[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87628-87633]
[FR Doc No: 2016-29116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79428; File No. SR-NASDAQ-2016-161]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Adopt a New Extended Life
Priority Order Attribute Under Rule 4703, and To Make Related Changes
to Rules 4702, 4752, 4753, 4754, and 4757

November 30, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 17, 2016, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt a new Extended Life Priority Order
Attribute under Rule 4703, and to make related changes to Rules 4702,
4752, 4753, 4754, and 4757.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The

Exchange has prepared summaries, set forth in sections A, B, and C
below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange is proposing a new Extended Life Priority Order
Attribute, which will allow Displayed Orders that are committed to a
one-second or longer resting period to receive higher priority than
other Displayed Orders of the same price on the Nasdaq Book. From its
inception, Nasdaq has been an innovator and change agent in the
financial markets. Innovation is in Nasdaq's DNA, beginning with the
development of electronic trading and continuing today as we seek to
bring new ideas to the financial markets, such as streamlined proxy
voting using blockchain technology,\3\ strengthening investor
protection through Limit Order Protection,\4\ and enhancing investor
confidence in the Opening Cross.\5\ Nasdaq has not shied away from
experimenting with new market structure in an effort to further refine
our markets.\6\ The change proposed herein is another step forward in a
long line of innovations Nasdaq has brought to the U.S. financial
markets.
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    \3\ See http://ir.nasdaq.com/releasedetail.cfm?releaseid=954654;
see also http://www.pcworld.com/article/3033075/nasdaq-to-use-blockchain-to-record-shareholder-votes.html.
    \4\ See Securities Exchange Act Release No. 78246 [sic] (August
24, 2016), 81 FR 59672 (August 30, 2016) (SR-NASDAQ-2016-067).
    \5\ See Securities Exchange Act Release No. 77235 (February 25,
2016), 81 FR 10935 (March 2, 2016) (SR-NASDAQ-2015-159).
    \6\ For example, in February 2015 Nasdaq implemented an access
fee pilot to determine the effect of reduced access fees on market
quality. See Securities Exchange Act Release No. 73967 (December 30,
2014), 80 FR 594 (January 6, 2015) (SR-NASDAQ-2014-128).
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Background
    As the markets became more automated in the 1990s and 2000s, and in
particular since the implementation of the Regulation NMS Order
Protection Rule (Rule 611) and the Access Rule (Rule 610) beginning in
2006,\7\ exchanges have generally based their execution algorithms on a
price/display/time priority. Under this priority structure, the first
displayed order at a price has priority over the next order and so on
(this is also sometimes referred to as ``First In First Out'' or
``FIFO''). All displayed orders have priority over non-displayed orders
at a price level. The price/display/time priority structure has brought
with it many benefits:
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    \7\ See Securities Exchange Act Release No. 53829 (May 18,
2006), 71 FR 30038 (May 24, 2006); see also Securities Exchange Act
Release No. 55160 (January 24, 2007), 72 FR 4202 (January 30, 2007).

 Competition has increased
 Bid/Offer spreads have decreased
 Trading costs have decreased
 Access to the markets has been democratized

    Nonetheless, the price/display/time priority system may not serve
the interests of all market participants. In particular, the price/
display/time priority system provides incentives to set new prices and
optimize trading strategies based on the time priority in an order
book. Increasing competition in the price/time priority structure has
led to market velocity and displayed order duration becoming widely
discussed and debated topics in recent years. Over time, as order
placement competition on Nasdaq has grown, the importance of an order's
ranking in the order queue has increased. In addition, orders that
access resting liquidity on exchanges have decreased in size due to the
fragmented nature of the broader market and the adoption of algorithmic
trading and routing strategies. As a result, when these smaller orders
come to an exchange to access liquidity in the most liquid securities,
there are orders deep in the queue that may not always have the
opportunity to participate.
    As an innovator, Nasdaq develops new functionality to promote the
evolution of the markets. Nasdaq believes that it is imperative to
address the needs of various market participants in new ways.
Specifically, Nasdaq is proposing to supplement the ubiquitous price/
display/time priority structure in the U.S. Equities markets to address
the needs of market participants that focus their passive trading
strategies on their ability to assume market risk by resting orders for
an extended duration. Nasdaq believes that many of these participants
have a longer investment horizon (i.e., long term investors) and
therefore are not necessarily monitoring minute changes in the best bid
and offer over very short time periods and simply want opportunities to
participate passively at the prevailing market when transactions occur.
Nasdaq has consulted a wide swath of its market participants, including
buy-side institutions, market makers, investment banks, and retail
broker-dealers. In addition, Nasdaq has consulted with corporate
issuers that list their securities on Nasdaq. Nasdaq has weighed
various ideas on how to expand interaction on Nasdaq's order book to
more participants (e.g., long term investors) and believes that it is
better to provide incentives to reduce the potential for order
adjustment and cancellation, rather than apply artificial latency
mechanisms that may distort or have unintended consequences on market
quality. Specifically, Nasdaq is proposing to provide an incentive to
market participants that enter orders that are required to remain
unaltered on the Nasdaq Book for a minimum time.
Proposal
    Nasdaq is proposing to offer a new Order Attribute \8\ that will
allow certain Displayed Orders \9\ to have priority ahead of other
resting Displayed Orders on the Nasdaq Book at the same price. To
receive this priority, an Order must be designated with the Order
Attribute ``Extended Life Priority'' (``ELO'') to indicate that the
Order will not be altered or canceled by the member before the minimum
resting time has elapsed.
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    \8\ The term ``Order'' means an instruction to trade a specified
number of shares in a specified System Security submitted to the
Nasdaq Market Center by a Participant. See Rule 4701(e). An ``Order
Type'' is a standardized set of instructions associated with an
Order that define how it will behave with respect to pricing,
execution, and/or posting to the Nasdaq Book when submitted to
Nasdaq. Id. An ``Order Attribute'' is a is a [sic] further set of
variable instructions that may be associated with an Order to
further define how it will behave with respect to pricing,
execution, and/or posting to the Nasdaq Book when submitted to
Nasdaq. Id. The Exchange describes the Order Types available on
Nasdaq under Rule 4702 and describes the Order Attributes available
on Nasdaq under Rule 4703.
    \9\ Display is an Order Attribute that allows the price and size
of an Order to be displayed to market participants via market data
feeds. All Orders that are Attributable are also displayed, but an
Order may be displayed without being Attributable. As discussed in
Rule 4702, a Non-Displayed Order is a specific Order Type, but other
Order Types may also be non-displayed if they are not assigned a
Display Order Attribute; however, depending on context, all Orders
that are not displayed may be referred to as ``Non-Displayed
Orders.'' An Order with a Display Order Attribute may be referred to
as a ``Displayed Order.'' See Rule 4703(k).
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    Currently, Nasdaq's System \10\ places a time-stamp on each Order
entered by a member, which determines the time ranking of the Order for
purposes of processing the Order.\11\ The System presents resting
Orders on the Nasdaq Book for execution against incoming Orders in
accordance with a price/display/time algorithm.\12\ Price means that
better priced Orders will be presented for execution first. For
example, an order to buy at $10.00 would be ranked before an order to
buy at $9.99. Display and Time mean that equally priced Orders with a
Display

