[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77879-77880]
[FR Doc No: 2010-31298]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0037 and FDA-2010-E-0038]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SAMSCA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SAMSCA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.

Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product SAMSCA
(tolvaptan). SAMSCA is indicated for the treatment of clinically
significant hypervolemic and euvolemic hyponatremia, including patients
with heart failure, cirrhosis, and Syndrome of Inappropriate
Antidiuretic Hormone. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
SAMSCA (U.S. Patent Nos. 5,258,510 and 5,753,677) from Otsuka
Pharmaceutical Co., Ltd., and the Patent and Trademark Office requested
FDA's assistance in determining these patents' eligibility for patent
term restoration. In a letter dated March 3, 2010, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of SAMSCA represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
SAMSCA is 4,722 days. Of this time, 4,147 days occurred during the
testing phase of the regulatory review period, while 575 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: June 16, 1996. The applicant claims October 23, 1997, as the
date the investigational new drug application (IND) became effective.
However, according to FDA records, this IND was not the first IND
received for this active ingredient. In general, FDA has used the first
IND of the active ingredient of the drug product as the beginning of
the testing phase, if information derived from this first IND was or
could have been relied on or was relevant for approval to market the
drug product. FDA records indicate that the effective date of the first
IND for tolvaptan was June 16, 1996, which was 30 days after FDA
receipt of this first IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October
23, 2007. FDA has verified the applicant's claim that the new drug
application (NDA) for SAMSCA (NDA 22-275) was submitted on October 23,
2007.
    3. The date the application was approved: May 19, 2009. FDA has
verified the applicant's claim that NDA 22-275 was approved on May 19,
2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,826 days or
1,827 days respectively of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 14, 2011. Furthermore, any interested
person may petition FDA for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period by June 13, 2011. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31298 Filed 12-13-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Notices]
[Pages 29305-29308]
[FR Doc No: 2021-11408]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92015; File No. SR-CboeBZX-2021-041]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Define
the Terms ``Derivative Security'' and ``UTP Derivative Security'' and
Amend Certain Related Rules

