[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89176-89181]
[FR Doc No: 2016-29465]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79467; File No. SR-BatsBZX-2016-81]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to BZX
Rule 11.23, Auctions, To Amend How the Official Auction Prices Are
Calculated and Add Additional Specificity Regarding the Handling of RHO
Orders During an Opening Auction for a BZX Listed Security

December 5, 2016
    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 November 30, 2016, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6) thereunder,\4\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 5 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend Exchange Rule 11.23,
Auctions, to: (i) Amend how the official auction prices are calculated
and make related changes to the definitions of Indicative Price and
Auction Only Price; and (ii)

add additional specificity regarding the handling of Regular Hours Only
(``RHO'') Orders \5\ during an Opening Auction for a BZX listed
security \6\ by describing situations in which RHO limit orders may be
modified prior to the auction and cancelled after an auction.
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    \5\ An RHO Order is ``[a] limit or market order that is
designated for execution only during Regular Trading Hours, which
includes the Opening Auction, the Closing Auction, and IPO/Halt
Auctions for BZX listed securities and the Opening Process for non-
BZX-listed securities (as such terms are defined in Rule 11.23 and
11.24). Any portion of a market RHO order will be cancelled
immediately following any auction in which it is not executed.'' See
Exchange Rule 11.9(b)(7).
    \6\ A BZX listed security is a security listed on the Exchange
pursuant to Chapter 14 of the Exchange's Rules and includes both
corporate listed securities and Exchange Traded Products (``ETPs'').
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    The text of the proposed rule change is available at the Exchange's
Web site at 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Exchange Rule 11.23, Auctions, to:
(i) Amend how the official auction prices are calculated and make
related changes to the definitions of Indicative Price and Auction Only
Price; and (ii) add additional specificity regarding the handling of
RHO Orders during an Opening Auction for a BZX listed security by
describing situations in which RHO limit orders may be modified prior
to the auction and cancelled after an auction.
Official Auction Prices, Indicative Price, and Auction Only Price
    In general, the price for the Opening, Closing, IPO, Halt, and
Volatility Closing auctions is established by determining the price
level that maximizes the number of shares executed.\7\ In determining
the auction price, the Exchange takes into account all buy and sell
interest at each price level on the Auction Book \8\ and the Continuous
Book.\9\ Today, in the event of a volume based tie at multiple price
levels, the price of the Opening and Closing auctions will be the price
closest to the Volume Based Tie Breaker.\10\ In the event of a volume
based tie at multiple price levels for an IPO, Halt, and Volatility
Closing auctions, the price closest to the issuing price will be used
for IPO Auctions and the price level closest to the final last sale
eligible trade will be used for Halt and the Volatility Closing
Auctions.
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    \7\ See Exchange Rules 11.23(b)(2)(B), (c)(2)(B), (d)(2)(D), and
(e)(2)(D).
    \8\ See Exchange Rule 11.23(a)(1).
    \9\ See Exchange Rule 11.23(a)(7).
    \10\ ``Volume Based Tie Breaker'' is defined as ``the midpoint
of the NBBO for a particular security where the NBBO is a Valid
NBBO. A NBBO is a Valid NBBO where: (i) There is both a NBB and NBO
for the security; (ii) the NBBO is not crossed; and (iii) the
midpoint of the NBBO is less than the Maximum Percentage away from
both the NBB and the NBO. The Maximum Percentage will be determined
by the Exchange and will be published in a circular distributed to
Members with reasonable advance notice prior to initial
implementation and any change thereto. Where the NBBO is not a Valid
NBBO, the price of the Final Last Sale Eligible Trade will be
used.'' See Exchange Rule 11.23(a)(23).
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    The Exchange proposes to amend Exchange Rules 11.23(b)(2)(B),
(c)(2)(B), (d)(2)(D), and (e)(2)(D) to state that the prices of the
Opening Auction, Closing Auction, IPO Auction, Halt Auction, and
Volatility Closing Auction, respectively, will also occur at a price
that not only maximizes the number of shares executed, but also
minimizes the total imbalance. In all auctions, the auction price will
first be established by determining the price level within the Collar
Price Range \11\ that maximizes the number of shares executed. In the
event of a volume based tie at multiple price levels, the auction price
will be the price level that results in the minimum total imbalance.
Lastly, should there be both a volume based tie and a tie in minimum
total imbalance at multiple price levels, the auction price of the: (i)
Opening and Closing auctions will be the price closest to the Volume
Based Tie Breaker; (ii) Halt and Volatility Closing auctions will be
the price closest to the final last sale eligible trade; and (iii) IPO
auction will be the price closest to the issuing price.
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    \11\ See Exchange Rule 11.23(a)(6).
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    The below examples illustrate how the auction price, Auction Only
Price and Indicative Price is selected today and how these prices will
be selected under the proposed rule change. This first example
illustrates current behavior. Assume that the NBBO is $24.90 x $25.10,
which means that the Volume Based Tie Breaker is $25.00.

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                                                                                Total sell
                    Total buy shares                        Buy shares         Price        Sell shares       shares       Paired shares     Imbalance
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0.......................................................  ..............           25.05  ..............             300               0            -300
500.....................................................             500           25.01  ..............             300             300             200
700.....................................................             200           25.00             100             300             300             400
1,200...................................................             500           24.95             200             200             200           1,000
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    In this example, current behavior would dictate that $25.00 would
be selected as the auction price, Auction Only Price, and the
Indicative Price, as applicable, because at $25.00 the maximum number
of shares would be executed (300 shares, in a tie with $25.01) and of
the two price levels at which 300 shares would be executed, $25.00 is
closest to the Volume Based Tie Breaker.
    Under the same scenario described above, but using the price level
that minimizes the total imbalance where there is a tie for the maximum
number of shares executed in the auction at multiple price levels
instead of the Volume Based Tie Breaker, the price chosen as the
auction price, Auction Only Price, and Indicative Price would be
$25.01. $25.01 would be used because, as noted above, 300 shares would
be executed at both $25.00 and $25.01, but the imbalance at $25.01 is
200 shares while the imbalance at $25.00 is 400 shares. Stated another
way, less executable interest would

remain unexecuted at $25.01 (200 shares) than at $25.00 (400 shares).

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                                                                                Total sell
                    Total buy shares                        Buy shares         Price        Sell shares       shares       Paired shares     Imbalance
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0.......................................................  ..............           25.05  ..............             300               0            -300
500.....................................................             500           25.01  ..............             300             300             200
700.....................................................             200           25.00             100             300             300             400
1,200...................................................             500           24.95             200             200             200           1,000
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    This third example illustrates the proposed behavior when there is
a tie for the maximum number of shares executed in the auction at
multiple price levels and a tie in minimum total imbalance within those
price levels. In such a situation, the price level closest to the
Volume Based Tie Breaker will be used. Under this example, assume that
the NBBO is $24.94 x $25.16, which means that the Volume Based Tie
Breaker is $25.05.

