[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Page 13981]
[FR Doc No: 2018-06622]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER18-1149-000]

Walleye Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Walleye Energy, LLC`s application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 11, 2018.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected]. or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 22, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-06622 Filed 3-30-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Notices]
[Pages 12782-12784]
[FR Doc No: 2011-5138]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64004; File No. SR-FICC-2011-02]

Self-Regulatory Organizations; The Fixed Income Clearing
Corporation; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Make a Technical, Clarifying Change to the Corporation
Default Rule of the Government Securities Division

March 2, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on February 17, 2011, The
Fixed Income Clearing Corporation (``FICC'') filed with the Securities
and Exchange Commission (``Commission'') the proposed rule change
described in Items I and II below, which Items have been prepared
primarily by FICC. FICC filed the proposal pursuant to Section
19(b)(3)(A)(i) of the Act \2\ and Rule 19b-4(f)(1) \3\ thereunder so
that the proposal was effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the rule
change from interested parties.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(i).
    \3\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change will make a technical, clarifying change
to the Corporation Default Rule of the Government Securities Division
(``GSD'').

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

    In its filing with the Commission, FICC 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.
FICC has prepared summaries, set forth in sections (A), (B), and (C)
below, of the most significant aspects of these statements.\4\
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    \4\ The Commission has modified the text of the summaries
prepared by FICC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The purpose of this rule change is to make a technical, clarifying
change to GSD Rule 22B, entitled ``Corporation Default'' (``Corporation
Default Rule''). FICC adopted the Corporation Default Rule to make
explicit the close-out netting that would be applied to obligations
between FICC and its members in the event that FICC becomes insolvent
or defaults in its obligations to its members.\5\ By way of background,
FICC had been approached by some of its dealer members that had
requested that FICC add a provision to the rules of the GSD to make
explicit the close-out netting of obligations between FICC and its
members in the unlikely event that FICC becomes insolvent or defaults
on its obligations to its members. The members stated that the adoption
of the Corporation Default Rule would provide clarity in their
application of balance sheet netting to their positions with FICC under
U.S. GAAP in accordance with the criteria specified in the Financial
Accounting Standards Board's Interpretation No. 39, ``Offsetting of
Amounts Related to Certain Contracts'' (FIN 39). The members further
stated that the Corporation Default Rule would allow them to comply
with Basel Accord Standards relating to netting. Specifically, firms
are able to calculate their capital requirements on the basis of their
net credit exposure where they have legally enforceable netting
arrangements with their counterparties, which includes a close-out
netting provision in the event of the default of the counterparty (in
this case, the division of FICC acting as a CCP).
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    \5\ SEC Release No. 34-63038, File No. SR-FICC-2010-04 (October
5, 2010).
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    The proposed technical change adds a sentence to the Corporation
Default Rule that reads as follows: ``For purposes of this Rule 22B and
notwithstanding any other provision to the contrary, Novation is deemed
to occur and Deliver Obligations and Receive Obligations established
with respect to all Transactions at the time at which the data
submitted in respect of such Transactions is compared and constitutes a
Compared Trade.'' For purposes of clarity, this sentence brings into
Rule 22B, existing language of other provisions of the GSD's Rules. For
example, GSD Rule 11B (``Guaranty of Settlement'') provides that FICC
shall guarantee the settlement of a trade at the time at which the
comparison of such trade occurs pursuant to the FICC's comparison rules
and that FICC's guaranty means FICC's obligation to novate the deliver,
receive, and payment obligations that were created by the trade. The
addition of the proposed sentence in the Corporation Default Rule
clarifies that trades that have been compared and therefore guaranteed
by the GSD shall be deemed novated at the time of comparison for
purposes of Rule 22B and therefore included in the close-out netting
calculation that would be performed in the event of an FICC default
pursuant to Rule 22B.
    FICC believes that the proposed rule change is consistent with the
requirements of Section 17A of the Act \6\ and the rules and
regulations thereunder applicable to FICC because it provides members
with further clarity with respect to the Corporation Default Rule and
net credit exposure where members have legally enforceable netting
arrangements with their counterparties.
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    \6\ 15 U.S.C. 78q-1.
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(B) Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

