[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Pages 56411-56415]
[FR Doc No: 2014-22327]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73094; File No. SR-BYX-2014-018]

Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of
Filing of a Proposed Rule Change to Rules 11.9 of BATS Y-Exchange, Inc.

September 15, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 3, 2014, BATS Y-Exchange, Inc. (the ``Exchange'' or
``BYX'') 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 the
Substance of the Proposed Rule Change

    The Exchange is proposing to add Rule 11.23, entitled ``Opening
Process,'' as well as to make several corresponding changes in order to
modify the manner in which the Exchange opens trading in individual
securities at the beginning of the day and after trading halts.
    The text of the proposed rule addition is available at the
Exchange's Web site at http://www.batstrading.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these

statements may be examined at the places specified in Item IV below.
The Exchange has prepared summaries, set forth in Sections A, B, and C
below, of the most significant parts of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to amend Exchange Rules
11.9(b) and 11.18(f) and to add new Rule 11.23 in order to allow for
the entry of orders with a time-in-force of Regular Hours Only and to
amend the process by which the Exchange opens trading at the beginning
of the day and after trading halts. Specifically, the Exchange is
proposing to accept Regular Hours Only orders for queuing throughout
the Pre-Opening Session,\3\ as well as to establish a process for
handling queued orders in order to open trading on the Exchange for
Regular Trading Hours \4\ and following a halt. The Exchange is
proposing this rule change in order to create a more orderly opening of
trading and to facilitate the price formation process at the open of
trading by allowing Users to enter orders during the Pre-Market Session
and during a halt rather than requiring them to submit a flood of
orders to the Exchange immediately following the beginning of Regular
Trading Hours or the resumption of trading following a halt.
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    \3\ Pre-Opening Session is defined in BYX Rule 1.5(r).
    \4\ Regular Trading Hours is defined in BYX Rule 1.5(w).
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    Currently, the Exchange begins accepting orders for trading at the
beginning of the Pre-Opening Session and any such orders received by
the Exchange are immediately eligible for execution. Any such orders
that are on the BATS Book \5\ at the beginning of Regular Trading Hours
remain on the BATS Book, subject to the User's instruction, and trading
continues into Regular Trading Hours without any transition period.
Upon a halt, the Exchange currently cancels all orders on the BATS Book
and does not accept any orders until the halt is lifted. The Exchange
does not currently have a Regular Hours Only time-in-force.
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    \5\ BATS Book is defined in BYX Rule 1.5(e).
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    The Exchange is proposing to implement a process by which the
Exchange will accept and queue orders that have a time-in-force of
Regular Hours Only (or ``RHO'') during the Pre-Opening Session for
execution at the midpoint of the NBBO \6\ shortly after the beginning
of Regular Trading Hours (the ``Opening Process''). The Exchange is
also proposing to implement a similar opening process after a halt,
suspension, or pause (a ``Halt'' and the ``Halt Opening Process'') in
which a User's orders will remain on the BATS Book, unless the User has
designated that its orders be cancelled upon a halt, as further
described below.
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    \6\ NBBO is defined in BYX Rule 1.5(o).
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    As mentioned above, the Exchange is proposing to add Rule
11.9(b)(7) which would define the new RHO time-in-force as a limit or
market order that is designated for execution only during Regular
Trading Hours, which includes the Opening Process, as defined in Rule
11.23. The Exchange is also proposing to make a non-substantive change
to Rule 11.9(b) in order to delete the word ``limit'' because an RHO
order can be both a limit order or a market order. Each other time-in-
force clearly states that it applies only to limit orders.
    The Exchange proposes that prior to the beginning of Regular
Trading Hours, Users \7\ that wish to participate in the Opening
Process may enter orders to buy or sell with a time in force of Regular
Hours Only. Orders cancelled before the completion of the Opening
Process will not participate in the Opening Process. Any order that is
not designated as RHO will not be eligible for participation in the
Opening Process. Proposed Rule 11.23(a)(2) provides that all orders
that are marked as RHO may participate in the Opening Process except
BATS Post Only Orders,\8\ Partial Post Only at Limit Orders,\9\ ISO
\10\ orders not modified by Rule 11.23(a)(1), as described below, and
Minimum Quantity Orders.\11\ Because RHO orders received prior to the
completion of the Opening Process are not immediately executable, but
rather queued for later participation in the Opening Process, BATS Post
Only Orders, Partial Post Only at Limit Orders, and Minimum Quantity
Orders marked as RHO do not make sense in the context of the Opening
Process and, thus, the Exchange is proposing to exclude them from the
Opening Process. Similarly, because an order designated as an ISO
implies that there is currently a protected bid or offer and there are
no protected bids or offers prior to 9:30 a.m. Eastern Time, the
Exchange proposes to reject any ISOs designated RHO entered prior to
the beginning of Regular Trading Hours. While this functionality is
opposite of the way that ISOs are handled on the options platform
operated by BATS Exchange, Inc. (``BATS Options'') (ISOs are converted
to non-ISOs and entered for queuing), the Exchange believes that
because there is continuous trading during the Pre-Opening Session on
the Exchange while orders are also being queued for participation in
the Opening Process, an ISO tag could be interpreted in various ways
and there is no obvious way to eliminate this confusion and, as such,
the order should be rejected. On BATS Options, on the other hand, there
is no continuous book and all orders entered prior to 9:30 a.m. Eastern
Time are queued for participation in the BATS Options opening process,
so an ISO tag simply does not make sense in that context and can
reasonably be ignored and converted to a non-ISO for queuing.
Consistent with this logic and as further detailed below, the Exchange
is also proposing that, prior to a re-opening after a halt, any ISO
that is not IOC or FOK be converted into a non-ISO for queuing and
participation in the re-opening process because there is no continuous
trading while a security is halted.
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    \7\ User is defined in BYX Rule 1.5(cc).
    \8\ BATS Post Only Order is defined in BYX Rule 11.9(c)(6).
    \9\ Partial Post Only at Limit Order is defined in BYX Rule
11.9(c)(7).
    \10\ ISO is defined in BYX Rule 11.9(d).
    \11\ Minimum Quantity Order is defined in BYX Rule 11.9(c)(5).
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    Limit orders with a Reserve Quantity \12\ may participate to the
full extent of their displayed size and Reserve Quantity. Discretionary
Orders \13\ may participate only up to their ranked price for buy
orders or down to their ranked price for sell orders. The discretionary
range of such orders will not be eligible for participation in the
Opening Process. All Pegged Orders and Mid-Point Peg Orders, as defined
in Rule 11.9(c)(8) and (9), will be eligible for execution in the
Opening Process based on their pegged prices.
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    \12\ Reserve Quantity is defined in BYX Rule 11.9(c)(1).
    \13\ Discretionary Order is defined in BYX Rule 11.9(c)(10).
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    The Exchange will then attempt to perform the Opening Process, as
described in proposed Rule 11.23(b), in which the Exchange matches buy
and sell orders that are executable at the midpoint of the NBBO as
described in proposed Rule 11.23(c) below. All orders eligible to trade
at the midpoint will be processed in time sequence, beginning with the
order with the oldest time stamp. The Exchange believes that handling
orders in time priority makes more sense than price-time priority for
the Opening Process because the price of the order is not particularly
important

