[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Notices]
[Pages 69562-69565]
[FR Doc No: 2016-24146]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79017; File No. SR-NYSEARCA-2016-123]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Partial Amendment No. 1 and Order Granting Accelerated Approval of a
Proposed Rule Change, as Modified by Partial Amendment No. 1, Amending
Rule 7.46 Relating to the Exchange's Order Types To Implement the Tick
Size Pilot Program

September 30, 2016.

I. Introduction

    On August 25, 2016, NYSE Arca, Inc. (``Exchange'' or ``NYSE Arca'')
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:
(1) Change system functionality to implement the Plan to Implement a
Tick Size Pilot Program (``Plan'' or ``Pilot'') \3\ submitted to the
Commission pursuant to Rule 608 of Regulation NMS \4\ under the Act;
(2) clarify the operation of certain exceptions to the Trade-at
Prohibition \5\ on Pilot Securities in Test Group Three; (3) amend the
Limit Up/Limit Down (``LULD'') price controls pursuant to the
Regulation NMS Plan to Address Extraordinary Market Volatility (``LULD
Plan''); \6\ and (4) amend the Exchange's limit order price protection
rule. The proposed rule change was published for comment in the Federal
Register on September 15, 2016.\7\ The Commission received two comment
letters in response to the Notice.\8\ On September 27, 2016, the
Exchange filed a partial amendment to the proposed rule change
(``Amendment No. 1'').\9\
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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. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (``Approval Order''). Unless otherwise
specified, capitalized terms used in this rule filing are defined as
set forth in the Plan.
    \4\ 17 CFR 242.608.
    \5\ Exchange Rule 7.46(e)(4)(A) defines the ``Trade-at
Prohibition'' to mean the prohibition against executions by a
Trading Center of a sell order for a Pilot Security at the price of
a Protected Bid or the execution of a buy order for a Pilot Security
at the price of a Protected Offer during regular trading hours. See
also Plan Section I(LL) and Plan Section VI(D).
    \6\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (File No. 4-631).
    \7\ Securities Exchange Act Release No. 78801 (September 9,
2016), 81 FR 63525 (``Notice'').
    \8\ See Letters from Eric Swanson, EVP, General Counsel, Bats
Global Markets, Inc., Elizabeth K. King, General Counsel and
Corporate Secretary, New York Stock Exchange; and Thomas A. Wittman,
EVP, Global Head of Equities, Nasdaq, Inc., dated September 9, 2016
(``Comment Letter No. 1''); and Eric Swanson, EVP, General Counsel,
Bats Global Markets, Inc., dated September 12, 2016 (``Comment
Letter No. 2'').
    \9\ In Amendment No. 1, the Exchange proposes to do the
following: (1) Delete the proposal to amend Rule 7.35P because the
Exchange recently filed a separate proposed rule change to make the
same amendment, which is now operative. See Securities Exchange Act
Release No. 78861 (September 16, 2016) (SR-NYSEArca-2016-129)
(``Rule 7.35P Filing''); (2) modify Rule 7.46(f)(3) to provide that
Market Pegged Orders in all Pilot Securities would be rejected and
delete references to Market Pegged Orders in Rule 7.46(f)(5)(H); and
(3) correct typographical errors in the original proposal.
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    This order provides notice of filing of Amendment No. 1 and
approves the proposal, as modified by Amendment No. 1, on an
accelerated basis.

II. Description of the Amended Proposal

    The Exchange proposes to: (1) Change system functionality to
implement the Plan; (2) clarify the operation of certain exceptions to
the Trade-at Prohibition on Pilot Securities in Test Group Three; (3)
amend the LULD price controls pursuant to the LULD Plan; and (4) amend
the Exchange's limit order price protection rule.

A. Amendments to System Functionality To Implement the Plan

1. Trade-at Intermarket Sweep Orders (``TA ISO'') \10\
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    \10\ See proposed Exchange Rule 7.46(f)(1).
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    The Exchange proposes to accept TA ISOs in all securities. Further,
TA ISOs must be designated as Immediate or Cancel (``IOC''), may be
designated with a ``no midpoint execution'' modifier, may not be
designated with a minimum trade size, and do not route. TA ISO would be
immediately traded with contra-side displayed and non-displayed
interest in the NYSE Arca Book up to its full size and limit price and
the quantity not so traded will be immediately and automatically
cancelled.
2. Permitted Price Increment for Pilot Securities \11\
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    \11\ See proposed Exchange Rule 7.46(f)(2).
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    The Exchange proposes that references in Exchange rules to the
minimum price variation (``MPV'') \12\ would mean $0.05 instead of the
current $0.01 for Pilot Securities in Test Groups One, Two, and Three.
Further, references to truncating to the MPV in Exchange rules would
mean rounding down to the applicable quoting MPV for Pilot Securities
in Test Groups One, Two, and Three. Mid-Point Liquidity Orders \13\
must be entered with a limit price in a $0.05 pricing increment.
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    \12\ See Exchange Rule 7.6 for a definition of the MPV.
    \13\ A Mid-Point Liquidity Order is a Limit Order that is not
displayed, does not route, and has with a working price at the
midpoint of the PBBO. See Exchange Rule 7.31P(d)(3).
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3. Rejection of Market Pegged Orders in Pilot Securities \14\
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    \14\ See proposed Exchange Rule 7.46(f)(3). See also Amendment
No. 1.
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    The Exchange proposes that Market Pegged Orders \15\ will be
rejected for all Pilot Securities.
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    \15\ A Market Pegged Order is an order to buy (sell) with a
working price that is pegged to the PBO (PBB). See Exchange Rule
7.31P(h). A Market Pegged Order to buy (sell) will be rejected on
arrival, or cancelled when resting, if there is no PBO (PBB) against
which to peg. Market Pegged Orders will not participate in any
auctions. Market Pegged Orders are not displayed and are ranked
``Priority 3--Non-Display Orders.'' A Market Pegged Order to buy
(sell) may include an offset value that will set the working price
below (above) the PBO (PBB) by a specified offset.
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4. Retail Price Improvement Orders Increment \16\
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    \16\ See proposed Exchange Rule 7.46(f)(4).
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    The Exchange proposes that for Test Group Two and Test Group Three,
Retail Price Improvement Orders \17\