Attribute will be ranked in time priority. Orders with a Non-Display
Attribute, including the Non-Displayed portion of an Order with Reserve
Size, are ranked in time priority behind all Displayed Orders.\13\
Processing Orders in this manner rewards market participants that take
market risk by quickly and efficiently submitting Displayed Orders to
the System to drive price formation on the Nasdaq Book. Price/display/
time processing benefits the market by driving competition in Order
flow, resulting in tighter bid/offer spreads and reducing overall costs
to buy and sell securities. While this drive to reward setting new
price levels (i.e., being first at a given price) has led to highly
efficient markets with significant volume on Nasdaq being attributed to
firms that provide two-sided liquidity, pure price/display/time
processing may limit certain customer segments from effectively
participating, particularly in highly-liquid securities where the
sequence of the arrival of Orders is important to participation in the
ensuing transactions on the Nasdaq Book.
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    \10\ As defined by Rule 4701(a).
    \11\ See Rule 4756(a)(2).
    \12\ See Rule 4757. The Exchange is proposing to amend Rule 4757
to reflect the proposed exception to the price/display/time
algorithm, as discussed below.
    \13\ Non-Displayed Orders are not displayed in the System, and
have lower priority within the System than an equally priced
Displayed Order, regardless of time stamp, and shall be executed
pursuant to Rule 4757. See Rule 4756(c)(3)(C).
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    The Exchange has observed that many of the market participants that
have not focused on efficient Order queue placement of Displayed Order
entry often represent retail customer and institutional Order flow,
which tend to have longer investment time horizons. Nasdaq believes
that promoting Displayed Orders with longer time horizons will enhance
the market so that it works for a wider array of market participants,
and will benefit publicly traded companies by promoting long-term
investment in corporate securities, whether listed on Nasdaq or other
exchanges. To further this goal, the Exchange is proposing an exception
to the general priority rules \14\ to allow Displayed Orders with an
Extended Life Priority Attribute to earn queue priority on the Nasdaq
Book at any given price level ahead of all other Displayed Orders
without the Extended Life Priority Attribute. As discussed below, when
there are multiple Orders with Extended Life Priority resting on the
Nasdaq Book at the same price they would be ranked by time, therefore
making the priority price/display/ELO/time.
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    \14\ Supra note 12.
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    Another component to consider with regards to the optimal priority
structure is the risk associated with submitting a Displayed Order into
the market. There are various elements of risk that are considered when
a market participant chooses a price and a time at which to post a
Displayed Order on the Nasdaq Book. As noted earlier, price/display/
time priority does not necessarily reward or recognize the various
types of risks associated with an Order. Nasdaq believes that rewarding
market participants that enter Displayed Orders and commit to a longer
resting time on the Nasdaq Book, would enable it to broaden the types
of behavior and incentives provided, in particular in securities in
which the depth of the Nasdaq Book may inhibit these Orders from being
placed on Nasdaq. As noted above, these market participants are
typically considered long term investors, representing retail and
institutional order flow.
    In its initial implementation, Nasdaq plans to support the Extended
Life Priority Attribute for Designated Retail Orders.\15\ While the
Extended Life Priority Attribute may ultimately prove to benefit a
broader set of participants, Nasdaq recognizes that any change of this
magnitude can be disruptive to its membership and, consequently, it is
prudent to implement this concept in a phased and measured manner.
Generally, retail investors are longer term investors who measure stock
performance over hours, days, months, etc. rather than seconds or
milliseconds. Nasdaq recognizes that there are other market
participants that are also long term investors in the market, such as
institutional investors. To ensure that these market participants'
needs are addressed, Nasdaq anticipates that it will extend the program
to all Orders that meet the requirements of the Extended Life Priority
Attribute after its successful implementation with Designated Retail
Orders. During the initial retail phase, to be eligible to use the
Extended Life Priority Attribute, a member must complete an attestation
provided by Nasdaq, stating that the Designated Retail Orders it
assigns an Extended Life Priority Attribute will meet the minimum
performance standards required by Nasdaq. Nasdaq will determine from
time to time what the appropriate parameters are with regards to how
firms may qualify for the Extended Life Attribute on Designated Retail
Orders. Initially, Nasdaq will require that at least 99% of Designated
Retail Orders with the Extended Life Priority Attribute exist unaltered
on the Nasdaq Book for a minimum of one second.\16\ Nasdaq will require
any member that enters Designated Retail Order with an Extended Life
Priority Attribute to attest that it will comply with the minimum
performance standards required by Nasdaq under the proposed new Rule
4703(m) to be eligible to enter Designated Retail Orders with an
Extended Life Priority Attribute.
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    \15\ A ``Designated Retail Order'' is an agency or riskless
principal order that meets the criteria of FINRA Rule 5320.03 and
that originates from a natural person and is submitted to Nasdaq by
a member that designates it pursuant to this rule, provided that no
change is made to the terms of the order with respect to price or
side of market and the order does not originate from a trading
algorithm or any other computerized methodology. An order from a
``natural person'' can include orders on behalf of accounts that are
held in a corporate legal form--such as an Individual Retirement
Account, Corporation, or a Limited Liability Company--that has been
established for the benefit of an individual or group of related
family members, provided that the order is submitted by an
individual. Members must submit a signed written attestation, in a
form prescribed by Nasdaq, that they have implemented policies and
procedures that are reasonably designed to ensure that substantially
all orders designated by the member as ``Designated Retail Orders''
comply with these requirements. Orders may be designated on an
order-by-order basis, or by designating all orders on a particular
order entry port as Designated Retail Orders. See Rule 7018. The
proposed change will not affect how Orders entered by sponsored
access are treated for purposes of determining whether they are
Designated Retail Orders.
    \16\ Note that executions would not be counted as modifications.
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    Nasdaq will carefully monitor members' use of the Extended Life
Priority Attribute on a quarter-by-quarter basis and will not rely
solely on a member's attestation with regard to Extended Life Priority
usage. Nasdaq will determine whether a member was in compliance with
the eligibility requirements for a given quarter within five business
days of the end of that quarter. Any member that has not met the
requirements in a quarter will be ineligible to receive Extended Life
Priority treatment for its Orders in the quarter immediately following
the quarter in which it did not comply.\17\ Following an ineligible
quarter, a member may once again participate in the program if it
completes a new attestation for the following quarter. If a member
fails to meet the eligibility standards a second time, its Orders will
not be eligible for Extended Life Priority for the two quarters
immediately following the quarter in which it did not meet the
eligibility requirements for the second time. If a member fails to meet
the eligibility standards for a third time, it is no longer eligible to
receive Extended Life Priority for its Orders.
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    \17\ The System will prevent a member that is not eligible to
participate in the program from entering Orders that are flagged
with Extended Life Priority (including such designation on the port
level).
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    To implement the retail phase of the Extended Life Priority
Attribute, Nasdaq is developing a unique identifier that