to the Opening Process, so long as the order is priced at or more
aggressively than the Opening Price and, as such, there is no reason to
reward a more aggressive order with priority in the Opening Process.
Thus, the Exchange is proposing that all orders that are priced equal
to or more aggressively than the Opening Price be matched based only on
time priority and will be matched until there is no remaining volume or
there is an imbalance of orders (the ``Opening Match''). All MTP
modifiers, as defined in Rule 11.9(f), will be ignored as it relates to
executions occurring as part of the Opening Match because the
counterparty against which an order executes is mostly random and
completely out of the control of the User entering the order. It does
not make sense to cancel an order because the order happens to execute
against an order entered using the same MPID, but to allow both orders
to execute at the exact same price to the exact same effect where the
orders happen to execute against different orders. An imbalance of
orders on the buy side or sell side may result in orders that are not
executed in whole or in part. Such orders may, in whole or in part, be
placed on the BATS Book, cancelled, executed, or routed to other away
Trading Centers \14\ in accordance with Rule 11.13(a)(2). If no matches
can be made, the Opening Process will conclude with all orders that
participated in the Opening Process being placed in the BATS Book,
cancelled, executed, or routed to away Trading Centers in accordance
with Rule 11.13(a)(2) related to order execution and routing. Because
an RHO order is not executable until the Opening Process (rather than
upon entry), to the extent that any order is not executed during the
Opening Process and is placed on the BATS Book, such order will receive
a time stamp that reflects the time that the order was placed on the
BATS Book during the Opening Process and not the time that the order
was entered for queuing.
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    \14\ Trading Center is defined in BYX Rule 2.11(a).
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    Under proposed Rule 11.23(c), the Exchange will determine the price
of the Opening Process by using the midpoint of the NBBO, as follows:
(a) When the listing exchange is either the NYSE or NYSE MKT, the
Opening Process will be priced at the midpoint of the: (i) First NBBO
subsequent to the first reported trade on the listing exchange after
9:30:00 a.m. Eastern Time; or (ii) then prevailing NBBO when the first
two-sided quotation is published by the listing exchange after 9:30:00
a.m. Eastern Time if no first trade is reported by the listing exchange
within one second of publication of the first two-sided quotation by
the listing exchange; or (b) for any other listing market, the Opening
Process will be priced at the midpoint of the first NBBO disseminated
after 9:30:00 a.m. Eastern Time. The Exchange is proposing to
differentiate the treatment between NYSE and NYSE MKT listed securities
and securities listed on any other exchange because NYSE and NYSE MKT
do not offer continuous trading prior to 9:30:00 a.m. Eastern Time and
the market for trading in securities listed on these exchanges may take
a moment to develop. Using the first NBBO disseminated for NYSE and
NYSE MKT listed securities to establish the Opening Price may result in
executions that are not necessarily reflective of market conditions
after the first execution on the listing market or one second after the
listing market's first quote. Every other listing exchange allows for
continuous trading prior to 9:30:00 a.m. Eastern Time, which results in
a more fully developed market immediately after 9:30:00 a.m. Eastern
Time and, thus, a more immediately reliable Opening Price.
    Proposed Rule 11.23(a)(1) provides that during the period between
9:30 a.m. Eastern Time and the occurrence of the Opening Process, all
non-RHO orders, subject to order instructions, and ISOs designated RHO
may execute against eligible Pre-Opening Session contra-side interest
resting in the BATS Book. The Exchange will convert any unexecuted
portion of an ISO designated RHO entered during this period into a non-
ISO and queue the order for participation in the Opening Process.
    If the conditions to establish the price of the Opening Process set
forth under proposed Rule 11.23(c) do not occur by 9:45:00 a.m. Eastern
Time, proposed Rule 11.23(d) describes a contingent opening process
(the ``Contingent Open Process'') in which instead of matching orders
at the midpoint of the NBBO, orders will be handled in time sequence,
beginning with the order with the oldest time stamp, and will be placed
on the BATS Book, routed, cancelled, or executed in accordance with the
terms of the order. Because an RHO order is not executable until the
Opening Process (rather than upon entry), any order subject to the
Contingent Open Process that is placed on the BATS Book will receive a
time stamp that reflects the time that the order was placed on the BATS
Book during the Opening Process and not the time that the order was
entered for queuing.
    In the event of a Halt, the proposed amendment to Rule 11.18(f)
provides that, except where a User has designated that its orders be
cancelled, all outstanding orders in the System \15\ will remain on the
BATS Book. Proposed Rule 11.23(e) then provides that the Exchange will
accept orders for queuing prior to the resumption of trading in order
to participate in the Halt Opening Process. While a security is subject
to a Halt, the Exchange will accept orders for queuing prior to the
resumption of trading in the security for participation in the Halt
Opening Process. The Halt Opening Process will occur in the same manner
described in proposed Rules 11.23(a)(2) and (b) with the following
exceptions: (1) Non-RHO orders will be eligible for participation in
the re-opening, but IOC,\16\ FOK, BATS Post Only Orders, Partial Post
Only at Limit Orders, and Minimum Quantity Orders will be cancelled or
rejected, as applicable, and any ISO that is not IOC or FOK will be
converted into a non-ISO and be queued for participation in the Halt
Opening Process; and (2) the re-opening will occur at the midpoint of
the: (i) First NBBO subsequent to the first reported trade on the
listing exchange following the resumption of trading after a Halt; or
(ii) NBBO when the first two-sided quotation is published by the
listing exchange following the resumption of trading after a Halt if no
first trade is reported by the listing exchange within one second of
publication of the first two-sided quotation by the listing exchange.
Similar to the rationale for waiting for the sooner of the first
execution on the primary or one second to use the midpoint of the NBBO
for the Opening Process for NYSE and NYSE MKT, the Exchange is
proposing to wait until the sooner of the first execution on the
primary or one second to use the midpoint of the NBBO for the Halt
Opening Process because there is no continuous trading occurring on any
market during a Halt and waiting will provide time for the market to be
more fully established before determining the price at which the Halt
Opening Process will occur. Where neither of the above conditions
required to establish the price of the re-opening have occurred, the
security may be opened for trading at the discretion of the Exchange.
Where the security is opened by the Exchange subject to this
discretion, orders will be handled in the same manner as the Contingent
Open Process.
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    \15\ System is defined in BYX Rule 1.5(aa).
    \16\ IOC is defined in BYX Rule 11.9(b)(1).

