[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16304-16307]
[FR Doc No: 2012-6620]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66596; File No. SR-ISE-2012-18]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Increase Certain Rebates for Certain Complex Orders

March 14, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is
hereby given that on March 1, 2012, the International Securities
Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with the
Securities and Exchange Commission (the ``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to increase certain rebate amounts for certain
complex orders. The text of the proposed rule change is available on
the Exchange's Web site (http://www.ise.com), at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange currently assesses per contract transaction charges
and credits to market participants that add or remove liquidity from
the Exchange (``maker/taker fees'') in a number of options classes (the
``Select Symbols'').\3\ The Exchange's maker/taker fees are applicable
to regular and complex orders executed in the Select Symbols. The
maker/taker fees for complex orders in the Select Symbols also apply to
all symbols that are in the Penny Pilot program.\4\ The Exchange also
currently assesses maker/taker fees for complex orders in symbols that
are in the Penny Pilot program but are not a Select Symbol (``Non-
Select Penny Pilot Symbols'') \5\ and for complex orders in all symbols
that are not in the Penny Pilot Program (``Non-Penny Pilot
Symbols'').\6\ Maker/taker fees (and rebates) for complex orders are
assessed on the following order-type categories: ISE Market Maker,\7\
Market Maker Plus,\8\ Firm Proprietary, Customer (Professional),\9\
Non-ISE Market Maker,\10\ and Priority Customer.\11\ The Exchange is
proposing to increase certain rebates for certain complex orders, as
follows.
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    \3\ Options classes subject to maker/taker fees are identified
by their ticker symbol on the Exchange's Schedule of Fees.
    \4\ See Exchange Act Release Nos. 65021 (August 3, 2011), 76 FR
48933 (August 9, 2011) (SR-ISE-2011-45); and 65550 (October 13,
2011), 76 FR 64984 (October 19, 2011) (SR-ISE-2011-65).
    \5\ See Exchange Act Release No. 65724 (November 10, 2011), 76
FR 71413 (November 17, 2011) (SR-ISE-2011-72).
    \6\ See Exchange Act Release Nos. 66084 (January 3, 2012), 77 FR
1103 (January 9, 2012) (SR-ISE-2011-84); and 66392 (February 14,
2012), 77 FR 10016 (February 21, 2012) (SR-ISE-2012-06).
    \7\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \8\ A Market Maker Plus is an ISE Market Maker who is on the
National Best Bid or National Best Offer 80% of the time for series
trading between $0.03 and $5.00 (for options whose underlying
stock's previous trading day's last sale price was less than or
equal to $100) and between $0.10 and $5.00 (for options whose
underlying stock's previous trading day's last sale price was
greater than $100) in premium in each of the front two expiration
months and 80% of the time for series trading between $0.03 and
$5.00 (for options whose underlying stock's previous trading day's
last sale price was less than or equal to $100) and between $0.10
and $5.00 (for options whose underlying stock's previous trading
day's last sale price was greater than $100) in premium across all
expiration months in order to receive the rebate. The Exchange
determines whether a Market Maker qualifies as a Market Maker Plus
at the end of each month by looking back at each Market Maker's
quoting statistics during that month. If at the end of the month, a
Market Maker meets the Exchange's stated criteria, the Exchange
rebates $0.10 per contract for transactions executed by that Market
Maker during that month. The Exchange provides Market Makers a
report on a daily basis with quoting statistics so that Market
Makers can determine whether or not they are meeting the Exchange's
stated criteria.
    \9\ A Customer (Professional) is a person who is not a broker/
dealer and is not a Priority Customer.
    \10\ A Non-ISE Market Maker, or Far Away Market Maker
(``FARMM''), is a market maker as defined in Section 3(a)(38) of the
Securities Exchange Act of 1934, as amended (``Exchange Act''),
registered in the same options class on another options exchange.
    \11\ A Priority Customer is defined in ISE Rule 100(a)(37A) as a
person or entity that is not a broker/dealer in securities, and does
not place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s).
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    In the Select Symbols, the Exchange currently provides a rebate of
$0.30 per contract, per leg, for Priority Customer complex orders when
these orders trade with non-Priority Customer complex orders in the
complex orderbook. In order to enhance the Exchange's competitive
position and to incentivize Members to increase the amount of Priority
Customer complex orders that they send to the Exchange, the Exchange is
proposing to increase the base amount of that rebate to $0.32 per
contract. Additionally, the Exchange is proposing to increase the
amount of that rebate even further, on a month-by-month and Member-by-
Member basis, if such Member achieves a certain average daily volume
(ADV) of Priority Customer complex order contracts executed during the
calendar month, as follows: if the Member achieves an ADV of 75,000
Priority Customer complex order contracts, the rebate amount shall be
$0.33 per contract per leg; if the Member achieves an ADV of 125,000
Priority Customer complex order contracts, the rebate amount shall be
$0.34 per contract per leg. The highest rebate amount achieved by the
Member for the current calendar month shall apply retroactively to all
Priority Customer complex order contracts that trade with non-Priority
Customer complex orders in the complex orderbook executed by the Member
during such calendar month.
    In the Non-Select Penny Pilot Symbols, the Exchange currently
provides a rebate of $0.25 per contract, per leg, for Priority Customer
complex orders when these orders trade with non-Priority Customer
complex orders in the complex orderbook. In order to enhance the
Exchange's competitive position and to incentivize Members to increase
the amount of Priority Customer complex orders that they send to the
Exchange, the Exchange is proposing to increase the base amount of that
rebate to $0.26 per contract. Additionally, the Exchange is proposing
increase [sic] the amount of that rebate even further, on a month-by-
month and Member-by-Member basis, if such Member achieves a certain
average daily volume (ADV) of Priority Customer complex order contracts
executed during the calendar month, as follows: if the Member achieves
an ADV of 75,000 Priority Customer complex order contracts, the rebate
amount shall be $0.28 per contract per leg; if the Member achieves an
ADV of 125,000 Priority Customer complex order contracts, the rebate
amount shall be $0.30 per contract per leg. The highest rebate amount
achieved by the Member for the current calendar month shall apply
retroactively to all Priority Customer complex order contracts that
trade with non-Priority Customer complex orders in the complex
orderbook executed by the Member during such calendar month.
    In the Non-Penny Pilot Symbols, the Exchange currently provides a
rebate of $0.50 per contract, per leg, for Priority Customer complex
orders when these orders trade with non-Priority Customer complex
orders in the complex orderbook. In order to enhance the Exchange's
competitive position and to incentivize Members to increase the amount
of Priority Customer complex orders that they send to the Exchange, the
Exchange is proposing to increase the base amount of that rebate to
$0.52 per contract. Additionally, the Exchange is proposing increase
[sic] the amount of that rebate even further, on a month-by-month and
Member-by-Member basis, if such Member achieves a certain average daily
volume (ADV) of Priority Customer complex order contracts executed
during the calendar month, as follows: if the Member achieves an ADV of
75,000 Priority Customer complex order contracts, the rebate amount
shall be $0.54 per contract per leg; if the Member achieves an ADV of
125,000 Priority Customer complex order contracts, the rebate amount
shall be

