[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12532-12535]
[FR Doc No: 2014-04800]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30969; File No. 812-14282]

Hatteras Alternative Mutual Funds Trust, et al., Notice of
Application

February 27, 2014.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements.

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Summary of Application: Applicants request an order that would permit
them to enter into and materially amend sub-advisory agreements with
Wholly-Owned Sub-Advisers (as defined below) and Non-Affiliated Sub-
Advisers (as defined below) without shareholder approval and would
grant relief from certain disclosure requirements. The order would
supersede a prior order that granted relief with respect to non-
affiliated sub-advisers and from certain disclosure requirements
(``Prior Order'').\1\
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    \1\ AIP Alternative Strategies Funds and Alternative Investment
Partners LLC, Investment Company Act Release Nos. 26284 (Dec. 4,
2003) (notice) and 26318 (Jan. 5, 2004) (order).

Applicants: Hatteras Alternative Mutual Funds Trust (``HAMFT'') (f/k/a/
AIP Alternative Strategies Funds), Underlying Funds Trust (``UFT'')
(HAMFT and UFT, each, a ``Trust'' and, together, the ``Trusts''), and
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Scotland Acquisition, LLC, d/b/a Hatteras Funds, LLC (``Adviser'').

DATES: Filing Dates: The application was filed on February 21, 2014.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on March 24, 2014 and should be accompanied by proof of service on
applicants, in the form of an affidavit or, for lawyers, a certificate
of service. Hearing requests should state the nature of the writer's
interest, the reason for the request, and the issues contested. Persons
who wish to be notified of a hearing may request notification by
writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: 8540 Colonnade
Center Drive, Suite 401, Raleigh, NC 27615.

FOR FURTHER INFORMATION CONTACT: Laura J. Riegel, Senior Counsel, at
(202) 551-6873, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. Each Trust is organized as a Delaware statutory trust and is
registered under the Act as an open-end management investment company.
Each Trust currently is comprised of five separate series of shares
(each, a ``Series''), each with its own distinct investment objective,
strategies, policies and restrictions. The Series of HAMFT pursue their
respective investment objectives by investing substantially all of
their assets in one or more of the Series of UFT pursuant to section
12(d)(1)(G) of the Act. The Adviser, a Delaware limited liability
company, is a wholly-owned subsidiary of RCS Advisory Services, LLC,
which is an operating subsidiary of RCS Capital

Corporation.\2\ The Adviser is registered as an investment adviser
under the Investment Advisers Act of 1940 (``Advisers Act'').\3\ Any
future Adviser will also be registered as an investment adviser under
the Advisers Act.
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    \2\ The term ``Adviser'' includes (a) Scotland Acquisition, LLC,
d/b/a/Hatteras Funds, LLC and (b) any entity controlling, controlled
by or under common control with, Scotland Acquisition, LLC, d/b/a
Hatteras Funds, LLC or its successors. For the purposes of the
requested order, ``successor'' is limited to an entity that results
from a reorganization into another jurisdiction or a change in the
type of business organization.
    \3\ Applicants request that the relief apply to applicants, as
well as to any future Series and any other existing or future
registered open-end management investment company or series thereof
that: (a) Is advised by the Adviser; (b) uses the manager of
managers structure described in the application (``Manager of
Managers Structure''); and (c) complies with the terms and
conditions of the application (``Sub-Advised Series''). All
registered open-end management investment companies that currently
intend to rely on the requested order are named as applicants. Any
entity that relies on the requested order will do so only in
accordance with the terms and conditions contained in the
application. If the name of any Sub-Advised Series contains the name
of a Sub-Adviser, the name of the Adviser that serves as the primary
adviser to the Sub-Advised Series, or a trademark or trade name that
is owned by that Adviser, will precede the name of the Sub-Adviser.
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    2. The Adviser will serve as the investment adviser to each Series
pursuant to an investment advisory agreement with the applicable Trust
(``Investment Advisory Agreement'').\4\ The Investment Advisory
Agreement has been approved, or will be approved, by the board of
trustees of the applicable Trust (``Board''),\5\ including a majority
of the members of the Board who are not ``interested persons,'' as
defined in section 2(a)(19) of the Act, of the applicable Trust, of a
Series or the Adviser (``Independent Trustees'') and by the
shareholders of the relevant Series as required by sections 15(a) and
15(c) of the Act and rule 18f-2 thereunder. The terms of the Investment
Advisory Agreement comply with section 15(a) of the Act.
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    \4\ On October 1, 2013, RCS Capital Corporation and the Adviser
entered into an asset purchase agreement (``Purchase Agreement'')
with Hatteras Alternative Mutual Funds, LLC (``HAMF'') (f/k/a AIP
Alternative Investment Partners LLC), the current investment adviser
to the Trusts. Under the Purchase Agreement, the Adviser will
purchase from HAMF, and HAMF will sell to the Adviser, substantially
all the assets related to the business and operations of HAMF (the
``Transfer''). The consummation of the Transfer is subject to
various conditions, including shareholder approval of the Investment
Advisory Agreements between the Adviser and the applicable Trust.
The requested order would supersede the Prior Order following the
consummation of the Transfer.
    \5\ The term ``Board'' also includes the board of trustees or
directors of a future Series.
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    3. Under the terms of the Investment Advisory Agreement, the
Adviser, subject to the supervision of the Board, will provide
continuous investment management of the assets of each Series. The
Adviser will periodically review each Series' investment objective,
policies and strategies, and based on the need of a Series may
recommend changes to the investment objective, policies and strategies
of the Series for consideration by the Board. For its services to each
Series under the Investment Advisory Agreement, the Adviser will
receive an advisory fee from that Series based on the average daily net
assets of that Series. The Investment Advisory Agreement provides that
the Adviser may, subject to the approval of the Board, including a
majority of the Independent Trustees, and the shareholders of the
applicable Series (if required), delegate portfolio management
responsibilities of all or a portion of the assets of a Series to a
Sub-Adviser.\6\
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    \6\ As used herein, a ``Sub-Adviser'' for a Series is: (a) An
indirect or direct ``wholly-owned subsidiary'' (as such term is
defined in the Act) of the Adviser for that Series; (b) a sister
company of the Adviser for that Series that is an indirect or direct
``wholly-owned subsidiary'' (as such term is defined in the Act) of
the same entity that, indirectly or directly, wholly owns the
Adviser (each of (a) and (b), a ``Wholly-Owned Sub-Adviser'' and
collectively, the ``Wholly-Owned Sub-Advisers''); or (c) an
investment sub-adviser for that Series that is not an ``affiliated
person'' (as such term is defined in section 2(a)(3) of the Act) of
the applicable Series, the applicable Trust, or the Adviser, except
to the extent that an affiliation arises solely because the Sub-
Adviser serves as a sub-adviser to a Series (each, a ``Non-
Affiliated Sub-Adviser'').
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    4. Applicants request an order to permit the Adviser, subject to
the approval of the Board, including a majority of the Independent
Trustees, to, without obtaining shareholder approval: (i) Select Sub-
Advisers to manage all or a portion of the assets of a Series and enter
into Sub-Advisory Agreements (as defined below) with the Sub-Advisers;
and (ii) materially amend Sub-Advisory Agreements with the Sub-
Advisers.\7\ The requested relief will not extend to any sub-adviser,
other than a Wholly-Owned Sub-Adviser, who is an affiliated person, as
defined in section 2(a)(3) of the Act, of the Sub-Advised Series, of
the Trust, or of the Adviser, other than by reason of serving as a sub-
adviser to one or more of the Sub-Advised Series (``Affiliated Sub-
Adviser'').
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    \7\ Shareholder approval will continue to be required for any
other sub-adviser change (not otherwise permitted by rule or other
action of the Commission or staff) and material amendments to an
existing sub-advisory agreement with any sub-adviser other than a
Non-Affiliated Sub-Adviser or a Wholly-Owned Sub-Adviser (all such
changes referred to as ``Ineligible Sub-Adviser Changes'').
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    5. Pursuant to the terms of the Investment Advisory Agreement, the
Adviser will have overall responsibility for the management and
investment of each Series' assets. These responsibilities include
recommending the removal or replacement of Sub-Advisers, determining
the portion of that Sub-Advised Series' assets to be managed by any
given Sub-Adviser and reallocating those assets as necessary from time
to time.
    6. The Adviser will enter into sub-advisory agreements with various
Sub-Advisers (``Sub-Advisory Agreements'') to provide investment
management services to the Sub-Advised Series. The terms of the Sub-
Advisory Agreements will comply with the requirements of section 15(a)
of the Act and will be approved by the Board, including a majority of
the Independent Trustees, in accordance with sections 15(a) and 15(c)
of the Act and rule 18f-2 thereunder. The specific day-to-day
investment decisions for each applicable Series will be made by that
Series' Sub-Adviser, which has discretionary authority to invest the
assets or a portion of the assets of that Series subject to the general
supervision of the Adviser and the Board. The Adviser will compensate
each Sub-Adviser out of the advisory fees paid to the Adviser under the
Investment Advisory Agreement; in the future, Sub-Advised Series may
directly pay advisory fees to the Sub-Advisers.
    7. Sub-Advised Series will inform shareholders of the hiring of a
new Sub-Adviser pursuant to the following procedures (``Notice and
Access Procedures''): (a) Within 90 days after a new Sub-Adviser is
hired for any Sub-Advised Series, that Sub-Advised Series will send its
shareholders either a Multi-Manager Notice or a Multi-Manager Notice
and Multi-Manager Information Statement; \8\ and (b) the Sub-Advised
Series will make the Multi-Manager Information Statement available on
the Web site identified in

