rule change also would make a number of amendments to
correct or remove references to material found in other ICE Clear
Europe policies or in the Rules. For example, Section 2.2.1 of the
Procedures, which describes the process to approve an application for
clearing membership, provides that the Clearing Risk department will
conduct a review based on financial and qualitative information of
prospective clearing members. The proposed rule change would remove
this statement because this review is described in, and governed by,
ICE Clear Europe's Counterparty Credit Risk Policy and Counterparty
Credit Risk Procedures.\5\
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    \5\ For a description of the Counterparty Credit Risk Policy and
Counterparty Credit Risk Procedures, see Self-Regulatory
Organizations; ICE Clear Europe Limited; Order Approving Proposed
Rule Change Relating to Adoption of the Counterparty Credit Risk
Policy and Counterparty Credit Risk Procedures, Exchange Act Release
No. 93880 (Dec. 30, 2021), 87 FR 513 (Jan. 5, 2022) (SR-ICEEU-2021-
015).
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    Section 2.4 describes how ICE Clear Europe may terminate the
membership of a Clearing Member. Section 2.4.2 states that ICE Clear
Europe may terminate Clearing Membership in accordance with ICE Clear
Europe Rule 209 and that the ICE Clear Europe Board is required to
approve the issuance of a Termination Notice against a Clearing Member.
The proposed rule change would delete the requirement that the ICE
Clear Europe Board approve the issuance of a Termination Notice. The
proposed rule change would remove this requirement because it is not
part of Rule 209, and ICE Clear Europe would instead rely on the
general delegation of authority provided by ICE Clear Europe Rule
114.\6\
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    \6\ Rule 114(a) provides that ``any action permitted or required
to be taken by the Clearing House may be taken by the Board, the
Chairman, the President, any other Director or any other employee,
officer or committee (or any individual committee member) to whom or
which authority has been delegated by the Clearing House, the Board,
the Chairman, the President or any committee.'' Although ICE Clear
Europe has not issued a specific delegation of authority with
respect to the issuance of a termination notice, ICE Clear Europe
believes its existing general Delegation of Authority to its
President implemented pursuant to Rule 114(a) could potentially
apply to issuance of a Termination Notice in certain emergency
scenarios. Notice, 87 FR at 56111.
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    Section 3.1.1 of the Procedures describes the minimum capital
requirements for Clearing Members. Section 3.1.1 states that the data
sources used to determine a Clearing Member's capital are found in the
Counterparty Credit Policy. The proposed rule change would remove this
statement because this information is described in, and governed by,
ICE Clear Europe's Counterparty Credit Risk Policy and Counterparty
Credit Risk Procedures.\7\
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    \7\ See Self-Regulatory Organizations; ICE Clear Europe Limited;
Order Approving Proposed Rule Change Relating to Adoption of the
Counterparty Credit Risk Policy and Counterparty Credit Risk
Procedures, Exchange Act Release No. 93880 (Dec. 30, 2021), 87 FR
513 (Jan. 5, 2022) (SR-ICEEU-2021-015).
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    Section 3.1.1 also states that in relation to the minimum capital
requirement, ICE Clear Europe may, among other things, establish
additional risk-based requirements for Clearing Members which are FCM/
BD Clearing Members (meaning Clearing Members that are registered as
futures commission merchants and/or broker-dealers) and that wish to
provide client clearing services. The proposed rule change would
clarify that ICE Clear Europe could only establish these additional
requirements for CDS Clearing Members, which are Clearing Members that
are authorized to clear CDS Contracts. The proposed rule change would
add this statement because this provision is actually referring to
Section 2 of the ICE Clear Europe CDS Procedures, which specify
additional membership requirements for CDS Clearing Members.
    Section 3.1.2 of the Procedures describes, in general, the
contributions that Clearing Members must make to ICE Clear Europe's CDS
and Futures and Options (``F&O'') Guaranty Funds. The proposed rule
change would add to this description references to the F&O Guaranty
Fund Policy and the CDS Risk Policy because these are the correct ICE
Clear Europe policies that describe these requirements.
    Section 3.1.3 of the Procedures briefly describes ICE Clear
Europe's margin-to-capital ratio, which helps to ensure that a Clearing
Member's maximum margin requirement does not exceed a specified
multiple of its balance sheet capital. The proposed rule change would
delete this section as unnecessary because this information is
described in, and governed by, ICE Clear Europe's Counterparty Credit
Risk Policy and Counterparty Credit Risk Procedures.\8\
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    \8\ See Self-Regulatory Organizations; ICE Clear Europe Limited;
Order Approving Proposed Rule Change Relating to Adoption of the
Counterparty Credit Risk Policy and Counterparty Credit Risk
Procedures, Exchange Act Release No. 93880 (Dec. 30, 2021), 87 FR
513 (Jan. 5, 2022) (SR-ICEEU-2021-015).
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    Section 4 of the Procedures describes in general how ICE Clear
Europe monitors Clearing Members on an ongoing basis. Section 4
currently contains a general statement that further