must be entered in pricing increments of $0.005.
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    \17\ A Retail Price Improvement Order consists of non-displayed
interest in NYSE Arca-listed securities and UTP Securities,
excluding NYSE-listed (Tape A) securities, that would trade at
prices better than the PBB or PBO by at least $0.001 and that is
identified as such. See Exchange Rule 7.44P(a)(4).
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5. Trading in Test Group Three Pilot Securities
a. Change in Priority \18\
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    \18\ See proposed Exchange Rule 7.46(f)(5)(A).
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    The Exchange proposes to revise the priority of resting orders \19\
for Pilot Securities in Test Group Three, as follows: (A) First
priority would be given to ``Priority 2--Display Orders,'' which are
non-marketable Limit Orders with a displayed working price; (B) second
priority would be given to ``protected quotations of Away Markets
\20\;'' (C) third priority would be given to ``Priority 1--Market
Orders,'' which are unexecuted Market Orders; and (D) fourth priority
would be given to ``Priority 3--Non-Display Orders,'' which are non-
marketable Limit Orders for which the working price is not displayed,
including reserve interest of Reserve Orders.
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    \19\ Exchange Rule 7.36P(e) sets forth the priority of orders
for all securities.
    \20\ See Exchange Rule 1.1(ffP).
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b. Routing to Away Markets \21\
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    \21\ See proposed Exchange Rule 7.46(f)(5)(B).
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    The Exchange proposes that for Pilot Securities in Test Group
Three, orders would not be routed to Away Markets that are not
displaying Protected Quotations.
c. Repricing of Limit Orders \22\
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    \22\ See proposed Exchange Rule 7.46(f)(5)(C).
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    The Exchange proposes to assign a working price equal to the re-
priced display price in Test Group Three for displayed limit orders to
avoid ranking orders undisplayed at the price of a Protected Quotation.
The Exchange currently assigns a display price of a displayed Limit
Order one MPV below (above) the contra-side PBO (PBB), and a working
price equal to the contra-side PBBO to prevent locking or crossing the
PBBO.\23\
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    \23\ See Exchange Rule 7.31P(a)(2)(C).
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d. Non-Displayed Portion of Reserve Orders \24\
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    \24\ See proposed Exchange Rule 7.46(f)(5)(D).
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    The Exchange proposes that for Pilot Securities in Test Group
Three, if a Reserve Order \25\ to buy (sell) is displayed at a price
that is locked or crossed by a protected offer (bid), the non-displayed
portion of the Reserve Order would be assigned a working price of $0.05
below (above) the protected offer (bid), but if routable, would route
to a protected offer (bid) based on the limit price of the order.
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    \25\ A Reserve Order is defined as a limit or inside limit order
with a quantity of the size displayed and with a reserve quantity of
the size (``reserve interest'') that is not displayed. See Exchange
Rule 7.31P(d)(1).
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e. Limit Non-Displayed Orders \26\
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    \26\ See proposed Exchange Rule 7.46(f)(5)(E).
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    The Exchange proposes that for Pilot Securities in Test Group
Three, a Limit Non-Displayed Order would be assigned a working price
one MPV away from the PBBO. Currently, if the limit price of a Limit
Non-Displayed Order to buy (sell) is equal to the PBO (PBB), the order
will be assigned a working price equal to the limit price, i.e., the
same price as the PBO (PBB).\27\
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    \27\ See Rule 7.31P(d)(2)(A).
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f. Orders That Do Not Route \28\
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    \28\ See proposed Exchange Rule 7.46(f)(5)(F).
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    The Exchange proposes changes to how orders with instructions do
not route would interact with the NYSE Arca Book. These orders include:
``Arca Only Orders,'' \29\ ``ALO Orders,'' \30\ and ``Intermarket Sweep
Orders.'' \31\ The Exchange proposes that on arrival, orders that do
not route would trade with resting orders in the NYSE Arca Book,
consistent with the terms of the order and the Trade-at Prohibition.
Day ISOs, on arrival, would be eligible for the Trade-at Intermarket
Sweep Orders exception to the Trade-at Prohibition. An IOC ISO to buy
(sell) would not trade with orders to sell (buy) ranked ``Priority 1--
Market Orders'' or ``Priority 3--Non-Display Orders'' that are the same
price as a protected offer (bid) unless the limit price of such IOC ISO
is higher (lower) than the price of the protected offer (bid).
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    \29\ An ``Arca Only Order'' is a limit order that does not
route. See Exchange Rule 7.31P(e)(1).
    \30\ An ``ALO Order'' is an Arca Only Order that, with some
exceptions, will not remove liquidity from the NYSE Arca Book and
must have a minimum on one displayed round lot. See Exchange Rule
7.31P(e)(2).
    \31\ An ``Intermarket Sweep Order'' is a Limit Order that does
not route and meets the requirements of Rule 600(b)(30) of
Regulation NMS. See Exchange Rule 7.31P(e)(3).
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    For Arca Only Order or ALO Orders, the Exchange proposes that when
being added to the NYSE Arca Book, such orders to buy (sell) with a
limit price equal to or above (below) the PBO (PBB) would be assigned a
display price and working price one MPV below (above) the PBO (PBB).
Once the Arca Only Order or ALO Order to buy (sell) is resting on the
NYSE Arca Book, such orders would not be eligible to trade with later-
arriving orders to sell (buy) ranked ``Priority 2--Display Orders''
priced equal to the PBO (PBB). A later-arriving order to buy (sell)
that is eligible to trade with the PBO (PBB) may trade before such
resting order.
g. Block Size Exception to the Trade-at Prohibition \32\
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    \32\ See proposed Exchange Rule 7.46(f)(5)(G).
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    The Exchange proposes that the only orders eligible for the block
size exception to the Trade-at Prohibition would be Limit IOC Cross
Orders \33\ that meet the Block Size definition. A Limit IOC Cross
Order that is at the same price as the PBBO but does not meet the Block
Size definition would be rejected in Test Group Three.
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    \33\ A Limit IOC Cross Order is a two-sided order with
instructions to match the buy-side with the identified sell-side at
a specified price and that does not route and will cancel at the
time of entry if the cross price is not between the BBO or would
trade through the PBBO. See Exchange Rule 7.31P(g)(1).
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h. Rejection of Tracking Orders \34\
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    \34\ See proposed Exchange Rule 7.46(f)(5)(H).
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    The Exchange proposes that Tracking Orders \35\ will be rejected
for Test Group Three Pilot Securities.
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    \35\ A Tracking Order is an order to buy (sell) with a limit
price that is not displayed, does not route, must be entered in
round lots and designated Day, and will trade only with an order to
sell (buy) that is eligible to route. The working price of a
Tracking Order to buy (sell) is the PBB (PBO), provided that such
price is at or below (above) the limit price of the Tracking Order.
See Exchange Rule 7.31P(d)(4).
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B. Limit Up-Limit Down (``LULD'') Price Bands