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2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\17\ Specifically, the
proposed change is consistent with Section 6(b)(5) of the Act,\18\
because 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. The Exchange believes that
allowing for the entry of RHO orders during the Pre-Opening Session and
transitioning into Regular Trading Hours pursuant to the Opening
Process will help to ensure that the Exchange opens trading in a fair
and orderly manner. Specifically, the Exchange believes that allowing
Users to enter and cancel orders during the Pre-Opening Session to be
queued for execution at the midpoint of the NBBO and/or entry on to the
BATS Book shortly following the beginning of Regular Trading Hours will
create a more orderly opening and facilitate the price formation
process at the opening of trading because Users are able to enter
orders to participate in the Opening Process during the Pre-Market
Session rather than having a flood of orders submitted to the Exchange
immediately following the beginning of Regular Trading Hours.
Similarly, the Exchange believes that implementing substantially
similar functionality in non-BATS listed securities for accepting
orders during re-opening after a Halt will also create a more orderly
opening and facilitate price formation as a security is coming out of a
Halt. Additionally, using the midpoint of the NBBO as the price for the
Opening Process (regardless of the time at which such NBBO is selected
as described under proposed Rule 11.23(c)) will further create a more
orderly opening and facilitation of the price formation process by
basing the price at which the Opening Process will occur on the best
available pricing under current market conditions.
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    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes that excluding BATS Post Only Orders,
Partial Post Only at Limit Orders, ISOs, and Minimum Quantity Orders
from participation in the Opening Process 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; and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers because, as described above, such order
types combined with an RHO time-in-force do not make sense in the
context of queuing orders for the Opening Process. Further, the
Exchange believes that allowing certain RHO orders and all non-RHO
orders to interact with interest (and, in the case of non-RHO orders,
to be added to the BATS Book where there is no contra-side interest)
from the Pre-Opening Session after 9:30 a.m. Eastern Time, but before
the completion of the Opening Process will also create a more orderly
opening and facilitate the price formation process because Users will
have the option to enter orders that will either participate in the
Opening Process or immediately interact with liquidity from the Pre-
Opening Session, allowing trading to continue while the Exchange is
waiting for the conditions necessary to complete the Opening Process.
The Exchange also believes that allowing an ISO marked RHO to execute
against eligible Pre-Opening Session interest after 9:30 a.m. Eastern
and before completion of the Opening Process and then converting the
unexecuted portion of the order into a non-ISO for queuing for
participation in the Opening Process is consistent with the Act because
it is consistent with the requirements of Regulation NMS.\19\ In
particular, because after 9:30 a.m. Eastern Time there may be a
protected bid or offer displayed by the Exchange that the User entering
the order is trying to execute against, the Exchange is proposing to
allow an ISO designated as an RHO to interact with liquidity currently
on the BATS Book prior to queuing for participation in the Opening
Process.
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    \19\ 17 CFR 242.600.
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    The Exchange also believes that the proposal is designed 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 because it would create a contingent opening process
under which the orders queued for participation in the Opening Process
would be entered on to the BATS Book in the event that the conditions
for determining the price of the Opening Process are not met prior to
9:45:00 a.m. Eastern Time, which will further help to ensure that the
Exchange opens trading in a fair and orderly manner by providing a
means for trading in a security to open where there is no two-sided
NBBO in the security for fifteen minutes after the beginning of Regular
Trading Hours. The Exchange believes that fifteen minutes is a
reasonable amount of time to wait for the establishment of a two-sided
NBBO because it marks a point at which the market in a security has had
a sufficient amount of time to develop while simultaneously providing a
reasonable cut-off point at which the Exchange may open the security
for Regular Trading Hours trading. The Exchange also believes that
handling all orders queued for participation in the Opening Process in
time sequence after fifteen minutes will help to ensure that trading
opens in as fair and orderly a manner as possible.
    The implementation of the Opening Process will also provide Users
with greater control and flexibility with respect to entering orders,
allowing them to enter orders for participation during Regular Trading
Hours during the Pre-Opening Session, rather than only after Regular
Trading Hours begin at 9:30 a.m. Eastern Time. This simplifies the
order entry process for Users that do not want to participate in the
Pre-Opening Session by allowing them to enter their orders designated
as Regular Hours Only prior to Regular Trading Hours, which removes
impediments to a free and open market and benefits all Users of the
Exchange.

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

    The Exchange 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. To the contrary, the Exchange's
inability to accept orders prior to 9:30 a.m. Eastern Time for
participation during Regular Trading Hours limits competition in that
the listing exchange is able to begin accepting orders in such
securities, while the Exchange cannot accept such orders. Thus,
approval of the proposed rule change will promote competition because
it will allow the Exchange to offer its Users the ability to enter
orders prior to the beginning of Regular Trading Hours for queuing and
entry during Regular Trading Hours and thus compete more directly with
other exchanges for order flow that a User may not have directed to the
Exchange if they were not able to enter orders for queuing prior to
Regular Trading Hours.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BYX-2014-018 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-BYX-2014-018. 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 at 100 F Street NE.,
Washington, DC 20549-1090 on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-BYX-
2014-018, and should be submitted on or before October 10, 2014.

    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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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-22327 Filed 9-18-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16422-16423]
[FR Doc No: 2018-07984]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Unified Carrier Registration Plan Board of Directors
meeting.

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TIME AND DATE: The meeting will be held on April 19, 2018, from 12:00
noon. to 3:00 p.m., Eastern Daylight Time.