information on the ongoing monitoring of Clearing Members can be found
in the Counterparty Credit Risk Policy. The proposed rule change would
delete this reference as unnecessary because this information is
described in, and governed by, ICE Clear Europe's Counterparty Credit
Risk Policy and Counterparty Credit Risk Procedures.\9\
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    \9\ Id.
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    Section 4.3 describes in general ICE Clear Europe's Quarterly
Counterparty Rating System Report. Section 4.3 currently states that
ICE Clear Europe's counterparty rating system aggregates risk factors
covering credit, market price, liquidity and operational risk for each
Clearing Member and is updated at least once per quarter. The proposed
rule change would delete this reference as unnecessary because this
information is described in, and governed by, ICE Clear Europe's
Counterparty Credit Risk Policy and Counterparty Credit Risk
Procedures.\10\
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    \10\ Id.
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iv. Clarifying Other Aspects of the Clearing Membership Process

    Finally, the proposed rule change would clarify certain aspects of
the clearing membership process.
    Section 2.2.1 of the Procedures provides that ICE Clear Europe's
list of Approved Jurisdiction for applicants for clearing membership
(meaning those jurisdictions for which additional legal and regulatory
analysis is not required) is maintained in ICE Clear Europe's Clearing
Membership Parameters. The proposed rule change would delete this
statement because ICE Clear Europe's legal department maintains this
list, and ICE Clear Europe does not keep this list in the Clearing
Membership Parameters.
    Section 4.1 of the Procedures describes ICE Clear Europe's periodic
reviews of its Clearing Members. Section 4.1 currently states that ICE
Clear Europe conducts periodic reviews of the financial position and
compliance with the membership requirements of each Clearing Member to
provide a baseline measurement of each Clearing Member's reported
financial position and a measure of relative performance. The proposed
rule change would retain this description, but would add that ICE Clear
Europe's periodic reviews include know-your-customer and anti-money
laundering assessments. ICE Clear Europe is adding this to memorialize
a review that it already performs in practice.\11\
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    \11\ Notice, 87 FR at 56111.
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    Section 4.5 of the Procedures describes ICE Clear Europe's Annual
Member Return. The Annual Member Return is an annual process through
which ICE Clear Europe requests that Clearing Members provide and
confirm information related to their membership. ICE Clear Europe uses
the Annual Member Return to update information about its Clearing
Members. Section 4.5 currently states that the Annual Member Return
includes information on, among other things, key contacts, authorized
signatories, and compliance with ICE Clear Europe rules. The proposed
rule change would retain this description and add to it ``updated
Clearing Member information.'' ICE Clear Europe would be making this
change to require that Clearing Members provide, as part of the Annual
Member Return, updated information about the legal entity that is the
Clearing Member, such as its address and legal name.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\12\ For the reasons discussed below, the Commission finds
that the proposed rule change is consistent with section 17A(b)(3)(F)
of the Act \13\ and Rules 17Ad-22(e)(2)(i) and 17Ad-22(e)(18)
thereunder.\14\
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    \12\ 15 U.S.C. 78s(b)(2)(C).
    \13\ 15 U.S.C. 78q-1(b)(3)(F).
    \14\ 17 CFR 240.17Ad-22(e)(2)(i) and (e)(18).
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i. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of ICE Clear Europe be designed to promote the prompt and
accurate clearance and settlement of securities transactions and, to
the extent applicable, derivative agreements, contracts, and
transactions.\15\ Based on its review of the record, and for the
reasons discussed below, the Commission believes the proposed changes
to the Procedures are consistent with the promotion of the prompt and
accurate clearance and settlement of securities transactions.
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    \15\ 15 U.S.C. 78q-1(b)(3)(F).
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    The Commission believes that a number of the changes discussed
above would improve the overall operation and application of the
Procedures. For example, the Commission believes that correcting the
errors and introducing the defined term discussed in Part II.i above
would help to ensure that ICE Clear Europe personnel apply the
Procedures in a consistent manner and free from error. The Commission
further believes that correcting the names of responsible ICE Clear
Europe departments and committees discussed Part II.ii above would help
to ensure that the correct ICE Clear Europe personnel complete the
processes and responsibilities specified in the Procedures. Finally,
the Commission believes that correcting and removing references to
material found in other ICE Clear Europe policies or in the Rules would
help to reduce the possibility of conflict between the Procedures and
other ICE Clear Europe policies or the Rules. The Commission believes
these changes would help to ensure that ICE Clear Europe personnel
apply the Procedures in a manner consistent with other ICE Clear Europe
policies or Rules.
    The Commission further believes that the changes discussed in Part
II.iv above would help to improve the overall operation and application
of the Procedures by clarifying certain aspects of ICE Clear Europe's
process for review and approving clearing membership. Specifically, the
changes to Section 2.2.1 and 4.1 would make the Procedures consistent
with ICE Clear Europe's current practices in maintaining the list of
Approved Jurisdictions and reviewing know-your-customer and anti-money
laundering compliance. Memorializing these practices in the Procedures
should help to ensure that ICE Clear Europe continues to perform these
practices consistently in the future. Similarly, the amendment to
Section 4.5 should help to ensure that Clearing Members provide to ICE
Clear Europe updated legal entity information, as needed, as part of
the Annual Member Return.
    The Commission believes that the Procedures help to ensure that ICE
Clear Europe effectively manages the potential risks posed by its
Clearing Members in the clearance and settlement of securities
transactions. The Commission further believes that these potential
membership risks, if not properly managed, could threaten ICE Clear
Europe's ability to operate and thereby clear and settle transactions.
The Commission therefore believes that the proposed rule change, in
improving the Procedures, would help to ensure that that ICE Clear
Europe effectively manages the potential risks posed by its Clearing
Members and thereby should help to ensure ICE Clear Europe's ability to
promptly and accurately clear and settle securities transactions,
consistent with Section 17A(b)(3)(F) of the Act.\16\
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    \16\ 15 U.S.C. 78q-1(b)(3)(F).

