[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Notices]
[Pages 29419-29425]
[FR Doc No: 2012-11914]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66966; File No. SR-NYSEArca-2012-37]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change Proposing a Pilot Program To Create a Lead
Market Maker Issuer Incentive Program for Issuers of Certain Exchange-
Traded Products Listed on NYSE Arca, Inc.

May 11, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that, on April 27, 2012, NYSE Arca, Inc. (``Exchange''
or ``NYSE Arca'') 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 substantially prepared
by the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes a pilot program to create a Lead Market Maker
(``LMM'') Issuer Incentive Program (``Fixed Incentive Program'') for
issuers of certain exchange-traded products (``ETPs'') listed on the
Exchange. The text of the proposed rule change is available at the
Exchange, www.nyse.com, the Commission's Public Reference Room, and the
Commission's Web site at www.sec.gov.

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

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

1. Purpose
    The Exchange proposes a pilot program to create a Fixed Incentive
Program for issuers of certain ETPs listed on the Exchange.
Background
    Under the current Fee Schedule for listings, an issuer of an ETP is
required to pay a Listing Fee that ranges from $5,000 to $45,000.\3\
ETP issuers also pay a graduated Annual Fee based on the number of
shares of the ETP that are outstanding. The Annual Fee ranges from
$5,000 to $55,000.
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    \3\ The Exchange has one Schedule of Fees and Charges for
Exchange Services that is for listings (``Listing Fee Schedule'')
and another that is for trade-related charges (``Trading Fee
Schedule''). To differentiate them, the Exchange proposes to change
the name of the former to ``SCHEDULE OF FEES AND CHARGES FOR
EXCHANGE LISTING SERVICES.'' ETPs are generally classified as either
Derivative Securities Products or Structured Products for purposes
of the Listing Fee Schedule. See Listing Fee Schedule, available at
http://www.nyse.com/pdfs/NYSEArca_Listing_Fees.pdf.
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    A qualified Market Maker may request an assignment as an LMM for an
ETP, and the request is subject to approval by the Exchange.\4\ For
some ETPs, no Market Maker requests an assignment as an LMM, and the
ETP therefore trades without an LMM assigned to it. The Exchange
operates under the price-time priority model for all market
participants, so there is no distinct transactional benefit to being
assigned as an LMM. However, LMMs are obligated to meet certain
obligations and requirements \5\ and therefore incur greater risks than
other market participants on the Exchange. The risks include those
associated with managing position inventory as well as those associated
with maintaining quotes. Inventory risks may be higher for certain ETPs
with low volume and low shares outstanding because there are fewer
opportunities to turn over positions in such ETPs and the accumulation
of costs from carrying those positions as well as positions in the
underlying securities used for hedging.\6\ LMMs are required to
continuously quote on both sides of the market; therefore, they must be
willing to buy as well as sell by posting displayed and firm quotes on
the Exchange. When there is a low volume of shares outstanding, there
is often less supply for securities lending purposes. In order to meet
settlement requirements established by Regulation SHO,\7\ LMMs acting
in ETPs with low shares outstanding are often required to maintain a
long ETP position. Quoting risks exist due to the complexity of pricing
ETPs and the potential for human and/or technological errors. ETPs are
open-ended and derivatively priced securities that typically track
returns of underlying assets. If, due to human error such as the input
of an inaccurate underlying basket or technological error such as a
static data

feed caused by networking or hardware breakdowns, the LMM's quote
diverges from the underlying assets value, the LMMs are more likely to
buy (sell) at prices that are above (below) theoretical fair values.
Because LMMs are required to continuously quote on both sides of the
market and maintain certain minimum performance standards, they are
more likely to face these types of risks because other market
participants have more freedom to withdraw quotes upon experiencing
difficulties or unusual market conditions.
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    \4\ See NYSE Arca Equities Rule 7.22(d).
    \5\ An LMM is subject to the obligations for Market Makers that
are set forth in NYSE Arca Equities Rule 7.23 and the minimum
performance standards that are referenced in NYSE Arca Equities Rule
7.24. Under NYSE Arca Equities Rule 7.24, the minimum performance
standards include (i) percent of time at the National Best Bid or
Offer (``NBBO''), (ii) percent of executions better than the NBBO,
(iii) average displayed size, (iv) average quoted spread, and (v) in
the event the security is a derivative security, the ability to
transact in underlying markets. An LMM's minimum performance
standards are higher than those of a Designated Market Maker and are
described in an official NYSE Arca policy titled NYSE Arca LMM
Requirements, which may be amended from time to time. The minimum
performance standards are measured daily and reviewed as a monthly
average. The Exchange believes that they are stringent and help
foster liquidity provision and stability in the market. References
in this rule filing, including in the proposed rule text, to an
LMM's minimum performance standards mean those set forth in NYSE
Arca LMM Requirements.
    \6\ Costs of carrying ETP inventories include the expense ratio,
which includes the management fee, financing costs or the cost of
capital, and the opportunity cost of allocating capital. At times it
may also include stock loan costs for maintaining a hedge in hard-
to-borrow securities.
    \7\ See 17 CFR 242.203-204.
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    To incentivize firms to take on the LMM designation and foster
liquidity provision and stability in the market, the Exchange currently
provides LMMs with an opportunity to receive incrementally higher
transaction credits and incur incrementally lower transaction fees
(``LMM Rates'') compared to standard liquidity maker-taker rates
(``Standard Rates'').\8\ LMM Rates are intended to balance the
increased risks and requirements assumed by LMMs. Accordingly, the
value of acting as an LMM could be measured by the incremental
difference in the transaction credits or fees under the LMM Rates as
compared to the Standard Rates. However, the absolute incremental
difference depends on the LMM's volume traded. Trading volume for
different ETPs can vary significantly and result in a corresponding
variance in LMM trading volume. The benefit of acting as an LMM can
therefore vary significantly depending upon the ETP to which the LMM is
assigned. There are fewer financial benefits for LMM assignments in
ETPs with lower CADV than ETPs with higher CADV. The table below
provides hypothetical examples based on assumptions that NYSE Arca
market share equals 22%, LMM participation rate equals 20%, LMM make
ratio equals 80%, and LMM take ratio equals 20%: \9\
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    \8\ The Exchange generally employs a maker-taker transactional
fee structure, whereby an ETP Holder that removes liquidity is
charged a fee (``Take Rate''), and an Equity Trading Permit Holder
(``ETP Holder'') that provides liquidity receives a credit (``Make
Rate''). The Take Rate for LMMs is currently $0.0025 per share. The
Make Rate for LMMs is currently between $0.0035 and $0.0045 per
share depending on consolidated average daily volume (``CADV'').
Standard NYSE Arca Tape B Make Rates (rebates paid for adding
liquidity) range from $0.0022 to $0.0033 per share. Standard NYSE
Arca Tape B Take Rates (fees charged for removing liquidity) range
from $0.0026 to $0.0030 per share. See the Trading Fee Schedule,
available at https://usequities.nyx.com/sites/usequities.nyx.com/files/nyse_arca_marketplace_fees__3_01_12_.pdf.
    \9\ Market share is the percentage of CADV traded on NYSE Arca.
Participation rate is the percentage of NYSE Arca volume traded by
the LMM. Make ratio is the percentage of LMM volume that provides
liquidity. Take ratio is the percentage of LMM volume that takes
liquidity. The formula for calculating the transaction credit is as
follows: (LMM make volume * Make Rate) + (LMM take volume * Take
Rate). LMM make volume equals CADV * NYSE Arca market share * LMM
participation rate * LMM make ratio. LMM take volume equals CADV *
NYSE Arca market share * LMM participation rate * LMM take ratio.