the Multi-Manager Notice no later than when the Multi-Manager Notice
(or Multi-Manager Notice and Multi-Manager Information Statement) is
first sent to shareholders, and will maintain it on that Web site for
at least 90 days thereafter. In the circumstances described in the
application, a proxy solicitation to approve the appointment of new
Sub-Advisers provides no more meaningful information to shareholders
than the proposed Multi-Manager Information Statement. Applicants state
that each Board would comply with the requirements of sections 15(a)
and 15(c) of the Act before entering into or amending a Sub-Advisory
Agreement.
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    \8\ A ``Multi-Manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Securities
Exchange Act of 1934 (``Exchange Act''), and specifically will,
among other things: (a) Summarize the relevant information regarding
the new Sub-Adviser; (b) inform shareholders that the Multi-Manager
Information Statement is available on a Web site; (c) provide the
Web site address; (d) state the time period during which the Multi-
Manager Information Statement will remain available on that Web
site; (e) provide instructions for accessing and printing the Multi-
Manager Information Statement; and (f) instruct the shareholder that
a paper or email copy of the Multi-Manager Information Statement may
be obtained, without charge, by contacting the Sub-Advised Series.
    \\A ``Multi-Manager Information Statement'' will meet the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the Exchange Act for an information statement, except as
modified by the order to permit Aggregate Fee Disclosure (as defined
below). Multi-Manager Information Statements will be filed with the
Commission via the EDGAR system.
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    8. Applicants also request an order exempting the Sub-Advised
Series from certain disclosure obligations that may require each Sub-
Advised Series to disclose fees paid by the Adviser to each Sub-
Adviser. Applicants seek relief to permit each Sub-Advised Series to
disclose (as a dollar amount and a percentage of the Sub-Advised
Series' net assets): (a) The aggregate fees paid to the Adviser and any
Wholly-Owned Sub-Advisers; (b) the aggregate fees paid to Non-
Affiliated Sub-Advisers; and (c) the fee paid to each Affiliated Sub-
Adviser (collectively, the ``Aggregate Fee Disclosure'').

