[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60265-60268]
[FR Doc No: 2017-27229]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82310; File No. SR-OCC-2017-010]

Self-Regulatory Organizations; the Options Clearing Corporation;
Order Approving Proposed Rule Change Relating to The Options Clearing
Corporation's Default Management Policy

December 13, 2017.
    On October 12, 2017, The Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission'')
proposed rule change SR-OCC-2017-010 pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on November 1, 2017.\3\ The Commission did not
receive any comment letters on the proposed rule change. This order
approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 34-81955 (Oct. 26,
2017), 82 FR 50707 (Nov. 1, 2017) (File No. SR-OCC-2017-010).
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I. Description of the Proposed Rule Change

    This proposed rule change by OCC will formalize OCC's Default
Management Policy (``DM Policy''). The proposed rule change does not
require any changes to the text of OCC's By-Laws or Rules.\4\
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    \4\ All terms with initial capitalization that are not otherwise
defined herein have the same meaning as set forth in the OCC By-Laws
and Rules.
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    As described by OCC, the DM Policy would apply in the event of a
default by a Clearing Member, settlement bank, or a financial market
utility (``FMU'') with which OCC has a relationship.\5\ The purpose of
the DM Policy is to outline OCC's default management framework and
describe the default management steps that OCC has authority to take
depending upon the facts and circumstances of a default. The DM Policy
focuses on Clearing Member default, which OCC believes is appropriate
because Clearing Member default represents a substantial part of the
overall default risk that is posed to OCC in connection with its
central counterparty clearing services.\6\ OCC notes that the DM Policy
is part of a broader framework used by OCC to manage the default of a
Clearing Member, settlement bank, or FMU, including OCC's By-Laws,
Rules, and other policies and procedures. The broader framework is
designed to collectively ensure that OCC would appropriately manage any
such default consistent with OCC's obligations as a covered clearing
agency.\7\
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    \5\ The DM Policy identifies the following securities or
commodities clearing organizations as examples of such FMUs: The
Depository Trust Company, National Securities Clearing Corporation,
and the Chicago Mercantile Exchange. In an event of default by one
of these securities or commodities clearing organizations, or by a
settlement bank, OCC has authority under certain conditions pursuant
to Article VIII, Sections 1(a)(vii) and 5(b) of the By-Laws to
manage the default using Clearing Member contributions to the
Clearing Fund.
    \6\ For purposes of the DM Policy, references to a Clearing
Member suspension or default contemplate the circumstances specified
in OCC Rule 1102, which constitute events of ``default'' under
Interpretation and Policy .01 to the Rule.
    \7\ On September 28, 2016, the Commission amended Rule 17Ad-22
under the Act by adding new Rule 17Ad-22(e) to establish
requirements for the operation and governance of registered clearing
agencies that meet the definition of a covered clearing agency, as
defined by Rule 17Ad-22(a)(5). Standards for Covered Clearing
Agencies, Securities Exchange Act Release No. 34-78961 (Sept. 28,
2016), 81 FR 70786 (Oct. 13, 2016).
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    The DM Policy describes the authority of OCC's Board of Directors
(``Board'') or a Designated Officer \8\ to summarily suspend a Clearing
Member pursuant to OCC Rule 1102(a) in the event the Clearing Member
defaults. The DM Policy further provides that, pursuant to OCC Rule
707, OCC may suspend a Clearing Member that participates in a cross-
margining program in the event of a default regarding its cross-
margining accounts. Upon any suspension of a Clearing Member, the DM
Policy states that OCC would immediately notify a number of parties,
including the suspended Clearing Member, regulatory authorities,
participant and other exchanges (as applicable) in which the suspended
Clearing Member is a common member, other Clearing Members,\9\ and
OCC's Board.\10\
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    \8\ For this purpose, the term Designated Officer includes the
Executive Chairman, Chief Administrative Officer (``CAO''), Chief
Operating Officer (``COO''), Chief Risk Officer (``CRO''), and
Executive Vice President--Financial Risk Management (``EVP-FRM'').
    \9\ OCC Rule 1103 requires OCC to notify all Clearing Members of
the suspension as soon as possible.
    \10\ With respect to pending transactions of a suspended
Clearing Member, the DM Policy provides that these will be handled
pursuant to OCC Rule 1105, provided that OCC has no obligation to
accept the trades effected by a suspended Clearing Member post-
suspension.
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    In the event of a Clearing Member suspension, the DM Policy
provides that