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                                                                                Annual
                                                                      Annual        transaction       Annual
                     Symbol                            CADV         transaction     credit/fee      incremental
                                                                    credit/fee       (standard      difference
                                                                    (LMM rates)       rates)
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ABC.............................................      25,000,000        $637,560        $332,640        $304,920
DEF.............................................       5,100,000         130,062          67,859          62,204
GHI.............................................       2,500,000          74,844          33,264          41,580
JKL.............................................       1,100,000          32,931          14,636          18,295
MNO.............................................         750,000          25,780           9,979          15,800
PQR.............................................         500,000          17,186           6,653          10,534
STU.............................................         100,000           3,437           1,331           2,107
VWX.............................................          10,000             344             133             211
YZ..............................................           1,000              34              13              21
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    The Exchange believes that the assignment of an LMM, which is held
to higher standards as compared to Market Makers and other market
participants, is a critical component of the promotion of a consistent,
fair and orderly market in ETPs on the Exchange. However, market
participants may be forgoing LMM assignments in ETPs--instead choosing
to trade ETPs as Market Makers or ETP Holders with lower or no
obligations or minimum performance standards--because the incentives to
serve as an LMM are insufficient to outweigh the obligations, minimum
performance standards, and other risks described above. To illustrate
how this change has transpired, the following table highlights the
increasing proportion of new NYSE Arca ETPs that are listed without an
LMM present:

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                                   2003     2004     2005     2006     2007     2008     2009     2010     2011
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New NYSE Arca ETP Listings.....       11       34       49      133      223      195      124      196      297
Listed with LMM................       11       34       49      133      218      190      121      175      271
Listed without LMM.............        0        0        0        0        5        5        3       21       26
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    Since January 2008, nearly 100% of all LMM withdrawal requests for
ETPs already listed and trading were made for securities that exhibited
low CADV in the period prior to the withdrawal request being made. This
behavior signals a connection between low CADV and low interest levels
from firms seeking to act as the LMM. Likewise, it supports the
assertion that there is less value relative to risks of acting as the
LMM for certain ETPs.
Proposed Fixed Incentive Program
    The Exchange proposes to add new NYSE Arca Equities Rule 8.800,
which would offer a pilot program to incentivize Market Makers to
undertake LMM assignments in ETPs. An issuer of an ETP that
participates in the proposed Fixed Incentive Program would continue to
pay the currently applicable Listing and Annual Fees. Such issuer also
could elect to pay the Exchange an Optional Incentive Fee, which would
range from $10,000 to $40,000 per year.\10\
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    \10\ The Exchange would provide notification on its Web site
regarding the ETPs participating in the Fixed Incentive Program and
the assigned LMMs.
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    Proposed NYSE Arca Equities Rule 8.800(a) would describe the ETPs
that would be eligible for inclusion in the

Fixed Incentive Program. Eligible products would include any ETP that
is listed on the Exchange as of the commencement of the pilot period or
that becomes listed during the pilot period, and the listing is under
NYSE Arca Equities Rules 5.2(j)(3) (Investment Company Units),
5.2(j)(5) (Equity Gold Shares), 5.2(j)(6) (Equity Index-Linked
Securities, Commodity-Linked Securities, Currency-Linked Securities,
Fixed Income Index-Linked Securities, Futures-Linked Securities, and
Multifactor Index-Linked Securities), 8.100 (Portfolio Depositary
Receipts), 8.200 (Trust Issued Receipts), 8.201 (Commodity-Based Trust
Shares), 8.202 (Currency Trust Shares), 8.203 (Commodity Index Trust
Shares), 8.204 (Commodity Futures Trust Shares), 8.300 (Partnership
Units), 8.600 (Managed Fund Shares), and 8.700 (Managed Trust
Securities).
    Proposed NYSE Arca Equities Rule 8.800(b)(1) would describe the
issuer's application process. An issuer that wishes to have an ETP
participate in the Fixed Incentive Program and pay the Exchange an
Optional Incentive Fee would be required to submit a written
application in a form prescribed by the Exchange for each ETP. The
issuer could elect to participate at the time of listing or thereafter
at the beginning of each quarter during the pilot period. An issuer
could not have more than five existing ETPs, that are listed on the
Exchange prior to pilot [sic], participate in the Fixed Incentive
Program. The Exchange would communicate the ETP(s) proposed for
inclusion in the Fixed Incentive Program on a written solicitation that
would be sent to all qualified LMM firms \11\ along with the Optional
Incentive Fee the issuer proposes to pay the Exchange for each ETP. The
permitted range for the Optional Incentive Fee would be set forth in
the Exchange's Fee Schedule. The issuer and the LMM thereafter would
agree upon the final Optional Incentive Fee for each ETP. If more than
one qualified LMM proposed to serve as such, the issuer would choose
the LMM.
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    \11\ The written solicitation would be included in the Green
Sheet, which is the common term for an email communication sent by
NYSE Arca staff members to all qualified LMMs prior to an LMM
selection. The Green Sheet includes, among other things, the name,
symbol, and description of the ETP(s) as well as the name of the
issuer and a link to the ETP prospectus. A qualified LMM must
complete the application for a specific ETP or group of ETPs.
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    Proposed NYSE Arca Equities Rule 8.800(b)(2) would set forth
eligibility requirements for issuers' participation in the Fixed
Incentive Program. To be eligible to participate in the Fixed Incentive
Program, an issuer would be required to be current in all payments due
to the Exchange if it had other securities listed on the Exchange. In
addition, the issuer would be required to be current in all payments
due to the Exchange and compliant with continuing listing standards for
the ETP proposed for inclusion if the issuer elected to participate in
the Fixed Incentive Program after listing such ETP on the Exchange.
    Proposed NYSE Arca Equities Rule 8.800(c) would describe the
process for the payment of the Optional Incentive Fee for each ETP. The
Optional Incentive Fee would be paid by the issuer to the Exchange in
quarterly installments for each participating ETP at the beginning of
each quarter and prorated if the issuer commences participation for an
ETP in the Fixed Incentive Program after the beginning of a quarter.
The issuer would receive a prorated credit from the Exchange following
the end of the quarter if the LMM did not meet its minimum performance
standards for an ETP in any given month in such quarter. The credit
would be applied against the issuer's next quarterly installment of the
Optional Incentive Fee for the ETP, or otherwise credited or refunded
to the issuer if the ETP was withdrawn from the Fixed Incentive
Program. If an issuer did not pay its quarterly installments to the
Exchange on time and the ETP continued to be listed, the Exchange would
continue to credit the LMM as described in proposed Rule 8.800(d)
below, except that after two quarters, if an issuer was not current in
its quarterly installments for an ETP, such ETP would be automatically
terminated from the Fixed Incentive Program.
    Proposed NYSE Arca Equities Rule 8.800(d) would describe the LMM
Payments by the Exchange. Under this provision, the Exchange would
credit an LMM for the LMM Payment, which would be equal to the Optional
Incentive Fee paid by the issuer, less an Exchange administration fee
set forth in the Fee Schedule.\12\ An LMM that receives an LMM Payment
would not be eligible for LMM Rates for such ETP under the Exchange's
Fee Schedule while participating in the Fixed Incentive Program but
would instead be subject to Standard Rates.\13\
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    \12\ As noted below, the Exchange proposes that the initial
administration fee be 5%.
    \13\ See supra note 8.
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    The Exchange would credit an LMM for the LMM Payment at the end of
each quarter. If an LMM did not meet or exceed its minimum performance
standards for the ETP for a particular month, then the LMM Payment
would be prorated accordingly. As noted above, the issuer in turn would
receive a prorated credit that could be used toward the following
quarterly LMM Payment for that particular ETP or others that they have
elected to participate in the Fixed Incentive Program. As is the case
with all liquidity-adding credits currently payable to NYSE Arca
members, LMM Payments would be paid directly by the Exchange from its
general revenues.
    Proposed NYSE Arca Equities Rule 8.800(e) would describe the
circumstances for withdrawal from the Fixed Incentive Program and a
reallocation process. If an ETP no longer met continuing listing
standards or is being liquidated, it would be automatically withdrawn
from the Fixed Incentive Program as of the ETP suspension date. In
addition, NYSE Arca, in its discretion, could allow an issuer to
withdraw an ETP from the Fixed Incentive Program before the end of the
pilot if the assigned LMM was unable to meet its minimum performance
standards for any two of the three months of a quarter or five months
during the pilot and no other qualified ETP Holder was able to take
over the assignment.
    An LMM also could withdraw from all of its ETP assignments in the
Fixed Incentive Program. Alternatively, NYSE Arca, in its discretion,
could allow an LMM to withdraw from a particular ETP before the end of
the pilot period if the Exchange determined that there were extraneous
circumstances that prevented the LMM from meeting its minimum
performance standards for such ETP that did not affect its other ETP
assignments in the Fixed Incentive Program. In either such event, the
LMM's ETP(s) would be reallocated as described below.
    If an LMM, for a particular ETP, did not meet or exceed its minimum
performance standards for any two of the three months of a quarter or
five months during the pilot, or chose to withdraw from the Fixed
Incentive Program, and at least one other qualified Market Maker agreed
to become the assigned LMM under the Fixed Incentive Program, then the
ETP would be reallocated via the written solicitation process described
above. The issuer could select another LMM and renegotiate the Optional
Incentive Fee. The reallocation process would be completed no sooner
than the end of the current quarter and no later than the end of the
following quarter.
    The proposed LMM Payment is designed to encourage additional Market
Makers to pursue LMM assignments and thereby support the

