[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Page 35959]
[FR Doc No: 2015-15327]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0002]

Determination That ABILIFY (Aripiprazole) Solution Was Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug product listed in this document was not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug product listed in the table is
no longer being marketed.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 021713..................  ABILIFY               Otsuka
                               (aripiprazole)        Pharmaceutical
                               Solution; Oral, 1     Development and
                               milligram/1           Commercialization
                               milliliter.           Inc., 2440 Research
                                                     Blvd., Rockville,
                                                     MD 20850.
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    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug product listed in this document was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug product listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDA listed in this document are
unaffected by the discontinued marketing of the products subject to
that NDA. Additional ANDAs that refer to this product may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: June 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15327 Filed 6-22-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 72 (Tuesday, April 14, 2020)]
[Notices]
[Pages 20793-20794]
[FR Doc No: 2020-07776]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88599; File No. SR-CboeBZX-2020-006]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order
Approving a Proposed Rule Change To Provide Members Certain Optional
Risk Settings Under Proposed Interpretation and Policy .03 of Rule
11.13

April 8, 2020.

I. Introduction

    On February 12, 2020, Cboe BZX Exchange, Inc. (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
provide members certain optional risk settings under proposed
Interpretation and Policy .03 of Rule 11.13. The proposed rule change
was published for comment in the Federal Register on February 27,
2020.\3\ The Commission received no comment letters on the proposed
rule change. This order approves the proposed rule change.
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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. 88263 (February 21,
2020), 85 FR 11421 (``Notice'').
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II. Description of the Proposal

    The Exchange proposes to offer two optional credit risk settings
that would authorize the Exchange to take automated action if a
designated limit for a member is breached. Specifically, the Exchange
proposes to offer: (i) The ``Gross Credit Risk Limit,'' a pre-
established maximum daily dollar amount for purchases and sales across
all symbols, where both purchases and sales are counted as positive
values, and (ii) the ``Net Credit Risk Limit,'' a pre-established
maximum daily dollar amount for purchases and sales across all symbols,
where purchases are counted as positive values and sales are counted as
negative values.\4\
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    \4\ See proposed Interpretation and Policy .03(a) of Rule 11.13.
For purposes of calculating both the Gross Credit Risk Limit and the
Net Credit Risk Limit, only executed orders would be included. See
id.
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    The Exchange also proposes to provide that if a member does not
self-clear, the member may allocate the responsibility for establishing
and adjusting the Gross Credit and Net Credit risk settings to a
clearing member that clears transactions on behalf of the member, if
designated in a manner prescribed by the Exchange.\5\ A member that
allocates this responsibility to its clearing member would be able to
view any risk setting established by the clearing member and would be
notified of any action taken by the Exchange with respect to the
member's trading activity.\6\ However, the member would cede all
control and ability to establish and adjust the risk settings to its
clearing member,\7\ but the member would retain the ability to revoke
the responsibility allocated to its clearing member at any time, if
designated in a manner prescribed by the Exchange.\8\
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    \5\ See proposed Interpretation and Policy .03(c) of Rule 11.13.
The Exchange notes that all members are required to either clear
their own transactions or to have in place a relationship with a
clearing member that has agreed to clear transactions on their
behalf in order to conduct business on the Exchange. See Notice,
supra note 3, at 11422.
    \6\ See proposed Interpretation and Policy .03(c) of Rule 11.13.
    \7\ See Notice, supra note 3, at 11422.
    \8\ See proposed Interpretation and Policy .03(c) of Rule 11.13.
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    Pursuant to the proposal, any specified limits for the risk
settings applicable to the Gross Credit or Net Credit Risk Limits may
only be set at the MPID level and may be established or adjusted before
the beginning of a trading day or during the trading day.\9\ Both the
member and the clearing member may enable alerts to signal when the
member is approaching the designated limits.\10\ These alerts would
generate when a member breaches certain percentage thresholds of its
designated risk limit, which would send an email message to the
recipients designated by the member or clearing member.\11\ According
to the Exchange, it anticipates initially setting the thresholds at
fifty, seventy, or ninety percent of the designated risk limit.\12\
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    \9\ See proposed Interpretation and Policy .03(b) of Rule 11.13.
    \10\ See proposed Interpretation and Policy .03(d) of Rule
11.13. The Exchange notes that a clearing member would have the
ability to enable alerts regardless of whether it was allocated
responsibilities pursuant to proposed Interpretation and Policy
.03(c) of Rule 11.13. See Notice, supra note 3, at 11423 n.11.
    \11\ See Notice, supra note 3, at at 11423.
    \12\ See id.
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    The proposed rule change would also specify that if a risk setting
is breached, the Exchange would automatically block new orders
submitted and cancel open orders until the applicable risk control is
adjusted to a higher limit by the member or clearing member with the
responsibility of establishing and adjusting the risk settings.\13\
Finally, the Exchange proposes to amend Rule 11.15(f) to specify that
the Exchange may share any of a member's risk settings specified in
Interpretation and Policy .03 of Rule 11.13 with the clearing member
that clears transactions on behalf of the member.
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    \13\ See proposed Interpretation and Policy .03(e) of Rule
11.13. The Exchange notes, however, that orders entered for
participation in the opening or closing auction cannot be canceled
or modified after the applicable ``cut-off'' time, but will be
marked for cancellation. See Notice, supra note 3, at 11423 n.13.
Similarly, the Exchange notes that orders entered for participation
in the Cboe Market Close (``CMC'') will be matched for execution at
the applicable cut-off time, and cannot be canceled or modified
after such time. See id. According to the Exchange, therefore, if a
risk setting breach occurs after the applicable cut-off time for an
opening or closing auction, or the CMC, the auction orders or CMC
auction orders would not be canceled or modified. See id. See also
Rule 11.23(b)(1)(B) and (c)(1)(B) and Rule 11.28(a) and (b).
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\14\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\15\ 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, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
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    \14\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \15\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the proposed rule change is reasonably
designed to provide members with an optional tool to manage their
credit risk. The Commission notes that other exchanges have established
risk protection controls that are similar in many respects to the
Exchange's proposal.\16\ The Commission also notes that the Exchange
currently provides credit controls that measure gross and net exposure,
similar to the proposed risk limits.\17\ Unlike the proposed risk
limits, however, the Exchange's existing credit controls apply at the
logical port level, rather than by MPID, and are applied based on a
combination of