OCC's Financial Risk Management Department (``FRM'') shall prepare an
exposure summary report to be provided to OCC's Management Committee
detailing, among other things, the open obligations of the suspended
Clearing Member, collateral deposited by the Clearing Member,
obligations to other FMUs, and a summary of related entity exposure.
The report summarizes the net settlement obligation of the suspended
Clearing Member at the time of default. The DM Policy further provides
that a recommendation as to any liquidity needs requiring a draw on
OCC's credit facilities would be provided to OCC's Management Committee
and subsequently be authorized, as applicable, by the Executive
Chairman, CAO, or COO, as provided for in Article VIII, Section 5 of
the By-Laws. These practices ensure that OCC's Management Committee
remains properly informed and can make appropriate decisions in the
default management process.
    The DM Policy describes OCC's existing authority under OCC Rule 505
to extend the time for OCC's settlement obligations (i.e., payment
obligations owed by OCC to Clearing Members). The DM Policy notes that,
as set forth in OCC Rule 505, any such determination to extend the
settlement time and the reasons thereof will be promptly reported by
OCC to the Commission and the Commodity Futures Trading Commission
(``CFTC''); however, the effectiveness of the extension would not be
conditioned upon such reporting. The DM Policy notes that such an
extension may be necessary as a result of a Clearing Member default or
a failure of a Clearing Member's settlement bank.
    To address situations in which a Clearing Member's settlement bank
fails or experiences an operational outage that prevents the Clearing
Member from meeting its settlement obligations to OCC, the DM Policy
provides that OCC requires each Clearing Member to maintain procedures
detailing how it would meet its settlement obligations in such an
event. The DM Policy further provides that a Designated Officer would
determine whether to enact alternate settlement procedures in the event
that a Clearing Member's settlement bank is unable to perform.
    The DM Policy sets forth the sequence or ``waterfall'' of financial
resources that OCC may use to meet its obligations in the event of a
Clearing Member suspension to provide certainty regarding the order in
which these resources would be applied. Specifically, the DM Policy
describes that OCC is able to use the following financial resources:
(i) Margin deposits of the suspended Clearing Member; (ii) deposits in
lieu of margin of the suspended Clearing Member; \11\ (iii) Clearing
Fund deposits of the suspended Clearing Member; (iv) Clearing Fund
deposits of non-defaulting Clearing Members; (v) Clearing Fund
assessments against Clearing Members; and (vi) the current or retained
earnings of OCC, subject to the unanimous approval of certain OCC
shareholders.\12\
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    \11\ See OCC Rules 610(f) and (g).
    \12\ See OCC By-Law Article VIII, Section 5(d). In lieu of
charging a loss or deficiency proportionately to the computed
Clearing Fund contributions of non-defaulting Clearing Members, OCC
may charge the loss or deficiency to current or retained earnings.
This discretion applies in connection with any loss by reason of the
failure of a bank or securities or commodities clearing organization
to perform an obligation to OCC.
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    In the case of a suspended Clearing Member, the DM Policy outlines
the means by which OCC may close out positions and liquidate collateral
of the suspended Clearing Member pursuant to OCC's Rules, including
certain provisions under Chapter XI of the Rules. Based upon
recommendations from OCC's risk staff, the EVP-FRM may take any one, or
any combination, of the following actions pursuant to the terms of
OCC's By-Laws and Rules: (i) Net the suspended Clearing Member's
positions by offset; (ii) effect close out open short positions, long
positions, and collateral through market transactions; (iii) transfer
the positions and related collateral to a non-suspended Clearing
Member; (iv) effect hedging transactions to reduce the risk to OCC of
open positions; (v) conduct a private auction of the positions and
collateral of the suspended Clearing Member; (vi) exercise unsegregated
and segregated long options; (vii) set cash settlement values or
perform buy-in or sell-out processes; and (viii) defer close-out, as
may be authorized by certain officers of OCC.\13\
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    \13\ The DM Policy also provides that any determination to defer
close-out or hedging transactions under the Close-out Action Plan
(as discussed herein) would be reported to the Board and/or the
Board Risk Committee, as required under OCC Rule 1106.
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    In addition, the DM Policy specifies that OCC risk staff will
develop a Close-out Action Plan (``CAP'') and present it to the EVP-FRM
for approval. The DM Policy provides that upon approval of the CAP by
the EVP-FRM, FRM, and other designated business officers/departments
will be responsible for its execution. The DM Policy also provides that
OCC's legal department would advise OCC's Management Committee on OCC's
authority to execute the proposed CAP and describe the responsibilities
for the execution, monitoring, and reporting of the CAP and escalation
of issues to OCC's Management Committee. The CAP process is designed to
ensure that OCC has an appropriate process in place to analyze its
exposures, take into consideration current and expected market
conditions, and evaluate the tools and resources available to deal with
those exposures under the circumstances so that OCC can appropriately
manage any default in a manner that would protect Clearing Members,
investors, the public interest, and the markets that OCC serves.
    The DM Policy provides that OCC would generally liquidate all
positions and collateral of a suspended Clearing Member, and the
proceeds would be attributed to the account type from which they
originated. It also specifies that as a registered clearing agency with
the Commission and a registered derivatives clearing organization with
the CFTC, OCC is required to comply with regulatory requirements to
safeguard customer assets.
    In the event of a default, OCC would immediately demand any pledged
collateral of the suspended Clearing Member from custodian(s) to ensure
those resources are available for default management purposes. For
example, the DM Policy provides that, among other things, cash and
proceeds from any liquidated collateral or demand of payment on a
letter of credit would be placed in the appropriate liquidating
settlement account, pursuant to OCC Rule 1104. The DM Policy further
provides that all pledged valued margin collateral will be moved by
OCC's Collateral Services Department into an OCC account and may be
transferred to an auction recipient, delivered to a liquidating agent,
or delivered to a liquidating settlement account. In the case of
deposits in lieu of margin, however, the DM Policy states that OCC
would only demand such collateral to meet obligations arising from the
assignment of a related contract.
    After the close-out of the positions and collateral of the
suspended Clearing Member is completed, the DM Policy describes that
the Executive Chairman, CAO, or COO would determine whether, consistent
with Article VIII, Section 5(a) of OCC's By-Laws, an assessment must be
made against the Clearing Fund in connection with the liquidation. In
the event of a shortfall whereby the close-out of the suspended
Clearing Member does not result in enough resources to cover its
obligations, the DM Policy states that each Clearing Member, consistent
with

Article VIII, Section 6 of OCC's By-Laws, may be assessed an additional
amount equal to the amount of its initial Clearing Fund deposit, as
determined by the Executive Chairman, CAO, or COO. The DM Policy notes
that any such assessment decision would be communicated via email in
accordance with the applicable OCC procedure covering the assessment
process. The DM Policy also specifies that a Clearing Member is liable
for further assessments until the balance of OCC's losses are covered
or the Clearing Member has withdrawn from membership as set forth in
Article VIII, Sections 6 and 7 of OCC's By-Laws.
    The DM Policy provides that, on at least an annual basis, OCC's
default management working group will provide OCC's Management
Committee with recommended areas for testing, including close-out
procedures, and that the Management Committee is responsible for
reviewing and ultimately approving the overall test plan.\14\ In
addition, the DM Policy specifies that the default management working
group maintains the authority to approve individual test plans and
overall plan changes, but that any changes to the overall plan would be
reported to and reviewed by OCC's Management Committee. The DM Policy
further provides that testing is recommended and performed more
frequently than annually if a material change is made to OCC's default
management procedures or if it is deemed necessary by OCC's default
management working group.
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    \14\ The DM Policy also provides that Clearing Members are
required to participate in default management testing pursuant to
OCC Rules 218(c) and (d). See Securities Exchange Act Release No.
80372 (April 4, 2017), 82 FR 17311 (April 10, 2017) (SR-OCC-2017-
003).
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    In addition, the DM Policy outlines the execution of the testing
plan and the review of the results of the testing plan, including the
production of annual reports to OCC's Management Committee and Risk
Committee of OCC's Board regarding the results of OCC's default tests
to provide appropriate oversight over the default testing process.

II. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \15\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and rules and regulations thereunder applicable
to such organization. The Commission finds that the proposal is
consistent with Section 17A(b)(3)(F) of the Act \16\ and Rules 17Ad-22
(e)(4)(ix) and (e)(13) \17\ thereunder, as described in detail below.
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    \15\ 15 U.S.C. 78s(b)(2)(C).
    \16\ 15 U.S.C. 78q-1(b)(3)(F).
    \17\ 17 CFR 240.17Ad-22(e)(4)(ix), (e)(13).
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A. Consistency With Section 17A(b)(3)(F) of the Act

    The Commission finds OCC's proposed changes to be consistent with
Section 17A(b)(3)(F) of the Act,\18\ which requires, among other
things, that the rules of a clearing agency be designed to promote the
prompt and accurate clearance and settlement of securities
transactions, in general, to protect investors and the public interest.
As noted above, the DM Policy focuses on the processes that OCC would
use to take timely action to contain losses and liquidity demands in an
event of default by a Clearing Member, such as closing out open
positions and collateral of a defaulted Clearing Member, using
alternate settlement bank procedures, or relying on Clearing Fund
contributions of Clearing Members under certain conditions. In this
regard, the DM Policy is designed to ensure that OCC can maintain its
resilience in the event of a default, thereby enabling OCC to continue
to provide its clearance and settlement services to the public in such
circumstances. By formalizing the components of the DM Policy, OCC has
taken measures to provide that its rules are designed to promote the
prompt and accurate clearance and settlement of securities
transactions, and, in general, to protect investors and the public
interest.
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    \18\ 15 U.S.C. 78q-1(b)(3)(A).
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B. Consistency With Rule 17Ad-22(e)(4)(ix)