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

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

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

    The foregoing proposed rule change has become effective upon filing
pursuant to Section 19(b)(3)(A)(i) of the Act \7\ and Rule 19b-4(f)(1)
\8\ thereunder because the proposed rule change constitutes a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule. At any time within
60 days of the filing of the proposed rule change, the Commission
summarily may temporarily suspend such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
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    \7\ 15 U.S.C. 78s(b)(3)(A)(i).
    \8\ 17 CFR 240.19b-4(f)(1).
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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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FICC-2011-02 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-FICC-2011-02. This file
number should be included on the subject line if e-mail 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
a.m. and 3 p.m. Copies of such filings also will be available for
inspection and copying at the principal office of FICC and on FICC's
Web site at http://www.dtcc.com/downloads/legal/rule_filings/2011/ficc/2011-02.pdf. 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-FICC-2011-02 and should be submitted on or before March
29, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-5138 Filed 3-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Proposed Rules]
[Pages 32219-32221]
[FR Doc No: 2018-14862]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0281; Product Identifier 2018-NE-06-AD]
RIN 2120-AA64

Airworthiness Directives; Hoffmann Propeller GmbH & Co. KG
Propellers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Hoffmann Propeller GmbH & Co. KG model HO-V 62 propellers. This
proposed AD was prompted by the failure of the propeller blade lag
screws. This proposed AD would require removal of the affected
propeller blades and installation of modified propeller blades marked
with change letter ``A'' or ``B.'' We are proposing this AD to address
the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by August 27, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Hoffmann
Propeller GmbH & Co. KG, Sales and Service, K[uuml]pferlingstrasse 9,
83022 Rosenheim, Germany; phone: +49 (0) 8031 1878 0; fax: +49 (0) 8031
1878 78; email: prop.com">[email protected]prop.com. You may view this service
information at the FAA, Engine & Propeller Standards Branch, 1200
District Avenue, Burlington, MA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0281; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the mandatory continuing airworthiness information (MCAI),
the regulatory evaluation, any comments received, and other
information. The address for Docket Operations (phone:<PHONE_NUMBER>) is
listed above. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Maureen Maisttison, Aerospace
Engineer, AIR-7B1, FAA, 1200 District Ave, Burlington, MA 01803; phone:
781-238-7076; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0281;
Product Identifier 2018-NE-06-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2017-0220, dated November 10, 2017 (referred to hereinafter as ``the
MCAI''), to address the unsafe condition on these products. The MCAI
states:

    In 1983, occurrences were reported of fatigue failure of
propeller blade lag screws, at rotation speeds between 2950 and 3250
revolutions per minute (RPM) in flight.
    This condition, if not detected and corrected, could lead to in-
flight propeller blade detachment, possibly resulting in damage to
the powered sailplane and/or injury to persons on the ground.
    To address this potential unsafe condition, Hoffmann issued
Service Bulletin (SB) 4, providing the necessary instructions.
Consequently, LBA Germany issued AD 83-150 (later revised), which
applied only to HO-V 62 propellers with R/L 160T blades, when in
combination with a Limbach L 2000 engine, to require a limitation of
continuous operation to 2 900 RPM, to prohibit aerobatic flights,
calibrate the tachometer, install a placard, and inspection of the
propeller blades. LBA AD 83-150/4 also required overhaul and
replacement of the affected propeller blades with modified blades,
either having 5 lag screws with 12 mm diameter, or 6 screws, and
required implementing a time between overhaul (TBO) of 600 flight
hours (FH).
    Since that AD was issued, based on a stress analysis of lag
screws on blades with continuous operating speed above 2 900 RPM, it
was determined that the 6-screws configuration or the 5 screws
configuration with increased strength is necessary to ensure safe
propeller operation. In addition, since the LBA AD applied only to a
limited population (Limbach engine only), many propellers have not
been modified as described in Hoffmann SB 4C. Consequently, Hoffmann
issued SB E34 Revision B, to provide blade replacement instructions.

    You may obtain further information by examining the MCAI in the AD
docket on the internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2018-0281.

Related Service Information

    We reviewed Hoffmann Propeller GmbH & Co. KG Service Bulletin (SB)
E34, Rev. B, dated September 18, 2017. The SB describes the
instructions for the removal and installation of the propeller blades.