will be appended to each Order entered by the member. Orders with the
Extended Life Priority Attribute may be individually designated with
the new identifier or entered through an Order port that has been set
to designate, by default, all Orders with the new identifier. Orders
marked with the new identifier--whether on an order-by-order basis or
via a designated port--will be disseminated via Nasdaq's TotalView ITCH
data feed.\18\ Thus, market participants will be able to identify
Designated Retail Orders that have the Extended Life Priority
Attribute.
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    \18\ See http://www.nasdaqtrader.com/Trader.aspx?id=Totalview2
for a description of TotalView ITCH.
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    As noted above, if an Order with Extended Life Priority is not
marketable upon entry, the Order will post and display at its limit
price, and will be ranked under the price/display/ELO/time priority
structure. In other words, an Order with the Extended Life Priority
Attribute will be ranked ahead of other Displayed Orders that do not
have the Extended Life Priority attribute and behind any other
Displayed Orders with Extended Life Priority that were received
previously. For example, if five members attest to enter Orders
designated with the Extended Life Priority Attribute and each member
enters a Displayed Order so designated at the same price, the Order
entered first will receive the highest priority among the five, the
second Order will be ranked second, and so on; all Displayed Orders
entered at the same price and not designated with the Extended Life
Priority Attribute will be ranked behind the five Orders designated
with the Extended Life Priority Attribute.
    There are three instances in which an Order entered with the
Extended Life Priority Attribute will not gain ELO priority. First, an
Order with the Extended Life Priority Attribute will only have Extended
Life Priority ranking at its displayed price. If an Order with the
Extended Life Priority Attribute is ranked at a Non-Displayed price, it
will be ranked without Extended Life Priority among Non-Displayed
Orders. For example, if a Price to Comply Order \19\ with an Extended
Life Priority Attribute to buy at $11 would lock a Protected Offer of
$11, the Price to Comply Order will be displayed at $10.99, but ranked
at a non-displayed price of $11 without Extended Life Priority. If the
Best Offer changes to $11.01, the Price to Comply Order would be ranked
and displayed at $11 with Extended Life Priority.
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    \19\ See Rule 4702(b)(1).
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    Second, a Designated Retail Order with a Non-Display Attribute that
is also entered with Extended Life Priority will be added to the Nasdaq
Book as a Non-Display Order without Extended Life Priority, following
price/display/time processing among resting Orders without Extended
Life Priority.
    Third, while cross-specific Orders marked with Extended Life
Priority will be eligible to participate in the Nasdaq Opening,\20\
Closing \21\ and Halt \22\ Crosses, they will be ranked without
Extended Life Priority.\23\ Orders with the Extended Life Priority
Attribute that are ranked on the Nasdaq Order Book (i.e., orders that
are in the continuous market) will retain Extended Life Priority if
they are part of the Cross execution.
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    \20\ See Rule 4752.
    \21\ See Rule 4754.
    \22\ See Rule 4753.
    \23\ These are Orders that are designated to participate in the
Opening or Closing Cross, and are not available for execution in
continuous trading.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\24\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\25\ in particular, in that it is designed 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. Nasdaq believes that the proposed change is consistent with
this provision of the Act because it is an attempt to improve the
quality of the market by rewarding market participants for longer-life
Order flow. Importantly, Nasdaq is not applying any programmatic or
intentional delay to incoming Orders that are attempting to access the
market. Instead, Nasdaq's proposal seeks to provide an incentive to
market participants to improve the market on Nasdaq by recognizing the
value of certain behaviors. Nasdaq currently provides incentives in the
form of reduced fees and rebates in return for market-improving
behavior. For example, Nasdaq's NBBO Program provides pricing
incentives for participants that, among other things, establish the
NBBO.\26\ With Extended Life Priority, Nasdaq is providing members an
opportunity to gain priority at any particular price level in return
for providing market-improving behavior in the form of longer-lived
displayed quote. As discussed above, a great deal of the liquidity that
is provided on exchanges is from market makers and automated liquidity
providers, who have invested in technology and efficiency, which has
resulted in many positive developments such as deep and liquid markets.
The proposed Extended Life Priority Attribute has the potential to
attract a more diverse set of liquidity providers with a longer term
focus on investing and trading.
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    \24\ 15 U.S.C. 78f(b).
    \25\ 15 U.S.C. 78f(b)(5).
    \26\ See Rule 7014(g).
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    Nasdaq believes that requiring Designated Retail Orders to exist on
the Nasdaq Book unaltered for at least one second is a meaningful time,
representing a significant level of risk taken by the market
participant in return for the priority in the Nasdaq Book. In addition,
Nasdaq is initially requiring members to attest that at least 99% of
the Designated Retail Orders submitted with Extended Life Priority
exist on the Nasdaq Book unaltered for at least one second.\27\ As
discussed above, Nasdaq will review Orders from members marked as
Designated Retail Orders with the Extended Life Priority Attribute for
compliance on a quarterly basis. Eligibility for a given quarter will
be based on the previous quarter's analysis. Within five business days
of the end of a given quarter, Nasdaq will determine whether a
participant has met the eligibility requirements. If a member's Orders
do not qualify, it will not be eligible for Extended Life Priority for
the quarter immediately following the quarter in which it did not meet
the eligibility requirements. Following an ineligible quarter a member
may once again participate in the program if it completes a new
attestation. If a member is determined to have not met the eligibility
standards a second time, it will not be eligible for Extended Life
Priority for the two quarters immediately following the quarter in
which it did not meet the eligibility requirements for the second time.
If a member is determined to have not met the eligibility standards for
a third time, it is no longer eligible to participate in the program.
Thus, Nasdaq believes that the attestation process coupled with
rigorous quarterly monitoring and increasing periods of ineligibility
for repeated non-compliance with the eligibility standards will serve
to dissuade any member from abusing the attestation process, thereby
protecting investors and the public interest.\28\
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    \27\ Nasdaq will periodically assess the effectiveness of the
eligibility criteria, and make any changes to the criteria through
rulemaking.
    \28\ Nasdaq notes that members entering Orders with Extended
Life Priority are subject to regulatory review and inspection,
including a review of their procedures and processes for compliance
with Extended Life Priority eligibility.