provision of consistent liquidity in ETPs listed on the Exchange. The
Exchange would administer all aspects of the LMM Payments and believes
that providing a quarterly LMM Payment would create a more equitable
system of incentives for LMMs. The Exchange notes that the proposal
would not alter the current requirements and obligations of LMMs under
Exchange rules or any policies and procedures related to LMMs.\14\
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    \14\ See supra note 5.
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Implementation of Fixed Incentive Program
    The pilot program would be offered to issuers from the date of
implementation, which would occur no later than 90 days after the
effective date of this filing, until December 31, 2013. As referenced
above, each issuer could select ETPs to participate in the Fixed
Incentive Program. During the course of the pilot period, the Exchange
would assess the Fixed Incentive Program and may expand the criteria
for ETPs that are eligible to participate for example, to permit
issuers to include more than five ETPs that were listed on the Exchange
before the pilot. At the end of the pilot, the Exchange would determine
whether to continue or discontinue the pilot or make it permanent and
submit a rule filing as necessary. If the Exchange determines to change
the terms of the pilot while it is ongoing, it would submit a rule
filing to the Commission.
    During the pilot program, the Exchange would provide the Commission
with certain market quality data on a confidential basis each month.
Such data would include, for all ETPs listed as of the date of
implementation of the pilot program and listed during the pilot (for
comparative purposes), volume (CADV and NYSE Arca ADV), NBBO bid/ask
spread differentials, LMM participation rates, NYSE Arca market share,
LMM time spent at the inside, LMM time spent within $0.03 of the
inside, percent of time NYSE Arca has the best price with the best
size, LMM quoted spread, LMM quoted depth, and Rule 605 statistics
(one-month delay) as agreed upon by the Exchange and the Commission
staff. In connection with this proposal, the Exchange would provide
such data as may be periodically requested by the Commission.
Amendments to Listing Fee Schedule and Trading Fee Schedule
    To implement the pilot, the Exchange also proposes to amend its
Listing Fee Schedule to provide that the Optional Incentive Fee under
NYSE Arca Rule 8.800 may range from $10,000 to $40,000 and to amend its
Trading Fee Schedule to provide that at the end of each quarter, the
Exchange would credit the LMM assigned to an ETP the Optional Incentive
Fee, less a 5% Exchange administration fee, and that an LMM that
receives an LMM Payment under NYSE Arca Rule 8.800 would be subject to
Standard Rates rather than LMM Rates.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\15\ in general, and
Sections 6(b)(4) and 6(b)(5) of the Act,\16\ in particular.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that the proposed rule change is consistent
with Section 6(b)(4) of the Act in that it is designed to provide for
the equitable allocation of reasonable dues, fees, and other charges
among its members and issuers and other persons using its facilities
and that it is not unfairly discriminatory. The Exchange believes that
the proposed Optional Incentive Fees for ETPs are reasonable, given the
additional costs to the Exchange of providing the LMM Payment. The
Exchange also believes that the proposed fees are reasonable because
they would be used by the Exchange to offset, in part, the cost that
the Exchange incurs to provide listing services for ETPs. These costs
include, but are not limited to, ETP rulemaking initiatives, listing
administration processes, issuer services, consultative legal services
provided to ETP issuers in support of new product development, and
administration of the proposed quarterly LMM Payment.
    The Exchange believes that the Optional Incentive Fee is
reasonable, equitably allocated, and not unreasonably discriminatory.
The fee would be equitably allocated and not unfairly discriminatory
because it is entirely voluntary on the issuer's part to join the pilot
program. The amount of the fee would be determined and paid by the
issuer within the $10,000 to $40,000 band per ETP.
    The Exchange believes that the LMM Payment and standard transaction
fees and credits are equitable in that any LMM could seek to
participate in the program. The Exchange further believes that the
range of credits is fair and equitable in light of the LMM's
obligations and minimum performance standards and that it is reasonable
for the Exchange to retain an administration fee to recover the costs
of administering the pilot program.
    The Exchange further believes that the proposed rule change is
consistent with Section 6(b)(5) of the Act in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, and to remove impediments to and perfect the mechanism of a
free and open market and a national market system. In particular, the
Exchange believes that creating an incentive for an ETP Holder to act
as an LMM would foster cooperation and coordination with persons
engaged in facilitating securities transactions and enhance the
mechanism of a free and open market. The assignment of an LMM, which is
held to higher minimum performance standards as compared to other
market participants, helps to promote fair and orderly markets in ETPs
on the Exchange.
    The Exchange believes that its implementation plan and the pilot
period are reasonable in that they would permit the Commission, the
Exchange, LMMs, and issuers to assess the impact of the Fixed Incentive
Program before making it available to all ETPs. In particular, the
Exchange believes that it is beneficial and not unfairly discriminatory
to limit the ETPs participating so that the Exchange and issuers could
measure the experience against non-participating ETPs and thereby
conserve the commitment of resources to the pilot program.
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products to monitor trading in the
ETPs participating in the pilot program, which the Exchange believes
are adequate to properly monitor Exchange trading of the participating
ETPs in all trading sessions and to deter and detect violations of
Exchange rules and applicable federal securities laws.
    Finally, the Exchange believes that the pilot program would not be
inconsistent with Financial Industry Regulatory Authority (``FINRA'')
Rule 5250, which prohibits payment for market making. The Exchange
believes that FINRA Rule 5250 is designed to address issues associated
with securities of operating companies, and such issues are not present
with ETPs, which have derivative pricing, creation and/or redemption
features, or upsizing that would preclude the type of manipulation that
FINRA Rule 5250 is designed to prevent. Moreover, the Exchange believes
that the structure of

its proposal is unique and has appropriate safeguards. For example, the
proposal includes the interposition of the Exchange between the issuers
and LMMs, the payment of fees from the general revenues of the
Exchange, and the existing obligations and minimum performance
standards that are monitored by the Exchange under NYSE Arca Equities
Rules 7.23 and 7.24, respectively. For these reasons, the Exchange does
not believe that its proposal would be inconsistent with FINRA Rule
5250.\17\
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    \17\ Notwithstanding the Exchange's views, and based upon
discussions with FINRA, subsequent to the Exchange's filing of this
proposal FINRA will file an immediately effective rule change
indicating that participation by LMMs and issuers in the Fixed
Incentive Program would not be prohibited by FINRA Rule 5250.
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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 that is 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 solicited or received with respect to the
proposed rule change.

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

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. The Commission requests comment, in
particular, on the following aspects of the proposed rule change:
    1. The Exchange asserts that LMMs in ETPs incur higher inventory,
quoting, and other risks than other market participants on the Exchange
and that there is less value relative to risk of acting as an LMM for
ETPs that exhibit low CADV. Do commenters agree that low interest
levels by LMMs in ETPs that have low CADV is a result of such value/
risk discrepancy? Why or why not? What other factors could contribute
to a lack of interest by LMMs in such ETPs? What other factors could
explain the apparent increasing proportion of new ETPs that are listed
on the Exchange without a designated LMM?
    2. The Exchange asserts that providing a quarterly LMM Payment to
LMMs assigned to ETPs in the Fixed Incentive Program will create a more
equitable system of incentives for LMMs. Do commenters believe that the
Fixed Incentive Program will incentivize more LMMs to take assignments
in ETPs. If so, how? If not, why not?
    3. Given the inherent arbitrage link between trading ETPs and their
underlying holdings, would a lack of liquidity in an ETP impact the
ability of LMMs to quote relatively narrow bids and offers? What, if
anything, does a lack of liquidity in an ETP indicate about the ability
of an LMM or other market maker to make effective use of arbitrage and
the creation/redemption mechanisms often associated with ETPs? How, if
at all, would a market-making incentive program affect any intraday
premium (discount) of the traded price of an ETP above (below) its
intraday indicative value?
    4. The Exchange states that the Fixed Incentive Program is designed
to encourage additional Market Makers to pursue LMM assignments and
thereby support the provision of consistent liquidity in ETPs listed on
the Exchange. The Commission seeks specific commentary on any potential
impact of the proposed rules on the market quality of ETPs. Do
commenters agree with the Exchange that the Fixed Incentive Program
would support the provision of consistent liquidity in ETPs listed on
the Exchange? If so, please explain. If not, why not?
    5. If two ETPs share similar market quality characteristics (quoted
spread, size, volume, etc.) but one is supported by the Fixed Incentive
Program and the other is not, what, if anything, does that suggest
about the fundamental market qualities of the two ETPs? Would investors
understand, and should they be concerned about, the differences
underlying the seemingly similar market qualities of the two ETPs? Are
there other aspects of this type of incentivized market quality that
should concern investors? Are such apparent improvements in market
quality consistent with the Act and investor protection? Why or why
not?
    6. Under the proposal, LMMs for ETPs in the Fixed Incentive Program
would continue to be subject to the current LMM performance standards
and would not be subject to higher performance standards. Do commenters
believe this is appropriate? Why or why not? Should LMMs for ETPs in
the Fixed Incentive Program be subject to higher standards because of
the LMM Payments that LMMs could be entitled to receive? Why or why
not?
    7. FINRA Rule 5250 prohibits FINRA members from directly or
indirectly accepting payment from an issuer of a security for acting as
a market maker. The Exchange asserts that FINRA Rule 5250 is designed
to address issues associated with securities of operating companies,
and such issues are not present with ETPs, because they have derivative
pricing, creation and/or redemption features, or upsizing that would
preclude the type of manipulation that FINRA Rule 5250 is designed to
prevent. Do commenters agree with this assertion? If so, why? If not,
why not?
    8. The Exchange notes in its filing that it expects FINRA to file a
proposed rule change to amend its Rule 5250 to indicate that
participation by LMMs and issuers in the Fixed Incentive Program would
not be prohibited by FINRA Rule 5250. FINRA Rule 5250 (previously NASD
Rule 2460) was implemented, in part, to address concerns about issuers
paying market makers to improperly influence the price of an issuer's
stock.\18\ Do commenters believe the Fixed Incentive Program would
raise the types of concerns that FINRA Rule 5250

was designed to address? Why or why not?
---------------------------------------------------------------------------

