[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 830-833]
[FR Doc No: 2019-00474]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84963; File No. SR-CboeBZX-2018-095]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the BZX Equities Fee Schedule

December 26, 2018.
    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 December 21, 2018, Cboe BZX Exchange, Inc. (``Exchange'' or ``BZX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III 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

    Cboe BZX Exchange, Inc. is proposing a rule change to change the
nomenclature associated with the current logical port fees charged for
order entry ports to reflect a new match capacity fee that better
captures the service offering of these products. The text of the
proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, 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 offers two types of logical ports that permit members
to enter orders into its trading system--i.e., Financial Information
eXchange (``FIX'') and Binary Order Entry (``BOE''). The purpose of the
proposed rule change is to amend the BZX Equities fee schedule to
change the nomenclature associated with the current logical port fees
charged for these offerings to reflect a new match capacity fee that
better captures the service offering of these products. As communicated
to members, although the Exchange is changing its nomenclature to
better reflect the services provided to market participants, the
proposed capacity allocations described in this proposed rule change
would continue to operate in the same manner as logical ports currently
used to connect to the Exchange. The Exchange believes, however, that
properly characterizing these fees as ``capacity fees,'' and specifying
the actual levels of message traffic supported by these products, will
increase transparency and clarity around its charges and reduce
confusion about the value of the services being provided to market
participants that choose to access these services.
    Today, the Exchange charges all logical connectivity fees on a
``per port'' basis. A logical port represents a technical port
established by the Exchange within the Exchange's trading system for
the delivery and/or receipt of trading messages--i.e., orders, accepts,
cancels, transactions, etc.\3\ Market participants that wish to connect
directly to the Exchange can request a number of different types of
ports, including ports that support order entry, customizable purge
functionality, or the receipt of market data. Firms can also choose to
connect indirectly through a number of different third party providers,
such as another broker-dealer or service bureau that the Exchange
permits through specialized access to the Exchange's trading system and
that may provide additional services or operate at a lower mutualized
cost by providing access to multiple members.\4\ Each logical port that
supports order entry entitles a firm to submit message traffic of up to
5,000 messages per second, an amount equivalent to 117 million messages
daily, and is currently charged at a rate of $550 per month.\5\
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    \3\ The Exchange separately offers physical ports that grant
access to the Exchange's physical connectivity infrastructure.
    \4\ 24% of members that traded equities on BZX in November
determined that their business does not require direct order entry
access, and instead connect indirectly to the Exchange today through
a service bureau or other service provider.
    \5\ Logical port fees are limited to logical ports within the
primary data center. No logical port fees are assessed for redundant
secondary data center ports. See BZX Equities Fee Schedule, Logical
Port Fees. New requests are prorated for the first month of service.
Cancellation requests are billed in full month increments as firms
are required to pay for the service for the remainder of the month,
unless the session is terminated within the first month of service.
Id.
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    An obvious driver for a member's decision to purchase multiple
ports is their desire to send or receive additional levels of message
traffic in some manner, either by increasing the member's total amount
of message capacity available, or by segregating order flow for
different trading desks and clients to avoid latency sensitive
applications from competing for a single thread of resources. For
example, a member may purchase one or more ports for its market making
business based on the amount of message traffic needed to support that
business, and then purchase separate ports for proprietary trading or
customer facing businesses so that those businesses have their own
distinct connection, allowing the firm to send multiple messages into
the Exchange's trading system in parallel rather than sequentially.
Some members that provide direct market access to their customers also
purchase separate ports for different clients as a service for latency
sensitive customers that desire the lowest possible latency to improve
trading performance. Thus, while a smaller firm with a simple business
model may be able to transact on the Exchange using one or two FIX or
BOE ports that are billed at a modest rate of $550 per month each,\6\ a
larger

market participant with a substantial and diversified U.S. equities
business may purchase additional order entry ports to support both the
volume and types of activity that they conduct on the Exchange.
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    \6\ 18% of members that traded equities on BZX in November
purchased only one or two order entry ports.
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    Based on data analyzed by the Exchange, the top ten BZX members,
which account as a group for nearly two-thirds of BZX equities volume,
have chosen to purchase 47% of order entry ports. More simply put, the
top ten BZX members have purchased the ability to use 47% of the
capacity of the BZX trading system. In addition to the Exchange's
commercial obligations to maintain resilient systems capable of
efficiently processing the message traffic that originates from those
firms, the Exchange is now also under regulatory obligations to
maintain resilient systems while receiving messages at the peak
capacity of those ports. While the Exchange does not know the trading
results of its members, it is clear that the members with larger
businesses, based on volume executed, have larger demands for the
capacity of the Exchange's systems. It should also be noted that half
of those top ten members are net positive in terms of total revenue
flows as the trading rebates provided to these firms for liquidity and
order flow exceed the sum of all non-transaction and transaction fees
collected from them.
    In addition to volume, the types of trading strategies employed by
a particular member may also impact the amount of message traffic
delivered to Exchange systems, and hence the number of ports purchased
to support their equities trading business. As a national securities
exchange, the Exchange is tasked with cultivating a vibrant and
competitive market that facilitates fair and orderly trading between a
wide range of market participants that employ a wide range of trading
strategies. These market participants together help cultivate the
equities trading ecosystem, and both support that ecosystem in
different ways and use different amounts of resources (i.e., capacity)
in doing so. Some simple trading strategies such as those employed by
investors seeking to source available liquidity at the national best
bid or offer may require a modest amount of capacity. Other trading
strategies used by professional market makers or algorithmic traders
that involve the frequent entry, modification, and cancellation of
orders, may require additional capacity, including potentially higher
peak capacity when multiple trading strategies or algorithms across
multiple logical ports attempt to access the Exchange at similar and
granular time intervals due to anticipated changes in the market. The
Exchange believes that charging for capacity ensures that firms that
demand the most resources are charged appropriately, while firms that
demand relatively less capacity can connect and trade on the Exchange
at a low cost.
    Charging fees based on allocated capacity thus ensures that the
cost of access is equitably apportioned between market participants
based on their business needs. Nevertheless, the Exchange believes that
there is some confusion in the industry surrounding how the Exchange
and other national securities exchanges charge for connectivity,
including the burden on smaller firms that actually benefit from the
current structure where market participants are charged based on the
number of ports (i.e., capacity) that they request. In the interest of
transparency, the Exchange is therefore proposing to replace its ``per
port'' fees with capacity fees that more accurately capture the intent
this fee. While the Exchange's logical connectivity offerings will
continue to operate in the same manner as they do today, the Exchange
believes that the proposed changes in terminology, which connect the
fees charged for logical connectivity to the capacity requested by
market participants, would shed additional light on this service
offering. As proposed, fees would be explicitly assessed based on the
capacity allocation (i.e., messages per second) requested for order
entry in the Exchange's primary data center.\7\ Specifically, the match
capacity fee would be $550 per month for an allocation of 5,000
messages per second.\8\ Members that require more capacity due to the
size of their U.S. equities business, the trading strategies that they
employ, the desire to reduce latency by maintaining multiple separate
logical connections, or any other reason, would be able to continue
purchasing additional capacity allocations in the primary data center
at the same monthly rate. As is the case today, no fee would be
assessed for redundant capacity in the secondary data center thus
providing members with free, identical capacity allocations in the
secondary data center based on their capacity requests in the primary.
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    \7\ Firms that already connect through logical ports would have
uninterrupted service across the established connections and would
not need to re-request capacity allocations.
    \8\ New requests would continue to be prorated for the first
month of service, and cancellation requests would be billed in full
month increments. See note 5 supra.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Act,\9\ in general, and furthers the requirements
of Section 6(b)(4),\10\ in particular, as it is designed to provide for
the equitable allocation of reasonable dues, fees and other charges
among its members and other persons using its facilities. In light of
recent debate and calls for transparency around exchange charges for
market access, the Exchange believes that the proposed changes to how
fees for logical connectivity are reflected on the fee schedule would
shed additional light on how market participants are charged for
connectivity. The Exchange believes that its fees for logical
connectivity, which would now be reflected as a match capacity fee,
continue to be reasonable, equitable, and not unfairly discriminatory
as they are designed to ensure that firms that use the most capacity
pay for that capacity, rather than placing that burden on market
participants that have more modest needs.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
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    Today, the Exchange charges a ``per port'' fee for logical
connectivity. This fee is in effect a capacity fee as each FIX or BOE
port used for order entry supports a specified capacity (i.e., messages
per second) in the matching engine, and firms purchase additional
logical ports when they require more capacity due to their business
needs. Smaller members that demand more limited message traffic may
connect through a service bureau or other service provider, as chosen
by 24% of members,\11\ or may choose to purchase one or two order entry
ports, as chosen by 18% of members.\12\ At the same time, firms with
more order flow, or that employ unique trading strategies that result
in increased message traffic throughout the trading day or at times of
higher peak traffic, may choose to purchase additional ports to support
their business. The Exchange believes that the proposed match capacity
fees are appropriate as these fees would ensure that market
participants continue to pay for the amount of capacity that they
request. The Exchange therefore believes that its logical connectivity
fees are aligned with the goals of the Commission in facilitating a
competitive