FAA's Determination

    This product has been approved by EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are proposing this AD because we evaluated all the relevant
information provided by EASA and determined the unsafe condition
previously described is likely to exist or develop in other products of
the same type design.

Proposed AD Requirements

    This proposed AD would require removal of the affected propeller
blades and installation of the modified propeller blades marked with
change letter ``A'' or ``B'' on the blade.

Differences Between This Proposed AD and the MCAI or Service
Information

    EASA AD 2017-0220 partially restates the requirements of AD 83-150,
issued on December 21, 1984, by German aviation authority Luftfahrt-
Bundesamt (LBA), which is based on Propellerwerk Hoffmann Rosenheim SB
4, Revision C, dated February 20, 1984. EASA AD 2017-0220 also adds new
requirements based on the issuance of

Hoffmann Propeller GmbH & Co. KG SB E34, Rev. B dated September 18,
2017.
    In restating LBA AD 83-150, EASA AD 2017-0220 maintains a
requirement to remove certain propellers from service within 10 flight
hours after December 21, 1984, but not later than 31 March 31, 1985.
Service Bulletin E34 requires a mandatory immediate maximum propeller
rotational speed limitation until the permanent corrective action is
completed, within 50 flight hours. The EASA AD 2017-0220 partially
restated requirements of SB 4. Additionally, Hoffmann Propeller GmbH &
Co. KG SB E34 Revision B and SB 4 Revision C temporarily prohibit
acrobatic flight. EASA AD 2017-0220 also adds a new requirement for a
mandatory maximum propeller rotational speed limitation within 30 days
until the propeller is replaced within 50 flight hours.
    This proposed AD does not require a propeller speed limitation but
would require removal of the affected propeller blades and installation
of modified propeller blades within 30 days of the effective date of
this AD.

Costs of Compliance

    We estimate that this proposed AD affects 50 propellers installed
on airplanes of U.S. registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replace Blades between overhaul.......  3.0 work-hours x $85 per       $3,150.00       $3,405.00      $85,125.00
                                         hour = $255.00.
Replace Blades at overhaul............  0 work-hours x $85 per          3,150.00        3,150.00       78,750.00
                                         hour = $0.00.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Hoffmann Propeller GmbH & Co. KG: Docket No. FAA-2018-0281; Product
Identifier 2018-NE-06-AD.

(a) Comments Due Date

    We must receive comments by August 27, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Hoffmann Propeller GmbH & Co. KG model HO-V
62 propellers without modified blades marked with change letter
``A'' or ``B'' suffix to the S/N.

(d) Subject

    Joint Aircraft System Component (JASC) Code 6110, Propeller
Assembly.

(e) Unsafe Condition

    This AD was prompted by the failure of the propeller blade lag
screws. We are issuing the AD to prevent failure of the propeller.
The unsafe condition, if not addressed, could result in the release
of the propeller blade, damage to the aircraft, injury and/or loss
of life.

(f) Compliance

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

(g) Required Actions

    Within 30 days of the effective date of this AD, remove the
applicable propeller blades and install modified propeller blades
marked with a change letter ``A'' or ``B'' suffix to the S/N marked
on the blade.

(h) Installation Prohibition

    After the effective date of this AD, do not install a propeller
blade if it is not marked with a change letter ``A'' or ``B'' suffix
to the S/N marked on the blade.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards

District Office, as appropriate. If sending information directly to
the manager of the Boston ACO Branch, send it to the attention of
the person identified in paragraph (j)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Maureen
Maisttison, Aerospace Engineer, AIR-7B1, FAA, 1200 District Ave,
Massachusetts, 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to European Aviation Safety Agency AD 2017-0220, dated
November 10, 2017, for more information. You may examine the EASA AD
in the AD docket on the internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2018-0281.
    (3) For service information identified in this proposed AD,
contact Hoffmann Propeller GmbH & Co. KG, Sales and Service,
K[uuml]pferlingstrasse 9, 83022 Rosenheim, Germany; phone: +49 (0)
8031 1878 0; fax: +49 (0) 8031 1878 78; email: prop.com">[email protected]prop.com. You may view this referenced service information at the
FAA, Engine & Propeller Standards Branch, 1200 District Avenue,
Burlington, MA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on July 6, 2018.
Karen M. Grant,
Acting Manager, Engine and Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2018-14862 Filed 7-11-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33199-33200]
[FR Doc No: 2014-13445]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-1241]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Xience Prime Ll Everolimus Eluting Coronary Stent System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for Xience Prime Ll Everolimus Eluting
Coronary Stent System and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that medical device.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257,

Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device Xience Prime Ll
Everolimus Eluting Coronary Stent System. Xience Prime Ll Everolimus
Eluting Coronary Stent System is indicated for improving coronary
luminal diameter in patients with symptomatic heart disease due to de
novo native coronary artery lesions (length <= 32 millimeters (mm))
with reference vessel diameters of >=2.25 mm to <= 4.25 mm. Subsequent
to this approval, the USPTO received a patent term restoration
application for Xience Prime Ll Everolimus Eluting Coronary Stent
System (U.S. Patent No. 5,514,154) from Abbott Cardiovascular Systems
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
March 4, 2013, FDA advised the USPTO that this medical device had
undergone a regulatory review period and that the approval of Xience
Prime Ll Everolimus Eluting Coronary Stent System represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that the FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
Xience Prime Ll Everolimus Eluting Coronary Stent System is 890 days.
Of this time, 694 days occurred during the testing phase of the
regulatory review period, while 196 days occurred during the approval
phase. These periods of time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: May 27, 2009. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective May 27, 2009.
    2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): April 20, 2011. The applicant claims October 28,
2010, as the date the premarket approval application (PMA) for Xience
Prime Ll Everolimus Eluting Coronary Stent System (PMA P110019) was
initially submitted. However, FDA records indicate that PMA P110019 was
submitted in full on April 20, 2011.
    3. The date the application was approved: November 1, 2011. FDA has
verified the applicant's claim that PMA P110019 was approved on
November 1, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 630 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 11, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by December 8, 2014. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13445 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22611-22612]
[FR Doc No: 2016-08878]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0238]

Facility Definition Under Section 503B of the Federal Food, Drug,
and Cosmetic Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Facility
Definition Under Section 503B of the Federal Food, Drug, and Cosmetic
Act.'' Section 503B defines an outsourcing facility, in part, as ``a
facility at one geographic location or address.'' FDA has received
questions from outsourcing facilities and other stakeholders about the
meaning of this term, such as whether multiple suites used for
compounding human drugs at a single street address constitute one or
multiple facilities, or whether a single location where human drugs are
compounded can be subdivided into separate operations compounding under
different standards. FDA is issuing this draft guidance to answer these
questions.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 18, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-0238 for ``Facility Definition Under Section 503B of the
Federal Food, Drug, and Cosmetic Act; Availability.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation

and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 5197, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Facility Definition Under Section 503B of the Federal Food,
Drug, and Cosmetic Act.''
    Section 503B, added to the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by the Drug Quality and Security Act in 2013, created a
new category of compounders called outsourcing facilities. Section 503B
describes the conditions that must be satisfied for human drug products
compounded by or under the direct supervision of a licensed pharmacist
in an outsourcing facility to qualify for exemptions from three
sections of the FD&C Act:
     Section 502(f)(1) (concerning labeling requirements);
     Section 505 (concerning drug approval requirements); and
     Section 582 (concerning Drug Supply Chain Security Act
requirements).
    Section 503B(d)(4) of the FD&C Act defines an outsourcing facility
as a facility at one geographic location or address that: (1) Is
engaged in the compounding of sterile drugs; (2) has elected to
register as an outsourcing facility; and (3) complies with all of the
requirements of this section. In addition, an outsourcing facility is
not required to be a licensed pharmacy, and it may or may not obtain
prescriptions for identified individual patients. Because drugs
compounded by outsourcing facilities are not exempt from section
501(a)(2)(B) of the FD&C Act, outsourcing facilities are subject to
current good manufacturing practice (CGMP) requirements.
    FDA has received questions from outsourcing facilities and other
stakeholders about the meaning of the term ``facility at one geographic
location or address,'' such as whether multiple suites used for
compounding human drugs at a single street address constitute one or
multiple facilities, or whether a single location where human drugs are
compounded can be subdivided into separate operations compounding under
different standards. FDA is issuing this draft guidance to answer these
questions.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the meaning of
the term ``facility at one geographic location or address'' under
section 503B of the FD&C Act. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

