[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Page 37953]
[FR Doc No: 2020-13594]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-0813]

Determination That TENEX (Guanfacine Hydrochloride) Tablets, 1
Milligram, 2 Milligrams, and 3 Milligrams, Was Not Withdrawn From Sale
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that TENEX (guanfacine hydrochloride) tablets, 1 milligram
(mg), 2 mg, and 3 mg, was not withdrawn from sale for reasons of safety
or effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Jessica Tierney, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-9120<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 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 known generally as the ``Orange
Book.'' Under FDA regulations, drugs are 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).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, is
the subject of NDA 019032, held by Promius Pharma LLC, and initially
approved on October 27, 1996. TENEX is indicated in the management of
hypertension.
    TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, is
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book. Unichem Pharmaceuticals (USA), Inc. submitted a
citizen petition dated February 13, 2020 (Docket No. FDA-2020-P-0813),
under 21 CFR 10.30, requesting that the Agency determine whether TENEX
(guanfacine hydrochloride) tablets, 1 mg and 2 mg, was withdrawn from
sale for reasons of safety or effectiveness. Although the citizen
petition did not address the 3 mg strength, that strength has also been
discontinued. On our own initiative, we have also determined whether
that strength was withdrawn for safety or effectiveness reasons.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that TENEX (guanfacine hydrochloride) tablets, 1
mg, 2 mg, and 3 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that TENEX (guanfacine hydrochloride) tablets, 1
mg, 2 mg, and 3 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of TENEX (guanfacine hydrochloride) tablets,
1 mg, 2 mg, and 3 mg, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have found no information that would indicate that this drug product
was withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list TENEX (guanfacine
hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: June 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13594 Filed 6-23-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 230 (Thursday, December 1, 2022)]
[Notices]
[Page 73803]
[FR Doc No: 2022-26111]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Reopening of Comment Period for Proposed Voluntary Agreement at
Statue of Liberty National Monument and Governors Island National
Monument

AGENCY: Federal Aviation Administration (FAA), Transportation.

ACTION: Notice; reopening of comment period.

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SUMMARY: The FAA, in cooperation with the National Park Service (NPS),
announces the reopening of the public comment period for an additional
30 days on the proposed voluntary agreement for Statue of Liberty
National Monument and Governors Island National Monument. On October
21, 2022 the agencies announced a 30-day comment period ending November
21, 2022. Comments previously submitted need not be resubmitted.

DATES: The comment period for the notice published at 87 FR 64130 on
October 21, 2022 is reopened. Comments must be received on or before 30
days from this notice.

ADDRESSES: Comments will be received on the NPS Planning, Environment
and Public Comment System (PEPC) website. The PEPC website for the
Parks is: https://parkplanning.nps.gov/NYHarborAirTours.

FOR FURTHER INFORMATION CONTACT: Sandra Fox, Special Programs Staff,
Federal Aviation Administration, Western-Pacific Region Headquarters,
777 S. Aviation Boulevard, Suite 150, El Segundo, CA 90245, telephone:
(424) 405-7016, email: [email protected].

SUPPLEMENTARY INFORMATION: The FAA and NPS issued the proposed
voluntary agreement for Statue of Liberty National Monument and
Governors Island National Monument pursuant to the National Parks Air
Tour Management Act of 2000 on October 21, 2022 and announced a 30-day
comment period. A voluntary agreement manages commercial air tour
operations over a national park by establishing conditions for the
conduct of the commercial air tour operations that help protect park
resources and visitor experience without compromising aviation safety
or the air traffic control system. During the comment period, the
agencies received requests to extend the public comment. As the
previous comment period has closed, the agencies are now reopening
comment for an additional 30 days.
    Written comments on the proposed voluntary agreement can be
submitted via PEPC. The voluntary agreement document is also available
at the PEPC site link included in the ADDRESSES section above. Comments
will not be accepted by fax, email, or any other way than those
specified above. All written comments become part of the official
record. Before including your address, phone number, email address, or
other personal identifying information in your comment, you should be
aware that your entire comment--including your personal identifying
information--may be made publicly available at any time. While you can
ask us in your comment to withhold your personal identifying
information from public review, we cannot guarantee that we will be
able to do so.

    Issued in El Segundo, CA, on November 25, 2022.
Sandra Fox,
Special Programs Staff Western-Pacific Region.
[FR Doc. 2022-26111 Filed 11-30-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Rules and Regulations]
[Pages 43400-43403]
[FR Doc No: 2022-15485]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0508; Project Identifier MCAI-2021-01120-T;
Amendment 39-22118; AD 2022-14-13]
RIN 2120-AA64

Airworthiness Directives; BAE Systems (Operations) Limited
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2015-07-
05, which applied to all BAE Systems (Operations) Limited Model BAe 146
series airplanes and Model Avro 146-RJ series airplanes. AD 2015-07-05
required repetitive external eddy current inspections on the aft skin
lap joints of the rear fuselage for cracking, corrosion, and other
defects, and repair if necessary. This AD continues to require the
actions in AD 2015-07-05, at certain revised compliance times, and also
requires repetitive low frequency eddy current (LFEC) inspections for
any cracking, corrosion, and other defects in the aft skin lap joints
of the rear fuselage and in the fuselage skin panels, and repair if
necessary. This AD was prompted by a report of a pressurization problem
on an airplane during climb-out; a subsequent investigation showed a
crack in the fuselage skin; and that repetitive LFEC inspections in the
rear fuselage aft skin lap joints and in the fuselage skin panels are
necessary. Certain compliance times must also be revised. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective August 25, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 25,
2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of May
19, 2015 (80 FR 19871, April 14, 2015).

ADDRESSES: For service information identified in this final rule,
contact BAE Systems (Operations) Limited, Customer Information
Department, Prestwick International Airport, Ayrshire, KA9 2RW,
Scotland, United Kingdom; telephone +44 1292 675207; fax +44 1292
675704; email [email protected]; internet https://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may view
this referenced service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0508.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0508; 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 final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Civil Aviation Authority (CAA), which is the aviation authority
for the United Kingdom, has issued CAA AD G-2021-0008, dated September
8, 2021 (also referred to as the Mandatory Continuing Airworthiness
Information, or the MCAI), to correct an unsafe condition for all BAE
Systems (Operations) Limited Model BAe 146 series airplanes and Model
Avro 146-RJ series airplanes. You may examine the MCAI in the AD docket
on the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0508.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2015-07-05, Amendment 39-18133 (80 FR
19871, April 14, 2015) (AD 2015-07-05). AD 2015-07-05 applied to all
BAE Systems (Operations) Limited Model BAe 146 series airplanes and
Model Avro 146-RJ series airplanes. The NPRM published in the Federal
Register on May 6, 2022 (87 FR 27037). The NPRM was prompted by a
report of a pressurization problem on an airplane during climb-out; a
subsequent investigation showed a crack in the fuselage skin; and that
repetitive LFEC inspections in the rear fuselage aft skin lap joints
and in the fuselage skin panels are necessary. Certain compliance times
must also be revised. The NPRM proposed to continue the actions
required in AD 2015-07-05, at certain revised compliance times, and
also require repetitive LFEC inspections for any cracking, corrosion,
and other defects in the aft skin lap joints of the rear fuselage and
in the fuselage skin panels, and repair if necessary. The FAA is
issuing this AD to address cracking, corrosion, and other defects on
the rear fuselage aft skin joints and frames and in the fuselage
panels, which could affect the structural integrity of the airplane.
See the MCAI for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
requires adopting this AD as proposed. Except for minor editorial
changes, this AD is adopted as proposed in the NPRM. None of the
changes will increase the economic burden on any operator. Accordingly,
the FAA is issuing this AD to address the unsafe condition on these
products.