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    Nasdaq believes that, if successful, the proposed change may bring
greater stability to the Displayed quote and increase Displayed size on
Nasdaq. Thus, Nasdaq believes that the Extended Life Priority Attribute
is good for market structure because it may provide incentive to market
participants that are long-term investors and may diversify Order
interaction on Nasdaq, thereby enhancing price discovery and market
resiliency.
    Although the proposed change is novel in U.S. equity markets,
certain U.S. options markets currently grant preference in their order
books for customer orders.\29\ On the NASDAQ PHLX options market,
priority in the order book is given to Orders entered for a customer
account over a controlled account. A controlled account includes any
account controlled by or under common control with a broker-dealer, and
customer accounts are all other accounts.\30\ Moreover, the concept of
rewarding market participants that provide Orders that live for a
certain minimum time is currently used in Canada by the Toronto Stock
Exchange. Named the ``Long Life'' order type, it is designed to enhance
the quality of execution for natural investors and their dealers by
rewarding those willing to commit liquidity to the book for a minimum
period of time and by enabling participants to gain priority in return
for a longer resting time.\31\ The Exchange is proposing to initially
limit the proposed change to Designated Retail Orders. Nasdaq believes
that the retail customers represented by such Orders have the potential
to immediately and with minimal technological effort, benefit from the
proposed change. Moreover, Nasdaq believes that implementing the change
incrementally will reduce risk, ensure that market participants are
allowed adequate time to adjust to the new Order Attribute, and provide
Nasdaq with useful data with which it can further improve the proposed
Order Attribute.
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    \29\ See, e.g., PHLX Rule 1014(g)(vii)(B) (providing that
quotations entered electronically by the specialist, an RSQT or an
SQT that do not cause an order resting on the limit order book to
become due for execution may be matched at any time by quotations
entered electronically by the specialist and/or other SQTs and
RSQTs, and by ROT limit orders and shall be deemed to be on parity,
subject to the requirement that orders of controlled accounts must
yield priority to customer orders as set forth in Rule
1014(g)(i)(A)).
    \30\ See PHLX Rule 1014(g)(i)(A).
    \31\ See https://www.tmx.com/newsroom/press-releases?id=352; see
also http://www.osc.gov.on.ca/documents/en/Marketplaces/xxr-tsx_20150818_amd-rule-book-policies.pdf (Notice of Approval).
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    For these reasons Nasdaq believes that the proposed Extended Life
Order further perfects the mechanism of a free and open market,
promotes competition, broadens participation in the market, considers
the cost/benefit of implementation and provides market participants
with incentive to provide market-improving Order flow.