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ii. Consistency With Rule 17Ad-22(e)(2)(i)

    Rule 17Ad-22(e)(2)(i) requires that ICE Clear Europe establish,
implement, maintain and enforce written policies and procedures
reasonably designed to provide for governance arrangements that are
clear and transparent.\17\ The Commission believes that deleting the
requirement that the ICE Clear Europe Board approve the issuance of a
Termination Notice from Section 2.4.2., as discussed in Part II.iii
above, would help to clarify the process for issuing such a Termination
Notice. Because Board approval is not a requirement of Rule 209, and
because Board approval could potentially conflict with a delegation
issued under ICE Clear Europe Rule 114, the Commission believes this
proposed change would reduce the possibility for conflict and thereby
clarify the governance arrangement for issuing a Termination Notice.
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    \17\ 17 CFR 240.17Ad-22(e)(2)(i).
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    Therefore, the Commission finds that the proposed rule change is
consistent with Rule 17Ad-22(e)(2)(i).\18\
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    \18\ Id.
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iii. Consistency With Rule 17Ad-22(e)(18)

    Rule 17Ad-22(e)(18) requires that ICE Clear Europe establish,
implement, maintain and enforce written policies and procedures
reasonably designed to, as applicable, establish objective, risk-based,
and publicly disclosed criteria for participation, which permit fair
and open access by direct and, where relevant, indirect participants
and other financial market utilities, require participants to have
sufficient financial resources and robust operational capacity to meet
obligations arising from participation in the clearing agency, and
monitor compliance with such participation requirements on an ongoing
basis.\19\ As discussed above, the proposed rule change would require
that Clearing Members provide, as part of the Annual Member Return,
updated information about the legal entity that is the Clearing Member,
such as its address and legal name. The Commission believes this
requirement is an objective, risk-based, and publicly disclosed
criteria for participation by Clearing Members.
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    \19\ 17 CFR 240.17Ad-22(e)(18).
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    Therefore, the Commission finds that the proposed rule change is
consistent with Rule 17Ad-22(e)(18).\20\
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    \20\ Id.
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IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act,
and in particular, with the requirements of Section 17A(b)(3)(F) of the
Act \21\ and Rules 17Ad-22(e)(2)(i) and 17Ad-22(e)(18).\22\
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    \21\ 15 U.S.C. 78q-1(b)(3)(F).
    \22\ 17 CFR 240.17Ad-22(e)(2)(i) and (e)(18).
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    It is therefore ordered pursuant to section 19(b)(2) of the Act
\23\ that the proposed rule change (SR-ICEEU-2022-010) be, and hereby
is, approved.\24\
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    \23\ 15 U.S.C. 78s(b)(2).
    \24\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
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    \25\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-23481 Filed 10-27-22; 8:45 am]
BILLING CODE 8011-01-P