			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

	    Issued by the Department of Transportation on July 1, 2002

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-12691

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no

additional confirming order will be issued in this matter).

Applicant:  Volga-Dnepr J.S. Cargo Airline				Date Filed:  June 28, 2002

Relief requested:  Exemption pursuant to 49 U.S.C. section 40109(g) to
permit it to operate one one-way cargo charter flight between
Philadelphia, PA, and Moffet Field, CA, on/about July 3, 2002, using its
AN-124 aircraft, to transport outsized cargo consisting of one NIMIQ-2
Satellite and associated equipment, on behalf of Lockheed Martin
Commercial Space Systems.  The applicant stated that Lockheed Martin
required urgent delivery of the satellite to complete final assembly and
mission integration activities in order to meet scheduled shipment
deadlines to Cape Canaveral for subsequent launch processing; that the
cargo is too large for transportation on U.S. carrier aircraft; and that
surface transportation is not feasible because of the time involved, the
adverse effect a long road trip could have on the high-value cargo, and
the cargo’s size and highway oversized load restrictions.

Applicant representative:  Glenn Wicks<PHONE_NUMBER>

Responsive pleadings:  Volga-Dnepr served its application on those U.S.
carriers operating large all-cargo aircraft.  Each carrier indicated
that it did not have aircraft available to conduct the proposed
operation and that it had no comment or did not oppose grant of the
requested authority to Volga-Dnepr.

Statutory Standards:  Under 49 U.S.C. section 40109(g), we may authorize
a foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49 U.S.C. section 41102; that all
possible efforts have been made to place the traffic on U.S. carriers;
and that the transportation is necessary to avoid unreasonable hardship
to the traffic involved (an additional required finding, concerning
emergency transportation during labor disputes, was not relevant here).
For examples of earlier grants of authority of this type, see, e.g.,
Order 2001-5-23.

	DISPOSITION

Action:  Approved								Action date:  July 1, 2002

Effective dates of authority granted:  July 3-5, 2002

Basis for approval:  We found that the application met all the relevant
criteria of 49 U.S.C. section 40109(g) for the grant of an exemption of
this type and that the grant was required in the public interest.
Specifically, we were persuaded that the need to move the satellite
promptly in order to complete scheduled assembly and integration
activities and subsequent launch processing deadlines; the fact that the
satellite could not be transported by surface either in time to meet
that schedule or without the risk of damage; the potential negative
impact of delivery delays; and the unique, outsized nature of the cargo,
constituted an emergency not arising in the normal course of business.
Moreover, based on the representations of the U.S. carriers, we
concluded that no U.S. carrier had aircraft available which could be
used to conduct the operation at issue here.  We also found that grant
of Volga-Dnepr’s request would prevent undue hardship to the cargo and
Lockheed Martin.  Finally, we found that the applicant was qualified to
perform its proposed operations (see, e.g., Order 94-10-13).

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions (attached) and to the condition that
Volga-Dnepr comply with an FAA-approved flight routing for the
authorized flight.

Action taken by:   	Read C. Van de Water

			Assistant Secretary for Aviation

			   and International Affairs

An electronic version of this document is available on the World Wide
Web at:  http://dms.dot.gov//reports/reports_aviation.asp

												        Appendix A

FOREIGN AIR CARRIER CONDITIONS OF AUTHORITY

In the conduct of the operations authorized, the holder shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are:

   (a)  based on its operations in international air transportation
that, according to the contract of carriage, include a point in the
United States as a point of origin, point of destination, or agreed
stopping place, or for which the contract of carriage was purchased in
the United States; or

   (b)  based on a claim under any international agreement or treaty
cognizable in any court or other tribunal of the United States.

In this condition, the term "international air transportation" means
"international transportation" as defined by the Warsaw Convention,
except that all States shall be considered to be High Contracting
Parties for the purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code (formerly the
Federal Aviation Act of 1958, as amended).

U.S. Department of Transportation

Office of the Secretary of Transportation									      (41301/40109)
6/2002


[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Rules and Regulations]
[Pages 14276-14279]
[FR Doc No: 2012-5782]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0084]
RIN 1625-AA11

Regulated Navigation Area; Little Bay Bridge Construction, Little
Bay, Portsmouth, NH

AGENCY: Coast Guard, DHS.

ACTION: Temporary interim rule with request for comments.

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SUMMARY: The Coast Guard is establishing a regulated navigation area
(RNA) on the navigable waters of Little Bay in the Piscataqua River
under and surrounding the Little Bay and General Sullivan Bridges in
order to facilitate construction of the Little Bay Bridge between
Newington, NH and Dover, NH. This temporary interim rule is necessary
to provide for the safety of life on the navigable waters during bridge
construction operations that could pose an imminent hazard to vessels
operating in the area. This rule implements certain safety measures,
including speed restrictions and the temporary suspension of vessel
traffic during construction operations.

DATES: This rule is effective in the CFR from March 9, 2012 through
July 31, 2013, and effective with actual notice for purposes of
enforcement from February 28, 2012, through July 31, 2013. Public
comments will be accepted and reviewed by the Coast Guard through July
31, 2013.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0084 using any one of the following methods:
    (1) Federal e-Rulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.
    Documents indicated in this preamble as being available in the
docket are part of docket USCG-2012-0084 and are available online by
going to http://www.regulations.gov, inserting USCG-2012-0084 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Ensign Elizabeth V. Morris of the
Waterways Management Division, U.S. Coast Guard Sector Northern New
England, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>or
Lieutenant Junior Grade Isaac Slavitt of the Waterways Management
Branch, U.S. Coast Guard First District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.
    As this interim rule will be in effect before the end of the
comment period, the Coast Guard will evaluate and revise this rule as
necessary to address significant public comments.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2012-0084), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via www.regulations.gov, it will be considered received
by the Coast Guard when you successfully transmit the comment. If you
fax, hand deliver, or mail your comment, it will be considered as
having been received by

the Coast Guard when it is received at the Docket Management Facility.
We recommend that you include your name and a mailing address, an email
address, or a telephone number in the body of your document so that we
can contact you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2012-0084'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit comments by mail or hand delivery, submit them in
an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change this rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2012-0084'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting in connection with the
public comment period for this interim rule. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Regulatory Information