market for all firms that trade on the Exchange.
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    \11\ See supra note 4.
    \12\ See supra note 6. Altogether, a significant percentage of
members (42%) that trade equities on BZX purchase two or fewer order
entry ports--i.e., including members that purchase no ports and
connect indirectly instead.
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    The proposed match capacity fee would not change the services
provided to market participants, and would be billed at the same
monthly rate as currently charged today on a per port basis, but would
ensure that the way the Exchange's fees are described is more closely
aligned with the goal of those fees. Specifically, each match capacity
fee paid by a member would allow that firm to continue to submit up to
5,000 messages per second to the Exchange for processing in accordance
with the Exchange's trading rules.\13\ For only $550 per month a member
would therefore be able submit as many as 117 million messages daily
into the Exchange's trading system. In addition, market participants
that desire more total capacity due to their business needs, or that
wish to segregate order flow by purchasing separate capacity
allocations to reduce latency or for other operational reasons, would
be permitted to choose to purchase such additional capacity at the same
marginal cost. The Exchange believes that it is reasonable, equitable,
and not unfairly discriminatory to charge for connectivity in this
manner as this structure ensures that the firms can choose based on
their needs, and the firms that pay the most are the ones that demand
the most resources from the Exchange.
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    \13\ The Exchange has invested considerable time and resources
in designing and maintaining a resilient trading system that is
capable of handling the message traffic produced by members in a
manner that complies with its obligations as a national securities
exchange.
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    To illustrate the large variance in message traffic used by BZX
members, the Exchange compiled statistics on the average message
traffic generated during November 2018 by each firm across three
periods: (1) The open (9:30 a.m.-9:35 a.m.), (2) regular trading (9:35
a.m.-3:55 p.m.), and (3) the close (3:55 p.m.-4:00 p.m.).\14\ The
summary table below shows the average order rate/second for firms,\15\
bucketed in groups based on their rank in the distribution.
Significantly higher message traffic is generated by firms at the top
of the distribution, which represents the firms with the largest U.S.
equities businesses, with firms at the bottom of the distribution
accounting for a small percentage of traffic generated.
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    \14\ The dataset includes all firms that have purchased order
entry ports, including BZX members or non-members that provide
indirect access to the Exchange.
    \15\ The order rate includes, for each firm, all new orders,
modifies, and cancel messages submitted into the trading system. The
average order rate is calculated by dividing the number of messages
by the number of seconds for the period.

                                    Summary Table--Average Order Rate/Second
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                                                                                Regular
                              Rank                                     Open           trading          Close
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1-5.............................................................           4,693           2,059           3,904
6-10............................................................           1,743             739           1,173
11-20...........................................................             666             296             437
21-30...........................................................             176              99             207
31-40...........................................................             123              42              68
41-50...........................................................              68              12              28
51+.............................................................               2               1               2
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    While message traffic for individual market participants typically
peaks at higher levels during certain periods of greater market
activity, not a single firm had an average order rate that exceeded the
5,000 messages per second permitted over a single port for the period
of regular trading that accounts for the substantial majority of the
trading day. In fact, only five firms exceeded an average of greater
than 1,000 messages per second, and these firms collectively generated
more message traffic than every other firm combined.\16\ In the first
and last five minutes of the trading day around the open and close of
trading, where volatility and therefore message traffic is typically
higher, only three firms had an average order rate that exceeded 5,000
messages per second, with the top five again accounting for more
message traffic than all other market participants combined in both of
these periods. A number of sophisticated market participants may also
have higher peak traffic intraday if their business involves the
frequent modification or cancellation of a large number of orders at
very granular millisecond or microsecond time intervals, particularly
when multiple trading strategies or algorithms that come through
different logical connections attempt to access the market
simultaneously. The Exchange must build resilient trading systems that
are able support significant bursts in message traffic from such firms,
including most recently on October 18, 2018 when the Exchange
successfully processed a historical high burst in message traffic of
1,140,183 messages per second.
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    \16\ Individually, all but one of the firms in the top five
generated more message traffic than the total message traffic
generated by all firms outside of the top 20 combined, and the firm
with the highest order rate alone generated almost twice as much as
such firms.
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    Thus, although certain broker-dealers with large and profitable
U.S. equities businesses may purchase multiple order entry ports, the
Exchange believes that this is appropriately driven by the amount of
message traffic that they generate throughout the day and at periods
where more message traffic is generated. Furthermore, the data shows
that market participants with modest capacity needs can access the
Exchange at a very low cost. While the Exchange believes that
encouraging order flow and liquidity from a diverse set of market
participants facilitates price discovery and improves the quality of
our markets, the Exchange also believes that firms that desire
additional capacity to support trading strategies with higher peak
traffic should continue to be charged for the capacity that they
request rather than have this cost mutualized across firms with a much
smaller footprint.
    With the proposed fees, firms with modest capacity needs could
continue to pay for and operate their business with the baseline
capacity of 5,000 messages per second, which represents the equivalent
of one logical port today. Furthermore, large and sophisticated market
participants that require significantly more capacity than their
smaller counterparts would be able to purchase that capacity from the
Exchange at a reasonable marginal cost and thereby satisfy their
business needs, including the need for higher peak traffic. The
Exchange therefore believes that the proposed match capacity fee both
appropriately reflects the benefits