Applicants' Legal Analysis

    1. Section 15(a) of the Act states, in part, that it is unlawful
for any person to act as an investment adviser to a registered
investment company ``except pursuant to a written contract, which
contract, whether with such registered company or with an investment
adviser of such registered company, has been approved by the vote of a
majority of the outstanding voting securities of such registered
company.'' Rule 18f-2 under the Act provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires a registered
investment company to disclose in its statement of additional
information the method of computing the ``advisory fee payable'' by the
investment company, including the total dollar amounts that the
investment company ``paid to the adviser (aggregated with amounts paid
to affiliated advisers, if any), and any advisers who are not
affiliated persons of the adviser, under the investment advisory
contract for the last three fiscal years.''
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to a registered investment company to comply with Schedule 14A under
the Exchange Act. Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and
22(c)(9) of Schedule 14A, taken together, require a proxy statement for
a shareholder meeting at which the advisory contract will be voted upon
to include the ``rate of compensation of the investment adviser,'' the
``aggregate amount of the investment adviser's fee,'' a description of
the ``terms of the contract to be acted upon,'' and, if a change in the
advisory fee is proposed, the existing and proposed fees and the
difference between the two fees.
    4. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b), and (c) of Regulation S-X require
a registered investment company to include in its financial statement
information about the investment advisory fees.
    5. Section 6(c) of the Act provides that the Commission by order
upon application may conditionally or unconditionally exempt any
person, security, or transaction or any class or classes of persons,
securities, or transactions from any provisions of the Act, or from any
rule thereunder, if such exemption is necessary or appropriate in the
public interest and consistent with the protection of investors and the
purposes fairly intended by the policy and provisions of the Act.
Applicants state that their requested relief meets this standard for
the reasons discussed below.
    6. Applicants assert that the shareholders expect the Adviser,
subject to the review and approval of the Board, to select the Sub-
Advisers that are suited to achieve the Series' investment objective.
Applicants assert that, from the perspective of the shareholder, the
role of the Sub-Adviser is substantially equivalent to the role of the
individual portfolio managers employed by an investment adviser to a
traditional investment company. Applicants believe that permitting the
Adviser to perform the duties for which the shareholders of the Sub-
Advised Series are paying the Adviser--the selection, supervision and
evaluation of the Sub-Adviser--without incurring unnecessary delays or
expenses is appropriate in the interest of the Series' shareholders and
will allow the Series to operate more efficiently. Applicants state
that the Investment Advisory Agreement will continue to be fully
subject to section 15(a) of the Act and rule 18f-2 under the Act and
approved by the Board, including a majority of the Independent
Trustees, in the manner required by sections 15(a) and 15(c) of the
Act. Applicants are not seeking an exemption with respect to the
Investment Advisory Agreement.
    7. Applicants assert that disclosure of the individual fees that
the Adviser or Sub-Advised Series would pay to the Sub-Advisers would
not serve any meaningful purpose. Applicants contend that the primary
reasons for requiring disclosure of individual fees paid to Sub-
Advisers are to inform shareholders of expenses to be charged by a
particular Sub-Advised Series and to enable shareholders to compare the
fees to those of other comparable investment companies. Applicants
believe that the requested relief satisfies these objectives because
the advisory fee paid to the Adviser, or the Aggregate Fee Disclosure,
in the case of a Sub-Advised Series that directly compensates a Sub-
Adviser, will be fully disclosed and, therefore, shareholders will know
what the Sub-Advised Series' fees and expenses are and will be able to
compare the advisory fees a Sub-Advised Series is charged to those of
other investment companies. Applicants assert that the requested
disclosure relief would benefit shareholders of the Sub-Advised Series
because it would improve the Adviser's ability to negotiate the fees
paid to Sub-Advisers. Applicants state that the Adviser may be able to
negotiate rates that are below a Sub-Adviser's ``posted'' amounts if
the Adviser is not required to disclose the Sub-Advisers' fees to the
public. Applicants submit that the relief requested to use Aggregate
Fee Disclosure will encourage Sub-Advisers to negotiate lower sub-
advisory fees with the Adviser if the lower fees are not required to be
made public.
    8. For the reasons discussed above, applicants submit that the
requested relief meets the standards for relief under section 6(c) of
the Act. Applicants state that the operation of the Sub-Advised Series
in the manner described in the application must be approved by
shareholders of a Sub-Advised Series before that Sub-Advised Series may
rely on the requested relief. In addition, applicants state that the
proposed conditions to the requested relief are designed to address any
potential conflicts of interest, including any posed by the use of
Wholly-Owned Sub-Advisers, and provide that shareholders are informed
when new Sub-Advisers are hired. Applicants assert that conditions 6,
7, 9, 10 and 11 are designed to provide the Board with sufficient
independence and the resources and information it needs to

monitor and address any conflicts of interest with affiliated persons
of the Adviser, including Wholly-Owned Sub-Advisers. Applicants state
that, accordingly, they believe the requested relief is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policy and
provisions of the Act.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Sub-Advised Series may rely on the order requested in
the application, the operation of the Sub-Advised Series in the manner
described in the application, including the hiring of Wholly-Owned Sub-
Advisers, has been, or will be, approved by, a majority of the Sub-
Advised Series' outstanding voting securities, as defined in the Act,
or in the case of a Sub-Advised Series whose public shareholders
purchase shares on the basis of a prospectus containing the disclosure
contemplated by condition 2 below, by the sole initial shareholder
before offering the Sub-Advised Series' shares to the public.
    2. The prospectus for each Sub-Advised Series will disclose the
existence, substance, and effect of any order granted pursuant to the
application. Each Sub-Advised Series will hold itself out to the public
as employing the Manager of Managers Structure. Each prospectus will
prominently disclose that the Adviser has the ultimate responsibility,
subject to oversight by the Board, to oversee the Sub-Advisers and
recommend their hiring, termination and replacement.
    3. The Adviser will provide general management services to each
Sub-Advised Series, including overall supervisory responsibility for
the general management and investment of the Sub-Advised Series'
assets, and, subject to review and approval by the Board, the Adviser
will: (a) Set the Sub-Advised Series' overall investment strategies;
(b) evaluate, select, and recommend Sub-Advisers to manage all or a
portion of the Sub-Advised Series' assets; and (c) implement procedures
reasonably designed to ensure that the Sub-Advisers comply with a Sub-
Advised Series' investment objectives, policies and restrictions.
Subject to review by the Board, the Adviser will (a) when appropriate,
allocate and reallocate the Sub-Advised Series' assets among multiple
Sub-Advisers; and (b) monitor and evaluate the performance of Sub-
Advisers.
    4. A Sub-Advised Series will not make any Ineligible Sub-Adviser
Changes without the approval of the shareholders of the applicable Sub-
Advised Series.
    5. A Sub-Advised Series will inform shareholders of the hiring of a
new Sub-Adviser within 90 days after the hiring of the new Sub-Adviser
pursuant to the Notice and Access Procedures.
    6. At all times, at least a majority of the Board will be
Independent Trustees, and the selection and nomination of new or
additional Independent Trustees will be placed within the discretion of
the then-existing Independent Trustees.
    7. Independent Legal Counsel, as defined in rule 0-1(a)(6) under
the Act, will continue to be engaged to represent the Independent
Trustees. The selection of such counsel will be within the discretion
of the then-existing Independent Trustees.
    8. The Adviser will provide the Board, no less frequently than
quarterly, with information about the profitability of the Adviser on a
per Sub-Advised Series basis. The information will reflect the impact
on profitability of the hiring or termination of any sub-adviser during
the applicable quarter.
    9. Whenever a sub-adviser is hired or terminated, the Adviser will
provide the Board with information showing the expected impact on the
profitability of the Adviser.
    10. Whenever a sub-adviser change is proposed for a Sub-Advised
Series with an Affiliated Sub-Adviser or a Wholly-Owned Sub-Adviser,
the Board, including a majority of the Independent Trustees, will make
a separate finding, reflected in the applicable Trust's Board minutes,
that such change is in the best interests of the Sub-Advised Series and
its shareholders and does not involve a conflict of interest from which
the Adviser or the Affiliated Sub-Adviser or Wholly-Owned Sub-Adviser
derives an inappropriate advantage.
    11. No trustee or officer of the Trusts or of a Sub-Advised Series
or any partner, director, manager or officer of the Adviser will own
directly or indirectly (other than through a pooled investment vehicle
that is not controlled by such person) any interest in a Sub-Adviser
except for: (a) Ownership of interests in the Adviser or any entity,
other than a Wholly-Owned Sub-Adviser, that controls, is controlled by,
or is under common control with the Adviser; or (b) ownership of less
than 1% of the outstanding securities of any class of equity or debt of
a publicly traded company that is either a Sub-Adviser or an entity
that controls, is controlled by, or is under common control with a Sub-
Adviser.
    12. Each Sub-Advised Series will disclose the Aggregate Fee
Disclosure in its registration statement.
    13. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the application, the requested order will expire on the effective
date of that rule.
    14. For Sub-Advised Series that pay fees to a Sub-Adviser directly
from fund assets, any changes to a Sub-Advisory Agreement that would
result in an increase in the total management and advisory fees payable
by a Sub-Advised Series will be required to be approved by the
shareholders of the Sub-Advised Series.