    The Coast Guard is issuing this temporary interim rule without
prior Federal Register notice pursuant to authority under section 4(a)
of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice
when the agency for good cause finds that those procedures are
``impracticable, unnecessary, or contrary to the public interest.''
Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists
for not publishing a notice of proposed rulemaking (NPRM) with respect
to this rule because immediate action is necessary to ensure the safety
of the public during construction of the existing Little Bay Bridge.
The need for waterway closures was not brought to the attention of the
Coast Guard until January 30, 2012 when the New Hampshire Department of
Transportation (NHDOT) requested a complete waterway closure for an
eight and a half hour period tentatively scheduled for April 10, 2012.
    The Coast Guard discussed with NHDOT a number of alternatives to
complete waterway closure, including delaying this portion of
construction to allow the Coast Guard to publish a notice of proposed
rulemaking with respect to this rule, rerouting traffic through an
alternate channel, or arranging the construction barges and cranes in a
manner that leaves a portion of the main channel navigable. A delay
until at least the middle of May would unnecessarily prolong
construction and increase costs to the public. In addition, the
construction operations are currently ongoing, and construction barges
and cranes are already in place. Delaying bridge repairs to allow for a
full notice and comment period while repair equipment is already in
place is contrary to the public interest due to increased cost to
taxpayers. Furthermore, facilitating a waterway closure to allow bridge
repairs before recreational boater traffic escalates in May is in the
public's interest because it will reduce the impact of the waterway
closure on the public.
    For the reasons discussed, delaying the project would be contrary
to the public interest. For the same reasons, under 5 U.S.C. 553(d)(3),
the Coast Guard finds that good cause exists for making this rule
effective less than 30 days after publication in the Federal Register.

Basis and Purpose

    Under the Ports and Waterways Safety Act, the Coast Guard has the
authority to establish RNAs in defined water areas that are determined
to have hazardous conditions and in which vessel traffic can be
regulated in the interest of safety. See 33 U.S.C. 1231 and Department
of Homeland Security Delegation No. 0170.1.
    The purpose of this temporary interim rule is to ensure the safe
transit of vessels in the area, and to protect persons, vessels, and
the marine environment during construction operations for the duration
of the Little Bay Bridge construction.

Discussion of Rule

    The construction of the Little Bay Bridge involves large machinery
and construction vessel operations on and over the navigable waters of
Little Bay in the Piscataqua River. The ongoing operations are
hazardous by their nature, and pose risks both to recreational and
commercial traffic, as well as to the construction crew. In order to
mitigate the inherent risks involved in construction, it is necessary
to control vessel movement through the area.
    The purpose of this temporary interim rule is to ensure the safe
transit of vessels in the area, and to protect persons, vessels, and
the marine environment during construction operations for the duration
of the Little Bay Bridge construction work through July 31, 2013.
    Heavy-lift operations are sensitive to water movement, and wake
from passing vessels could pose significant risk of injury or death to
construction workers. In order to minimize such unexpected or
uncontrolled movement of water, the RNA will limit vessel speed and
wake of all vessels operating in the vicinity of the bridge
construction zone. This will be achieved by implementing a five (5)
knot speed limit and ``NO WAKE'' zone in the vicinity of the
construction as well as providing a means to suspend all vessel traffic
for emergent situations that pose imminent threat to waterway users in
the area. The RNA will also protect vessels desiring to transit the
area by ensuring that vessels are only permitted to transit when it is
safe to do so.
    The Coast Guard may close the regulated area described in this rule
to all vessel traffic during any circumstance that poses an imminent
threat to waterway users operating in the area. Complete waterway
closures

will be made with as much advanced notice as possible. At present, we
expect at least two days when the area will be completely closed, but
those days have not yet been scheduled by the project managers.
    The Captain of the Port (COTP) Sector Northern New England will
cause notice of enforcement to be made by appropriate means to ensure
the widest distribution among the affected segments of the public. Such
means of notification may include, but are not limited to, Broadcast
Notice to Mariners and Local Notice to Mariners. In addition, the COTP
maintains a telephone line that is staffed 24 hours a day, seven days a
week. The public can obtain information concerning enforcement of the
regulated navigation area by contacting Coast Guard Sector Northern New
England Command Center at<PHONE_NUMBER>.
    Entry into the regulated area during a closure is prohibited unless
specifically authorized by the Sector Northern New England Captain of
the Port (COTP). Any violation of this RNA is punishable by civil and
criminal penalties, in rem liability against the offending vessel, and
the initiation of suspension or revocation proceedings against Coast
Guard-issued merchant-mariner credentials.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    We expect the economic impact of this rule to be minimal because
this regulated navigation area only requires vessels to reduce speed
through 600 yards of Little Bay, therefore causing only a minimal delay
to a vessel's transit. In addition, periods when the regulated
navigation area will be closed to all traffic are expected to be short
in duration, and the Coast Guard will give advance notice of such
closures.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on substantial number of small
entities. This rule will affect the following entities some of which
may be small entities: The owners or operators of marinas, charter
fishing vessels, commercial fishing vessels, and recreational vessels
who intend to transit in those portions of Little Bay beneath the new
Little Bay Bridge during the effective period. In addition, periods
when the regulated navigation area is closed to all traffic are
expected to be short in duration, and the Coast Guard expects to give
advance notice of such closures.
    This regulation may have some impact on the public, but the
potential impact will be minimized for the following reasons: It
requires vessels to reduce speed through only 600 yards of Little Bay,
therefore causing only a minimal delay to a vessel's transit. We will
use various appropriate means to inform the public before, during, and
at the conclusion of any RNA enforcement period.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the

Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of an RNA. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES. Any comments received concerning environmental impacts will
be considered and changes made to the environmental analysis checklist
and categorical exclusion determination as appropriate.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for Part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T01-0084 to read as follows:

Sec.  165.T01-0084  Regulated Navigation Area; Little Bay Bridge
Construction, Little Bay, Portsmouth, NH.

    (a) Location. The following area is a Regulated Navigation Area
(RNA): all navigable waters of Little Bay between Newington, NH and
Dover, NH, from surface to bottom, within a 300 yard radius of position
43[deg]07'05'' N, 070[deg]49'33'' W.
    (b) Regulations. (1) The general regulations contained in 33 CFR
165.10, 165.11, and 165.13 apply within the RNA. In addition, the
following regulations apply:
    (2) In accordance with the general regulations, entry into or
movement within this zone, during periods of enforcement, is prohibited
unless authorized by Captain of the Port Sector Northern New England
(COTP).
    (3) A speed limit of five (5) knots will be in effect within the
regulated area. All vessels must proceed through the area with caution
and operate in such a manner as to produce no wake.
    (4) All persons and vessels must comply with all directions given
to them by the COTP or his on-scene representative. The ``on-scene
representative'' of the COTP is any Coast Guard commissioned, warrant
or petty officer who has been designated by the COTP to act on the
COTP's behalf. The on-scene representative may be on a Coast Guard
vessel, New Hampshire State Police vessel, New Hampshire Marine Patrol
vessel or other designated craft, or may be on shore, and will
communicate with vessels via VHF-FM radio or loudhailer. Members of the
Coast Guard Auxiliary may be present to inform vessel operators of this
regulation.
    (5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel must proceed
as directed.
    (6) All other relevant regulations, including but not limited to
the Rules of the Road (33 CFR part 84--Subchapter E, Inland
Navigational Rules) remain in effect within the regulated area and must
be strictly followed at all times.
    (c) Enforcement Period. (1) This section is enforceable from
February 28, 2012 until 11:59 p.m. on July 31, 2013.
    (2) The COTP will give notice of enforcement by appropriate means
to inform the affected segments of the public, and such notification
will include dates and times. Means of notification may include, but
are not limited to, Broadcast Notice to Mariners and Local Notice to
Mariners.
    (d) Penalties. Failure to comply with this section may result in
civil or criminal penalties pursuant to the Ports and Waterways Safety
Act, 33 U.S.C. 1221 et seq. Report violations of this regulated
navigation area to the COTP Sector Northern New England, at 207-767-
0303 or on VHF--Channel 16.