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                                                                                Total sell
                    Total buy shares                        Buy shares         Price        Sell shares       shares       Paired shares     Imbalance
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500.....................................................             500           25.08  ..............             200             200             300
500.....................................................  ..............           25.07  ..............             200             200             300
500.....................................................  ..............           25.06  ..............             200             200             300
1,000...................................................             500           25.05  ..............             200             200             800
1,200...................................................             200           25.00  ..............             200             200           1,000
1,700...................................................             500           24.95             200             200             200           1,500
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    In this example, there is a tie for the maximum number of shares
executed in the auction at 200 shares for every price level from $24.95
to $25.08. Looking at the imbalance, there is also a tie at 300 shares
at each of $25.06, $25.07, and $25.08. As such, the proposed behavior
would look to the Volume Based Tie Breaker to determine the auction
price, Auction Only Price, and Indicative Price. Because the Volume
Based Tie Breaker is $25.05, $25.06 is selected because it is the
closest of $25.06, $25.07, and $25.08 to the Volume Based Tie Breaker.
    The Exchange believes the proposed amendments are necessary to
ensure that the price selected for the auction is reasonably based on
all buying and selling interest for that security and is the price at
which the most orders may be matched resulting in the minimal
imbalance. Selecting a price that would minimize the imbalance best
reflects the value of the security based on the auction's price
discovery process because it is the price level where the amount of buy
and sell interest is closest to equal. As noted above, minimizing the
imbalance at the price levels at which the most shares will execute in
the auction will result in the price closest to equilibrium because
that price level has the least amount of executable interest that
remains unexecuted. As a result, the proposed rule changes should also
enhance the Exchange's auction processes resulting in improved price
discovery of BZX listed securities.
    As a result of the above changes to the determination of the
official auction price, the Exchange also proposes to make a related
change to the definition of Indicative Price under paragraph (a)(10) of
Rule 11.23. Indicative Price is currently defined as the price at which
the most shares from the Auction Book and the Continuous Book would
match.\12\ The Indicative Price is disseminated publicly beginning at
8:00 a.m. Eastern Time for an Opening \13\ and IPO Auction,\14\ 3:00
p.m. Eastern Time for a Closing Auction,\15\ five (5) minutes prior to
the commencement of a Halt Auction,\16\ and at the time a security is
halted after 3:50 p.m. Eastern Time for a Volatility Closing
Auction.\17\ The Indicative Price is designed to facilitate price
discovery and transparency while helping resolve order imbalances in
the time leading up to an auction and the determination of the auction
price.
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    \12\ See Exchange Rule 11.23(a)(10).
    \13\ See Exchange Rule 11.23(b)(2)(A).
    \14\ See Exchange Rule 11.23(d)(2)(A).
    \15\ See Exchange Rule 11.23(c)(2)(A).
    \16\ See Exchange Rule 11.23(d)(2)(A).
    \17\ See Exchange Rule 11.23(e)(2)(A).
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    Today, the Exchange will publish the price at which the most shares
may be executed as the Indicative Price by taking into account all buy
and sell interest at each price level. Like the determination of each
of the auction prices discussed above, the Indicative Price reflects
the price at which the maximum number of shares may be executed, but
may not reflect the price which would result in the minimum total
imbalance where there are multiple price levels at which the most
shares may be executed. Therefore, like the amendments to the
determination of auction prices above, the Exchange proposes to amend
the definition of Indicative Price to ensure that the maximum number of
shares will ultimately be executed in the auction resulting in the
minimum total imbalance. Indicative Price will continue to be defined
as ``the price at which the most shares from the Auction Book and the
Continuous Book would match.'' However, the definition of Indicative
Price would be expanded to state that in the event of a volume based
tie at multiple price levels, the Indicative Price will be the price
which results in the minimum total imbalance. In the event of a volume
based tie and a tie in minimum total imbalance at multiple price
levels, the Indicative Price will be the price closest to the Volume
Based Tie Breaker.
    Lastly, the Exchange also publishes an Auction Only Price, which is
the price at which the most shares from the Auction Book would match.
Currently, in the event of a volume based tie at multiple price levels,
the Auction Only Price will be the price closest to the Volume Based
Tie Breaker. Auction Only Price will continue to be defined under
Exchange Rule 11.23(a)(2) to state that the Auction Only Price will be
the price at which the most shares from the Auction Book would match.
However, the definition will be expanded to harmonize the calculation
of the Auction Only Price with the above changes. As amended, in the
event of a volume based tie at multiple price levels, the Auction Only
Price will be the price which results in the minimum

total imbalance. In the event of a volume based tie and a tie in
minimum total imbalance at multiple price levels, the Auction Only
Price will be the price closest to the Volume Based Tie Breaker.
RHO Orders
    An RHO Order is ``[a] limit or market order that is designated for
execution only during Regular Trading Hours, which includes the Opening
Auction, the Closing Auction, and IPO/Halt Auctions for BZX listed
securities and the Opening Process for non-BZX-listed securities (as
such terms are defined in Rule 11.23 and 11.24). RHO orders are also
Eligible Auction Orders \18\ and may participate in the Opening
Auction.\19\ Any Eligible Auction Orders designated for the Opening
Auction will be queued until 9:30 a.m. at which time they will be
eligible to be executed in the Opening Auction. Any portion of a RHO
market order will be cancelled immediately following any auction in
which it is not executed.'' \20\ However, any portion of an RHO limit
order that is not executed in the auction will be placed on the
Continuous Book at the conclusion of the auction and commencement of
Regular Trading Hours (subject to the cancelling of certain RHO limit
orders are described below).
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    \18\ See Exchange Rule 11.23(a)(8).
    \19\ See id.
    \20\ See Exchange Rule 11.9(b)(7).
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    In general, Eligible Auction Orders designated for the Opening
Auction may not be cancelled or modified between 9:28 a.m. and 9:30
a.m.\21\ The Exchange now proposes to add additional specificity to
Rule 11.23(b)(1) regarding how RHO limit orders are handled in the
Opening Auction. Specifically, the Exchange proposes to amend Rule
11.23(b)(1)(B) to describe current behavior that allows Members to
modify, but not cancel, RHO limit orders designated for the Opening
Auction between 9:28 a.m. and 9:30 a.m.\22\
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    \21\ See Exchange Rule 11.23(b)(1)(B).
    \22\ Currently, RHO market orders submitted between 9:28 a.m.
and 9:30 a.m. are rejected. See Exchange Rule 11.23(b)(1)(A).
Modifications to RHO limit orders between 9:28 a.m. and 9:30 a.m.
would not be limited by Exchange Rule 11.9(e)(3) as such orders are
not active until the Opening Auction occurs at 9:30 a.m.
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    The rule text currently provides that RHO limit orders submitted
between 9:28 a.m. and 9:30 a.m. are treated as Late-Limit-On-Open
(``LLOO'') \23\ orders until the Opening Auction has concluded. The
Exchange proposes to amend Rule 11.23(b)(1)(B) to state that RHO limit
orders that are modified between 9:28 a.m. and 9:30 a.m. will also be
treated as LLOO orders until the Opening Auction is concluded. During
the Opening Auction, RHO limit orders will be priced in accordance with
the operation of LLOO orders as described in Rule 11.23(a)(12),\24\
subject to the order's limit price. At the conclusion of the Opening
Auction, any unexecuted portion of a RHO limit order will be placed on
the Continuous Book at its limit price (subject to the cancelling of
certain RHO limit orders are described below). The Exchange believes
that such treatment is consistent with the existing treatment of RHO
limit orders submitted between 9:28 a.m. and 9:30 a.m. which are
subject to the pricing restrictions applicable to LLOO orders. However,
because, unlike LLOO orders, RHO limit orders will be added to the
Continuous Book at the conclusion of the Opening Auction at their limit
price, Members should be able to modify such orders between 9:28 a.m.
and 9:30 a.m. Such functionality provides Members the price protections
necessary to incentivize early entry of orders for participation in the
Opening Auction while simultaneously allowing a Member to control an
order that will be entered onto the Continuous Book if it is not
executed in the Opening Auction.
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    \23\ See Exchange Rule 11.23(a)(12).
    \24\ Under Exchange Rule 11.23(a)(12), LLOO orders are priced as
follows: to the extent a LLOO bid or offer received by the Exchange
has a limit price that is more aggressive than the NBB or NBO, the
price of such bid or offer is adjusted to be equal to the NBB or
NBO, respectively, at the time of receipt by the Exchange. Where the
NBB or NBO becomes more aggressive, the limit price of the LLOO bid
or offer will be adjusted to the more aggressive price, only to the
extent that the more aggressive price is not more aggressive than
the original User entered limit price. The limit price will never be
adjusted to a less aggressive price. If there is no NBB or NBO, the
LLOO bid or offer, respectively, will assume its entered limit
price. Notwithstanding the foregoing, a LLOO order entered during
the Quote-Only Period of an IPO will be converted to a limit order
with a limit price equal to the original User entered limit price
and any LLOO orders not executed in their entirety during the IPO
Auction will be cancelled upon completion of the IPO Auction.
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    The Exchange also proposes to describe within Exchange Rule
11.23(b)(1) how RHO orders with a limit price outside of the Collar
Price Range are handled. Where the Opening Auction would have occurred
at a price level but for such price level being greater than (less
than) the high (low) range of the Collar Price Range (i.e., outside the
Collar Price Range), all buy (sell) limit RHO orders with a limit price
more aggressive than the BZX Official Opening Price that are not
executed in the Opening Auction will be cancelled.
    The Collar Price Range is utilized to help limit volatility during
the auction process and to reduce the possibility that an auction would
occur at a price that would qualify as clearly erroneous under Exchange
Rule 11.17(c)(1) and that may result in cancelled executions.\25\ The
process to select the price of an Opening Auction as described above
could lead to a price that is outside of the Collar Price Range. In
that case, the Exchange will then look to find a price to execute the
auction within the Collar Price Range and in accordance with the price
selection process set forth above. The Exchange selecting a less
aggressive price for the auction within the Collar Price Range can
result in the unexecuted RHO limit orders priced more aggressively than
the auction price being placed on the Continuous Book upon conclusion
of the Opening Auction.
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    \25\ As set forth under Exchange Rule 11.23(a)(6), the ``Collar
Price Range'' is the range from a set percentage below the Collar
Midpoint (as defined below) to above the Collar Midpoint, such set
percentage being dependent on the value of the Collar Midpoint at
the time of the auction, as described below. The Collar Midpoint
will be the Volume Based Tie Breaker for all applicable auctions,
except for IPO Auctions in ETPs (as defined in Rule 11.8,
Interpretation and Policy .02(d)(2)), for which the Collar Midpoint
will be the issue price. Specifically, the Collar Price Range will
be determined as follows: Where the Collar Midpoint is $25.00 or
less, the Collar Price Range shall be the range from 10% below the
Collar Midpoint to 10% above the Collar Midpoint; where the Collar
Midpoint is greater than $25.00 but less than or equal to $50.00,
the Collar Price Range shall be the range from 5% below the Collar
Midpoint to 5% above the Collar Midpoint; and where the Collar
Midpoint is greater than $50.00, the Collar Price Range shall be the
range from 3% below the Collar Midpoint to 3% above the Collar
Midpoint.
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    The Exchange believes that it is necessary and appropriate to
cancel RHO orders with a limit price that is more aggressive than the
auction price in such circumstances. Other than RHO limit orders, all
Eligible Auction Orders will simply be cancelled if they do not execute
in the Opening Auction. RHO limit orders, however, are unique in that
they rest on the Auction Book until the conclusion of the Opening
Auction, at which point any unexecuted portion is added to the
Continuous Book. This could result in unexecuted RHO limit orders
priced more aggressively than the auction price to be added to the
Continuous Book, immediately applying price pressure in the direction
of the price that the Opening Auction would have initially occurred but
for the Exchange selecting a price within the Collar Price Range,
thereby controverting the purpose of the Collar Price Range. Further,
such a set of circumstances would also undermine the value of the price
discovery process of the Opening Auction and could result in executions
eligible for review as