    \18\ See Securities Exchange Act Release No. 38812 (July 3,
1997), 62 FR 37105 (July 10, 1997) (SR-NASD-97-29) (``Specifically,
the Commission finds that the rule preserves the integrity of the
marketplace by ensuring that quotations accurately reflect a broker-
dealer's interest in buying or selling a security. The decision by a
firm to make a market in a given security and the question of price
generally are dependent on a number of factors, including, among
others, supply and demand, the firm's expectations toward the
market, its current inventory position, and exposure to risk and
competition. This decision should not be influenced by payments to
the member from issuers or promoters. Public investors expect
broker-dealers' quotations to be based on the factors described
above. If payments to broker-dealers by promoters and issuers were
permitted, investors would not be able to ascertain which quotations
in the marketplace are based on actual interest and which quotations
are supported by issuers or promoters. This structure would harm
investor confidence in the overall integrity of the marketplace. The
Commission finds that the proposed rule supports a longstanding
policy and position of the NASD and establishes a clear standard of
fair practice for member firms.'')
---------------------------------------------------------------------------

    9. The Exchange asserts that the structure of its proposal is
unique and has appropriate safeguards to dispel the concerns that FINRA
Rule 5250 was designed to address. For example, the Exchange notes that
the proposal includes the interposition of the Exchange between the
issuers and LMMs, the payment of fees from the general revenues of the
Exchange, and the existing obligations and minimum performance
standards that are monitored by the Exchange under NYSE Arca Equities
Rules 7.23 and 7.24, respectively. Do commenters agree that the
Exchange's proposal adequately addresses the policies and concerns
behind FINRA Rule 5250? Why or why not? What are commenters' views on
whether, and if so, how, the Fixed Incentive Program would be
consistent with the rationale behind FINRA Rule 5250?
    10. Could there be conflicts of interest between an issuer of an
ETP in the Fixed Incentive Program and the LMM assigned to such ETP? If
so, what are those conflicts of interest? \19\ Please explain whether
the Exchange's proposal adequately addresses such potential conflicts,
and if so, how, and if not, why not.
---------------------------------------------------------------------------

    \19\ The Commission's order approving NASD Rule 2460 discussed
conflicts of interest that may exist between issuers and market
makers. See id. at 37106 (``It has been a longstanding policy and
position of the NASD that a broker-dealer is prohibited from
receiving compensation or other payments from an issuer for quoting,
making a market in an issuer's securities or for covering the
member's out-of-pocket expenses for making a market, or for
submitting an application to make a market in an issuer's
securities. As stated in Notice to Members 75-16 (February 20,
1975), such payments may be viewed as a conflict of interest since
they may influence the member's decision as to whether to quote or
make a market in a security and, thereafter, the prices that the
member would quote.'')
---------------------------------------------------------------------------

    11. Are the proposed criteria for participation by potential ETP
issuers and/or LMMs in the Fixed Incentive Program sufficiently clear,
precise, and objective to address concerns about potential conflicts of
interest between issuers and market makers? Why or why not? Should such
participation standards be more objective to ensure that there is a
level playing field in determining who the issuers and market makers
are for a particular ETP in the Fixed Incentive Program? Would more
clear and objective standards help to address conflicts of interest
that may be present between issuers and market makers, if any? Under
the proposed Fixed Incentive Program, if more than one qualified LMM
proposes to serve as such, the issuer would choose the LMM. What are
commenters' views on allowing the issuer that has chosen to participate
in the Fixed Incentive Program to choose the LMM? Should the Exchange
establish objective standards and be responsible for choosing the
designated LMM for a particular issuer and ETP in the Fixed Incentive
Program? Would allowing an issuer that has chosen to participate in the
Fixed Incentive Program to choose its LMM for the particular ETP be
consistent or inconsistent with the policies and concerns behind FINRA
Rule 5250?
    12. Is it appropriate and consistent with the Act to allow issuers
to choose to enter into the Fixed Incentive Program and pay the
Optional Incentive Fee? Why or why not? Would it be more or less
appropriate to require all, or a fixed subset of, ETP issuers to enter
the Fixed Incentive Program and pay the Optional Incentive Fee? What
would be the impact on market maker incentives of allowing issuers to
choose to enter into the Fixed Incentive Program and pay the Optional
Incentive Fee?
    13. Is it appropriate and consistent with the Act to allow issuers
and LMMs to negotiate the Optional Incentive Fee? Why or why not? Does
allowing issuers to negotiate such fees directly with LMMs raise
concerns regarding investor confidence, market integrity, and member
standards, similar to those discussed in connection with FINRA Rule
5250? \20\ If so, what are those concerns? Should the Optional
Incentive Fee agreed upon between the issuer and the LMM for a
particular ETP be publicly disclosed? Why or why not?
---------------------------------------------------------------------------

    \20\ See supra note 18.
---------------------------------------------------------------------------

    14. With respect to an ETP, should the entity paying the Optional
Incentive Fee be the sponsor or the fund? What impact, if any, would it
have on fund investors if the fund pays the Optional Incentive Fee as
opposed to the sponsor? Are the proposed rules sufficiently clear as to
which entity will be paying the Optional Incentive Fee?
    15. Section 11(d)(1) of the Act generally prohibits a firm that is
both a broker and a dealer in securities from extending or maintaining
any credit on any new issue security if the broker-dealer participated
in the distribution of the new issue security within the preceding 30
days. The Commission has granted relief to authorized participants from
these restrictions if, among other things, neither the broker-dealer
authorized participant, nor any natural person associated with such
broker-dealer authorized participant, directly or indirectly, receives
from the fund complex any payment, compensation, or other economic
incentive to promote or sell the shares of the fund to persons outside
the fund complex, other than non-cash compensation permitted under NASD
Rule 2380. Should authorized participants participating in the creation
and redemption of shares of ETPs that are also LMMs in those same ETPs
be eligible to receive LMM Payments? Would the LMM Payments give these
authorized participants economic incentives to promote or sell shares
of the ETP? Should such payments be viewed by the Commission as coming
directly or indirectly from the fund complex of the ETP? Should LMM
Payments disqualify broker-dealer authorized participants from relying
on the Commission's exemption from Section 11(d)(1) of the Act?
    16. Could the Fixed Incentive Program have an impact (either
positive or negative) on incentives for market making in other ETPs
listed and traded on the Exchange that are not eligible for and/or do
not participate in the Fixed Incentive Program, either because the
Exchange has limited the number of ETPs that an issuer may have in the
program, the issuer does not qualify for the program, or the issuer's
application for participation is otherwise denied? If so, what type of
impact, and why? If not, why not? Please explain.
    17. The Exchange's stated rationale for the Fixed Incentive Program
is that market makers need additional incentives to take on LMM
assignments in ETPs with low CADV. However, the Fixed Incentive Program
does not limit which ETPs can be included within the program based on
trading volume, and does not provide for the removal or withdrawal of
an ETP from the program if such ETP reaches a certain CADV level. Would
it be more appropriate for an ETP to be removed from the Program once
it reaches a certain liquidity level or volume threshold? Why or why
not? If so, what would be an appropriate threshold? Would it be more
appropriate to limit inclusion in the program to newly listed or low
volume ETPs? Why or why not?
    18. Could the Fixed Incentive Program have unintended consequences
on fair and orderly markets in an ETP when such security leaves the
program? If so, what could these consequences be? If not, why not?
Please explain.
    19. The Exchange has proposed to implement the Fixed Incentive
Program on a pilot basis beginning no later than 90 days after the
effective date of this filing, until December 31, 2013. Is this a
reasonable amount of time to assess the impact of the proposed rules?
If not, why not? Please explain.