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

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08878 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 70 (Friday, April 10, 2020)]
[Notices]
[Pages 20309-20312]
[FR Doc No: 2020-07548]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88568; File No. SR-NASDAQ-2020-014]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to the First Trust California Municipal High Income ETF and
the First Trust Municipal High Income ETF

April 6, 2020.
    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 March 27, 2020, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes a rule change relating to the First Trust
California Municipal High Income ETF (the ``California Fund'') and the
First Trust Municipal High Income ETF (the ``Municipal Fund''), each a
series of First Trust Exchange-Traded Fund III (the ``Trust''), the
shares of which have been approved by the Commission for listing and
trading under Nasdaq Rule 5735 (``Managed Fund Shares''). The
California Fund and the Municipal Fund are each, a ``Fund'' and
collectively, the ``Funds.'' The shares of the Funds are collectively
referred to herein as the ``Shares.''
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.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 Commission has approved the listing and trading of Shares under
Nasdaq Rule 5735, which governs the listing and trading of Managed Fund
Shares on the Exchange.\3\ The Exchange

believes the proposed rule change reflects no significant issues not
previously addressed in the Prior Releases.
---------------------------------------------------------------------------

    \3\ 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 Commission previously approved
the listing and trading of the Shares of each Fund. With respect to
the California Fund, see Securities Exchange Act Release No. 80745
(May 23, 2017), 82 FR 24755 (May 30, 2017) (SR-NASDAQ-2017-033)
(Order Granting Approval of a Proposed Rule Change, as Modified by
Amendments No. 1 and 2, To List and Trade Shares of the First Trust
California Municipal High Income ETF) (the ``California 2017
Release''). With respect to the Municipal Fund, see Securities
Exchange Act Release No. 78913 (September 23, 2016), 81 FR 69109
(October 5, 2016) (SR-NASDAQ-2016-002) (Notice of Filing of
Amendment No. 3, and Order Granting Accelerated Approval of Proposed
Rule Change, as Modified by Amendment No. 3, To List and Trade
Shares of the First Trust Municipal High Income ETF of First Trust
Exchange-Traded Fund III) (the ``Municipal 2016 Release'').
Subsequently, the Commission approved a proposed rule change
relating to the Municipal Fund, the primary purpose of which was to
modify certain representations included in the Municipal 2016
Release. See Securities Exchange Act Release No. 81265 (July 31,
2017), 82 FR 36460 (August 4, 2017) (SR-NASDAQ-2017-038) (Notice of
Filing of Amendment No. 1, and Order Granting Accelerated Approval
of a Proposed Rule Change, as Modified by Amendments No. 1 and 2,
Relating to the First Trust Municipal High Income ETF) (the
``Municipal 2017 Release''). The Municipal 2016 Release, together
with the Municipal 2017 Release, are referred to collectively as the
``Municipal 2016/2017 Release.'' In 2019, the Commission approved a
proposed rule change relating to each Fund, the primary purpose of
which was to modify certain representations included in the
Municipal 2017 Release and the California 2017 Release. See
Securities Exchange Act Release No. 85666 (April 16, 2019), 84 FR
16739 (April 22, 2019) (SR-NASDAQ-2019-021) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change to the First Trust
California Municipal High Income ETF and the First Trust Municipal
High Income ETF) (the ``2019 Release''). The Municipal 2016/2017
Release, together with the 2019 Release, are referred to
collectively as the ``Municipal Prior Release.'' The California 2017
Release, together with the 2019 Release, are referred to
collectively as the ``California Prior Release.'' The California
Prior Release and the Municipal Prior Release are each, a ``Prior
Release'' and collectively, the ``Prior Releases.''
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    Each Fund is an actively-managed exchange-traded fund (``ETF'').
The Shares of each Fund are offered by the Trust, which was established
as a Massachusetts business trust on January 9, 2008. The Trust, which
is registered with the Commission as an investment company under the
Investment Company Act of 1940 (the ``1940 Act''), has, with respect to
each Fund, filed a post-effective amendment to its registration
statement on Form N-1A (``Registration Statement'') with the
Commission.\4\ Each Fund is a series of the Trust.
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    \4\ See, with respect to each Fund, Post-Effective Amendment No.
103 to Registration Statement on Form N-1A for the Trust, dated
November 27, 2019 (File Nos. 333-176976 and 811-22245). The
descriptions of the Funds and the Shares contained herein are based,
in part, on information in the Registration Statement. First Trust
Advisors L.P. (the ``Adviser'') represents that the Adviser will not
implement the changes described herein until the instant proposed
rule change is operative.
---------------------------------------------------------------------------