Related Service Information Under 1 CFR Part 51

    BAE Systems (Operations) Limited has issued Inspection Service
Bulletin 53-239, Revision 5, including Appendix 2, Revision 5, and
Appendix 3, Revision 1, all dated March 2, 2017. This service
information describes procedures for repetitive external eddy current
and LFEC inspections on the aft skin lap joints of the rear fuselage
and in the fuselage skin panels, for any cracking, corrosion, and other
defects (e.g., surface damage and spot displacement); and repair if
necessary.
    This AD also requires BAE Systems (Operations) Limited Inspection
Service Bulletin 53-239, including Appendix 2, Revision 3, dated May 7,
2014, which the Director of the Federal Register approved for
incorporation by reference as of May 19, 2015 (80 FR 19871, April 14,
2015).
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 20 airplanes of U.S.
registry.
    The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                    Parts
            Action                  Labor cost       cost       Cost per  product       Cost on U.S.  operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD        8 work-hours x          $0  $680 per inspection cycle  $13,600 per inspection
 2015[dash]07[dash]05.           $85 per hour =                                         cycle.
                                 $680 per
                                 inspection cycle.
New proposed actions..........  5 work-hours x           0  $425.....................  $8,500 per inspection
                                 $85 per hour =                                         cycle.
                                 $425.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the repairs specified in this AD.

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.
    The FAA is 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.

Regulatory Findings

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) 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 Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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:
0
a. Removing Airworthiness Directive (AD) 2015-07-05, Amendment 39-18133
(80 FR 19871, April 14, 2015); and
0
b. Adding the following new AD:

2022-14-13 BAE Systems (Operations) Limited: Amendment 39-22118;
Docket No. FAA-2022-0508; Project Identifier MCAI-2021-01120-T.

(a) Effective Date

    This airworthiness directive (AD) is effective August 25, 2022.

(b) Affected Airworthiness Directives (ADs)

    This AD replaces AD 2015-07-05, Amendment 39-18133 (80 FR 19871,
April 14, 2015) (AD 2015-07-05).

(c) Applicability

    This AD applies to all BAE Systems (Operations) Limited Model
BAe 146-100A, -200A, and -300A airplanes; and Model Avro 146-RJ70A,
146-RJ85A, and 146-RJ100A airplanes; certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by a report of a pressurization problem on
an airplane during climb-out; a subsequent investigation showed a
crack in the fuselage skin; and that repetitive low frequency eddy
current (LFEC) inspections in the rear fuselage aft skin lap joints
and in the fuselage skin panels are necessary. Certain compliance
times must also be revised. The FAA is issuing this AD to address
cracking, corrosion, and other defects on the rear fuselage aft skin
joints and frames and in the fuselage panels, which could affect the
structural integrity of the airplane.

(f) Compliance

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

(g) Retained Repetitive Inspections, With New Service Information

    This paragraph restates the requirements of paragraph (g) of AD
2015-07-05, with new service information.
    (1) Within the compliance times specified in paragraphs
(g)(1)(i) and (ii) of this AD, as applicable: Do an external eddy
current inspection on the aft skin lap joints of the rear fuselage
for cracking, corrosion, and other defects (i.e., surface damage and
spot displacement); in accordance with paragraph 2.C. of the
Accomplishment Instructions of BAE Systems (Operations) Limited
Inspection Service Bulletin 53-239, including Appendix 2, Revision
3, dated May 7, 2014; or paragraph 2. of the Accomplishment
Instructions of BAE Systems (Operations) Limited Inspection Service
Bulletin 53-239, Revision 5, including Appendix 2, Revision 5, and
Appendix 3, Revision 1, all dated March 2, 2017. As of the effective
date of this AD, use BAE Systems (Operations) Limited Inspection
Service Bulletin 53-239, Revision 5, including Appendix 2, Revision
5, and Appendix 3, Revision 1, all dated March 2, 2017, only.
    (i) For any airplane which has accumulated 9,000 flight cycles
or more since the airplane's first flight as of May 19, 2015 (the
effective date of AD 2015-07-05): Do the inspection within 1,000
flight cycles or 6 months after May 19, 2015, whichever occurs
first.
    (ii) For any airplane which has accumulated less than 9,000
flight cycles since the airplane's first flight as of May 19, 2015
(the effective date of AD 2015-07-05): Do the inspection before
accumulating 10,000 flight cycles since the airplane's first flight.
    (2) Repeat the inspection required by paragraph (g)(1) of this
AD thereafter at intervals not to exceed the times specified in
paragraphs (g)(2)(i) and (ii) of this AD, as applicable to the
airplane's modification status.
    (i) For Model BAe 146 series airplanes and Model Avro 146-RJ
series airplanes post modification HCM50070E, or post modification
HCM50070F, or post modification HCM50259A, repeat the inspection at
intervals not to exceed 4,000 flight cycles.
    (ii) For Model BAe 146 series airplanes and Model Avro 146-RJ
series airplanes premodification HCM50070E, and premodification
HCM50070F, and premodification HCM50259A, repeat the inspection at
intervals not to exceed 7,500 flight cycles.

(h) Retained Corrective Action With Revised Repair Approval

    This paragraph restates the requirements of paragraph (h) of AD
2015-07-05, with revised repair approval. If any cracking,
corrosion, or other defect is found during any inspection required
by AD 2015-07-05: Before further flight as of May 19, 2015 (the
effective date of AD 2015-07-05), repair using a method approved by
the Manager, Large Aircraft Section, International Validation
Branch, FAA; or the European Aviation Safety Agency (EASA); or BAE
Systems (Operations) Limited's EASA Design Organization Approval
(DOA). If approved by the DOA, the approval must include the DOA-
authorized signature. Accomplishment of the repair does not
constitute a terminating action for the inspections required by
paragraph (g) of this AD. As of the effective date of this AD,
repair approvals must be obtained through the Manager, Large
Aircraft Section, International Validation Branch, FAA; or the Civil
Aviation Authority of the United Kingdom (UK CAA); or BAE Systems
(Operations) Limited's UK CAA DOA.

(i) New Requirement of This AD: Repetitive LFEC Inspections

    After the effective date of this AD, at the applicable times
specified in paragraph 1.D. ``Compliance'' of BAE Systems
(Operations) Limited Inspection Service Bulletin 53-239, Revision 5,
including Appendix 2, Revision 5, and Appendix 3, Revision 1, all
dated March 2, 2017: Do an LFEC inspection for any cracking,
corrosion, and other defects in the aft skin lap joints of the rear
fuselage and in the fuselage skin panels, in accordance with
paragraph ``1. Procedure'' of Appendix 2 and Appendix 3 of BAE
Systems (Operations) Limited Inspection Service Bulletin 53-239,
Revision 5, including Appendix 2, Revision 5, and Appendix 3,
Revision 1, all dated March 2, 2017. Repeat the LFEC inspection
thereafter at intervals not to exceed the times specified in
paragraph 1.D. ``Compliance'' of BAE

Systems (Operations) Limited Inspection Service Bulletin 53-239,
Revision 5, including Appendix 2, Revision 5, and Appendix 3,
Revision 1, all dated March 2, 2017.