    Rule 17Ad-22(e)(4)(ix) \19\ requires each covered clearing agency
to establish, implement, maintain and enforce written policies and
procedures reasonably designed to effectively identify, measure, and
manage its credit exposures to participants and those arising from its
payment, clearing, and settlement processes, including by describing
its process to replenish any financial resources it may use following a
default or other event in which use of such resources is contemplated.
The DM Policy describes the process by which OCC may initiate a
Clearing Fund assessment to replenish financial resources that may be
used following a default and the attendant suspension of a Clearing
Member. Specifically, the DM Policy provides that where the liquidation
of a suspended Clearing Member results in a shortfall, certain officers
of OCC may require that all Clearing Members be assessed an additional
amount equal to the amount of their respective Clearing Fund deposits,
consistent with OCC's By-Laws, and that a Clearing Member is liable for
further assessments until the balance of OCC's losses are covered or
the Clearing Member has withdrawn from membership as set forth in OCC's
By-Laws. In addition, the DM Policy also provides that, pursuant to the
waterfall of financial resources used in the event of a Clearing Member
suspension, OCC could use current or retained earnings, consistent with
OCC's By-Laws, to continue meeting its financial obligations.
Accordingly, the Commission finds that the proposed changes are
consistent with Rule 17Ad-22(e)(4)(ix).\20\
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    \19\ 17 CFR 240.17Ad-22(e)(4)(ix).
    \20\ Id.
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C. Consistency With Rule 17Ad-22(e)(13)

    Rule 17Ad-22(e)(13) \21\ requires each covered clearing agency to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to ensure that it has the authority and
operational capacity to take timely action to contain losses and
liquidity demands and continue to meet its obligations by, at a
minimum, requiring its participants and, when practicable, other
stakeholders to participate in the testing and review of its default
procedures, including any close-out procedure, at least annually and
following material changes thereto. The DM Policy, among other things,
sets forth OCC's authority and operational capabilities to take timely
action to contain losses and liquidity demands and continue to meet its
obligations. For example, the DM Policy sets forth the procedures by
which OCC would suspend a Clearing Member as well as the waterfall of
financial resources that OCC would use to contain losses arising from
the Clearing Member's default. The DM Policy also describes, among
other things, the various means by which OCC may close-out the
positions of a suspended Clearing Member and the process it uses to
make such determinations, which OCC believes helps ensure that it has
sufficient operational capacity to take timely action to contain losses
and liquidity demands and continue to meet its obligations. In
addition, the DM Policy sets forth OCC's processes for managing annual
default management testing, or more frequent testing following a change
to OCC's default management

procedures. Accordingly, the Commission finds that these policies and
procedures are consistent with the requirements in Rule 17Ad-
22(e)(13).\22\
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    \21\ 17 CFR 240.17Ad-22(e)(13).
    \22\ Id.
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III. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed change is consistent with the requirements of the Act, and in
particular, with the requirements of Section 17A of the Act \23\ and
the rules and regulations thereunder.
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    \23\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\24\ that the proposed rule change (SR-OCC-2017-010) be, and it
hereby is, approved.
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    \24\ 15 U.S.C. 78s(b)(2).
    \25\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated Authority.\25\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-27229 Filed 12-18-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Notices]
[Pages 57633-57635]
[FR Doc No: 2012-22913]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67840; File No. SR-EDGX-2012-41]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to the EDGX Exchange, Inc. Fee Schedule

September 12, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 5, 2012 the EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its fees and rebates applicable to
Members \3\ of the Exchange pursuant to EDGX Rule 15.1(a) and (c). All
of the changes described herein are applicable to EDGX Members. The
text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.directedge.com, at the Exchange's
principal office, and at the Public Reference Room of the Commission.
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    \3\ As defined in Rule 1.5(n).
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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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 Exchange proposes to add Flag RP to the Exchange's fee schedule
for Non-Displayed Orders that add liquidity using the Route Peg Order
type.\4\ The Exchange proposes to offer a rebate of $0.0015 per share
for orders that yield Flag RP. The volume associated with Flag RP will
also count towards the volume tiers for orders that add liquidity.
Accordingly, the Exchange proposes making conforming changes to the
text of Footnotes 12 and 13 to include Flag RP as part of the ``added
flags.''
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    \4\ See Securities and Exchange Act Release No. 67727 (August
24, 2012), (SR-EDGX-2012-25).
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    As defined in Exchange Rule 11.5(c)(17), a Route Peg Order is a
non-displayed limit order that posts to the EDGX Book, and thereafter
is eligible for execution at the National Best Bid (``NBB'') for buy
orders and National Best Offer for sell orders (``NBO'', and together
with the NBB, the ``NBBO'') against the original size of the routable
orders that are equal to or less than the original size of the Route
Peg Orders. Route Peg Orders are passive, resting orders on the EDGX
Book and do not take liquidity. Route Peg Orders may be entered,
cancelled, and cancelled/replaced prior to and during Regular Trading
Hours.\5\ Route Peg Orders are eligible for execution in a given
security during Regular Trading Hours, except that, even after the
commencement of Regular Trading Hours, Route Peg Orders are not
eligible for execution (1) in the opening cross, and (2) until such
time that regular session orders in that security can be posted to the
EDGX Book. A Route Peg Order does not