    The Exchange proposes that after the Exchange opens or reopens an
Exchange-listed security but before receiving Price Bands from the
Securities Information Processor (``SIP'') under the LULD Plan, the
Exchange would calculate Price Bands based on the first Reference Price
provided to the SIP and, if such Price Bands are not in the MPV for the
security, round such Price Bands to the nearest price at the applicable
MPV.

C. Limit Order Price Protection

    The Exchange proposes to specify that the limit order price
protection for both buy and sell orders that are not in the MPV for the
security would be rounded down to the nearest price at the applicable
MPV.

D. Miscellaneous Changes

    The Exchange proposes to add the phrase ``or Intermarket Sweep
Orders'' to the definition of ``Trade-at ISO'' as well as into the
Trade-at ISO exception to the Trade-at Prohibition to clarify that ISOs
may be routed to execute against

the full displayed size of the Protected Quotation that was traded
at.\36\
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    \36\ See proposed Exchange Rules 7.46(a)(1)(D)(ii) and
7.46(e)(4)(C)(x).
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    The Exchange proposes to amend the Block Size exception to the
Trade-at Prohibition to allow a Block Size order to execute on multiple
Trading Centers for the purpose of compliance with Rule 611 of
Regulation NMS.\37\
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    \37\ See proposed Exchange Rule 7.46(e)(4)(C)(iii).
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    Finally, the Exchange proposes to correct numerous typographical
errors in the proposed rule text.

III. Summary of Comment Letters

    Both comment letters express support for the proposed rule change
and suggest that the Commission should approve the proposal. In Comment
Letter No. 1, the commenters stated that if the proposal is approved as
proposed, then NYSE would be able to meet the October 3, 2016
implementation date. Further, in Comment Letter No. 1, the commenters
stated their belief that the requirements from the Commission have been
unclear. In Comment Letter No. 2, the commenter questioned Commission
staff's authority.

IV. Discussion and Commission's Findings

    After careful review of the proposed rule change, as modified by
Amendment No. 1, and the comment letters, the Commission finds that the
proposal, as modified by Amendment No. 1, is consistent with the
requirements of the Act, Rule 608 of Regulation NMS,\38\ and the rules
and regulations thereunder that are applicable to a national securities
exchange.\39\ Specifically, the Commission finds that the rule change
is consistent with Section 6(b)(5) of the Act,\40\ which requires that
the rules of a national securities exchange be designed, among other
things, to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and to protect investors and the public interest; and
are not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \38\ 17 CFR 242.608.
    \39\ In approving this rule change, the Commission has
considered the rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \40\ 15 U.S.C. 78f(b)(5).
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    As noted in the Approval Order, the Plan is by design, an
objective, data-driven test to evaluate how a wider tick size would
impact trading, liquidity, and market quality of securities of smaller
capitalization companies. In addition, the Plan is designed with three
Test Groups and a Control Group, to allow analysis and comparison of
incremental market structure changes on the Pilot Securities and is
designed to produce empirical data that could inform future policy
decisions.
    The Exchange proposes changes to modify how the Exchange will
handle orders during the Pilot Period. Specifically, the Exchange
proposes to accept TA ISOs in all securities, to specify how references
to MPV should be considered for Pilot Securities in the Test Groups, to
require that MPL Orders with a limit price must be entered in a $0.05
pricing increment for Pilot Securities in the Test Groups, to reject
Market Pegged Orders \41\ and to specify the pricing increment for
Retail Price Improvement Orders in Test Groups Two and Three. The
Exchange further proposes changes for Pilot Securities in Test Group
Three to comply with the Trade-at Prohibition, including a different
priority for execution of resting orders, how display price and working
price would be determined for certain Limit Orders, Reserve Orders and
Non-Displayed Limit Orders, how orders that do not route would operate,
and that Tracking Orders would be rejected for Test Group Three Pilot
Securities. In addition, the Exchange proposes to not route to Away
Markets that are not displaying Protected Quotations. Finally, the
Exchange proposes to only permit Limit IOC Cross Orders that meet the
Block Size definition to be eligible for the Block Size exception to
the Trade-at Prohibition.\42\
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    \41\ See Amendment No. 1. The Exchange originally proposed to
reject Market Pegged Orders only in Test Group Three. The Commission
believes that the amendment to reject all Market Pegged Orders in
Pilot Securities modifies the proposal so that it does not cause a
disparate impact on different Test Groups and the Control Group.
    \42\ The Commission notes that the Limit IOC Cross Orders that
meet the definition of Block Size must also satisfy the provisions
of the Block Size exception, including that it may not be an
aggregation of non-block orders, or broken into orders small than
Block Size prior to submitting the order to a Trading Center for
execution. See NYSE Acra Rule 7.46(e)(4)(C).
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    The Commission believes that these changes are reasonably designed
to comply with the Plan. Further, the Commission believes that the
proposed changes that are targeted at particular Test Groups are
necessary for compliance with the Plan. Accordingly, the Commission
finds that these changes are consistent with Section 6(b)(5) of the Act
\43\ and Rule 608 of Regulation NMS \44\ because they implement the
Plan and clarify Exchange Rules.
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    \43\ 15 U.S.C. 78f(b)(5).
    \44\ 17 CFR 242.608.
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    In addition, the Exchange proposes to adopt a rule to specify how
the Exchange will calculate LULD Price Bands after the Exchange opens
or reopens. The Commission believes that this change should help to
ensure that trading does not occur outside of Price Bands when LULD is
in effect.
    Finally, the Exchange proposes to specify that if Limit Order Price
Protection is not in the MPV it would be rounded down to the nearest
price at the applicable MPV. The Commission believes that this change
should provide clarity in the Exchange's rules.
    For these reasons, the Commission finds that the proposed rule
change, as modified by Amendment No.1, is consistent with the
requirements of the Act and Rule 608 of Regulation NMS.