$0.56 per contract per leg. The highest rebate amount achieved by the
Member for the current calendar month shall apply retroactively to all
Priority Customer complex order contracts that trade with non-Priority
Customer complex orders in the complex orderbook executed by the Member
during such calendar month.
    Finally, the Exchange does not currently provide a rebate for
Priority Customer complex orders when these orders trade against quotes
or orders in the regular orderbook. In order to enhance the Exchange's
competitive position and to incentivize Members to increase the amount
of Priority Customer complex orders that they send to the Exchange, the
Exchange is proposing to provide a rebate of $0.06 per contract, per
leg, for Priority Customer complex orders, regardless of size, when
these orders trade against quotes or orders in the regular orderbook.
This rebate shall apply in the Select Symbols, Non-Select Penny Pilot
Symbols, and Non-Penny Pilot Symbols. For the avoidance of doubt, this
rebate is not included in the ADV incentive program described above for
Priority Customer complex orders executed in the complex orderbook.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Exchange Act \12\ in
general, and furthers the objectives of Section 6(b)(4) of the Exchange
Act \13\ in particular, in that it is an equitable allocation of
reasonable dues, fees and other charges among Exchange members and
other persons using its facilities. The impact of the proposal upon the
net fees paid by a particular market participant will depend on a
number of variables, most important of which will be its propensity to
interact with and respond to certain types of orders.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that it is reasonable and equitable to
provide rebates for Priority Customer complex orders when these orders
trade with Non-Priority Customer complex orders in the complex order
book because paying a rebate would continue to attract additional order
flow to the Exchange and create liquidity in the symbols that are
subject to the rebate, which the Exchange believes ultimately will
benefit all market participants who trade on ISE. The Exchange already
provides these types of rebates, and is now merely proposing to
increase those rebate amounts. The Exchange believes that the proposed
rebates are competitive with rebates provided by other exchanges and
are therefore reasonable and equitably allocated to those members that
direct orders to the Exchange rather than to a competing exchange.
    The Exchange is also establishing a volume-based incentive program,
designed to encourage Members to send their Priority Customer complex
orders to the Exchange. The concept of a volume-based incentive program
is not novel. The Exchange notes that it currently has other incentive
programs to promote and encourage growth in specific business areas.
For example, the Exchange has lower fees (or no fees) for customer
orders; \14\ and tiered pricing that reduces rates for ISE Market
Makers based on the level of business they bring to the Exchange.\15\
This proposed rule change targets a particular segment in which the
Exchange seeks to attract greater order flow. The Exchange also has a
volume-based rebate program in place for Qualified Contingent Cross
(``QCC'') and Solicitation orders, which gives Members who trade a
minimum of 200,000 qualifying contracts in QCC and Solicitation orders
on the Exchange a benefit by way of a rebate. This program is similar
to the proposed program in that once a Member reaches an established
volume threshold, all of the trading activity in the specified order
type by that Member will be subject to the corresponding rebate.
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    \14\ For example, the customer fee is $0.00 per contract for
products other than Singly Listed Indexes, Singly Listed ETFs and FX
Options. For Singly Listed Options, Singly Listed ETFs and FX
Options, the customer fee is $0.18 per contract. The Exchange also
currently has an incentive plan in place for certain specific FX
Options which has its own pricing. See ISE Schedule of Fees.
    \15\ The Exchange currently has a sliding scale fee structure
that ranges from $0.01 per contract to $0.18 per contract depending
on the level of volume a Member trades on the Exchange in a month.
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    The Exchange also believes that it is reasonable and equitable to
provide rebates for Priority Customer complex orders when these orders
trade against quotes or orders in the regular orderbook because paying
a rebate, in those instances, would also attract additional order flow
to the Exchange. The Exchange notes that the rebate amount is the same
for all symbols, including Select Symbols, Non-Select Penny Pilot
Symbols, and Non-Penny Pilot Symbols.
    The complex order pricing employed by the Exchange has proven to be
an effective pricing mechanism and attractive to Exchange participants
and their customers. The Exchange believes that increasing its complex
order rebates will attract additional complex order business.
    The Exchange further believes that the Exchange's complex order
rebates are not unfairly discriminatory because the fee structure is
consistent with fee structures that exist today at other options
exchanges. Additionally, the Exchange believes that the proposed
rebates are fair, equitable and not unfairly discriminatory because the
proposed rebates are consistent with price differentiation that exists
today at other option exchanges. The Exchange operates in a highly
competitive market in which market participants can readily direct
order flow to another exchange if they deem fee levels at a particular
exchange to be excessive. With this proposed rebate change, the
Exchange believes it remains an attractive venue for market
participants to trade complex orders.