    Dated: February 28, 2012.
J.B. McPherson,
Captain, U.S. Coast Guard, Acting Commander, First Coast Guard
District.
[FR Doc. 2012-5782 Filed 3-8-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Notices]
[Pages 55050-55054]
[FR Doc No: 2014-21868]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73022; File No. SR-NYSEArca-2014-79]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of Proposed Rule Change, as Modified by Amendments No. 1 and
No. 2, To List and Trade Shares of InfraCap MLP ETF Under NYSE Arca
Equities Rule 8.600

September 9, 2014.

I. Introduction

    On July 9, 2014, NYSE Arca, Inc. (``NYSE Arca'' or ``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 InfraCap MLP ETF (``Fund'') under
NYSE Arca Equities Rule 8.600. The proposed rule change was published
for comment in the Federal Register on July 28, 2014.\3\ On July 25,
2014, NYSE Arca filed

Amendment No. 1 to the proposal.\4\ On August 8, 2014, NYSE Arca filed
Amendment No. 2 to the proposal.\5\ The Commission received no comments
on the proposal. This order grants approval of the proposed rule
change, as modified by Amendments No. 1 and No. 2.
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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. 72651 (July 22,
2014), 79 FR 43801 (``Notice'').
    \4\ Amendment No. 1 replaced and superseded the original filing
in its entirety. In Amendment No. 1, the Exchange amended the
proposed rule change to: (a) Clarify the type of investment company
securities that the Fund may invest in as part of its principal
investment strategy; (b) clarify that the real estate investment
trust interests that the Fund may invest in as part of its non-
principal investment strategy will be exchange-traded; (c) state
that not more than 10% of the assets of the Fund will be invested in
equity securities that are traded on an exchange that is not a
member of the Intermarket Surveillance Group (``ISG'') or with which
the Exchange does not have in place a comprehensive surveillance
sharing agreement; (d) describe how the over-the-counter (``OTC'')
securities in which the Fund invests will be valued for purposes of
calculating the Fund's Net Asset Value (``NAV'') of the Fund, and
specify where pricing information for such securities may be
obtained; and (e) state, for surveillance purposes, that the
Financial Industry Regulatory Authority (``FINRA''), on behalf of
the Exchange, is able to access, as needed, trade information for
certain fixed income securities held by the Fund reported to FINRA's
Trade Reporting and Compliance Engine (``TRACE''). See Amendment No.
1, available at: http://www.sec.gov/comments/sr-nysearca-2014-79/nysearca201479-1.pdf. Amendment No. 1 provided clarification to the
proposed rule change, and because it does not materially affect the
substance of the proposed rule change or raise novel or unique
regulatory issues, Amendment No. 1 is not subject to notice and
comment.
    \5\ Amendment No. 2 amended the filing, as modified by Amendment
No. 1, to: (a) Reflect a name change to the Fund from ``InfraCap
Active MLP ETF'' to ``InfraCap MLP ETF;'' and (b) clarify that all
of the principal investments of the Fund, including the other open-
end and closed-end investment companies that the Fund may invest in
as part of its principal investment strategy, will be exchange-
traded. Amendment No. 2 provided clarification to the proposed rule
change, and because it does not materially affect the substance of
the proposed rule change or raise novel or unique regulatory issues,
Amendment No. 2 is not subject to notice and comment.
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II. Description of the Proposed Rule Change

    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 ETFis Series
Trust I (``Trust''). The Trust is registered with the Commission as an
investment company.\6\
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    \6\ The Trust is registered under the Investment Company Act of
1940 (``1940 Act''). The Exchange states that on February 26, 2014,
the Trust filed with the Commission a post-effective amendment to
its registration statement on Form N-1A under the Securities Act of
1933 and under the 1940 Act relating to the Fund (File Nos. 333-
187668 and 811-22819) (``Registration Statement''). In addition, the
Exchange states that the Trust filed an Amended and Restated
Application for an Order under Section 6(c) of the 1940 Act for
exemptions from various provisions of the 1940 Act and rules
thereunder (File No. 812-14080), dated June 19, 2013, and that the
Commission has issued an order granting certain exemptive relief to
the Trust under the 1940 Act. See Investment Company Act Release No.
30607 (July 23, 2013) (File No. 812-14080).
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    Etfis Capital LLC (``Adviser'') will serve as the investment
adviser to the Fund and Infrastructure Capital Advisors, LLC (``Sub-
Adviser'') will serve as sub-adviser for the Fund. The Exchange states
that neither the Adviser nor the Sub-Adviser is registered as a broker-
dealer. The Exchange states that the Adviser (but not the Sub-Adviser)
is affiliated with a broker-dealer; that the Adviser has implemented a
fire wall with respect to such broker-dealer affiliate regarding access
to information concerning the composition of, or changes to, the
portfolio; and that the Adviser will be subject to procedures designed
to prevent the use and dissemination of material non-public information
regarding the portfolio.\7\
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    \7\ See Commentary .06 to NYSE Arca Equities Rule 8.600. The
Exchange states that, in the event (a) the Adviser or any sub-
adviser registers as a broker-dealer or becomes newly affiliated
with a broker-dealer, or (b) any new adviser or sub-adviser is a
registered broker-dealer or becomes affiliated with a broker-dealer,
the adviser or sub-adviser will implement a fire wall with respect
to its relevant personnel or broker-dealer affiliate, as applicable,
regarding access to information concerning the composition of, or
changes to, the portfolio, and that adviser or sub-adviser will be
subject to procedures designed to prevent the use and dissemination
of material non-public information regarding such portfolio.
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    ETF Distributors LLC will be the principal distributor of the
Fund's Shares. The Bank of New York Mellon will serve as the
administrator, accountant, custodian, and transfer agent for the Fund.
    The Exchange has made the following representations and statements
in describing the Fund and its investment strategies, including
portfolio holdings and investment restrictions.\8\
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    \8\ The Commission notes that additional information regarding
the Trust, the Fund, and the Shares, investment strategies, risks,
NAV calculation, creation and redemption procedures, fees, portfolio
holdings disclosure policies, distributions, and taxes, among other
information, is included in the Notice, Amendment Nos. 1 and 2, and
the Registration Statement, as applicable. See Notice, Amendment
Nos. 1 and 2, and Registration Statement, supra notes 3, 4, 5, and 6
respectively.
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Principal Fund Investments