clearly erroneous under Exchange Rule 11.17. The Exchange notes that
Members whose RHO limit orders are cancelled because the price of the
order is more aggressive than the Collar Price Range may always
resubmit such orders at less aggressive prices or after regular trading
begins.
2. Statutory Basis
    The Exchange believes that the proposed rule change 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.\26\
Specifically, the proposed change is consistent with Section 6(b)(5) of
the Act,\27\ 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 proposed
rule change will enhance the Exchange's auction processes resulting in
improved price discovery of BZX listed securities. Specifically, the
Exchange believes amending the calculations of auction prices and the
definitions of Indicative Price and Auction Only Price promotes just
and equitable principles of trade by ensuring that the maximum number
of shares will ultimately be executed in the auction resulting in the
minimum total imbalance generally because selecting a price that would
minimize the imbalance best reflects the value of the security based on
the auction's price discovery process because it is the price level
where the amount of buy and sell interest is closest to equal. Further,
minimizing the imbalance at the price levels at which the most shares
will execute in the auction will result in the price closest to
equilibrium because that price level has the least amount of executable
interest that remains unexecuted. These proposed amendments are similar
to auction price selection process of other exchanges \28\ and would
enhance the price discovery and transparency while helping resolve
order imbalances in the time leading up to an auction and the
determination of the ultimate auction price.
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    \26\ 15 U.S.C. 78f(b).
    \27\ 15 U.S.C. 78f(b)(5).
    \28\ See e.g., Nasdaq Stock Market LLC (``Nasdaq'') Rules
4752(a)(2)(A) and 4752(d)(2) (outlining the selection of the Nasdaq
Current Reference Price and auction price).
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    The Exchange believes allowing Members to modify RHO limit orders
between 9:28 a.m. and 9:30 a.m. promotes just and equitable principles
of trade, removes impediments to, and perfects the mechanism of, a free
and open market and a national market system. Such functionality
provides Members the price protections necessary to incentivize early
entry of orders for participation in the Opening Auction while
simultaneously allowing a Member to control an order that will be
entered onto the Continuous Book if it is not executed in the Opening
Auction. In addition, the modification of a RHO limit order between
9:28 a.m. and 9:30 a.m. would have no impact on the pricing of the
Opening Auction as such order are priced in accordance with the
operation of LLOO orders as described in Rule 11.23(a)(12),\29\ subject
to the order's limit price, on the Continuous Book.
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    \29\ See supra note 24.
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    The proposal also supports the objectives of perfecting the
mechanism of a free and open market and the national market system
because not cancelling RHO orders with limit prices more aggressive
than the Collar Price Range would result in executions vastly different
from the auction price shortly after the regular trading commences. As
such, the proposal also protects investors because it would prevent the
executions of orders at prices not related to the current market for
the security and possibly not in line with the investor's intent at the
time they entered the orders prior to the commencement of the auction
process. The Exchange believes this undermines the price discovery
process of the auction and could result in executions eligible for
review as clearly erroneous under Exchange Rule 11.17. The Exchange
notes that Members whose RHO limit orders are cancelled because the
price of the order is more aggressive than the Collar Price Range may
always resubmit such orders at less aggressive prices or after regular
trading begins. Therefore, the Exchange believes the proposed rule
change promotes just and equitable principles of trade, removes
impediments to, and perfects the mechanism of, a free and open market
and a national market system.

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 proposal
will promote competition because the Exchange believes the proposal
improves and enhances the Exchange's auction processes, thereby
attracting additional order flow to the Exchange. The proposed rule
change is, in effect, pro-competition as it promotes fair and orderly
markets and protects investors through enhanced auction processes.

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

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

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \30\ and Rule 19b-4(f)(6) thereunder.\31\
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    \30\ 15 U.S.C. 78s(b)(3)(A).
    \31\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
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 No. SR-BatsBZX-2016-81 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 No. SR-BatsBZX-2016-81. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BatsBZX-2016-81, and should be
submitted on or before December 30, 2016.

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

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-29465 Filed 12-8-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24997-24999]
[FR Doc No: 2012-10025]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66838; File No. SR-Phlx-2012-50]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Routing Fees

April 20, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 11, 2012, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend certain Routing Fees to recoup costs
incurred by the Exchange in routing to BATS Exchange, Inc. (``BATS'').
    The Exchange intends for these amendments to be effective upon
filing, except with respect to the amendments related to the Firm/
Broker-Dealer/Market Maker category, which Routing Fees will be
operative on April 27, 2012 when SR-Phlx-2012-41 becomes operative.\3\
---------------------------------------------------------------------------

    \3\ See Securities and Exchange Act Release No. 66754 (April 6,
2012) (SR-Phlx-2012-41) which filing is immediately effective and
will become operative on April 27, 2012.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqtrader.com/micro.aspx?id=PHLXfilings, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The purpose of this filing is to recoup costs that the Exchange
incurs for routing and executing certain orders in equity and index
options to BATS. The Exchange's Pricing Schedule at Section V currently
includes the following Routing Fees for routing Customer, Professional,
Firm, Broker-Dealer and Market Maker orders to away markets.\4\
---------------------------------------------------------------------------

    \4\ The Exchange recently amended its Pricing Schedule to adopt
a ``Firm/Broker-Dealer/Market Maker'' Routing Fee category. See
Securities and Exchange Act Release No. 66755 (April 6, 2012) (SR-
Phlx-2012-42). The pricing change was filed for immediate
effectiveness with an operative date of April 27, 2012.