to different firms of being able to send messages into the Exchange's
trading system, and facilitates the Commission's goal of ensuring that
critical market infrastructure has ``levels of capacity, integrity,
resiliency, availability, and security adequate to maintain their
operational capability and promote the maintenance of fair and orderly
markets.'' \17\
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    \17\ See Securities Exchange Act Release No. 73639 (November 19,
2014), 79 FR 72251 (December 5, 2014) (File No. S7-01-13)
(Regulation SCI Adopting Release).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change would
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As explained
herein, the proposed rule change is designed to increase transparency
around the Exchange's fees by changing the nomenclature associated with
``per port'' fees for order entry logical ports to reflect a capacity
fee. The Exchange believes that charging logical connectivity fees
based on the capacity used by a market participant is pro-competitive
because it ensures that firms with the largest U.S. equities market
share, or that employ trading strategies that result in increased
message traffic, continue to pay for the capacity that they request,
while smaller firms can connect and trade at a low cost.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \18\ and paragraph (f) of Rule 19b-4 \19\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f).
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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-CboeBZX-2018-095 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-CboeBZX-2018-095. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2018-095 and should be submitted
on or before February 21, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-00474 Filed 1-30-19; 8:45 am]
BILLING CODE P


Comment Info: =================

General Comment:I am commenting on behalf of my self as well as many vapers I speak to in my daily contacts as a vape shop owner. The proposed regulations are very complicated and took a staff of over 100 people to draft and took over two years to release to the public but we are only given 75 days to comment. This is a very important subject and as written I am opposed to them. I am asking that you consider extending the comment period for a least an additional 180 days so I and others may do additional research prior to submitting a final comment. Thank You


[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11257-11258]
[FR Doc No: 2013-03545]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68899; File No. SR-NASDAQ-2013-027]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to a Pricing Clarification

February 11, 2013.
    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 February 4, 2013, 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, II, and III below, which Items have been prepared by NASDAQ.
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

    NASDAQ proposes to add references to certain terms in Chapter XV,
entitled ``Options Pricing,'' which governs pricing for NASDAQ members
using the NASDAQ Options Market (``NOM''), NASDAQ's facility for
executing and routing standardized equity and index options. The
Exchange also proposes a technical amendment to Section 2 of Chapter
XV, entitled ``NASDAQ Options Market--Fees and Rebates.''
    The text of the proposed rule change is also available on the
Exchange's Web site at http://www.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. 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to add certain references to Chapter
XV in order to provide greater clarity to the terms used throughout
this Chapter for the purpose of assessing fees and paying rebates.
Specifically, the Exchange proposes to add the terms ``Customer,''
``NOM Market Maker,'' ``Non-NOM Market Maker,'' ``Firm,''
``Professional,'' and ``Broker-Dealer'' to Chapter XV to provide
guidance on how the Exchange applies the fees and rebates in Chapter XV
to these categories of market participants. The Exchange proposes to
state that the term ``Customer'' or (``C'') applies to any transaction
that is identified by a NOM Participant for clearing in the Customer
range at The Options Clearing Corporation (``OCC'') which is not for
the account of a broker or dealer or for the account of a
``Professional'' (as that term is defined in Chapter I, Section
1(a)(48)). The Exchange proposes to state that the term ``NOM Market
Maker'' or (``M'') is a NOM Participant that has registered as a Market
Maker on NOM pursuant to Chapter VII, Section 2, and must also remain
in good standing pursuant to Chapter VII, Section 4. In order to
receive NOM Market Maker pricing in all securities, the NOM Participant
must be registered as a NOM Market Maker in at least one security. The
Exchange proposes to state that the term ``Non-NOM Market Maker'' or
(``O'') is a registered market maker on another options exchange that
is not a NOM Market Maker. A Non-NOM Market Maker must append the
proper Non-NOM Market Maker designation to orders routed to NOM. The
Exchange proposes to state that the term ``Firm'' or (``F'') applies to
any transaction that is identified by a NOM Participant for clearing in
the Firm range at OCC. The Exchange proposes to state that the term
``Professional'' or (``P'') means any person or entity that (i) is not
a broker or dealer in securities, and (ii) places more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s) pursuant to Chapter I, Section 1(a)(48). All
Professional orders shall be appropriately marked by NOM Participants.
Finally, the Exchange proposes to state that the term ``Broker-Dealer''
or (``B'') applies to any transaction which is not subject to any of
the other transaction fees applicable within a particular category. The
order capacity codes, ``C,'' ``M,'' ``O,'' ``F,'' ``P,'' and ``B'' are
codes that have been established by the Exchange related to the order
entry ports using the Financial Information Exchange (``FIX'')
protocol.
    The Exchange also proposes to define the term ``Common Ownership''
in Chapter XV. That term is currently defined and used throughout
Section 2 of Chapter XV. The Exchange proposes to define it once at the
beginning of Chapter XV as Participants under 75% common ownership or
control and remove all other definitions in Section 2. The Exchange is
not amending the current use of that term, but rather proposing to
create a single definition for ease of reference.
    The Exchange also proposes to define the terms ``adding liquidity''
and ``removing liquidity'' for purposes of Chapter XV, Section 2(1)
pricing. Specifically, the Exchange proposes to state that ``[w]ith
respect to Chapter XV, Sections 2(1) and (2) the order that is received
by the trading system first in time shall be considered an order adding
liquidity and an order that trades against that order shall be
considered an order removing liquidity.'' The Exchange believes that
specifying which orders are considered adding and which orders are
considered removing liquidity would further clarify NOM's pricing.
    Finally, the Exchange proposes to amend the numbering in Section 2
of Chapter XV to renumber the current Section 2(4). The Exchange
recently filed a rule change to eliminate Section 2(3).\3\ At this
time, the Exchange is proposing to renumber Section 2(4) as Section
2(3).
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    \3\ See SR-NASDAQ-2013-013 (not yet published).
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2. Statutory Basis
    NASDAQ believes that its proposal to amend Chapter XV of the Rules
to add references to various terms is consistent with Section 6(b) of
the Act \4\ in general, and furthers the objectives of Section 6(b)(5)
of the Act \5\ in particular. The Exchange's proposal to clarify its
pricing is intended to provide additional guidance to market
participants with respect to the application of fees and rebates in
Chapter XV, similar to other options exchanges.\6\ Further, the
Exchange also proposes to provide clarification regarding the manner in
which the Exchange applies fee and rebates for adding and removing
liquidity and define Common Ownership for ease of

reference. The Exchange believes the addition of these references will
provide additional transparency to Chapter XV of the Exchange's Rules.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5) [sic].
    \6\ See NASDAQ OMX PHLX LLC's Pricing Schedule. See also the
International Securities Exchange, LLC's Fee Schedule.
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    The Exchange does not believe that there is confusion among market
participants with respect to the terms described herein, but rather
that the addition of these terms to Chapter XV would serve to provide
transparency and guidance to the benefit of all market participants.
The Exchange believes that the proposal is consistent with Section
6(b)(5) 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, by clarifying what fees and
rebate in Chapter XV apply to certain transactions and market
participants.
    The Exchange is not amending the manner in which it applies pricing
to various Participants. The proposed terms merely codify the manner in
which the Exchange assesses fees and pays rebates today and defines
Common Ownership today. Similarly, the manner in which fees and rebates
for adding and removing liquidity are applied is not changing but
merely codified by the addition of the terms to Chapter XV.