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 Exchange 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)(A)(ii) of the Exchange Act.\16\ 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 Exchange Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
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    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing,

including whether the proposed rule change is consistent with the
Exchange 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-ISE-2012-18 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-ISE-2012-18. 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-ISE-2012-18 and should be
submitted on or before April 10, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-6620 Filed 3-19-12; 8:45 am]
BILLING CODE 8011-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on April 2, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST 2000-6816

________________________________________________________________________
________________________________________________________

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

Applicant:  AEROVIAS de MEXICO, S.A. de C.V.
                        Date Filed:  March 10, 2004

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct scheduled, combination service between
Mexico City, Mexico, and Chicago, Illinois.

If renewal, date and citation of last action:  April 14, 2003, in this
Docket.

Applicant representative:  William C. Evans,<PHONE_NUMBER>       DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.
                                           Action date:  April 2, 2004

Effective dates of authority granted:  April 2, 2004, through April 14,
2005.

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement.

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

Special conditions/Remarks:

Action taken by:   Paul L. Gretch, Director, Office of International
Aviation

________________________________________________________________________
______________________________________________________

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

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

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

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Notices]
[Page 56571-56573]
[DOCID:fr27se06-146]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54477; File No. SR-NASDAQ-2006-034]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Practice of Using a Fifth Character Identifier With the
Symbol of Foreign Securities

September 20, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 28, 2006, The NASDAQ Stock Market LLC (``Nasdaq'') 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 Nasdaq. Nasdaq filed the proposal pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(1) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(1).

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

    Nasdaq is filing with the Commission a proposed rule change to
clarify the non-applicability of the record-keeping fee in Nasdaq Rule
4510(e) and Nasdaq Rule 4520(d) when a non-U.S. issuer requests to
eliminate the fifth character identifier affixed to the symbol of its
securities.\5\
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    \5\ This proposal does not require changes to Nasdaq's rule
text. Telephone conversation between Jonathan F. Cayne, Associate
General Counsel, The Nasdaq Stock Market, Inc., and Nataliya Cowen,
Special Counsel, Division of Market Regulation, Commission, on
September 19, 2006.
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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, Nasdaq 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. Nasdaq 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
    Prior to 1999, Nasdaq required an ``F'' or ``Y'' be affixed to the
symbol of all non-U.S. securities and American Depositary Receipts that
traded on the Nasdaq Stock Market. In 1999, Nasdaq ceased this practice
for new listings and allowed existing non-U.S. listed companies to
remove the fifth character identifier upon request.\6\ For those non-
U.S. issuers that have not so requested, Nasdaq continues to include
the fifth character identifier on the symbol of their securities.
Nasdaq is making this filing to clarify that the record-keeping fee in
Rule 4510(e) and Rule 4520(d) is not applicable to a non-U.S. issuer
that requests that Nasdaq eliminate the fifth character identifier.
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    \6\ See Securities Exchange Act Release No. 41076 (Feb. 19,
1999); 64 FR 9552 (Feb. 26, 1999).
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    The $2,500 record-keeping fee set forth in Nasdaq Rule 4510(e) and
Nasdaq Rule 4520(d) is used to address the costs associated with
revising Nasdaq's records when issuers engage in certain actions,
including a voluntary change in trading symbol. However, Nasdaq notes
that these non-U.S. issuers did not choose to have the fifth character
identifier, as before 1999 it was mandatory. Further, these issuers are
not requesting any change to their ``root'' four letter symbol.
Accordingly, Nasdaq believes that these changes should not be treated
as a voluntary symbol change and, therefore, it is inappropriate to
charge the $2,500 record-keeping fee when a non-U.S. issuer drops the
fifth character identifier.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
Section 6(b) of the Act \7\ in general and furthers the objectives of
Section 6(b)(5) \8\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to remove impediments to, and perfect
the mechanism of, a free and open market and a national market system,
and in general, to protect investors and the public interest.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in 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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(i) of the Act \9\ and subparagraph (f)(1) of Rule 19b-4
thereunder \10\ in that it constitutes a stated policy, practice or
interpretation with respect to the meaning, administration, or
enforcement of an existing rule. As such, this proposed rule change is
effective upon filing.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(i).
    \10\ 17 CFR 240.19b-4(f)(1).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASDAQ-2006-034 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2006-034. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal offices of Nasdaq. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2006-034 and should be submitted on or before
October 18, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-15799 Filed 9-26-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 244 (Friday, December 19, 2014)]
[Notices]
[Pages 75821-75822]
[FR Doc No: 2014-29725]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1092]

Minimizing Risk for Children's Toy Laser Products; Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Minimizing Risk for Children's
Toy Laser Products.'' This guidance is intended to inform manufacturers
of laser products, FDA headquarters and field personnel, and the public
of the Center for Devices and Radiological Health's (CDRH) current
thinking on the safety of children's toy laser products and to provide
specific safety recommendations for the manufacture and labeling of
children's toy laser products.