----------------------------------------------------------------------------------------------------------------
                                                                                Firm/broker-
                          Exchange                                Customer       Professional    dealer/ market
                                                                                maker
----------------------------------------------------------------------------------------------------------------
NYSE AMEX...................................................           $0.11            $0.31             $0.55
BATS........................................................            0.55             0.55              0.55
BOX.........................................................            0.11             0.11              0.55
CBOE........................................................            0.11             0.31              0.55
CBOE orders greater than 99 contracts in RUT, RMN, NDX, MNX,            0.29             0.31              0.55
 ETFs, ETNs and HOLDRs......................................
C2..........................................................            0.55             0.56              0.55
ISE.........................................................            0.11             0.29              0.55
ISE Select Symbols*.........................................            0.31             0.39              0.55
NYSE ARCA (Penny Pilot).....................................            0.55             0.55              0.55
NYSE ARCA (Standard)........................................            0.11             0.11              0.55
NOM.........................................................            0.54             0.54              0.55
NOM (NDX and MNX)...........................................            0.56             0.56              0.55
----------------------------------------------------------------------------------------------------------------
* These fees are applicable to orders routed to ISE that are subject to Rebates and Fees for Adding and Removing
  Liquidity in Select Symbols. See ISE's Schedule of Fees for the complete list of symbols that are subject to
  these fees.

    The Exchange is proposing to amend the current BATS Routing Fees by
renaming those fees as ``BATS Penny.'' \5\ The Exchange is not
proposing to amend the current rate of $0.55 per contract for
Customers, Professionals, Firms, Broker-Dealers, and Market Makers, but
proposes to apply those fees solely to Penny options routed to BATS.
---------------------------------------------------------------------------

    \5\ BATS defines Penny options as those issues that are quoted
pursuant to BATS Rule 21.5, Interpretation and Policy .01.
---------------------------------------------------------------------------

    The Exchange proposes to create new Routing Fees to BATS for non-
Penny options. BATS recently adopted a $0.75 per contract non-Penny fee
for customers that remove liquidity from the BATS Options order book
and a $0.80 per contract non-Penny fee for professionals, firms and
market makers that remove liquidity from the BATS Options order
book.\6\ The Exchange is proposing to adopt BATS non-Penny Routing Fees
to account for the new

BATS fees for removing liquidity and other routing costs incurred by
the Exchange when routing to BATS, as follows:
---------------------------------------------------------------------------

    \6\ See SR-BATS-2012-015.

----------------------------------------------------------------------------------------------------------------
                                                                                Firm/broker-
                            Exchange                                Customer      Professional    dealer/market
                                                                                maker
----------------------------------------------------------------------------------------------------------------
BATS non-Penny.................................................           $0.86           $0.91            $0.91
----------------------------------------------------------------------------------------------------------------

    In May 2009, the Exchange adopted Rule 1080(m)(iii)(A) to establish
Nasdaq Options Services LLC (``NOS''), a member of the Exchange, as the
Exchange's exclusive order router.\7\ NOS is utilized by the Exchange's
fully automated options trading system, PHLX XL[supreg],\8\ solely to
route orders in options listed and open for trading on the PHLX XL
system to destination markets. Each time NOS routes to away markets NOS
is charged a $0.06 clearing fee and, in the case of certain exchanges,
a transaction fee is also charged in certain symbols, which fees are
passed through to the Exchange. The Exchange currently recoups clearing
and transaction charges incurred by the Exchange as well as certain
other costs incurred by the Exchange when routing to away markets, such
as administrative and technical costs associated with operating NOS,
membership fees at away markets, and technical costs associated with
routing.\9\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 59995 (May 28,
2009), 74 FR 26750 (June 3, 2009) (SR-Phlx-2009-32).
    \8\ This proposal refers to ``PHLX XL'' as the Exchange's
automated options trading system. In May 2009 the Exchange enhanced
the system and adopted corresponding rules referring to the system
as ``Phlx XL II.'' See Securities Exchange Act Release No. 59995
(May 28, 2009), 74 FR 26750 (June 3, 2009) (SR-Phlx-2009-32). The
Exchange intends to submit a separate technical proposed rule change
that would change all references to the system from ``Phlx XL II''
to ``PHLX XL'' for branding purposes.
    \9\ The Exchange is therefore adopting BATS non-Penny Routing
Fees to account for the BATS fees of $0.75 per contract for customer
orders and $0.80 per contract for professional, firm and market
maker orders, the $0.06 clearing cost and another $0.05 per contract
associated with administrative and technical costs associated with
operating NOS.
---------------------------------------------------------------------------

    The Exchange intends for these amendments to be effective upon
filing, except with respect to the amendments related to the Firm/
Broker-Dealer/Market Maker category, which Routing Fees will be
operative on April 27, 2012 when SR-Phlx-2012-41 becomes operative.\10\
---------------------------------------------------------------------------

    \10\ The Exchange recently filed a rule change to expand the
routing capabilities of certain options orders that are eligible for
electronic routing to other market centers by PHLX XL. See
Securities and Exchange Act Release No. 66754 (April 6, 2012) (SR-
Phlx-2012-41). Specifically, Exchange Rule 1080(m) was amended to
permit Firm, Broker-Dealer and Market Maker orders to be eligible
for routing to other market centers when the Exchange cannot execute
such orders at the National Best Bid or Offer. SR-Phlx-2012-[sic].
The rule change is immediately effective and will be operative on
April 27, 2012.
---------------------------------------------------------------------------

    As with all fees, the Exchange may adjust these Routing Fees in
response to competitive conditions by filing a new proposed rule
change.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Pricing
Schedule is consistent with Section 6(b) of the Act \11\ in general,
and furthers the objectives of Section 6(b)(4) of the Act \12\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among Exchange members.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed amendment to the current
BATS Routing Fees to rename those fees as ``BATS Penny'' and apply
those fees to Penny options routed to BATS and adopt separate Routing
Fees for non-Penny options routed to BATS is reasonable because the two
separate categories take into account the different fees for removing
liquidity assessed by BATS for non-Penny versus Penny options. The
Exchange seeks to recoup costs incurred when routing orders to BATS on
behalf of its members.
    The Exchange believes that the proposed amendment to the current
BATS Routing Fees to rename those fees as ``BATS Penny'' and apply
those fees to Penny options routed to BATS and adopt separate Routing
Fees for non-Penny options routed to BATS is equitable and not unfairly
discriminatory because the Exchange will uniformly apply the BATS Penny
as well as BATS non-Penny Routing Fees to its members based on the type
of options orders routed to BATS.\13\
---------------------------------------------------------------------------

    \13\ See note 5.
---------------------------------------------------------------------------

    The proposed BATS non-Penny Routing Fees are reasonable because
they seek to recoup costs that are incurred by the Exchange when
routing Customer, Professional, Firm, Broker-Dealer and Market Maker
orders to BATS on behalf of members. Each destination market's
transaction charge varies and there is a standard clearing charge for
each transaction incurred by the Exchange along with other
administrative and technical costs that are incurred by the Exchange.
The Exchange believes that the proposed Routing Fees would enable the
Exchange to recover the remove fees assessed by BATS for non-Penny
options, plus clearing and other administrative and technical fees for
the execution of such orders when routed to BATS. The Exchange also
believes that the proposed BATS non-Penny Routing Fees are equitable
and not unfairly discriminatory because they would be uniformly applied
to all non-Penny orders that are routed to BATS.
    With respect to the Firm/Broker-Dealer/Market Maker category, the
Exchange recently adopted those fees and proposed to assess a fixed
Routing Fee of $0.55 per contract applicable to all away markets.\14\
The Exchange noted in that rule change that pricing on the various
options exchanges varies significantly from exchange to exchange for
non-Customer orders. Accordingly, the Exchange proposed a $0.55 per
contract side Routing Fee in order to capture the majority of the
transaction and clearing fees for Firm, Broker-Dealer and Market Maker
orders, while making the Exchange's Routing Fees easier to calculate
and predict for members whose proprietary orders are routed away. In
addition, fixed Routing Fees are easier to comprehend by the members
whose orders are routed away. Further, predicting, calculating and
charging back ``pass-through'' fees is an unduly burdensome, expensive
and complicated task for members whose orders are routed away. The
Exchange noted that fixed Routing Fees for Firm, Broker-Dealer and
Market Maker orders should ease the burden, expense and complexity of
this task. Furthermore, fixed fees are easier to manage and maintain
for the Exchange, ensuring accurate billing and accounting. The
Exchange believes its proposal to increase the BATS non-Penny Customer
Routing Fee from $0.55 per contract to $0.86 per contract and the
Professional, Firm, Broker-Dealer and Market Maker Routing Fees from
$0.55 per contract to $0.91 per contract is reasonable because the fees
proposed by BATS are not within the range of fees assessed by other
exchanges since the recent

increase in the BATS fee to removing liquidity from $0.44 per contract
to $0.75 per contract for customer non-Penny options and from $0.44 per
contract to $0.80 for professionals, firms and market makers. The
Exchange believes it is reasonable to recoup the BATS remove fees plus
the clearing and other costs to recoup Routing Fees.\15\ The Exchange
believes that the increase to the Firm/Broker-Dealer/Market Maker non-
Penny BATS Routing Fees are equitable and not unfairly discriminatory
because, as previously mentioned, those fees would be similarly
calculated for Customers, Professionals, Firms, Broker-Dealers and
Market Makers.\16\ Additionally, the non-Penny BATS Routing Fees would
be uniformly assessed for all non-Penny orders routed to BATS.
---------------------------------------------------------------------------