execute at a price that is inferior to a Protected Quotation, and is
not permitted to execute if the NBBO is locked or crossed. Any and all
remaining, unexecuted Route Peg Orders are cancelled at the conclusion
of Regular Trading Hours.
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    \5\ As defined in Rule 1.5(y).
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    The Exchange proposes to implement these amendments to its fee
schedule on September 7, 2012.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\6\ in general, and
furthers the objectives of Section 6(b)(4),\7\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
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    The Exchange proposes to add Flag RP to the Exchange's fee schedule
for Non-Displayed Orders that add liquidity using the Route Peg Order
type. The Exchange believes that offering a rebate of $0.0015 per share
for orders that yield Flag RP represents an equitable allocation of
reasonable dues, fees and other charges among its Members and other
persons using its facilities because a rebate of $0.0015 per share is
equal to the prevailing rebate of $0.0015 that the Exchange offers for
Flag HA, which is a non-displayed order type that adds liquidity but
less than the default rebate of $0.0023 per share for adding displayed
liquidity on EDGX. By offering a proposed rebate of $0.0015 per share
for Flag RP, the Exchange believes it will encourage use of the new
order type, while maintaining consistency with the Exchange's overall
pricing philosophy of encouraging displayed liquidity. In addition, the
Exchange is setting the rebate at such level in order to incentivize
liquidity by encouraging Members to use Route Peg Orders (Flag RP)
since these orders provide Members that enter them and other Members an
additional way to offer/access liquidity at the NBBO, respectively. In
addition, since Flag RP has lowest priority according to Rule
11.8(a)(2), it would otherwise be rebated more than Flag HA, which has
a higher priority. However, the Exchange is offering the same rebate as
Flag HA because of the Route Peg Order type's unique features which
provides Members the ability to control interaction with certain types
of contra-side liquidity (i.e., routable orders of equal or lesser
size). This contributes to additional depth of book at the NBBO.
    Furthermore, as stated in SR-EDGX-2012-25, the Exchange believes
that by encouraging the use of the Route Peg Order, Members seeking to
access liquidity at the NBBO would be more motivated to direct their
orders to EDGX because they would have a heightened expectation of the
availability of liquidity at the NBBO. The increased liquidity also
benefits all investors by deepening EDGX's liquidity pool, offering
additional flexibility for all investors to enjoy cost savings,
supporting the quality of price discovery, and improving investor
protection. In addition, a User \8\ whose order executed against a
Route Peg Order would be able to obtain an execution at the NBB or NBO
while minimizing the risk that incremental latency associated with
routing the order to an away destination may result in an inferior
execution.
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    \8\ As defined in Rule 1.5(ee).
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    The Exchange believes that offering a proposed rebate of $0.0015
per share for orders that yield Flag RP is reasonable because the
pricing is similar to analogous order types offered by other exchanges.
On NASDAQ, customers earn a rebate of $0.0015 per share executed for
MPIDs adding less than 1 million shares of Supplemental Orders and
customers earn a rebate of $0.0018 per share executed for MPIDs adding
greater than 1 million shares of Supplemental Orders.\9\ Similarly,
NYSE Arca offers the Tracking Order type where its customers earn
credits ranging from $0.001 to $0.0015 per share based on achieving
applicable tiers.\10\ Lastly, the Exchange believes that the proposed
amendment is non-discriminatory because it applies uniformly to all
Members.
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    \9\ See Securities Exchange Act Release No. 66540 (March 8,
2012), 77 FR 15167 (March 14, 2012) (SR-NASDAQ-2012-031). The Route
Peg Order is functionally similar to NASDAQ's Supplemental Order
type, as the Supplemental Order is a non-displayed order that posts
to the book, that is accessed only after other liquidity on the
NASDAQ book, and that executes only at the NBBO. See also NASDAQ's
Price List--Trading & Connectivity, at http://www.nasdaqtrader.com/Trader.aspx?id=PriceListTrading2.
    \10\ See Securities Exchange Act Release No. 60944 (November 5,
2009), 74 FR 58668 (November 13, 2009) (SR-NYSEArca-2009-99). The
Route Peg Order is functionally similar to NYSE Arca's Tracking
Order type, which is a non-displayed order that will only execute at
the NBBO and incoming orders are matched against all other orders on
the book before executing against NYSE Arca's Tracking Orders. See
also NYSE Arca Equities Order Types, at https://usequities.nyx.com/sites/usequities.nyx.com/files/nyse_arca_marketplace_fees__8_01_12.pdf.
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    The Exchange's proposal to amend the text of Footnotes 12 and 13 of
the fee schedule to list Flag RP as one of the ``added flags'' where
the volume associated with Flag RP will count toward the volume
thresholds in Footnotes 12 and 13 is reasonable and equitable as the
volume tiers in Footnotes 12 and 13 include ``added'' liquidity flags
and Flag RP is an added liquidity flag. The Exchange notes that the
liquidity ratio will now capture the RP ``add flag'' as one of several
add flags in the calculation of the ``add liquidity'' ratio.\11\ The
Exchange believes this amendment to Footnotes 12 and 13 supports the
Exchange's efforts to achieve consistent application and specificity
among the flags on the fee schedule and provide transparency for its
Members.
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    \11\ The ``add liquidity'' ratio is the ratio of the ``added''
flags/(``added'' flags + ``removal'' flags) x 100. If the resulting
ratio is equal to or greater than 10%, the MPID qualifies for the
lower removal rate of $0.0029 per share instead of $0.0030 per
share.
---------------------------------------------------------------------------

    The Exchange believes that the above proposal is nondiscriminatory
in that it applies uniformly to all Members.
    The Exchange also notes that it operates in a highly-competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive. The proposed rule change reflects a competitive pricing
structure designed to incent market participants to direct their order
flow to the Exchange. The Exchange believes that the proposed rates are
equitable and non-discriminatory in that they apply uniformly to all
Members. The Exchange believes the fees and credits remain competitive
with those charged by other venues and therefore continue to be
reasonable and equitably allocated to Members.

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

    The proposed rule change does not 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

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

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) of

the Act \12\ and Rule 19b-4(f)(2) \13\ thereunder. At any time within
60 days of the filing of such 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.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-EDGX-2012-41 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-EDGX-2012-41. 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 the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-2012-41 and should be
submitted on or before October 9, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-22913 Filed 9-17-12; 8:45 am]
BILLING CODE 8011-01-P


20593-7126.
164.019-3.......................  G-MSE.............  CG-521.
164.019-3.......................  2100 Second St.,    2100 2nd St., SW.,
                                   SW., Washington,    Stop 7126,
                                   DC 20593-0001.      Washington, DC
                                                       20593-7126.
164.023-3(a)....................  G-MSE-4...........  CG-5214.
164.023-3(a)....................  Washington, DC      2100 2nd St., SW.,
                                   20593-0001.         Stop 7126,
                                                       Washington, DC
                                                       20593-7126.
------------------------------------------------------------------------

PART 167--PUBLIC NAUTICAL SCHOOL SHIPS

0
184. The authority citation for Part 167 continues to read as follows:

    Authority: 46 U.S.C. 3306, 3307, 6101, 8105; E.O. 12234, 45 FR
58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security
Delegation No. 0170.1.

Sec.  167.15-30  [Amended]

0
185. In Sec.  167.15-30, remove the parenthetical phrase ``(G-MOC)''
from paragraph (e) and add, in its place, the parenthetical phrase
``(CG-543)''.

PART 169--SAILING SCHOOL VESSELS

0
186. The authority citation for Part 169 continues to read as follows:

    Authority: 33 U.S.C. 1321(j); 46 U.S.C. 3306, 6101; Pub. L. 103-
206, 107 Stat. 2439; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975
Comp., p. 793; Department of Homeland Security Delegation No.
0170.1; Sec.  169.117 also issued under the authority of 44 U.S.C.
3507.

PART 169--[AMENDED]

0
187. In the table below, for each section indicated in the left column,
remove the text indicated in the middle column from wherever it appears
in the section, and, in its place, add the text indicated in the right
column:

------------------------------------------------------------------------
             Section                    Remove                Add
------------------------------------------------------------------------
169.115(b)......................  Washington, DC      (CG-521), 2100 2nd
                                   20593.              St., SW., Stop
                                                       7126, Washington,
                                                       DC 20593-7126.
169.229(e)......................  G-MOC.............  CG-543.
------------------------------------------------------------------------

PART 170--STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS

0
188. The authority citation for Part 170 continues to read as follows:

    Authority:  43 U.S.C. 1333; 46 U.S.C. 2103, 3306, 3703; E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of
Homeland Security Delegation No. 0170.1.

