[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40734-40736]
[FR Doc No: 2016-14715]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78091; File No. SR-Phlx-2016-41]

Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Make Clarifying
Amendments to and Remove Obsolete Language From Rules 1053 and 1056

June 16, 2016.
    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 June 8, 2016, NASDAQ PHLX LLC (``Phlx'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III, below, which Items
have been prepared by the Exchange. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to make clarifying amendments to and remove
obsolete language from Exchange Rules 1053, Filing of Trade
Information, and 1056, Maintaining Office and Filing Signatures,
relating to clearing of Exchange options transactions.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, 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
    The Exchange proposes to make minor amendments to Rules 1053 and
Rule 1056 relating to options clearing responsibilities of members. The
changes are intended to update and improve readability of the rules by
deleting archaic and internally inconsistent provisions.
    Phlx Rule 1053 currently provides that member organizations which
are clearing members are responsible for supplying, ``at the time of
execution'' certain trade information to the Exchange covering each
Exchange options transactions ``effected during said business day'' for
which such clearing member is responsible.\3\ The Exchange is deleting
the phrase ``effected during said business day'' because the word
``said'' has no antecedent in the rule and is therefore meaningless. As
written the sentence is therefore awkward and illogical. The phrase
being deleted adds nothing to the rule and stands in the way of
comprehension of the rule's meaning.
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    \3\ Rule 1053 provides that ``[a]t the time of execution, each
member organization which is a clearing member of the Options
Clearing Corporation shall be responsible for supplying to the
Exchange trade information in a form prescribed by the Exchange,
covering each Exchange options transaction effected during said
business day for which such clearing member is responsible. The
trade information shall show for each transaction (i) the identity
of the purchasing clearing member and the writing clearing member
given up at the time of execution, (ii) the underlying stock,
Exchange-Traded Fund Share or foreign currency, as the case may be,
(iii) the exercise price, (iv) the expiration month, (v) the number
of option contracts, (vi) the premium per share of the underlying
stock or the premium per unit of the underlying foreign currency,
(vii) whether a purchase or a writing transaction, (viii) except for
a transaction in a specialist's account, whether an opening or
closing, (ix) the identity of the account of the clearing member in
which the transaction was effected, (x) if a closing writing
transaction, whether a certificate will be surrendered, (xi) whether
a put or call, and (xii) such other information as may be required
by the Exchange. Each member or member organization which is a
clearing member of the Options Clearing Corporation shall be
responsible to the Exchange in respect of all trade information
filed with the Exchange on such form prescribed by the Exchange.''
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    The Exchange is also deleting obsolete language following clause
(x) in Rule 1053 which requires the clearing member to supply to the
Exchange information as to whether a certificate will be surrendered if
the transaction is a closing writing transaction. The deleted text is
replaced with the word ``Reserved''. At one time, the By-Laws and the
Rules of The Options Clearing Corporation (``OCC'') provided for the
issuance of physical certificates in respect of options contracts at
the request of OCC participants. Certificates could be issued in
respect of any option contract included in a long position in a
customer's account to evidence a clearing member's position as the
holder of one or more options of a specified type (put or call) in a
specified options series. The certificate was nonnegotiable and
conferred no separate legal rights on the holder. Certificated options
contracts could only be exercised or closed out upon the surrender of
the physical certificate. Until the certificate was surrendered, any
attempt by a clearing member to write a closing options transaction
with respect to a corresponding long certificated options position was
considered by OCC to be an opening transaction subject to OCC's margin
requirements on short positions. In 1982, OCC eliminated all provisions
in its By-Laws and Rules providing for, or referring to certificates,
after concluding that certificates were unnecessary and imposed
administrative burdens and costs on OCC and on clearing members.\4\
Because OCC no longer issues these certificates, Phlx Rule 1053(x) is
obsolete.
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    \4\ See Securities Exchange Act Release No. 19064 (September 20,
1982), 47 FR 42483 (September 27, 1982) (order approving SR-OCC-82-
15). The Exchange notes that the Chicago Board Options Exchange
(``CBOE'') Rule 6.51(d) once contained the same language as Exchange
Rule 1053(x). See Securities Exchange Act Release No. 16618 (March
3, 1980), 45 FR 15352 (March 10, 1980). That language no longer
appears in the CBOE rulebook.
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    Phlx Rule 1056 currently requires clearing members to maintain an
office at a location approved by the Exchange for the purpose of
comparing Exchange options transactions.\5\ The Exchange is

deleting the Exchange approval requirement because it has determined
that the location of the clearing member's office is of no importance
to the Exchange. The Exchange is also deleting the last sentence of the
rule which requires that each member organization shall file with the
Exchange a certified list of signatures of its representatives who are
authorized to sign instruments and transact all business necessary for
conducting comparison of Exchange options transactions. Although
certain Exchange forms and procedures continue to require manual
signatures, the Exchange does not believe the burdens of constantly
updating the list of certified signatures is justified by any marginal
benefit such a list may provide to Exchange staff who are not in any
case handwriting experts trained to ascertain the validity of
signatures.
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    \5\ Rule 1056 provides that ``[e]very member organization which
is a clearing member of the Options Clearing Corporation shall
maintain an office at a location approved by the Exchange for the
purpose of comparing Exchange options transactions. Any such member
organization may use for the purpose of these Rules the office of
another member organization which is a clearing member of the
Options Clearing Corporation provided such use is pursuant to a
written agreement approved by the Exchange. There shall be present
at such office, between such hours as the Exchange shall from time
to time fix, on every business day a representative of the member
organization authorized to sign in the name of the member
organization all instruments and transact all business requisite in
connection with the comparison of Exchange options transactions.
Each such member organization shall file with the Exchange, in such
form as the Exchange shall prescribe, a certified list of signatures
of its representatives who are authorized to sign instruments and
transact all business necessary for conducting comparison of
Exchange options transactions.''
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to promote
just and equitable principles of trade, 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,
by improving the accuracy and readability of the amended rules.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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    With respect to Rules 1053, deleting the illogical reference to
``effected during said business day'' makes the rule understandable.
Deleting an obsolete reference to a certificate which no longer has any
meaning also eliminates a barrier to comprehension of that rule. With
respect to Rule 1056, deleting the Exchange approval requirement
eliminates a rule imposing an unnecessary administrative burden on the
Exchange, given that the Exchange is indifferent in any event as to a
clearing member's office location, thereby perfecting the mechanism of
a free and open market and a national market system. Additionally,
deleting the requirement that the Exchange be provided with a certified
list of signatures eliminates another rule imposing an unnecessary
administrative burden from the rulebook, streamlining the rulebook by
removing a requirement whose marginal benefit, if any, is not justified
by its cost. The Exchange notes that at least two other options
exchanges, NASDAQ BX and NASDAQ Options Market, do not impose a similar
``certified list of signatures'' requirement.

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

    The Exchange does not believe that clarifying amendments proposed
herein will impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act inasmuch as they
simply improve the accuracy and readability of the rules and delete
unnecessary administrative burdens. As noted above with respect to the
certified list of signatures requirement, at least two other options
exchanges, NASDAQ BX and NASDAQ Options Market, do not impose a similar
requirement. Eliminating the requirement on Phlx should therefore
reduce a burden on competition.

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

    No written comments were either solicited or received.