    \14\ See note 4.
    \15\ See note 9.
    \16\ The Exchange's proposed non-Penny BATS Routing Fees are
calculated similarly for all participants by adding the fee to
remove liquidity assessed by BATS for the particular market
participant plus a fee of $.11 per contract which represents
clearing and other costs noted herein.
---------------------------------------------------------------------------

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.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\17\ At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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 No. SR-Phlx-2012-50 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-Phlx-2012-50. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-Phlx-2012-50 and should be
submitted on or before May 17, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-10025 Filed 4-25-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Pages 128-129]
[FR Doc No: 2016-31779]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4436]

Premarket Notification (510(k)) Submissions for Bone Anchors;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Premarket
Notification (510(k)) Submissions for Bone Anchors.'' The guidance
provides recommendations for the information and testing that should be
included in premarket submissions for bone anchor (suture anchor)
devices used in the appendicular skeleton for attachment of soft tissue
to bone. This draft guidance is not final nor is it in effect at this
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): 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-2016-D-4436 for ``Premarket Notification (510(k)) Submissions for
Bone Anchors.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the 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 https://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 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 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 draft guidance document entitled
``Premarket Notification (510(k)) Submissions for Bone Anchors'' 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. Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Daniel Ramsey, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1451, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled '''Premarket Notification (510(k)) Submissions
for Bone Anchors.'' FDA has developed this guidance document for
members of industry who submit and FDA staff who review premarket
submissions regarding bone anchor (suture anchor) devices used in the
appendicular skeleton for attachment of soft tissue to bone. When
finalized, this guidance is intended to provide recommendations for
information to include in premarket notifications (510(k)) for bone
anchor (suture anchor) devices (e.g., descriptive characteristics,
labeling, biocompatibility, sterility, and bench testing). This
guidance is a reissuance of the April 20, 1996 ``Guidance Document for
Testing Bone Anchor Devices'' with updated content.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on Premarket
Notification (510(k)) Submissions for Bone Anchors. 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 draft 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 https://www.regulations.gov. Persons
unable to download an electronic copy of ``Premarket Notification
(510(k)) Submissions for Bone Anchors'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1400005 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485.

    Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31779 Filed 12-30-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37662-37664]
[FR Doc No: 2016-13774]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA--2016-0167

Parts and Accessories Necessary for Safe Operation, Lamps and
Reflective Devices; Application for an Exemption From STEMCO LP

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

ACTION: Notice of application for exemption; request for comments.

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

SUMMARY: FMCSA requests public comment on an application for exemption
from STEMCO LP (STEMCO) to allow motor carriers to operate commercial
motor vehicles (CMVs) that are equipped with STEMCO's
TrailerTail[supreg] aerodynamic device with rear identification lamps
and rear clearance lamps that are mounted lower than currently
permitted by the Agency's regulations. The Federal Motor Carrier Safety
Regulations (FMCSRs) require rear identification lamps and rear
clearance lamps to be located ``as close as practicable to the top of
the vehicle.'' While the TrailerTail[supreg] aerodynamic device is
currently mounted slightly below the roof of the vehicle, STEMCO states
that this offset prevents the device from delivering the maximum
available fuel economy benefit as opposed to mounting it flush with the
top of the vehicle which may block the visibility of the rear
identification lamps and rear clearance lamps. STEMCO believes that
locating the rear identification lamps and rear clearance lamps lower
on the vehicle, on a horizontal plane with other required lamps (stop,
turn, and tail lamps) as is done on a flatbed trailer or an intermodal
chassis, will maintain a level of safety that is equivalent to, or
greater than, the level of safety achieved without the exemption.
STEMCO is requesting the temporary exemption in advance of petitioning
FMCSA to conduct a rulemaking to amend 49 CFR 393.11.

DATES: Comments must be received on or before July 11, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2016-0167 using any of the
following methods:
     Web site: http://www.regulations.gov. Follow the
instructions for submitting comments on the Federal electronic docket
site.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue SE., Washington,
DC 20590-0001.
     Hand Delivery: Ground Floor, Room W12-140, DOT Building,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.
e.t., Monday-Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number for this notice. For detailed instructions on submitting
comments and additional information on the exemption process, see the
``Public Participation'' heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the ``Privacy Act''
heading for further information.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to Room W12-140,
DOT Building, 1200 New Jersey Avenue SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
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comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
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generally available 24 hours each day,

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FOR FURTHER INFORMATION CONTACT: Mr. Jose Cestero, Vehicle and Roadside
Operations Division, Office of Bus and Truck Standards and Operations,
MC-PSV,<PHONE_NUMBER>; Federal Motor Carrier Safety Administration,
1200 New Jersey Avenue SE., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Background

    Section 4007 of the Transportation Equity Act for the 21st Century
(TEA- 21) [Pub. L. 105-178, June 9, 1998, 112 Stat. 401] amended 49
U.S.C. 31315 and 31136(e) to provide authority to grant exemptions from
the Federal Motor Carrier Safety Regulations (FMCSRs). On August 20,
2004, FMCSA published a final rule (69 FR 51589) implementing section
4007. Under this rule, FMCSA must publish a notice of each exemption
request in the Federal Register (49 CFR 381.315(a)). The Agency must
provide the public with an opportunity to inspect the information
relevant to the application, including any safety analyses that have
been conducted. The Agency must also provide an opportunity for public
comment on the request.
    The Agency reviews the safety analyses and the public comments and
determines whether granting the exemption would likely achieve a level
of safety equivalent to or greater than the level that would be
achieved by the current regulation (49 CFR 381.305).
    The decision of the Agency must be published in the Federal
Register (49 CFR 381.315(b)). If the Agency denies the request, it must
state the reason for doing so. If the decision is to grant the
exemption, the notice must specify the person or class of persons
receiving the exemption and the regulatory provision or provisions from
which an exemption is granted. The notice must specify the effective
period of the exemption (up to 5 years) and explain the terms and
conditions of the exemption. The exemption may be renewed (49 CFR
381.315(c) and 49 CFR 381.300(b)).

STEMCO Application for Exemption

    STEMCO, on behalf of motor carriers utilizing its
TrailerTail[supreg] aerodynamic devices, applied for an exemption from
49 CFR 393.11 to allow rear identification lamps and rear clearance
lamps to be mounted lower than currently permitted by the Agency's
regulations. A copy of the application is included in the docket
referenced at the beginning of this notice.
    Table 1 of Sec.  393.11, ``Required lamps and reflectors on
commercial motor vehicles,'' specifies the requirements for lamps,
reflective devices and associated equipment by the type of CMV. All
CMVs manufactured on or after December 25, 1968, must, at a minimum,
meet the applicable requirements of Federal Motor Vehicle Safety
Standard (FMVSS) No. 108, ``Lamps, reflective devices, and associated
equipment,'' in effect at the time of manufacture of the vehicle. Rear
identification lamps must be mounted as close as practicable to the top
of the vehicle. One lamp must be as close as practicable to the
vertical centerline and one on each side of the center lamp with the
lamp centers spaced not less than 6 inches or more than 12 inches
apart, and all on the same level. One rear clearance lamp must be
located on each side of the vertical centerline of the vehicle to
indicate overall width, both of which must be on the same level and as
high as practicable.
    The U.S. Environmental Protection Agency (EPA) and the Department
of Transportation's National Highway Traffic Safety Administration
(NHTSA) have jointly proposed a national program that would establish
the next phase of greenhouse gas (GHG) emissions and fuel efficiency
standards for medium- and heavy-duty vehicles. This ``Phase 2 program''
would significantly reduce carbon emissions and improve the fuel
efficiency of heavy-duty vehicles, helping to address the challenges of
global climate change and energy security. In February 2015, STEMCO
purchased ATDynamics and its TrailerTail[supreg] product line, a
collapsible boat tail technology that improves the rear aerodynamic
shape of CMVs. STEMCO states that motor carriers are evaluating the
TrailerTail[supreg] rear aerodynamic device to help meet (1) the
proposed Phase 2 program standards, and (2) the California Air
Resources Board (CARB) Tractor-Trailer Greenhouse Gas Regulation for
dry van and refrigerated van type trailers that has been in effect
since 2010.
    For newly manufactured trailers, STEMCO states that the
TrailerTail[supreg] top panel is mounted 1.5--3.5 inches below the roof
of the trailer in order to comply with the FMVSS No. 108 and FMCSR
mounting location requirements for rear identification and clearance
lamps. However, STEMCO states:

    This inset creates an unaeordynamic gap as airflow transitions
from the trailer roof onto the TrailerTail panels and has prevented
TrailerTails from delivering the maximum available fuel economy
benefit. Wind tunnel flow visualization highlights the contrast in
airflow between flush and inset panels and our own internal testing
estimates an additional 0.14 delta CDA (measured drag
area) gain and 70 million gallons of annual diesel fuel savings can
be achieved simply by installing TrailerTails flush with the trailer
roof. In order to evaluate the actual performance of flush mounted
TrailerTail aerodynamic systems on actual fleet based fuel economy,
it is necessary to request relief from the location requirements for
upper identification lamps and rear clearance lamps on commercial
van trailers and box trucks. Additionally, these lower clearance and
identification lamp locations will pave the way for the commercial
launch of collapsible boat tails for roll door box trailers, where
the rear upper header is a critical mounting location of boat tail
components.

    In support of its application, STEMCO states that ``The relocation
of the rear identification lamps and rear clearance lamps to a lower
location on the trailer or box truck are equivalent to the current
required lamp location on a flatbed trailer or intermodal chassis, so
no safety impact is anticipated.'' In addition, according to the
application:

    STEMCO believes that there will be no safety impact from the
relocation of both the rear identification lamps and the rear
clearance lamps to a location on an approximate horizontal plane
with other rear lamps. NHTSA issued legal interpretations from 1968
until approximately 1999 to trailer manufacturers to allow the lower
mounting location for rear identification lamps and rear clearance
lamps when there was no ``practicable'' means of installing the
lamps ``as close as practicable to the top of the vehicle.'' NHTSA
subsequently issued an interpretative rule on April 5, 1999, 64 FR
16358, suggesting that trailer manufacturers could no longer mount
lamps at the lower location as narrow lamps were now readily
available, and NHTSA would no longer defer to a manufacturer's
subjective determination of practicability for locating lamps in the
rear upper header location on van trailers and box trucks. However,
NHTSA noted in that same Notice that they did not intend to bring
enforcement actions based on this interpretive rule immediately.
Subsequently, trailer manufacturers continued to manufacture van
trailers and box trucks with the rear identification lamps and rear
clearance lamps mounted lower on the vehicles on an approximate
horizontal plane with the other required lamps.''

    STEMCO states that without the exemption, it will be unable to
verify fleet performance of a higher performance TrailerTail[supreg]
design that is expected to provide the maximum available fuel economy
benefit that may

be necessary in order to meet future fuel efficiency requirements.

Request for Comments

    In accordance with 49 U.S.C. 31315 and 31136(e), FMCSA requests
public comment from all interested persons on STEMCO's application for
an exemption from 49 CFR 393.11. All comments received before the close
of business on the comment closing date indicated at the beginning of
this notice will be considered and will be available for examination in
the docket at the location listed under the ADDRESSES section of this
notice.
    Comments received after the comment closing date will be filed in
the public docket and will be considered to the extent practicable. In
addition to late comments, FMCSA will continue to file relevant
information in the public docket that becomes available after the
comment closing date. Interested persons should continue to examine the
public docket for new material.

    Issued on: June 2, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-13774 Filed 6-9-16; 8:45 am]
 BILLING CODE 4910-EX-P


Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 1 of 10 Primary Evaluator: Sarah J. Levy, Chemist Registration Action Branch 1 ( RAB1) Health Effects Division ( HED; 7509C) Date: 06 APR 2006 Approved by: George Kramer, Ph. D., Chemist RAB1/ HED ( 7509C) Date: 06 APR 2006 This DER was originally prepared under contract by Dynamac Corporation ( 1910 Sedwick Road, Building 100, Suite B, Durham, NC 27713; submitted 10/ 17/ 2005. The DER has been reviewed by HED and revised to reflect current Office of Pesticide Programs ( OPP) policies.

STUDY REPORTS:

45794202. Schwarts, N. Heitcamp, J. ( 2001) [ 14C] Bifenthrin: Nature of the Residue in the Potato Tubers Following an At planting Soil Application and Two Pre Harvest Foliar Applications. Lab Project Number: 46249. Study No. 182POTOOM1 Unpublished study prepared by ABC Laboratories. 134 pages.

EXECUTIVE SUMMARY:

The metabolism of bifenthrin in potatoes was examined in two trials using either [ cyclopropyl 1 14C] or [ U phenyl 14C] labeled bifenthrin ( 14C CP or 14C PH). Each 14C label was formulated as an EC and applied to potatoes as a single in furrow application at 0.3 lb ai/ A, followed by two broadcast foliar applications at 0.1 lb ai/ A/ application, for a total of 0.5 lb ai/ A. The foliar applications were made late in the season during the vegetative stage, at a retreatment interval ( RTI) of 14 days. Samples of potato tubers and foliage were collected at 2 and 14 day preharvest intervals ( PHIs). An exaggerated treatment rate study for the in furrow application was also performed; however, samples were not analyzed as there were sufficient levels of 14Cresidues in samples conducted from the non exaggerated rate study ( total application rate 0.5 lb ai/ A).

The levels of radioactivity in foliage and tubers were similar for the [ 14C CP] and [ 14C PH] labeled samples. Total radioactive residues ( TRR) in foliage were 2.89 3.29 ppm at 2 day PHI and declined to 1.94 2.70 ppm by 14 day PHI. TRR were substantially lower in tubers ( 0.020 0.068 ppm) at both sampling intervals, indicating that translocation of [ 14C] bifenthrin from leaves to the tubers was minimal.

Mature ( 14 day PHI) samples of tubers and foliage were extracted with acetonitrile ( ACN), releasing 91.4 95.7% of the TRR from each matrix. Solubilized residues were subsequently partitioned into hexane, ether/ ACN, and aqueous fractions. Radioactivity remaining in the residual solids accounted for 7.5 8.6% TRR in tubers and 4.3% of the TRR in foliage.

With the exception of several minor metabolites, the 14C residue profiles in tubers and foliage were similar for the two 14C labels, with identified residues accounting for 75 81% of the TRR in tubers and 95% of the TRR in foliage. In all matrices, bifenthrin was the major 14C residue accounting for 73.3 81.1 % of the TRR in tubers and 94.7 95.1% of the TRR in foliage. Minor amounts (  1.2% TRR, < 0.001 ppm) of the following metabolites were also tentatively identified by high performance liquid chromatography ( HPLC) in tubers: 4 OH bifenthrin, biphenyl Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 2 of 10 alcohol or acid metabolites, a biphenyl aldehyde metabolite, and TFP acid. No metabolites were detected in foliage. Considering the type of metabolites detected, the metabolism of bifenthrin in potatoes appears to involve hydrolytic cleavage of the ester linkage and hydroxylation of the biphenyl moiety.

STUDY/ WAIVER ACCEPTABILITY/ DEFICIENCIES/ CLARIFICATIONS:

Under the conditions and parameters used in the study, the potato metabolism data are classified as scientifically acceptable. The acceptability of this study for regulatory purposes is addressed in the forthcoming U. S. EPA Residue Chemistry Summary Document [ DP#: 310089].

COMPLIANCE:

Signed and dated Good Laboratory Practice ( GLP), Quality Assurance and Data Confidentiality statements were provided. No deviations from GLP standards were reported for this substance.