PLACE: This meeting will be open to the public via conference call. Any
interested person may call 1-877-422-1931, passcode<PHONE_NUMBER>, to
listen and participate in this meeting.

STATUS: Open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board. An agenda for
this meeting will be available no later than 5:00 p.m. Eastern Daylight
Time, April 10, 2018 at: https://ucrplan.org.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Issued on: April 10, 2018.
Larry W. Minor,
Associate Administrator, Office of Policy, Federal Motor Carrier Safety
Administration.
[FR Doc. 2018-07984 Filed 4-12-18; 4:15 pm]
BILLING CODE 4910-EX-P


FACT SHEET ON NORTH CAROLINA’S REQUEST TO REVISE ITS PUBLIC WATER
SYSTEM SUPERVISION PROGRAM

Public Notification Rule

Status:

The primacy revision application submitted by the State of North
Carolina (State) for its Public Notification Rule (Rule) has been
reviewed by the Drinking Water Section (DWS) and the Office of Water
Legal Support (OWLS).  Both offices have concluded that this regulation
is no less stringent than the corresponding federal regulations.

Background:

The State submitted a request that the Region approve the revision to
the State’s Safe Drinking Water Act Primacy Program to include the
authority to implement and enforce this Rule.

As required by 40 C.F.R. §142.12(c)(1)(iii), and pursuant to authority
delegated by the Attorney General of The State of North Carolina, the
Senior Deputy Attorney General, Environmental Division, North Carolina
Department of Justice, certified that the laws of the State to carry out
this Rule have been duly adopted and are enforceable.   Furthermore, the
Senior Deputy Attorney General certified that the State has not enacted
any environmental audit privilege or immunity laws.

The DWS and the OWLS staff reviewed this package using the federal
regulations, state regulations, and guidance to determine whether this
Rule is approvable.

Notice of EPA’s tentative approval of the State’s revision to this
Rule will be published in the federal register.  Should no appropriate
request for a hearing be submitted within thirty (30) days of this
publication, EPA’s approval will automatically become final.

OMB Issues

Not Applicable

Anticipated Stakeholder Reaction

The program does not anticipate adverse stakeholder reaction or requests
for a hearing.


[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4356-4358]
[FR Doc No: 2017-00604]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1777]

Factors To Consider When Making Benefit-Risk Determinations for
Medical Device Investigational Device Exemptions; Guidance for
Investigational Device Exemption Sponsors, Sponsor-Investigators, and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Factors to Consider When
Making Benefit-Risk Determinations for Medical Device Investigational
Device Exemptions.'' The purpose of this guidance is to provide greater
clarity for FDA staff and Investigational Device Exemptions (IDE)
application sponsors and sponsor-investigators regarding the principal
factors that the Agency considers when assessing the benefits and risks
of IDE applications for human clinical study. The guidance also
characterizes benefits in the context of investigational research,
which includes direct benefits to the subjects and benefits to others.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

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

comment, as well as any attachments, except for information submitted,
marked and identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-1777 for ``Factors to Consider When Making Benefit-Risk
Determinations for Medical Device Investigational Device Exemptions.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Factors to Consider When Making Benefit-Risk Determinations for
Medical Device Investigational Device Exemptions'' to the Office of the
Center Director, 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 or 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 request.

FOR FURTHER INFORMATION CONTACT: Karen Ulisney, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1545, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
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

    A primary goal of this guidance is to clarify the factors that FDA
considers when assessing risks and anticipated benefits for IDE
studies, and how uncertainty may be offset by a variety of risk
mitigation measures that can ensure appropriate patient and participant
protections in investigational research settings. At earlier stages of
device development, FDA considers appropriate mitigation measures for
anticipated possible risks and unanticipated risks, whereas in later
stages, risk mitigation focuses increasingly on the most probable
risks. Another important goal of this guidance is to characterize
benefits in the context of investigational research, which includes
direct benefits to the subjects and benefits to others (to the extent
there are indirect benefits to subjects or reflect the importance of
knowledge to be gained).
    As with the benefit-risk framework for evaluating marketing
applications, FDA assessment of benefits and risks for an IDE
application takes into account the contextual setting in which the
study is being proposed, including, but not limited to, the
characterization of the disease or condition being treated or
diagnosed, the availability of alternative treatments or diagnostics,
and the risks associated with them. When available, information
characterizing subject tolerance for risk and perspective on benefit
may provide useful context during this assessment.
    In the Federal Register on June 18, 2015 (80 FR 34909), FDA
announced the availability of the draft guidance and interested parties
were requested to comment by September 16, 2015. FDA has considered all
of the public comments received prior to finalizing this guidance.

II. Significance of Guidance

    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 ``Factors to Consider When Making Benefit-
Risk Determinations for Medical Device Investigational Device
Exemptions.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to
download an electronic copy of ``Factors to Consider When Making
Benefit-Risk Determinations for Medical Device Investigational Device
Exemptions'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 1783 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-

3520). The collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078; the collections of
information in 21 CFR 50.23 (Exception from general requirements for
informed consent) have been approved under OMB control number 0910-
0586; the collections of information in 21 CFR 56.115 (Institutional
Review Board records) have been approved under OMB control number 0910-
0130; and the collections of information in 21 CFR part 50, subpart B
(Informed Consent of Human Subjects) and part 56 (Institutional Review
Boards) have been approved under OMB control number 0910-0755.

    Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00604 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 13, 2007 (Volume 72, Number 113)]
[Notices]
[Page 32644-32646]
[DOCID:fr13jn07-65]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-0273; FRL-8129-5]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Polychlorinated Biphenyls, Consolidated Reporting and
Recordkeeping Requirements; EPA ICR No. 1446.09, OMB Control No. 2070-
0112

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``Polychlorinated Biphenyls (PCBs), Consolidated Reporting
and Recordkeeping Requirements'' and identified by EPA ICR No. 1446.09
and OMB Control No. 2070-0112, is scheduled to expire on February 29,
2008. Before submitting the ICR to OMB for review and approval, EPA is
soliciting comments on specific aspects of the proposed information
collection.

DATES: Comments must be received on or before August 13, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-0273, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID number EPA-HQ-OPPT-2007-0273. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0273. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only

available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm.

3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The
EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    For technical information contact: Peter Gimlin, National Program
Chemicals Division (7404T), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What Information Collection Activity or ICR Does this Action Apply
to?