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)(iii) of the Act \8\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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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    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2016-41 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-Phlx-2016-41. 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 Web site (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 Web site 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; the Commission does
not edit personal identifying information from

submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
Phlx-2016-41 and should be submitted on or before July 13, 2016.
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    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-14715 Filed 6-21-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43187-43188]
[FR Doc No: 2013-17287]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2381-063]

PacifiCorp, St. Anthony Hydro LLC; Notice of Application Accepted
for Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Types of Application: Application for Partial Transfer and
Amendment of License.
    b. Project No.: 2381-063.
    c. Date Filed: June 11, 2013.
    d. Applicants: PacifiCorp (transferor) and St. Anthony Hydro LLC
(transferee).
    e. Name of Project: Ashton-St. Anthony Project.
    f. Location: On the Henry's Fork of the Snake River, in Fremont
County, Idaho.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicants Contact: Mr. John P. Sample, Assistant General
Counsel, PacifiCorp, 825 NE Multnomah Street, Suite 1500, Portland, OR
97232-2135,<PHONE_NUMBER><EMAIL_ADDRESS>    Mr. Ted S. Sorenson, Member, St. Anthony Hydro LLC, 5203 South 11th
East, Idaho Falls, ID 83404,<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Mr. Jeremy Jessup,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests, is 30 days from the issuance date of this notice by the
Commission. All documents may be filed electronically via the Internet.
See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site at http://www.ferc.gov/docs-filing/efiling.asp.
If unable to be filed electronically, documents may be paper-filed. To
paper-file, an original and seven copies should be mailed to:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments.
    Please include the project number (P-2381-063) on any comments,
motions, or recommendations filed.
    k. Description of Request: The applicants request to transfer the
St. Anthony development from PacifiCorp to St. Anthony Hydro LLC.
PacifiCorp also requests that the Commission amend the license for
Project No. 2381 effective upon the partial transfer of license from
PacifiCorp to St. Anthony Hydro LLC, to delete all references in the
license to the St. Anthony development and remove it from the project
boundary. Upon completion of the partial transfer of the license to St.
Anthony Hydro LLC, the applicants request that FERC re-designate the
St. Anthony development with a new project number.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the

document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or email<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All motions to intervene, protests, or comments should relate
to project works which are the subject of the application. Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: July 12, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-17287 Filed 7-18-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53799-53807]
[FR Doc No: 2013-21184]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70253; File No. SR-NASDAQ-2013-107]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change Relating to the Listing and
Trading of the Shares of the First Trust Global Tactical Commodity
Strategy Fund of First Trust Exchange-Traded Fund VII

August 26, 2013.
    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 August 16, 2013, The NASDAQ Stock Market LLC (``Exchange'' or
``Nasdaq'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to list and trade the shares of the First Trust
Global Tactical Commodity Strategy Fund (the ``Fund'') of First Trust
Exchange-Traded Fund VII (the ``Trust'') under Nasdaq Rule 5735
(``Managed Fund Shares''). The shares of the Fund are collectively
referred to herein as the ``Shares.''
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com/, at Nasdaq's principal office, 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, NASDAQ 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. NASDAQ 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
    The Exchange proposes to list and trade the Shares of the Fund
under Nasdaq Rule 5735, which governs the listing and trading of
Managed Fund Shares \3\ on the Exchange.\4\ The Fund will be an
actively managed exchange-traded fund (``ETF''). The Shares will be

offered by the Trust, which was established as a Massachusetts business
trust on November 6, 2012.\5\ The Trust is registered with the
Commission as an investment company and has filed a registration
statement on Form N-1A (``Registration Statement'') with the
Commission.\6\ The Fund is a series of the Trust. With respect to the
futures contracts held indirectly through a wholly-owned subsidiary
controlled by the Fund and organized under the laws of the Cayman
Islands (referred to herein as the ``First Trust Subsidiary''), not
more than 10% of the weight \7\ of such futures contracts in the
aggregate shall consist of instruments whose principal trading market
is not a member of the Intermarket Surveillance Group (``ISG'') or is a
market with which the Exchange does not have a comprehensive
surveillance sharing agreement.
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    \3\ A Managed Fund Share is a security that represents an
interest in an investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a-1) (the ``1940 Act'') organized
as an open-end investment company or similar entity that invests in
a portfolio of securities selected by its investment adviser
consistent with its investment objectives and policies. In contrast,
an open-end investment company that issues Index Fund Shares, listed
and traded on the Exchange under Nasdaq Rule 5705, seeks to provide
investment results that correspond generally to the price and yield
performance of a specific foreign or domestic stock index, fixed
income securities index or combination thereof.
    \4\ The Commission approved Nasdaq Rule 5735 in Securities
Exchange Act Release No. 57962 (June 13, 2008), 73 FR 35175 (June
20, 2008) (SR-NASDAQ-2008-039). The Fund would not be the first
actively-managed fund listed on the Exchange; see Securities
Exchange Act Release No. 66489 (February 29, 2012), 77 FR 13379
(March 6, 2012) (SR-NASDAQ-2012-004) (order approving listing and
trading of WisdomTree Emerging Markets Corporate Bond Fund).
Additionally, the Commission has previously approved the listing and
trading of a number of actively managed WisdomTree funds on NYSE
Arca, Inc. pursuant to Rule 8.600 of that exchange. See, e.g.,
Securities Exchange Act Release No. 64643 (June 10, 2011), 76 FR
35062 (June 15, 2011) (SR-NYSEArca-2011-21) (order approving listing
and trading of WisdomTree Global Real Return Fund). The Exchange
believes the proposed rule change raises no significant issues not
previously addressed in those prior Commission orders.
    \5\ The Commission has issued an order granting certain
exemptive relief to the Trust under the 1940 Act (the ``Exemptive
Order''). See Investment Company Act Release No. 30029 (April 10,
2012) (File No. 812-13795). In compliance with Nasdaq Rule
5735(b)(5), which applies to Managed Fund Shares based on an
international or global portfolio, the Trust's application for
exemptive relief under the 1940 Act states that the Fund will comply
with the federal securities laws in accepting securities for
deposits and satisfying redemptions with redemption securities,
including that the securities accepted for deposits and the
securities used to satisfy redemption requests are sold in
transactions that would be exempt from registration under the
Securities Act of 1933 (15 U.S.C. 77a).
    \6\ See Registration Statement on Form N-1A for the Trust, dated
November 13, 2012 (File Nos. 333-184918 and 811-22767). The
descriptions of the Fund and the Shares contained herein are based,
in part, on information in the Registration Statement.
    \7\ To be calculated as the value of the contract divided by the
total absolute notional value of the First Trust Subsidiary's
futures contracts.
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    First Trust Advisors L.P. will be the investment adviser
(``Adviser'') to the Fund. First Trust Portfolios L.P. (the
``Distributor'') will be the principal underwriter and distributor of
the Fund's Shares. Brown Brothers Harriman & Co. (``BBH'') will act as
the administrator, accounting agent, custodian (``Custodian'') and
transfer agent to the Fund.
    Paragraph (g) of Rule 5735 provides that if the investment adviser
to the investment company issuing Managed Fund Shares is affiliated
with a broker-dealer, such investment adviser shall erect a ``fire
wall'' between the investment adviser and the broker-dealer with
respect to access to information concerning the composition and/or
changes to such investment company portfolio.\8\ In addition, paragraph
(g) further requires that personnel who make decisions on the open-end
fund's portfolio composition must be subject to procedures designed to
prevent the use and dissemination of material, non-public information
regarding the open-end fund's portfolio. Rule 5735(g) is similar to
Nasdaq Rule 5705(b)(5)(A)(i); however, paragraph (g) in connection with
the establishment of a ``fire wall'' between the investment adviser and
the broker-dealer reflects the applicable open-end fund's portfolio,
not an underlying benchmark index, as is the case with index-based
funds. The Adviser is not a broker-dealer, although it is affiliated
with the Distributor, a broker-dealer. The Adviser has implemented a
fire wall with respect to its broker-dealer affiliate regarding access
to information concerning the composition and/or changes to the
portfolio. In the event (a) the Adviser becomes newly affiliated with a
broker-dealer, or (b) any new adviser or sub-adviser is a registered
broker-dealer or becomes affiliated with a broker-dealer, it will
implement a fire wall with respect to its relevant personnel and/or
such broker-dealer affiliate, if applicable, regarding access to
information concerning the composition and/or changes to the portfolio
and will be subject to procedures designed to prevent the use and
dissemination of material non-public information regarding such
portfolio. The Fund does not currently intend to use a sub-adviser.
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    \8\ An investment adviser to an open-end fund is required to be
registered under the Investment Advisers Act of 1940 (the ``Advisers
Act''). As a result, the Adviser and its related personnel are
subject to the provisions of Rule 204A-1 under the Advisers Act
relating to codes of ethics. This Rule requires investment advisers
to adopt a code of ethics that reflects the fiduciary nature of the
relationship to clients as well as compliance with other applicable
securities laws. Accordingly, procedures designed to prevent the
communication and misuse of non-public information by an investment
adviser must be consistent with Rule 204A-1 under the Advisers Act.
In addition, Rule 206(4)-7 under the Advisers Act makes it unlawful
for an investment adviser to provide investment advice to clients
unless such investment adviser has (i) adopted and implemented
written policies and procedures reasonably designed to prevent
violation, by the investment adviser and its supervised persons, of
the Advisers Act and the Commission rules adopted thereunder; (ii)
implemented, at a minimum, an annual review regarding the adequacy
of the policies and procedures established pursuant to subparagraph
(i) above and the effectiveness of their implementation; and (iii)
designated an individual (who is a supervised person) responsible
for administering the policies and procedures adopted under
subparagraph (i) above.
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First Trust Global Tactical Commodity Strategy Fund
    According to the Registration Statement, the Fund's investment
objective will be to provide total return by providing investors with
commodity exposure while seeking a relatively stable risk profile. The
Fund will pursue its objective by seeking to invest through a wholly-
owned subsidiary in a broadly diversified portfolio comprised
principally of commodity futures contracts.
Principal Investments
Fund's Investments
    The Fund will be an actively managed ETF that will seek to achieve
attractive risk adjusted returns by investing in exchange-traded
commodity futures contracts and exchange-traded commodity linked
instruments \9\ (collectively, ``Commodities'') through the First Trust
Subsidiary. The Fund will seek to gain exposure to the futures markets
through investments in the First Trust Subsidiary. The Fund's
investment in the First Trust Subsidiary may not exceed 25% of the
Fund's total assets. The remainder of the Fund's assets will primarily
be invested in: (1) Short-term investment grade fixed income securities
that include U.S. government and agency securities,\10\ sovereign debt
obligations of non-U.S. countries, and repurchase agreements; \11\ (2)
money market instruments; \12\ (3) ETFs and other investment companies