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

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Minimizing Risk for Children's Toy Laser Products'' to the Office of
the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
    Submit electronic comments on the guidance 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: Daniel Hewett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4250, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance is intended to inform manufacturers of laser
products, FDA headquarters and field personnel, and the public of
CDRH's current thinking on the safety of children's toy laser products.
Lasers with outputs above certain levels that are operated in an unsafe
and uncontrolled manner may cause injury to the user and/or others
within range of the laser beam. This is a particular concern for lasers
intended for entertainment purposes, especially when intended to be
used as toys by children.
    Federal law requires that, other than for certain exceptions, laser
products manufactured or assembled after August 1, 1976, must be in
compliance with the federal performance standards for laser products
(21 CFR 1040.10 and 1040.11). At present FDA regulations do not
specifically identify what constitutes children's toy laser products.
In the Federal Register of June 24, 2013, FDA issued a proposed rule
that proposed to define children's toy laser products and require them
to be within the International Electrotechnical Commission (IEC) Class
1 emission limit (see proposed 21 CFR 1040.10(b)(1), (2) and 1040.11(d)
at 78 FR 37723 (June 24, 2013)). While this rulemaking process is
ongoing, CDRH recommends that manufacturers keep children's toy laser
products within the FDA Class I or IEC Class 1 emission limits in order
to minimize the risk they pose to users and/or others in range of the
laser beam, including the vulnerable population for whom they are
intended. For those children's toy laser products that meet the
definition of a ``demonstration laser product'' or ``surveying,
leveling, or alignment laser product,'' CDRH will not object to
compliance with the International Electrotechnical Commission Class I
emission limit (set forth in IEC 60825-1:2007). To that end, this
guidance supersedes in part the policy set forth in the Guidance on
Laser Products--Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser
Notice No. 50), which will cease to be effective by its own terms upon
the effective date of amendments to the regulations applicable to laser
products. (Ref. #1). However, because IEC Classes 1M and 2M do not have
comparable analogs in FDA's classification system, manufacturers should
not conform to the parameters for IEC Classes 1M or 2M unless they also
comply with FDA's performance standards for laser products.
    In the Federal Register of August 7, 2013 (78 FR 48172), the Agency
issued the draft guidance entitled ``Minimizing Risk for Children's Toy
Laser Products--Draft Guidance for Industry and Food and Drug
Administration Staff.'' The Agency received two comments on the 2013
draft guidance and has incorporated most of the recommendations in this
final guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on children's toy laser products. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of
``Minimizing Risk for Children's Toy Laser Products'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 1810 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to a previously approved collection of
information found in FDA regulations. This collection of information is
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in part 1040 is approved under OMB control
number 0910-0025.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and

will be posted to the docket at http://www.regulations.gov.

VI. References

    The following reference has 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, and is
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address in this reference section, but we are not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)

1. FDA Guidance on Laser Products--Conformance with IEC 60825-1 and IEC
60601-2-22 (Laser Notice No. 50) (June 2007), available at http://www.fda.gov/downloads/MedicalDevices/.../ucm094366.pdf.

    Dated: December 15, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29725 Filed 12-18-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 4, 2006 (Volume 71, Number 64)]
[Notices]
[Page 16841-16845]
[DOCID:fr04ap06-76]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53561; File No. SR-Amex-2005-103]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of Proposed Rule Change and Amendment Nos. 1, 2, 3 and
4 Thereto Allowing Issuers of Listed Equity Securities, Structured
Products, and Exchange Traded Funds a Right To Request a New Specialist

March 29, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 13, 2005, the American Stock Exchange LLC (``Amex'' or
``Exchange'') 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 Amex. On January 26,
2006, Amex filed Amendment No. 1 to the proposed rule change.\3\ On
January 30, 2006, Amex filed Amendment No. 2 to the proposed rule
change.\4\ On February 17, 2006, Amex filed Amendment No. 3 to the
proposed rule change.\5\ On March 6, 2006, Amex filed Amendment No. 4
to

the proposed rule change.\6\ The Commission is publishing this notice
to solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, the Exchange proposed further changes to
Amex Rule 27(e) and (f) and made revisions to the purpose section of
the proposed rule change.
    \4\ In Amendment No. 2, the Exchange made revisions to the
purpose section of the proposed rule change to discuss changes to
the text of Amex Rule 27(f) made in Amendment No. 1.
    \5\ In Amendment No. 3, the Exchange proposed further changes to
Amex Rule 27(e) and (f) and made revisions to the purpose section of
the proposed rule change.
    \6\ In Amendment No. 4, the Exchange proposed minor technical
changes to the text of Amex Rule 27(e) and (f).
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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 Amex Rule 27 to give issuers of
listed equity securities and structured products, as well as exchange
traded fund (``ETF'') sponsors, a right to request a new specialist.
    The text of the proposed rule change is available on the Amex's Web
site (http://www.amex.com), the Office of the Secretary, Amex, and at