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

    Nasdaq does not believe that the proposed rule change will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Act. Rather, Nasdaq believes that the proposed
change increases competition among market participants because it
allows certain market participants to compete based on elements other
than the sequence of order arrival. Specifically, the proposed change
will allow market participants that have not invested in limit order
queue placement but rather take risk by allowing an Order to rest on
the Nasdaq Book unchanged for a certain duration to gain priority in
the Nasdaq Book. Although market participants that do not submit Orders
that qualify as Extended Life Orders may lose priority to Extended Life
Orders on the Nasdaq Book, any burden arising therefrom is necessary to
further refine the market to serve a broader group of market
participants. In particular, Nasdaq believes Extended Life Priority
will incentivize behavior from participants that currently, may
struggle to participate and are willing to provide market-improving
Order flow, which benefits all market participants. Moreover, the
Exchange notes that it operates in a highly competitive market in which
market participants can readily choose between competing venues if they
deem participation in Nasdaq's market is no longer desirable. In such
an environment, the Exchange must carefully consider the impact that
any change it proposes may have on its participants, understanding that
it will likely lose participants to the extent a change is viewed as
unfavorable by them. Because competitors are free to modify the
incentives and structure of their markets, the Exchange believes that
the degree to which modifying the market structure of an individual
market may impose any burden on competition is limited. Last, to the
extent the proposed change is successful in attracting retail Order
flow, Nasdaq also believes that the proposed change will promote
competition among trading venues by making Nasdaq a more attractive
trading venue for long-term investors and therefore capital formation.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2016-161 on the subject line.

Paper comments

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

All submissions should refer to File Number SR-NASDAQ-2016-161. 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 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; 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-NASDAQ-2016-161 and should
be submitted on or before December 27, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-29116 Filed 12-2-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 15 (Tuesday, January 24, 2012)]
[Rules and Regulations]
[Pages 3382-3384]
[FR Doc No: 2012-366]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1454; Directorate Identifier 2011-SW-054-AD;
Amendment 39-16910; AD 2011-27-08]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A. Helicopters

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

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Agusta S.p.A. (Agusta) model A109S and AW109SP helicopters. This AD is
prompted by a fatigue crack found in the left elevator assembly along
the riveting of the upper skin to the fourth rib on an Agusta A109S
helicopter. These actions are intended to detect a crack, which could
lead to a failure of the elevator, reduced maneuverability of the
helicopter, and subsequent loss of control of the helicopter.

DATES: This AD becomes effective February 8, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of February 8,
2012.
    We must receive comments on this AD by March 26, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Examining the AD Docket: You may examine the AD docket on the
Internet at http://www.regulations.gov or in person at the Docket
Operations Office between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this AD, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this AD, contact Agusta
Westland, Customer Support & Services, Via Per Tornavento 15, 21019
Somma Lombardo (VA) Italy, ATTN: Giovanni Cecchelli; telephone 39-0331-
711133; fax 39 0331 711180; or at http://www.agustawestland.com/technical-bullettins. You may review copies of the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Jim Grigg, Manager, FAA, Rotorcraft
Directorate, Safety Management Group, 2601 Meacham Blvd. Fort Worth TX
76137, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you to participate in this rulemaking by submitting written
comments, data, or views. We also invite comments relating to the
economic, environmental, energy, or federalism impacts that resulted
from adopting this AD. The most helpful comments reference a specific
portion of the AD, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit them only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive

public contact with FAA personnel concerning this rulemaking during the
comment period. We will consider all the comments we receive and may
conduct additional rulemaking based on those comments.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2011-0150, dated August 9, 2011 (AD 2011-0150), to correct an unsafe
condition for the Agusta A109S and AW109SP helicopters. EASA advises
that a fracture of the left elevator assembly part number (P/N) 109-
0200-02-601, along the riveting of the upper skin to the fourth rib has
recently occurred on an A109S helicopter. The elevator assembly, left
and right, P/N 109-0200-02-601 or -801, and 109-0200-02-602 or -802,
installed on an A109S helicopter are very similar to the elevator
assembly, left and right, P/N 109-0200-02-803 and -804, installed on
the AW109SP helicopter. The technical investigation conducted by Agusta
revealed that the crack in the left elevator assembly was due to
fatigue. The EASA AD requires, as an interim measure pending the
development of a terminating action, repetitive inspections of the
elevator upper skin in the area of the fourth rib, and if a crack is
found, replacing the cracked elevator assembly with a serviceable unit
or contacting Agusta for an approved repair.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, their technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs.

Related Service Information

    We reviewed Agusta Mandatory Bollettino Tecnico (ABT) No. 109S-44
and No 109SP-032, both dated August 5, 2011. The ABTs describe
procedures for visually inspecting with a 5-10X magnifying glass to
verify the presence of cracks on the upper skin of the left elevator
assembly, P/N 109-0200-02-601 or -801, and right elevator assembly, P/N
109-0200-02-602 or -802, on the A109S and P/N 109-0200-02-803 and -804
on the AW109SP. The ABTs also provide instructions to carry out a dye
penetrant inspection if there is any doubt as to the presence of a
crack during the visual inspection. EASA classified this service
information as mandatory and issued AD No. 2011-0150 to ensure the
continued airworthiness of these helicopters.

AD Requirements

    This AD requires an inspection of the area depicted in figure 1 of
the manufacturer's service bulletin.
     For elevator assemblies with less than 400 hours time-in-
service (TIS), upon or before reaching 400 hours TIS, and thereafter at
intervals not to exceed 50 hours TIS, inspect with a 10X power
magnifying glass an area of the left and right elevator upper skin for
a crack along the 4th rib station rivet line.
     For elevator assemblies with 400 or more hours TIS, within
30 hours TIS, and thereafter at intervals not to exceed 50 hours TIS,
inspect with a 10X power magnifying glass an area of the left and right
elevator upper skin for a crack along the 4th rib station rivet line.
     Replace any cracked elevator assembly with an airworthy
elevator assembly before further flight.

Differences Between This AD and the EASA AD

    The EASA AD specifies a 5-10X power magnifying glass; this AD
specifies a 10X power or higher magnifying glass.