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. The Exchange is merely filing this
clarification to specify how certain fees and rebates in Chapter XV are
applied to market participants. The Exchange believes that this
clarification will provide greater transparency to market participants.
The Exchange does not believe that this amendment creates intramarket
competition among Participants as it is applied uniformly to all
Participants. The Exchange believes that clarifying the applicability
of certain fees and rebates for adding and removing liquidity within
the Pricing Schedule provides market participants clear guidance.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(ii) of the Act \7\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved. The Exchange has
provided the Commission written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the date of
filing of the proposed rule change.

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-2013-027 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2013-027. 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 such filing also will be available
for inspection and copying at NASDAQ's principal office. 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-2013-027, and should
be submitted on or before March 8, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-03545 Filed 2-14-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42485-42487]
[FR Doc No: 2022-15161]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1615]

Instructions for Use--Patient Labeling for Human Prescription
Drug and Biological Products--Content and Format; 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 final guidance for industry entitled
``Instructions for Use--Patient Labeling for Human Prescription Drug
and Biological Products--Content and Format.'' This guidance provides
recommendations for developing the content and format of an
Instructions for Use (IFU) document for human prescription drug and
biological products, as well as drug-led or biologic-led combination
products submitted under a new drug application (NDA) or a biologics
license application (BLA). The IFU is written for patients (or their
caregivers) who use drug products that have complicated or detailed
patient-use instructions. The recommendations in this guidance are
intended to help ensure that patients receive clear and concise
information that is easily understood for the safe and

effective use of such products. This guidance finalizes the draft
guidance issued on July 2, 2019, entitled ``Instructions for Use--
Patient Labeling for Human Prescription Drug and Biological Products
and Drug-Device and Biologic-Device Combination Products--Content and
Format.''

DATES: The announcement of the guidance is published in the Federal
Register on July 15, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-1615 for ``Instructions for Use--Patient Labeling for Human
Prescription Drug and Biological Products.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, 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 that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Chris Wheeler, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993, 301-796-
0151; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Instructions for Use--Patient Labeling for Human
Prescription Drug and Biological Products--Content and Format.'' The
recommendations in this guidance are intended to help ensure that
patients receive clear and concise information that is easily
understood for the safe and effective use of such products and to help
provide consistency to the content and format of IFU documents.
    The IFU is a form of prescription drug labeling. For drugs for
which self-administration may be complicated (such as requiring the
patient to perform multiple steps to prepare, administer, store, and/or
dispose of the drug), the IFU is intended to give directions that are
clear and understandable for patients, and therefore, promote the safe
and effective use of that drug. For example, IFUs may be appropriate
for a drug product with one set of dosing instructions for adult
patients and another set for pediatric patients. The IFU is developed
by the applicant, reviewed and approved by FDA, and provided to
patients when the drug product is dispensed.
    This guidance finalizes the draft guidance entitled ``Instructions
for Use--Patient Labeling for Human Prescription Drug and Biological
Products and Drug-Device and Biologic-Device Combination Products--
Content and Format,'' issued on July 2, 2019 (84 FR 31598). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include a
change in title in addition to editorial changes to improve clarity.
    This 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 ``Instructions for Use--Patient Labeling for
Human Prescription Drug and Biological Products--Content and Format.''
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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 201 have been approved under OMB control
number 0910-0572; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15161 Filed 7-14-22; 8:45 am]
BILLING CODE 4164-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on September 23, 2002

NOTICE OF ACTION TAKEN -- DOCKET OST 1997-2073

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AVIACION COMERCIAL de AMERICA, S.A. de C.V.
     Date Filed: September 5, 2002

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct passenger charter operations between
Mexico and the United States, and other passenger charter operations in
accordance with 14 CFR Part 212, using small equipment.

Applicant representative(s):  Michelle C. Pardo,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.
         Action date:  September 23, 2002

Effective dates of authority granted:  September 23, 2002, through
September 23, 2003.

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement of August 15, 1960, as
amended and extended (Agreement).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:  Standard exemption
conditions.

Special conditions/Partial grant/Denial basis/Remarks:  In the conduct
of these operations, the carrier must adhere to all applicable
provisions of the U.S.-Mexico Agreement.  In the conduct of these
operations, the carrier may only use aircraft capable of carrying no
more than 60 passengers and having a maximum payload capacity of no more
than 18,000 pounds (small equipment).  The above grant includes
authority to conduct Third and Fourth Freedom charter operations.  While
we have subjected, consistent with the provisions of the Agreement,
Mexican carriers conducting charter operations with large aircraft to
prior approval or submission of notice for their Third and Fourth
Freedom charters, we determined that any such requirement was not
necessary on public interest grounds in this case, since the carrier
will be conducting these operations solely with small aircraft.  (Other
charter operations to/from the United States under this authority,
however, are subject to prior approval under 14 CFR Part 212.)  Further,
we are continuing to allow Mexican carriers conducting passenger
charters using small equipment to make stopovers in the United States in
the conduct of such operations.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviati湯愮灳


August 14, 2007

EPA and National Paint and Coatings Association (NPCA)

Teleconference

Participants:

Heidi McAuliffe, Counsel

Government Affairs Division

National Paint and Coatings Association

J. Kaye Whitfield, EPA Project Lead

National VOC Emission Standards for Aerosol Coatings

Bruce Moore, EPA Team Leader

Consumer and Commercial Products Sector

	The teleconference was held at the request of NPCA.  NPCA requested the
meeting to ask EPA clarifying questions about the proposed regulation.

	EPA explained that, because the comment period for the regulation was
open, EPA would consider the discussion as comments on the proposal and
the teleconference would be documented and submitted to the EPA docket
for the rule (EPA-HQ-OAR-2006-0971).

Subject: Small quantity manufacturer exemption and special compliance
extension provisions in proposed rule

NPCA asked if there are comparable provisions in any other EPA
regulations, or were they newly created.

EPA explained that it was considering a small manufacturer exemption in
order to assist small businesses that produce only small quantities of
aerosol coatings.  EPA explained that it was considering the compliance
date extension in order to allow extra time for product reformulation
for all regulated entities that have never manufactured or marketed
California compliant aerosol coatings. EPA indicated that there are
provisions in other EPA rules that are intended to accomplish similar
objectives.

NPCA described a business scenario in which fillers who fill cans for
companies both within California and outside California may have their
names on the product labels.

EPA asked NPCA to submit its recommendations to EPA for how to address
such a scenario in the regulation.