PART 170--[AMENDED]

0
189. In the table below, for each section indicated in the left column,
remove the text indicated in the middle column from wherever it appears
in the section, and add, in its place, the text indicated in the right
column:

------------------------------------------------------------------------
             Section                    Remove                Add
------------------------------------------------------------------------
170.010.........................  JR10-0525, 2100     2100 2nd St., SW.,
                                   2nd Street, SW.,    Stop 7102,
                                   Washington, DC      Washington, DC
                                   20593.              20593-7102.
170.015(a)......................  Second Street,      2nd St., SW., Stop
                                   SW., Washington,    7126, Washington,
                                   D.C. 20593-0001.    DC 20593-7126.
170.100(b)......................  JR10-0525, 2100     2100 2nd St., SW.,
                                   2nd Street, SW.,    Stop 7102,
                                   Washington, DC      Washington, DC
                                   20593.              20593-7102.
------------------------------------------------------------------------

Sec.  170.160  [Amended]

0
190. In Sec.  170.160 (c)(1), remove the words ``Table 151.01-10(b)''
and add, in their place, the words ``Table 151.05''.

PART 172--SPECIAL RULES PERTAINING TO BULK CARGOES

0
191. The authority citation for Part 172 continues to read as follows:

    Authority:  46 U.S.C. 3306, 3703, 5115; E.O. 12234, 45 FR 58801,
3 CFR, 1980 Comp., p. 277; Department of Homeland Security
Delegation No. 0170.1.

Sec.  172.020  [Amended]

0
192. In Sec.  172.020, remove the phrase ``2100 Second Street, SW.,
Washington, DC 20593-0001'' from paragraph (a) and add, in its place,
the phrase ``(CG-521), 2100 2nd St., SW., Stop 7126, Washington, DC
20593-7126 ''.

Sec.  172.080  [Amended]

0
193. In Sec.  172.080, remove the words ``Table 151.01-10(b)'' and add,
in their place, the words ``Table 151.05''.

PART 174--SPECIAL RULES PERTAINING TO SPECIFIC VESSEL TYPES

0
194. The authority citation for Part 174 continues to read as follows:

    Authority: 42 U.S.C. 9118, 9119, 9153; 43 U.S.C. 1333; 46 U.S.C.
3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277;
Department of Homeland Security Delegation No. 0170.1.

Sec.  174.007  [Amended]

0
195. In Sec.  174.007, remove the phrase ``(G-MSE), 2100 Second Street,
SW., Washington, DC 20593-0001'' from paragraph (a) and add in its
place the phrase ``(CG-521), 2100 2nd St., SW., Stop 7126, Washington,
DC 20593-7126''.

PART 175--GENERAL PROVISIONS

0
196. The authority citation for Part 175 continues to read as follows:

    Authority:  46 U.S.C. 2103, 3205, 3306, 3307, 3703; Pub. L. 103-
206, 107 Stat. 2439; 49 U.S.C. App. 1804; Department of Homeland
Security Delegation No. 0170.1; 175.900 also issued under authority
of 44 U.S.C. 3507.

Sec.  175.540  [Amended]

0
197. In Sec.  175.540, remove the parenthetical phrase ``(G-MOC)'' from
paragraph (d) and add, in its place, the parenthetical phrase ``(CG-
543)''.

Sec.  175.600  [Amended]

0
198. In Sec.  175.600, remove the phrase ``Second Street, SW.,
Washington, DC 20593-0001'' from paragraph (a) and add, in its place,
the phrase ``2nd St., SW., Stop 7126, Washington, DC 20593-7126''.

PART 177--CONSTRUCTION AND ARRANGEMENT

0
199. The authority citation for Part 177 continues to read as follows:

    Authority: 46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3 CFR,
1980 Comp., p. 277; Department of Homeland Security Delegation No.
0170.1.

PART 177--[AMENDED]

0
200. In Part 177, remove the phrase ``JR10-0525, 2100 2nd Street, SW.,
Washington, DC 20593'' from wherever it appears and add in its place
the phrase ``2100 2nd St., SW., Stop 7102, Washington, DC 20593-7102''.

PART 188--GENERAL PROVISIONS

0
201. The authority citation for Part 188 continues to read as follows:

    Authority: 46 U.S.C. 2113, 3306; Pub. L 103-206, 107 Stat. 2439;
49 U.S.C. 5103, 5106; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p.
277; Department of Homeland Security Delegation No. 0170.1.

Sec.  188.10-33  [Amended]

0
202. In Sec.  188.10-33, remove the phrase ``Washington, DC 20593-
0001'' and add in its place the phrase ``2100 2nd St., SW., Stop 7000,
Washington, DC 20593-7000''.

Sec.  188.35-5  [Amended]

0
203. Amend Sec.  188.35-5(b) as follows:
0
a. Remove the parenthetical phrase ``(G-MOC)'' and add in its place the
parenthetical phrase ``(CG-543)''; and
0
b. Remove the phrase ``Washington, DC 20593-0001'' and add in its place
the phrase ``2100 2nd St. SW., Stop 7581, Washington, DC 20593-7581''.

PART 189--INSPECTION AND CERTIFICATION

0
204. The authority citation for Part 189 continues to read as follows:

    Authority: 33 U.S.C. 1321(j); 46 U.S.C. 2113, 3306, 3307; E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR
54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security
Delegation No. 0170.1.

PART 189--[AMENDED]

0
205. In the table below, for each section indicated in the left column,
remove the text indicated in the middle column from wherever it appears
in the section, and add, in its place, the text indicated in the right
column:

------------------------------------------------------------------------
             Section                    Remove                Add
------------------------------------------------------------------------
189.15-5(b).....................  Second St., SW.,    2nd St., SW., Stop
                                   Washington, DC      7126, Washington,
                                   20593-0001.         DC 20593-7126.
189.40-3........................  G-MOC.............  CG-543.
189.55-15(a)(2).................  JR10-0525, 2100     2100 2nd St., SW.,
                                   2nd Street, SW.,    Stop 7102,
                                   Washington, DC      Washington, DC
                                   20593.              20593-7102.
------------------------------------------------------------------------

PART 193--FIRE PROTECTION EQUIPMENT

0
206. The authority citation for Part 193 continues to read as follows:

    Authority: 46 U.S.C. 2213, 3102, 3306; E.O. 12234, 45 FR 58801,
3 CFR, 1980 Comp., p. 277; Department of Homeland Security
Delegation No. 0170.1.

0
207. Revise Sec.  193.01-3 to read as follows:

Sec.  193.01-3  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that
specified in this section, the Coast Guard must publish notice of
change in the Federal Register and the material must be available to
the public. All approved material is available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call<PHONE_NUMBER> or go to
http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html. Also, it is available for inspection
at the Coast Guard, Office of Design and Engineering Standards (CG-
521), 2100 2nd St., SW., Stop 7126, Washington, DC 20593-7126, 202-372-
1405, and is available from the sources listed below.
    (b) American Society for Testing and Materials (ASTM), 100 Barr
Harbor Drive, West Conshohocken, PA 19428-2959, telephone<PHONE_NUMBER>,
http://www.astm.org.
    (1) ASTM F 1121-87 (1993), Standard Specification for International
Shore Connections for Marine Fire Applications, incorporation by
reference approved for Sec.  193.10-10.
    (2) [Reserved]
    (c) National Fire Protection Association (NFPA), 1 Batterymarch
Park, Quincy, MA 02269-9101, telephone<PHONE_NUMBER>, http://
www.nfpa.org.
    (1) NFPA 13-1996, Standard for the Installation of Sprinkler
Systems, incorporation by reference approved for Sec.  193.30-1.
    (2) [Reserved]

PART 194--HANDLING, USE, AND CONTROL OF EXPLOSIVES AND OTHER
HAZARDOUS MATERIALS

0
208. The authority citation for Part 194 continues to read as follows:

    Authority: 46 U.S.C. 2103, 2113, 3306; 49 U.S.C. App. 1804; E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of
Homeland Security Delegation No. 0170.1.