Costs of Compliance

    We estimate that this AD will affect 14 helicopters of U.S.
Registry.
    We estimate that operators may incur the following costs in order
to comply with this AD. Inspecting the elevator assemblies will require
3 work-hours at an average labor rate of $85 per hour, for a cost of
$255 per inspection cycle. To replace a cracked elevator assembly with
an airworthy elevator assembly will require 10 work-hours at an average
labor rate of $85 per hour, and parts will cost $19,921, for a cost per
helicopter of $20,771.
    According to the PAHs service information some of the costs of this
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage by the PAH.
Accordingly, we have included all costs in our cost estimate.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to the adoption of this rule because some of the required
corrective actions must be accomplished within 30 hours time-in-
service, a very short time period based on the average flight-hour
utilization rate of these helicopters.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice an opportunity for
public comment before issuing this AD are impracticable and contrary to
the public interest and that good cause exists for making this
amendment effective in less than 30 days.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed, I certify that this AD:
    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);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities

under the criteria of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2011-27-08 Agusta S.p.A.: Amendment 39-16910; Docket No. FAA-2011-
1454; Directorate Identifier 2011-SW-054-AD.

(a) Applicability

    This AD applies to model A109S and AW109SP helicopters with
elevator assemblies, part number (P/N) 109-0200-02-601, 109-0200-02-
801, 109-0200-02-602, 109-0200-02-802, 109-0200-02-803, or 109-0200-
02-804 installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a fatigue crack on the
elevator assembly. This condition could result in failure of the
elevator, reduced maneuverability of the helicopter, and subsequent
loss of control of the helicopter.

(c) Effective Date

    This airworthiness directive (AD) becomes effective February 8,
2012.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Corrective Action

    (1) For elevator assemblies with less than 400 hours time-in-
service (TIS), upon or before reaching 400 hours TIS, and thereafter
at intervals not to exceed 50 hours TIS, inspect the left and right
elevator upper skin along the 4th rib station rivet line from the
leading edge to 200 mm inboard with a 10X or higher magnifying glass
for a crack in the area depicted in Figure 1 of Agusta Mandatory
Bollettino Tecnico (ABT) No. 109S-44 or 109SP-032, both dated August
5, 2011, for your model helicopter.
    (2) For elevator assemblies with 400 or more hours TIS, within
the next 30 hours TIS, and thereafter at intervals not to exceed 50
hours TIS, inspect the left and right elevator upper skin along the
4th rib station rivet line from the leading edge to 200 mm inboard
with a 10X or higher magnifying glass for a crack in the area
depicted in Figure 1 of the ABT for your model helicopter.
    (3) If there is a crack, replace the cracked elevator assembly
with an airworthy elevator assembly before further flight.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Jim Grigg, Manager, FAA,
Rotorcraft Directorate, Safety Management Group, 2601 Meacham Blvd.,
Fort Worth, TX 76137, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>,
email<EMAIL_ADDRESS>    (2) For operations conducted under a Part 119 operating
certificate or under Part 91, Subpart K, we suggest that you notify
your principal inspector, or lacking a principal inspector, the
manager of the local flight standards district office or certificate
holding district office, before operating any aircraft complying
with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2011-0150, dated August 11, 2011.

 (h) Subject

    Joint Aircraft System Component (JASC) Code 5520: Elevator
Structure.

(i) Material Incorporated by Reference

    You must use the specified portions of the service information
specified in this AD to do the actions required. The Director of the
Federal Register approved the incorporation by reference of this
service information under 5 U.S.C. 552(a) and 1 CFR part 51.
    (1) Agusta Mandatory Bollettino Tecnico No. 109S-44, dated
August 5, 2011, for model A109S helicopters; or
    (2) Agusta Mandatory Bollettino Tecnico No. 109SP-032, dated
August 5, 2011, for model AW109SP helicopters.
    (3) For service information identified in this AD, contact
Agusta Westland, Customer Support & Services, Via Per Tornavento 15,
21019 Somma Lombardo (VA) Italy, ATTN: Giovanni Cecchelli; telephone
39-0331-711133; fax 39 0331 711180; or at http://www.agustawestland.com/technical-bullettins.
    (4) You may review copies of the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 2601
Meacham Blvd., Room 663, Fort Worth, Texas 76137 or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html

    Issued in Fort Worth, Texas, on December 27, 2011.
M. Monica Merritt,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-366 Filed 1-23-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31875-31876]
[FR Doc No: 2019-14146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-0692]

Determination That THAM Solution (Tromethamine) Injectable, 3.6
Grams/100 Milliliters, Was Not Withdrawn From Sale for Reasons of
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that THAM Solution (tromethamine) injectable, 3.6 grams (g)/
100 milliliters (mL), was not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new

drug applications (ANDAs) for tromethamine injectable, 3.6g/100 mL, if
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Katelyn Mineo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-1054.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    THAM Solution (tromethamine) injectable, 3.6 g/100 mL, is the
subject of NDA 013025, held by Hospira, Inc., and initially approved on
December 16, 1965. THAM Solution is indicated for the prevention and
correction of metabolic acidosis.
    In a letter dated February 26, 2018, Pfizer Inc., Hospira, Inc.'s
parent company, notified FDA that THAM Solution (tromethamine)
injectable, 3.6 g/100 mL, was being discontinued, and FDA moved the
drug product to the ``Discontinued Drug Product List'' section of the
Orange Book.
    Arent Fox LLP submitted a citizen petition dated January 30, 2019
(Docket No. FDA-2019-P-0692), under 21 CFR 10.30, requesting that the
Agency determine whether THAM Solution (tromethamine) injectable, 3.6
g/100 mL, was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that THAM Solution (tromethamine) injectable, 3.6
g/100 mL, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
THAM Solution (tromethamine) injectable, 3.6 g/100 mL, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of THAM Solution
(tromethamine) injectable, 3.6 g/100 mL, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list THAM Solution
(tromethamine) injectable, 3.6 g/100 mL, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to THAM Solution (tromethamine)
injectable, 3.6 g/100 mL, may be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14146 Filed 7-2-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12500-12501]
[FR Doc No: 2016-05215]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0349]