registered under the 1940 Act; and (4) cash and other cash equivalents.
---------------------------------------------------------------------------

    \9\ Exchange-traded commodity linked instruments include: (1)
ETFs that provide exposure to commodities as would be listed under
Nasdaq Rules 5705 and 5735; and (2) pooled investment vehicles that
invest primarily in commodities and commodity-related instruments as
would be listed under Nasdaq Rules 5710 and 5711. Such pooled
investment vehicles are commonly referred to as ``exchange traded
funds'' but they are not registered as investment companies because
of the nature of their underlying investments.
    \10\ Such securities will include securities that are issued or
guaranteed by the U.S. Treasury, by various agencies of the U.S.
government, or by various instrumentalities, which have been
established or sponsored by the U.S. government. U.S. Treasury
obligations are backed by the ``full faith and credit'' of the U.S.
government. Securities issued or guaranteed by federal agencies and
U.S. government-sponsored instrumentalities may or may not be backed
by the full faith and credit of the U.S. government.
    \11\ According to the Registration Statement, the Fund intends
to enter into repurchase agreements only with financial institutions
and dealers believed by the Adviser to present minimal credit risks
in accordance with criteria approved by the Fund's Board of Trustees
(the ``Board''). The Adviser will review and monitor the
creditworthiness of such institutions. The Adviser will monitor the
value of the collateral at the time the transaction is entered into
and at all times during the term of the repurchase agreement.
    \12\ For the Fund's purposes, money market instruments will
include: Short-term, high-quality securities issued or guaranteed by
non-U.S. governments, agencies and instrumentalities; non-
convertible corporate debt securities with remaining maturities of
not more than 397 days that satisfy ratings requirements under Rule
2a-7 of the 1940 Act; money market mutual funds; and deposits and
other obligations of U.S. and non-U.S. banks and financial
institutions. As a related matter, according to the Registration
Statement, the Fund may invest in shares of money market mutual
funds to the extent permitted by the 1940 Act.
---------------------------------------------------------------------------

    The Fund will not invest directly in Commodities. The Fund expects
to exclusively gain exposure to these investments by investing in the
First Trust Subsidiary.
    The Fund will use the fixed-income securities as investments and to
collateralize the First Trust Subsidiary's commodity exposure on a day-
to-day basis. The Fund may also invest directly in ETFs \13\ and other
investment companies, including exchange-traded closed-end funds that
provide exposure to commodities, equity securities and fixed income
securities to the extent permitted under the 1940 Act.\14\
---------------------------------------------------------------------------

    \13\ As described in the Registration Statement, an ETF is an
investment company registered under the 1940 Act that holds a
portfolio of securities. Many ETFs are designed to track the
performance of a securities index, including industry, sector,
country and region indexes. ETFs included in the Fund will be listed
and traded in the U.S. on registered exchanges. The Fund may invest
in the securities of ETFs in excess of the limits imposed under the
1940 Act pursuant to exemptive orders obtained by other ETFs and
their sponsors from the Commission. The ETFs in which the Fund may
invest include Index Fund Shares (as described in Nasdaq Rule 5705),
Portfolio Depositary Receipts (as described in Nasdaq Rule 5705),
and Managed Fund Shares (as described in Nasdaq Rule 5735). While
the Fund may invest in inverse ETFs, the Fund will not invest in
leveraged or inverse leveraged (e.g., 2X or -3X) ETFs.
    \14\ The equity securities (including shares of ETFs and closed-
end funds) in which the Fund may invest will be limited to
securities that trade in markets that are members of the ISG, which
includes all U.S. national securities exchanges, or are parties to a
comprehensive surveillance sharing agreement with the Exchange.
---------------------------------------------------------------------------

    The Fund's investment in the First Trust Subsidiary will be
designed to help the Fund achieve exposure to commodity returns in a
manner consistent with the federal tax requirements applicable to the
Fund and other regulated investment companies.
First Trust Subsidiary's Investments
    The First Trust Subsidiary will seek to make investments generally
in Commodities while managing volatility, as measured by annualized
standard deviation, to a more consistent range than statistically
weighted commodity indices. The investment weightings of the underlying
Commodities held by the First Trust Subsidiary will be rebalanced in an
attempt to stabilize risk levels. The dynamic weighting process will
result in a disciplined, systematic investment process which will be
keyed off of the Adviser's volatility forecasting process.
    The First Trust Subsidiary will be advised by the Adviser.\15\ The
Fund's investment in the First Trust Subsidiary is intended to provide
the Fund with exposure to commodity markets within the limits of
current federal income tax laws applicable to investment companies such
as the Fund, which limit the ability of investment companies to invest
directly in the derivative instruments. The First Trust Subsidiary will
have the same investment objective as the Fund, but unlike the Fund, it
may invest without limitation in Commodities. The First Trust
Subsidiary's investments will provide the Fund with exposure to
domestic and international markets.
---------------------------------------------------------------------------

    \15\ The First Trust Subsidiary will not be registered under the
1940 Act and will not be directly subject to its investor
protections, except as noted in the Registration Statement. However,
the First Trust Subsidiary will be wholly-owned and controlled by
the Fund and will be advised by the Adviser. Therefore, the Fund's
ownership and control of the First Trust Subsidiary will prevent the
First Trust Subsidiary from taking action contrary to the interests
of the Fund or its shareholders. The Board will have oversight
responsibility for the investment activities of the Fund, including
its expected investment in the First Trust Subsidiary, and the
Fund's role as the sole shareholder of the First Trust Subsidiary.
The Adviser will receive no additional compensation for managing the
assets of the First Trust Subsidiary. The First Trust Subsidiary
will also enter into separate contracts for the provision of
custody, transfer agency, and accounting agent services with the
same or with affiliates of the same service providers that provide
those services to the Fund.
    \16\ The exchange codes listed are Bloomberg shorthand codes for
the corresponding exchanges. The New York Board of Trade is
currently owned by the ICE Futures Exchange; Bloomberg continues to
use NYB as its shorthand code for certain contracts formerly traded
on the New York Board of Trade.
    \17\ All of the exchanges are ISG members except for the London
Metal Exchange (``LME''). The LME falls under the jurisdiction of
the United Kingdom Financial Conduct Authority (``FCA''). The FCA is
responsible for ensuring the financial stability of the exchange
members' businesses, whereas the LME is largely responsible for the
oversight of day-to-day exchange activity, including conducting the
arbitration proceedings under the LME arbitration regulations.
---------------------------------------------------------------------------

    The First Trust Subsidiary may have both long and short positions
in Commodities. However, for a given Commodity the First Trust
Subsidiary will have a net long exposure. The First Trust Subsidiary
will initially consider investing in futures contracts set forth in the
following table. The table also provides each instrument's trading
hours, exchange and ticker symbol. The table is subject to change.