the Commission's Public Reference Room. The text of the proposed rule
change also appears below. Proposed new language is italicized;
proposed deletions are in [brackets].
Rule 27. Allocations Committee
    (a)-(d) No change.
    (e) (i) If the issuer of an [listed] equity security to be
initially listed on the Exchange chooses to participate in the
allocation process, the Allocations Committee shall prepare a list of
qualified specialists based on the criteria set forth in paragraph (b).
In the case of an equity security, Exchange Traded Fund or Structured
Product, the list shall consist of five specialists. [In the case of an
Exchange Traded Fund or Structured Product, the list shall consist of
five specialists.] The issuer may request that one or more specialists
be placed on the list of eligible specialists. The Allocations
Committee, however, is not obligated to honor such requests.
Specialists that are subject to a preclusion on new allocations as a
result of a disciplinary proceeding or action by the Performance
Committee only are eligible for allocations of ``related securities''
as described in Commentary .05 of this Rule. The issuer may ask to meet
with representatives of the specialists units on the list.
    The issuer shall select its specialist from the list within five
business days of receiving the list by providing the Exchange with a
letter signed by person of Secretary rank or higher indicating the
issuer's choice of specialist. In the case of an Exchange Traded Fund
or Structured Product, the selection may be made by a senior officer of
the sponsor or issuer who has been authorized to make such selection.
If the issuer does not make its selection in a timely manner, the
Allocation Committee may select the specialist as provided in paragraph
(b) of this Rule. This procedure only applies to issuers of equity
securities, and sponsors of Exchange Traded Funds and Structured
Products that initially list on the Exchange.
    [The security shall remain with its initial specialist for at least
120 days. After that time, but during the first 12 months after
listing, the issuer or sponsor may request that the security be
reallocated should it become dissatisfied with its specialist. This is
the case whether or not the issuer or sponsor has participated in the
selection process. The issuer or sponsor is expected to furnish an
explanation for the basis for its dissatisfaction, and if after
counseling the issuer or sponsor and the specialist such change is
still desired, the Exchange shall reallocate the security within 30
days. In any such reallocation, the Exchange shall follow the
allocation procedures described in this paragraph (e) unless the issuer
or sponsor requests the Allocations Committee to select the specialist
without any issuer or sponsor input under the procedures described in
paragraph (b) of this Rule.]
    (ii) (a) The issuer of any listed equity security or Structured
Product or the Exchange Traded Fund sponsor, may, at any time after 120
days from the start of trading on the Exchange, file a written notice
(``Notice'') with the officer in charge of Equities Administration or
the officer in charge of the Exchange Traded Fund Marketplace, as
applicable, signed by the issuer's or sponsor's chief executive
officer, requesting a change of specialist unit for ``good cause,'' as
defined below. The issuer or sponsor is afforded one opportunity to do
so. The Notice shall indicate the specific issues prompting this
request, and what steps, if any, have been taken to try to address them
before the filing of the Notice. The officer in charge of Equities
Administration or the officer in charge of the Exchange Traded Fund
Marketplace, as applicable, shall provide copies of the Notice to the
Chief Regulatory Officer (``CRO'') and the Committee on Floor Member
Performance.
    (b) ``Good cause,'' for the purposes of (e)(ii)(a), shall consist
of the failure of the specialist to make competitive markets; the
failure of the specialist unit to risk capital commensurate with the
type of security; the failure of the specialist unit to assign
competent personnel to the stock; or any statements made publicly by
the specialist unit that substantially denigrate the security. The
Committee on Floor Member Performance shall make any determination that
``good cause'' does not exist, as defined herein. Such a determination
shall be made prior to the commencement of an Issuer or Sponsor Change
of Specialist Mediation (``Mediation''). In this circumstance the
issuer or sponsor may appeal the decision of the Committee on Floor
Member Performance to the Amex Adjudicatory Council. If the decision of
the Committee on Floor Member Performance is upheld, there shall be no
Mediation, and the security shall not be reallocated.
    (iii) The officer in charge of Equities Administration or the
officer in charge of the Exchange Traded Fund Marketplace, as
applicable, shall notify the subject specialist unit that Mediation is
being commenced pursuant to this provision, and shall provide the
specialist with a copy of the Notice. Within two weeks, the specialist
unit may submit a written response to either the officer in charge of
Equities Administration or the officer in charge of the Exchange Traded
Fund Marketplace, as applicable. The officer in charge of Equities
Administration or the officer in charge of the Exchange Traded Fund
Marketplace, as applicable, shall provide copies of any such written
response to the CRO, and the Committee on Floor Member Performance. The
date the specialist submits a response shall be referred to herein as
the ``Specialist Response Date.'' If the specialist does not submit a
response, there shall be no Mediation, and the Allocation Committee
shall be convened to reallocate securities pursuant to paragraph (b) of
this Rule.
    (iv) The CRO shall review the Notice and any specialist response,
and may request a review of the matter by the Regulatory Oversight
Committee (``ROC'') of the Exchange's Board of Directors. In addition,
the Committee on Floor Member Performance shall review the Notice and
any specialist response. The Mediation process described hereunder may
continue during the CRO's reviews, however, where a review by the ROC
has been requested, no change of specialist unit may occur until the
ROC makes a final determination that it is appropriate to permit such
change. In making such determination, the ROC may consider all relevant
regulatory issues, including without limitation whether the requested
change appears to be in aid or furtherance of conduct that is illegal
or violates Exchange rules, or is in retaliation for a refusal by a
specialist to engage in conduct that is illegal or violates Exchange
rules. The ROC may request a statement from the issuer or