    For the Comission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-04800 Filed 3-4-14; 8:45 am]
BILLING CODE 8011-01-P


sufficiently developed or evaluated the cost and air quality data and
factors that the EPA has generally relied on in step 3, has not
conducted any sort of multifactor analysis to determine whether cost-
effective controls are available at the named sources, and has not
provided any alternative analysis that would support a conclusion at
step 3 that the named sources will significantly contribute to
nonattainment or interfere with maintenance of the NAAQS. The petition,
therefore, has not adequately supported the conclusions that the
sources named in its petition will significantly contribute to
nonattainment or interfere with maintenance of either the 2008 or the
2015 ozone NAAQS. Here, the petition simply names facilities that
appear to have larger emissions than other facilities (at least 400
tons of NOX per year) without supporting why the named
facilities should make certain reductions. The petition could have
included one or more of the following potential analyses to evaluate,
compare and identify ``significant'' emissions from of the named
sources, consistent with the EPA's past practice in evaluating regional
ozone transport: (i) Verifying that the named sources whose emissions
are those from the most recent emissions inventory continue to emit
NOX at the same rate or continue to operate; \63\ (ii)
describing or quantifying potentially available emissions reductions
from the named sources (i.e., the control technologies/techniques and
the costs of those control technologies/techniques); (iii) describing
the downwind air quality impacts of controlling the named sources
relative to other sources; or (iv) providing information on the
relative cost of the available emissions reductions and whether they
are less expensive than other reductions from other sources. In the
absence of such analyses, the petition has not demonstrated, based on
information available at this time, that the sources named in the
petition should be required to make further emissions reductions under
the good neighbor provision.
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    \63\ Such information may be found in the EPA's Enforcement and
Compliance Data (ECHO), which is a publicly available database
containing information for nearly all point sources in the U.S. Data
are typically updated several times a month. The operating status of
the point source at the facility level is available. Thus, the
operating status of non-EGU point sources can be determined outside
of having an up to date NEI version available. This is likely to be
accurate for the operating status of EGUs as well.
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    The petition also has not demonstrated how relevant cost and air
quality factors should be weighed to determine an appropriate level of
control for the named sources. Instead, the petition simply suggests
that upwind sources should be subject to a comparable level of control
as sources in downwind states (i.e., the $5,000/ton level of control
sources in New York are subjected to for purposes of RACT). While
information such as costs of controls in the downwind area may provide
useful data for consideration when evaluating upwind emissions
reduction potential, such information is not determinative of the
appropriate level of upwind control. Nothing in the text of the good
neighbor provision indicates that upwind states are required to
implement RACT, which is a requirement that applies to designated
nonattainment areas, see CAA section 172(c)(1) (nonattainment areas
generally), 182(b)(2) (ozone nonattainment areas classified as
Moderate), nor does the provision require uniformity of control
strategies imposed in both upwind and downwind states. Rather, the
provision indicates that states are required to prohibit those
emissions which ``contribute significantly to nonattainment'' or
``interfere with maintenance'' of the NAAQS in a downwind state, terms
that the Supreme Court has found to be ambiguous. See EME Homer City,
134 S. Ct. 1584. The EPA has always considered cost under the good
neighbor provision as part of a multifactor analysis based on the facts
and circumstances of the air quality problem at the time of each
evaluation, but the EPA has never set upwind control obligations based
solely on the level of controls imposed for purposes of RACT in
downwind nonattainment areas, as the petition suggests the EPA do here.
The EPA believes that such a multifactor analysis that considers
relevant cost and air quality factors is important for any evaluation
of a CAA section 126(b) petition regarding interstate transport of
ozone (a regional pollutant with contribution from a variety of
sources), as the EPA reviews whether the particular sources identified
in the petition should be controlled in light of the costs and
collective impact of emissions on air quality in the area, including
emissions from other anthropogenic sources. The petition fails to
conduct any comparable analysis. Review of the named sources in New
York's petition provides a starting point for such an analysis but does
not complete the analysis or even provide the type of data that would
be necessary for the EPA to conduct such an analysis to determine
whether the named sources emit or would emit in violation of the good
neighbor provision.
    The petition also suggests that upwind sources should be subject to
a comparable level of control as sources

in downwind states, in part, because it asserts that, while the CSAPR
program provides the legal and technical basis for states to eliminate
their significant contributions to excessive ozone pollution, the EPA
has failed to implement a full, federal-level remedy to completely
address the issue of transported ozone. Instead the EPA issued EGU
NOX ozone season emissions budgets as a partial remedy for
interstate transport for the 2008 ozone NAAQS. The petition asserts
that, according to the analyses in the CSAPR Update, after application
of the rule's NOX budgets, the EPA's modeling still
projected multiple remaining nonattainment and maintenance receptors in
the NYMA, including monitoring sites in Fairfield and New Haven
Counties in the Connecticut portion of the area, which would continue
to project nonattainment in 2017.
    While the EPA acknowledged in the CSAPR Update that the FIPs may
only be a partial remedy for interstate transport for the 2008 ozone
NAAQS, the EPA subsequently promulgated the Determination Rule, in
which the EPA concluded that the existing CSAPR Update fully addresses
the interstate transport obligations under CAA section
110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS for certain states,
including eight of the states named in New York's petition (Illinois,
Indiana, Maryland, Michigan, Ohio, Pennsylvania, Virginia and West
Virginia), because the downwind air quality problems projected in 2017
would be resolved in 2023. 83 FR 65878 (December 21, 2018). The EPA
also approved a SIP from Kentucky which similarly determined that the
CSAPR Update FIP would fully satisfy the state's good neighbor
obligation with respect to the 2008 ozone NAAQS (83 FR 33730).
Together, the EPA found that these actions fully address the good
neighbor requirements with respect to the 2008 ozone NAAQS for the
states named in the petition. For the reasons explained in this
section, the petition has failed to demonstrate that it is necessary to
implement additional, source-specific, unit-level emissions limits at
any of the sources named in the petition to ensure reductions are being
achieved under the CSAPR Update.
    As discussed earlier, the EPA interprets CAA section 126(b) as
placing the burden on the petitioner to demonstrate in the first
instance that a finding under the provision is justified. The breadth
of New York's petition demonstrates why the EPA's interpretation is
particularly reasonable. The petition names over 350 sources from
several different source sectors (both EGUs and non-EGUs) in nine
different upwind states and asked the EPA to evaluate and implement
source-specific emissions limits for each source. While the EPA has air
quality modeling information relevant to the step 1 and 2 analyses
discussed earlier, this analysis was conducted for separate rulemaking
actions and not solely for use in evaluating this petition. The EPA has
not already conducted the type of multifactor analysis that would
normally be used in step 3 to determine whether such a large group of
upwind sources emits or would emit in violation of the good neighbor
provision. The EPA also does not currently have information available
to independently conduct such an analysis, especially for such a
variety of sources. As noted in the Determination Rule (81 FR 65878),
the EPA lacks the relevant data to conduct such an analysis for the
multiple non-EGU source categories, including those referred to in this
petition. Collecting the relevant data and conducting such an analysis
independently would require the EPA to invest significant time and
resources. As the EPA noted in Section IV.B, the 60-day deadline
provided by Congress for action under CAA section 126(b) is evidence
that Congress did not intend for the EPA to be required to conduct such
detailed independent analyses before acting on the petitions,
especially where a petition addresses a large number and variety of
sources and seeks tailored unit-level remedies, as New York's petition
does. While the EPA acknowledges that this task may also be resource-
and time-intensive for a petitioner, the EPA nonetheless interprets the
timeframe imposed on the EPA in CAA section 126(b) (along with the
potentially severe consequences under CAA section 126(c) if a finding
is made) as evidence that the burden is on the petitioner in the first
instance to demonstrate that the statutory threshold has been met. For
the reasons discussed in this section, the petition does not provide
the EPA with a sufficient basis to conclude at step 3 that sources in
the named states will significantly contribute to nonattainment or
interfere with maintenance in New York with respect to either the 2008
or 2015 ozone NAAQS. Therefore, on this basis, the EPA is proposing to
deny New York's petition as to all named sources because, in addition
to the specific failures described above for steps 1 and 2, the state
has also failed to meet its burden to demonstrate at step 3 that the
sources emit or would emit in violation of the good neighbor provision.