    Affected entities: Entities potentially affected by this action are
persons who currently possess PCB items, PCB-contaminated equipment, or
other PCB waste.
    Title: PCBs, Consolidated Reporting and Recordkeeping Requirements.
    ICR numbers: EPA ICR No. 1446.09, OMB Control No. 2070-0112.
    ICR status: This ICR is currently scheduled to expire on February
29, 2008. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: Section 6(e)(1) of the Toxic Substances Control Act
(TSCA), 15 U.S.C. 2605(e), directs EPA to regulate the marking and
disposal of PCBs. Section 6(e)(2) of TSCA bans the manufacturing,
processing, distribution in commerce, and use of PCBs in other than a
totally enclosed manner. Section 6(e)(3) of TSCA establishes a process
for obtaining exemptions from the prohibitions on the manufacture,
processing, and distribution in commerce of PCBs. Since 1978, EPA has
promulgated numerous rules addressing all aspects of the life cycle of
PCBs as required by the statute. The regulations are intended to
prevent the improper handling and disposal of PCBs and to minimize the
exposure of human beings or the environment to PCBs. These regulations
have been codified in the various subparts of 40 CFR part 761. There
are approximately 100 specific reporting, third-party reporting, and
recordkeeping requirements covered by 40 CFR part 761.
    To meet its statutory obligations to regulate PCBs, EPA must obtain
sufficient information to conclude that specified activities do not
result in an unreasonable risk of injury to health or the environment.
EPA uses the information collected under the 40 CFR part 761
requirements to ensure that PCBs are managed in an environmentally safe
manner and that activities are being conducted in compliance with the
PCB regulations. The information collected by these requirements will
update the Agency's knowledge of ongoing PCB activities, ensure that
individuals using or disposing of PCBs are held accountable for their
activities, and demonstrate compliance with the PCB regulations.
Specific uses of the information collected include determining the
efficacy of a disposal technology; evaluating exemption requests and
exclusion notices; targeting compliance inspections; and ensuring
adequate storage capacity for PCB waste.
    Responses to the collection of information are mandatory (see 40
CFR part 761). Respondents may claim all or part of a document
confidential. EPA will disclose information that is covered by a claim
of confidentiality only to the extent permitted by, and in accordance
with, the procedures in TSCA section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to be 1.2 hours
per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal Agency. This
includes the time needed to review instructions; develop,

acquire, install, and utilize technology and systems for the purposes
of collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 576,811.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 696,055 hours.
    Estimated total annual costs: $21,034,240. This includes an
estimated burden cost of $21,021,640 and an estimated cost of $12,600
for capital investment or maintenance and operational costs.

IV. Are There Changes in the Estimates from the Last Approval?

    There is a net decrease of 128,723 hours (from 824,778 hours to
696,055 hours) in the total estimated respondent burden compared with
that identified in the ICR currently approved by OMB. This decrease
primarily reflects EPA's revised estimates in the total number of
respondents. This change is an adjustment.

V. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: May 30, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-11415 Filed 6-12-07; 8:45 am]

BILLING CODE 6560-50-S


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on May 10, 2004

   NOTICE OF ACTION TAKEN -- DOCKET OST-2004-17680

________________________________________________________________________
_________________________________

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).

Application of    American Airlines, Inc.    filed   4/29/04  for:

XX Exemption under 49 U.S.C. 40109 to provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between Honolulu, Hawaii, and Tokyo, Japan.

XX  Allocation of seven weekly U.S.-Japan combination frequencies for
Honolulu-Tokyo services

Applicant rep:  Carl B. Nelson, Jr.<PHONE_NUMBER>    DOT Analyst:
Sylvia Moore<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (see below)

The exemption authority granted was effective when taken:  May 10, 2004,
through  May 10, 2006

The frequency allocation was effective when taken:  May 10, 2004, and
will remain in effect indefinitely, subject to conditions described
below.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the Air Transport Services
Agreement between the United States and Japan.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX  Holder’s
certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

Conditions:  Consistent with our standard practice, the frequency
allocation granted is subject to the condition that if any of the
frequencies are not used for a period of 90 days, the allocation as to
that unused frequency will expire automatically and the frequency will
revert to the Department for reallocation.  The 90-day dormancy period
will begin November 1, 2004, the date on which American proposes to
inaugurate operations with these frequencies.

2

Remarks:  We acted on this application without awaiting expiration of
the 15-day answer period with the consent of all parties served.

________________________________________________________________________
____________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

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) grant of the exemption authority was consistent with the
public interest; and (3) 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, 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_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

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

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

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

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										05/2004


[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57310]
[DOCID:fr30se05-118]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-3258-EM]

New Hampshire; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, Emergency Preparedness and
Response Directorate, Department of Homeland Security.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of New Hampshire (FEMA-3258-EM), dated
September 19, 2005, and related determinations.

DATES: Effective September 19, 2005.

FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal
Emergency Management Agency, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 19, 2005, the President declared an emergency
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford
Act), as follows:

    I have determined that the emergency conditions in the State of
New Hampshire, resulting from the influx of evacuees from states
impacted by Hurricane Katrina beginning on August 29, 2005, and
continuing, are of sufficient severity and magnitude to warrant an
emergency declaration under the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford
Act). Therefore, I declare that such an emergency exists in the
State of New Hampshire.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act to save lives and protect public health and safety, or
to lessen or avert the threat of a catastrophe in the designated
areas. Specifically, you are authorized to provide emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program, at 100 percent
Federal funding. This assistance excludes regular time costs for
subgrantees' regular employees. In addition, you are authorized to
provide such other forms of assistance under Title V of the Stafford
Act as you may deem appropriate.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal emergency assistance and
administrative expenses.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Acting Under Secretary for
Emergency Preparedness and Response, Department of Homeland Security,
under Executive Order 12148, as amended, Kenneth L. Horak, of FEMA is
appointed to act as the Federal Coordinating Officer for this declared
emergency.
    I do hereby determine the following areas of the State of New
Hampshire to have been affected adversely by this declared emergency:

    All 10 counties in the State of New Hampshire for Public
Assistance Category B (emergency protective measures), including
direct Federal assistance, at 100 percent Federal funding.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services Program; 97.034,
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and Households Housing; 97.049,
Individuals and Households Disaster Housing Operations; 97.050
Individuals and Households Program-Other Needs, 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation Grant Program.)