    As described in more detail below, the purpose of this proposed
rule change is to delete a representation that was set forth (a) with
respect to the California Fund, the California 2017 Release (and not
subsequently modified in the 2019 Release) and (b) with respect to the
Municipal Fund, the Municipal 2016 Release (and not subsequently
modified in the Municipal 2017 Release or the 2019 Release) relating to
weighted average maturity (i.e., the ``Average Maturity
Representation,'' as defined below) in order to provide the Adviser
with additional flexibility in constructing and managing the applicable
Fund's portfolio. The Exchange believes that the proposed modification
would provide each Fund with greater ability to select ``Municipal
Securities'' (as defined below) that would support such Fund's
investment goals and should not raise concerns. In this regard, the
Exchange notes that the Commission has previously approved other
proposed rule changes involving ETFs investing in municipal securities
that did not include a representation comparable to the Average
Maturity Representation.\5\ In addition, the generic listing standards
for actively-managed ETFs that invest in fixed income securities (the
``Fixed Income GLS'') do not impose a requirement relating to the
average maturity of securities in a portfolio.\6\ Further, the 2019
Release includes certain representations that relate to each Fund's
diversity, liquidity and mitigation of risks associated with
manipulation that would not be affected by the proposed change.\7\
---------------------------------------------------------------------------

    \5\ See, e.g., Securities Exchange Act Release Nos. 84381
(October 5, 2018), 83 FR 51752 (October 12, 2018) (SR-NYSEArca-2018-
72) (Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Listing and Trading of Shares of the First Trust
Ultra Short Duration Municipal ETF Under NYSE Arca Rule 8.600-E);
84379 (October 5, 2018), 83 FR 51724 (October 12, 2018) (SR-
NYSEArca-2018-73) (Notice of Filing and Immediate Effectiveness of
Proposed Rule Change Relating to Listing and Trading of Shares of
the First Trust Short Duration Managed Municipal ETF Under NYSE Arca
Rule 8.600-E); 83982 (August 29, 2018), 83 FR 45168 (September 5,
2018) (SR-NYSEArca-2018-62) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change Relating to Listing and
Trading of Shares of the American Century Diversified Municipal Bond
ETF Under NYSE Arca Rule 8.600-E); and 71913 (April 9, 2014), 79 FR
21333 (April 15, 2014) (SR-NASDAQ-2014-019) (Notice of Filing of
Amendment No. 1 and Order Granting Accelerated Approval of Proposed
Rule Change, as Modified by Amendment No. 1 Thereto, Relating to the
Listing and Trading of the Shares of the First Trust Managed
Municipal Fund of First Trust Exchange-Traded Fund III)
(collectively, the ``Other Municipal Approvals'').
    \6\ See Nasdaq Rule 5735(b)(1)(B).
    \7\ See infra footnote 12 and accompanying text.
---------------------------------------------------------------------------

    As described in the California Prior Release,\8\ the primary
investment objective of the California Fund is to seek to provide
current income that is exempt from regular federal income taxes and
California income taxes, and its secondary objective is long-term
capital appreciation. As described in the Municipal Prior Release,\9\
the primary investment objective of the Municipal Fund is to generate
current income that is exempt from regular federal income taxes, and
its secondary objective is long-term capital appreciation. Under normal
market conditions, each Fund seeks to achieve its investment objectives
by investing at least 80% of its net assets (including investment
borrowings) in municipal debt securities (referred to as ``Municipal
Securities'') that pay interest that is exempt from regular federal
income taxes (and, in the case of the California Fund, California
income taxes).
---------------------------------------------------------------------------

    \8\ See the California 2017 Release and the 2019 Release.
    \9\ See the Municipal 2016 Release and the 2019 Release.
---------------------------------------------------------------------------