----------------------------------------------------------------------------------------------------------------
                                   Bloomberg
          Commodity              exchange code     Exchange name    Trading hours     Contract ticker (generic
                                      \16\              \17\            (E.T.)            Bloomberg ticker)
----------------------------------------------------------------------------------------------------------------
Cattle, Live/Choice Average..  CME                Chicago          18:00-17:00....  LC
                                                   Mercantile
                                                   Exchange.
Cocoa........................  NYB                ICE Futures      04:00-14:00....  CC
                                                   Exchange.
Cotton/1-1/16''..............  NYB                ICE Futures      21:00-14:30....  CT
                                                   Exchange.
Feeder Cattle................  CME                Chicago          18:00-17:00....  FC
                                                   Mercantile
                                                   Exchange.
Coffee `C'/Colombian.........  NYB                ICE Futures      03:30-14:00....  KC
                                                   Exchange.
Soybeans/No. 2 Yellow........  CBT                Chicago Board    20:00-14:15....  S
                                                   of Trade.
Soybean Meal/48% Protein.....  CBT                Chicago Board    20:00-14:15....  SM
                                                   of Trade.
Soybean Oil/Crude............  CBT                Chicago Board    20:00-14:15....  BO
                                                   of Trade.
Corn/No. 2 Yellow............  CBT                Chicago Board    20:00-14:15....  C
                                                   of Trade.
Wheat/No. 2 Hard Winter......  KCB                Kansas City      20:00-14:15....  KW
                                                   Board of Trade.
Wheat/No. 2 Soft Red.........  CBT                Chicago Board    20:00-14:15....  W
                                                   of Trade.
Sugar 11/World Raw..  NYB                ICE Futures      02:30-14:00....  SB
                                                   Exchange.
Hogs, Lean/Average Iowa/S      CME                Chicago          18:00-17:00....  LH
 Minn.                                             Mercantile
                                                   Exchange.
Crude Oil, WTI/Global Spot...  NYM                New York         18:00-17:15....  CL
                                                   Mercantile
                                                   Exchange.
Crude Oil, Brent/Global Spot.  ICE                ICE Futures      20:00-18:00....  CO
                                                   Exchange.
NY Harb ULSD.................  NYM                New York         18:00-17:15....  HO
                                                   Mercantile
                                                   Exchange.
Gas-Oil-Petroleum............  ICE                ICE Futures      20:00-18:00....  QS
                                                   Exchange.
Natural Gas, Henry Hub.......  NYM                New York         18:00-17:15....  NG
                                                   Mercantile
                                                   Exchange.
Gasoline, Blendstock (RBOB)..  NYM                New York         18:00-17:15....  XB
                                                   Mercantile
                                                   Exchange.
Gold.........................  CMX                COMEX..........  18:00-17:15....  GC
Silver.......................  CMX                COMEX..........  18:00-17:15....  SI
Platinum.....................  NYM                New York         18:00-17:15....  PL
                                                   Mercantile
                                                   Exchange.
Copper High Grade/Scrap No. 2  CMX                COMEX..........  18:00-17:15....  HG
 Wire.
Aluminum, LME Primary 3 Month  LME                London Metal     15:00-14:45....  LA
 Rolling Forward.                                  Exchange.

Lead, LME Primary 3 Month      LME                London Metal     15:00-14:45....  LL
 Rolling Forward.                                  Exchange.
Nickel, LME Primary 3 Month    LME                London Metal     15:00-14:45....  LN
 Rolling Forward.                                  Exchange.
Tin, LME Primary 3 Month       LME                London Metal     15:00-14:45....  LT
 Rolling Forward.                                  Exchange.
Zinc, LME Primary 3 Month      LME                London Metal     15:00-14:45....  LX
 Rolling Forward.                                  Exchange.
----------------------------------------------------------------------------------------------------------------

    As U.S. and London exchanges list additional contracts, as
currently listed contracts on those exchanges gain sufficient liquidity
or as other exchanges list sufficiently liquid contracts, the Adviser
will include those contracts in the list of possible investments of the
First Trust Subsidiary. The list of commodities futures and commodities
markets considered for investment can and will change over time.
Commodities Regulation
    The Commodity Futures Trading Commission (``CFTC'') has recently
adopted substantial amendments to CFTC Rule 4.5 relating to the
permissible exemptions and conditions for reliance on exemptions from
registration as a commodity pool operator. As a result of the
instruments that will be indirectly held by the Fund, the Adviser has
registered as a commodity pool operator \18\ and is also a member of
the National Futures Association (``NFA''). The Fund and the First
Trust Subsidiary are subject to regulation by the CFTC and NFA and
additional disclosure, reporting and recordkeeping rules imposed upon
commodity pools.
---------------------------------------------------------------------------

    \18\ As defined in Section 1a(11) of the Commodity Exchange Act.
---------------------------------------------------------------------------

Other Investments
    The Fund may invest in certificates of deposit issued against funds
deposited in a bank or savings and loan association. In addition, the
Fund may invest in bankers' acceptances, which are short-term credit
instruments used to finance commercial transactions.
    The Fund may invest in bank time deposits, which are monies kept on
deposit with banks or savings and loan associations for a stated period
of time at a fixed rate of interest. In addition, the Fund may invest
in commercial paper, which are short-term unsecured promissory notes,
including master demand notes issued by corporations to finance their
current operations. Master demand notes are direct lending arrangements
between the Fund and a corporation. The Fund may invest in commercial
paper only if it has received the highest rating from at least one
nationally recognized statistical rating organization or, if unrated,
judged by the Adviser to be of comparable quality.
Investment Restrictions
    According to the Registration Statement, the Fund may not invest
more than 25% of the value of its total assets in securities of issuers
in any one industry or group of industries. This restriction will not
apply to obligations issued or guaranteed by the U.S. government, its
agencies or instrumentalities, or securities of other investment
companies.\19\
---------------------------------------------------------------------------

    \19\ See Form N-1A, Item 9. The Commission has taken the
position that a fund is concentrated if it invests more than 25% of
the value of its total assets in any one industry. See, e.g.,
Investment Company Act Release No. 9011 (October 30, 1975), 40 FR
54241 (November 21, 1975).
---------------------------------------------------------------------------

    The First Trust Subsidiary's shares will be offered only to the
Fund and the Fund will not sell shares of the First Trust Subsidiary to
other investors. The Fund and the First Trust Subsidiary will not
invest in any non-U.S. equity securities (other than shares of the
First Trust Subsidiary). The Fund will not purchase securities of open-
end or closed-end investment companies except in compliance with the
1940 Act.
    Pursuant to the Exemptive Order, the Fund will not invest directly
in options contracts, futures contracts or swap agreements, however,
this restriction will not apply to the First Trust Subsidiary.
    The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid securities (calculated at the time of investment),
including Rule 144A securities deemed illiquid by the Adviser and
master demand notes.\20\ The Fund will monitor its portfolio liquidity
on an ongoing basis to determine whether, in light of current
circumstances, an adequate level of liquidity is being maintained, and
will consider taking appropriate steps in order to maintain adequate
liquidity if, through a change in values, net assets, or other
circumstances, more than 15% of the Fund's net assets are held in
illiquid securities. Illiquid securities include securities subject to
contractual or other restrictions on resale and other instruments that
lack readily available markets as determined in accordance with
Commission staff guidance.\21\
---------------------------------------------------------------------------