(j) New Requirement of This AD: Corrective Action

    If any cracking, corrosion, or other defect is found during any
inspection required by this AD: Before further flight, repair using
a method approved by the Manager, Large Aircraft Section,
International Validation Branch, FAA; or the UK CAA; or BAE Systems
(Operations) Limited's UK CAA DOA. If approved by the DOA, the
approval must include the DOA-authorized signature. Accomplishment
of the repair does not constitute a terminating action for the
inspections required by paragraph (i) of this AD.

(k) Credit for Previous Actions

    This paragraph provides credit for the following actions
required by this AD.
    (1) This paragraph provides credit for the initial inspection
and corrective action on stringer 30, left hand (LH) and right hand
(RH), as required by paragraph (g) of this AD, if those actions were
performed before May 19, 2015 (the effective date of AD 2015-07-05),
using BAE Systems (Operations) Limited Inspection Service Bulletin
53-239, dated June 13, 2012, which is not incorporated by reference
in this AD.
    (2) This paragraph provides credit for the initial inspection
and corrective action, as required by paragraph (g) of this AD, if
those actions were performed before May 19, 2015 (the effective date
of AD 2015-07-05), using BAE Systems (Operations) Limited Inspection
Service Bulletin 53-239, Revision 1, dated June 18, 2013, which is
not incorporated by reference in this AD.
    (3) This paragraph provides credit for the initial inspection
and corrective action, as required by paragraph (g) of this AD, if
those actions were performed before May 19, 2015 (the effective date
of AD 2015-07-05), using BAE Systems (Operations) Limited Inspection
Service Bulletin 53-239, Revision 2, dated July 15, 2013, which is
not incorporated by reference in this AD.
    (4) This paragraph provides credit for the initial inspection
and corrective action, as required by paragraph (g) of this AD, if
those actions were performed before May 19, 2015 (the effective date
of AD 2015-07-05), using BAE Systems (Operations) Limited Inspection
Service Bulletin 53-239, including Appendix 2, Revision 3, dated May
7, 2014, which was incorporated by reference in AD 2015-07-05,
Amendment 39-18133 (80 FR 19871, April 14, 2015).
    (5) This paragraph provides credit for the actions required by
paragraph (i) of this AD, if those actions were performed before the
effective date of this AD using BAE Systems (Operations) Limited
Inspection Service Bulletin 53-239, Revision 4, including Appendix
2, Revision 4, and Appendix 3, Initial issue, dated March 31, 2016.

(l) No Reporting Requirement

    Although BAE Systems (Operations) Limited Inspection Service
Bulletin 53-239, Revision 5, including Appendix 2, Revision 5, and
Appendix 3, Revision 1, all dated March 2, 2017, specifies to report
inspection findings, this AD does not require any report.

(m) Other FAA AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (n)(2) of
this AD. Information may be emailed to: [email protected].
    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (ii) AMOCs for the repetitive external eddy current inspections
approved previously for AD 2015-07-05 are approved as AMOCs for the
corresponding actions in paragraph (g) of this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain instructions from
a manufacturer, the instructions must be accomplished using a method
approved by the Manager, Large Aircraft Section, International
Validation Branch, FAA; or the UK CAA; or BAE Systems (Operations)
Limited's UK CAA DOA. If approved by the DOA, the approval must
include the DOA-authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) CAA AD G-2021-0008, dated September 8, 2021, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2022-0508.
    (2) For more information about this AD, contact Todd Thompson,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
206-231-3228; email [email protected].
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(5) and (6) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
August 25, 2022.
    (i) BAE Systems (Operations) Limited Inspection Service Bulletin
53-239, Revision 5, including Appendix 2, Revision 5, and Appendix
3, Revision 1, all dated March 2, 2017.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
May 19, 2015 (80 FR 19871, April 14, 2015).
    (i) BAE Systems (Operations) Limited Inspection Service Bulletin
53-239, including Appendix 2, Revision 3, dated May 7, 2014.
    (ii) [Reserved]
    (5) For service information identified in this AD, contact BAE
Systems (Operations) Limited, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
[email protected]; internet https://www.baesystems.com/Businesses/RegionalAircraft/index.htm.
    (6) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 30, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-15485 Filed 7-20-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27302-27307]
[FR Doc No: 2017-12260]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80885; File No. SR-NYSEArca-2017-44]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of a Proposed Rule Change, as Modified by Amendment Nos. 1 and
2, To List and Trade of Shares of the IQ Municipal Insured ETF, IQ
Municipal Short Duration ETF, and IQ Municipal Intermediate ETF Under
NYSE Arca Equities Rule 8.600

June 8, 2017.

I. Introduction

    On April 20, 2017, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares (``Shares'') of the IQ Municipal Insured ETF, IQ Municipal Short
Duration ETF, and IQ Municipal Intermediate ETF (each a ``Fund,'' and
collectively, the ``Funds'') under NYSE Arca Equities Rule 8.600. The
Commission published notice of the proposed rule change in the Federal
Register on May 9, 2017.\3\ On May 9, 2017, the Exchange filed
Amendment No. 1 to the proposed rule change and on May 31, 2017, the
Exchange filed Amendment No. 2 to the proposed rule change.\4\ The
Commission received no

comments on the proposed rule change. The Commission is approving the
proposed rule change, as modified by Amendment Nos. 1 and 2 thereto.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 80584 (May 3, 2017),
82 FR 21573.
    \4\ In Amendment No. 1, which replaced the original filing in
its entirety, the Exchange: (1) Clarified that each of the Adviser
(as defined herein) and Subadviser (as defined herein) is not a
registered broker-dealer but each is affiliated with a broker-dealer
and each will maintain a ``fire wall'' with respect to such broker-
dealer affiliate regarding access to information concerning the
composition of and/or changes to each Fund's portfolio; (2)
clarified that cash creations and redemptions will be the default
mechanism for creation and redemption of Shares, and provided
additional information relating to creation and redemption of Shares
when a Fund utilizes in-kind creations and redemptions; (3)
represented that upon the commencement of operations of a Fund, a
copy of the Funds' prospectus will be available on the Funds' Web
site in a form that may be downloaded; (4) provided additional
information regarding publicly available information relating to the
Shares and each Fund's underlying investments; (5) clarified that
less than 75% of the weight of a Fund's portfolio may consist of
components with $100 million or more minimum original principal
amount outstanding; (6) represented that trading in the Shares of
the Funds will be subject to NYSE Arca Equities Rule 8.600(d)(2)(D),
which sets forth circumstances under which Shares of the Funds may
be halted; and (7) made other non-substantive, technical amendments.
Amendment No. 1 is available at: https://www.sec.gov/comments/sr-nysearca-2017-44/nysearca201744-1745942-151492.pdf. In Amendment No.
2, which replaced Amendment No. 1 in its entirety, the Exchange: (1)
Clarified that each of the Adviser and Subadviser has implemented
and will maintain a ``fire wall'' with respect to its broker-dealer
affiliate regarding access to information concerning the composition
of and/or changes to each Fund's portfolio; (2) represented that the
quantitative information on the Funds' Web site relating to the
Shares and relating to the underlying portfolio securities and other
assets held by the Funds will be publicly available at no charge;
(3) represented that trade price and other information relating to
Municipal Bonds (as defined below) is available through the
Municipal Securities Rulemaking Board's Electronic Municipal Market
Access (``EMMA'') system; and (4) made other clarifying and
technical amendments. Amendment No. 2 is available at: https://www.sec.gov/comments/sr-nysearca-2017-44/nysearca201744-1780627-152846.pdf. Because Amendment Nos. 1 and 2 do not materially alter
the substance of the proposed rule change or raise unique or novel
regulatory issues, Amendment Nos. 1 and 2 are not subject to notice
and comment.
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II. The Exchange's Description of the Proposal