    20. What additional data, if any, should be provided by the
Exchange to help assess during the pilot period whether the Fixed
Incentive Program is achieving its stated goals? For example, if the
Exchange required ETPs to be listed and traded outside the Fixed
Incentive Program for a period of time before being eligible for the
program, could such a requirement provide useful ``before and after''
data for ETPs to permit the Exchange and the Commission to more
accurately assess the market quality of the securities before
participating in the program and the market quality of the same
securities while participating in the program? If so, how? If not,
please explain.
    21. The Exchange represents that it will provide certain public
disclosures relating to the Fixed Incentive Program (i.e., notification
on its Web site regarding the ETPs participating in the Fixed Incentive
Program and the assigned LMMs). Do commenters believe that these
disclosures would provide sufficient information to investors? If not,
why not? Do commenters believe the program is sufficiently transparent?
Why or why not? Is there any other information that the Exchange should
provide on its Web site regarding the Fixed Incentive Program and
participating ETPs, issuers, and LMMs? For example, should the Exchange
be required to publish on its Web site any notices from an issuer or
LMM to withdraw from the program, or notices that an issuer or LMM has
been removed from the program? Should the Exchange be required to
publish on its Web site the performance standards to which LMMs in the
program are subject? What advantages or disadvantages would such
disclosures provide? Please explain.
    22. Would it be helpful to investors to have public notice of an
issuer's participation in the Fixed Incentive Program through means
other than on the Exchange's Web site, such as in the issuer's periodic
reports to the Commission, on the issuer's Web site, or through a
ticker symbol identifier on the consolidated tape? Why or why not?
    23. What are commenters' views on whether the proposed disclosures
are sufficient to enable all investors, even less sophisticated
investors, to understand the potential impact of the proposed Fixed
Incentive Program on an ETP, including that an issuer's participation
in the program is voluntary and subject to withdrawal?
    24. Should the Exchange be required to publicly (and anonymously)
disclose statistics on the performance of LMMs? Would such disclosure
provide meaningful information to investors (e.g., would such
disclosure provide investors the opportunity to assess how much
perceived liquidity is being provided by LMMs in the Fixed Incentive
Program, as opposed to liquidity provided by market makers and other
market participants who are not paid an LMM Payment)? If so, what
information should be disclosed and why? If not, why not? What
advantages or disadvantages would such disclosure provide? Please
explain.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2012-37 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2012-37. 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 Section, 100 F Street
NE., Washington, DC 20549-1090, on official business days between 10:00
a.m. and 3:00 p.m. Copies of the filing also will be available for
inspection and copying at the NYSE's principal office and on its
Internet Web site at www.nyse.com. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2012-37 and should be submitted on or before
June 7, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-11914 Filed 5-16-12; 8:45 am]
BILLING CODE 8011-01-P


ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

                                                                                PREVENTION, PESTICIDES AND

                                                                                TOXIC SUBSTANCES

January 9, 2008

MEMORANDUM

SUBJECT:	Environmental Fate Assessment of Diiodomethyl p-tolyl sulfone  for RED

Case No.:  4009		DP Barcode:  344849

FROM:		James Breithaupt, Agronomist

Environmental Risk Branch II

Environmental Fate and Effects Division (7507P)

TO:			Marshall Swindell, Risk Manager

K. Avivah Jakob, Risk Manager Reviewer

Regulatory Management Branch I

Antimicrobials Division (7510P)

THRU:	Richard C. Petrie, Team Leader, Team Three

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Norman Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Chemical Name				PC Code	CAS#		Common Name

(p-tolyl diiodomethyl sulfone			101002	20018-09-1	Amical 48™

Environmental Fate Science Chapter and Fate Assessment on Diiodomethyl p-tolyl sulfone technical is submitted for Reregistration.

Diiodomethyl p-tolyl sulfone Technical

ENVIRONMENTAL FATE SCIENCE CHAPTER

EXECUTIVE SUMMARY

	Amical 48™ Technical is an anti-fouling preservative that contains 95% of the active ingredient (p-tolyl diiodomethyl sulfone).  It is used for food handling/storage establishments premises and equipment (drains, grease traps), Materials Preservatives [Paints (in-can), coatings, fire retardant, adhesives, caulks, sealants, slurries, dispersions/emulsions/ solutions/suspensions, rubber products, plastic/PVC/vinyl products, hides/leathers/leather products, textiles, papermaking, paper and paperboard, nitrocellulose, melamine formaldehyde thermosetting resins, Industrial Processes and Water Systems (septic systems), and Wood Preservatives (mildew, sapstain, and wood-rotting organisms for wood above ground, no pressure treatment).

	Diiodomethyl p-tolyl sulfone is a wettable powder that is slightly soluble in water.  The chemical structure of diiodomethyl p-tolyl sulfone is as follows:

Figure 1.  Structure of Diiodomethyl p-tolyl sulfone

Figure 2.  Structure of MIMPTS (monoiodomethyl-p-tolylsulfone)

Figure 3.  Structure of MPTS (methyl-p-tolylsulfone)

Figure 4.  Structure of PTSA (p-toluene sulfinic acid)

Figure 5.  Structure of PTS-O-A (p-toluene sulfonic acid)

	Diiodomethyl p-tolyl sulfone (Figure 1) is stable to hydrolysis at pH 5, but degraded with half-lives of 2-4 days at pH 7 and 9.  MIMPTS (Figure 2, Monoiodomethyl-p-tolylsulfone, parent minus one iodo group) was the major degradate formed, and increased until the end of the study (30 days).  MPTS (Figure 3, methyl-p-tolylsulfone, parent minus both iodo groups) and PTSA (Figure 4, p-toluene sulfinic acid, parent minus methyl group) reached minor concentrations.  Soil photolysis half-lives of 13 days (linear) and 5.3 (non-linear) were observed for parent compound. MIMPTS was stable in the dark control but degraded with a half-life of 12.5 day in irradiated sample.  Volatiles and non-extractables were negligible.

	Degradation by microorganisms will reduce diiodomethyl p-tolyl sulfone concentrations in the environment, but residues are expected to partition to water in the presence of soil or sediment.   In aerobic soil (the top layer of non-flooded soil), the non-linear parent, MIMPTS, and MPTS half-lives were 1.5, 32, and 53 days, respectively.   The linear half-life of MPTS was 173 days.  PTS-O-A (p-toluene sulfonic acid, parent minus methyl plus added oxygen, Figure 5) did not exceed 0.7 % in the study.  In the anaerobic soil metabolism study (the second layer of soil), the half-lives of parent diiodomethyl p-tolyl sulfone were 1.7 and 4.2 days in aerobic (non-flooded) and anaerobic (flooded soil) portions of the study, respectively.  Diiodomethyl p-tolyl sulfone was found in equal portions in water and sediment.  MIMPTS was a major degradate with a half-life of 21 days and was found predominantly in water.  MPTS reached 81 % by the end of the study and was primarily found in water.  Anaerobic aquatic metabolism (representing bottom sediment) degrades parent and MIMPTS with total system half-lives of 9.6 and 11 days, respectively.  MPTS was the terminal metabolite and increased to 95 % by 4-6 months.  Aqueous residues were greater than sediment residues for parent, MIMPTS, and MPTS for 7, 180, and 60 days, respectively.

	Diiodomethyl p-tolyl sulfone was mobile in columns of soil that were leached with water.  The amounts of parent compound that leached through 12-inch columns were 73, 84, 34, and 8 % in sand, silt loam, sandy loam, and clay soils.  An average of 2, 1.5, 5, and 8 % of applied compound was present in each inch of the columns, respectively.

The Log Kow (Log P) for parent diiodomethyl p-tolyl sulfone is 2.66, and the estimated (EPI-SUITE) Log Kow values for MIMPTS, MPTS, and PTSA were 2.2, 1.1, and 0.56, respectively.  None of these compounds are expected to bioconcentrate significantly because the Log Kow values are below 3.0.

	An average of 43 % of diiodomethyl p-tolyl sulfone from wooden tongue depressors leached into pH 5, 7, 9 unfiltered buffers over a 30-day study (median of 42 %).  Maximum residues in water were observed at day zero, followed by a decrease to the minimum values at day 7 and a general increase.  In filtered samples, the aqueous residues averaged 4.3 %, indicating that some sorption to organic materials may occur in the environment.

	There was no inhibition of microorganisms in sewage sludge treated at 9 mg/l.

I.	Environmental Fate Assessment

	A.	Abiotic

Diiodomethyl p-tolyl sulfone (Figure 1) forms sequential metabolites MIMPTS (parent minus one iodo group, Figure 2), MPTS (parent minus both iodo groups, Figure 3), PTSA (parent minus methyl group, Figure 4), and PTS-O-A (MPTS minus methyl plus oxygen, Figure 5).  The degree of formation of metabolites depends on the level of oxidation potential present in the test system.  Diiodomethyl p-tolyl sulfone and its metabolites are largely present in water in the presence of soil/sediment and degradation forms compounds that are more polar and water soluble than parent compound.

Diiodomethyl p-tolyl sulfone is stable to hydrolysis at pH 5, but degrades rapidly in pH 7 and 9 buffered solutions with linear half-lives of 2.1-3.6 days.  The major degradate was MIMPTS, whose concentrations did not decline in the study and reached 90-100 % of applied by the end of the study.  The minor degradates MPTS and PTSA were formed in the study.  Soil photolysis half-lives of 13 days (linear) and 5.3 (non-linear) were observed for parent compound. MIMPTS was stable in the dark control but degraded with a half-life of 12.5 day in irradiated sample.  Volatiles and non-extractables were negligible.