    \20\ In reaching liquidity decisions, the Adviser may consider
the following factors: The frequency of trades and quotes for the
security; the number of dealers wishing to purchase or sell the
security and the number of other potential purchasers; dealer
undertakings to make a market in the security; and the nature of the
security and the nature of the marketplace trades (e.g., the time
needed to dispose of the security, the method of soliciting offers,
and the mechanics of transfer).
    \21\ The Commission has stated that long-standing Commission
guidelines have required open-end funds to hold no more than 15% of
their net assets in illiquid securities and other illiquid assets.
See Investment Company Act Release No. 28193 (March 11, 2008), 73 FR
14618 (March 18, 2008), FN 34. See also Investment Company Act
Release No. 5847 (October 21, 1969), 35 FR 19989 (December 31, 1970)
(Statement Regarding ``Restricted Securities''); Investment Company
Act Release No. 18612 (March 12, 1992), 57 FR 9828 (March 20, 1992)
(Revisions of Guidelines to Form N-1A). A fund's portfolio security
is illiquid if it cannot be disposed of in the ordinary course of
business within seven days at approximately the value ascribed to it
by the fund. See Investment Company Act Release No. 14983 (March 12,
1986), 51 FR 9773 (March 21, 1986) (adopting amendments to Rule 2a-7
under the 1940 Act); Investment Company Act Release No. 17452 (April
23, 1990), 55 FR 17933 (April 30, 1990) (adopting Rule 144A under
the Securities Act of 1933).
---------------------------------------------------------------------------

    The Fund intends to qualify for and to elect to be treated as a
separate regulated investment company under SubChapter M of the
Internal Revenue Code.\22\
---------------------------------------------------------------------------

    \22\ 26 U.S.C. 851.
---------------------------------------------------------------------------

    Under the 1940 Act, the Fund's investment in investment companies
will be limited to, subject to certain exceptions: (i) 3% of the total
outstanding voting stock of any one investment company, (ii) 5% of the
Fund's total assets with respect to any one investment company, and
(iii) 10%

of the Fund's total assets with respect to investment companies in the
aggregate.
    The Fund's and the First Trust Subsidiary's investments will be
consistent with the Fund's investment objective and will not be used to
enhance leverage.
Net Asset Value
    According to the Registration Statement, the Fund's net asset value
(``NAV'') will be determined as of the close of trading (normally 4:00
p.m., Eastern time (``E.T.'')) on each day the New York Stock Exchange
(``NYSE'') is open for business. NAV will be calculated for the Fund by
taking the market price of the Fund's total assets, including interest
or dividends accrued but not yet collected, less all liabilities, and
dividing such amount by the total number of Shares outstanding. The
result, rounded to the nearest cent, will be the NAV per Share. All
valuations will be subject to review by the Board or its delegate.
    The Fund's and the First Trust Subsidiary's investments will be
valued at market value or, in the absence of market value with respect
to any investment, at fair value in accordance with valuation
procedures adopted by the Board and in accordance with the 1940 Act.
Portfolio securities traded on more than one securities exchange will
be valued at the last sale price or, if so disseminated by an exchange,
the official closing price, as applicable, on the business day as of
which such value is being determined at the close of the exchange
representing the principal market for such securities. Portfolio
securities traded in the over-the-counter market will be valued at
their closing bid prices. Short-term investments that mature in less
than 60 days when purchased will be valued at cost adjusted for
amortization of premiums and accretion of discounts.
    Exchange-traded futures contracts will be valued at the closing
price in the market where such contracts are principally traded.
    Certain securities may not be able to be priced by pre-established
pricing methods. Such securities may be valued by the Board or its
delegate at fair value. The use of fair value pricing by the Fund will
be governed by valuation procedures adopted by the Board and in
accordance with the provisions of the 1940 Act. These securities
generally include, but are not limited to, restricted securities
(securities which may not be publicly sold without registration under
the Securities Act of 1933) for which a pricing service is unable to
provide a market price; securities whose trading has been formally
suspended; a security whose market price is not available from a pre-
established pricing source; a security with respect to which an event
has occurred that is likely to materially affect the value of the
security after the market has closed but before the calculation of the
Fund's net asset value or make it difficult or impossible to obtain a
reliable market quotation; and a security whose price, as provided by
the pricing service, does not reflect the security's ``fair value.'' As
a general principle, the current ``fair value'' of a security would
appear to be the amount which the owner might reasonably expect to
receive for the security upon its current sale. The use of fair value
prices by the Fund generally results in the prices used by the Fund
that may differ from current market quotations or official closing
prices on the applicable exchange. A variety of factors may be
considered in determining the fair value of such securities.
Creation and Redemption of Shares
    The Trust will issue and sell Shares of the Fund only in Creation
Unit aggregations, and only in aggregations of 50,000 Shares, on a
continuous basis through the Distributor, without a sales load, at the
NAV next determined after receipt, on any business day, of an order in
proper form.
    The consideration for purchase of Creation Unit aggregations of the
Fund may consist of (i) cash in lieu of all or a portion of the Deposit
Securities, as defined below, and/or (ii) a designated portfolio of
securities determined by the Adviser that generally will conform to the
holdings of the Fund consistent with its investment objective (the
``Deposit Securities'') per each Creation Unit aggregation and
generally an amount of cash (the ``Cash Component'') computed as
described below. Together, the Deposit Securities and the Cash
Component (including the cash in lieu amount) will constitute the
``Fund Deposit,'' which will represent the minimum initial and
subsequent investment amount for a Creation Unit aggregation of the
Fund.
    The consideration for redemption of Creation Unit aggregations of
the Fund may consist of (i) cash in lieu of all or a portion of the
Fund Securities as defined below, and/or (ii) a designated portfolio of
securities determined by the Adviser that generally will conform to the
holdings of the Fund consistent with its investment objective per each
Creation Unit aggregation (``Fund Securities'') and generally a Cash
Component, as described below.
    The Cash Component is sometimes also referred to as the Balancing
Amount. The Cash Component will serve the function of compensating for
any differences between the NAV per Creation Unit aggregation and the
Deposit Amount (as defined below). For example, for a creation the Cash
Component will be an amount equal to the difference between the NAV of
Fund Shares (per Creation Unit aggregation) and the ``Deposit
Amount''--an amount equal to the market value of the Deposit Securities
and/or cash in lieu of all or a portion of the Deposit Securities. If
the Cash Component is a positive number (i.e., the NAV per Creation
Unit aggregation exceeds the Deposit Amount), the Authorized
Participant (defined below) will deliver the Cash Component. If the
Cash Component is a negative number (i.e., the NAV per Creation Unit
aggregation is less than the Deposit Amount), the Authorized
Participant will receive the Cash Component.
    The Custodian, through the National Securities Clearing Corporation
(``NSCC''), will make available on each business day, prior to the
opening of business of the NYSE (currently 9:30 a.m., E.T.), the list
of the names and the quantity of each Deposit Security to be included
in the current Fund Deposit (based on information at the end of the
previous business day). Such Fund Deposit will be applicable, subject
to any adjustments as described below, in order to effect creations of
Creation Unit aggregations of the Fund until such time as the next-
announced composition of the Deposit Securities is made available.
    The identity and quantity of the Deposit Securities required for a
Fund Deposit for the Shares may change as rebalancing adjustments and
corporate action events are reflected within the Fund from time to time
by the Adviser consistent with the investment objective of the Fund. In
addition, the Trust will reserve the right to permit or require the
substitution of an amount of cash, i.e., a ``cash in lieu'' amount, to
be added to the Cash Component to replace any Deposit Security that may
not be available in sufficient quantity for delivery or which might not
be eligible for trading by an Authorized Participant or the investor
for which it is acting or other relevant reason.
    In addition to the list of names and numbers of securities
constituting the current Deposit Securities of a Fund Deposit, the
Custodian, through the NSCC, will also make available on each business
day, the estimated Cash Component, effective through and including the
previous business day, per Creation Unit aggregation of the Fund.
    According to the Registration Statement, to be eligible to place
orders with respect to creations and