A. BACKGROUND INFORMATION Bifenthrin is a broad spectrum, non systemic insecticide/ miticide in the class of synthetic pyrethroids ( MOA Group 3). It is registered to FMC Corporation for use as foliar applications on a variety of field, fruit and vegetable crops. Bifenthrin is formulated for use on crop plants as a 2.0 lb/ gal emulsifiable concentrate ( EC; Capture ® 2 EC; EPA Reg. No. 279 3069) and as a 1.15% granule ( G; Capture 1.15G; EPA Reg. No. 279 3244).

TABLE A. 1. Nomenclature of Bifenthrin Compound O O Cl F 3 C CH 3 CH 3 C H 3 Common name Bifenthrin Company experimental names Capture ® Insecticide/ Miticide IUPAC name 2 methylbiphenyl 3 ylmethyl( Z)( 1RS, 3RS) 3( 2 chloro 3,3,3 trifluoroprop 1 enyl) 2,2dimethylcyclopropanecarboxylate or 2 methylbiphenyl 3 ylmethyl( Z)( 1RS) cis 3( 2 chloro 3,3,3 trifluoroprop 1 enyl) 2,2dimethylcyclopropanecarboxylate CAS name rel 2 methyl( 1,1' biphenyl) 3 yl) methyl( 1R, 3R) 3(( 1Z) 2 chloro 3,3,3 trifluoro 1 propenyl) 2,2 dimethylcyclopropanecarboxylate CAS # 82657 04 03 End use products/ EPs 2.0 lb/ gal EC ( Capture ® 2EC; EPA Reg No. 279 3069)

1.15% G ( Capture ® 1.15G; EPA Reg No. 279 3244) Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 3 of 10 TABLE A. 2. Physicochemical Properties of the Technical Grade Bifenthrin Parameter Value Reference Melting point/ range 68 70.6 ° C pH NA Density at 24 ° C 1.26 g/ mL Water solubility < 0.1 Fg/ L Solvent solubility ( g/ 100 mL) 8.9 in heptane and methanol 125 in acetone, chloroform, ether, methylene chloride, and toluene Vapor pressure ( Pa) at 25 ° C 2.41 x 10 5 Dissociation constant ( pKa) NA Octanol/ water partition coefficient) Kow > 1 x 10 6 UV/ visible absorption spectrum NA Product Chemistry Chapter of the Tolerance Reassessment Eligibility Decision ( TRED)

B. EXPERIMENTAL DESIGN B. 1. Trial Site and Crop Information The in life phase of the study was conducted by ABC Laboratories, Columbia, MO from 23 JAN 2001 to 14 JUN 2001. Potato plants were grown in a loam soil in oval galvanized stock tanks with interior coatings of fiberglass resin ( Table B. 1.1). One furrow was made at the top of each tank and seed potatoes were planted following the initial in furrow application of [ 14C] bifenthrin. Tanks were separated by a minimum of 5 ft to prevent cross contamination due to spray drift from foliar applications. The potato plants were maintained indoors in a greenhouse throughout the study and grown in accordance with typical agricultural practices. There were no deviations noted.

TABLE B. 1.1. Test Site Information.

Soil characteristics1 Testing Environment Type % OM pH CEC Potatoes were grown in fiberglass coated galvanized stock tanks in a greenhouse Loam 1.6 5.6 11.4 1 OM = Organic matter, CEC = Cation exchange capacity. These parameters are only required for studies involving a soil treatment.

TABLE B. 1.2. Crop Information.

Crop; crop group Variety Growth stage at applications Growth stage at harvest Harvested Matrix Potato; Crop group 1 Atlantic The initial application was made prior to planting seed potatoes and the foliar applications were made at approximately 28 and 14 days prior to normal maturity. Maturity Foliage was cut at ground level and tubers dug from the soil Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 4 of 10 B. 2. Test Materials The 14C test materials ( Table B. 2.1) were directly mixed with a blank EC formulation and diluted with water for application.

TABLE B. 2.1. Test Material Characteristics. Chemical structure O O Cl F 3 C CH 3 CH 3 C H 3 * O O Cl F 3 C CH 3 CH 3 C H 3 *

Radiolabel position The 1 position of the cyclopropyl ring Uniformly in the phenyl ring Lot No. PR 2030 PC PR 2030 PC Purity 99.1% 99.1% Specific activity 29,051dpm/ µ g ( 5.54 mCi/ mmol) 30,814 dpm/ µ g ( 5.87 mCi/ mmol)

B. 3. Study Use Pattern TABLE B. 3.1. Use Pattern Information. Chemical name [ 14C PH] Bifenthrin [ 14C CP] Bifenthrin Application method In Furrow Broadcast Foliar In Furrow Broadcast Foliar Application rate 0.3 lb ai/ A 0.1 lb ai/ A 0.3 lb ai/ A 0.1 lb ai/ A Number of applications 1 2 1 2 Timing of applications Pre planting 28 and 14 days PHI Pre planting 28 and 14 days PHI PHI 2 and 14 days 2 and 14 days B. 4. Identification/ Characterization of Residues B. 4.1. Sample Handling, Preparation,

Samples of potato foliage and tubers were harvested at 2 and 14 day PHIs. Foliage was removed close to the ground and placed unwashed into sample bags. Tubers were dug from the soil and rinsed in distilled water to remove excess soil residue. Tubers were then cut into smaller pieces with a knife, and placed into sample bags. All samples were directly transported to the freezer (  20 ° C) until analysis. Foliage and tuber samples were ground with dry ice, and the TRR in each sample was determined in triplicate using combustion/ liquid scintillation counting ( LSC) analysis. The limit of detection ( LOD) for the radioassay was 0.001 ppm For identification and characterization of 14C residues in tubers, samples were initially extracted with ACN and centrifuged. The ACN fraction was then partitioned sequentially with hexane and ethyl ether, resulting in a hexane fraction, an ether/ ACN fraction, and residual aqueous fraction. The hexane and ether/ ACN fractions were concentrated, redissolved in ACN and analyzed by HPLC. The post extraction solids were solubilized using 5.25% sodium hypochlorite and analyzed by LSC to determine % TRR remaining as non extractable residues.

Potato foliage samples were extracted three times with ACN and centrifuged. The ACN extracts were combined and partitioned three times with hexane, with the ACN fraction being acidified * indicates position of 14C label * indicates position of 14C label Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 5 of 10 for the third partition. The resulting hexane fractions were combined, concentrated, and analyzed using HPLC and thin layer chromatography ( TLC). The ACN/ water fraction was not further analyzed.

B. 4.2. Analytical Methodology Radioactive residues in solvent fractions were analyzed and quantified by reverse phase HPLC. The HPLC system used a C18 column with a mobile phase gradient of water to ACN. The system included both an in line radioactivity monitor and a variable wavelength detector. Retention times of the HPLC peaks were compared with the retention time of the standards. Including parent, a total of six reference standards were used for comparison. The identity of parent in hexane fractions was confirmed by one dimensional normal phase TLC using a solvent system of hexane/ toluene/ ethyl ether/ acetic acid ( 11.5: 8.5: 2: 0.3, v/ v/ v/ v). Radioactivity in extracts and HPLC fractions was determined by LSC.

C. RESULTS AND DISCUSSION C. 1. Storage Stability Potato tubers and foliage were stored frozen at  20 ° C for up to 3 and 4 months prior to analysis ( Table C. 1). As analyses were completed within 6 month of sampling, no supporting storage stability data are required. In addition, the identification of parent as the major component of the TRR in tubers ( 73 81% TRR) and foliage ( 95 96% TRR) indicates that 14C residues were stable in frozen storage.

TABLE C. 1. Summary of Storage Conditions. Potato Matrix Storage Temperature ( ° C) Actual Storage Duration ( Months) Interval of Demonstrated Storage Stability ( Months) Tubers 3 NR Foliage  20 ° C 4 NR 1 NR= Not required as samples analyses were completed within 6 months.

C. 2. Identification, Characterization, and Distribution of Residues The distribution and levels of radioactivity in the tubers and foliage were similar of the two 14Clabels TRR in foliage were 2.89 3.29 ppm at 2 day PHI and declined to 1.94 2.70 ppm by 14 day PHI. TRR were substantially lower in tubers ( 0.020 0.068 ppm) at both sampling intervals, indicating minimal translocation of 14C residues from leaves to the tubers ( Table C. 2.1).