V. Conclusion

    Based on the information discussed in this notice, the EPA is
proposing to deny New York's CAA section 126(b) petition. The EPA has
described several technical deficiencies with the petition and,
therefore, proposes to deny on the basis that New York has not met its
burden to demonstrate that the named sources emit or would emit in
violation of the good neighbor provision with respect to the 2008 ozone
NAAQS or the 2015 ozone NAAQS. For Chautauqua County, the petition does
not provide sufficient information to indicate that there will be a
downwind air quality problem (either nonattainment or maintenance) with
respect to either the 2008 or the 2015 ozone NAAQS. For the NYMA, with
respect to the 2008 ozone NAAQS, the petition does not provide
sufficient information to indicate that the NYMA should be considered a
nonattainment or maintenance receptor pursuant to the good neighbor
provision. Furthermore, the EPA's own independent analysis of available
information indicates that there is not currently nor is there
projected to be an air quality problem with respect to either NAAQS in
Chautauqua County, and that there is not projected to be any further
air quality problem with respect to the 2008 ozone NAAQS in the NYMA.
As an additional independent basis for the proposed denial, even if the
EPA assumed that the named upwind states were linked to downwind air
quality problems in New York at steps 1 and 2 of its interstate
transport framework, material elements in the petition's step 3
analysis are insufficient, such that the EPA cannot conclude that any
named source or group of sources in any of the named states will
significantly contribute to nonattainment or interfere with maintenance
in any area in New York with respect to either NAAQS. The EPA requests
comment on its proposed denial of New York's CAA section 126(b)
petitions, including the bases for the decision described herein.

VI. Judicial Review

    Section 307(b)(1) of the CAA indicates which Federal Courts of
Appeal have venue for petitions of review of final actions by the EPA.
This section provides, in part, that petitions for review must be filed
in the Court of Appeals for the District of Columbia Circuit if: (i)
The agency action consists of ``nationally applicable regulations
promulgated, or final action taken, by the Administrator;'' or (ii)
such action is locally or regionally applicable, but ``such action is
based on a

determination of nationwide scope or effect and if in taking such
action the Administrator finds and publishes that such action is based
on such a determination.''
    To the extent a court finds this action to be locally or regionally
applicable, the EPA proposes to find that this action is based on a
determination of ``nationwide scope or effect'' within the meaning of
CAA section 307(b)(1). This action addresses emissions impacts from
sources located in nine states, which are located in multiple EPA
Regions and federal circuits. The proposed action is also based on a
common core of factual findings and analyses concerning the transport
of pollutants between the different states.
    For these reasons, to the extent a court finds this action to be
locally or regionally applicable, the Administrator proposes to
determine that any final action related to this proposal is based on a
determination of nationwide scope or effect for purposes of section
307(b)(1) of the CAA. Thus, pursuant to CAA section 307(b), any
petitions for review of any final action related to this proposal must
be filed in the Court of Appeals for the District of Columbia Circuit
within 60 days from the date such final action is published in the
Federal Register.

VII. Statutory Authority

    42 U.S.C. 7410, 7426, 7601.

    Dated: May 6, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-09928 Filed 5-17-19; 8:45 am]
BILLING CODE 6560-50-P


From:	Lydia Wegman/RTP/USEPA/US
To<EMAIL_ADDRESS>Cc:	Joseph-J Dougherty/DC/USEPA/US@EPA, Beth Hassett-Sipple/RTP/USEPA/US@EPA
Date:	06/13/2012 10:45 AM
Subject:	Could you please send me the materials that have been provided by the outside groups with whom you've met this week?

Each of the groups has mentioned documents they've left with you and I'd like to have them for our record and for our review.  Also, could you please send me a list of the attendees at each of the meetings?  I can't always hear the introductions that clearly.  Thanks a lot.


[Federal Register Volume 81, Number 191 (Monday, October 3, 2016)]
[Notices]
[Pages 68105-68106]
[FR Doc No: 2016-23791]

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DEPARTMENT OF TRANSPORTATION

Global Positioning System Adjacent Band Compatibility Assessment
Workshop V Meeting

AGENCY: Office of the Assistant Secretary for Research and Technology
(OST-R), Department of Transportation.

ACTION: Notice of meeting.

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

SUMMARY: The purpose of this notice is to inform the public that the
U.S. Department of Transportation will host its fifth workshop on the
Global Positioning System (GPS) Adjacent Band Compatibility Assessment
effort. The purpose of this workshop is to discuss the results from
testing of various categories of GPS/Global Navigation Satellite System
(GNSS) receivers to include aviation (non-certified), cellular, general
location/navigation, high precision and networks, timing, and space-
based receivers. The workshop also will include a discussion on the
development of use-case scenarios for these categories.

DATES:
    Meeting date/time: October 14, 2016 10 a.m.-4 p.m. (Eastern
Daylight Time).
    Registration deadline: October 11, 2016. Request alternative
meeting formats or services by October 7, 2016.

ADDRESSES: RTCA, Inc., 1150 18th St. NW., Suite 910, Washington, DC
20036.
    Several days leading up to the workshop, an email containing the
agenda, dial-in, and WebEx information will be provided.