redemptions of Creation Units, an entity must be (i) a ``Participating
Party,'' i.e., a broker-dealer or other participant in the clearing
process through the continuous net settlement system of the NSCC or
(ii) a Depository Trust Company (``DTC'') Participant (a ``DTC
Participant''). In addition, each Participating Party or DTC
Participant (each, an ``Authorized Participant'') must execute an
agreement that has been agreed to by the Distributor and the Custodian
with respect to purchases and redemptions of Creation Units.
    All orders to create Creation Unit aggregations must be received by
the transfer agent no later than the closing time of the regular
trading session on the NYSE (ordinarily 4:00 p.m., E.T.) in each case
on the date such order is placed in order for creations of Creation
Unit aggregations to be effected based on the NAV of Shares of the Fund
as next determined on such date after receipt of the order in proper
form.
    In order to redeem Creation Units of the Fund, an Authorized
Participant must submit an order to redeem for one or more Creation
Units. All such orders must be received by the Fund's transfer agent in
proper form no later than the close of regular trading on the NYSE
(ordinarily 4:00 p.m. E.T.) in order to receive that day's closing NAV
per Share.
Availability of Information
    The Fund's Web site (www.ftportfolios.com), which will be publicly
available prior to the public offering of Shares, will include a form
of the prospectus for the Fund that may be downloaded. The Web site
will include the Share's ticker, Cusip and exchange information along
with additional quantitative information updated on a daily basis,
including, for the Fund: (1) Daily trading value, the prior business
day's reported NAV and closing price, mid-point of the bid/ask spread
at the time of calculation of such NAV (the ``Bid/Ask Price'') \23\ and
a calculation of the premium and discount of the Bid/Ask Price against
the NAV; and (2) data in chart format displaying the frequency
distribution of discounts and premiums of the daily Bid/Ask Price
against the NAV, within appropriate ranges, for each of the four
previous calendar quarters. On each business day, before commencement
of trading in Shares in the Regular Market Session \24\ on the
Exchange, the Fund will disclose on its Web site the identities and
quantities of the portfolio of securities, Commodities and other assets
(the ``Disclosed Portfolio'' as defined in Nasdaq Rule 5735(c)(2)) held
by the Fund and the First Trust Subsidiary that will form the basis for
the Fund's calculation of NAV at the end of the business day.\25\ The
Disclosed Portfolio will include, as applicable, the names, quantity,
percentage weighting and market value of securities, Commodities and
other assets held by the Fund and the First Trust Subsidiary and the
characteristics of such assets. The Web site and information will be
publicly available at no charge.
---------------------------------------------------------------------------

    \23\ The Bid/Ask Price of the Fund will be determined using the
midpoint of the highest bid and the lowest offer on the Exchange as
of the time of calculation of the Fund's NAV. The records relating
to Bid/Ask Prices will be retained by the Fund and its service
providers.
    \24\ See Nasdaq Rule 4120(b)(4) (describing the three trading
sessions on the Exchange: (1) Pre-Market Session from 4 a.m. to 9:30
a.m. E.T.; (2) Regular Market Session from 9:30 a.m. to 4 p.m. or
4:15 p.m. E.T.; and (3) Post-Market Session from 4 p.m. or 4:15 p.m.
to 8 p.m. E.T.).
    \25\ Under accounting procedures to be followed by the Fund,
trades made on the prior business day (``T'') will be booked and
reflected in NAV on the current business day (``T+1'').
Notwithstanding the foregoing, portfolio trades that are executed
prior to the opening of the Exchange on any business day may be
booked and reflected in NAV on such business day. Accordingly, the
Fund will be able to disclose at the beginning of the business day
the portfolio that will form the basis for the NAV calculation at
the end of the business day.
---------------------------------------------------------------------------

    In addition, for the Fund, an estimated value, defined in Rule
5735(c)(3) as the ``Intraday Indicative Value,'' that reflects an
estimated intraday value of the Fund's portfolio (including the First
Trust Subsidiary's portfolio), will be disseminated. Moreover, the
Intraday Indicative Value, available on the NASDAQ OMX Information LLC
proprietary index data service \26\ will be based upon the current
value for the components of the Disclosed Portfolio and will be updated
and widely disseminated by one or more major market data vendors and
broadly displayed at least every 15 seconds during the Regular Market
Session.
---------------------------------------------------------------------------

    \26\ Currently, the NASDAQ OMX Global Index Data Service
(``GIDS'') is the NASDAQ OMX global index data feed service,
offering real-time updates, daily summary messages, and access to
widely followed indexes and Intraday Indicative Values for ETFs.
GIDS provides investment professionals with the daily information
needed to track or trade NASDAQ OMX indexes, listed ETFs, or third-
party partner indexes and ETFs.
---------------------------------------------------------------------------

    The dissemination of the Intraday Indicative Value, together with
the Disclosed Portfolio, will allow investors to determine the value of
the underlying portfolio of the Fund on a daily basis and will provide
a close estimate of that value throughout the trading day.
    Intra-day, executable price quotations on the securities,
Commodities and other assets held by the Fund and the First Trust
Subsidiary, will be available from major broker-dealer firms or on the
exchange on which they are traded, as applicable. Intra-day price
information will also be available through subscription services, such
as Bloomberg, Markit and Thomson Reuters, which can be accessed by
Authorized Participants and other investors.
    Investors will also be able to obtain the Fund's Statement of
Additional Information (``SAI''), the Fund's Shareholder Reports, and
its Form N-CSR and Form N-SAR, filed twice a year. The Fund's SAI and
Shareholder Reports will be available free upon request from the Fund,
and those documents and the Form N-CSR and Form N-SAR may be viewed on-
screen or downloaded from the Commission's Web site at www.sec.gov.
Information regarding market price and volume of the Shares will be
continually available on a real-time basis throughout the day on
brokers' computer screens and other electronic services. The previous
day's closing price and trading volume information for the Shares will
be published daily in the financial section of newspapers. Quotation
and last sale information for the Shares will be available via Nasdaq
proprietary quote and trade services, as well as in accordance with the
Unlisted Trading Privileges and the Consolidated Tape Association plans
for the Shares and any underlying exchange-traded products.
    Additional information regarding the Fund and the Shares, including
investment strategies, risks, creation and redemption procedures, fees,
Fund holdings disclosure policies, distributions and taxes will be
included in the Registration Statement. All terms relating to the Fund
that are referred to, but not defined in, this proposed rule change are
defined in the Registration Statement.
Initial and Continued Listing
    The Shares will be subject to Rule 5735, which sets forth the
initial and continued listing criteria applicable to Managed Fund
Shares. The Exchange represents that, for initial and/or continued
listing, the Fund and the First Trust Subsidiary must be in compliance
with Rule 10A-3 \27\ under the Act. A minimum of 100,000 Shares will be
outstanding at the commencement of trading on the Exchange. The
Exchange will obtain a representation from the issuer of the Shares
that the NAV per Share will be calculated daily and that the NAV and
the Disclosed Portfolio

will be made available to all market participants at the same time.
---------------------------------------------------------------------------

    \27\ See 17 CFR 240.10A-3.
---------------------------------------------------------------------------