V. Solicitation of Comments on Amendment No. 1 to the Proposed Rule
Change

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether Amendment No. 1
is consistent with the Act. Comments may be submitted by any of the
following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2016-123 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR- NYSEArca-2016-123. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be

available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549-1090, on
official business days between the hours of 10:00 a.m. and 3:00 p.m.
Copies of such filing will also be available for inspection and copying
at the principal office of the Exchange. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEArca-2016-123 and should be
submitted on or before October 27, 2016.

VI. Accelerated Approval of Proposed Rule Change, as Modified by
Amendment No. 1

    The Commission finds good cause to approve the proposed rule
change, as modified by Amendment No. 1, prior to the thirtieth day
after the date of publication of notice of the proposed rule change, as
modified by Amendment No. 1 in the Federal Register. As described
above, the Exchange proposes to amend its rules to comply with the Plan
and clarify other rules related to LULD and Limit Order Price
Protection.
    The Commission believes that the proposals to clarify how LULD
Price Bands that are calculated by the Exchange would be rounded in
instances where they are not in the MPV for a security and how Limit
Order Price Protection would be rounded in instances where it is not in
the MPV for a security provides clarity in the Exchange rules.
    In addition, the Commission notes that the Pilot is scheduled to
start on October 3, 2016, and accelerated approval of the proposal
would ensure that the rules of the Exchange would be in place for the
start of the Pilot. Accordingly, the Commission finds good cause,
pursuant to Section 19(b)(2) of the Exchange Act,\45\ to approve the
proposed rule change, as modified by Amendment No. 1, on an accelerated
basis.
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    \45\ 15 U.S.C. 78s(b)(2).
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VII. Conclusion

    It is therefore ordered that, pursuant to Section 19(b)(2) of the
Act,\46\ that the proposed rule change (SR-NYSEArca-2016-123), as
modified by Amendment No. 1, be and hereby is, approved on an
accelerated basis.
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    \46\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\47\
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    \47\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-24146 Filed 10-5-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 5 (Wednesday, January 8, 2014)]
[Proposed Rules]
[Pages 1336-1337]
[FR Doc No: 2014-00100]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-0901; Notice No. 25-13-23-SC]

Special Conditions: Airbus, Model A350-900 Series Airplane;
Flight Envelope Protection: High Speed Limiting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed special conditions.

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SUMMARY: This action proposes special conditions for Airbus Model A350-
900 series airplanes. These airplanes will have a novel or unusual
design feature associated with high speed limiting. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These proposed special conditions
contain the additional safety standards that the Administrator
considers necessary to establish a level of safety equivalent to that
established by the existing airworthiness standards.

DATES: Send your comments on or before February 7, 2014.

ADDRESSES: Send comments identified by docket number FAA-2013-0901
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC., between 9 a.m. and 5 p.m.,
Monday through Friday, except federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays.

FOR FURTHER INFORMATION CONTACT: Joe Jacobsen, FAA, Airplane and
Flightcrew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile (425) 227-
1320.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite interested people to take part in this rulemaking by
sending

written comments, data, or views. The most helpful comments reference a
specific portion of the special conditions, explain the reason for any
recommended change, and include supporting data.
    We will consider all comments we receive on or before the closing
date for comments. We may change these special conditions based on the
comments we receive.

Background

    On August 25, 2008, Airbus applied for a type certificate for their
new Model A350-900 series airplane. Later, Airbus requested and the FAA
approved an extension to the application for FAA type certification to
June 28, 2009. The Model A350-900 series has a conventional layout with
twin wing-mounted Rolls-Royce Trent engines. It features a twin aisle
9-abreast economy class layout, and accommodates side-by-side placement
of LD-3 containers in the cargo compartment. The basic Model A350-900
series configuration will accommodate 315 passengers in a standard two-
class arrangement. The design cruise speed is Mach 0.85 with a Maximum
Take-Off Weight of 602,000 lbs. Airbus proposes the Model A350-900
series to be certified for extended operations (ETOPS) beyond 180
minutes at entry into service for up to a 420-minute maximum diversion
time.
    The longitudinal control law design of the Airbus Model A350-900
incorporates an overspeed protection system in the normal mode; this
would prevent the pilot from inadvertently or intentionally exceeding a
speed approximately equivalent to VFC or attaining
VDF. Current Title 14 Code of Federal Regulations (14 CFR)
part 25 sections do not relate to a high speed limiting protection
system that might preclude or modify flying qualities assessments in
the overspeed region. However, the requirements of Sec.  25.253 (High-
speed characteristics) and its related policy are applicable to the
Model A350-900 series and not affected by this proposed special
condition.