R. David Paulison,
Acting Under Secretary, Emergency Preparedness and Response, Department
of Homeland Security.
[FR Doc. 05-19629 Filed 9-29-05; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70862-70863]
[FR Doc No: 2014-28112]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-357-000]

Chief Keystone Power, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Chief Keystone Power, LLC's application for market-based rate
authority, with an

accompanying rate schedule, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability is December 11, 2014.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 21, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-28112 Filed 11-26-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 61 (Friday, March 29, 2013)]
[Notices]
[Page 19354]
[FR Doc No: 2013-07363]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Certificates of Public Convenience and Necessity and Foreign Air
Carrier Permits

    Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(formerly Subpart Q) during the Week Ending March 16, 2013. The
following Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits were filed under Subpart B
(formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et. seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2013-0049.
    Date Filed: March 11, 2013.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: April 1, 2013.
    Description: Application of Air China Limited d/b/a Air China
requesting an amendment of its foreign air carrier permit to include
Houston, Texas as a coterminal point in the United States, together
with the existing coterminal points authorized in its foreign air
carrier permit.

    Docket Number: DOT-OST-2013-0053.
    Date Filed: March 14, 2013.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: April 4, 2013.
    Description: Joint application of Delta Air Lines, Inc. (``Delta'')
and Pinnacle Airlines, Inc. (``Pinnacle'') requesting a disclaimer of
jurisdiction or, in the alternative, approval of the de facto transfer
of certain international certificate and other authorities held by
Pinnacle to Delta.

Barbara J. Hairston,
Acting Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2013-07363 Filed 3-28-13; 8:45 am]
BILLING CODE 4910-9X-P


Docket Numbers OAR 2003   0048 ( Electronic) and A 98 44 ( Legacy)

The memorandum from B. Ferrero and T. Olsen, Radian, to S. Milliken, EPA/ SDB, June 17, 1992, HON Process Vents Flow Rate and Concentration Limits, is filed in EPA Docket No. A 90 19 as Docket Item No. II B 272.


% Food exposure
% Once daily oral exposure, dose from cpfs SS F13_49 foodonly exp distribution.csv 90th percentile
% Female adult, Body weight set to 72.9 kg
% Cecilia Tan
% August 26, 2015

prepare @clear @all
% Setting model parameters
start @NoCallback
use human_parameters_MRP
use preg_female_parameters

BWSW=1;		% Set to 1 if BWT is provided
BWST=72.9;	% Initial BW in kg
PREG=0;		% Not pregnant
TSTOP= 1008; 	% Exposure duration in hrs

%Single oral daily exposure
DT = xlsRead("Food.xls", "90p", "A1:A43"); % Dosing Times
DORAL=xlsRead("Food.xls", "90p", "B1:B43"); % Dose in ug/kg
prepare time rbcce cv urinetcpy
start@nocallback

mytable = [_time _rbcce _urinetcpy _cv*350.6];	% unit of conc = ug/L
save mytable @file='food_90.txt' @format=ascii

min(_rbcce)		% display peak RBC AChE inhibition


[Federal Register Volume 87, Number 118 (Tuesday, June 21, 2022)]
[Notices]
[Pages 36861-36864]
[FR Doc No: 2022-13210]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0799]

Improving 510(k) Submission Preparation and Review: Center for
Biologics Evaluation and Research; Voluntary Electronic Submission
Template and Resource Pilot Program; Request for Comments

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

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Biologics Evaluation and Research (CBER) is announcing a pilot program
for sponsors of CBER premarket notification (510(k)) submissions that
wish to use the voluntary Electronic Submission Template and Resource
(eSTAR) Pilot Program. CBER's voluntary eSTAR Pilot Program is intended
to improve consistency and efficiency in both industry's preparation
and FDA's review of premarket notification (510(k)) submissions. During
CBER's voluntary eSTAR Pilot Program, participants will have the
opportunity to provide input to FDA on the eSTAR Pilot Program for
submissions to CBER.

DATES: FDA is seeking participation in CBER's voluntary eSTAR Pilot
Program beginning June 21, 2022. See section I.A. for instructions on
how to submit a request to participate. The CBER voluntary eSTAR Pilot
Program will select up to nine participants who best match the
selection criteria. This pilot program will begin June 21, 2022. Submit
either electronic or written comments on the notice by August 22, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 22, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-0799 for ``Improving 510(k) Submission Preparation and
Review: Center for Biologics Evaluation and Research; Voluntary
Electronic Submission Template and Resource Pilot Program.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:

I. Background

    In the Medical Device User Fee Amendments of 2012 (MDUFA III)
Commitment Letter from the Secretary of Health and Human Services to
Congress, FDA committed to streamlining review processes by moving
beyond paper-based review (Ref. 1). Under section 745A(b) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1),
added by section 1136 of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), an electronic copy (eCopy) is
required for certain premarket submission types, including 510(k)
submissions. FDA provided additional information about the submissions
subject to the eCopy requirements in section 745A(b) of the FD&C Act
and recommendations about the use of eCopy generally in a guidance
initially issued in 2013 (Ref. 2). FDA subsequently published a final
rule in the Federal Register of December 16, 2019 (84 FR 68334),
amending FDA's regulations, where appropriate, to reflect the
requirement of a single submission in electronic format, including the
use of eCopy requirements.
    In the Medical Device User Fee Amendments of 2017 (MDUFA IV)
Commitment Letter from the Secretary of Health and Human Services to
Congress (Ref. 3), FDA committed to developing ``electronic submission
templates that will serve as guided submission preparation tools for
industry to improve submission consistency and enhance efficiency in
the review process.'' In addition, section 745A(b) of the FD&C Act, as
amended by section 207 of the FDA Reauthorization Act of 2017 (Pub. L.
115-52), requires that certain presubmissions and submissions for
devices, including 510(k) submissions, be submitted in such electronic
format as specified in guidance by FDA.
    FDA considers both eCopies and eSubmissions to be submissions in
electronic format. eSubmissions are submission packages produced by an
electronic submission template that contains the data of a ``complete''
(see Ref. 4) submission. To support the next step in transition to
510(k) submissions solely in electronic format, FDA has developed
eSTAR, an electronic submission template built within a structured
dynamic PDF that guides a user through construction of an eSubmission.
eSTAR includes the following benefits:
     automation (e.g., form construction, autofilling);
     content and structure that is complementary to FDA
internal review templates;
     integration of multiple resources (e.g., guidances,
databases);
     guided construction for each submission section;
     automatic verification (i.e., FDA does not intend to
conduct a Refuse to Accept (RTA) review (Ref. 4)); and
     it is free to use.
    eSTAR contains the following additional benefits:
     intuitive interface;
     no special software installation (if the user has Adobe
Acrobat or similar software already installed);
     support for images and dynamic pop-up messages;
     mobile device and Apple iOS support;
     ability to comment when converted to a static PDF;
     ability to share (e.g., email) an eSTAR file that is in
the process of being constructed; and
     no packaging process.
    In February 2020, CDRH piloted the use of the eSTAR electronic
submission template (85 FR 11371). FDA then issued a draft guidance in
September 2021 describing the technical standards associated with
preparation of the electronic submission template for 510(k)s (Ref. 5)
that, when the guidance is finalized, will enable submission of 510(k)
electronic submissions solely in electronic format. In the draft
guidance, FDA noted that CBER also intended to pilot eSTAR. FDA is now
announcing CBER's voluntary eSTAR Pilot Program and soliciting
participation from 510(k) submitters for this program. This pilot will
provide an opportunity for CBER staff to gain experience with review of
and internal processes for 510(k) submissions using the eSTAR template.
It will also provide experience with use of the FDA Electronic
Submissions Gateway for 510(k) submissions using the eSTAR template.
Information collected through the pilot program will help inform FDA on
how to improve eSTAR and identify any additional considerations
specific to submissions for CBER-regulated devices.