FOR FURTHER INFORMATION CONTACT: Stephen M. Mackey, U.S. Department of
Transportation, John A. Volpe National Transportation Systems Center,
V-345, 55 Broadway, Cambridge, MA 02142<EMAIL_ADDRESS>617-
494-2753.

SUPPLEMENTARY INFORMATION: The goal of the GPS Adjacent Band
Compatibility Assessment Study is to evaluate the adjacent radio
frequency band power levels that can be tolerated by GPS/GNSS
receivers, and advance the Department's understanding of the extent to
which such power levels impact devices used for transportation safety
purposes, among other GPS/GNSS applications. The Department obtained
input from broad public outreach in development of its GPS Adjacent
Band Compatibility Assessment Test Plan that included four public
meetings with stakeholders on September 18 and December 4, 2014, and
March 12 and October 2, 2015, public issuance of a draft test plan on
September 9, 2015 (see 80 FR 54368), and comments received regarding
the test plan. The final test plan was published March 9, 2016 (see 81
FR 12564) and requested voluntary participation in this Study by any
interested GPS/GNSS device manufacturers or other parties whose
products incorporate GPS/GNSS devices. In April 2016, radiated testing
of GNSS devices took place in an anechoic chamber at the U.S. Army
Research Laboratory at the White Sands Missile Range (WSMR) facility in
New Mexico. Additional lab testing was conducted in July 2016 at Zeta
Associates in Fairfax, Virginia and

MITRE Corporation in Bedford, Massachusetts (see 81 FR 44408).

Registration

    This workshop is open to the general public by registration only.
For those who would like to attend the workshop, we request that you
register no later than October 11, 2016. Please use the following link
to register: https://volpecenterevents.webex.com/volpecenterevents/onstage/g.php?MTID=e856d4f062c520e41d0793b581a9ead82
    You must include:

 Name
 Organization
 Telephone number
 Mailing and email addresses
 Attendance method (WebEx or on site)
 Country of citizenship

    The U.S. Department of Transportation is committed to providing
equal access to this workshop for all participants. If you need
alternative formats or services because of a disability, please contact
Stephen Mackey (see FOR FURTHER INFORMATION CONTACT section) with your
request by close of business October 7, 2016.

    Issued in Washington, DC, on September 26, 2016.
Gregory D. Winfree,
Assistant Secretary for Research and Technology.
[FR Doc. 2016-23791 Filed 9-30-16; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51439-51441]
[FR Doc No: 2011-21025]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65114; File No. SR-NSX-2011-10]

Self-Regulatory Organizations; National Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change to
Amend NSX Rule 11.19(c) Relating to Clearly Erroneous Transactions

August 11, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 11, 2011, National Stock Exchange, Inc. filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change, as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comment on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    National Stock Exchange, Inc. (``NSX[reg]'' or ``Exchange'')
proposes to amend its rules to ensure NSX Rule 11.19(c) will continue
to operate in the same way after changes to the single stock trading
pauses are effective.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nsx.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Background
    The exchanges \3\ and FINRA (collectively, the ``Markets''), in
consultation with the Securities and Exchange Commission (``SEC'' or
the ``Commission''), have made changes to their respective rules in a
concerted effort to strengthen the markets after the severe market
disruption that occurred on May 6, 2010. One such effort by the Markets
was to adopt a uniform trading pause process during periods of
extraordinary market volatility as a pilot in S&P 500 Index stocks
(``Pause Pilot''), approved by the Commission on June 10, 2010.\4\ On
September 10, 2010, the Commission approved the Market's proposals to
add the securities included in the Russell 1000 Index and specified
ETPs to the Pause Pilot.\5\ On September 10, 2010, the Commission also
approved changes proposed by the Markets to amend certain of their
respective rules to set forth clearer standards and curtail their
discretion with respect to breaking erroneous trades.\6\ The changes,
among other things, provided uniform treatment of clearly erroneous
execution

reviews in the event of transactions that result in the issuance of an
individual stock trading pause pursuant to the Pause Pilot on the
listing market and those that occur up to the time the trading pause
message is received by the other markets from the single plan processor
responsible for consolidation and dissemination of information for the
security (``Latency Trades'').
---------------------------------------------------------------------------

    \3\ For purposes of this filing, the term ``Exchanges'' refers
collectively to BATS Exchange, Inc., BATS Y-Exchange, Inc., NASDAQ
OMX BX, Inc., Chicago Board Options Exchange, Inc., Chicago Stock
Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc.,
International Securities Exchange LLC, The NASDAQ Stock Market LLC,
New York Stock Exchange LLC, NYSE Amex LLC, NYSE Arca, Inc.,
National Stock Exchange, Inc., and NASDAX [sic] OMX PHLX LLC.
    \4\ Securities Exchange Act Release Nos. 62252 (June 10, 2010),
75 FR 34186 (June 16, 2010) (File Nos. SR-BATS-2010-014; SR-EDGA-
2010- 01; SR-EDGX-2010-01; SR-BX-2010-037; SR-ISE- 2010-48; SR-NYSE-
2010-39; SR-NYSEAmex- 2010-46; SR-NYSEArca-2010-41; SR-NASDAQ- 2010-
061; SR-CHX-2010-10; SR-NSX-2010-05; and SR-CBOE-2010-047); 62251
(June 10, 2010), 75 FR 34183 (June 16, 2010) (SR-FINRA-2010- 025).
    \5\ See e.g.,Securities Exchange Act Release Nos. 62884
(September 10, 2010), 75 FR 56618 (September 16, 2010) (File Nos.
SR-BATS-2010-018; SR-BX-2010-044; SR-CBOE-2010-065; SR-CHX-2010-14;
SR-EDGA-2010-05; SR-EDGX-2010-05; SR-ISE-2010-66; SR-NASDAQ-2010-
079; SR-NYSE-2010-49; SR-NYSEAmex-2010-63; SR-NYSEArca-2010-61; and
SR-NSX-2010-08); and Securities Exchange Act Release No. 62883
(September 10, 2010), 75 FR 56608 (September 16, 2010) (SR-FINRA-
2010-033).
    \6\ Securities Exchange Act Release No. 62886 (September 16,
2010), 75 FR 56613 (September 16, 2010) (File Nos. SR-BATS-2010-016;
SR-BX-2010-040; SR-CBOE-2010-056; SR-CHX-2010-13; SR-EDGA-2010-03;
SR-EDGX-2010-03; SR-ISE-2010-62; SR-NASDAQ-2010-076; SR-NSX-2010-07;
SR-NYSE-2010-47; SR-NYSEAmex-2010-60; and SR-NYSEArca-2010-58).
---------------------------------------------------------------------------