May 25, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 19, 2021, Cboe BZX Exchange, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I and II below, which Items have been
prepared by the Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BZX Exchange, Inc. (the ``Exchange'' or ``BZX'') is filing
with the Securities and Exchange Commission (``Commission'') a proposed
amendment to define the terms ``Derivative Security'' and ``UTP
Derivative Security'' in Exchange Rule 1.5. Additionally, the Exchange
proposes to make certain amendments to Rules 3.21 and 14.11 to both
simplify and clarify the Exchange's rules as they pertain to UTP
Derivative Securities. The text of the proposed rule change is provided
in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    As part of this proposal, the Exchange proposes to (1) adopt a new
definition for Derivative Security under proposed Rule 1.5(dd); (2)
move the definition of unlisted trading privileges (``UTP'') Derivative
Security \5\ from Rule 14.11(j) to Exchange Rule 1.5(ee); and (3) amend
Exchange Rule 14.11(j) applicable to UTP Derivative Securities. The
Exchange also proposes to make ministerial changes to update numbering,
lettering, Rule references, and provide clarifying text to Rules 1.5,
3.21, and 14.11. As discussed in further detail below, all of the
proposed substantive changes are substantially similar to other
exchange rules.
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    \5\ See Rule 14.11(j) and proposed amendments to Rule 1.5(ee).
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(1) Proposal To Define Derivative Security in Exchange Rule 1.5(dd) and
UTP Derivative Security in Exchange Rule 1.5(ee)
    The Exchange proposes to define ``Derivative Security'' in proposed
Rule 1.5(dd) and amend existing Rule 1.5(ee) to include the definition
of ``UTP Derivative Security''. ``Derivative Security'' would be a new
definition and would mean a security that meets the definition of ``new
derivative securities product'' in Rule 19b-4(e) under the Act. ``UTP
Derivative Security'' would refer to any one of a list of Derivative
Securities that trades on the Exchange pursuant to unlisted trading
privileges. The list of proposed Derivative Securities that may meet
the definition of UTP Derivative Security are as follows: Equity Linked
Notes; Index Fund Shares listed pursuant to Exchange Rule 14.11(c) or
Nasdaq Stock Market LLC (``Nasdaq'') Rule 5705(b) and Investment
Company Units listed pursuant to NYSE Arca, Inc. (``NYSE Arca'') Rule
5.2-E(j)(3); Index-Linked Exchangeable Notes; Equity Gold Shares;
Equity Index-Linked Securities; Commodity-Linked Securities; Currency-
Linked Securities; Fixed Income Index-Linked Securities; Futures-Linked
Securities; Multifactor Index-Linked Securities; Trust Certificates;
Currency and Index Warrants; Portfolio Depository Receipts; Trust
Issued Receipts; Commodity-Based Trust Shares; Currency Trust Shares;
Commodity Index Trust Shares; Commodity Futures Trust Shares;
Partnership Units; Paired Trust Shares; Trust Units; Managed Fund
Shares; Managed Trust Securities; Managed Portfolio Shares; Tracking
Fund Shares listed pursuant to Exchange Rule 14.11(m), Active Proxy
Portfolio Shares listed pursuant to NYSE Arca Rule 8.601-E, and Proxy
Portfolio Shares listed pursuant to Nasdaq Stock Market LLC Rule 5750;
Selected Equity-linked Debt Securities (``SEEDS''); and Exchange-Traded
Fund Shares.\6\ The proposal is substantially similar to NYSE National,
Inc. (``NYSE National'') Rule 1.1(m), but the list of Derivative
Securities that may be UTP Derivative Securities includes two
additional Derivative Securities, SEEDS and Exchange-Traded Fund
Shares. While SEEDS and Exchange-Traded Fund Shares are not included in
NYSE National Rule 1.1(m), they are Derivative Securities set forth not
only in Exchange Rules 14.11(e)(12) and 14.11(l), respectively, but
also in section 5700 of the Nasdaq Rules.
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    \6\ For inclusiveness, all Derivative Securities that are
subject to unlisted trading privileges have been identified in the
list of proposed UTP Derivative Securities.
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    The Exchange also proposes to re-letter existing Rules 1.5(dd)
through (ee) to allow for the addition of proposed Rule 1.5(dd).
Further, the Exchange proposes to amend Rule 3.21 to reference the
proposed definition of UTP Derivative Securities in Rule 1.5(ee).
(2) Proposal To Amend the Exchange's Rule Applicable to UTP Derivative
Securities
    First, the Exchange proposes to re-name Rule 14.11(j) to ``UTP
Derivative Securities'' so that it is consistent with the proposed
definition set forth in Rule 1.5(ee). The Exchange also proposes to
amend the preamble to Rule 14.11(j) to refer to the defined term UTP
Derivative Security, as proposed in Exchange Rule 1.5(ee).
    The Exchange also proposes to eliminate existing Rule 14.11(j)(1),
which provides that the Exchange shall file with the Commission a Form
19b-4(e) with respect to each UTP Derivative Security. The Exchange
believes that it should not be necessary to file a Form 19b-4(e) with
the Commission if it begins trading a UTP Derivative Security because
Rule 19b-4(e) under the Act refers to the ``listing and trading'' of a
``new derivative securities product''. The Exchange believes that the
requirements of Rule 19b-4(e) refer to when an exchange lists and
trades a Derivative Security, and not when an exchange seeks only to
trade such product on a UTP basis pursuant to Rule 12f-2 under the
Act.\7\ The proposal is substantially identical to rule amendments made
by other exchanges.\8\
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    \7\ 17 CFR 240.12f-2.
    \8\ See Securities Exchange Act No. 83289 (May 17, 2018) 83 FR
23968 (May 23, 2018) (SR-NYSENAT-2018-02). See also Securities
Exchange Act No. 84546 (November 7, 2018) 83 FR 56888 (November 14,
2018) (SR-BX-2018-051).
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    The Exchange proposes to amend proposed Rule 14.11(j)(1) to replace
the term ``new derivative securities product'' with the defined term
``Derivative Security'' as provided in proposed Rule 1.5(dd).
Additionally, the Exchange proposes to clarify that the Early Trading
Session is from 7:00 a.m. to 8:00 a.m. Eastern Time in order to
consistently reference the relevant time zone throughout the paragraph.
    The Exchange also proposes to add additional explanatory language
to paragraph (j)(3) that states nothing in the Rule will limit the
power of the Exchange under the Rules or procedures of the Exchange
with respect to the Exchange's ability to suspend trading in any
securities if such suspension is necessary for the protection of
investors or in the public interest. The proposed text is identical to
that included in NYSE National Rule 5.1(a)(2)(C). Further, the proposed
text reinforces existing Exchange Rule 11.18(d).
    Lastly, based on the proposal to eliminate Rule 14.11(j)(1), the
Exchange proposes to renumber existing paragraphs (j)(2) through (j)(6)
accordingly.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act. Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \9\ requirements that the rules of
an 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.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \10\ requirement that the rules of
an exchange not be designed