A. CBER Voluntary eSTAR Pilot Program Participation

    FDA seeks participation from 510(k) submitters in CBER's voluntary
eSTAR Pilot Program beginning June 21, 2022. The CBER voluntary eSTAR
Pilot Program will select up to nine participants whose submissions to
CBER meet the selection criteria.
    Companies that may be eligible to participate in CBER's voluntary
eSTAR Pilot Program are limited to those firms following the procedures
set out in section I.B. of this document and that also meet all the
selection criteria that follow:
    1. intent to submit a traditional, special, or abbreviated 510(k)
for a medical device regulated by CBER (Ref. 6) using eSTAR within 1
month of acceptance to the CBER voluntary eSTAR Pilot Program; and
    2. willingness to provide feedback on eSTAR as outlined in section
I.C. of this document.
    At its discretion, FDA may withdraw a manufacturer from the CBER
voluntary eSTAR Pilot Program for not carrying out any of the
commitments mentioned previously.

B. CBER Voluntary eSTAR Pilot Program Procedure

    To be considered for CBER's voluntary eSTAR Pilot Program, a
company should submit a statement of interest for participation to
[email protected]. The statement of interest should
include ``CBER Voluntary eSTAR Pilot Program'' in the subject line and
agreement to the selection criteria listed in section I.A. of this
document, as well as a description of the device in enough detail to
allow verification that it is a CBER regulated device.
    The following captures the process for the CBER voluntary eSTAR
Pilot Program:
    1. FDA will collect statements of interest for participation in the
pilot program beginning June 21, 2022.
    The statement of interest should include:

 agreement to the selection criteria listed in section I.A. of
this document
 the device(s) that is/are likely to be submitted during the
pilot program using eSTAR

    2. FDA will select no more than nine participants, who best meet
the

selection criteria and who reflect the broad spectrum of device
manufacturers, including companies that develop a range of products.
Enrollment in the pilot program will be ongoing throughout the duration
of the program. FDA will apply lessons learned from the initial
participants in the pilot program to refine eSTAR with participants, as
appropriate.
    3. FDA intends to notify the manufacturer via email if the
manufacturer is enrolled as a participant in the CBER's voluntary eSTAR
Pilot Program.
    4. The enrolled manufacturer should navigate to the FDA ``Voluntary
eSTAR Program'' web page at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/premarket-submissions and download eSTAR
from the ``Voluntary eSTAR Program'' web page (Ref. 7). Note: eSTAR
should not be submitted to CBER unless the sponsor is a pilot
participant.
    5. Directions for preparing and submitting a 510(k) using eSTAR to
FDA are in the final section of the eSTAR pdf. We recommend that all
eSTAR elements including the cover letter be submitted through the FDA
Electronic Submissions Gateway (refer to ``Electronic Submissions
Gateway'') (Ref. 8) or on physical media through CBER's Document
Control Center in accordance with the ``Regulatory Submissions in
Electronic and Paper Format for CBER-Regulated Products'' web page
(Ref. 9). We recommend that you use Adobe Acrobat Pro with eSTAR. Be
aware that eSTARs should not be submitted to CDRH via the Electronic
Submission Gateway, as CDRH does not use the Electronic Submission
Gateway to receive submissions.
    6. If eligible and enrolled as a participant, the manufacturer
should submit a 510(k) submission prepared and verified using eSTAR
within the timeframe identified in the selection criteria in section
I.A. of this document.
    7. Once the eSTAR prepared 510(k) is received by FDA, FDA does not
intend to conduct the RTA process. However, FDA intends to employ a
technical screening process for the eSTAR like the one described in FDA
draft guidance ``Electronic Submission Template for Medical Device
510(k) Submissions'' (Ref. 5). The technical screening process is a
process for verifying that eSTAR responses accurately describe the
device(s) (e.g., there are, in fact, no tissue contacting components if
indicated as such) and that there is at least one relevant attachment
per each applicable attachment-type question (e.g., a Software
Description attachment is included in response to the Software
Description question if software is applicable to the submission). The
technical screening process is anticipated to occur within 15 calendar
days of FDA receiving the 510(k) eSTAR. FDA intends to only begin the
technical screening for 510(k) electronic submissions where the
appropriate user fee has been paid. If the eSTAR is not complete when
submitted, FDA intends to notify the submitter via email and identify
the missing information, and the 510(k) may be placed on hold until a
complete replacement eSTAR is submitted to FDA. The remainder of the
review will be conducted according to the FDA guidance ``The 510(k)
Program: Evaluating Substantial Equivalence in Premarket
Notifications'' (Ref. 10), and the procedures identified in part 807,
subpart E (21 CFR part 807, subpart E).
    8. Following completion of the review of 510(k)s in the CBER
voluntary eSTAR Pilot Program, participating manufacturers will have
the opportunity to provide individual feedback on the CBER voluntary
eSTAR Pilot Program through the procedures outlined on the ``Voluntary
eSTAR Program'' web page (Ref. 7). Non-pilot participants are welcome
to submit feedback to the Docket (see ADDRESSES).
    During the CBER voluntary eSTAR Pilot Program, CBER staff intends
to be available to answer questions from or concerns of pilot
participants that may arise.