    The Exchange proposes to list and trade the Shares under NYSE Arca
Equities Rule 8.600, which governs the listing and trading of Managed
Fund Shares on the Exchange. The Shares will be offered by the IndexIQ
Active ETF Trust (``Trust''), which is registered with the Commission
as an open-end management investment company.\5\ Each Fund is a series
of the Trust. The investment adviser to each Fund will be IndexIQ
Advisors LLC (``Adviser''), and MacKay Shields LLC will be each Fund's
sub-adviser (``Subadviser'').\6\ ALPS Distributors, Inc. will serve as
the distributor of each Fund's Shares on an agency basis and the Bank
of New York Mellon will serve as each Fund's administrator, custodian,
transfer agent, and securities lending agent (``Administrator'').
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    \5\ According to the Exchange, on February 24, 2017, the Trust
filed with the Commission a registration statement on Form N-1A
under the Securities Act of 1933 and the Investment Company Act of
1940 (``1940 Act'') relating to the Funds (File Nos. 333-183489 and
811-22739) (``Registration Statement''). According to the Exchange,
the Commission has issued an order granting certain exemptive relief
to the Trust under the 1940 Act. See Investment Company Act Release
No. 30198 (September 10, 2012) (File No. 812-13956).
    \6\ According to the Exchange, neither the Adviser nor
Subadviser is a registered broker-dealer; however, each is
affiliated with a broker-dealer. Each of the Adviser and Subadviser
has implemented and will maintain a ``fire wall'' with respect to
such broker-dealer affiliate regarding access to information
concerning the composition of and/or changes to each Fund's
portfolio. In the event (a) the Adviser or Subadviser becomes
registered as a broker-dealer or newly affiliated with a broker-
dealer, or (b) any new adviser or sub-adviser to a Fund is a
registered broker-dealer or becomes affiliated with a broker-dealer,
the applicable adviser or sub-adviser will implement and maintain a
fire wall with respect to its relevant personnel or broker-dealer
affiliate regarding access to information concerning the composition
and/or changes to a Fund's portfolio, and will be subject to
procedures designed to prevent the use and dissemination of material
non-public information regarding such portfolio.
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    The Exchange has made the following representations and statements
in describing the Funds and their investment strategies, including each
Fund's portfolio holdings and investment restrictions.\7\
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    \7\ The Commission notes that additional information regarding
the Trust, the Funds, and the Shares, including investment
strategies, risks, creation and redemption procedures, calculation
of net asset value (``NAV''), fees, distributions, and taxes, among
other things, is included in the proposed rule change, as modified
by Amendment Nos. 1 and 2, and the Registration Statement, as
applicable. See Amendment No. 2 and Registration Statement, supra
notes 4 and 5, respectively.
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A. The Exchange's Description of the Principal Investments of the Funds

    According to the Exchange, for purposes of the filing, the term
``Municipal Bonds'' as applied to each of the Funds means the
following:
     Municipal lease obligations (and certificates of
participation in such obligations);
     municipal general obligation bonds (including industrial
development bonds issued pursuant to federal tax law), which are issued
for either project or enterprise financings in which the bond issuer
pledges to the bondholders the revenues generated by the operating
projects financed from the proceeds of the bond issuance;
     limited obligation bonds, which are payable only from the
revenues derived from a particular facility or class of facilities or,
in some cases from the proceeds of a special excise or other specific
revenue source;
     municipal revenue bonds (which are typically secured by
revenues generated by the issuer), including revenue anticipation
notes;
     municipal bond anticipation notes (which are normally
issued to provide interim financial assistance until long-term
financing can be arranged);
     municipal bonds that feature credit enhancements, such as
lines of credit, letters of credit, municipal bond insurance, and
standby bond purchase agreements;
     discount municipal bonds (which may be originally issued
at a discount to par value or sold at market price below par value);
     premium municipal bonds, which are sold at a premium to
par value;
     zero coupon municipal bonds, which are issued at an
original issue discount, with the full value, including accrued
interest, paid at maturity;
     taxable municipal bonds, including Build America Bonds;
     municipal notes;
     municipal cash equivalents;
     private activity bonds (including without limitation
industrial development bonds);
     pre-refunded and escrowed to maturity municipal bonds; and
     securities issued by entities whose underlying assets are
Municipal Bonds (i.e., tender option bond trusts and custodial receipts
trusts and variable rate demand notes that pay interest monthly or
quarterly based on a floating rate that is reset daily or weekly based
on an index of short-term municipal rates).
    For each Fund, the Subadviser's investment process will begin with
an assessment of macro factors that may impact the municipal bond
market, as well as other regulatory, tax, governmental, and technical
factors that may impact the municipal bond market. Following the
assessment of these factors, the Subadviser will develop an investment
strategy to position a Fund among various sectors of the municipal bond
market and different states. The Subadviser then will employ a
fundamental, ``bottom-up'' credit research analysis to select
individual Municipal Bonds.
(i) Principal Investments of the IQ Municipal Insured ETF
    According to the Exchange, the Fund will seek current income exempt
from federal income tax. The Fund, under normal market conditions,\8\
will invest

at least 80% of its assets in Municipal Bonds that are covered by
insurance policies that guarantee the timely payment of principal and
interest. The Fund generally will maintain a dollar-weighted average
duration within plus or minus two years of the dollar-weighted average
duration of the S&P Municipal Bond Insured Index.\9\
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    \8\ The term ``under normal market conditions'' as used herein
includes, but is not limited to, the absence of adverse market,
economic, political or other conditions, including extreme
volatility or trading halts in the fixed income markets or the
financial markets generally; operational issues (e.g., systems
failure) causing dissemination of inaccurate market information; or
force majeure type events such as natural or man-made disaster, act
of God, armed conflict, act of terrorism, riot or labor disruption
or any similar intervening circumstance. On a temporary basis,
including for defensive purposes, during the initial invest-up
period (i.e., the six-week period following the commencement of
trading of Shares on the Exchange) and during periods of high cash
inflows or outflows (i.e., rolling periods of seven calendar days
during which inflows or outflows of cash, in the aggregate, exceed
10% of a Fund's net assets as of the opening of business on the
first day of such periods), a Fund may depart from its principal
investment strategies; for example, it may hold a higher than normal
proportion of its assets in cash. During such periods, a Fund may
not be able to achieve its investment objectives. A Fund may adopt a
defensive strategy when the Adviser believes securities in which a
Fund normally invests have elevated risks due to political or
economic factors and in other extraordinary circumstances.
    \9\ Municipal bonds are issued by or on behalf of the District
of Columbia, states, territories, commonwealths, and possessions of
the United States and their political subdivisions and agencies,
authorities, and instrumentalities. Municipal securities, which may
be issued in various forms, including bonds and notes, are issued to
obtain funds for various public purposes.
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(ii) Principal Investments of the IQ Municipal Short Duration ETF
    According to the Exchange, the Fund will seek current income exempt
from federal income tax. The Fund, under normal market conditions, will
invest at least 80% of its assets in Municipal Bonds. The Fund
generally will maintain a dollar-weighted average portfolio duration of
three years or less.
(iii) Principal Investments of the IQ Municipal Intermediate ETF
    According to the Exchange, the Fund will seek current income exempt
from federal income tax. The Fund, under normal market conditions, will
invest at least 80% of its assets in Municipal Bonds. The Fund
generally will maintain a dollar-weighted average duration within plus
or minus two years of the dollar-weighted average duration of the S&P
Municipal Bond Intermediate Index.