	B.	Biotic

	Under aerobic soil conditions, parent Diiodomethyl p-tolyl sulfone and MIMPTS degraded with non-linear half-lives of 1.5 and 32 days in sandy loam soil, respectively.  The next sequential metabolite was MPTS which degraded with calculated non-linear and linear half-lives of 53 (poor fit) and 173 (better fit) days, respectively.  The metabolite PTS-O-A (MPTS minus methyl plus oxygen) did not exceed 0.7 % in the study.  Based on the increase in non-extractable residues, the decrease in extractable residues, and the formation of CO2, complete mineralization of some of the product in aerobic soil was occurring.

In sandy loam soil, diiodomethyl p-tolyl sulfone degraded with calculated half-lives of 1.7 and 4.2 days in aerobic and anaerobic conditions, respectively.  Diiodomethyl p-tolyl sulfone was found in equal portions in water and soil in the anaerobic portion of the study.   MIMPTS degraded with a non-linear half-life of 21 days in the anaerobic portion of the study and was found primarily in the water phase.  MPTS increased to 81 % by the end of the study (60 days) and was found in the water instead of the sediment.  PTS-O-A was not formed in significant quantities.  Extractable residues declined in the study, non-extractables were not in significant quantities, and water soluble residues increased to 84 % by 60 days.  The lack of non-extractables and the increase in water soluble residues is consistent with the formation of metabolites with increasing water solubility.  Volatiles did not exceed 0.05 % indicating that complete mineralization or volatility of organic compounds did not occur.

Under anaerobic aquatic conditions (sandy loam sediment, water, and nitrogen atmosphere), the total system, non-linear half-lives of diiodomethyl p-tolyl sulfone and MIMPTS were 9.6 and 11 days, respectively.  Parent compound was associated more with water than sediment through 7 days and more in sediment afterwards.  MIMPTS reached 16.2 % by 7 days, and then declined to <1 % by 3-6 months.  MIMPTS was associated more in water than sediment for 60 days and then in equal portions thereafter.  MPTS increased to 94.5 by 4-6 months, and was associated with water rather than sediment over the duration of the study.  PTS-O-A did not reach significant levels in the study.  Extractable residues were 23-31 % (0-14 days) and 16-18 % by 30-180 days, and non-extractable residues never exceeded 2 %.  Water soluble residues ranged from 68 to 85 % and volatiles did not exceed 0.8 %.

In columns of sand, silt loam, sandy loam, and clay soils, 73, 84, 34, and 8 % of radioactivity passed through the columns into the leachate, respectively.  An average of 2, 1.5, 5, and 8 % of applied diiodomethyl p-tolyl sulfone was detected in each inch of the 12-inch columns.  These results indicate that diiodomethyl p-tolyl sulfone residues will eventually leach through the columns.

	An average of 43 % of diiodomethyl p-tolyl sulfone from wooden tongue depressors leached into pH 5, 7, 9 unfiltered buffers over a 30-day study (median of 42 %).  Maximum residues in water were observed at day zero, followed by a decrease to the minimum values at day 7 and a general increase.  The wood extract accounted for 2.1-6 % of applied for pH 5, 7, and 9.  In filtered samples, the aqueous residues averaged 4.3 %, indicating that some sorption to organic materials may occur in the environment.

There was no inhibition of microorganisms in sewage sludge treated at 9 mg/l.

APPENDIX

Environmental Fate Data for Diiodomethyl p-tolyl sulfone Technical

A.	Environmental Fate Guideline Studies

	1.	Hydrolysis (Guideline Number OPPTS 161-1, MRID No.  43008701)

	This hydrolysis study, submitted under MRID No. 43008701, was reviewed by the Agency and found to be acceptable for the active ingredient, di-iodomethyl-p-tolylsulfone.  The hydrolysis data requirement for diiodomethyl p-tolyl sulfone technical has been fulfilled.

Amical 48 (di-iodomethyl-p-tolylsulfone, Figure 1) is stable to hydrolysis at pH 5, but degrades rapidly in pH 7 and 9 buffered solutions with linear half-lives of 2.1-3.6 days.  The major degradate was MIMPTS (Monoiodomethyl-p-tolylsulfone, parent minus 1 iodo group, Figure 2).  MIMPTS concentrations did not decline in the study and reached 90-100 % of applied by the end of the study (14-30 days).  However, some MIMPTS did degrade to the minor degradates MPTS (methyl-p-tolylsulfone, parent minus both iodo group, Figure 3) and PTSA (p-toluene sulfinic acid, parent minus methyl group, Figure 4).   MPTS and PTSA were formed at <2.8 and <4.4 % of applied, respectively (MRID 43008701).

Photodegradation in Water and on Soil (Guideline Nos. OPPTS 161-2 and 161-3, Waived)

	The Agency is waiving the data requirement for the photodegradation of diiodomethyl p-tolyl sulfone Technical in water.  The active ingredient is hydrolytically unstable (2-4 days) and rapidly degrades.  The aerobic soil metabolism study also demonstrates a half-life of 1.5 days.   However, the registrant submitted a soil photolysis study (Madsen, S. and M.D. Williams.  ABC Report No. 38727, no MRID).   Soil photolysis half-lives of 13 days (linear) and 5.3 (non-linear) were observed for parent compound. MIMPTS was stable in the dark control but degraded with a half-life of 12.5 day in irradiated sample.  Volatiles and non-extractables were negligible.

	3.	Aerobic Soil Metabolism (Guideline No. OPPTS 162-1, MRID No. 41765405)

	This aerobic soil metabolism study, submitted under MRID No. 41765405, was reviewed by the Agency and found to be supplemental for the active ingredient, di-iodomethyl-p-tolylsulfone.

Under aerobic soil conditions, parent diiodomethyl p-tolyl sulfone degraded with a non-linear half-life of 1.5 days in sandy loam soil.  Parent compound  declined from 87 % of applied at time zero to 1.3-3 % by 60-366 days (end of study).  The first sequential metabolite was MIMPTS (Figure 2), which reached a maximum of 65 % by day five and declined to 1.2-2.1 % by 182-366 days.  It declined with a calculated non-linear (formation/decline) half-life of 32 days.   The next sequential metabolite was MPTS (Figure 3), which reached about 56 % of applied by 121 days and declined to about 20 % of applied by 366 days.  The calculated non-linear and linear half-lives were 53 and 173 days, respectively.  The 173-day linear half-life more closely represents the MPTS data.  The metabolite PTS-O-A (parent minus methyl plus oxygen, Figure 5) did not exceed 0.7 % in the study.  Non-extractable residues reached consistent levels of 18-27 % by 21-366 days, and extractable residues declined from 77 % (21 days) to 25 % (366 days).  Volatiles (virtually all CO2) increased to 53 % of applied by 366 days, indicating complete mineralization of some residues (MRID 41765405).

	4.	Anaerobic Soil Metabolism (Guideline No. OPPTS 162-2, MRID No. 41765406)

	This anaerobic soil metabolism study, submitted under MRID No. 41765406, was reviewed by the Agency and found to be supplemental for the active ingredient, di-iodomethyl-p-tolylsulfone.

Under aerobic soil and anaerobic conditions, diiodomethyl p-tolyl sulfone degraded with half-lives of 1.7 and 4.2 days, respectively.  Parent compound was found in equal portions in water and soil in the anaerobic portion of the study.  MIMPTS (Figure 2) was the first major metabolite, and degraded under anaerobic conditions with a non-linear half-life of 21 days.  Aqueous residues were about 4.6 times higher than those in sediment.  MPTS (Figure 3) increased to 81 % by the end of the study (60 days) and was found in the water over the sediment (4X).  PTS-O-A (Figure 5) was formed at <1.4 % of applied in the study.  Extractable residues declined from 99 % at day zero to 15 % at 60 days and non-extractables did not exceed 5 % in the study.  Water soluble residues increased from 56 % at the start of the anaerobic period (15 days) and increased to 84 % by 60 days.  The lack of non-extractables and the increase in water soluble residues is consistent with the formation of metabolites with increasing water solubility.  Volatiles did not exceed 0.05 % (MRID 41765406).

	5.	Anaerobic Aquatic Metabolism (Guideline No. OPPTS 162-3, MRID No. 42177201)

	This anaerobic aquatic metabolism study was reviewed by the Agency and found to be supplemental for the active ingredient di-iodomethyl-p-tolylsulfone.

Under anaerobic aquatic conditions (sandy loam sediment, water, and nitrogen atmosphere), the total system, non-linear half-lives of diiodomethyl p-tolyl sulfone and MIMPTS were 9.6 and 11 days, respectively.  Parent compound was associated more with water than sediment through 7 days and more in sediment afterwards.  MIMPTS reached 16.2 % by 7 days, and then declined to <1 % by 3-6 months.  MIMPTS was associated more in water than sediment for 60 days and then in equal portions thereafter.  MPTS increased to 94.5 by 4-6 months, and was associated with water rather than sediment over the duration of the study.  PTS-O-A did not reach significant levels in the study.  Extractable residues were 23-31 % (0-14 days) and 16-18 % by 30-180 days, and non-extractable residues never exceeded 2 %.  Water soluble residues ranged from 68 to 85 % and volatiles did not exceed 0.8 % (MRID 42177201).