Type Certification Basis

    Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Airbus
must show that the Model A350-900 series meets the applicable
provisions of 14 CFR part 25, as amended by Amendments 25-1 through 25-
129.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Airbus Model A350-900 series
because of a novel or unusual design feature, special conditions are
prescribed under Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and
proposed special conditions, the Model A350-900 series must comply with
the fuel vent and exhaust emission requirements of 14 CFR part 34 and
the noise certification requirements of 14 CFR part 36 and the FAA must
issue a finding of regulatory adequacy under section 611 of Public Law
92-574, the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19,
under Sec.  11.38, and they become part of the type-certification basis
under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Model A350-900 series will incorporate the following novel or
unusual design features: An overspeed protection system which prevents
the pilot from inadvertently or intentionally exceeding a speed
approximately equivalent to VFC or attaining VDF.
    At VMO + 10 knots or MMO + 0.02, an automatic
nose up pitch is applied with phase advance in case of high
acceleration. The speed stabilizes at VD - 10kts/
MD - 0.02 if the stick is full forward, or the speed will
return below VMO/MMO if the stick is released.

Discussion

    This proposed special condition establishes requirements to ensure
that operation of the high speed limiting protection system does not
impede normal attainment of speeds up to the overspeed warning. Its
main features are:
    1. It protects the airplane against high speed/high Mach number
flight conditions beyond VMO/MMO.
    2. It does not interfere with flight at VMO/
MMO, even in turbulent air.
    3. It still provides load factor limitation through the ``pitch
limiting'' function described below.
    4. It restores positive static stability beyond VMO/
MMO.

Applicability

    As discussed above, these proposed special conditions apply to
Airbus Model A350-900 series airplanes. Should Airbus apply later for a
change to the type certificate to include another model incorporating
the same novel or unusual design feature, the proposed special
conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on the Airbus Model A350-900 series airplanes. It is not a rule of
general applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Proposed Special Conditions

    Accordingly, the Federal Aviation Administration (FAA) proposes the
following special condition as part of the type certification basis for
Airbus Model A350-900 series airplanes.
    In addition to Sec.  25.143, the following requirements apply:
Operation of the high speed limiter during all routine and descent
procedure flight must not impede normal attainment of speeds up to
overspeed warning

    Issued in Renton, Washington, on October 22, 2013.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-00100 Filed 1-7-14; 8:45 am]
BILLING CODE 4910-13-P


1Section 182( b)( 3) specifies that EPA would approve any request from a State to reclassify to a higher classification. Technical Support Document for Cass County, Michigan September 2004 Chapter 1.0 Summary On July 15, 2004 Steven Chester, Michigan Department of Environmental Quality ( MDEQ) Director and Governor's designee, submitted a request to reclassify Cass County from Moderate ozone nonattainment to Marginal ozone nonattainment. A subsequent submittal supplying additional information was made on August 20, 2004. The petition is based on the area's Moderate design value of 93 ppb being within 5% of the maximum Marginal design value of 91 ppb as allowed by the Clean Air Act.

EPA has reviewed this request and believes the area should be reclassified as Marginal ozone nonattainment.

2.0 Introduction This section describes the statutory provisions and EPA guidance regarding reclassification of ozone nonattainment areas. Sections 181( a)( 4) and 182( b)( 3) of the Clean Air Act provide that areas may be reclassified under certain circumstances. This technical support document addresses the provisions of section 181( a)( 4) and a specific request for reclassifications received by the State of Michigan. The EPA has not received any requests for reclassification under section 182( b)( 3) for the 8 hour ozone standard. 1 Under section 181( a)( 4), an ozone nonattainment area may be reclassified " if an area classified under paragraph ( 1) ( Table 1) would have been classified in another category if the design value in the area were 5 percent greater or 5 percent less than the level on which such classification was based." In the April 30, 2004 notice, we indicated that an area with a moderate design value of 96 ppb ( or less) would be eligible to request a bump down because five percent less than 96 ppb is 91 ppb, a marginal design value.

The EPA previously described criteria to implement the section 181( a)( 4) provisions in a final rule designating and classifying areas published on November 6, 1991 ( 56 FR 56698). As stated in that notice, the provisions of section 181( a)( 4) set out general  2

criteria and grant the Administrator broad discretion in making or determining not to make, a reclassification. As part of the 1991 action, EPA developed more specific criteria to evaluate whether it is appropriate to reclassify a particular area. The EPA also described these criteria in the April 30, 2004 final rule. The general and specific criteria are as follows:

General: The EPA may consider the number of exceedances of the national primary ambient air quality standard for ozone in the area, the level of pollution transport between the area and other affected areas, including both intrastate and interstate transport, and the mix of sources and air pollutants in the area.

Request by State: The EPA does not intend to exercise its authority to bump down areas on EPA's own initiative. Rather, EPA intends to rely on the State to submit a request for a bump down. A Tribe may also submit such a request and, in the case of a multi state nonattainment area, all affected States must submit the reclassification request.

Discontinuity: A five percent reclassification must not result in an illogical or excessive discontinuity relative to surrounding areas. In particular, in light of the areawide nature of ozone formation, a reclassification should not create a " donut hole" where an area of one classification is surrounded by areas of higher classification.

Attainment: Evidence should be available that the proposed area would be able to attain by the earlier date specified by the lower classification in the case of a bump down.

Emissions reductions: Evidence should be available that the area would be very likely to achieve the appropriate total percent emission reduction necessary in order to attain in the shorter time period for a bump down.

Trends: Near and long term trends in emissions and air quality should support a reclassification. Historical air quality data should indicate substantial air quality improvement for a bump down. Growth projections and emission trends should support a bump down. In addition, we will consider whether vehicle miles traveled and other indicators of emissions are increasing at higher than normal rates.