B. The Exchange's Description of the Other Investments of the Funds

    With respect to each of the Funds, while a Fund, under normal
market conditions, will invest at least 80% of its assets in Municipal
Bonds, as described above, a Fund may invest its remaining assets in
other assets and financial instruments, as described below.
    Each Fund may invest in shares of exchange-traded funds (``ETFs'')
and money market funds.\10\ In addition, each Fund may invest, directly
and indirectly, in fixed rate and floating rate U.S. government
securities, including bills, notes and bonds differing as to maturity
and rates of interest, which are either issued or guaranteed by the
U.S. Treasury or by U.S. government agencies or instrumentalities;
repurchase agreements; and commercial paper; and may purchase
securities on a when-issued basis or for settlement at a future date
(forward commitment), if a Fund holds sufficient liquid assets to meet
the purchase price (collectively, ``Other Investments'').
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    \10\ For purposes of the filing, ETFs include Investment Company
Units (as described in NYSE Arca Equities Rule 5.2(j)(3)); Portfolio
Depositary Receipts (as described in NYSE Arca Equities Rule 8.100);
and Managed Fund Shares (as described in NYSE Arca Equities Rule
8.600). The ETFs all will be listed and traded in the U.S. on
registered exchanges.
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C. The Exchange's Description of the Funds' Investment Restrictions

    Each Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment) deemed
illiquid by the Adviser, consistent with Commission guidance. Each 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 a Fund's
net assets are held in illiquid assets. Illiquid assets 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.
    Each Fund's investments will be consistent with its investment
objective and will not be used to provide multiple returns of a
benchmark or to produce leveraged returns.
    Each Fund may invest more than 25% of its total assets in Municipal
Bonds that are related in such a way that an economic, business or
political development or change affecting one such security could also
affect the other securities. However, a Fund's investments will be
diversified among a minimum of ten different sectors of the municipal
bond market.\11\
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    \11\ According to the Exchange, the IQ Municipal Insured ETF's
investments in Municipal Bonds will include investments in state and
local (e.g., county, city, town) and authority-issued Municipal
Bonds relating to such sectors as the following: State general
obligation, local general obligation, education, hospital, housing,
industrial development revenue/pollution control revenue, power,
resource recovery, transportation, water/sewer, leasing, special
tax, and pre-refunded bonds.
---------------------------------------------------------------------------

    A Fund's investments will be diversified among at least 15
different states, with no more than 30% of a Fund's securities invested
in municipal securities from a single state.
    Under normal market conditions, no security (excluding Treasury
securities) will represent more than 25% of the weight of the
portfolio, and the five highest weighted securities will not, in the
aggregate, account for more than 50% of the weight of a Fund. No
Municipal Bond held by a Fund will exceed 5% of the weight of a Fund's
portfolio and no single Municipal Bond issuer will account for more
than 8% of the weight of a Fund's portfolio. A Fund will hold Municipal
Bonds of a minimum of 25 non-affiliated issuers.\12\
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    \12\ For purposes of this restriction, each state and each
separate political subdivision, agency, authority, or
instrumentality of such state, each multi-state agency or authority,
and each guarantor, if any, will be treated as separate issuers of
Municipal Bonds.
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D. The Exchange's Description of the Application of the Generic Listing
Requirements to the Funds

    The Exchange states that it is submitting the proposed rule change
because the portfolios for the Funds will not meet all of the
``generic'' listing requirements of Commentary .01 to NYSE Arca
Equities Rule 8.600 applicable to the listing of Managed Fund Shares.
The Exchange states that each Fund's portfolio will meet all the
requirements set forth in Commentary .01 to NYSE Arca Equities Rule
8.600 except for those set forth in Commentary .01(b)(1), which
requires that components that in the aggregate account for at least 75%
of the fixed income weight of the portfolio each shall have a minimum
original principal amount outstanding of $100 million or more.

III. Discussion and Commission Findings

    After careful review, the Commission finds that the Exchange's
proposal to list and trade the Shares is consistent with the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\13\ In particular, the Commission finds that the
proposed rule change, as modified by Amendment Nos. 1 and 2, is
consistent with Section 6(b)(5) of the Act,\14\ which requires, among
other things, that the Exchange's rules be designed to prevent
fraudulent and manipulative acts and practices, 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.
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    \13\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \14\ 15 U.S.C. 78f(b)(5).
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    The Commission also finds that the proposal to list and trade the
Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of
the Act,\15\ which sets forth the finding of Congress that it is in the
public interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for and transactions in securities. Quotation and last-sale
information for the Shares and the underlying ETFs will be available
via the Consolidated Tape Association (``CTA'') high-speed line, and
from the national securities exchange on which they are listed.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    The approximate value of each Fund's investments on a per-Share
basis, the Indicative Intra-Day Value (``IIV'') (which is the Portfolio
Indicative Value, as defined in NYSE Arca Equities Rule 8.600(c)(3)),
will be disseminated every 15 seconds during the Exchange's Core
Trading Session (ordinarily 9:30 a.m. to 4:00 p.m., Eastern Time) by
one or more major market data vendors.\16\ On each business day, before
commencement of trading in Shares on the Exchange, each Fund will
disclose on its Web site the identities and quantities of the portfolio
securities and other assets held by each Fund (each Fund's ``Disclosed
Portfolio,'' as defined in NYSE Arca Equities Rule 8.600(c)(2)) that
will form the basis for the calculation of NAV at the end of the
business day.\17\ In addition, with respect to each Fund, the
Administrator, through the National Securities Clearing Corporation,
will make available on each business day immediately prior to the
opening of business on the Exchange (currently 9:30 a.m., Eastern
Time), the designated portfolio of securities and estimated cash
component, if applicable, per each creation unit that will be
applicable to creation and redemption requests on that day. The NAV of
Shares of each Fund will normally be determined as of the close of the
Core Trading Session on the Exchange (ordinarily 4:00 p.m., Eastern
Time) on each business day.
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    \16\ The Exchange represents that several major market data
vendors display and/or make widely available IIVs taken from CTA or
other data feeds. According to the Exchange, the IIV for a Fund will
be calculated by an independent third party calculator by dividing
the ``Estimated Fund Value'' as of the time of the calculation by
the total number of outstanding Shares of that Fund. ``Estimated
Fund Value'' is the sum of the estimated amount of cash held in a
Fund's portfolio, the estimated amount of accrued interest owed to a
Fund, and the estimated value of the securities held in a Fund's
portfolio, minus the estimated amount of a Fund's liabilities. The
IIV will be calculated based on the same portfolio holdings
disclosed on the Funds' Web site.
    \17\ On a daily basis, the Funds will disclose the information
required under NYSE Arca Equities Rule 8.600 (c)(2) to the extent
applicable. The Web site information will be publicly available at
no charge.
---------------------------------------------------------------------------