TABLE C. 2.1. TRR in Potato Tubers and Foliage. 14C CP label 14C PH label Matrix Timing and Applic. No. PHI ( days) ppm ppm Immature Tubers 2 0.0681 0.0201 Immature Foliage 2 3.29 2.89 Mature Tubers 14 0.0468 0.0379 Mature Foliage One In furrow treatment at planting and two broadcast foliar treatments at approximately 28 and 14 days prior to normal harvest. 14 2.70 1.94 Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 6 of 10 For both 14C labels, solvent extraction released 91.4 95.7% of the TRR from mature samples of foliage and tubers. Radioactivity in the residual solids accounted for 7.5 8.6% TRR in tubers and 4.3% of the TRR in foliage ( Table C. 2.2). Identified residues accounted for 75 81% of the TRR in mature tubers and 95% of the TRR in foliage.

The 14C residue profiles in tuber and foliage were also similar for the two 14C labels ( Table C. 2.3). Bifenthrin ( parent) was the major 14C residue detected in both tubers and foliage. At 14 day PHI, bifenthrin accounted for 73.3 81.1 % of the TRR in tubers and 94.7 95.1% of the TRR in foliage. The identity of parent in tubers and foliage was confirmed by TLC. Minor amounts (  1.2% TRR, < 0.001 ppm) of the following metabolites were also tentatively identified by HPLC in tubers: 4 OH bifenthrin, biphenyl alcohol or acid metabolite, a biphenyl aldehyde metabolite, and TFP acid. Other minor unknowns and polar residues in tubers accounted for 3.4 12.6% of the TRR, with each individual metabolite/ fraction accounting for < 8% of the TRR. No metabolites were detected in foliage, and all unknown fractions or metabolites accounted for   1.2% of the TRR.

TABLE C. 2.2. Distribution of the 14C Residues in Mature Potato Tubers and Foliage Harvested 14 Days Following the Final Application of [ 14C] Bifenthrin. [ 14C CP] 14 day PHI [ 14C PH] 14 day PHI Tuber Foliage Tuber Foliage TRR = 0.0468 ppm TRR = 2.70 ppm TRR = 0.0379 ppm TRR = 1.94 ppm Metabolite/ Fraction % TRR ppm % TRR ppm % TRR ppm % TRR ppm ACN Extracts ( solvent partitioning) 92.5 0.0433 95.7 2.58 91.4 0.0346 95.7 1.85 Hexane ( HPLC analysis) Parent 74.4 71.7 0.0348 0.0336 94.5 95.1 2.55 2.56 87.3 80.9 0.0331 0.0307 95.7 94.7 1.85 1.83 Ethyl ether/ ACN ( HPLC analysis) Parent Polar residues TFP acid 4' OH bifenthrin Biphenyl Alcohol and/ or Acid Biphenyl Aldehyde Total unknowns ( each   0.8% TRR) 14.2 1.61 7.62 0.93 1.20 ND ND 1.05 0.0067 0.0008 0.0036 0.0004 0.0006   0.0005 NA                1.91 0.16 0.55 ND 0.10 0.09 0.07 0.72 0.0007 < 0.0001 0.0002  < 0.0001 < 0.0001 < 0.0001 0.0003 NA

Aqueous ( not further analyzed) 3.89 0.0018 1.20 0.03 2.17 0.0008 < 0.1  Post extraction solids ( PES) 7.51 0.0035 4.27 0.12 8.62 0.0033 4.29 0.08 NA = not applicable. ND = not detected. Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 7 of 10 Table C. 2.3. Summary of Characterization and Identification of 14C Residues in Mature Potato Matrices Harvested 14 day PHI Following Applications of [ 14C] Bifenthrin totaling 0.5 lb ai/ A. [ 14C CP] Bifenthrin [ 14C PH] Bifenthrin TRR = 0.0468 ppm TRR = 0.0379 ppm Compound/ Fractions % TRR ppm % TRR ppm Tubers Parent 73.3 0.0344 81.1 0.0308 4 OH Bifenthrin 1.20 0.0006 0.10 < 0.0001 Biphenyl Alcohol or Acid ND  0.09 < 0.0001 Biphenyl Aldehyde ND  0.07 < 0.0001 TFP acid 0.93 0.0004 ND  Total identified 75.43 0.0354 81.36 0.0308 Minor unknowns ( Each   0.8% TRR) 1.05 0.0005 0.72 0.0003 Minor Polar components1 11.51 0.0054 2.72 0.0010 Total characterized 87.99 0.0412 84.80 0.0321 Total extractable 92.5 0.0433 91.4 0.0346 Unextractable ( PES) 2 7.51 0.0035 8.62 0.0033 Accountability3 100.0 100.0 Foliage TRR = 2.70 ppm TRR = 1.94 ppm Compound % TRR ppm % TRR ppm Parent 95.1 2.56 94.7 1.83 Total identified 95.1 2.56 94.7 1.83 Minor aqueous fraction 1.2 0.03 < 0.01  Total characterized 96.3 2.59 94.7 1.83 Total extractable 95.7 2.58 95.7 1.85 Unextractable ( PES) 2 4.27 0.12 4.29 0.08 Accountability3 100.0 100.0 1 Includes polar HPLC fractions and minor aqueous fractions 2 Post extraction solids. 3 Accountability = ( Total extractable + Total unextractable)/( TRR from combustion analysis; see TABLE C. 2.1) * 100. Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 8 of 10 C. 3. Proposed Metabolic Profile FIGURE C. 3.1. Proposed Metabolic Profile of Bifenthrin in Potatoes.

O O Cl F 3 C CH 3 CH 3 C H 3 Cl O OH F 3 C CH 3 C H 3 OH C H 3 O O Cl F 3 C OH CH 3 C H 3 CH 3 O C H 3 OH O C H 3 Bifenthrin cis TFP acid BP alcohol 4' Hydroxy bifenthrin BP aldehyde BP acid Polar Products Hydrolysis Oxidation Oxidation Oxidation Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 9 of 10 TABLE C. 3.1. Bifenthrin Metabolites from Potato Metabolism Study Common name/ code Figure C. 3.1 ID No. Chemical name Chemical structure TFP Acid Cis 3( 2 chloro 3, 3, 3 trifluoroprop 1 enyl) 2, 2 dimethylcyclopropanecarboxylic acid Cl O OH F 3 C CH 3 C H 3 Biphenyl Aldehyde 2 methylbiphenyl 3 carboxaldehyde O C H 3 Biphenyl Acid 2 methylbiphenyl 3 carboxylic acid OH O C H 3 4' Hydroxy bifenthrin 4' hydroxy 2 methylbiphenyl 3 ylmethyl ( Z) cis 3( 2 chloro 3, 3, 3 trifluoroprop 1 enyl) 2, 2 dimethylcyclopropanecarboxylate O O Cl F 3 C OH CH 3 C H 3 CH 3 Biphenyl Alcohol 2 methylbipheny 3 methanol OH C H 3 Bifenthrin/ 128825/ IR 4 DACO 6.3/ OPPTS 860.1300/ OECD II 6.2.2, 6.2.3 & IIIA 8.2, 8.4.1, 8.4.2 Nature of the Residues in Plants  Potato DP#: 310089/ MRID#: 45794202 Page 10 of 10 D. CONCLUSION The potato metabolism study is adequate. Following a single in furrow application at planting and two foliar applications totaling 0.50 lb ai/ A, TRR were 0.0379 0.0468 ppm in/ on tubers and 1.94 2.70 ppm in/ on foliage collected at a 14 day PHI. The 14C residue profiles in tubers and foliage were similar between the two 14C labels, with the exception of several trace metabolites in tubers.

The metabolism of bifenthrin in potatoes was minimal. Bifenthrin ( parent) was the only compound detected in foliage, accounting for 94.7 95.1% of the TRR and was the major residue in tubers, accounting for 73.3 81.1% of the TRR. The minor metabolites detected in tubers suggest that the metabolism of bifenthrin in potatoes involves hydrolysis of the ester linkage prior to or after hydroxylation of the biphenyl moiety ( Figure C. 3.1).

E. REFERENCES DP#: 283808 Subject: Bifenthrin. Residue and Product Chemistry Considerations for the Tolerance Reassessment Eligibility Decision ( TRED) From: S. Levy To: T. Myers Dated: 21 AUG 2002 MRID( s): None F. DOCUMENT TRACKING RDI: RAB1 Chemists ( 16 NOV 2005) Petition#: 3E6882 DP#: 310089 PC Code: 128825 Template Version June 2005