    According to the Exchange, the Fund seeks total return primarily
through investments in equity securities of publicly-traded master
limited partnerships and limited liability companies taxed as
partnerships (``MLPs'').\9\ The Fund will seek to achieve its
investment objective by normally \10\ investing up to 100% (but not
less than 80%) of its total assets in exchange-traded securities of
MLPs in the energy infrastructure sector. The Fund will focus on
investing in MLPs selected by the Sub-Adviser that trade on the New
York Stock Exchange (``NYSE'') or the NASDAQ Stock Market (``Nasdaq'')
and that, as their principal business, operate assets used in the
gathering, transporting, processing, storing, refining, distributing,
mining, or marketing of natural gas, natural gas liquids, crude oil,
refined petroleum products, or coal.
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    \9\ According to the Exchange, the Fund may invest in MLP units,
securities of companies holding primarily general partner or
managing member interests in MLPs, and securities that themselves
own interests in MLPs (e.g., exchange-traded funds (``ETFs''),
exchange-traded notes (``ETNs''), and other exchange-traded open-end
and closed-end investment companies that invest in MLPs). The
Exchange states that, for purposes of this filing, ETFs include the
following: 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 Exchange
further states that, for purposes of this filing, ETNs include
securities listed and traded on the Exchange under NYSE Arca
Equities Rule 5.2(j)(6) (Index-Linked Securities).
    \10\ The term ``normally'' includes, but is not limited to, the
absence of extreme volatility or trading halts in the equity markets
or the financial markets generally; operational issues causing
dissemination of inaccurate market information; or force majeure
type events such as systems failure, natural or man-made disaster,
act of God, armed conflict, act of terrorism, riot or labor
disruption, or any similar intervening circumstance. According to
the Registration Statement, the Fund may, from time to time, take
temporary defensive positions that are inconsistent with its
principal investment strategies in an attempt to respond to adverse
market, economic, political, or other conditions. In such
circumstances, the Fund may also hold up to 100% of its portfolio in
cash and cash equivalent positions. According to the Registration
Statement, when the Fund takes a temporary defensive position, it
may not be able to achieve its investment objective.
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    According to the Exchange, the Fund will typically focus on
``midstream'' MLPs which are MLPs that collect, gather, process,
transport, and store natural resources and their byproducts (primarily
crude oil, natural gas, and refined petroleum products), generally
without taking ownership of the energy products.\11\
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    \11\ According to the Exchange, Midstream MLPs may also operate
ancillary businesses, including the marketing of energy products and
logistical services related thereto, but are typically not engaged
in the mining, production, or distribution of energy products.
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    The Fund expects to typically invest in a portfolio of between 25
and 50 MLPs, but there is no limit on the number of MLPs in which the
Fund will invest.\12\ The Sub-Adviser's investment decisions will be
based on a variety of quantitative, qualitative, and relative

valuation factors. The Sub-Adviser will typically evaluate potential
investments with respect to certain key variables that the Sub-Adviser
believes make a business successful over time, including, without
limitation, a company's competitive position, its perceived ability to
earn a high return on capital, the historical and projected stability
and reliability of its earnings and cash flow, its anticipated ability
to generate cash in excess of its growth needs, and its access to
additional capital. The Sub-Adviser also expects to utilize its
personnel's experience in evaluating energy infrastructure investments
and long-term relationships with energy industry participants to help
identify investment opportunities.
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    \12\ Under normal circumstances, the Fund will not invest more
than 15% of its total assets in any one issuer.
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Other Fund Investments

    According to the Exchange, although the Fund will normally invest
not less than 80% of its total assets as described above, the Fund has
flexibility to invest the remaining 20% of its assets in other types of
securities, including exchange-traded equity securities of large,
medium, and small capitalization companies; money market mutual funds;
ETFs; and other open-end or closed-end investment companies unrelated
to the energy infrastructure sector, when the Sub-Adviser believes they
offer more attractive opportunities or to meet liquidity, redemption,
or short-term investing needs.
    According to the Exchange, the Fund may invest up to 20% of its
total assets in securities convertible into common stock. Convertible
securities eligible for purchase by the Fund will be exchange-traded
and include convertible bonds, convertible preferred stocks, and
warrants. The Fund will not invest directly in real estate, but may
invest in exchange-traded readily marketable securities issued by
companies that invest in real estate or interests therein. The Fund may
also invest in readily marketable interests in exchange-traded real
estate investment trusts.
    According to the Exchange, the Fund may invest in money market
instruments and foreign debt traded on U.S. exchanges or in OTC
markets, and the Fund may invest in equity securities (including equity
securities in the form of American Depositary Receipts) traded on U.S.
exchanges or in the OTC markets.
    The Fund may also invest, or establish short positions, in ETFs,
exchange-traded options, or futures contracts in an effort to hedge
against market, interest rate, or commodity risks in the Fund's
portfolio.