    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. Information
regarding the previous day's closing price and trading volume
information for the Shares will be publicly available and published
daily in the financial section of newspapers. Quotation information
from brokers and dealers or pricing services will be available for
Municipal Bonds and Other Investments. Price information for money
market funds will be available from the applicable investment company's
Web site and from market data vendors. Pricing information regarding
Municipal Bonds and Other Investments (other than money market funds)
will generally be available through nationally recognized data service
providers through subscription agreements. Trade price and other
information relating to Municipal Bonds is available through the
Municipal Securities Rulemaking Board's EMMA system. Upon the
commencement of operations of a Fund, a copy of the Funds' prospectus
will be available on the Funds' Web site (www.IQetfs.com) in a form
that may be downloaded. In addition, the Funds' Web site will include
additional data relating to NAV and other applicable quantitative
information relating to the Shares.
    The Commission further believes that the proposal to list and trade
the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately and
to prevent trading when a reasonable degree of transparency cannot be
assured. The Exchange will obtain a representation from the issuer of
the Shares that the NAV per Share for each Fund will be calculated
daily and that the NAV and the Disclosed Portfolio for each Fund will
be made available to all market participants at the same time.\18\
Trading in Shares of the Funds will be halted if the circuit breaker
parameters in NYSE Arca Equities Rule 7.12 have been reached or because
of market conditions or for reasons that, in the view of the Exchange,
make trading in the Shares inadvisable.\19\ Trading in the Shares will
be subject to NYSE Arca Equities Rule 8.600(d)(2)(D), which sets forth
additional circumstances under which Shares of the Funds may be halted.
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    \18\ See NYSE Arca Equities Rule 8.600(d)(1)(B).
    \19\ 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 a Fund.
---------------------------------------------------------------------------

    The Exchange represents that it has a general policy prohibiting
the distribution of material, non-public information by its employees.
In addition, Commentary .06 to NYSE Arca Equities Rule 8.600 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 Exchange represents that the Adviser
and Sub-Adviser are not registered as broker-dealers; however, each of
the Adviser and the Sub-Adviser is affiliated with a broker-dealer, and
each of the Adviser and Sub-Adviser has implemented and will maintain a
fire wall with respect to their relevant personnel and each such
broker-dealer affiliate regarding access to information concerning the
composition of, and/or changes to, a portfolio.\20\
---------------------------------------------------------------------------

    \20\ See supra note 6. The Exchange represents that an
investment adviser to an open-end fund is required to be registered
under the Investment Advisers Act of 1940.
---------------------------------------------------------------------------

    Prior to the commencement of trading, the Exchange will inform its
Equity Trading Permit Holders in an Information Bulletin (``Bulletin'')
of the special characteristics and risks associated with trading the
Shares. The Exchange represents that trading in the Shares will be
subject to the existing trading surveillances, administered by the
Financial Industry Regulatory Authority (``FINRA'') on behalf of the
Exchange, or by regulatory staff of the Exchange, which are designed to
detect violations of Exchange rules and applicable federal securities
laws.\21\ The Commission believes that the Exchange's initial and
continued listing requirements, combined with the Funds' investment
criteria and restrictions that would apply to Municipal Bonds in the
portfolio, are designed to mitigate the potential for price
manipulation of the Shares.
---------------------------------------------------------------------------

    \21\ The Exchange states that FINRA conducts cross-market
surveillances on behalf of the Exchange pursuant to a regulatory
services agreement. The Exchange is responsible for FINRA's
performance under this regulatory services agreement.
---------------------------------------------------------------------------

    The Exchange represents that it deems the Shares to be equity
securities, thus rendering trading in the Shares subject to the
Exchange's existing rules governing the trading of equity securities.

    In support of this proposal, the Exchange has made the following
additional representations:
    (1) The Shares of each Fund will conform to the initial and
continued listing criteria under NYSE Arca Equities Rule 8.600.
    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (3) Trading in the Shares will be subject to the existing trading
surveillances, administered by FINRA on behalf of the Exchange, or by
regulatory staff of the Exchange, which are designed to detect
violations of Exchange rules and applicable federal securities laws.
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 federal securities
laws applicable to trading on the Exchange.
    (4) The Exchange or FINRA, on behalf of the Exchange, or both, will
communicate as needed regarding trading in the Shares and ETFs with
other markets and other entities that are members of the Intermarket
Surveillance Group (``ISG''), and the Exchange or FINRA, on behalf of
the Exchange, or both, may obtain trading information regarding trading
in the Shares and ETFs from such markets and other entities. In
addition, the Exchange may obtain information regarding trading in the
Shares and ETFs from markets and other entities that are members of ISG
or with which the Exchange has in place a comprehensive surveillance
sharing agreement. FINRA, on behalf of the Exchange, is able to access,
as needed, trade information for certain fixed income securities held
by a Fund reported to FINRA's Trade Reporting and Compliance Engine.
FINRA also can access data obtained from the Municipal Securities
Rulemaking Board relating to municipal bond trading activity for
surveillance purposes in connection with trading in the Shares.
    (5) Prior to the commencement of trading, the Exchange will inform
its Equity Trading Permit Holders in a Bulletin of the special
characteristics and risks associated with trading the Shares.
Specifically, the Bulletin will discuss: (a) The procedures for
purchases and redemptions of Shares in creation unit aggregations (and
that Shares are not individually redeemable); (b) NYSE Arca Equities
Rule 9.2(a), which imposes a duty of due diligence on its Equity
Trading Permit Holders to learn the essential facts relating to every
customer prior to trading the Shares; (c) the risks involved in trading
the Shares during the Opening and Late Trading Sessions when an updated
IIV will not be calculated or publicly disseminated; (d) how
information regarding the IIV and the Disclosed Portfolio is
disseminated; (e) the requirement that Equity Trading Permit Holders
deliver a prospectus to investors purchasing newly issued Shares prior
to or concurrently with the confirmation of a transaction; and (f)
trading information. In addition, the Bulletin will discuss any
exemptive, no-action, and interpretive relief granted by the Commission
from any rules under the Act.
    (6) For initial and continued listing, a Fund will be in compliance
with Rule 10A-3 under the Act,\22\ as provided by NYSE Arca Equities
Rule 5.3.
---------------------------------------------------------------------------