NPCA asked how companies with all California compliant products, except
one or two products, would be addressed in the regulation.  NPCA
inquired whether EPA would be willing to extend the compliance extension
to companies on a product by product basis.

EPA explained that the intended purpose of the proposed compliance
extension is to assist regulated entities that have never complied with
California limits, and therefore would potentially need additional time
to reformulate their products. EPA indicated that the suggestion made by
NPCA would not be consistent with the intent of the proposed provision.

Subject: Table 2A Reactivity Factors

NPCA stated that California made amendments to the Maximum Incremental
Reactivity (MIR) values Table in 2003, where the MIR values for 14
compounds were adjusted.  Table 2A in the EPA proposal has the old MIR
values.

EPA indicated that will check the MIR values in Table 2A of the proposed
rule and make any revisions it deems appropriate.

Issue: Recordkeeping and Reporting

NPCA asked what regulated entity bears the responsibility to submit
reports. NPCA also indicated that the proposed regulation appears to
require duplication of recordkeeping activities.

EPA explained that under the proposal, the regulated entity is generally
the entity whose name appears on the product label.  The regulated
entity is responsible for reporting and ensuring that records are kept.
EPA noted that other consumer products regulations/guidelines allow a
recordkeeping agent to be designated by the regulated entity, and that
such a provision might be appropriate in this regulation as well.

Issue: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

NPCA pointed out that California Air Resources Board has exempted
aerosol coatings that are also regulated under FIFRA.

EPA indicated that it would consider a compliance date extension for
aerosol coatings subject to FIFRA, consistent with current consumer
product regulations/guidelines.

Issues: Category Codes in Table 1

NPCA stated that each company has its own category codes, date codes and
batch information codes.

EPA indicated that it would consider whether it should request regulated
entities to submit their category codes, along with an explanation of
the codes, with the initial notification reports proposed in the
regulation.

 PAGE

 PAGE   1


[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72981-72983]
[FR Doc No: 2021-27894]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1128]

Digital Health Technologies for Remote Data Acquisition in
Clinical Investigations; Draft Guidance for Industry, Investigators,
and Other Stakeholders; 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 draft guidance for industry, investigators, and
other stakeholders entitled ``Digital Health Technologies for Remote
Data Acquisition in Clinical Investigations.'' This guidance provides
recommendations to sponsors, investigators, and other stakeholders on
the use of digital health technologies (DHTs) to acquire data remotely
from participants in clinical investigations evaluating medical
products. DHTs may take the form of hardware and/or software and may be
used to gather health-related information from study participants and
transmit that information to study investigators and/or other
authorized parties to evaluate the safety and effectiveness of medical
products.

DATES: Submit either electronic or written comments on the draft
guidance by March 23, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management

Staff, FDA will post your comment, as well as any attachments, except
for information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-1128 for ``Digital Health Technologies for Remote Data
Acquisition in Clinical Investigations.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of Policy, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Kunkoski, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3332, Silver Spring, MD 20993, 301-796-
6439; Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993,<PHONE_NUMBER>; or Matthew Diamond, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5540, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for
industry, investigators, and other stakeholders entitled ``Digital
Health Technologies for Remote Data Acquisition in Clinical
Investigations.'' Advances in sensor technology, general-purpose
computing platforms, and methods for data transmission and storage have
revolutionized the ability to remotely obtain and analyze clinically
relevant information from individuals. DHTs used for remote data
acquisition are playing a growing role in healthcare and offer
important opportunities in clinical research. DHTs provide
opportunities to record data directly from trial participants (e.g.,
ambulation, sleep, performance of everyday tasks) wherever the
participants may be (e.g., home, school, work, outdoors); this may
provide a broader picture of how participants function in their daily
lives. DHTs may also facilitate the direct collection of information
from participants who are unable to report their experiences (e.g.,
infants, cognitively impaired individuals).
    This guidance outlines recommendations intended to facilitate the
use of DHTs in a clinical investigation as appropriate for the
evaluation of medical products. The guidance provides recommendations
on (1) selection of DHTs that are suitable for use in a clinical
investigation; (2) the description of DHTs in regulatory submissions;
(3) verification and validation of DHTs for use in a clinical
investigation; (4) the definition and evaluation of clinical endpoints
from data collected using DHTs; (5) risk management considerations when
using DHTs; (6) the protection and retention of records; and (7)
additional sponsor and investigator considerations for using DHTs in a
clinical investigation.
    On October 29, 2015, FDA published a notice in the Federal Register
(80 FR 66543) establishing a public docket (FDA-2015-N-3579) to solicit
input from a broad group of stakeholders on the scope and direction of
the use of technologies and innovative methods in the conduct of
clinical trials. FDA considered relevant stakeholder comments received
to the public docket when writing this draft guidance.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Digital
Health Technologies for Remote Data Acquisition in Clinical
Investigations.'' 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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by the OMB under the PRA. The
collections of information in 21 CFR part 11 have been approved under
OMB control number 0910-0303; the collections of information in 21 CFR
part 312, including submissions under subpart E, and 21 CFR 312.41,
312.57, 312.58, 312.62, and 312.120 have been approved under OMB
control number 0910-0014; the collections of

information in 21 CFR part 801 have been approved under OMB control
number 0910-0485; the collections of information under 21 CFR part 807,
subpart E, have been approved under OMB control number 0910-0120; the
collections of information under 21 CFR part 814, subparts A through E,
have been approved under OMB control number 0910-0231; the collections
of information under 21 CFR part 814, subpart H, have been approved
under OMB control number 0910-0332; the collections of information in
21 CFR part 812 have been approved under OMB control number 0910-0078;
the collections of information for the De Novo Classification Process
(Evaluation of Automatic Class III Designation) have been approved
under OMB control number 0910-0844; and the collections of information
in the guidance document entitled ``Requests for Feedback and Meetings
for Medical Device Submissions: The Q-Submission Program'' have been
approved under OMB control number 0910-0756. The collections of
information in 21 CFR part 314 (Applications for FDA Approval to Market
a New Drug) and 21 CFR part 601 (General Licensing Provisions:
Biologics License Application, Changes to an Approved Application,
Labeling, Revocation and Suspension) have been approved under OMB
control numbers 0910-0001 and 0910-0338, respectively. The collections
of information in 21 CFR parts 50 and 56 (Protection of Human Subjects:
Informed Consent; Institutional Review Boards) have been approved under
OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: December 20, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27894 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P


Alan Stout EPA OAR, OTAQ, ASD Transmission Date: 03/ 08/ 2005 01: 34: 04 PM To: rgault@ emamail. org cc: Subject: part 90 amendments Roger, Attached is the draft reg language for part 90, as we discussed last week. We will be ready to talk about any remaining questions or comments at our meeting on Thursday.

Alan Stout U. S. EPA Office of Transportation and Air Quality 2000 Traverwood Dr. Ann Arbor, MI 48105 734 214 4805 734 214 4816 ( fax) stout. alan@ epa. gov www. epa. gov/ otaq/ equip ld. htm PART 91   CONTROL OF EMISSIONS FROM MARINE SPARK IGNITION ENGINES 1. The authority citation for part 91 is revised to read as follows: Authority: 42 U. S. C. 7401  7671q.