outstanding orders on the Exchange's book and notional execution value,
rather than based simply on a notional execution value.\18\ The
Commission believes that the proposed rule change would provide an
additional option for members seeking to further tailor their risk
management capability while transacting on the Exchange. The Commission
also believes that the proposed rule change is reasonably designed to
provide clearing members additional opportunity to monitor and manage
the potential risks that they assume when clearing for members of the
Exchange, as well as to provide clearing members with greater control
over their risk tolerance and exposure on behalf of their correspondent
members, while also providing an alert system designed to help ensure
that both members and clearing members are made aware of developing
issues.
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    \16\ See, e.g., Investors Exchange LLC Rule 11.380.
    \17\ See Interpretation and Policy .01(h) of Rule 11.13.
    \18\ See id. See also Notice, supra note 3, at 11422.
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    The Commission notes that the proposed Gross Credit and Net Credit
Risk Limits are optional functionalities. The Commission reminds
members electing to use the proposed risk limits to be mindful of their
obligations to, among other things, seek best execution of orders they
handle on an agency basis. A broker-dealer has a legal duty to seek to
obtain best execution of customer orders, and the decision to utilize
the proposed risk settings, including the parameters set forth by the
member for the risk setting, must be consistent with this duty.\19\ For
instance, under the proposal, members, or their respective clearing
members on their behalf, have discretion to set the Gross Credit Risk
Limit or Net Credit Risk Limit. While the Exchange did not
affirmatively establish minimum and maximum permissible settings for
these limits in its proposed rule change, the Commission expects the
Exchange to periodically assess whether the risk limits are operating
in a manner that is consistent with the promotion of fair and orderly
markets. In addition, the Commission expects that members will consider
their best execution obligations when establishing the parameters for
the risk limits.\20\ For example, to the extent that a member's risk
settings are set to overly-sensitive parameters, particularly if a
member's order flow to the Exchange contains agency orders, a member
should consider the effect of its chosen settings on its ability to
receive a timely execution on marketable agency orders that it sends to
the Exchange in various market conditions.\21\ The Commission cautions
that brokers considering their best execution obligations should be
aware that agency orders they represent may be blocked or canceled on
account of the Gross Credit and Net Credit Risk Limits.
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    \19\ See Securities Exchange Act Release Nos. 37619A (September
6, 1996), 61 FR 48290 (September 12, 1996) (``Order Handling Rules
Release''); 51808 (June 9, 2005), 70 FR 37496, 37537-38 (June 29,
2005).
    \20\ The Commission reminds broker-dealers that they must
examine their procedures for seeking to obtain best execution in
light of market and technology changes and modify those practices if
necessary to enable their customers to obtain the best reasonably
available prices. See Order Handling Rules Release, supra note 19,
at 48323.
    \21\ For example, a marketable agency order that would have
otherwise executed on the Exchange might be prevented from reaching
the Exchange on account of other interest from the member that
causes it to exceed the pre-established risk limit and thereby
results in the Exchange blocking new orders from the member.
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    Based on the foregoing, the Commission finds that the proposed rule
change is consistent with the Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\22\ that the proposed rule change (SR-CboeBZX-2020-006) be, and
hereby is, approved.
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    \22\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-07776 Filed 4-13-20; 8:45 am]
 BILLING CODE 8011-01-P