    \22\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    (7) A minimum of 100,000 Shares for each Fund will be outstanding
at the commencement of trading on the Exchange.
    (8) Each Fund's investments will be consistent with its investment
objective and will not be used to provide multiple returns of a
benchmark or to produce leveraged returns.
    (9) Under normal market conditions, each Fund will invest at least
80% of its assets in Municipal Bonds.
    (10) Each Fund's investments will be diversified among a minimum of
ten different sectors of the Municipal Bond market.
    (11) Each Fund's investments will be diversified among at least 15
different states, with no more than 30% of a Fund's securities invested
in municipal securities from a single state.
    (12) Under normal market conditions, no security (excluding
Treasury securities) will represent more than 25% of the weight of the
portfolio of a Fund, and the five highest weighted securities will not,
in the aggregate, account for more than 50% of the weight of a Fund.
    (13) No Municipal Bond held by a Fund will exceed 5% of the weight
of that Fund's portfolio, and no single Municipal Bond issuer will
account for more than 8% of the weight of a Fund's portfolio.
    (14) Each Fund will hold Municipal Bonds of a minimum of 25 non-
affiliated issuers.
    (15) Each Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment) deemed
illiquid by the Adviser, consistent with Commission guidance. Each 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 a Fund's
net assets are held in illiquid assets.
    (16) The ETFs in which a Fund may invest will be listed and traded
in the U.S. on registered exchanges.
    The Exchange has represented that all statements and
representations made in the filing regarding (a) the description of the
portfolio, (b) limitations on portfolio holdings or reference assets,
or (c) the applicability of Exchange listing rules specified in the
filing shall constitute continued listing requirements for listing the
Shares of a Fund on the Exchange. 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.\23\ If
a Fund is not in compliance with the applicable listing requirements,
the Exchange will commence delisting procedures under NYSE Arca
Equities Rule 5.5(m).
---------------------------------------------------------------------------

    \23\ The Commission notes that certain other proposals for the
listing and trading of managed fund shares include a representation
that the exchange will ``surveil'' for compliance with the continued
listing requirements. See, e.g., Securities Exchange Act Release No.
78005 (Jun. 7, 2016), 81 FR 38247 (Jun. 13, 2016) (SR-BATS-2015-
100). In the context of this representation, it is the Commission's
view that ``monitor'' and ``surveil'' both mean ongoing oversight of
the Funds' compliance with the continued listing requirements.
Therefore, the Commission does not view ``monitor'' as a more or
less stringent obligation than ``surveil'' with respect to the
continued listing requirements.
---------------------------------------------------------------------------

    This approval order is based on all of the Exchange's
representations, including those set forth above and in Amendment Nos.
1 and 2, and the Exchange's description of the Funds. The Commission
notes that the Funds and the Shares must comply with the requirements
of NYSE Arca Equities Rule 8.600 to be initially and continuously
listed and traded on the Exchange.
    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act \24\ and the
rules and regulations thereunder applicable to a national securities
exchange.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78f(b)(5).

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

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\25\ that the proposed rule change (SR-NYSEArca-2017-44), as
modified by Amendment Nos. 1 and 2 thereto, be, and it hereby is,
approved.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(2).
    \26\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-12260 Filed 6-13-17; 8:45 am]
 BILLING CODE 8011-01-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: Kimberly Nesci,<PHONE_NUMBER>.
Marrone Bio Innovations (EPA Reg. No. 84059)
Petition #6F8444

	EPA has received a pesticide petition #6F8444 from Marrone Bio Innovations, 1540 Drew Avenue, Davis, California 95618 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for the microbial pesticide  Bacillus amyloliquefaciens strain F727.
	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, Marrone Bio Innovations has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Marrone Bio Innovations and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

I. Marrone Bio Innovations Petition Summary
#6F8444
A. Product Name and Proposed Use Practices

Product Names:	MBI-110 TGAI (Technical Grade Active Ingredient; for manufacturing use only)
	MBI-110 EP (End-use Product; for agricultural use, including greenhouse, field and post-harvest uses, for turf use, for home and garden use)

Active Ingredient:	Bacillus amyloliquefaciens strain F727 (CAS No. not applicable)
	Bacillus amyloliquefaciens strain F727 was isolated from a soil sample collected in Northern California. The bacterium was recovered from the sample by traditional plate dilution methods.
                  Bacillus amyloliquefaciens strain F727 is intended for use in end use products as a fungicide, bactericide and plant health product for agricultural, ornamental, turf, and home and garden uses.
                  Information regarding the name, identity and composition has been submitted to EPA and can be found in MRID No. 49788501-49788503.
                  The purpose of this petition is to apply for an exemption from the requirement of a tolerance for residues of products containing the active ingredient Bacillus amyloliquefaciens strain F727 in and on all food commodities when used according to good agricultural practices.

Mode of Action:
                  Bacillus amyloliquefaciens strain F727 was isolated from a soil collected in Jonesville, CA using traditional plate dilution methods. Bacillus amyloliquefaciens strain F727 was identified via 16S rRNA amplification and sequencing; amplification and sequencing of housekeeping genes, and characterized using several biochemical assays. This isolate has potential to be used as a biopesticide product for fungicide, bactericide and plant health applications for agricultural, ornamental, turf, and home and garden uses (MRID 49788502-49788503.
                  Bacillus amyloliquefaciens strain F727 has demonstrated activity against bacterial pathogens in vitro and against fungal pathogens both in vitro and in vivo. With in vitro testing, the most inhibited pathogens are Sclerotinia, Macrophomina, Eutypa, Rhizoctonia, and Sclerotium.
                  Bacillus amyloliquefaciens strain F727 is also a beneficial rhizobacterium that colonizes plant root hairs, leaves and other plant surfaces to prevent establishment of fungal /bacterial plant diseases, and bioassays indicate the bacterium also produces secondary metabolites and/or proteins that inhibit bacterial/mycelial growth and spore germination. It has also been reported that this microbe can induce resistance in plants.
                  Information on the mode of action has been submitted to EPA and can be found in MRID No. 497885-03
Use Pattern:
            	Bacillus amyloliquefaciens strain F727 is intended as a foliar spray,  soil treatment or seed treatment to control fungal and bacterial diseases and to promote plant health on numerous agricultural crops, nursery crops, ornamental plants and turfgrass in both field and greenhouse conditions.

B. Product Identity/Chemistry
 		Identity of the Pesticide and Corresponding Residues
                    Not applicable.
 		Magnitude of Residues at the Time of Harvest and 				Method Used to Determine the Residue
       		Not applicable.
 		Statement of Why an Analytical Method of Detecting and 			Measuring the Levels of the Pesticide Residue are not 			Needed
                  An analytical method for detecting and measuring the levels of the pesticide residue for Bacillus amyloliquefaciens strain F727 is not applicable.  It is expected that, when used as proposed, Bacillus amyloliquefaciens strain F727 would not result in residues that are of toxicological concern.

C. Mammalian Toxicological Profile

Mammalian Toxicological Profile

            A variety of toxicity studies have been performed with Bacillus amyloliquefaciens strain F727.  The toxicity studies performed are listed below in Table 1 and include an acute oral toxicity study in rats, an acute dermal toxicity study in rats, an acute inhalation toxicity study in rats, an acute intravenous toxicity study in rats, an acute dermal irritation study in rabbits, and an acute eye irritation study in rabbits. The oral, dermal and inhalation routes of exposure are the routes relevant for human health risk assessment. When mammals were exposed through oral and dermal routes, the results of these studies consistently showed that Bacillus amyloliquefaciens strain F727 was non-toxic and also lacked irritation to eyes and skin.  Following inhalation of undiluted Bacillus amyloliquefaciens strain F727, the test substance was rated as non-toxic in rats. Given that human inhalation exposure would not be to undiluted liquid substance, the relevance of these data to risks associated with undiluted Bacillus amyloliquefaciens strain F727 is minimal. The results of the intravenous toxicity study showed that Bacillus amyloliquefaciens strain F727 containing Bacillus amyloliquefaciens strain F727 cells was not pathogenic in mammals. No reports of hypersensitivity have been recorded from personnel working with this organism.  As evidenced by the results of toxicity testing summarized below in Table 1, there is no anticipated risk to human health following exposure to Bacillus amyloliquefaciens strain F727 through oral, dermal or inhalation routes.
TABLE 1      Summary of Bacillus amyloliquefaciens strain F727 Mammalian Toxicity Data
MRID
Mammalian Toxicity Test
Species
Dose Tested
Results