Investigating and Reporting Adverse Reactions Related to Human
Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a document entitled ``Investigating and Reporting
Adverse Reactions Related to Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of
the Public Health Service Act and 21 CFR part 1271; Guidance for
Industry.'' The guidance document provides establishments that
manufacture human cells, tissues, and cellular and tissue-based
products (HCT/Ps) for which no premarket submissions are required
because they are not also regulated as drugs, devices, and/or
biological products, with recommendations for complying with the
requirements for investigating and reporting adverse reactions
involving communicable disease in recipients of these HCT/Ps. The
guidance also provides updated information specific to reporting
adverse reactions related to HCT/Ps to supplement the general
instructions accompanying the MedWatch mandatory reporting form, Form
FDA 3500A. The guidance supplements section XXII of FDA's guidance
entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP)
and Additional Requirements for Manufacturers of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011
and supersedes the guidance entitled ``Guidance for Industry: MedWatch
Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)''
dated November 2005. The guidance announced in this notice finalizes
the draft guidance of the same title dated February 2015.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-0349 for ``Investigating and Reporting Adverse Reactions
Related to Human Cells, Tissues, and Cellular and Tissue-Based Products
Regulated Solely under Section 361 of the Public Health Service Act and
21 CFR part 1271; Guidance for Industry.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,

Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist the office in processing your requests. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Investigating and Reporting Adverse Reactions Related to Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated
Solely under Section 361 of the Public Health Service Act and 21 CFR
part 1271; Guidance for Industry.'' The guidance provides
establishments that manufacture HCT/Ps, with recommendations for
complying with the requirements for investigating and reporting adverse
reactions involving communicable disease in recipients of HCT/Ps that
are regulated solely under section 361 of the Public Health Service Act
(PHS Act) and 21 CFR part 1271 (361 HCT/Ps).
    In the Federal Register of February 20, 2015 (80 FR 9267), FDA
announced the availability of the draft guidance of the same title
dated February 2015. FDA received several comments on the draft
guidance and those comments were considered as the guidance was
finalized. In addition, editorial changes were made to improve clarity.
    The guidance supplements section XXII of FDA's guidance entitled
``Guidance for Industry: Current Good Tissue Practice (CGTP) and
Additional Requirements for Manufacturers of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011 by
providing additional recommendations specific to the responsibilities
to investigate complaints of adverse reactions concerning 361 HCT/Ps
under 21 CFR 1271.160(b)(2), 21 CFR 1271.320 and 21 CFR 1271.350(a)(1)
and, supersedes the guidance entitled ``Guidance for Industry: MedWatch
Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)''
dated November 2005. The guidance provides updated information specific
to reporting adverse reactions related to HCT/Ps to supplement the
general instructions accompanying the MedWatch mandatory reporting
form, Form FDA 3500A. The guidance announced in this notice finalizes
the draft guidance of the same title dated February 2015.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Investigating and Reporting Adverse
Reactions Related to Human Cells, Tissues, and Cellular and Tissue-
Based Products Regulated Solely under Section 361 of the Public Health
Service Act and 21 CFR part 1271; Guidance for Industry. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 1271 have been approved under
OMB control number 0910-0543; and the collections of information in
MedWatch Form FDA 3500A has been approved under OMB control number
0910-0291.

III. Electronic Access

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

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05215 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Rules and Regulations]
[Pages 20550-20551]
[FR Doc No: 2012-8137]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

23 CFR Part 1340

[Docket No. NHTSA-2010-0002]
RIN 2127-AL23

Uniform Criteria for State Observational Surveys of Seat Belt Use

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Final rule.

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SUMMARY: This final rule amends the implementation date for use of the
revised uniform criteria for State Observational Surveys of Seat Belt
Use. With this change, States may continue in calendar year 2012 to use
a survey design that was approved under the old uniform criteria or, at
their election, use a survey design approved under the revised uniform
criteria. In calendar year 2013, all States must use a survey design
approved under the revised uniform criteria.

DATES: This final rule is effective April 5, 2012.

FOR FURTHER INFORMATION CONTACT: Ms. Jin Kim, Attorney-Advisor, Office
of the Chief Counsel, National Highway Traffic Safety Administration,
1200 New Jersey Avenue SE., NCC-113, Washington, DC 20590. Telephone
number:<PHONE_NUMBER>; Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Discussion

    On April 1, 2011, the National Highway Traffic Safety
Administration (NHTSA) published a final rule setting forth ``Uniform
Criteria for State Observational Surveys of Seat Belt Use.'' 76 FR
18042. That final rule amended the regulation establishing uniform
criteria for designing and conducting State observational surveys of
seat belt use and the procedures for obtaining NHTSA approval of survey
designs, and provided a new form for reporting seat belt use rates to
NHTSA.
    The final rule specified that beginning with calendar year 2012
surveys, States must use survey designs that have been approved by
NHTSA as conforming to the revised uniform criteria. Under the rule,
States were required to submit proposed survey designs by January 3,
2012. Almost all States met this deadline. However, in reviewing the
proposed survey designs, NHTSA found it necessary to seek clarification
from States, in some cases several times. Due to the unanticipated
complexity of the review process, only a few States have survey designs
that have been approved at this time by NHTSA.
    Most States conduct seat belt use surveys in May and June, during
the time of the nationally-supported seat belt enforcement
mobilization. NHTSA does not believe that proposed survey designs will
be approved in time for all States to train data collectors and conduct
seat belt use surveys in May and June of 2012. For this reason, NHTSA
is amending the final rule to allow States to conduct calendar year
2012 seat belt use surveys using designs approved by NHTSA under the
old uniform criteria or, at a State's election if its new survey design
has been approved, under the revised uniform criteria. Beginning in
calendar year 2013, all States must conduct a survey whose design
satisfies and is approved by NHTSA under the revised uniform criteria.