Sec.  194.05-3  [Amended]

0
209. In Sec.  194.05-3, remove the parenthetical phrase ``(G-MSO)''
from paragraph (b) and add in its place the parenthetical phrase ``(CG-
522)''.

PART 195--VESSEL CONTROL AND MISCELLANEOUS SYSTEMS AND EQUIPMENT

0
210. The authority citation for Part 195 continues to read as follows:

    Authority: 46 U.S.C. 2113, 3306, 3307; 49 U.S.C. App. 1804; E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of
Homeland Security Delegation No. 0170.1.

Sec.  195.01-3  [Amended]

0
211. In Sec.  195.01-3, remove the phrase ``2100 Second Street, SW.,
Washington, DC 20593-0001'' from paragraph (a) and add in its place the
phrase ``(CG-521), 2100 2nd St., SW., Stop 7126, Washington, DC 20593-
7126''.

PART 197--GENERAL PROVISIONS

0
212. The authority citation for Part 197 continues to read as follows:

    Authority: 33 U.S.C. 1509; 43 U.S.C. 1333; 46 U.S.C. 3306, 3703,
6101; Department of Homeland Security Delegation No. 0170.1.

Sec.  197.510  [Amended]

0
213. In Sec.  197.510, remove the phrase ``(G-MSO), 2100 Second Street,
SW., Washington, DC 20593-0001'' from paragraph (a) and add in its
place the phrase ``(CG-522), 2100 2nd St., SW., Stop 7126, Washington,
DC 20593-7126''.

PART 199--LIFESAVING SYSTEMS FOR CERTAIN INSPECTED VESSELS

0
214. The authority citation for Part 199 continues to read as follows:

    Authority: 46 U.S.C. 3306, 3703; Pub. L. 103-206, 107 Stat.
2439; Department of Homeland Security Delegation No. 0170.1.

PART 199--[AMENDED]

0
215. In the table below, for each section indicated in the left column,
remove the text indicated in the middle column from wherever it appears
in the section, and add the text indicated in the right column:

------------------------------------------------------------------------
             Section                    Remove                Add
------------------------------------------------------------------------
199.05(a).......................  G-MSE-4...........  CG-5214.
199.05(a).......................  Second Street,      2nd St., SW., Stop
                                   SW., Washington,    7126, Washington,
                                   DC 20593-0001.      DC 20593-7126.
199.09..........................  G-MSE.............  CG-521.
199.20..........................  G-MOC.............  CG-543.
199.30 (Major character)........  G-MOC.............  CG-543.
199.40(c).......................  G-MSE.............  CG-521.
199.40(d).......................  G-MSC.............  Marine Safety
                                                       Center.
------------------------------------------------------------------------

PART 401--GREAT LAKES PILOTAGE REGULATIONS

0
216. The authority citation for Part 401 continues to read as follows:

    Authority: 46 U.S.C. 2104(a), 6101, 7701, 8105, 9303, 9304;
Department of Homeland Security Delegation No. 0170.1; 46 CFR
401.105 also issued under the authority of 44 U.S.C. 3507.

Sec.  401.110  [Amended]

0
217. Amend Sec.  401.110 as follows:
0
a. Remove the phrase ``Washington, DC 20593-0001'' from paragraph
(a)(2) and add in its place the phrase ``2100 2nd St., SW., Stop 7000,
Washington, DC 20593-7000''; and
0
b. Remove the phrase ``Second Street, SW., Washington, DC 20593-0001,''
from paragraph (a)(9) and add in its place the phrase ``2nd St., SW.,
Stop 7581, Washington, DC 20593-7581,''.

Title 49--Transportation

PART 450--GENERAL

0
218. The authority citation for Part 450 continues to read as follows:

    Authority: Sec. 4, 91 Stat. 1475 (46 U.S.C. 1503); Department of
Homeland Security Delegation No. 0170.1.

PART 450--[AMENDED]

0
219. Remove the parenthetical phrase ``(G-MSO)'' from wherever it
appears and add in its place the phrase ``(CG-522)''.

Sec.  450.11  [Amended]

0
220. In Sec.  450.11, remove the words ``Washington, DC 20593'' from
paragraph (a) and add, in their place, the words ``2100 2nd St., SW.,
Stop 7126, Washington, DC 20593-7126''.

PART 451--TESTING AND APPROVAL OF CONTAINERS

0
221. The authority citation for Part 451 continues to read as follows:

    Authority: Sec. 4, 91 Stat 1475 (46 U.S.C. 1503); Department of
Homeland Security Delegation No. 0170.1.

PART 451--[AMENDED]

0
222. In Part 451, remove the parenthetical phrase ``(G-MSO)'' from
wherever it appears and add, in its place, the phrase ``(CG-522)''.

Sec.  451.1  [Amended]

0
223. In Sec.  451.1, remove the phrase ``Washington, DC 20593'' from
paragraph (a) and add in its place the phrase ``2100 2nd St. SW., Stop
7126, Washington, DC 20593-7126''.

PART 452--EXAMINATION OF CONTAINERS

0
224. The authority citation for Part 452 continues to read as follows:

    Authority: Sec. 4, 91 Stat 1475 (46 U.S.C. 1503); Department of
Homeland Security Delegation No. 0170.1.

Sec.  452.7  [Amended]

0
225. Amend Sec.  452.7(a) as follows:
0
a. Remove the parenthetical phrase ``(G-MSO)'' and add in its place the
phrase ``(CG-522)''; and
0
b. Remove the words ``Second Street, SW., Washington, DC 20593'' and
add in their place the words ``2nd St. SW., Stop 7126, Washington, DC
20593-7126''.

PART 453--CONTROL AND ENFORCEMENT

0
226. The authority citation for Part 453 continues to read as follows:

    Authority: Sec. 4, 91 Stat 1475 (46 U.S.C. 1503); Department of
Homeland Security Delegation No. 0170.1.

PART 453--[AMENDED]

0
227. Remove the parenthetical phrase ``(G-MSO)'' from wherever it
appears and add, in its place, the phrase ``(CG-522)''.

    Dated: September 1, 2009.
Stefan G. Venckus,
Chief, Office of Regulations and Administrative Law, United States
Coast Guard.
[FR Doc. E9-21588 Filed 9-24-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Page 6684]
[FR Doc No: 2011-2542]

Vol. 76

Monday,

No. 25

February 7, 2011

Part III

Department of Health and Human Services

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

Food and Drug Administration

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

 Information Related to Risks and Benefits of Powdered Gloves; Request
for Comments; Draft Guidance for Industry and Food and Drug
Administration Staff; Recommended Warning for Surgeon's Gloves and
Patient Examination Gloves That Use Powder; Notices

Federal Register / Vol. 76 , No. 25 / Monday, February 7, 2011 /
Notices

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0027]

Information Related to Risks and Benefits of Powdered Gloves;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a public docket to receive comments related to
surgeon's gloves and patient examination gloves (medical gloves) that
contain or use donning or dusting powder. FDA is interested in the
potential health effects from the use of powder on medical gloves and
is soliciting comments regarding risks and benefits of powdered gloves.
FDA is interested in any potential benefits of powdered gloves so that
the Agency can consider how best to address the risks in light of any
benefits. Elsewhere in this issue of the Federal Register, FDA is
publishing a notice of availability for a draft guidance document
entitled ``Recommended Warning for Surgeon's Gloves and Patient
Examination Gloves That Use Powder.'' The draft guidance document
provides a recommended warning statement for powdered glove labeling
that will inform health care providers and consumers of the risks
associated with glove powder.