497885-06
Acute oral toxicity

Rat
5000 mg/kg

LD50 >5000 mg/kg
Category IV

497885-07
Acute dermal toxicity

Rat

5050 mg/kg

LD50 >5050 mg/kg
Category IV

497885-08
Acute inhalation toxicity

Rat
5.19 mg/L (undiluted liquid test substance for 4 hours)
LC50 = >5.19mg/L
Category IV
497885-04
Acute intravenous pathogenicity-toxicity
Rat

2.9 x 109 cfu/mL

Non-toxic, non-pathogenic; Clearance in blood by  Day 3; clearance in brain and cecum contents by Day 7; and clearance in lungs, spleen, kidneys and lymph nodes by Day 14

497885-10
Acute dermal irritation

Rabbit

0.5 mL undiluted product for 4 hours
Non-irritating
Category IV

497885-09
Acute eye irritation

Rabbit

0.1 mL undiluted product for 24 hours
Minimally-irritating
Category IV

Literature searches have demonstrated that there are no reports of ecological or human health hazards caused by Bacillus amyloliquefaciens strains.  It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity.   The results of toxicity testing show there is no risk to human health from the active ingredient.  Bacillus amyloliquefaciens strain F727 is not toxic, pathogenic, infective or irritating to mammals.

D. Aggregate Exposure

      1)  Dietary Exposure

            Dietary exposure from use of Bacillus amyloliquefaciens strain F727, as proposed, is minimal based on the proposed pre-harvest use pattern. The results of toxicity testing following acute oral exposure, the route most relevant to assessment of risks to health from exposure to food, indicate there is no risk to human health from Bacillus amyloliquefaciens strain F727. There are no reports of human health hazards related to oral exposure to Bacillus amyloliquefaciens strain F727 cells. The absence of acute toxicity in laboratory animals following oral exposure to high doses of the product demonstrates the benign nature of Bacillus amyloliquefaciens strain F727.
	Bacillus species, including B. amyloliquefaciens, are commonly found in soils, including in agricultural settings, and are naturally present on fresh produce.  The Manual of Clinical Microbiology (9[th] Edition) states that dried foods, such as spices, milk powder and grains, often contain large amounts of Bacillus spores.  B. amyloliquefaciens is not known to produce any mammalian toxins, and no food-borne disease outbreaks association with B. amyloliquefaciens have been reported.  B. amyloliquefaciens is not recognized as a pathogen among Bacillus species (Logan and de Vos, 2009).
            Based on the data and other information submitted to satisfy the data requirements for registration of the manufacturing-use and end-use pesticide products containing the active ingredient, B. amyloliquefaciens strain F727, no toxicity, infectivity, pathogenicity or other adverse effects from dietary exposure are expected.

      2)  Drinking Water Exposure

            Similarly, exposure of humans to residues of Bacillus amyloliquefaciens strain F727 in drinking water would be minimal based on the proposed application rates of a maximum of 4 quarts of formulated product per acre applied by broadcast, in-furrow, banded, injected, drench or drip irrigation. Results of the acute oral toxicity testing described above have shown that Bacillus amyloliquefaciens strain F727 was non-toxic at the highest test dose (> 5000 mg/kg).   There are no reports of human health hazards related to oral exposure to Bacillus amyloliquefaciens strain F727 cells. The absence of acute toxicity in laboratory animals following oral exposure to high doses of the product demonstrates the benign nature of Bacillus amyloliquefaciens strain F727.
            Bacillus species, including B. amyloliquefaciens, are commonly found in soils, including in agricultural settings, and are naturally present on fresh produce (Logan and de Vos, 2009).  The Manual of Clinical Microbiology (9[th] Edition) states that dried foods, such as spices, milk powder and grains, often contain large amounts of Bacillus spores. According to the World Health Organization, Bacillus species are often detected in drinking water even after going through acceptable water treatment processes, largely because the spores are resistant to drinking water disinfection processes (World Health Organization, 2011) B. amyloliquefaciens is not known to produce any mammalian toxins, and no food-borne disease outbreaks association with B. amyloliquefaciens have been reported.  Should Bacillus amyloliquefaciens strain F727 be present, no adverse effects are expected from exposure to B. amyloliquefaciens strain F727 through drinking water based on the data and other information submitted to satisfy the data requirements for registration of the manufacturing-use and end-use pesticide products containing active ingredient, B. amyloliquefaciens strain F727.

 Non-dietary Exposure
            The potential for non-dietary exposure to the general population, including infants and children, is unlikely as the proposed use sites are application to growing plants or crops.

            The results of toxicity testing discussed above indicate there is no risk to human health or the environment from Bacillus amyloliquefaciens strain F727. There are no reports of ecological or human health hazards related to oral exposure to Bacillus amyloliquefaciens strain F727 cells. The absence of acute toxicity in laboratory animals following oral or dermal exposure to high doses of Bacillus amyloliquefaciens strain F727 demonstrates the benign nature of the product. As a result, non-dietary exposures would not be expected to pose any quantifiable risk.

E. Cumulative Effects

 Cumulative Effects

            It is not expected that, when used as proposed, Bacillus amyloliquefaciens strain F727 would result in residues that are of toxicological concern. The intended use of the product is to apply Bacillus amyloliquefaciens strain F727 as a plant disease control for food and non-food crops. The results of toxicity testing indicate there is no risk to human health or the environment from Bacillus amyloliquefaciens strain F727. There are no reports of ecological or human health hazards related to exposure to Bacillus amyloliquefaciens strain F727 cells. The absence of acute toxicity in laboratory animals following exposure to high doses of the product demonstrates the benign nature of Bacillus amyloliquefaciens strain F727. The lack of acute toxicity indicates that the hazard associated with the use of Bacillus amyloliquefaciens strain F727 is low.

F. Safety Determination

 U.S. Population

            Acute toxicity studies have shown that the Bacillus amyloliquefaciens strain F727 is non-toxic in mammals when exposure is through oral and dermal routes and also lacks irritation potential in mammals.  Further, testing in mammals of active microbes showed that the product was not pathogenic. There are no reports of ecological or human health hazards caused by Bacillus amyloliquefaciens strain F727 cells. The lack of acute toxicity indicates that the hazard associated with the use of Bacillus amyloliquefaciens strain F727 is low.  There is a reasonable certainty of no harm to the general United States population from exposure to this active ingredient.

 Infants and Children

            As mentioned above, it is not expected that, when used as proposed, Bacillus amyloliquefaciens strain F727 would result in residues that are of toxicological concern. There is a reasonable certainty of no harm for infants and children from exposure to Bacillus amyloliquefaciens strain F727 from the proposed uses.

G. Effects on the Immune and Endocrine Systems

            To date, there is no evidence to suggest that Bacillus amyloliquefaciens strain F727, functions in a manner similar to any known hormone, or can act as an endocrine disrupter.

H. Existing Tolerances
            There are no current tolerances or tolerance exemptions in place for Bacillus amyloliquefaciens strain F727.

I. International Tolerances

            A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established  for Bacillus amyloliquefaciens strain F727.