to permit unfair discrimination between customers, issuers, brokers, or
dealers.
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    \9\ 15 U.S.C. 78f(b)(5).
    \10\ Id.
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    In particular, the Exchange believes the proposed definitions of
Derivative Security and UTP Derivative Security are reasonable as the
proposed substantive changes are substantially similar to other
exchanges' rules. Specifically, the proposed definition of Derivative
Security in Rule 1.5(dd) is substantially similar to the definition of
Exchange Traded Product provided for in NYSE National Rule 1.1(m),
except that it better conforms to the defined term ``new derivative
securities product'' of Rule 19b-4(e) under the Act. The proposed
definition of UTP Derivative Securities is substantially similar to UTP
Exchange Traded Product provided under NYSE National Rule 1.1(m), but
includes two additional Derivative Securities, SEEDS and Exchange-
Traded Fund Shares. While SEEDS and Exchange-Traded Fund Shares are not
included in NYSE National Rule 1.1(m), they are Derivative Securities
set forth not only in Exchange Rules 14.11(e)(12) and 14.11(l),
respectively, but also in section 5700 of the Nasdaq Rules.
    Eliminating the requirement to file a Form 19b-4(e) for each
Derivative Security is consistent with the Act because the regulatory
requirement was not intended to apply in the context of Derivative
Securities trading on a UTP basis. Moreover, the proposal to eliminate
Rule 14.11(j)(1) will provide for a more efficient process for adding
Derivative Securities to trading on the Exchange on a UTP basis. The
Exchange also notes that the proposal is substantially identical to
other exchange rules.\11\
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    \11\ See supra note 8.
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    The Exchange believes that its proposal to amend the preamble to
Rule 14.11(j) to correspond to Rule 1.5(ee) and the proposed defined
term UTP Derivative Security will add clarity to the Exchange's Rules.
Further, the Exchange believes that its proposal to amend the preamble
to Rule 14.11(j)(1) to reference the proposed term UTP Derivative
Security rather than ``new derivative securities product'' will conform
the Rule to proposed Rule 1.5(dd) and will add clarity to the
Exchange's Rules. Additionally, the proposal to add ``Eastern Time'' to
the description of the Early Trading Session in proposed Rule
14.11(j)(1) will consistently reference the applicable time zone
throughout the paragraph.
    The proposed amendment to proposed Rule 14.11(j)(3) is identical to
a sentence provided in NYSE National Rule 5.1(a)(2)(C) (trading halts).
Furthermore, the proposal reinforces existing Exchange Rule 11.18(d).
Lastly, the Exchange's proposal to renumber existing paragraphs
14.11(j)(2)-(j)(6) based on its proposal to eliminate Rule 14.11(j)(1)
will clarify and simplify the Exchange's Rules.
    The Exchange believes that its proposal to amend Rule 3.21 to
reference the proposed definition of UTP Derivative Securities in Rule
1.5(ee) will add clarity to the Exchange's Rules.
    In light of the above proposals, the Exchange has also proposed to
renumber and re-letter certain paragraphs or subparagraphs of Rules 1.5
and 14.11 and update applicable rule references.
    The proposal is intended to simplify and clarify the Exchange's
Rules as it relates to UTP Derivative Securities, which the Exchange
believes will 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. The Exchange believes that
renumbering and re-lettering current Rules to correspond to the
proposed changes will allow the Exchange to maintain a clear and
organized rule structure, thus preventing investor confusion. For these
reasons, the Exchange believes the proposed rule change is consistent
with the requirements of Section 6(b)(5) of the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not designed to address any competitive issues but rather to harmonize
certain Exchange Rules with those of other exchanges which will
simplify and clarify the Exchange's Rules. The Exchange further
believes that the proposed rule change would promote transparency on
the Exchange, thus making the Exchange's rules easier to navigate.

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

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
under the Act requires a self-regulatory organization to give the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\15\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay. Waiver of the
operative delay would allow certain of the Exchange's rules to conform
to equivalent rules on other exchanges, as discussed herein, and to
make clarifying and technical changes. The Commission therefore
believes that waiver of the 30-day operative delay is consistent with
the protection of investors and the public interest. Accordingly, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\16\
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    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.

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_ADDRESS>Please include
File Number SR-CboeBZX-2021-041 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeBZX-2021-041. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2021-041 and should be submitted
on or before June 23, 2021.
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    \17\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-11408 Filed 5-28-21; 8:45 am]
BILLING CODE 8011-01-P