sponsor confirming that the request does not stem in whole or in part
from the specialists' refusal or failure to engage in any wrongful
action. Notwithstanding the CRO, ROC and/or Committee on Floor Member
Performance reviews of any matter raised during the process described
herein, the Amex Division of Regulation and Compliance (including
Listing Qualifications) and/or the NASD Amex Division may at any time
take any regulatory action that it may determine to be warranted.
    (v) The Exchange shall facilitate a mediation of the issues that
have arisen between the issuer or sponsor and the specialist unit. The
Exchange shall appoint a committee consisting of at least one floor
broker, one senior floor official, one upstairs governor, and two
independent governors for each Mediation (``the Mediation Committee'').
    (vi) As soon as practicable after the Specialist Response Date, the
Mediation Committee shall commence to meet with representatives of the
issuer or sponsor and the specialist unit in an attempt to mediate the
matters indicated in the Notice.
    (vii) Any time after the filing of the Notice, the issuer or
sponsor may file with the officer in charge of Equities Administration
or the officer in charge of the Exchange Traded Fund Marketplace, as
applicable, a written notice, signed by the issuer's or sponsor's chief
executive officer, that it is concluding the Mediation because it
wishes to continue with the same specialist unit.
    (viii) After the expiration of one month from the Specialist
Response Date, subject to the conclusion of any review by the CRO and
ROC, the issuer and sponsor may file with the officer in charge of
Equities Administration or the officer in charge of the Exchange Traded
Fund Marketplace a written notice, signed by the issuer's or sponsor's
chief executive officer, that it wishes to proceed with the change of
specialist unit. Subject to paragraph (c) above, as soon as practicable
thereafter, the security shall be put up for allocation following the
procedures described in paragraph (b) of this Rule.
    (f) The Allocations Committee shall be convened to reallocate
securities when (1) the Committee on Floor Member Performance directs
reallocation, (2) a specialist requests to be relieved of a particular
security for good cause, (3) an issuer or sponsor files a written
notice requesting a change of specialist unit and the Mediation
Committee orders reallocation pursuant to paragraph (e)(viii) of this
Rule, or an issuer or sponsor files a written notice requesting a
change of specialist unit and the specialist unit does not submit a
response, or [(3)] (4) a specialist's registration in a security is
canceled due to disciplinary action. Whenever the Allocations Committee
reallocates a security for the reasons stated in (1) through [(3)] (4)
of this paragraph, the Allocations Committee shall follow the
procedures described in paragraph (b) of this Rule. The Allocations
Committee also shall be convened to reallocate securities when [(4)]
(5) a specialist dissolves or recombines, [(5)] (6) a specialist has
been determined to be in such financial or operating condition that it
cannot be permitted to continue to specialize in one or more of its
specialty securities with safety to investors, its creditors or other
members, or [(6)] (7) a specialist has become subject to the pre-
borrowing requirement of Rule 203(b)(3) of Regulation SHO under the
Securities Exchange Act of 1934 with respect to one of its specialty
securities or, in the case of an options specialist, with respect to
the underlying security. The Allocations Committee shall follow the
procedures described in paragraphs (g) or (h) of this Rule, as
appropriate, whenever it reallocates securities for the reasons stated
in [(4)] (5) through [(6)] (7) of this paragraph.
    (g)-(i) No change.
* * * Commentary
    No change.

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

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

1. Purpose
    The Amex proposes to set forth procedures in Amex Rule 27, whereby
issuers of equity securities, structured products and ETF sponsors may
request a new specialist.

Current Amex Rule 27

    Amex Rule 27(e) currently gives the issuer of an equity security or
a structured product and the sponsor of an ETF a one-time right to
request a reallocation to a different specialist unit within one (1)
year from the original listing. The Exchange believes that the one-year
restriction on this right does not provide an adequate amount of time
for issuers to reach an informed opinion regarding a specialist.
Moreover, the one-year limit does not address dissatisfaction linked to
fundamental changes in a specialist unit due to transfers of specialist
books or changes in a unit.

Proposed Amex Rule 27

    Amex proposes in Amex Rule 27(e)(ii) that at any time after 120
days from the start of trading of an issue, an issuer or sponsor may
request a specialist reassignment by filing a written notice
(``Notice'') with the officer in charge of Equities Administration or
the officer in charge of the ETF Marketplace, as applicable, indicating
the specific issues prompting the request and the steps previously
taken to attempt to address them. The issuer or sponsor may make this
request for ``good cause.'' Amex proposes to define ``good cause'' as
the failure of the specialist to make competitive markets; the failure
of the specialist unit to risk capital commensurate with the type of
security; the failure of the specialist unit to assign competent
personnel to the securities; or any statements made publicly by the
specialist unit that substantially denigrate the security.
    Further, the Amex proposes that the officer in charge of Equities
Administration or the officer in charge of the ETF Marketplace, as
applicable, will provide copies of the Notice to the Chief Regulatory
Officer of the Exchange (``CRO'') and to the Committee on Floor Member
Performance. In addition, the officer in charge of Equities
Administration or the officer in charge of the ETF Marketplace, as
applicable, will notify the subject specialist unit that mediation is
being commenced with respect to the request for reassignment, and will
provide the specialist with a copy of the Notice. The specialist unit
may submit a written response to the officer in charge of Equities
Administration or the officer in charge of the ETF Marketplace within
two (2) weeks, which response will be provided to the CRO and the
Committee on Floor Member Performance. If the specialist unit does not
submit a response during this two-week time period, however, there will
be no

further assessment by the CRO or Committee on Floor Member Performance,
and ultimately no mediation. The Allocations Committee will be convened
to reallocate securities pursuant to Amex Rule 27(b).
    The Exchange proposes in Amex Rule 27(e)(iv) that the CRO will
review the Notice and any specialist response, and may request a review
of the matter by the Regulatory Oversight Committee (``ROC'') of the
Exchange's Board of Governors. In addition, the Committee on Floor
Member Performance will review the Notice and any specialist response.
The Committee on Floor Member Performance will make any determination
that ``good cause,'' as proposed to be defined in Amex Rule
27(e)(ii)(b), does not exist prior to the commencement of the
mediation. A Committee on Floor Member Performance determination that
``good cause'' does not exist will preclude the commencement of
mediation. In this circumstance, the security will not be reallocated
and the issuer or sponsor may request an appeal of the decision of the
Committee on Floor Member Performance to be heard by the Amex
Adjudicatory Council.\7\ If the Committee on Floor Member Performance
decision is upheld, then the security will not be reallocated.
---------------------------------------------------------------------------

    \7\ See Article II, Section 7(a) of the Amex Constitution.
---------------------------------------------------------------------------