Investment Restrictions

    The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment),
including Rule 144A securities deemed to be illiquid by the Sub-
Adviser.\13\ The Fund will monitor its portfolio liquidity on an
ongoing basis to determine whether, in light of current circumstances,
an adequate level of liquidity is being maintained, and will consider
taking appropriate steps in order to maintain adequate liquidity if,
through a change in values, net assets, or other circumstances, more
than 15% of the Fund's net assets are held in illiquid assets. Illiquid
assets include assets subject to contractual or other restrictions on
resale and other instruments that lack readily available markets as
determined in accordance with Commission staff guidance.
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    \13\ In determining the liquidity of the Fund's investments, the
Sub-Adviser may consider various factors including: (i) The
frequency of trades and quotations; (ii) the number of dealers and
prospective purchasers in the marketplace; (iii) dealer undertakings
to make a market; (iv) the nature of the security (including any
demand or tender features); and (v) the nature of the marketplace
for trades (including the ability to assign or offset the Fund's
rights and obligations relating to the investment).
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    The Fund may lend portfolio securities in an amount equal to up to
33% of its total assets to broker-dealers, major banks, or other
recognized domestic institutional borrowers of securities that the Sub-
Adviser has determined are creditworthy under guidelines established by
the Board of Trustees. The Fund may not lend securities to any company
affiliated with the Sub-Adviser. Each loan of securities will be
collateralized by cash, securities, or letters of credit. The Fund
might experience a loss if the borrower defaults on the loan.
    The Fund will not invest in swaps. The Fund's investments will be
consistent with its investment objective.
    The Fund will not invest in unsponsored ADRs. The Fund will invest
only in ADRs, futures, and options that are traded on an exchange that
is a member of the ISG or with which the Exchange has in place a
comprehensive surveillance sharing agreement. Not more than 10% of the
assets of the Fund will be invested in equity securities that are
traded on an exchange that is not a member of the ISG or with which the
Exchange does not have in place a comprehensive surveillance sharing
agreement.
    The Fund may use leverage (including margin borrowing) to the
extent permitted by the 1940 Act. However, the Fund's investments will
not be used to seek performance that is the multiple or inverse
multiple (i.e., 2Xs and 3Xs) of an index.

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendments No. 1 and No. 2, is consistent with
the requirements of Section 6 of the Act \14\ and the rules and
regulations thereunder applicable to a national securities
exchange.\15\ In particular, the Commission finds that the proposed
rule change is consistent with the requirements of Section 6(b)(5) of
the Act,\16\ 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 foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. The
Commission notes that the Fund and the Shares must comply with the
requirements of NYSE Arca Equities Rule 8.600 for the Shares to be
listed and traded on the Exchange.
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    \14\ 15 U.S.C. 78f.
    \15\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \16\ 15 U.S.C. 78f(b)(5).
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    The Commission 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,\17\ which sets forth Congress' finding 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 will be available via the Consolidated
Tape Association (``CTA'') high-speed line. In addition, the Indicative
Optimized Portfolio Value (``IOPV''),\18\

which is the Portfolio Indicative Value, as defined in NYSE Arca
Equities Rule 8.600(c)(3), will be widely disseminated at least every
15 seconds during the Core Trading Session by one or more major market
data vendors.\19\ On each business day, before commencement of trading
in Shares in the Core Trading Session on the Exchange, the Fund will
disclose on its Web site the Disclosed Portfolio, as defined in NYSE
Arca Equities Rule 8.600(c)(2), that will form the basis for the Fund's
calculation of NAV at the end of the business day.\20\ The NAV of the
Fund will be determined as of the close of the regular trading session
on the Exchange (ordinarily 4:00 p.m. Eastern Time) on each day that
the Exchange is open.\21\ A basket composition file, which includes the
security names and share quantities required to be delivered in
exchange for the Fund's Shares, together with estimates and actual cash
components, will be publicly disseminated daily prior to the opening of
the NYSE via the National Securities Clearing Corporation. 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 published daily in the financial
section of newspapers. The intra-day, closing, and settlement prices of
the portfolio securities and other Fund investments will be readily
available from the national securities exchanges trading those
securities, automated quotation systems, published or other public
sources, or on-line information services such as Bloomberg or Reuters.
Quotation and last sale information for underlying securities that are
exchange-listed--including equity securities of MLPs and large, medium,
and small capitalization companies, ETFs, ETNs, ADRs, and convertible
securities--will be available via the CTA high-speed line. Information
relating to futures will be available from the exchange on which such
futures are traded. Information relating to exchange-traded options
will be available via the Options Price Reporting Authority.
Information for investment companies, including money market mutual
funds and open-end and closed-end investment companies, will be
available from publicly available pricing sources, including Bloomberg,
IDC, and Reuters. Quotation information for foreign debt securities,
domestic debt securities, and equity securities that trade in OTC
markets may be obtained from brokers and dealers who make markets in
those securities or through nationally recognized pricing services
through subscription agreements. The Fund's Web site
(www.infracapmlp.com), which will be publicly available prior to the
public offering of Shares, will include a form of the prospectus for
the Fund and additional data relating to NAV and other applicable
quantitative information.
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    \17\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \18\ According to the Exchange, the IOPV calculations will be
estimates of the value of the Fund's NAV per Share using market data
converted into U.S. dollars at the current currency rates. The IOPV
will be calculated by an independent third party calculator and will
be calculated based on the same portfolio holdings disclosed on the
Fund's Web site. The IOPV price will be based on quotes and closing
prices from the securities' local market and may not reflect events
that occur subsequent to the local market's close. The quotations of
certain Fund holdings may not be updated during U.S. trading hours
if such holdings do not trade in the United States. Premiums and
discounts between the IOPV and the market price may occur. The
Exchange states that the IOPV should not be viewed as a ``real-
time'' update of the NAV per Share of the Fund, which will be
calculated only once a day.
    \19\ According to the Exchange, several major market data
vendors currently display or make widely available IOPVs taken from
the CTA or other data feeds.
    \20\ On a daily basis, the Adviser will disclose for each
portfolio security or other financial instrument of the Fund the
following information on the Fund's Web site: ticker symbol, CUSIP
number or other identifier, if any; a description of the holding
(including the type of holding); the identity of the security,
commodity, index, or other asset or instrument underlying the
holding, if any; for options, the option strike price; quantity held
(as measured by, for example, par value, notional value, or number
of shares, contracts, or units); maturity date, if any; coupon rate,
if any; effective date, if any; market value of the holding; and the
percentage weighting of the holding in the Fund's portfolio. The Web
site information will be publicly available at no charge.
    \21\ The NAV per Share for the Fund will be computed by dividing
the value of the net assets of the Fund (i.e., the value of its
total assets less total liabilities) by the total number of Shares
outstanding, rounded to the nearest cent. Expenses and fees,
including the management fee, will be accrued daily and taken into
account for purposes of determining NAV. The Exchange represents
that for purposes of calculating NAV, exchange-traded securities
will be valued at market closing price or, if no sale has occurred,
at the last quoted bid price on the primary exchange on which they
are traded. Price information for exchange-traded securities--
including equity securities of MLPs and large, medium, and small
capitalization companies, ETFs, ETNs, ADRs, convertible securities,
and options--will be taken from the exchange where the security is
primarily traded. Futures will be valued at the settlement price
determined by the applicable exchange. Foreign debt securities,
domestic debt securities, and equity securities, in each case that
trade in the OTC market, will be valued based on price quotations
obtained from a broker-dealer who makes markets in such securities
or on other equivalent indications of value provided by a third-
party pricing service. Any such third-party pricing service may use
a variety of methodologies to value some or all such securities to
determine the market price. The Fund's foreign and domestic debt
securities that trade in the OTC market will generally be valued at
bid prices. Investment company securities, including money market
mutual funds and open-end and closed-end investment companies, will
be valued at NAV, utilizing pricing services. In computing the
Fund's NAV, the value of the Fund's portfolio holdings is based on
the holdings' closing price on local markets when available. When a
portfolio holding's market price is not readily available or does
not otherwise accurately reflect the fair value of such security,
the Fund will use that holding's fair value as determined in good
faith in accordance with the Fund's fair value pricing procedures,
which will be approved by the Board of Trustees. In addition, the
Fund may fair value foreign equity portfolio holdings each day the
Fund calculates its NAV. Accordingly, the Fund's NAV may reflect
certain portfolio holdings' fair values rather than their market
prices. In valuing non-exchange traded securities, the Fund will
first use publicly available pricing sources, including Bloomberg,
IDC, and Reuters. Non-exchange traded securities will only be fair
valued if their market prices are not readily available. To the
extent the assets of the Fund are invested in other open-end
investment companies that are registered under the 1940 Act, the
Fund's NAV is calculated based upon the NAVs reported by those
registered open-end investment companies.
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    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 Commission notes that the Exchange will obtain a
representation from the issuer of the Shares that the NAV per Share
will be calculated daily and that the NAV and the Disclosed Portfolio
will be made available to all market participants at the same time.\22\
The Exchange may halt trading in the Shares if trading is not occurring
in the securities or the financial instruments constituting the
Disclosed Portfolio of the Fund, or if other unusual conditions or
circumstances detrimental to the maintenance of a fair and orderly
market are present.\23\ In addition, 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 Fund may be halted.
The Exchange states that it has a general policy prohibiting the
distribution of material, non-public information by its employees.
Further, the Commission notes that the Reporting Authority that
provides the Disclosed Portfolio of the Fund must implement and
maintain, or be subject to, procedures designed to prevent the use and
dissemination of material, non-public information regarding the actual
components of the Fund's portfolio.\24\ In addition, the Exchange
states that, while neither the Adviser nor the Sub-Adviser is
registered as a broker-dealer, the