    As discussed in the Prior Release for each Fund,\10\ the applicable
Fund may invest in Municipal Securities of any maturity. However, each
Prior Release \11\ also states that under normal market conditions,
except for the initial invest-up period and periods of high cash
inflows or outflows, the weighted average maturity of the applicable
Fund will be less than or equal to 14 years (the ``Average Maturity
Representation''). With respect to each Fund, the Average Maturity
Representation has not previously been modified.
---------------------------------------------------------------------------

    \10\ See, with respect to the California Fund, the California
2017 Release and with respect to the Municipal Fund, the Municipal
2016 Release.
    \11\ See, with respect to the California Fund, the California
2017 Release and with respect to the Municipal Fund, the Municipal
2016 Release.
---------------------------------------------------------------------------

    In order to provide each Fund with greater ability to select
Municipal Securities that would support such Fund's investment goals,
the Exchange is proposing that, going forward, the Average Maturity
Representation be deleted. The Exchange does not believe that this
change should raise concerns. As noted above, the Other Municipal
Approvals did not include a similar representation and the Fixed Income
GLS do not impose a comparable requirement. Further, the Exchange notes
that the 2019 Release includes certain representations that relate to
each Fund's diversity, liquidity and mitigation of risks associated
with manipulation that would not be affected by the proposed
change.\12\
---------------------------------------------------------------------------

    \12\ As noted in the 2019 Release, under normal market
conditions, except for the initial invest-up period and periods of
high cash inflows or outflows, (a) for each Fund, no component fixed
income security (excluding specified U.S. government securities)
would represent more than 15% of such Fund's net assets, and the
five most heavily weighted component fixed income securities in each
Fund's portfolio (excluding U.S. government securities) would not,
in the aggregate, account for more than 25% of such Fund's net
assets; (b) each Fund's portfolio of Municipal Securities would
continue to be diversified among a minimum of 30 non-affiliated
issuers; (c) component securities that in the aggregate account for
at least 90% of the weight of each Fund's portfolio of Municipal
Securities would continue to be exempted securities as defined in
Section 3(a)(12) of the Act; and (d) each Fund's investments in
Municipal Securities would continue to provide exposure (based on
dollar amount invested) to at least 10 different industries (with no
more than 25% of the value of such Fund's net assets comprised of
Municipal Securities that provide exposure to any single industry).
In addition, each Fund's investments in illiquid assets (calculated
at the time of investment), including Rule 144A securities deemed
illiquid by the Adviser, would continue to be limited to 15% of such
Fund's net assets and, subject to certain exceptions, each Fund
would not invest 25% or more of the value of its total assets in
securities of issuers in any one industry. Further, with respect to
the Municipal Fund, under normal market conditions, except for the
initial invest-up period and periods of high cash inflows or
outflows, such Fund's investments in Municipal Securities would
continue to provide exposure (based on dollar amount invested) to at
least 15 different states (with no more than 30% of the value of
such Fund's net assets comprised of Municipal Securities that
provide exposure to any single state). The foregoing representations
set forth in this footnote 12 are referred to collectively as the
``2019 Representations.''

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

Continued Listing Representations
    For each Fund, all statements and representations made in this
filing regarding (a) the description of the portfolio or reference
assets, (b) limitations on portfolio holdings or reference assets, (c)
dissemination and availability of the reference asset or intraday
indicative values, or (d) the applicability of Exchange listing rules
shall constitute continued listing requirements for listing the
applicable Shares on the Exchange. In addition, the issuer has
represented to the Exchange that it will advise the Exchange of any
failure by a Fund to comply with the continued listing requirements,
and, pursuant to its obligations under Section 19(g)(1) of the Act, the
Exchange will monitor for compliance with the continued listing
requirements. If a Fund is not in compliance with the applicable
listing requirements, the Exchange will commence delisting procedures
with respect to such Fund under the Nasdaq 5800 Series.
    The Adviser represents that there would be no change to either
Fund's investment objectives. Except as provided herein, with respect
to each Fund, all currently effective representations (i.e.,
representations that have not previously been modified or superseded)
made in the applicable Prior Releases (collectively, the ``Prior
Release Representations'') would remain unchanged, including but not
limited to such currently effective representations regarding (a) the
description of the portfolio or reference assets, (b) limitations on
portfolio holdings or reference assets, (c) dissemination and
availability of the reference asset or intraday indicative values, or
(d) the applicability of Exchange listing rules.\13\ Except for the
generic listing provisions of Nasdaq Rule 5735(b)(1) (the ``generic
listing standards''),\14\ the Funds and the Shares would continue to
comply with the requirements applicable to Managed Fund Shares under
Nasdaq Rule 5735.
---------------------------------------------------------------------------