2. Section 91.3 is amended by revising the definitions for " Marine spark ignition engine", " Marine vessel", and " United States", adding definitions for " Amphibious vehicle", " Marine engine", and " Spark ignition" in alphabetical order to read as follows: § 91.3 Definitions. * * * * * Amphibious vehicle means a vehicle with wheels or tracks that is designed primarily for operation on land and secondarily for operation in water. * * * * * Marine engine means a nonroad engine that is installed or intended to be installed on a marine vessel. This includes a portable auxiliary marine engine only if its fueling, cooling, or exhaust system is an integral part of the vessel. There are two kinds of marine engines: ( 1) Propulsion marine engine means a marine engine that moves a vessel through the water or directs the vessel's movement. ( 2) Auxiliary marine engine means a marine engine not used for propulsion. Marine spark ignition engine means a spark ignition marine engine that propels a marine vessel. * * * * * Marine vessel has the meaning given in 1 U. S. C. 3, except that it does not include amphibious vehicles. The definition in 1 U. S. C. 3 very broadly includes every craft capable of being used as a means of transportation on water. * * * * * Spark ignition means relating to a gasoline fueled engine or any other type of engine with a spark plug ( or other sparking device) and with operating characteristics significantly similar to the theoretical Otto combustion cycle. Spark ignition engines usually use a throttle to regulate intake air flow to control power during normal operation. * * * * * United States means the States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, Guam, American Samoa, and the U. S. Virgin Islands. * * * * *

3. Section 91.113 is amended by removing and reserving paragraph ( d)( 2) and revising paragraphs ( c)( 6) and ( c)( 7) to read as follows: § 91.113 Requirement of certification   emission control information label and engine identification number. * * * * * ( c) * * * ( 6) The month and year identifying the engine's manufacturing date, with the month abbreviated to no fewer than the first three letters and the year abbreviated to no fewer than the last two digits ( for example, Sep 05); ( 7) The statement " This engine conforms to current U. S. EPA regulations for marine SI engines."; * * * * * ( d) * * * ( 2) [ Reserved] * * * * *

4. Section 91.207 is amended by revising the second equation for S( t) in paragraph ( a) to read as follows: § 91.207 Credit calculation and manufacturer compliance with emission standards.

( a) * * * S( t) = exp ( 0.906 × t/

life) 4 * * * * *

5. Section 91.301 is amended by revising paragraph ( c) to read as follows: § 91.301 Scope; applicability. * * * * * ( c) Additional information about system design, calibration methodologies, and so forth, for raw gas sampling can be found in 40 CFR part 1065. Examples for system design, calibration methodologies, and so forth, for dilute sampling can be found in 40 CFR part 1065.

6. Section 91.316 is amended by revising paragraphs ( b)( 2)( ii) and ( c) introductory text, and the first equation in paragraph ( d)( 6) to read as follows: § 91.316 Hydrocarbon analyzer calibration. * * * * * ( b) * * * ( 2) * * * ( ii) The HFID optimization procedures outlined in 40 CFR part 1065, subpart D. * * * * * ( c) Initial and periodic calibration. Prior to introduction into service and monthly thereafter, or within one month prior to the certification test, calibrate the FID or HFID hydrocarbon analyzer on all normally used instrument ranges, using the steps in this paragraph. Use the same flow rate and pressures as when analyzing samples. Introduce calibration gases directly at the analyzer. An optional method for dilute sampling described in 40 CFR part 1065, subpart F, may be used. * * * * * ( d) * * * ( 6) * * * percent O 2 I = ( B Analyzer response ( ppm C))/ B × 100 * * * * *

7. Section 91.318 is amended by revising paragraph ( d) and the equation in paragraph ( b)( 11) to read as follows: § 91.318 Oxides of nitrogen analyzer calibration. * * * * * ( b) * * * ( 11) * * * percent efficiency = ( 1 + ( a b)/( c d)) × 100 * * * * * ( d) The initial and periodic interference, system check, and calibration test procedures specified in 40 CFR part 1065, subparts C and D, may be used in lieu of the procedures specified in this section.

8. Section 91.320 is amended by revising paragraph ( b) to read as follows: § 91.320 Carbon dioxide analyzer calibration. * * * * * ( b) The initial and periodic interference, system check, and calibration test procedures specified in 40 CFR part 1065, subparts C and D, may be used in lieu of the procedures in this section.

9. Section 91.325 is amended by revising the equations in paragraphs ( c)( i)( iv) and ( c)( 2)( iii) and adding paragraph ( c)( 2)( iv) to read as follows: § 91.325 Analyzer interference checks. * * * * * ( c) * * * ( 1) * * * ( iv) * * * percent CO 2 quench = 100  100 × [ c × a/( d × a  d × b)] × a/ b * * * * * ( 2) * * * ( iii) * * * D1 = D × ( 1 Z1/ 100) ( iv)( A) The maximum raw or dilute exhaust water vapor concentration expected during testing ( designated as Wm) can be estimated from the CO 2 span gas ( or as defined in the equation in this paragraph and designated as A) criteria in paragraph ( c)( 1) of this section and the assumption of a fuel atom H/ C ratio of 1.8: 1 as: Wm(%)= 0.9xA(%) Where: A = maximum CO 2 concentration expected in the sample system during testing. ( B) Percent water quench shall not exceed 3 percent and shall be calculated by: % Water Quench = 100 × ( D1  AR)/ D1 × Wm/ Z1 10. Section 91.419 is amended by revising the entry defining " M HCexh" in paragraph ( b) to read as follows: § 91.419 Raw emission sampling calculations. * * * * * ( b) * * * M HCexh = Molecular weight of hydrocarbons in the exhaust; see the following equation: M HCexh = 12.01 + 1.008 ×   * * * * *

11. Section 91.421 is amended by revising paragraph ( b)( 4)( ii) and ( b)( 4)( iii) to read as follows: § 91.421 Dilute gaseous exhaust sampling and analytical system description. * * * * * ( b) * * * ( 4) * * * ( ii) Conform to the continuous NOX, CO, or CO2 sampling and analysis system to the specifications of 40 CFR 1065.145, with the following exceptions and revisions: ( A) Heat the system components requiring heating only to prevent water condensation, the minimum component temperature is 55  C. ( B) Coordinate analysis system response time with CVS flow fluctuations and sampling time/ test cycle offsets to meet the time alignment and dispersion specifications in 40 CFR pat 1065, subpart C. ( C) Use only analytical gases conforming to the specifications of 40 CFR 1065.750 for calibration, zero, and span checks. ( D) Use a calibration curve conforming to 40 CFR part 1065, subparts C and D, for CO, CO2, and NOX for any range on a linear analyzer below 155 ppm. ( iii) Convert the chart deflections or voltage output of analyzers with non linear calibration curves to concentration values by the calibration curve( s) specified in 40 CFR part 1065, subpart D, before flow correction ( if used) and subsequent integration takes place. * * * * *

12. Section 91.705 is amended by revising paragraph ( d) to read as follows: § 91.705 Prohibited acts; penalties. * * * * * ( d) An importer who violates § 91.1103( a)( 1), section 213( d) and section 203 of the Act is subject to a civil penalty under § 91.1106 and section 205 of the Act of not more than $ 32,500 for each marine engine subject to the violation. In addition to the penalty provided in the Act, where applicable, a person or entity who imports an engine under the exemption provisions of § 91.704( b) and, who fails to deliver the marine engine to the U. S. Customs Service by the end of the period of conditional admission is liable for liquidated damages in the amount of the bond required by applicable Customs laws and regulations. The maximum penalty value listed in this paragraph ( d) is shown for calendar year 2004. Maximum penalty limits for later years may be adjusted based on the Consumer Price Index. The specific regulatory provisions for changing the maximum penalties, published in 40 CFR part 19, reference the applicable U. S. Code citation on which the prohibited action is based.