    Proposed Amex Rule 27(e)(v) provides that the Exchange will
facilitate mediation of the issues that have arisen between the issuer
or sponsor and the specialist unit, which may be conducted pending the
outcome of the CRO's and, if applicable, the ROC's review of the
request. However, as set forth in proposed Amex Rule 27(e)(iv), where a
review by the ROC has been requested, no change of specialist unit may
occur until the ROC makes a final determination that it is appropriate
to permit such change. In making such determination, the ROC may
consider all relevant regulatory issues, including without limitation
whether the requested change appears to be in aid or furtherance of
conduct that is illegal or violates Exchange rules, or in retaliation
for a refusal by a specialist to engage in conduct that is illegal or
violates Exchange rules. Moreover, the Amex proposes that,
notwithstanding review by the CRO, ROC and/or Committee on Floor Member
Performance of any matter raised during the process described herein,
the Amex Division of Regulation and Compliance (including Listing
Qualifications) and/or the NASD Amex Division may at any time take any
regulatory action that it may determine to be warranted. The Amex
represents that reassignment may not occur without prior notice that
the CRO has decided not to refer the matter to the ROC or that the ROC
has determined that the change is appropriate.
    The Exchange proposes a committee consisting of at least one (1)
floor broker, one (1) senior floor official, one (1) upstairs governor,
and two (2) independent governors for each mediation (``the Mediation
Committee''). The Mediation Committee will meet with representatives of
the issuer or sponsor and the specialist unit in an attempt to mediate
the matters indicated in the Notice. During the course of the
mediation, the issuer or sponsor may conclude the mediation if it
determines that it wishes to continue with the same specialist unit. In
the alternative, after the expiration of one month from the time of the
specialist's response, subject to the conclusion of any review by the
CRO and ROC, the issuer or sponsor may file written notice with the
officer in charge of Equities Administration or the officer in charge
of the ETF Marketplace, as applicable, signed by the issuer's or
sponsor's chief executive officer, that it wishes to proceed with the
change of specialist unit. The new specialist unit will be selected by
the Allocations Committee pursuant to Amex Rule 27(b).
    Finally, the Exchange proposes to amend Amex Rule 27(f) to provide
that, in addition to the circumstances provided for in the existing
rule, the Allocations Committee will be convened to reallocate
securities when an issuer or sponsor files a written notice requesting
a change of specialist unit and the Mediation Committee orders
reallocation pursuant to proposed paragraph (e)(viii) of Amex Rule 27,
or an issuer or sponsor files a written notice requesting a change of
specialist unit and the specialist unit does not submit a response.
2. Statutory Basis
    The Exchange believes that the proposed rule change, as amended, is
consistent with the provisions of Section 6(b) of the Act,\8\ in
general, and with Section 6(b)(5) of the Act,\9\ in particular, in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, and, in
general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change, as
amended, 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

    The Exchange did not receive any written comments on the proposed
rule change.

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

    Within 35 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 self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, as amended; or
    B. Institute proceedings to determine whether the proposed rule
change, as amended, 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, as amended, 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Amex-2005-103 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-Amex-2005-103. This
file number should be included on the subject line if e-mail 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 inspection and copying in the Commission's
Public Reference Room. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Amex-2005-103 and should be
submitted on or before April 25, 2006.
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
Nancy M. Morris,
Secretary.
[FR Doc. E6-4829 Filed 4-3-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12737-12739]
[FR Doc No: 2016-05387]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0986]

Center for Devices and Radiological Health: Experiential Learning
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Devices
and Radiological Health (CDRH or Center) is announcing the 2016
Experiential Learning Program (ELP). This training component is
intended to provide CDRH staff with an opportunity to understand the
policies, laboratory practices, and challenges faced in broader
disciplines that impact the device development life cycle. The purpose
of this document is to invite medical device industry, academia, and
health care facilities to request to participate in this formal
training program for FDA's medical device review staff, or to contact
CDRH for more information regarding the ELP.

DATES: Submit either an electronic or written request for participation
in the ELP by April 11, 2016.

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

FOR FURTHER INFORMATION CONTACT: Christian Hussong, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5261, Silver Spring, MD 20993-0002, 240-
402-2246, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CDRH is responsible for helping to ensure the safety and
effectiveness of medical devices marketed in the United States.
Furthermore, CDRH assures that patients and providers have timely and
continued access to high-quality, safe, and effective medical devices.
In support of this mission, the Center launched various training and
development initiatives to enhance performance of its staff involved in
regulatory review and in the premarket review process. One of these
initiatives, the ELP Pilot, was launched in 2012 and fully implemented
on April 2, 2013 (78 FR 19711).
    CDRH is committed to advancing regulatory science, providing
industry with predictable, consistent, transparent, and efficient
regulatory pathways, and helping to ensure consumer confidence in
medical devices marketed in the United States

and throughout the world. The ELP is intended to provide CDRH staff
with an opportunity to understand the policies, laboratory practices,
and challenges faced in broader disciplines that impact the device
development life cycle. This component is a collaborative effort to
enhance communication and facilitate the premarket review process.
Furthermore, CDRH is committed to understanding current industry
practices, innovative technologies, regulatory impacts, and regulatory
needs.
    These formal training visits are not intended for FDA to inspect,
assess, judge, or perform a regulatory function (e.g., compliance
inspection), but rather, they are an opportunity to provide CDRH review
staff a better understanding of the products they review. Through this
notice, CDRH is formally requesting participation from companies,
academia, and clinical facilities, including those that have previously
participated in the ELP or other FDA site visit programs.