DATES: The Agency encourages interested parties to submit information
and comments by April 25, 2011.

ADDRESSES: Submit electronic comments or information to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Paul Gadiock, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4432, Silver Spring, MD 20993,<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA has received two citizen petitions (FDA-2008-P-0531-001 and
FDA-2009-P-0117-001) requesting that FDA ban powder on surgeon's gloves
and patient examination gloves under the authority granted to FDA by
section 516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360f). In their submissions to FDA, the petitioners highlight the
adverse health effects that can result from powdered glove use,
including allergic reactions, irritation, and foreign body reactions
resulting in inflammation, granulomas, and adhesions of peritoneal
tissue after surgery, as well as glove powder's ability to serve as a
carrier of endotoxin.
    FDA has considered this information and believes the petitions have
raised legitimate concerns about the use of powdered gloves. However,
FDA's regulatory approach to powdered gloves must consider the risks of
these gloves in light of any benefits. For example, if powdered gloves
offer unique benefits in performing certain procedures, FDA should
consider such benefits in determining how the risks of powdered gloves
should be addressed. To assist the FDA in developing its regulatory
approach, the Agency is seeking public input regarding the risks and
benefits of powdered gloves to determine whether such gloves present an
unreasonable and substantial risk of illness or injury. FDA is
interested in comments on both the risks and the benefits of powdered
gloves; however, because the risks associated with powdered glove use
have been extensively discussed in the citizen petitions, FDA is
particularly interested in whether there are any potential benefits
that powdered gloves may offer. Comments related to the benefits of
powdered glove use should also discuss whether those benefits are
available when using nonpowdered gloves. FDA plans to use this
information when considering how to address the risks in light of any
known benefits.
    Although FDA is still examining the potential risks and benefits of
powdered medical gloves, in the interim the Agency believes the risks
that have been identified support a recommended labeling statement
advising health care providers and consumers of the risks presented by
glove powder.
    Therefore, elsewhere in this issue of the Federal Register, FDA is
publishing a notice of availability for a draft guidance document
entitled ``Recommended Warning for Surgeon's Gloves and Patient
Examination Gloves That Use Powder.'' The draft guidance document
provides a recommended warning statement for powdered glove labeling
that will inform health care providers and consumers of the risks
associated with glove powder.
    The guidance document, when finalized, will help to address the
risks associated with powdered medical gloves while FDA determines if
additional measures, such as a ban, are necessary.

II. Submission of Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)

    1. Barbara, J., M. C. Santais, D. A. Levy, et al.,
``Immunoadjuvant Properties of Glove Cornstarch Powder in Latex-
Induced Hypersensitivity,'' Clinical & Experimental Allergy, vol.
33, pp. 106-112, 2003.
    2. Malinger, G., S. Ginath, L. Zeidel, et al., ``Starch
Peritonitis Outbreak After Introduction of a New Brand of Starch
Powdered Latex Gloves,'' Acta Obstetricia et Gynecologica
Scandinavica, vol. 79, pp. 610-611, 2000.
    3. Odum, B. C., J. S. O'Keefe, W. Lara, et al., ``Influence of
Absorbable Dusting Powders on Wound Infection,'' Journal of
Emergency Medicine, vol. 16(6), pp. 875-879, 1998.
    4. Stratmeyer, M., ``Medical Glove Powder Report,'' (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm113316.htm), September 1997.

    Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2542 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 94018-94020]
[FR Doc No: 2016-30577]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications delayed more than 180 days.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has

received the application described herein. Each mode of transportation
for which a particular special permit is requested is indicated by a
number in the ``Nature of Application'' portion of the table below as
follows: 1--Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo
aircraft only, 5--Passenger-carrying aircraft.

DATES: Comments must be received on or before January 23, 2017.

ADDRESS COMMENTS TO: Record Center, Pipeline and Hazardous Materials
Safety Administration U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with Part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(6); 49 CFR I.53(b)).

    Issued in Washington, DC, on December 8, 2016.
Donald Burger,
Chief, Office of the Special Permits and Approvals.

----------------------------------------------------------------------------------------------------------------
                                                                     Regulation(s)       Nature of the special
     Application No.         Docket No.          Applicant             affected             permits thereof
----------------------------------------------------------------------------------------------------------------
                                              Special Permits Data
----------------------------------------------------------------------------------------------------------------
11180-M..................  ..............  Arrival Inc.........  24..................  To modify the special
                                                                                permit to authorize
                                                                                metal tubes with a
                                                                                decreased diameter and
                                                                                an increased length to
                                                                                be authorized under the
                                                                                special permit.
11516-P..................  ..............  Essendant Inc.......  177.800, 172.500,     To authorize the
                                                                  173.304a, 172.200,    transportation in
                                                                  174.1, 172.400.       commerce of certain DOT
                                                                                Specification 2Q
                                                                                containers containing
                                                                                certain hazardous
                                                                                materials.
12412-R..................  ..............  Green Touch Systems   ....................  To consolidate the
                                            LLC.                                        exemptions that
                                                                                currently authorize the
                                                                                discharge of hazardous
                                                                                materials in UN
                                                                                Intermediate Bulk
                                                                                Containers (IBC) without
                                                                                removing the IBC from
                                                                                the motor vehicle on
                                                                                which it is transported.
13583-M..................  ..............  Structural            205, 3, 302A, 304A..  To authorize an increase
                                            Composites                                  in the maximum water
                                            Industries LLC.                             volume of the non-
                                                                                specification cylinders
                                                                                manufactured under the
                                                                                special permit.
14566-M..................  ..............  Nantong CIMC Tank     178.274(b),           To modify the special
                                            Equipment Co., Ltd.   178.274(b),           permit to authorize
                                                                  178.276(a)(2),        portable tanks with a
                                                                  178.276(b)(1).        design margin of 3.5:1
                                                                                instead of 4.0:1.
14691-R..................  ..............  Federal Express       ....................  To authorize the return
                                            Corporation.                                shipment by motor
                                                                                vehicle of hazardous
                                                                                materials that have been
                                                                                accepted, transported,
                                                                                and subsequently
                                                                                determined to be non-
                                                                                compliant with the
                                                                                Hazardous Materials
                                                                                Regulation's shipping
                                                                                paper, marking or
                                                                                labeling requirements.
14920-M..................  ..............  Nordco Rail Services  173.302a(b),          To modify the special
                                            LLC.                  172.203(a),           permit to authorize
                                                                  172.301(c), 180.205.  requalification of DOT
                                                                                specification 3A and 3AA
                                                                                cylinders with 24 inch
                                                                                outside diameters and to
                                                                                indicate that Ultrasonic
                                                                                Examination (UE) is not
                                                                                required on the sidewall-
                                                                                to-base transitions
                                                                                (SBT) region of a
                                                                                cylinder if the cylinder
                                                                                design does not permit.
16273-R..................  ..............  Lohman Helicopter,    ....................  To authorize the
                                            LLC.                                        transportation in
                                                                                commerce of certain
                                                                                hazardous materials by
                                                                                14 CFR part 133
                                                                                Rotorcraft External Load
                                                                                Operations transporting
                                                                                hazardous materials
                                                                                attached to or suspended
                                                                                from an aircraft, in
                                                                                remote areas of the U.S.
                                                                                only, without being
                                                                                subject to hazard
                                                                                communication
                                                                                requirements, quantity
                                                                                limitations and certain
                                                                                loading and stowage
                                                                                requirements.
16452-M..................  ..............  The Procter & Gamble  ....................  To modify the permit to
                                            Company.                                    clarify the requirement
                                                                                for strong outer
                                                                                packaging to meet the
                                                                                requirements normally
                                                                                applied to packages of
                                                                                ``limited quantities''
                                                                                moving by air.
16592-P..................  ..............  Maximum Rx Credit,    ....................  To authorize the
                                            Inc.                                        transportation in
                                                                                commerce of certain Drug
                                                                                Enforcement
                                                                                Administration (DEA)
                                                                                controlled substances
                                                                                transported for the
                                                                                purpose of disposal.
20220-N..................  ..............  Agility Fuel          173.220(a)..........  To authorize the
                                            Systems, Inc.                               transportation in
                                                                                commerce of compressed
                                                                                natural gas fuel systems
                                                                                that are not part of an
                                                                                internal combustion
                                                                                engine.