Trading Halts
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares of the Fund. Nasdaq will halt trading in the
Shares under the conditions specified in Nasdaq Rules 4120 and 4121,
including the trading pauses under Nasdaq Rules 4120(a)(11) and (12).
Trading may be halted because of market conditions or for reasons that,
in the view of the Exchange, make trading in the Shares inadvisable.
These may include: (1) The extent to which trading is not occurring in
the securities, Commodities and other assets constituting the Disclosed
Portfolio of the Fund and the First Trust Subsidiary; or (2) whether
other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present. Trading in the
Shares also will be subject to Rule 5735(d)(2)(D), which sets forth
circumstances under which Shares of the Fund may be halted.
Trading Rules
    Nasdaq deems the Shares to be equity securities, thus rendering
trading in the Shares subject to Nasdaq's existing rules governing the
trading of equity securities. Nasdaq will allow trading in the Shares
from 4:00 a.m. until 8:00 p.m. E.T. The Exchange has appropriate rules
to facilitate transactions in the Shares during all trading sessions.
As provided in Nasdaq Rule 5735(b)(3), the minimum price variation for
quoting and entry of orders in Managed Fund Shares traded on the
Exchange is $0.01.
Surveillance
    The Exchange represents that trading in the Shares will be subject
to the existing trading surveillances, administered by both Nasdaq and
also the Financial Industry Regulatory Authority (``FINRA'') on behalf
of the Exchange, which are designed to detect violations of Exchange
rules and applicable federal securities laws.\28\ The Exchange
represents that these procedures are adequate to properly monitor
Exchange trading of the Shares in all trading sessions and to deter and
detect violations of Exchange rules and applicable federal securities
laws.
---------------------------------------------------------------------------

    \28\ FINRA surveils trading on the Exchange pursuant to a
regulatory services agreement. The Exchange is responsible for
FINRA's performance under this regulatory services agreement.
---------------------------------------------------------------------------

    The surveillances referred to above generally focus on detecting
securities trading outside their normal patterns, which could be
indicative of manipulative or other violative activity. When such
situations are detected, surveillance analysis follows and
investigations are opened, where appropriate, to review the behavior of
all relevant parties for all relevant trading violations.
    FINRA, on behalf of the Exchange, will communicate as needed
regarding trading in the Shares and in the Commodities and other
exchange-traded securities and instruments held by the Fund and the
First Trust Subsidiary with other markets and other entities that are
members of the ISG \29\ and FINRA may obtain trading information
regarding trading in the Shares and in the Commodities and other
exchange-traded securities and instruments held by the Fund and the
First Trust Subsidiary from such markets and other entities. In
addition, the Exchange may obtain information regarding trading in the
Shares and in the Commodities and other exchange-traded securities and
instruments held by the Fund and the First Trust Subsidiary from
markets and other entities that are members of ISG, which includes
securities and futures exchanges, or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
---------------------------------------------------------------------------

    \29\ For a list of the current members of ISG, see
www.isgportal.org. The Exchange notes that not all components of the
Disclosed Portfolio may trade on markets that are members of ISG or
with which the Exchange has in place a comprehensive surveillance
sharing agreement.
---------------------------------------------------------------------------

    In addition, with respect to the futures contracts held indirectly
through the First Trust Subsidiary, not more than 10% of the weight
\30\ of such futures contracts in the aggregate shall consist of
instruments whose principal trading market is not a member of ISG or is
a market with which the Exchange does not have a comprehensive
surveillance sharing agreement. In addition, the Exchange also has a
general policy prohibiting the distribution of material, non-public
information by its employees.
---------------------------------------------------------------------------

    \30\ To be calculated as the value of the contract divided by
the total absolute notional value of the First Trust Subsidiary's
futures contracts.
---------------------------------------------------------------------------

Information Circular
    Prior to the commencement of trading, the Exchange will inform its
members in an Information Circular of the special characteristics and
risks associated with trading the Shares. Specifically, the Information
Circular will discuss the following: (1) The procedures for purchases
and redemptions of Shares in Creation Units (and that Shares are not
individually redeemable); (2) Nasdaq Rule 2111A, which imposes
suitability obligations on Nasdaq members with respect to recommending
transactions in the Shares to customers; (3) how information regarding
the Intraday Indicative Value is disseminated; (4) the risks involved
in trading the Shares during the Pre-Market and Post-Market Sessions
when an updated Intraday Indicative Value will not be calculated or
publicly disseminated; (5) the requirement that members deliver a
prospectus to investors purchasing newly issued Shares prior to or
concurrently with the confirmation of a transaction; and (6) trading
information.
    In addition, the Information Circular will advise members, prior to
the commencement of trading, of the prospectus delivery requirements
applicable to the Fund. Members purchasing Shares from the Fund for
resale to investors will deliver a prospectus to such investors. The
Information Circular will also discuss any exemptive, no-action and
interpretive relief granted by the Commission from any rules under the
Act.
    Additionally, the Information Circular will reference that the Fund
is subject to various fees and expenses described in the Registration
Statement. The Information Circular will also disclose the trading
hours of the Shares of the Fund and the applicable NAV calculation time
for the Shares. The Information Circular will disclose that information
about the Shares of the Fund will be publicly available on the Fund's
Web site.
2. Statutory Basis
    Nasdaq believes that the proposal is consistent with Section 6(b)
of the Act in general and Section 6(b)(5) of the Act in particular in
that it is 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 facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and in general, to protect
investors and the public interest.
    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares will be listed and traded on the Exchange pursuant to the
initial and continued listing criteria in Nasdaq Rule 5735. The
Exchange represents that trading in the Shares will be subject to the
existing trading surveillances, administered by both Nasdaq and also
FINRA on behalf of the Exchange, which are designed to

detect violations of Exchange rules and applicable federal securities
laws. The Adviser is affiliated with a broker-dealer and has
implemented a fire wall with respect to its broker-dealer affiliate
regarding access to information concerning the composition and/or
changes to the Fund's portfolio. In addition, paragraph (g) of Nasdaq
Rule 5735 further requires that personnel who make decisions on the
open-end fund's portfolio composition must be subject to procedures
designed to prevent the use and dissemination of material, non-public
information regarding the open-end fund's portfolio. The Fund's and the
First Trust Subsidiary's investments will be consistent with the Fund's
investment objective and will not be used to enhance leverage. FINRA
may obtain information via ISG from other exchanges that are members of
ISG. In addition, the Exchange may obtain information regarding trading
in the Shares and in the Commodities and other exchange-traded
securities and instruments held by the Fund and the First Trust
Subsidiary from markets and other entities that are members of ISG,
which includes securities and futures exchanges, or with which the
Exchange has in place a comprehensive surveillance sharing agreement.
With respect to the futures contracts held indirectly through the First
Trust Subsidiary, not more than 10% of the weight \31\ of such futures
contracts in the aggregate shall consist of instruments whose principal
trading market is not a member of the ISG or is a market with which the
Exchange does not have a comprehensive surveillance sharing agreement.
The Fund will invest up to 25% of its total assets in the First Trust
Subsidiary. The Fund may hold up to an aggregate amount of 15% of its
net assets in illiquid securities (calculated at the time of
investment), including Rule 144A securities and master demand notes.
The Fund will not invest directly in Commodities and the Fund expects
to exclusively gain exposure to these investments by investing in the
First Trust Subsidiary. The Fund will use the fixed-income securities
as investments and to collateralize the First Trust Subsidiary's
commodity exposure on a day-to-day basis. The Fund may also invest
directly in ETFs and other investment companies, including exchange-
traded closed-end funds, that provide exposure to commodities, equity
securities and fixed income securities to the extent permitted under
the 1940 Act. The Fund and the First Trust Subsidiary will not invest
in any non-U.S. equity securities (other than shares of the First Trust
Subsidiary).
---------------------------------------------------------------------------

    \31\ To be calculated as the value of the contract divided by
the total absolute notional value of the First Trust Subsidiary's
futures contracts.
---------------------------------------------------------------------------