II. Rulemaking Analyses and Notices

    The Administrative Procedure Act (APA) authorizes agencies to
dispense with certain notice procedures for rules when they find ``good
cause'' to do so. See 5 U.S.C. 553(b)(B). Specifically, the
requirements for prior notice and opportunity to comment do not apply
when the agency for good cause finds that those procedures are
``impractical, unnecessary, or contrary to the public interest.''
    This final rule would amend only the date by which States must
conduct seat belt use surveys using the revised uniform criteria. NHTSA
already sought public comment on all other aspects of the revised
uniform criteria. See 75 FR 4509 (Jan. 28, 2010). The earlier-published
final rule reflects the agency's consideration of and response to those
comments. See 76 FR 18042 (Apr. 1, 2011).
    This amendment would relieve a burden on the States and has no
safety impact. While most States met the deadline to submit proposed
survey designs under the revised criteria, there has been a need for
significant consultation during NHTSA's review of these proposed
designs. At this time, only a few States have survey designs that have
been approved by NHTSA under the revised uniform criteria. NHTSA does
not believe that proposed survey designs will be approved in time for
all States to conduct seat belt use surveys during May and June, as is
typical practice. Further, notice and comment are ``impractical,
unnecessary, or contrary to the public interest'' given this timeline.
This final rule would provide States with sufficient notice so that
States may elect to collect data in May and June 2012 using either the
old uniform criteria or the revised uniform criteria.
    The APA provides that rules generally may not take effect earlier
than thirty (30) days after they are published in the Federal Register.
See 5 U.S.C. 553(d). However, section 553(d)(1) provides that a
substantive rule which grants or recognizes an exemption or relieves a
restriction may take effect earlier. Today's final rule, which relieves
a restriction, is effective immediately upon publication.
    The agency has discussed the relevant requirements of regulatory
analyses and notices in the underlying final rule published at 76 FR
18042 (Apr. 1, 2011). Those discussions are not affected by this
amendment.

Regulatory Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN contained in the heading at the beginning of this document
to find this action in the Unified Agenda.

Privacy Act

    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.regulations.gov.

III. Regulatory Text

List of Subjects in 23 CFR Part 1340

    Grant programs--transportation, Highway safety, Intergovernmental
relations, Reporting and recordkeeping requirements.

    For the reasons discussed in the preamble, the National Highway
Traffic Safety Administration amends 23 CFR part 1340 as follows:

PART 1340--UNIFORM CRITERIA FOR STATE OBSERVATIONAL SURVEYS OF SEAT
BELT USE

0
1. The authority citation for part 1340 continues to read as follows:

    Authority: 23 U.S.C. 402; delegation of authority at 49 CFR
1.50.

0
2. Section 1340.2 is revised to read as follows:

Sec.  1340.2  Applicability.

    This part applies to State surveys of seat belt use beginning in
calendar year 2013 and continuing annually thereafter. However, a State
may elect to conduct its calendar year 2012 seat belt use survey using
a survey design approved under this part.

    Issued on: March 28, 2012.
David L. Strickland,
Administrator.
[FR Doc. 2012-8137 Filed 4-4-12; 8:45 am]
BILLING CODE 4910-59-P


LNG SITING AND OPERATIONS IN THE SER:

IMPACT CONSIDERATIONS AND ISSUES July 20, 2004 DIRECT CONSTRUCTION IMPACTS  DREDGE, FILL, STRUCTURE PLACEMENT   10s OF ACRES  PIPELINE CONSTRUCTION   100s OF ACRES DIRECT OPERATION IMPACTS

IMPINGEMENT   VELOCITIES UP TO 1 FPS

ENTRAINMENT ( INTAKE) OF EFH PREY AND MANGED SPECIES   100 250 MILLION GALLONS PER DAY

PROCESS WATER DISCHARGE   COLD WATER PLUME AND BIOCIDES IMPACTING 100s OF ACRES FISHERY IMPACTS

ENTRAINMENT  PORT PELICAN CASE STUDY  176 MGD  1.6 BILLION FISH LARVAE/ YR  3.3 BILLION FISH EGGS/ YR  60 MILLION SHRIMP LARVAE/ YR  500 BILLION ZOOPLANKTON/ YR POTENTIAL MONETARY IMPACTS ( EPA WEB)

 CONSERVATIVELY ESTIMATED TO BE $ 0.5 TO $ 1 MILLION/ YR/ 100MGD ( TAMPA AND NEW ENGLAND CASE STUDIES)

 DOESN'T CONSIDER BROWN OR WHITE SHRIMP OR MENHADEN CUMULATIVE IMPACTS

GULF OF MEXICO REGION   16 LNG FACILITIES EXISTING, APPROVED, AND PROPOSED

POTENTIAL LNG WATER USE  > 1,000 MGD

OTHER WATER USERS INCLUDE REFINERIES, ELECTRIC GENERATING FACILITIES, DESALINIZATION PLANTS PROBLEMS & ISSUES  FISHERY DATA LIMITED  INADEQUATE TIME OR MONEY TO GATHER NECESSARY INFORMATION TO ASSESS POPULATION IMPACTS  FMP IMPLICATIONS  CUMULATIVE EVALUATIONS INFORMATION NEEDS SCIENCE MANAGEMENT  ACCURATE ESTIMATES OF IMPACTS AND POPULATION LEVEL EFFECTS  UNDERSTANDING OF FOOD WEB ( ECOSYSTEM) CONSEQUENCES  MITIGATION OPTIONS FOR FISHERY IMPACTS  MONITORING REQUIREMENTS &

ADAPTIVE FACILITY OPERATIONS QUESTIONS?