    As part of the changes to the clearly erroneous process under Rule
11.19, the Exchange replaced existing Rule 11.19(c)(4) with all new
text to provide clarity in the clearly erroneous process when a Pause
Pilot trading pause is triggered. Pursuant to Rule 11.19(c)(4), Latency
Trades will be broken by the Exchange if they exceed the applicable
percentage from the Reference Price, as noted in the table found under
Rule 11.19(c)(1).\7\ The Reference Price, for purposes of Rule
11.19(c)(4), is the price that triggered a trading pause pursuant to
the Pause Pilot (the ``Trading Pause Trigger Price''). As such, Latency
Trades that occur on the Exchange would be broken by the Exchange
pursuant to Rule 11.19(c)(4) if the transaction occurred at either
three, five or ten percent above the Trading Pause Trigger Price.\8\
---------------------------------------------------------------------------

    \7\ Pursuant to Rule 11.19(c)(1), a security with a Reference
Price of greater than zero and up to and including $25 is subject to
a 10% threshold; a security with a Reference Price of greater than
$25 and up to and including $50 is subject to a 5% threshold; and a
security with a Reference Price of greater than $50 is subject to a
3% threshold.
    \8\ Rule 11.19 (c)(4).
---------------------------------------------------------------------------

    On June 23, 2011, the Commission approved a joint proposal to
expand the respective Pause Pilot rules of the Markets to include all
remaining NMS stocks (``Phase III Securities'').\9\ The new pilot
rules, which will be implemented on August 8, 2011, not only expand the
application of the Pause Pilot, but also apply larger percentage moves
that trigger a pause to the Phase III Securities. Specifically, the
rules of the listing markets were amended so that a pause in a Phase
III Security with a closing price on the previous trading day of $1 or
more is triggered by a 30 percent price move within a five minute
period. A pause in a Phase III Security with closing price on the
previous trading day of less than $1 is triggered by a 50 percent price
move within a five minute period. If no prior day closing price is
available, the last sale reported to the Consolidated Tape on the
previous trading day is used.
---------------------------------------------------------------------------

    \9\ Securities Exchange Act Release No. 64735 (June 23, 2011),
76 FR 38243 (June 29, 2011) (File Nos. SR-BATS-2011-016; SR-BYX-
2011-011; SR-BX-2011-025; SR-CBOE-2011-049; SR-CHX-2011-09; SR-EDGA-
2011-15; SR-EDGX-2011-14; SR-FINRA-2011-023; SR-ISE-2011-028; SR-
NASDAQ-2011-067; SR-NYSE-2011-21; SR-NYSEAmex-2011-32; SR-NYSEArca-
2011-26; SR-NSX-2011-06; SR-Phlx-2011-64).
---------------------------------------------------------------------------

    The Issue
    The recently-approved changes to the Pause Pilot will have the
unintended effect of removing the Phase III Securities from the normal
clearly erroneous process and potentially result in unfair outcomes in
the face of severe volatility in such securities. Phase III Securities
are currently subject to the clearly erroneous process under Rules
11.19(c)(1) to 11.19(c)(3), which apply to all securities except the
current Pause Pilot securities subject to a pause. For purposes of
transactions in securities not involving Pause Pilot securities, or
transactions involving Pause Pilot securities that occur when there is
not a pause pursuant to the Pause Pilot, the Reference Price is the
consolidated last sale price immediately prior to the execution(s)
under review, subject to certain exceptions.\10\ As noted above, the
Trading Pause Trigger Price is used as the Reference Price when a Pause
Pilot pause is in effect. As a consequence, under the current rules, a
Latency Trade is subject to the clearly erroneous thresholds based on
the Trading Pause Trigger Price, which represents a ten percent or
greater move in the transacted price of the security in a five minute
period.
---------------------------------------------------------------------------

    \10\ Id.
---------------------------------------------------------------------------

    Under the new Pause Pilot rules, a Latency Trade in a Phase III
Security occurs only after either a 30 or 50 percent (or greater) move
in the transacted price of the security in a five minute period. As a
result, a ETP Holder that trades in a Phase III Security that triggers
a clearly erroneous threshold of three, five or ten percent from the
Reference Price, yet falls below the Pause Pilot trigger of either 30
or 50 percent, would be able to avail themselves of a clearly erroneous
review. A similarly situated ETP Holder that transacts in the same
security as a Latency Trade at a price equal to or greater than the
Phase III Security thresholds, yet less than the clearly erroneous
thresholds under Rule 11.19(c)(1), would not be able to avail
themselves of the clearly erroneous process. Another ETP Holder that
transacts in the same security as a Latency Trade that exceeds three,
five or ten percent from the Trading Pause Trigger Price would
automatically receive clearly erroneous relief. The Exchange believes
that this would be an inequitable result and an arbitrary application
of the clearly erroneous process. Specifically, the Exchange believes
that, since the 30 and 50 percent triggers of the Pause Pilot are
substantially greater than the 10 percent threshold of the original
Pause Pilot, the Phase III Securities should remain under the current
clearly erroneous process of Rules 11.19(c)(1)-(3).
    Applying the clearly erroneous process under Rules 11.19(c)(1)-(3)
to the Phase III Securities would allow the Exchange to review all
transactions that exceed the normal clearly erroneous thresholds and
Reference Price, and, importantly, avoid arbitrary selection of
``winners'' and ``losers'' in the face of severe volatile moves in a
security of 30 or 50 percent over a five minute period. For example, an
ETP Holder that trades in a Phase III Security that triggers a clearly
erroneous threshold of three, five or ten percent, yet falls below the
Pause Pilot trigger threshold trading at 29 percent from the prior
day's closing price, would be potentially entitled to a clearly
erroneous break pursuant Rule 11.19(c)(1). Should trading in that same
stock trigger a trading pause at a price of 30 or 50 percent greater
than the prior day's close, the ETP Holder would not be entitled to a
clearly erroneous trade break unless that trade exceeded three, five or
ten percent beyond the price that triggered the pause. This scenario
causes an inequity among a group of ETP Holders that have transactions
in the Phase III Securities falling between the three, five and ten
percent thresholds from the Reference Price under the normal Rule
11.19(c)(1) clearly erroneous process and the Pause Pilot clearly
erroneous triggers of three, five or ten percent away from the Trading
Pause Trigger Price. Such ETP Holders would not be provided relief
under the clearly erroneous rules merely due to the imposition of a
Pause Pilot halt, notwithstanding that other ETP Holders with
transactions that occur at the same rolling five minute percentage
difference. The Exchange believes a better outcome is to afford all ETP
Holders transacting in Phase III Securities the opportunity of having
such trades reviewed.
Summary
    The expansion of the Pause Pilot to the Phase III Securities will
have the unintended consequence of setting the point at which a clearly
erroneous transaction occurs once a Pause Pilot pause is initiated far
beyond the triggers applied prior to the expansion, which will, in
turn, prevent certain market participants from availing themselves of
the clearly erroneous rules, notwithstanding that other similarly
situated participants are able to do so. The Exchange believes that
this would be an arbitrary application of the clearly erroneous process
in a manner that is

unfair and not consistent with the spirit and purpose of the rule.
Accordingly, the Exchange is proposing to amend Rules 11.19(c)(1)-(4)
to specify that Rule 11.19(c)(4) applies only to the current securities
of Pause Pilot, and not to Phase III Securities.\11\
---------------------------------------------------------------------------