Years of data: For the 8 hour ozone standard, the 2001 2003  3

period is central to determining classification. Data from 2004 may be used to corroborate a bump down request but should not be the sole foundation for the bump down request.

Limitations on Bump Downs An area may only be reclassified to the next lower classification. An area cannot present data from other years as justification to be reclassified to an even lower classification. In addition, section 181( a)( 4) does not permit moving areas from subpart 2 into subpart 1.

In 1991, EPA approved reclassifications when the area met the first requirement ( a request by the State to EPA) and at least some of the other criteria and did not violate any of the criteria ( emissions, reductions, trends, etc.). In our April 30, 2004 final rule on designations and classifications, we stated our intention to use this method and these criteria once again to evaluate reclassification requests under section 181( a)( 4), with minor changes described in that notice. In that notice we also described how we applied these criteria in 1991. For additional information, see section 5, " Areas requesting a 5% downshift per § 181( a)( 4) and EPA's response to those requests," of the Technical Support Document, October 1991, for the 1991 rule. [ Docket A 90 42A.]

EPA is not basing this reclassification determination on consideration of whether the nonattainment area being reclassified does or does not cause any pollution transport. The EPA is presently addressing ozone pollution transport issues throughout the eastern part of the United States under other Clean Air Act provisions. Specifically, EPA has proposed a determination that emissions from certain states contribute significantly to downwind nonattainment for ozone under CAA section 110( a)( 2)( D) through the Clean Air Interstate Rule ( CAIR). The CAIR proposal, published in a Federal Register notice dated January 30, 2004, would require upwind States to eliminate emissions that contribute significantly to nonattainment in downwind States. 69 Fed. Reg. 454566. The EPA previously issued the NOx SIP call ( 63 FR 57356) to address interstate ozone transport. In the event of any intrastate transport issue, states have the obligation to develop attainment SIPs for each area that show timely attainment, and can address any intrastate transport issues in that context.

The April 30, 2004 notice invited States to submit the reclassification requests within 30 days of the effective date of the designations and classifications. The effective date was June 15 which means that reclassification requests were to be  4

submitted by July 15, 2004. This relatively short time frame is necessary because section 181( a)( 4) only authorizes the Administrator to make such reclassifications within 90 days after the initial classification, September 15, 2004.

3.0 Background Cass County is highly impacted by transport due to the Lake Michigan ozone phenomenon. Cass County has low population and no major sources. EPA designated this area as Moderate due to high 8 hour values ( design value is 93 ppb) and 1 hour values ( 122 ppb).

4.0 Reclassification Request by State The State argues that Cass County should receive a reclassification from Moderate to Marginal. The demonstration is based on modeling showing earlier attainment ( 2007), identification of the ozone transport problem in the area, and a demonstration of less than one percent of contribution from local sources.

5.0 EPA Review of the Reclassification Request 5.1 Request by State The request was submitted by Steven Chester, Director of Michigan Department of Environmental Quality. The MDEQ Director is the Governor's designee.

5.2 Discontinuity If Cass County is reclassified from Moderate to Marginal, this will not result in a discontinuity. All of the counties immediately bordering Cass County are either designated as attainment or are Subpart 1 nonattainment.

5.3 Attainment The Lake Michigan Air Directors Consortium ( LADCo) used modeling results performed to support the 1 hour ozone attainment demonstration for the Lake Michigan area and applied 8 hour ozone metrics. This modeling conducted by LADCo indicates that Cass County will be in attainment ( 81 ppb) in 2007. However, as noted in Michigan's petition, the LADCO subregional modeling was completed in 2001 and designed to assess 1 hour ozone and, as such, there are some limitations with using it to assess 8 hour ozone. On the other hand, it should be noted that three of the  5

2Engine manufacturers will have flexibility to meet the new standards through a phase in approach between 2007 and 2010. The fuel provision will go into effect in June 2006 and will be phased in through 2009. four modeled episodes are representative periods for high 8 hour ozone and basecase model performance for 8 hour ozone was found to be as good as ( or better than) that for 1 hour ozone ( page 7 of the IDEM & LADCo July 2004 " Photochemical Modeling Analysis of 8 Hour Ozone for LaPorte County"). Since this modeling was performed before the Heavy Duty Engine rule was proposed, it does not reflect emission reductions from that national program. 2 Use of a more recent emission inventory and base design value would likely result in lower predicted concentrations.

Additional, regional scale, modeling from the January 2004 proposed Clean Air Interstate Rule however, indicates that the area will be in attainment ( 83 ppb) by 2010. The CAIR modeling, however, was not designed to provide results for years prior to 2010.

5.4 Emissions Reductions Because this area is so heavily impacted by transported pollution from upwind areas, it would be difficult to show that reductions from the area will help to achieve the area's earlier attainment date. It can be expected that ozone values will continue to decrease due to the implementation of various rules such as the NOx SIP Call, Tier II/ Low Sulfur, Heavy Duty Diesel Engine standards/ low sulfur diesel, and other national rules. In addition, implementation of emission reductions contained in 1 hour ozone attainment plans in the Lake Michigan area will further reduce emissions.

Other voluntary measures being implemented in the Lake Michigan area include:

° Schoolbus, nonroad vehicle and garbage truck diesel retrofit programs ° Alternative fuel fleets ° Gas can replacement programs ° Lawmower buyback programs ° Educational outreach programs and ozone action days 5.5 Trends  6

3The ozone values for the 2004 ozone season through September 1 and are preliminary. The 4th highest values for ozone from 2002, 2003 and 20043 show a decreasing trend at 103 ppb, 89 ppb and 74 ppb, respectively. Further, it can be expected that ozone values will continue at these lower levels due to the implementation of various rules such as the NOx SIP Call, Tier II/ Low Sulfur, Heavy Duty Diesel Engine standards/ low sulfur diesel, and other national rules. In addition, implementation of emission reductions contained in 1 hour ozone attainment plans in the Lake Michigan area will further reduce emissions and improve air quality.