13. A new § 91.707 is added to read as follows: § 91.707 Importation of incomplete engines. The provisions of 40 CFR 1068.330 apply for importation of incomplete engines.

14. Section 91.1106 is amended by revising paragraphs ( a)( 1), ( a)( 2), ( a)( 5), and ( c)( 1) and adding paragraph ( a)( 6) to read as follows: § 91.1106 Penalties. ( a) * * * ( 1) A person who violates § 91.1103 ( a)( 1), ( a)( 4), or ( a)( 5), or a manufacturer or dealer who violates § 91.1103( a)( 3)( i), is subject to a civil penalty of not more than $ 32,500 for each violation. ( 2) A person other than a manufacturer or dealer who violates § 91.1103( a)( 3)( i) or any person who violates § 91.1103( a)( 3)( ii) is subject to a civil penalty of not more than $ 2,750 for each violation. * * * * * ( 5) A person who violates § 91.1103 ( a)( 2) or ( a)( 6) is subject to a civil penalty of not more than $ 32,500 per day of violation. ( 6) The maximum penalty values listed in this section are shown for calendar year 2004. Maximum penalty limits for later years may be adjusted based on the Consumer Price Index. The specific regulatory provisions for changing the maximum penalties, published in 40 CFR part 19, reference the applicable U. S. Code citation on which the prohibited action is based. * * * * * ( c) * * * ( 1) Administrative penalty authority. In lieu of commencing a civil action under paragraph ( b) of this section, the Administrator shall assess any civil penalty prescribed in paragraph ( a) of this section, except that the maximum amount of penalty sought against each violator in a penalty assessment proceeding can not exceed $ 270,000, unless the Administrator and the Attorney General jointly determine that a matter involving a larger penalty amount is appropriate for administrative penalty assessment. Any such determination by the Administrator and the Attorney General is not subject to judicial review. Assessment of a civil penalty is made by an order made on the record after opportunity for a hearing held in accordance with the procedures found at part 22 of this chapter. The Administrator may compromise, or remit, with or without conditions, any administrative penalty which may be imposed under this section. * * * * *


memorandum Date: April 30, 2004 To: Martha Segal, EPA; Shari Goodwin, Tetra Tech From: . John Sunda, SAIC Subject: Results of Initial Research Concerning Reuse of Cooling Water at Industrial Facilities in the 316( b) Survey Database Identifying Facilities Employing Cooling Water Reuse After reviewing the survey responses of facilities that reuse cooling water for other uses that I initially identified through review of flow schematics, I have concluded that there is no consistent way to identify these facilities by reviewing the survey data alone. In some cases, in Part 2 Question 4 ( which asks for % cooling use by activity category), " reuse in process" is reported under Q4e ( Other) and in some the sum of all categories is > 100% reflecting the multiple use of the same water. However, there is no specific question or data attribute that clearly identifies cooling water reuse.

While Part 2 Question 26 asks about whether the facility ever implemented cooling water flow reduction measures to reduce entrainment, a quick review those that responded " yes" mostly checked " cooling towers" as the method under Q26( b)( 1) and the example facilities described below all checked " no" in Q26. I think the reasons why reuse does not show up in Q26 are that in many cases the water reduction was not prompted by a need to reduce entrainment but rather a requirement to reduce overall intake and discharge volumes. Also, reuse of cooling water does not necessarily reduce the volume of water used for cooling purposes and therefore it is not viewed as " cooling water" reduction. Rather, the reuse result is a reduction of overall plant water requirements where all or a portion of the process water requirements are replaced by warmed cooling water. In fact, in the pulp and paper industry there are economic incentives in that many processes require heated water and thus, the presence of waste heat in the spent cooing water reduces the heating ( i. e. energy) requirements associated with using unheated raw water as process water.

Ultimately, I found that review of the flow schematic diagrams provided the only reliable means of identifying facilities that reused cooling water. In many cases the diagrams did not provide sufficient detail to make a determination. I did not review all of the detailed survey responses from industrial facilities. I reviewed approximately 60+ detailed survey responses with survey ID prefixes.

Qualitative Results by Industry Type I was hoping to find examples from several different industries. What I found was numerous examples in the pulp and paper industry and one sugar cane processor. Non CBI examples are summarized below, but facility level information was not disclosed to avoid " codebreaker" information. In the case of chemical manufacturing and petroleum refining, cooling water use was almost always shown as a separate flow path with the use of cooling towers providing flow reduction. In the case of metals manufacturing, most showed separate flow paths or did not distinguish cooling water.

Defining Reuse I did not consider a flow configuration as reuse of cooling water if the reuse involved cooling also. In the metals industry, many of the process uses where cooling water might be directed for reuse involved contact cooling, so even if non contact cooling water ( e. g., once through condenser cooling) were reused as process contact cooling water, the water is still being used as cooling water.

REUSE EXAMPLES Presented below is a summary of the clear examples of cooling water reuse I was able to identify and that were not claimed as CBI. At least seven additional examples in the pulp and paper industry were identified but claimed technical data as confidential either by checking the circle on page vii of the instructions or at the bottom of the schematic diagram page and/ or pages concerning technical/ flow data. In the examples provided below it is clear from the survey and diagram that no claims of confidentiality are made regarding the technical information provided. As such, the facilities are identified by name and location. In addition, a copy of the flow diagrams will be sent separately.