C. Targeted Questions for the CBER Voluntary eSTAR Pilot Program

    FDA requests responses to the following questions about eSTAR from
pilot program participants and stakeholders outside the pilot who want
to submit comments to the docket.
    (1) Is eSTAR able to integrate into your organization's business
process?
    (2) Are you able to open eSTAR, and are you able to add values to
the structured data fields, as well as add attachments? Once entered
and added, are the data retained after closing and reopening eSTAR?
    (3) If you use Assistive Technology, are you able to navigate
through and complete eSTAR?
    (4) If eSTAR is not intuitive to use, why?
    (5) Is the organization and content in eSTAR as expected?
    (6) If applicable, did you experience any difficulties using the
Electronic Submission Gateway to submit eSTAR?
    (7) Is eSTAR able to accommodate PDF attachments that are of the
size you typically would provide in a submission?
    (8) If all the required questions (indicated by red or green
indicators) are provided values, and all the required attachments are
added, does eSTAR properly indicate it is complete on the first page,
and are all the sections listed in the ``Completed'' column in the
final section?
    (9) Do you have any suggestions to improve the effectiveness of
eSTAR in its purpose, or suggestions to improve the usability?

II. Paperwork Reduction Act of 1995

    This notice refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
part 807, subpart E have been approved under OMB control number 0910-
0120.

III. References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES), and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. MDUFA III Commitment Letter, available at: https://www.fda.gov/media/83244/download.
2. ``eCopy Program for Medical Device Submissions: Guidance for
Industry and Food and Drug Administration Staff,'' dated April 27,
2020; available at: https://www.fda.gov/media/83522/download.
3. MDUFA IV Commitment Letter, available at: https://www.fda.gov/media/102699/download.
4. ``Refuse to Accept Policy for 510(k)s: Guidance for Industry and
Food and Drug Administration Staff,'' dated September 13, 2019;
available at: https://www.fda.gov/media/83888/download.
5. ``Electronic Submission Template for Medical Device 510(k)
Submissions: Draft Guidance for Industry and Food and Drug
Administration Staff,'' dated September 29, 2021; available at:
https://www.fda.gov/media/152429/download.
6. Premarket Notification 510(k) Process for CBER-Regulated Products
at: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/premarket-notification-510k-process-cber-regulated-products.
7. Voluntary eSTAR Program, available at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.
8. Electronic Submission Gateway, available

at: https://www.fda.gov/industry/electronic-submissions-gateway.
9. Regulatory Submissions in Electronic and Paper Format for CBER-
Regulated Products; available at: https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper-format-cber-regulated-products.
10. ``The 510(k) Program: Evaluating Substantial Equivalence in
Premarket Notifications [510(k)]: Guidance for Industry and Food and
Drug Administration Staff,'' dated July 28, 2014; available at:
https://www.fda.gov/media/82395/download.

    Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13210 Filed 6-17-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 95 (Wednesday, May 17, 2023)]
[Notices]
[Pages 31505-31506]
[FR Doc No: 2023-10516]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-152-000.
    Applicants: Sun Pond, LLC.
    Description: Sun Pond, LLC submits Notice of Self-Certification of
Exempt Wholesale Generator Status.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5060.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: EG23-153-000.
    Applicants: Oak Lessee, LLC.
    Description: Oak Lessee, LLC submits Notice of Self-Certification
of Exempt Wholesale Generator Status.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5080.
    Comment Date: 5 p.m. ET 6/1/23.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL23-66-000.
    Applicants: Calpine Corporation v. PJM Interconnection, L.L.C.
    Description: Complaint of Calpine Corporation v. PJM
Interconnection, L.L.C.
    Filed Date: 5/10/23.
    Accession Number: 20230510-5181.
    Comment Date: 5 p.m. ET 6/9/23.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER23-762-002.
    Applicants: The Dayton Power and Light Company, PJM
Interconnection, L.L.C.
    Description: Compliance Filing and Motion to Accept Late Filing of
the Dayton Power and Light Company.
    Filed Date: 5/10/23.
    Accession Number: 20230510-5178.
    Comment Date: 5 p.m. ET 5/31/23.

    Docket Numbers: ER23-1123-001.
    Applicants: Portland General Electric Company.
    Description: Tariff Amendment: Response to Deficiency Letter--PGE
OATT Attachment P to be effective 4/16/2023.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5108.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: ER23-1418-001.
    Applicants: AES WR Limited Partnership.
    Description: Tariff Amendment: Amendment to Market-Based Rate
Application to be effective 6/1/2023.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5123.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: ER23-1861-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original IISA and ICSA,
Service Agreement Nos. 6897 and 6898; Queue No. AF2-120 to be effective
4/11/2023.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5019.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: ER23-1862-000.
    Applicants: Roundhouse Renewable Energy II, LLC.
    Description: Baseline eTariff Filing: Roundhouse Renewable Energy
II, LLC Application for MBR Authorization to be effective 7/11/2023.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5043.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: ER23-1863-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: NYISO 205: Transmission
Constraint Pricing Logic Enhancement to be effective 12/31/9998.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5051.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: ER23-1864-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original NSA, Service
Agreement No. 6883; Queue No. AF1-290 to be effective 7/11/2023.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5052.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: ER23-1865-000.
    Applicants: PacifiCorp.
    Description: Compliance filing: Compliance Filing of PacifiCorp to
Docket No. EL22-38 to be effective 4/27/2023.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5068.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: ER23-1866-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: UFA, Centennial Flats with
Upstream HC-1 LLC (TOT899-Q1529/SA300) to be effective 5/12/2023.
    Filed Date: 5/11/23.
    Accession Number: 20230511-5078.
    Comment Date: 5 p.m. ET 6/1/23.

    Docket Numbers: ER23-1867-000.
    Applicants: Southern Company Services, Inc.
    Description: Southern Companies requests waiver from certain
Version 003.3 business practice standards of the North American Energy
Standards Board and incorporated by reference into Commission
Regulations in Order No. 676-J.
    Filed Date: 5/1/23.
    Accession Number: 20230501-5596.
    Comment Date: 5 p.m. ET 5/22/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date.

Protests may be considered, but intervention is necessary to become a
party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 11, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-10516 Filed 5-16-23; 8:45 am]
BILLING CODE 6717-01-P