	6.	Aerobic Aquatic Metabolism (Guideline No. OPPTS 162-4, No data)

No data have been submitted.

	7.	Adsorption/Desorption (Guideline No. OPPTS 163-1, MRID No. 41765407)

	This soil column leaching study was reviewed by the Agency and found to be supplemental for the active ingredient di-iodomethyl-p-tolylsulfone.    Batch equilibrium studies using parent compound are not possible because of hydrolytic instability.

	In columns of sand, silt loam, sandy loam, and clay soils, 73, 84, 34, and 8 % of radioactivity passed through the columns into the leachate, respectively.  An average of 2, 1.5, 5, and 8 % of applied parent compound was detected in each inch of the 12-inch columns.  These results indicate that diiodomethyl p-tolyl sulfone residues will eventually leach through the columns (MRID 41765407).

	8	Bioaccumulation in Fish (Guideline No. OPPTS 165-4, Agency Estimated BCF) (No MRID Number))

	Based on the Log P (Log Kow) of 2.66 (<3), significant bioconcentration in fish is not likely.  Based on the Log P (assuming stability of parent), the maximum bioconcentration factor is 11X, which is far less the level of concern of 1,000X.  Also, the lack of persistence in hydrolysis (2-4 days) and the formation of metabolites with higher polarity and water solubility  than parent will prevent significant bioconcentration.

 	9.	Special Leaching Study (American Wood Preservers’ Association Standards-1998, Standard Method E11-97, MRID No. 43997001)

	This leaching study was reviewed by the Agency and was rejected because non-standard wood (tongue depressors) was used in the study.  The wood leaching data requirement for diiodomethyl p-tolyl sulfone Technical should be satisfied using the AWPA E11-97 protocol.

	Puritan® tongue depressors were treated with diiodomethyl p-tolyl sulfone stock solution to achieve a 1 % concentration in the wood (weight basis).  The treated wood sticks were placed into pH 5 (acetate buffer), pH 7 (HEPES buffer), pH 9 (Borate buffer), 0.1 N HCl, and into deionized water.  In unfiltered buffers, the aqueous residues within each buffer averaged 46, 42, 43, 42, and 40 % of the applied, respectively.  Within each test interval, the averages of aqueous residues were 53, 33, 40, 42, and 46 % for day 0, 7, 14, 21, and 30, respectively.  Maximum residues in water were observed at day zero, followed by a decrease to the minimum values at day 7 and a general increase.  The wood extract accounted for 2.1-6 % of applied for pH 5, 7, 9, HCl, and water, respectively.  In filtered samples, the aqueous residues generally declined from day zero (mean of 8 %), declined to about 1 % at day 7, and increased to 6 % by 30 days.  The average percent aqueous recovery in each buffer was 3-7 %.  Apparently, wood fragments sorbed the compound in the water.  MIMPTS (Figure 2) was only major (10 %) degradate, and minor amounts of PTSA (Figure 4), PTS-O-A (Figure 5) and MPTS (Figure 3) were formed.  The median ratio of unfiltered:filtered concentrations was 11, which could have occurred either from suspended wood particles or the filter itself (MRID 43997001).

Inhibition of Sewage Sludge Respiration (OECD Test Method 209), Gonsior, 2002.

The potential for diiodomethyl-p-tolylsulfone to inhibit the respiration of municipal activated sludge was evaluated using the test method OECD 209 “Activated Sludge, Respiration Inhibition Test.” This test method assesses the effect of a test chemical on microorganisms by measuring the respiration rate under defined conditions in the presence of different concentrations of the test chemical following a 3-hour contact period. Diiodomethyl p-tolyl sulfone , at a nominal concentration of 9 mg/L (approximately 90-fold higher than the reported water solubility of 0.1 mg/L), did not inhibit the respiration rate of the activated sludge compared to control mixtures (no test chemical added).Data Gap:  See Table below.

Environmental Fate Data Requirements for Diiodomethyl p-tolyl sulfone Technical

OPP Guideline

Data Requirement

MRID No.

Data Requirement Status

161-1

Hydrolysis	41765404

43008701	Satisfied

161-2

Photodegradation in Water	None	Not required

161-3	Photodegradation on Soil	Madsen and  Williams.  ABC Report No. 38727, no MRID)	Acceptable but not required

162-1	Aerobic Soil Metabolism	41765405	Acceptable but not required

162-2	Anaerobic Soil Metabolism	41765406	Acceptable but not required

162-3

Anaerobic Aquatic Metabolism	42177201	Acceptable but not required

162-4

Aerobic Aquatic Metabolism	None	Not required

163-1

Adsorption/Desorption	41765407	Acceptable but not required

OECD

305

Bioaccumulation in Fish	None	Not required

ASTM D5108-90

AWPA E11-06 protocol study required

Special Leaching Study	43997001	Rejected because of non-standard wood used in test

OECD 209	Inhibition of Sewage Sludge Respiration	Gonsior, 2002, no MRID Acceptable but not required

BIBLIOGRAPHY

MRID					CITATION

161-1       Hydrolysis

41765404	Carpenter, M. (1988) Hydrolysis as a Function of pH at 25(degrees)C of carbon 14|-Amical-48: Lab Project Number: 36019. Unpub- lished study prepared by Analytical Bio-Chemistry Labs., Inc. 756 p.

43008701	Williams, M.; Heim, L. (1993) Hydrolysis of AMICAL 48 as a Function of pH at 25 (degrees) C: Lab Project Number: 40886. Unpublished study prepared by ABC Laboratories, Inc. 63 p.

161-3		Photodegradation on Soil

Madsen, S. and M.D. Williams.  1991.  Determination of the Photolysis Rate of 14C-Amical 48 on the Surface of Soil.  ABC Laboratories Final Report No. 38727.  No MRID.

162-1       Aerobic soil metabolism

41765405	Cranor, W. (1990) Aerobic Soil Metabolism of carbon 14|-Abbott- 9248 (Amical 48): Lab Project Number: 36608. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 955 p.

162-2       Anaerobic soil metabolism

41765406	Madsen, S.; Williams, M. (1990) Anaerobic Soil Metabolism of carbon 14|-Amical 48: Lab Project Number: 38730. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 461 p.

162-3       Anaerobic aquatic metab.

42177201	Madsen, S.; Williams, M. (1991) Anaerobic Aquatic Metabolism of carbon 14| Amical 48: Final Report: Lab Project Number: 38729. Unpublished study prepared by ABC Labs, Inc. 532 p.

163-1       Leach/adsorp/desorption

41765407	Daly, D.; Cranor, W. (1987) Leaching Characteristics in Soil with carbon 14|-Amical-48 (Abbott-9248): Lab Project Number: 36021. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 277 p.

Special Leaching from Wood (ASTM D5108-90)

43997001 	Williams, M.; Bradley, A. (1996) Aqueous Availability of AMICAL 48: Final Report: Lab Project Number: 42782: ABC 42782. Unpublished study prepared by ABC Laboratories Europe, Ltd. 78 p.

Inhibition of Sewage Sludge Respiration

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 PAGE   1


[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Pages 61277-61279]
[FR Doc No: 2021-24236]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0515]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Adverse
Experience Reporting and Recordkeeping for Drug and Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by December 6, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0230. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Postmarketing Adverse Experience Reporting and Recordkeeping for Drug
and Biologics Products

OMB Control Number 0910-0230--Revision

    This information collection supports statutory provisions set forth
in the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the
monitoring of FDA-regulated products. Specifically,