5.6 Years of Data The design value being used a 2001 2003 value and it is 93 ppb.

5.7 Additional Information The CAMx ( version 4.03), with the OSAT technology, was used in this analysis to determine the geographic source ( i. e., Chicago) contribution of ozone precursors and source emissions type ( i. e., on road mobile) contribution at specific locations such as the Cassopolis monitor. Based on that analysis, less than one percent of the ozone recorded at the Cassopolis monitor can be attributed to local ( i. e., Cass Co. plus St. Joseph Co.) emissions.

5.8 Conclusions In summary, the following factors support the request for reclassification to marginal for Cass County: the design value of 93 ppb meets our criteria to qualify for consideration of bump down, local and regional modeling analyses indicate air quality will be improving over the next several years and support attainment by the marginal area attainment date, a short term trends analysis shows ozone values decreasing, and additional reductions from regional and national regulations will continue this trend in lowering ambient ozone values.

5.9 EPA Action The reclassification request for Cass County meets all of the criteria ( request, discontinuity, attainment, emission reductions, trends, and data) EPA established ( 69 FR 23863). Therefore, EPA is approving the reclassification request for Cass County.  7

6.0 Additional Information Additional information regarding the bump down request for this area is contained in the docket for this action. This information includes the State request, supporting documents, and other necessary material.


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4224-4226]
[FR Doc No: 2018-01655]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1279 and FDA-2016-E-1282]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SAPIEN 3 TRANSCATHETER HEART VALVE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for SAPIEN 3 TRANSCATHETER
HEART VALVE and is publishing this notice of that determination as
required by law. FDA has made the determination because of the
submission of applications 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
2, 2018. 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 July 30, 2018. 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 April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 2018. 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 Office, 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 Nos.
FDA-2016-E-1279 and FDA-2016-1282 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER
HEART VALVE.'' 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.
     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 Office. 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.gpo.gov/fdsys/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.

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 SAPIEN 3
TRANSCATHETER HEART VALVE. SAPIEN 3 TRANSCATHETER HEART VALVE is
indicated for relief of aortic stenosis in patients with symptomatic
heart disease due to severe native calcific aortic stenosis who are
judged by a heart team, including a cardiac surgeon, to be at high or
greater risk for open surgical therapy (i.e., Society of Thoracic
Surgeons Operative Risk score 8 percent or at a 15 percent risk of
mortality at 30 days). Subsequent to this approval, the USPTO received
a patent term restoration application for SAPIEN 3 TRANSCATHETER HEART
VALVE (U.S. Patent Nos. 7,585,321 and 8,591,575) from Edwards
Lifesciences PVT, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated July 12, 2016, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of SAPIEN 3 TRANSCATHETER HEART VALVE 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
SAPIEN 3 TRANSCATHETER HEART VALVE is 1,736 days. Of this time, 1,558
days occurred during the testing phase of the regulatory review period,
while 178 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: September 17, 2010. 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
July 31, 2014. However, FDA records indicate that the

IDE was determined substantially complete for clinical studies to have
begun on September 17, 2010, 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): December
22, 2014. The applicant claims December 19, 2014, as the date the
premarket approval application (PMA) for SAPIEN 3 TRANSCATHETER HEART
VALVE (PMA P140031) was initially submitted. However, FDA records
indicate that PMA P140031 was submitted on December 22, 2014.
    3. The date the application was approved: June 17, 2015. FDA has
verified the applicant's claim that PMA P140031 was approved on June
17, 2015.
    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 applications for patent extension,
this applicant seeks 250 days 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: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01655 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Rules and Regulations]
[Pages 52916-52918]
[FR Doc No: 2020-18962]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2020-0469]
RIN 1625-AA08

Special Local Regulation; Boat Parade; San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary special local
regulation (SLR) on the waters of San Diego Bay, California on
September 6, 2020. This temporary SLR is necessary to provide for the
safety of the participants, crew, spectators, sponsor vessels, and
general users of the waterway. This SLR temporarily establishes a
designated section of the commercial anchorage area as a First

Amendment area to be used at the discretion of the the Captain of the
Port, or his designated representative as a spectator area. Parade
participants operating within the SLR shall comply with all
instructions given by the on-scene PATCOM monitoring the event. During
the enforcement period, persons and vessels are prohibited from
anchoring, blocking, loitering, or impeding within this regulated area
unless authorized by the Captain of the Port, or his designated
representative.

DATES: This rule is effective from noon to 4 p.m. on September 6, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0469 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Merridith Morrison, Waterways
Management, U.S. Coast Guard Sector San Diego, CA; telephone (619) 278-
7656, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment 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 and
opportunity to comment 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 it is impracticable due to the short
time between the Coast Guard becoming aware of the event on July 24,
2020, and the scheduled event occurring on September 6, 2020. The
marine event sponsor of this boat parade is expecting to draw a high
concentration of vessels to the San Diego Bay area along the proposed
parade route. Traditionally, the San Diego Bay area serves as a major
thoroughfare for commercial traffic, naval operations, ferry routes,
and a number of other recreational uses. The Coast Guard is
establishing this SLR to monitor the parade before, during, and after
the event to minimize impacts on this congested waterway. We must
establish this SLR by September 6, 2020 to ensure the safety of
individuals, property, and the marine environment and we do not have
sufficient time to request and respond to comments.
    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. Delaying the effective date of
this rule would be contrary to public interest because immediate action
is needed to respond to the potential safety hazards associated with
the location, size and complexity of the boat parade that is planned to
take place on September 6, 2020.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70041. The Captain of the Port (COTP) Sector San Diego has determined
that potential hazards associated with the proposed parade will be a
safety concern for anyone within the vicinity of the parade route. This
rule is needed to protect personnel, vessels, spectators, and the
marine environment in the navigable waters within the SLR during the
enforcement period of this rule.