Cooling Water Reuse in the Pulp and Paper Industry Numerous examples of cooling water reuse were found in reviewing the flow schematics submitted with the detailed surveys. One example was obtained through facility contact information. This facility had only completed the screener survey and the contact was prompted by questions concerning whether the facility was in scope ( i. e., if cooling water is reused for noncooling process purposes, is it process water or cooling water?). While I did not tally the number of pulp and paper facilities where cooling water reuse was apparent versus those where it was not, it appeared that a major portion of those I reviewed reused at least some cooling water as process water. Probably the most common form of reuse in the pulp and paper industry is the reuse of noncontact cooling water as process water. In many cases, the heated once through non contact cooling water is combined with additional intake water and the combined volume is then used as the source for all process water and in many cases some is reused again as cooling water. In a few cases all or a portion of such reuse is seasonal with reuse decreasing during the summer. Sic Codes: 2621, 2611 This facility completed only the screener survey. The data below was obtained from a facility contact which was prompted by questions concerning whether the facility was in scope. No flow schematic diagram is available for this facility.

provided the following information about the plant:

° Average daily intake volume was mgd in 2003. ° Average NPDES discharge volume was with difference reflecting evaporative losses. This is consistent with the intake volume of mgd reported in the facility screener survey for a typical calendar year. ° Of that mgd goes to a recirculating cooling system as make up water. ° The recirculating system cools turbine condenser water, compressors, hardwood condensers, and gas condensers. ° He did not know the recirculating water flow rate. ° mgd goes to once through cooling systems for a number of purposes including oil coolers, generator cooling, lime kiln cooling, etc. This water is not discharged but rather is reused as process water. In this case the heated water is returned and mixed with other intake water. The added heat from the reused water offsets some process water heating requirements, so not only is the cooling water being reused but some of the heat is recovered as well. ° Through various measures, the facility has reduced the water intake volume from around mgd in the 1970' s to the current volume of mgd. The volume of water use by the plant is restricted in the NPDES permit to mgd. ° This reduction from mgd to mgd is the result of a number of steps taken to reduce water use including the addition of the recirculating cooling system and the reuse of mgd of once through cooling water as process water.

In this example only mgd of the mgd withdrawn is used solely for cooling purposes. mgd is first used as cooling water and then reused as process water.

SIC Code: 2631 This is a small facility with regard to intake flow volumes but is included because it provided detailed flow data. The flow schematic indicates the data below is from 1998:

° A total of gpd is withdrawn from and gpd enters the system with the raw materials. ° gpd ( 73.4% of total) is first used for cooling purposes as follows:

All of the above cooling water flows ( 100%) are then used as process water. Ultimately gpd goes to the POTW, evaporates from the process operations,. Item is process feed water that flows through a heat exchanger that recovers heat from spent process prior to treatment and discharge to the POTW. I would not consider this stream as cooling water. SIC Code: 2631 The flow schematic shows the following: ° A total of mgd is withdrawn from the river ° A total of mgd passes through # 1 turbine and evaporator condensers and then a cooling tower. mgd is then discharged as non contact cooling water. ° The remaining cooling tower effluent ( mgd) passes through a process water treatment system ( reactor/ clarifier) along with an additional mgd of intake water. ° Treated water ( mgd) then goes to mill water storage where a total of mgd is used as make up water in cooling water systems as follows:

° The remaining water from the mill storage water ( volume not shown but calculated to be ) goes to the pulpmill and papermill process.

In this example, mgd of the mgd initially used as cooling water is discharged as non contact cooling water. This ( 14% of the total intake) is not reused. The remaining is supplemented with intake water which means the mill storage influent is 62 % cooling water. ( 16% of total intake) is used for cooling again as cooling tower make up. The calculated of water ( 62% of which is reused cooling water) used in the processes represents 68% of the intake volume. The design intake volume reported in Q3( g) was and Q3( h) reported as apportioned to cooling water. Thus, the cooling water volume was estimated to be .

Sic Code: 2621, 2611 Intake volume is not shown on the diagram, Q 25( m) shows an annual total of . The flow schematic shows the following: ° The mill water intake receives: mgd of recycled non contact cooling water;

° The total outflow from the mill water intake of mgd includes: ° Of the mgd non contact cooling water, ° Of the entering the papermill,

Of the calculated mgd inflow only ( 6%) passes through as cooling water and exits without being used as process water. Of the total intake outflow ( 78%) is used for non contact cooling. The facility reported an intake design capacity of ( Q3( g)) with ( Q3( h)) apportioned to cooling water. At first the design values appears off by about a factor of but which is reasonably consistent with the sum of the mgd of non contact cooling water plus the mgd of water returned to the intake.

SIC Code: 2621 NOTE THIS FACILITY IS NOT INCLUDED IN PHASE III DATABASE The flow schematic showed the following: ° Of the total intake volume of ( 5.8%) is used for non contact cooling of compressors and air conditioners prior to recombining with the remaining intake water which is then used as process and cooling water within the plant. ° Individual flow volumes to various plant areas are not given. Yet at least a portion goes to the power house where it is likely that a portion of the water is used for cooling and is not reused.

The response to Q3( h), the estimated percentage of design capacity apportioned to cooling water was 3.8%. There are calculation notes in the margin that indicate that only the non contact cooling water was included in the 3.8% value reported. The design flow Q3( g) was .

SIC Code: 2611, 2621, 2647 The flow diagram shows the following: ° Intake volume was Cooling Water Reuse in the Sugar Cane Processing Industry SIC Code: 0133 Q3( h) indicates that the facility considers 100% of the water withdrawn from the reservoir as cooling water.

The flow schematic shows:

ATTACHMENTS FLOW SCHEMATICS FOR:


[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Notices]
[Page 36584-36585]
[DOCID:fr27jn08-114]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2008-0009, Notice No. 2]

Declaration of Emergency Event

AGENCY: Federal Railroad Administration (FRA), DOT.

ACTION: Notice of declaration of emergency event.

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

SUMMARY: On June 11, 2008, the Administrator of the FRA determined that
the recent flooding around the Midwest region of the United States

constituted an emergency event as related to railroad operations.
Accordingly, the Administrator activated the Emergency Relief Docket.
This document provides notice of the Administrator's determination.

SUPPLEMENTARY INFORMATION: On June 11, 2008, the Administrator of the
FRA determined that the recent flooding around the Midwest region of
the United States constituted an emergency event pursuant to 49 CFR
211.45(c) and that public safety would benefit from providing the
railroad industry with operational relief directly related to that
emergency. Accordingly, the Administrator activated the Emergency
Relief Docket (docket number FRA-2008-0009) and in accordance with 49
CFR 211.45(g), petitions received in that docket pursuant to this
emergency event will be handled according to the requirements of 49 CFR
211.45(g)-(j).
    Interested parties are reminded that the procedures in 49 CFR
211.45 provide for expedited review and processing of emergency waiver
petitions. Accordingly, in accordance with 49 CFR 211.45(h), any person
wishing to comment on petitions for emergency waivers should submit
their comments to the docket within 72 hours from the close of business
on the day that the petition is posted in the public docket. Any person
desiring a public hearing on any petition being processed in accordance
with the emergency waiver procedures must notify FRA of such request in
their comments submitted to the docket. 49 CFR 211.45(i).
    Interested persons may submit their comments using any of the
following methods:
    (1) E-mail to FRA at<EMAIL_ADDRESS>    (2) Fax to FRA at:<PHONE_NUMBER>; or
    (3) Hand deliver or expedited delivery to the Docket Clerk, Docket
Operations Facility, U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., W12-140, Washington, DC 20590 or electronically via the
Internet at http://www.regulations.gov.
    All communications concerning any petition in the Emergency Relief
Docket should identify the appropriate docket number (e.g., FRA-2008-
0009).

Privacy

    Anyone is able to search 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
665, Number 7, Pages 19477-78). The statement may also be found at
http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on June 23, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E8-14542 Filed 6-26-08; 8:45 am]

BILLING CODE 4910-06-P