FDA must be promptly informed of adverse experiences associated with
the use of marketed drugs, including human drugs and biological
products. Regulations in Sec. Sec.  310.305 and 314.80 (21 CFR 310.305
and 314.80) implement reporting and recordkeeping requirements that
enable FDA to take action to protect the public health from adverse
drug experiences. All applicants who have received marketing approval
for drug products are required to report serious, unexpected adverse
drug experiences (15-day ``Alert reports''), as well as followup
reports (Sec.  314.80(c)(1)) to FDA. This includes reports of all
foreign or domestic adverse experiences as well as those based on
information from applicable scientific literature and certain reports
from postmarketing studies. Section 314.80(c)(1)(iii) pertains to such
reports submitted by nonapplicants.
    Under Sec.  314.80(c)(2), applicants must provide periodic reports
of adverse drug experiences. For the reporting interval, a periodic
report includes reports of serious, expected adverse drug experiences,
all nonserious adverse drug experiences, and an index of these reports;
a narrative summary and analysis of adverse drug experiences; an
analysis of the 15-day Alert reports submitted during the reporting
interval; and a history of actions taken because of adverse drug
experiences. Under Sec.  314.80(j), applicants must keep for 10 years
records of all adverse drug experience reports known to the applicant.
    For marketed prescription drug products without approved new drug
applications (NDAs) or abbreviated new drug applications (ANDAs),
manufacturers, packers, and distributors are required to report to FDA
serious, unexpected adverse drug experiences as well as followup
reports (Sec.  310.305(c)). Section 310.305(c)(5) pertains to the
submission of followup reports to reports forwarded to the
manufacturers, packers, and distributors by FDA. Under Sec.
310.305(g), each manufacturer, packer, and distributor shall maintain
for 10 years records of all adverse drug experiences required to be
reported.
    Section 760 of the FD&C Act (21 U.S.C. 379aa) also provides for
mandatory safety reporting for over-the-counter (OTC) human drug
products not subject to applications approved under section 505 of the
FD&C Act (21 U.S.C. 355) (NDAs or ANDAs). These requirements apply to
all OTC drug products marketed without an approved application,
including those marketed under the OTC Drug Monograph Review process
(whether or not subject to a final monograph), those marketed outside
the monograph system, and including those that have been discontinued
from marketing but for which a report of an adverse event was received.
Under 21 CFR 329.100, respondents must submit reports according to
section 760 of the FD&C Act in an electronic format.
    To assist respondents with implementation of section 760 of the
FD&C Act, FDA developed the guidance for industry entitled
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application,'' available at
https://www.fda.gov/media/77193/download. The guidance document
discusses what should be included in a serious adverse drug event
report submitted under section 760(b)(1) of the FD&C Act, including how
to submit these reports and followup reports under section 760(c)(2) of
the FD&C Act.
    Section 760(e) of the FD&C Act also requires that responsible
persons maintain records of nonprescription drug adverse event reports,
whether the event is serious or not, for a period of 6 years. FDA's
guidance recommends that respondents maintain records of efforts to
obtain the minimum data elements for a report of a serious adverse drug
event and any followup reports.
    The primary purpose of FDA's adverse drug experience reporting
system is to enable identification of signals for potentially serious
safety problems with marketed drugs. Although premarket testing
discloses a general safety profile of a new drug's comparatively common
adverse effects, the larger and more diverse patient populations
exposed to the marketed drug provide the opportunity to collect
information on rare, latent, and long-term effects. Signals are
obtained from a variety of sources, including reports from patients,
treating physicians, foreign regulatory agencies, and clinical
investigators. Information derived from the adverse drug experience
reporting system contributes directly to increased public health
protection because the information enables FDA to make important
changes to the product's labeling (such as adding a new warning), to
make decisions about risk evaluation and mitigation strategies or the
need for postmarketing studies or clinical trials and, when necessary,
to initiate removal of a product from the market.
    In addition, this information collection includes an International
Council for Harmonisation (ICH) guidance for industry entitled
``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2)
Format (Periodic Benefit-Risk Evaluation Report),'' available at
https://www.fda.gov/media/85520/download. The guidance describes the
conditions under which applicants may use the ICH3 E2C(R2) Periodic
Benefit-Risk Evaluation Report format for certain types of adverse
event reporting. FDA regulations in Sec. Sec.  314.80(c)(2) and
600.80(c)(2) (21 CFR 600.80(c)(2)) require applicants to submit
postmarketing periodic safety reports for each approved application.
The reports must be submitted quarterly for the first 3 years following
the U.S. approval date and annually thereafter and must contain the
information described in Sec. Sec.  314.80(c)(2)(ii) and
600.80(c)(2)(ii) (the information collection associated with 21 CFR
part 600--Biological Products, is approved under OMB control number
0910-0308). The Agency guidance assists respondents with satisfying the
regulatory requirements in an alternative format, noting that the
process differs depending on whether an applicable periodic safety
update report (PSUR) waiver is in place. The information collection
burden for waivers of a PSUR are currently approved in OMB control
number 0910-0771; however, it is being consolidated with this
information collection for administrative efficiency.
    Similarly, the information collection accounts for burden that may
be applicable to the guidance document, ``Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During a
Pandemic,'' available at https://www.fda.gov/media/72498/download. In
response to the Coronavirus Disease 2019 public health emergency, we
revised the Agency guidance document to provide recommendations for
recordkeeping applicable to any pandemic, not just influenza, including
recommendations for planning, notification, and documentation for
continuity of operations for firms that report postmarketing adverse
events during any pandemic.
    Respondents to this collection of information are: (1)
Manufacturers, packers, distributors, and applicants of FDA-regulated
drug and biologic products; (2) manufacturers, packers, and
distributors of marketed prescription drug products without an FDA-
approved application; and (3) manufacturers, packers, and distributors
of marketed nonprescription drug products, including OTC drug products
marketed without an approved application, OTC drug products marketed
under the OTC Drug Monograph Review process (whether subject to a final
monograph or not), and

drug products marketed outside the monograph system.
    In the Federal Register of June 30, 2021 (86 FR 34759), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
   21 CFR section or type of       Number of      responses per   Total annual    Average burden    Total hours
    respondent and activity       respondents      respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
310.305(c)(5).................                3               1               3                1               3
314.80(c)(1)(iii).............                5               1               5                1               5
314.80(c)(2)..................              820           17.32          14,202               60         852,120
Reports of serious adverse                  285             690         196,650                6       1,179,900
 drug events (Sec.   329.100).
Applicants that have a PSUR                  55             3.4             187                1             187
 waiver for an approved
 application..................
Applicants that do not have a                29             2.3              67                2             134
 PSUR waiver for an approved
 application..................
Notifying FDA when normal                   350               1             350                8           2,800
 reporting is not feasible....
                               ---------------------------------------------------------------------------------
    Total \2\.................  ...............  ..............         211,464  ...............       2,035,149
----------------------------------------------------------------------------------------------------------------
\1\ The capital costs or operating and maintenance costs associated with this collection of information are
  approximately $25,000 annually.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
  21 CFR section or FD&C act       Number of       records per    Total annual         per          Total hours
     section and activity        recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
310.305.......................               25               1              25               16             400
314.80(j).....................              352           1,870         658,240               16      10,531,840
Recordkeeping of<PHONE_NUMBER>         265,700                8       2,125,600
 nonprescription drug adverse
 event reports (Section
 760(e)(1) of the FD&C Act)...
Adding Adverse Event report                 100               1             100               50           5,000
 planning to Continuity of
 Operations Plans.............
Maintaining documentation of                350               1             350                8           2,800
 pandemic conditions and
 resultant high absenteeism...
Maintaining records to                      350               1             350                8           2,800
 identify what reports have
 been stored and when the
 reporting process was
 restored.....................
                               ---------------------------------------------------------------------------------
    Total \2\.................  ...............  ..............         924,765  ...............      12,668,440
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.
\2\ There are maintenance costs of approximately $22,000 annually.

    We have increased our estimate to reflect expected adjustments to
the information collection since our last submission for OMB review and
approval.

    Dated: November 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24236 Filed 11-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 25, 2006 (Volume 71, Number 142)]
[Notices]
[Page 42139-42140]
[DOCID:fr25jy06-113]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collections; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extensions:
    Form T-6; OMB Control No. 3235-0391; SEC File No. 270-344.
    Form 11-K; OMB Control No. 3235-0082; SEC File No. 270-101.
    Form 144; OMB Control No. 3235-0101; SEC File No. 270-112.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities

and Exchange Commission (``Commission'') is soliciting comments on the
collections of information summarized below. The Commission plans to
submit these existing collections of information to the Office of
Management Budget for extension and approval.
    Form T-6 (17 CFR 269.9) is a statement of eligibility and
qualification for a foreign corporate trustee under the Trust Indenture
Act of 1939 (15 U.S.C. 77aaa et seq.). Form T-6 provides the basis for
determining if a trustee is qualified. Form T-6 takes approximately 17
burden hours per response and is filed by 1 respondent. We estimate
that 25% of the 17 total burden hours (4 hours) is prepared by the
filer. The remaining 75% of burden hours is prepared by outside
counsel.
    Form 11-K (17 CFR 249.311) is the annual report designed for use by
employee stock purchase, savings and similar plans. Form 11-K provides
employees with financial information so that they can assess the
performance of the investment vehicle in which their money is invested.
Form 11-K takes approximately 30 burden hours per response and is filed
by 2,000 respondents for total of 60,000 burden hours.
    Form 144 (17 CFR 239.144) is used to report the sale of securities
during any three-month period that exceeds 500 shares or other units or
has an aggregate sales price in excess of $10,000. Form 144 operates in
conjunction with Rule 144. Form 144 takes approximately 2 burden hours
per response and is filed by 60,500 respondents for a total of 121,000
total burden hours.
    Written comments are invited on: (a) Whether these proposed
collections of information are necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collections of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collections of information
on respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312,
or send an e-mail to<EMAIL_ADDRESS>
    July 14, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-11790 Filed 7-24-06; 8:45 am]

BILLING CODE 8010-01-P