II. CDRH ELP

A. Areas of Interest

    In this training program, groups of CDRH staff will observe
operations at research, manufacturing, academia, and health care
facilities. The focus areas and specific areas of interest for visits
may include the following:

         Table 1--Areas of Interest--Office of Device Evaluation
------------------------------------------------------------------------
               Focus area                   Specific areas of interest
------------------------------------------------------------------------
Usability testing......................  Observe usability testing
                                          throughout a device's life
                                          cycle and complex clinical
                                          simulations.
Reprocessing and reuse of single-use     Observe reprocessing and reuse
 devices (SUDs).                          of SUDs in a major health
                                          system (i.e. Hospital
                                          Reprocessor).
Transcatheter heart valves.............  Observe design, development,
                                          and testing of transcatheter
                                          heart valves, including
                                          pulmonic and aortic valve
                                          prostheses and related
                                          technology.
Cardiac electrophysiology (EP)           Observe clinical EP catheter
 diagnostic, mapping, and ablation        laboratory and observe
 devices.                                 catheter ablation procedures
                                          (manual and potentially
                                          robotic); including EP Lab
                                          manager and practicing EP
                                          physicians.
Neurological medical devices--early      Design, development, and
 feasibility clinical trials.             testing of novel neurological
                                          medical devices qualified
                                          under early feasibility
                                          clinical trials.
Neurostimulators and neuroprosthetics    Design, development, and
 including brain-to-computer interface    testing of neurostimulators
 (BCI).                                   and neuroprosthetics including
                                          BCI technologies.
Non-clinical testing--animal model.....  Observe non-clinical animal
                                          model testing demonstrating
                                          the performance of bone void
                                          fillers in the posterolateral
                                          spine.
Patient matched orthopaedic implants...  Observe the patient matched
                                          process from the surgeon's
                                          decision to utilize patient
                                          matched technology through
                                          surgery.
Auditory brainstem implants (ABI)......  Design, development, and
                                          testing of ABI and observe the
                                          surgical procedure and a post-
                                          implant programming session.
Contact lens care products.............  Design, development, and
                                          testing of contact lens care
                                          products and observe non-
                                          clinical testing for these
                                          devices.
Surgical mesh devices..................  Design, development, and
                                          testing of surgical mesh
                                          indicated for gynecologic and
                                          urologic indications.
Feeding tubes..........................  Design, development, and
                                          testing of nasogastric tubes,
                                          nasojejunal tubes, and
                                          percutaneous endoscopic
                                          gastrostomy tubes.
Robotically-assisted surgical devices    Design, development, testing,
 (RASD) and surgical simulators in        and validation of emerging
 robotic surgery.                         RASD and mechanized
                                          laparoscopic technologies
                                          adopted from other specialties
                                          and new-area specific; and
                                          surgical simulators
                                          incorporating tissue models
                                          and force feedback mechanism
                                          or haptic technology to reduce
                                          learning curve in robotic
                                          surgery.
Biological evaluation (i.e.,             Observe all implanted, surface
 biocompatibility) and viral              contacting, and external
 inactivation of medical devices.         communicating devices.
------------------------------------------------------------------------

     Table 2--Areas of Interest--Office of In Vitro Diagnostics and
                           Radiological Health
------------------------------------------------------------------------
               Focus area                   Specific areas of interest
------------------------------------------------------------------------
Continuous glucose monitoring systems    Design and development in-
 and insulin pumps.                       process, and finished device
                                          testing of continuous glucose
                                          monitoring systems and insulin
                                          pumps.
Urine test strips and readers..........  Design and development in-
                                          process, and finished device
                                          testing of urine test strips
                                          and readers.
Prothrombin (PT)/international           Design and development in-
 normalized ratio (INR) devices.          process, and finished device
                                          testing of PT/INR devices.
Direct anticoagulants (detection)......  Observe the detection of direct
                                          anticoagulants.
Antimicrobial susceptibility testing     Observe clinical microbiology
 (phenotypic, biochemical, and            laboratory, contract research
 molecular detection).                    organization (CRO), and/or
                                          industrial setting where
                                          antimicrobial susceptibility
                                          testing is being applied.
Next generation sequencing (NGS).......  Observe clinical microbiology
                                          laboratory, CRO, and/or
                                          industrial setting where NGS
                                          is being applied.
Immunohistochemistry (IHC) reagents or   Design, development, and
 digital pathology devices.               testing of IHC reagents or
                                          digital pathology devices that
                                          are commonly used in pathology
                                          labs.
Cell-free DNA/RNA biomarker technology.  Observe Clinical Laboratory
                                          Improvement Amendments labs
                                          involved with cfDNA, ctDNA, or
                                          miRNA for clinical
                                          diagnostics.
Radiological imaging equipment testing.  Observe radiological imaging
                                          equipment (e.g. CT, MR, PET,
                                          fluoroscopy, etc.) testing and
                                          evaluation of particular
                                          consensus standards.

Radiation therapy equipment............  Observe radiation therapy
                                          equipment (e.g., linear
                                          accelerator, proton beam
                                          therapy, brachytherapy)
                                          testing and evaluation.
------------------------------------------------------------------------

B. Site Selection

    CDRH will be responsible for CDRH staff travel expenses associated
with the site visits. CDRH will not provide funds to support the
training provided by the site to the ELP. Selection of potential
facilities will be based on CDRH's priorities for staff training and
resources available to fund this program. In addition to logistical and
other resource factors, all sites must have a successful compliance
record with FDA or another Agency with which FDA has a memorandum of
understanding. If a site visit involves a visit to a separate physical
location of another firm under contract with the site, that firm must
agree to participate in the ELP and must also have a satisfactory
compliance history.

III. Request To Participate

    Submit requests for participation with the docket number found in
the brackets in the heading of this document. Received requests may be
seen in the Division of Dockets Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through Friday.
    The request should include a description of your facility relative
to focus areas described in table 1 or 2. Please include the Area of
Interest (see table 1 or 2) that the site visit will demonstrate to
CDRH staff, a contact person, site visit location(s), length of site
visit, proposed dates, and maximum number of CDRH staff that can be
accommodated during a site visit. Requests submitted without this
minimum information will not be considered.
    Additional information regarding the CDRH ELP, including a sample
request and an example of the site visit agenda, is available on CDRH's
Web site at: http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

    Dated: March 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05387 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P