    \11\ NSX notes that the Exchanges are filing similar proposals
to make the changes proposed herein.
---------------------------------------------------------------------------

2. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Securities Exchange Act of 1934 (the ``Act''),\12\ which
requires the rules of an exchange to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system and, in general,
to protect investors and the public interest. The proposed rule change
also is designed to support the principles of Section 11A(a)(1) \13\ of
the Act in that it seeks to assure fair competition among brokers and
dealers and among exchange markets. The Exchange believes that the
proposed rule meets these requirements in that it promotes transparency
and uniformity across markets concerning decisions to break erroneous
trades, yet also ensures fair application of the process so that
similarly situated ETP Holders are provided the same opportunity of a
clearly erroneous review. The Exchange notes that the changes proposed
herein will in no way interfere with the operation of the Pause Pilot
process, as amended.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(5).
    \13\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any inappropriate burden on competition.

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

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \14\ and Rule 19b-
4(f)(6)(iii) thereunder.\15\ The Exchange has asked the Commission to
waive the 5-day written notice requirement and the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Commission believes that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest
because such waiver will allow the clearly erroneous rules to continue
to operate as they did prior to the effectiveness of the Pause Pilot
expansion to Phase III Securities so that similarly situated ETP
Holders are provided the same opportunity of a clearly erroneous
review. Accordingly, the Commission waives the 30-day operative delay
requirement and designates the proposed rule change as operative upon
filing with the Commission.\16\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Commission is waiving the five day written notice
requirement in this case. Therefore, the Commission notes that the
Exchange has satisfied this requirement.
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NSX-2011-10 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSX-2011-10. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-NSX-2011-10 and should be
submitted on or before September 8, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-21025 Filed 8-17-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Proposed Rules]
[Pages 53964-53965]
[FR Doc No: 2016-19116]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-3992; Airspace Docket No. 15-ANM-14]

Proposed Amendment of Class E Airspace, Albany, OR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace at Albany
Municipal Airport, Albany, OR. Advances in Global Positioning System
(GPS) mapping accuracy and a reliance on precise geographic coordinates
to define airport and airspace reference points have made airspace
redesign necessary for the safety and management of Instrument Flight
Rules (IFR) operations.

DATES: Comments must be received on or before September 29, 2016.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2016-3992; Airspace Docket No. 15-ANM-14, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays. The Docket Office (telephone 1-800-
647-5527), is on the ground floor of the building at the above address.
    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.9Z at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Tom Clark, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace at Albany Municipal Airport, Albany,
OR.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Persons wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2015-3992/
Airspace Docket No. 15-ANM-14.'' The postcard will be date/time stamped
and returned to the commenter.

    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.9Z, Airspace
Designations and Reporting Points, dated August 6, 2015, and effective
September 15, 2015. FAA Order 7400.9Z is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.9Z lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by modifying Class E5 airspace extending
upward from 700 feet above the surface at Albany Municipal Airport,
Albany, OR. Controlled airspace would extend to within a 6.7-mile
radius of the airport to accommodate IFR departures up to 1,200 feet
above the surface; would include a small extension to the southwest to
accommodate IFR arrivals below 1,500 feet above the surface; and a
segment east of longitude 123[deg] would be removed, as there are no
IFR operations within that area. The FAA found these modifications
necessary for the safety and management of IFR operations at the
airport, while preserving the navigable airspace for aviation.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9Z, dated August 6, 2015, and effective September 15,
2015, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures
    (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this rule,
when promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

     Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting Points, dated August 6, 2015, and
effective September 15, 2015, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

ANM OR E5 Albany, OR [Modified]

Albany Municipal Airport, OR
    (Lat. 44[deg]38'16'' N., Long. 123[deg]03'34'' W.)

    That airspace extending upward from 700 feet above the surface,
within a 6.7-mile radius of Albany Municipal Airport, beginning at
the 158[deg] bearing from the airport clockwise to the 022[deg]
bearing, thence to the point of beginning, and that airspace 1.4
miles each side of the 230[deg] bearing from the airport extending
from the 6.7-mile radius to 8.5 miles southwest of the airport.

    Issued in Seattle, Washington, on August 5, 2016.
Sam Shrimpton,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2016-19116 Filed 8-12-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 177 (Friday, September 11, 2020)]
[Notices]
[Pages 56229-56231]
[FR Doc No: 2020-20040]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-3015]

Determination of Regulatory Review Period for Purposes of Patent
Extension; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for EVERSENSE CONTINUOUS
GLUCOSE MONITORING SYSTEM (EVERSENSE CGM SYSTEM) and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that medical
device.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by November 10, 2020.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by March 10, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 10, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-E-3015 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; EVERSENSE CGM SYSTEM.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov

or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device EVERSENSE CGM
SYSTEM. EVERSENSE CGM SYSTEM is indicated for continually measuring
glucose levels in adults (18 years or older) with diabetes for up to 90
days. The system is intended to: (1) Provide real-time glucose
readings; (2) provide glucose trend information; and (3) provide alerts
for the detection and prediction of episodes of low blood glucose
(hypoglycemia) and high blood glucose (hyperglycemia). The system is a
prescription device. Historical data from the system can be interpreted
to aid in providing therapy adjustments. These adjustments should be
based on patterns seen over time. The system is indicated for use as an
adjunctive device to complement, not replace, information obtained from
standard home blood glucose monitoring devices. Subsequent to this
approval, the USPTO received a patent term restoration application for
EVERSENSE CGM SYSTEM (U.S. Patent No. 6,400,974) from Senseonics, Inc.,
and the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated October 29,
2019, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of EVERSENSE CGM SYSTEM
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
EVERSENSE CGM SYSTEM is 3,727 days. Of this time, 3,123 days occurred
during the testing phase of the regulatory review period, while 604
days occurred during the approval phase. These periods of time were
derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: April 9, 2008. The applicant claims that the
investigational device exemption (IDE) required under section 520(g) of
the FD&C Act for human tests to begin became effective on September 25,
2008. However, FDA records indicate that the IDE was determined
substantially complete for clinical studies to have begun on April 9,
2008, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): October
26, 2016. FDA has verified the applicant's claim that the premarket
approval application (PMA) for EVERSENSE CGM SYSTEM (PMA P160048) was
initially submitted October 26, 2016.
    3. The date the application was approved: June 21, 2018. FDA has
verified the applicant's claim that PMA P160048 was approved on June
21, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a

true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: September 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20040 Filed 9-10-20; 8:45 am]
BILLING CODE 4164-01-P