Adviser (but not the Sub-Adviser) is affiliated with a broker-dealer
and has implemented a fire wall with respect to that broker-dealer
regarding access to information concerning the composition of, or
changes to, the portfolio, and will be subject to procedures designed
to prevent the use and dissemination of material non-public information
regarding the portfolio.\25\ The Exchange represents that trading in
the Shares will be subject to the existing trading surveillances,
administered by FINRA on behalf of the Exchange, which are designed to
detect violations of Exchange rules and applicable federal securities
laws.\26\ The Exchange further represents that these procedures are
adequate to properly monitor Exchange trading of the Shares in all
trading sessions and to deter and detect violations of Exchange rules
and applicable federal securities laws.
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    \22\ See NYSE Arca Equities Rule 8.600(d)(1)(B).
    \23\ See NYSE Arca Equities Rule 8.600(d)(2)(C) (providing
additional considerations for the suspension of trading in or
removal from listing of Managed Fund Shares on the Exchange). With
respect to trading halts, the Exchange may consider all relevant
factors in exercising its discretion to halt or suspend trading in
the Shares of the Fund. Trading in Shares of the Fund will be halted
if the circuit breaker parameters in NYSE Arca Equities Rule 7.12
have been reached. Trading also may be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable.
    \24\ See NYSE Arca Equities Rule 8.600(d)(2)(B)(ii).
    \25\ See supra note 7 and accompanying text. An investment
adviser to an open-end fund is required to be registered under the
Investment Advisers Act of 1940 (``Advisers Act''). As a result, the
Adviser and Sub-Adviser and their related personnel are subject to
the provisions of Rule 204A-1 under the Advisers Act relating to
codes of ethics. This Rule requires investment advisers to adopt a
code of ethics that reflects the fiduciary nature of the
relationship to clients as well as compliance with other applicable
securities laws. Accordingly, procedures designed to prevent the
communication and misuse of non-public information by an investment
adviser must be consistent with Rule 204A-1 under the Advisers Act.
In addition, Rule 206(4)-7 under the Advisers Act makes it unlawful
for an investment adviser to provide investment advice to clients
unless such investment adviser has (i) adopted and implemented
written policies and procedures reasonably designed to prevent
violation, by the investment adviser and its supervised persons, of
the Advisers Act and the Commission rules adopted thereunder; (ii)
implemented, at a minimum, an annual review regarding the adequacy
of the policies and procedures established pursuant to subparagraph
(i) above and the effectiveness of their implementation; and (iii)
designated an individual (who is a supervised person) responsible
for administering the policies and procedures adopted under
subparagraph (i) above.
    \26\ The Exchange states that FINRA surveils trading on the
Exchange pursuant to a regulatory services agreement and that the
Exchange is responsible for FINRA's performance under this
regulatory services agreement.
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    The Exchange represents that the Shares are deemed 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
representations:
    (1) The Shares will conform to the initial and continuing 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) FINRA, on behalf of the Exchange, will communicate as needed
regarding trading in the Shares and exchange-traded assets held by the
Fund with other markets that are members of ISG, and FINRA, on behalf
of the Exchange, may obtain trading information regarding trading in
the Shares and exchange-traded assets held by the Fund from such
markets and other entities. In addition, the Exchange may obtain
information regarding trading in the Shares and exchange-traded assets
held by the Fund from markets and other entities that are members of
ISG or with which the Exchange has in place a comprehensive
surveillance sharing agreement. In addition, FINRA, on behalf of the
Exchange, is able to access, as needed, trade information for certain
fixed income securities held by the Fund reported to FINRA's TRACE.
    (4) Prior to the commencement of trading, the Exchange will inform
its Equity Trading Permit Holders in an Information Bulletin of the
special characteristics and risks associated with trading the Shares.
Specifically, the Bulletin will discuss the following: (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 IOPV will not be calculated or publicly
disseminated; (d) how information regarding the IOPV 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.
    (5) For initial and continued listing, the Fund will be in
compliance with Rule 10A-3 under the Act,\27\ as provided by NYSE Arca
Equities Rule 5.3.
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    \27\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    (6) The Fund will normally invest up to 100% (but not less than
80%) of its total assets in exchange-traded securities of MLPs in the
energy infrastructure sector.
    (7) The Fund will not invest in swaps.
    (8) The Fund will not invest in unsponsored ADRs. The Fund will
invest only in ADRs, futures, and options that are traded on an
exchange that is a member of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
    (9) Not more than 10% of the assets of the Fund will be invested in
equity securities that are traded on an exchange that is not a member
of the ISG or with which the Exchange does not have in place a
comprehensive surveillance sharing agreement.
    (10) The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment),
including Rule 144A securities deemed to be illiquid by the Sub-
Adviser. The Fund will monitor its portfolio liquidity on an ongoing
basis to determine whether, in light of current circumstances, an
adequate level of liquidity is being maintained and will consider
taking appropriate steps in order to maintain adequate liquidity if,
through a change in values, net assets, or other circumstances, more
than 15% of the Fund's net assets are held in illiquid assets.
    (11) The Fund's investments will be consistent with its investment
objective. The Fund may use leverage (including margin borrowing) to
the extent permitted by the 1940 Act. However, the Fund's investments
will not be used to seek performance that is the multiple or inverse
multiple (i.e., 2Xs and 3Xs) of an index.
    (12) A minimum of 100,000 Shares for the Fund will be outstanding
at the commencement of trading on the Exchange.
    This approval order is based on all of the Exchange's
representations and description of the Fund, including those set forth
above and in the Notice and Amendments No. 1 and No. 2.
    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendments No. 1 and No. 2, is consistent
with Section 6(b)(5) of the Act \28\ and the rules and regulations
thereunder applicable to a national securities exchange.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\29\ that the proposed rule change (SR-NYSEArca-2014-79), as
modified by Amendments No. 1 and No. 2, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
---------------------------------------------------------------------------