20222-N..................  ..............  Trinity Containers,   178.337-3(g)(3),      To authorize the
                                            LLC.                  172.203(a),           transportation in
                                                                  172.302(c).           commerce of certain DOT
                                                                                Specification MC-331
                                                                                cargo tank motor
                                                                                vehicles with a water
                                                                                capacity greater than
                                                                                3,000 gallons,
                                                                                manufactured to the DOT
                                                                                MC-331 specification,
                                                                                constructed of non-
                                                                                quenched and tempered
                                                                                (``NQT'') steel except
                                                                                that the cargo tanks
                                                                                have baffle supports
                                                                                welded directly to an
                                                                                angle on the inside of
                                                                                the cargo tank without
                                                                                the use of pads.
20226-N..................  ..............  Awesome Flight LLC..  173.27(b)(3)........  To authorize the
                                                                                transportation of
                                                                                lithium ion batteries in
                                                                                excess of the authorized
                                                                                quantity limitations via
                                                                                passenger and cargo
                                                                                aircraft.
20228-N..................  ..............  Worthington Cylinder  173.302(f)(3),        To authorize the
                                            Corporation.          173.302(f)(4),        manufacture, marking,
                                                                  173.302(f)(5),        sale and use of non-DOT
                                                                  173.302(a)(1),        specification fully
                                                                  173.304a(a)(1),       wrapped carbon fiber
                                                                  175.501(e)(3).        reinforced steel lined
                                                                                cylinders for the
                                                                                transportation in
                                                                                commerce.
20235-N..................  ..............  Union Pacific         174.83(c),            To authorize the
                                            Railroad Company      174.83(d),            transportation in
                                            Inc.                  174.83(e).            commerce of flat-cars
                                                                                carrying bulk packagings
                                                                                containing certain
                                                                                Division 4.3 materials
                                                                                without restricting its
                                                                                ability to couple with
                                                                                another railcar while
                                                                                moving under its own
                                                                                momentum.
20239-N..................  ..............  Paklook Air, Inc....  172.101(j)(1),        To authorize the
                                                                  172.301(c).           transportation in
                                                                                commerce of certain
                                                                                Class 1 explosive
                                                                                materials which are
                                                                                forbidden for
                                                                                transportation by air,
                                                                                to be transported by
                                                                                cargo aircraft within
                                                                                and around the State of
                                                                                Alaska when other means
                                                                                of transportation are
                                                                                impracticable or not
                                                                                available.
20251-N..................  ..............  Salco Products Inc..  172.203(a), 178.345-  To authorize the
                                                                  1, 180.413.           manufacture, mark, sale
                                                                                and use of manway
                                                                                assemblies constructed
                                                                                from stabilized
                                                                                polyethylene for
                                                                                installation on certain
                                                                                DOT specification cargo
                                                                                tank motor vehicles in
                                                                                transporting certain
                                                                                hazardous materials.
20260-N..................  ..............  Rogers Helicopters,   173.27(b)(2),         To authorize the
                                            Inc.                  172.101(j),           transportation in
                                                                  172.200(a),           commerce of certain
                                                                  172.200,              hazardous materials by
                                                                  172.204(c)(3),        14 CFR part 133
                                                                  172.400(b),           Rotorcraft External Load
                                                                  172.400a(a),          Operations transporting
                                                                  172.300(a),           hazardous materials
                                                                  172.300,              attached to or suspended
                                                                  172.301(c),           from an aircraft, in
                                                                  175.75(b),            remote areas of the US
                                                                  175.75(c),            only, without being
                                                                  178.1010(a)(1)        subject to hazard
                                                                  173.185(a).           communication
                                                                                requirements, quantity,
                                                                                limitations, and certain
                                                                                loading and stowage
                                                                                requirements.
20261-N..................  ..............  Saft S.A............  ....................  To authorize the
                                                                                transportation in
                                                                                commerce of prototype
                                                                                and low production
                                                                                lithium ion cells and
                                                                                batteries and lithium
                                                                                metal cells and
                                                                                batteries by cargo-only
                                                                                aircraft.
20262-N..................  ..............  Shuiazhuang Enric     173.302(a),           To authorize the
                                            Gas Equipment Co.,    173.304(a).           transportation of
                                            Ltd..                                       certain hazardous
                                                                                materials in non-DOT
                                                                                specification fiber
                                                                                reinforced composite
                                                                                cylinders.
20266-N..................  ..............  Zhejiang Tiantai      173.304(a),           To authorize the
                                            Zhantu Automobile     173.304(d).           manufacture, mark, sale
                                            Supplies Co., Ltd.                          and use of a non-
                                                                                refillable, non-DOT
                                                                                specification inside
                                                                                metal container
                                                                                conforming to all
                                                                                regulations applicable
                                                                                to a DOT specification
                                                                                2Q, except as specified
                                                                                herein, for the
                                                                                transportation in
                                                                                commerce of the
                                                                                materials authorized by
                                                                                this special aircraft.
20271-N..................  ..............  Ball Aerospace &      173.24(b)(1)........  To authorize the
                                            Technologies                                transportation in
                                            Corporation.                                commerce of DOT
                                                                                specification cylinders
                                                                                that have an
                                                                                identifiable release of
                                                                                hazardous materials
                                                                                during transportation.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-30577 Filed 12-21-16; 8:45 am]
 BILLING CODE 4909-60-M