IV. Discussion of the Rule

    This rule establishes an SLR from noon until 4 p.m. on September 6,
2020. The SLR will cover all navigable waters on a pre-determined
course in the northern portion of the San Diego Main Ship Channel from
Shelter Island Basin, past the Embarcadero, crossing the federal
navigable channel and ending off of Coronado Island. This SLR will also
temporarily establish a 200 yard radius within the commercial anchorage
as a First Amendment area to be used as authorized by the Captain of
the Port, or his designated representative. The First Amendment area
will encompass all navigable waters, from surface to bottom, within 200
yards of 32[deg]43'11.0'' N, 117[deg]10'59.8'' W, within the commercial
vessel anchorage.
    The duration of the SLR is intended to protect personnel, vessels,
specators, and the marine environment in these navigable waters while
the parade is scheduled to occur. During the enforcement period,
persons and vessels are prohibited from anchoring, blocking, loitering,
or impeding within this regulated area unless authorized by the Captain
of the Port, or his designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the special local regulation.
The Coast Guard will publish a LNM that details the vessel restrictions
of the regulated area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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 a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
SLR may be small entities, for the reasons stated in section V.A above,
this rule will not have a significant economic impact on any vessel
owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.

    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.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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.

E. 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 an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that 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 involves an SLR
lasting only 4 hours that will monitor entry to the SLR for the
duration of the enforcement period to cover before, during and after
the parade has concluded. It is categorically excluded from further
review under paragraph L61 of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels. All non-participant vessels or
persons engaged in protest activity will be directed to the commercial
vessel anchorage if they wish to remain in the regulated area.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T11-034 to read as follows:

Sec.  100.T11-034  President Trump Boat Parade, San Diego, CA.

    (a) Regulated areas. The regulations in this section apply to the
following area:
    (1) All navigable waters, from surface to bottom, on a pre-
determined course in the northern portion of the San Diego Main Ship
Channel from Shelter Island Basin, past the Embarcadero, crossing the
federal navigable channel and ending off of Coronado Island.
    (2) All navigable waters, from surface to bottom, within 200 yards
of 32[deg]43'11.0'' N, 117[deg]10'59.8'' W, within the commercial
vessel anchorage.
    (b) Definitions. As used in this section--
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Sector San Diego
(COTP) in the enforcement of the regulations in this section.
    Participant means all persons and vessels registered with the event
sponsor as a participants in the race.
    (c) Regulations. (1) All non-participants are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area described in paragraph (a) of this section unless
authorized by the Captain of the Port Sector San Diego or their
designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by calling the Sector San Diego JHOC at<PHONE_NUMBER>.
Those in the regulated area must comply with all lawful orders or
directions given to them by the COTP or the designated representative.
    (3) All non-participants, including those engaged in protest
activity, may be directed by a designated representative to the
enforcement area described in section (a)(2) of this section, where
they must remain during the effective period unless otherwise
authorized or directed.
    (4) The COTP will provide notice of the regulated area through
advanced notice via broadcast notice to mariners and by on-scene
designated representatives.
    (d) Enforcement period. This section will be enforced from noon to
4 p.m. on Sunday, September 6, 2020.

    Dated: August 14, 2020.
T.J. Barelli,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2020-18962 Filed 8-26-20; 8:45 am]
BILLING CODE 9110-04-P


-----Forwarded by Melanie King/RTP/USEPA/US on 02/15/2010 09:28PM -----
To: "Higgins, Cortney"<EMAIL_ADDRESS>From: Melanie King/RTP/USEPA/US
Date: 02/12/2010 12:14PM
cc: RobertJ Wayland/RTP/USEPA/US@EPA, Fred Talcott/DC/USEPA/US@EPA, Michael
Horowitz/DC/USEPA/US@EPA
Subject: RE: RICE package

Hi Cortney,
Glad you made it back in!  Did I hear there was a chance of more snow next week?  I hope
not.

I sent you the impacts memo that Kevin requested.  The underlying information for the
population estimates comes from the Power Systems Research population information that
we received from OTAQ.  Attached are the spreadsheets used to generate the population
estimates.
(See attached file: OTAQ-PSR 1998 RICE pop-sales data.xls) (See attached file: CI
Projection 2007-2017 by NAICS - January 2009.xls)

Melanie King
Energy Strategies Group
Sector Policies and Programs Division
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency

Mail Code D243-01
RTP, NC  27711

Phone:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
<EMAIL_ADDRESS>
"Higgins, Cortney" ---02/12/2010 09:20:43 AM---Hi Melanie, Thanks for the update -- let me
know when it will come over.

From:

"Higgins, Cortney"<EMAIL_ADDRESS>
To:

Melanie King/RTP/USEPA/US@EPA

Date:

02/12/2010 09:20 AM

Subject
:

RE: RICE package

Hi Melanie,
Thanks for the update -- let me know when it will come over.

I'm in the office today! It's good to be back.

Can you provide the memo (or send the citation for the memo) for the
sector estimates of engines?

Thanks,
Cortney

-----Original Message-----
From<EMAIL_ADDRESS>[<EMAIL_ADDRESS>]

Sent: Thursday, February 11, 2010 4:30 PM
To: Higgins, Cortney
Subject: RICE package

Hi Cortney,
We're finishing up our latest round of revisions to the RICE package.
It's been a bit of a slow go due to difficulties in getting in touch
with some of the EPA folks up in D.C.  We should send you the revised
package either later tonight or first thing tomorrow.

Take care,

Melanie King
Energy Strategies Group
Sector Policies and Programs Division
Office of Air Quality Planning and Standards U.S. Environmental
Protection Agency

Mail Code D243-01
RTP, NC  27711

Phone:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
<EMAIL_ADDRESS>