    \30\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-21868 Filed 9-12-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 119 (Wednesday, June 22, 2022)]
[Notices]
[Pages 37321-37322]
[FR Doc No: 2022-13335]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM22-17-000]

American Gas Association, American Public Gas Association,
Process Gas Consumers Group, Natural Gas Supply Association; Notice of
Petition for Rulemaking

    Take notice that, on June 2, 2022, American Gas Association,
American Public Gas Association, Process Gas Consumers Group, and
Natural Gas Supply Association (collectively, Petitioners), pursuant to
Rule 207(a)(4) of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(4),
filed a petition requesting that the Commission conduct a rulemaking to
adopt a rule precluding natural gas pipelines from the practice of
aggregating bids on non-contiguous segments of capacity in determining
the highest value bid for the purpose of allocating capacity.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on Petitioners.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all

interested persons an opportunity to view and/or print the contents of
this document via the internet through the Commission's Home Page
(http://www.ferc.gov) using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. At this time, the Commission has suspended access
to Commission's Public Reference Room, due to the proclamation
declaring a National Emergency concerning the Novel Coronavirus Disease
(COVID-19), issued by the President on March 13, 2020. For assistance,
contact FERC at [email protected] or call toll-free, (886)
208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments
in lieu of paper using the ``eFile'' link at http://www.ferc.gov. In
lieu of electronic filing, you may submit a paper copy. Submissions
sent via the U.S. Postal Service must be addressed to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Room 1A, Washington, DC 20426. Submissions sent via any other
carrier must be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    Comments due: 5:00 p.m. Eastern time on July 18, 2022.

    Dated: June 15, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-13335 Filed 6-21-22; 8:45 am]
BILLING CODE 6717-01-P


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[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Page 32113]
[FR Doc No: 2018-14813]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-488-000; CP17-489-000]

Kinetica Deepwater Express, LLC; Kinetica Energy Express, LLC;
Notice of Technical Conference

    Take notice that a technical conference will be held on Thursday,
July 12, 2018 at 10:00 a.m. (Eastern Standard Time), in a room to be
designated at the offices of the Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426.
    At the technical conference, the Commission staff and the parties
to the proceeding should be prepared to discuss all issues and comments
filed in the proceeding.
    Federal Energy Regulatory Commission conferences are accessible
under section 508 of the Rehabilitation Act of 1973. For accessibility
accommodations please send an email to [email protected] or call
toll free<PHONE_NUMBER> (voice) or<PHONE_NUMBER> (TTY), or send a fax
to<PHONE_NUMBER> with the required accommodations.
    All interested persons and staff are permitted to attend. For
further information please contact Shannon ONeil at<PHONE_NUMBER> or
email [email protected].

    Dated: July 5, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-14813 Filed 7-10-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 131 (Wednesday, July 8, 2020)]
[Notices]
[Pages 41050-41053]
[FR Doc No: 2020-14715]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2256]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by August
7, 2020, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by August 7, 2020. Nominations will be accepted for current
vacancies and for those that will or may occur through December 31,
2020.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to<EMAIL_ADDRESS>or by mail to
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002.
    Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002. Additional information about becoming a member
of an FDA advisory committee can also be obtained by visiting FDA's
website at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002,<PHONE_NUMBER><EMAIL_ADDRESS>    For questions relating to specific advisory committees or panels,
contact the appropriate Contact Person listed in table 1.

                  Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
                Contact person                      Committee/panel
------------------------------------------------------------------------
Kathleen Hayes, Center for Biologics           Allergenic Products
 Evaluation and Research, Food and Drug         Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-
 0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>LaTonya Bonner, Center for Drugs Evaluation    Dermatologic and
 and Research, Food and Drug Administration,    Ophthalmic Drugs
 10903 New Hampshire Ave., Bldg. 31, Rm.        Advisory Committee.
 2428, Silver Spring, MD 20992-0002, 301-796-
 2855<EMAIL_ADDRESS>Philip Bautista, Center for Drugs Evaluation   Drug Safety and Risk
 and Research, Food and Drug Administration,    Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2430, Silver Spring, MD 20992-0002, 240-762-
 8729<EMAIL_ADDRESS>Kalyani Bhatt, Center for Drugs Evaluation     Psychopharmacologic Drugs
 and Research, Food and Drug Administration,    Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2438, Silver Spring, MD 20993-0002, 301-796-
 9005<EMAIL_ADDRESS>Patricio Garcia, Center for Devices and        Clinical Chemistry and
 Radiological Health, Food and Drug             Clinical Toxicology
 Administration, 10903 New Hampshire Ave.,      Devices Panel,
 Bldg. 66, Rm. 5216, Silver Spring, MD 20993-   Gastroenterology and
 0002,<PHONE_NUMBER>,                            Urology Devices Panel,
<EMAIL_ADDRESS>                  Obstetrics and
                                                Gynecology Devices
                                                Panel.
James Swink, Center for Devices and            Circulatory Systems
 Radiological Health, Food and Drug             Devices Panel, Dental
 Administration, 10903 New Hampshire Ave.,      Products Devices Panel,
 Bldg. 66, Rm. 5211 Silver Spring, MD 20993-    National Mammography
 0002,<PHONE_NUMBER><EMAIL_ADDRESS>  Advisory Committee,
                                                Radiological Devices
                                                Panel.
Aden Asefa, Center for Devices and             Immunology Devices Panel;
 Radiological Health, Food and Drug             Microbiology Devices
 Administration, 10903 New Hampshire Ave.,      Panel.
 Bldg. 66, Rm. 5214, Silver Spring, MD 20993-
 0002,<PHONE_NUMBER><EMAIL_ADDRESS>------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA seeks to include the views of women and
men, members of all racial and ethnic groups, and individuals with and
without disabilities on its advisory committees and, therefore,
encourages nominations of appropriately qualified candidates from these
groups.
    FDA is requesting nominations for voting and/or nonvoting consumer
representatives for the vacancies listed in table 2:

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
   Committee/panel/areas of expertise needed            Type of  vacancy             Approximate  date needed
----------------------------------------------------------------------------------------------------------------
Allergenics Advisory Committee--Knowledgeable   1--Voting......................  August 2020.
 in the fields of allergy, immunology,
 pediatrics, internal medicine, biochemistry,
 and related specialties.
Dermatologic and Ophthalmic Advisory            1--Voting......................  Immediately.
 Committee--Knowledgeable in the fields of
 dermatology, ophthalmology, internal
 medicine, pathology, immunology, epidemiology
 or statistics, and other related professions.

Drug Safety and Risk Management Advisory        1--Voting......................  Immediately.
 Committee--Knowledgeable in risk
 communication, risk management, drug safety,
 medical, behavioral, and biological sciences
 as they apply to risk management, and drug
 abuse.
Psychopharmacologic Drugs Advisory Committee--  1--Voting......................  Immediately.
 Knowledgeable in the fields of
 psychopharmacology, psychiatry, epidemiology
 or statistics, and related specialties.
Clinical Chemistry and Clinical Toxicology      1--Non-Voting..................  Immediately.
 Devices Panel--Doctor of Medicine or
 philosophy with experience in clinical
 chemistry (e.g., cardiac markers), clinical
 toxicology, clinical pathology, clinical
 laboratory medicine, and endocrinology.
Gastroenterology and Urology Devices Panel--    1--Non-Voting..................  Immediately.
 Gastroenterologists, urologists and
 nephrologists.
Obstetrics and Gynecology Devices Panel--       1--Non-Voting..................  Immediately.
 Experts in perinatology, embryology,
 reproductive endocrinology, pediatric
 gynecology, gynecological oncology, operative
 hysteroscopy, pelviscopy, electro-surgery,
 laser surgery, assisted reproductive
 technologies, contraception, postoperative
 adhesions, and cervical cancer and
 colposcopy; biostatisticians and engineers
 with experience in obstetrics/gynecology
 devices; urogynecologists; experts in breast
 care; experts in gynecology in the older
 patient; experts in diagnostic (optical)
 spectroscopy; experts in midwifery; labor and
 delivery nursing.
Dental Products Device Panel--Dentists,         1--Non-Voting..................  Immediately.
 engineers and scientists who have expertise
 in the areas of dental implants, dental
 materials, periodontology, tissue
 engineering, and dental anatomy.
National Mammography Advisory Committee--       1--Non-Voting..................  Immediately.
 Physician, practitioner, or other health
 professional whose clinical practice,
 research specialization, or professional
 expertise includes a significant focus on
 mammography.
Circulatory Systems Devices Panel--             1--Non-Voting..................  Immediately.
 Interventional cardiologists,
 electrophysiologists, invasive (vascular)
 radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special
 interest in congestive heart failure.
Immunology Devices Panel--Persons with          1--Non-Voting..................  Immediately.
 experience in medical, surgical, or clinical
 oncology, internal medicine, clinical
 immunology, allergy, molecular diagnostics,
 or clinical laboratory medicine.
Microbiology Devices Panel--Clinicians with an  1--Non-Voting..................  Immediately.
 expertise in infectious disease, e.g.,
 pulmonary disease specialists, sexually
 transmitted disease specialists, pediatric
 infectious disease specialists, experts in
 tropical medicine and emerging infectious
 diseases, mycologists; clinical
 microbiologists and virologists; clinical
 virology and microbiology laboratory
 directors, with expertise in clinical
 diagnosis and in vitro diagnostic assays,
 e.g., hepatologists; molecular biologists
Radiology Devices Panel--Physicians with        1--Non-Voting..................  Immediately.
 experience in general radiology, mammography,
 ultrasound, magnetic resonance, computed
 tomography, other radiological subspecialties
 and radiation oncology; scientists with
 experience in diagnostic devices, radiation
 physics, statistical analysis, digital
 imaging and image analysis.
----------------------------------------------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

A. Allergenics Advisory Committee

    Reviews and evaluates available data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic disease as well as the affirmation or revocation of biological
product licenses, on the safety, effectiveness, and labeling of the
products, on clinical and laboratory studies of such products, on
amendments or revisions to regulations governing the manufacture,
testing and licensing of allergenic biological products, and on the
quality and relevance of FDA's research programs.

B. Dermatologic and Ophthalmic Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of dermatologic and ophthalmic disorders.

C. Drug Safety and Risk Management Advisory Committee

    Risk management, risk communication, and quantitative evaluation of
spontaneous reports for drugs for human use and for any other product
for which FDA has regulatory responsibility. Scientific and medical
evaluation of all information gathered by the Department of Health and
Human Services (HHS) and the Department of Justice with regard to
safety, efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by HHS with regard to the marketing,
investigation, and control of such drugs or other substances.

D. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human products for use in the practice
of psychiatry and related fields.

E. Certain Panels of the Medical Devices Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
on the classification or reclassification of devices into one of three
regulatory categories; advises on any possible risks to health
associated with the use of devices; advises on formulation of product
development protocols; reviews premarket approval applications for
medical devices; reviews guidelines and guidance documents; recommends
exemption of certain devices from the application of portions of the
Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices. With the exception of the Medical Devices
Dispute Resolution Panel, each panel,

according to its specialty area, may also make appropriate
recommendations to the Commissioner of Food and Drugs on issues
relating to the design of clinical studies regarding the safety and
effectiveness of marketed and investigational devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete r[eacute]sum[eacute] or
curriculum vitae for each nominee and a signed copy of the
``Acknowledgement and Consent'' form available at the FDA Advisory
Committee Nomination Portal (see ADDRESSES), and a list of consumer or
community-based organizations for which the candidate can demonstrate
active participation.
    Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, nominations must
also acknowledge that the nominee is aware of the nomination unless
self-nominated. FDA will ask potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest. Members will be invited to serve for
terms up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14715 Filed 7-7-20; 8:45 am]
BILLING CODE 4164-01-P