    \13\ The Exchange notes, however, that certain statements in the
Prior Releases include references that are no longer current and has
not specifically updated such statements in this filing. For
example, the Municipal 2016 Release includes references to Form N-
SAR (under the heading ``Availability of Information'') and a
``minimum price variation'' provision in Nasdaq Rule 5735(b)(3)
(under the heading ``Trading Rules''), neither of which is currently
in effect.
    \14\ With respect to the Municipal Fund, the generic listing
standards were specifically discussed in the Municipal 2017 Release
and the 2019 Release. With respect to the California Fund, the
generic listing standards were specifically discussed in the
California 2017 Release and the 2019 Release. The Exchange notes,
however, that references to Nasdaq Rule 5735(b)(1)(B)(v) in the
Municipal 2017 Release and the California 2017 Release did not
reflect a change to such rule that was effected in 2019. See
Securities Exchange Release No. 86399 (July 17, 2019), 84 FR 35446
(July 23, 2019) (SR-NASDAQ-2019-054).
---------------------------------------------------------------------------

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 purpose of this proposed rule change is to delete the Average
Maturity Representation in order to provide the Adviser with additional
flexibility in constructing and managing each Fund's portfolio. The
Exchange believes that the proposed modification would provide each
Fund with greater ability to select Municipal Securities that would
support such Fund's investment goals. Except as provided herein, with
respect to each Fund, all currently effective Prior Release
Representations would remain unchanged. Except for the generic listing
standards,\15\ the Funds and the Shares would continue to comply with
the requirements applicable to Managed Fund Shares under Nasdaq Rule
5735.
---------------------------------------------------------------------------

    \15\ See supra note 14.
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares would continue to be listed and traded on the Exchange pursuant
to Nasdaq Rule 5735. The Exchange also notes the continued listing
representations set forth above. The Exchange represents that trading
in the Shares would continue to 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.
    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 deletion of the Average Maturity Representation is intended to
provide each Fund with greater ability to select from Municipal
Securities that would support such Fund's investment goals. The
Exchange notes that the 2019 Representations would not be affected by
the proposed modification. Additionally, the Exchange notes that the
Other Municipal Approvals did not include a representation similar to
the Average Maturity Representation and the Fixed Income GLS do not
impose a comparable requirement.
    In addition, a large amount of information would continue to be
publicly available regarding the Funds and the Shares, thereby
promoting market transparency. For example, the Intraday Indicative
Value (as defined in Nasdaq Rule 5735(c)(3)), available on the Nasdaq
Information LLC proprietary index data service, would continue to be
widely disseminated by one or more major market data vendors and
broadly displayed 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, each Fund would continue
to disclose on its website the Disclosed Portfolio (as defined in
Nasdaq Rule 5735(c)(2)) that will form the basis for such Fund's
calculation of net asset value (``NAV'') at the end of the business
day.
    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 the additional flexibility to be afforded to
the Adviser under the proposed rule change is intended to enhance each
Fund's ability to meet its investment goals, to the benefit of
investors. In addition, NAV per Share would continue to be calculated
daily and each Fund's Disclosed Portfolio would continue to be made
available to all

market participants at the same time. Further, investors would continue
to have ready access to information regarding each 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 would provide the Adviser with additional
flexibility in managing the Funds, thereby helping each Fund to achieve
its investment goals. As such, it is expected that each Fund may become
a more attractive investment product in the marketplace and, therefore,
that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.

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 \16\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\17\
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    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 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 necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2020-014 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-NASDAQ-2020-014. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2020-014 and should be submitted
on or before May 1, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-07548 Filed 4-9-20; 8:45 am]
 BILLING CODE 8011-01-P