    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Exchange will obtain a representation from the issuer of the
Shares that the NAV per Share will be calculated daily and that the NAV
and the Disclosed Portfolio will be made available to all market
participants at the same time. In addition, a large amount of
information will be publicly available regarding the Fund and the
Shares, thereby promoting market transparency. Moreover, the Intraday
Indicative Value, available on the NASDAQ OMX Information LLC
proprietary index data service will be widely disseminated by one or
more major market data vendors at least every 15 seconds during the
Regular Market Session. On each business day, before commencement of
trading in Shares in the Regular Market Session on the Exchange, the
Fund will disclose on its Web site the Disclosed Portfolio of the Fund
and the First Trust Subsidiary that will form the basis for the Fund's
calculation of NAV at the end of the business day. Information
regarding market price and trading volume of the Shares will be
continually available on a real-time basis throughout the day on
brokers' computer screens and other electronic services, and quotation
and last sale information for the Shares will be available via Nasdaq
proprietary quote and trade services, as well as in accordance with the
Unlisted Trading Privileges and the Consolidated Tape Association plans
for the Shares and any underlying exchange-traded products. Intra-day
price information will be available through subscription services, such
as Bloomberg, Markit and Thomson Reuters, which can be accessed by
Authorized Participants and other investors.
    The Fund's Web site will include a form of the prospectus for the
Fund and additional data relating to NAV and other applicable
quantitative information. Trading in Shares of the Fund will be halted
under the conditions specified in Nasdaq Rules 4120 and 4121 or because
of market conditions or for reasons that, in the view of the Exchange,
make trading in the Shares inadvisable, and trading in the Shares will
be subject to Nasdaq Rule 5735(d)(2)(D), which sets forth circumstances
under which Shares of the Fund may be halted. In addition, as noted
above, investors will have ready access to information regarding the
Fund's holdings, the Intraday Indicative Value, the Disclosed
Portfolio, and quotation and last sale information for the Shares.
    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that it will facilitate the listing and trading of
an additional type of actively-managed exchange-traded product that
will enhance competition among market participants, to the benefit of
investors and the marketplace. As noted above, FINRA, on behalf of the
Exchange, will communicate as needed regarding trading in the Shares
and in the Commodities and other exchange-traded securities and
instruments held by the Fund and the First Trust Subsidiary with other
markets and other entities that are members of the ISG and FINRA may
obtain trading information regarding trading in the Shares and in the
Commodities and other exchange-traded securities and instruments held
by the Fund and the First Trust Subsidiary from such markets and other
entities. In addition, the Exchange may obtain information regarding
trading in the Shares and in the Commodities and other exchange-traded
securities and instruments held by the Fund and the First Trust
Subsidiary from markets and other entities that are members of ISG,
which includes securities and futures exchanges, or with which the
Exchange has in place a comprehensive surveillance sharing agreement.
Furthermore, as noted above, investors will have ready access to
information regarding the Fund's holdings, the Intraday Indicative
Value, the Disclosed Portfolio, and quotation and last sale information
for the Shares.
    For the above reasons, Nasdaq 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 Exchange believes that
the proposed rule change will facilitate the listing and trading of an
additional type of actively-managed exchange-traded fund that will
enhance competition among market participants, to the benefit of
investors and the marketplace.

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2013-107 on the subject line.

Paper Comments:

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

All submissions should refer to File Number SR-NASDAQ-2013-107. 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 Web site (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 Web site 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2013-107 and should
be submitted on or before September 20, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-21184 Filed 8-29-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15682-15683]
[FR Doc No: 2021-06059]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0279]

Determination That Folic Acid, Oral Tablets, 1 Milligram, and
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were 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
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products 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. 6236, 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 products listed in the table are
no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
   Application No.        Drug name        ingredient(s)       Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 006135..........  Folic Acid.......  Folic Acid.......  1 milligram (mg)  Tablet; Oral....  Eli Lilly & Co.
NDA 016131..........  CLOMID...........  Clomiphene         50 mg...........  Tablet; Oral....  Sanofi-Aventis
                                          Citrate.                                               U.S. LLC.
NDA 016419..........  Propranolol        Propanolol         1 mg/milliliter   Injectable;       Baxter
                       Hydrochloride.     Hydrochloride.     (mL).             Injection.        Healthcare
                                                                                Corp.
NDA 017473..........  ORAP.............  Pimozide.........  1 mg; 2 mg......  Tablet; Oral....  Teva Pharms.,
                                                                                USA, Inc.
NDA 019916..........  Morphine Sulfate.  Morphine Sulfate.  1 mg/mL; 5 mg/mL  Injectable;       ICU Medical,
                                                                               Injection.        Inc.
NDA 019967..........  ULTRAVATE........  Halobetasol        0.05%...........  Cream; Topical..  Sun
                                          Propionate.                                            Pharmaceutical
                                                                                Industries,
                                                                                Inc.
NDA 020647..........  ELDEPRYL.........  Selegiline         5 mg............  Capsule; Oral...  Somerset
                                          Hydrochloride.                                         Pharms., Inc.
NDA 020925..........  TAVIST-1.........  Clemastine         1.34 mg.........  Tablet; Oral....  GlaxoSmithKline
                                          Fumarate.                                              Consumer
                                                                                Healthcare.

NDA 021015..........  ANDROGEL.........  Testosterone.....  12.5 mg/1.25 g    Gel, Metered;     AbbVie Inc.
                                                             Actuation.        Transdermal.
NDA 021204..........  STARLIX..........  Nateglinide......  60 mg; 120 mg...  Tablets; Oral...  Novartis
                                                                                Pharms., Corp.
NDA 021217..........  EXALGO...........  Hydromorphone      8 mg; 12 mg; 16   Tablet, Extended- Specgx, LLC.
                                          Hydrochloride.     mg; 32 mg.        Release; Oral.
NDA 021365..........  LEXAPRO..........  Escitalopram       Equal to (EQ) 5   Solution; Oral..  Allergan Sales,
                                          Oxalate.           mg Base/5 mL.                       LLC.
NDA 021490..........  FEMCON FE........  Ethinyl            0.035 mg; 0.4 mg  Tablet,           Allergan
                                          Estradiol;                           Chewable; Oral.   Pharms.,
                                          Norethindrone.                                         International,
                                                                                Ltd.
NDA 021860..........  SARAFEM..........  Fluoxetine         EQ 15 mg Base...  Tablet; Oral....  Allergan Pharms.
                                          Hydrochloride.                                         International,
                                                                                Ltd.
NDA 021870..........  Fludeoxyglucose F- Fludeoxyglucose F- 20-200            Injectable;       Feinstein
                       18.                18.                Millicurie/mL.    Intravenous.      Institute
                                                                                Medical
                                                                                Research.
NDA 022442..........  REZIRA...........  Hydrocodone        5 mg/5 mL; 60 mg/ Solution; Oral..  Persion Pharms.,
                                          Bitartrate;        5 mL.                               LLC.
                                          Pseudoephedrine
                                          Hydrochloride.
NDA 050757..........  PREVPAC..........  Amoxicillin;       500 mg; 500 mg;   Capsule, Tablet,  Takeda Pharms.
                                          Clarithromycin;    30 mg.            Capsule; Oral.    USA, Inc.
                                          Lansoprazole.
NDA 203195..........  SUPRAX...........  Cefixime.........  400 mg..........  Capsule; Oral...  Lupin, Ltd.
NDA 207931..........  TECHNIVIE........  Ombitasvir;        12.5 mg; 75 mg;   Tablet; Oral....  AbbVie Inc.
                                          Paritaprevir;      50 mg.
                                          Ritonavir.
NDA 208624..........  VIEKIRA XR.......  Dasabuvir Sodium;  EQ 200 mg Base;   Tablet, Extended  AbbVie Inc.
                                          Ombitasvir;        8.33 mg; 50 mg;   Release; Oral.
                                          Paritaprevir;      33.33 mg.
                                          Ritonavir.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the Agency will
continue to list the drug products 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 NDAs listed are unaffected by the
discontinued marketing of the products subject to those NDAs.
Additional ANDAs that refer to these products may also be approved by
the Agency if they comply with relevant legal and regulatory
requirements. If FDA determines that labeling for these drug products
should be revised to meet current standards, the Agency will advise
ANDA applicants to submit such labeling.

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06059 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P