[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Page 71892]
[FR Doc No: 2020-25001]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL21-14-000]

NextEra Energy, Inc.; American Electric Power Company, Inc.;
Evergy, Inc.; Exelon Corporation; Xcel Energy Services Inc.; Notice of
Petition for Declaratory Order

    Take notice that on October 30, 2020, NextEra Energy, Inc.,
American Electric Power Company, Inc., Evergy, Inc., Exelon
Corporation, and Xcel Energy Services Inc. (Petitioners) submitted a
petition for declaratory order seeking to resolve two issues arising in
the wake of Order Nos. 860 and 860-A,\1\ as more fully explained in the
petition.
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    \1\ Data Collection for Analytics & Surveillance & Mkt.-Based
Rate Purposes, Order No. 860, 168 FERC 61,039 (2019), order on reh'g
and clarification, Order No. 860-A, 170 FERC 61,129 (2020).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Eergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern time on November 30, 2020.

    Dated: November 5, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-25001 Filed 11-10-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Pages 13668-13675]
[FR Doc No: 2012-5555]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66497; File No. SR-Phlx-2012-23]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Change To Amend Registration and Qualification
Requirements

March 1, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 \2\ thereunder, notice is hereby given
that on February 16, 2012, NASDAQ OMX PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The

Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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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 delete Rule 604 as well as amend and adopt
several new rules governing the registration and qualification of
members and persons associated with \3\ member organizations, as
described below. The text of the proposed rule change is available on
the Exchange's Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings, at the principal office of the Exchange,
and at the Commission's Public Reference Room.
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    \3\ The term ``associated person'' or ``person associated with''
a member organization means any partner, officer, director, or
branch manager of an Exchange member organization or applicant (or
person occupying a similar status or performing similar functions),
any person directly or indirectly controlling, controlled by, or
under common control with such member organization or applicant, or
any employee of such member or applicant, except that any person
associated with a member organization or applicant whose functions
are solely clerical or ministerial shall not be included in the
meaning of such term for purposes of the Exchange Rules. See Rule
1(b).
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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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to strengthen the
Exchange's current registration provisions in a number of ways. In
2010,\4\ in connection with the Exchange's proposal to launch the
Exchange's equity trading platform for NMS Stocks, NASDAQ OMX PSX
(``PSX''),\5\ the Exchange amended Rule 604 to adopt paragraph (h) to
govern the registration of representatives and Supplementary Material
.04 to Rule 604 regarding the specific category of such registration.
In addition, with respect to principal registration, the Exchange
adopted paragraph (g), Principal Registration, and Supplementary
Material .01-.03 governing the specific categories of principal
registration, to require that every member organization covered by
those rules have at least two registered principals as well as a
Financial/Operations Principal. The Exchange also adopted paragraph (i)
to establish which persons are exempt from registration. These
provisions became applicable only to PSX users pursuant to paragraph
(f). In that filing, the Exchange stated:
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    \4\ See Securities Exchange Act Release No. 62776 (August 26,
2010), 75 FR 53727 (September 1, 2010) (SR-Phlx-2010-91).
    \5\ See Securities Exchange Act Release No. 62877 (September 9,
2010), 75 FR 56633 (September 16, 2010) (SR-Phlx-2010-79).

    ``The Exchange intends to separately revise its registration and
qualification rules related to activity other than business
conducted on PSX, including its options business. The Exchange
understands that other self-regulatory organizations are expected to
adopt a framework that requires more fulsome registration and
qualification requirements clearly spelled out in rules. The
Exchange supports the Commission's commitment to ensure that such
rules are adopted by all self-regulatory organizations on a
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consistent basis.''

    Accordingly, the Exchange is now proposing to extend the principal
and representative registration requirements of Rule 604(g) and (h) to
all members, member organizations and associated persons by adopting
Rules 611-616 to replace Rule 604. As a result of the new registration
requirements, additional persons will become subject to the Exchange's
continuing education requirement in Rule 640.

Background and Current Requirements

    Currently, Rules 604(a)-(e) apply to all member organizations and
generally require the Series 7 examination for Registered
Representatives,\6\ off-floor traders \7\ and persons compensated
directly or indirectly for the solicitation or handling of business in
securities who are not otherwise required to register with the Exchange
by Rule 604(a).\8\ Furthermore, Rule 604(f) provides that members and
persons associated with member organizations that are registered with
the Exchange for the purpose of trading NMS Stocks \9\ through the
facilities of the Exchange, which is the PSX platform, are subject to
the provisions of Rule 604(g) and (h) governing principal and
representative registration, respectively. Thus, these provisions
currently cover members that trade on PSX, and are substantially
similar to the rules of The NASDAQ Stock Market LLC (``NASDAQ''),
Financial Industry Regulatory Authority (``FINRA'') and NASDAQ OMX BX,
Inc. (``BX'') requiring PSX users to register and qualify
representatives and principals with the Exchange in accordance with
such rules.
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    \6\ See Rule 604(a).
    \7\ See Rule 604(e).
    \8\ See Rule 604(d).
    \9\ See Rule 1(t).
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Proposal

    The Exchange is proposing to extend the current principal
requirement beyond PSX users to include all member organizations,
including those who trade options. This more extensive principal
requirement will be embodied in new Rules 611 and 612, which are
substantially similar to current Rule 604(g) and Supplementary Material
.01-.03.
    In connection with strengthening its registration rules, the
Exchange is proposing to reorganize and renumber its registration rules
to better align with those of NASDAQ and FINRA, albeit within its own
rule numbering structure. The following summarizes the new rule
numbering structure:

----------------------------------------------------------------------------------------------------------------
                                                                                New phlx rule
          Current phlx rule                          Topic                          NASDAQ
----------------------------------------------------------------------------------------------------------------
604(g)........................................  Principal Registration..........             611            1021
604.01-.03....................................  Categories of Principal                      612            1022
                                                 Registration.
604(h)........................................  Representative Registration.....             613            1031
604.04........................................  Categories of Representative                 613            1032
                                                 Registration.
604(i)........................................  Persons Exempt from Registration             614            1060
604(j)........................................  Waiver..........................             615         1070(d)
None..........................................  Electronic Filing...............             616            1140
----------------------------------------------------------------------------------------------------------------

Representative Registration

    Rule 604(h) currently governs the registration of representatives
\10\ with the Exchange; specifically, Rule 604(h)(1) requires that all
persons engaged or to be engaged in the investment banking or
securities business \11\ of a member organization who are to function
as representatives shall be registered as such with the Exchange
through WebCRD \12\ in the category of registration appropriate to the
function to be performed as specified in Supplementary Material .04 of
Rule 604. Before their registration can become effective, they shall
pass the Series 7 examination. Rule 604(h) is applicable today only to
PSX users pursuant to Rule 604(f).
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    \10\ The term ``representative'' is defined in Rule 1 as a
member or an associated person of a registered broker or dealer,
including assistant officers other than principals, who is engaged
in the investment banking or securities business for the member
organization including the functions of supervision, solicitation or
conduct of business in securities or who is engaged in the training
of persons associated with a broker or dealer for any of these
functions. To the extent provided in Rule 604, all representatives
are required to be registered with the Exchange, and representatives
that are so registered are referred to herein as ``Registered
Representatives.'' See Rule 1(cc).
    \11\ The term ``investment banking or securities business''
means the business, carried on by a broker or dealer, of
underwriting or distributing issues of securities, or of purchasing
securities and offering the same for sale as a dealer, or of
purchasing and selling securities upon the order and for the account
of others. See Rule 1(m). Of course, the federal securities laws may
require broker-dealers to become members of the FINRA in order to
perform some of these functions. See e.g., 15 U.S.C. 78o(b)(8).
    \12\ WebCRD is FINRA's automated Central Registration
Depository.
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    The provisions currently contained in Rule 604(h) are proposed to
be moved to new Rule 613, Representative Registration, in substantially
the same form, except with respect to trading floor personnel subject
to Rule 620. Specifically, new Rule 613(a) will expressly state that,
except members whose activities are limited to the Exchange's options
trading floor and who are registered pursuant to Rule 620(a) as well as
associated persons whose activities are limited to the Exchange's
options trading floor and are registered pursuant to Rule 620(b), all
persons engaged or to be engaged in the investment banking or
securities business of a member organization who are to function as
representatives shall be registered as such with the Exchange through
WebCRD in the category of registration appropriate to the function to
be performed as specified in Rule 613(e). This is the only change to
the language currently in Rule 604(h) that is being moved to new Rule
613.
    Accordingly, trading floor personnel will continue to be required
to register pursuant to Rule 620, in lieu of new Rule 613,\13\ such
that trading floor personnel will not be required to successfully
complete the Series 7 examination, as long as their activities are
limited to the trading floor. The Exchange believes that it is
appropriate to permit trading floor members and associated persons to
operate pursuant to a registration and qualification framework tailored
to their specific functions. These functions include handling and
executing electronic and phoned-in orders on the trading floor, as well
as providing markets, both verbally and electronically. Members on the
trading floor will continue to be subject to the Exchange's Trading
Floor Qualification Examination in lieu of the Series 7, which the
Exchange believes is appropriate because the examination focuses on the
rules and procedures most applicable to floor members.\14\ For example,
there are questions regarding the quoting obligations of Rule 1014(b),
crossing orders pursuant to Rule 1064, and Floor Broker obligations in
Rule 1063.
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    \13\ However, trading floor personnel and members on the trading
floor will be subject to new principal registration requirements, as
described below.
    \14\ The Exchange recently revised this examination. See
Securities Exchange Act Release No. 63603 (December 22, 2010), 75 FR
82419 (December 30, 2010) (SR-Phlx-2010-180).
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    Respecting trading floor members, Rule 620 requires registration on
Form U4 through WebCRD. Rule 620 will now require all trading floor
personnel, including clerks, interns and any other associated persons,
of a member organization not required to register pursuant to Rule
620(a) to register on Form U4 through WebCRD. Accordingly, the same
registration information will be available electronically within WebCRD
for trading floor members and associated persons as is available for
persons registered as General Securities Representatives.
    In terms of the actual category of registration that applies,
currently, Supplementary Material .04 to Rule 604, titled Categories of
Representative Registration--General Securities Representative,
contains the basic requirement \15\ that each member and each person
associated with a member organization who is included within the
definition of a representative in Rule 1(cc) is required to register
with the Exchange as a General Securities Representative and shall pass
the Series 7 examination before such registration may become effective.
The appropriate registration category on WebCRD is ``GS.'' This
provision is not changing, and was intended to capture traditional
securities personnel in a rule similar to that of several other
SROs.\16\ The Exchange continues to believe that this provision is
broad and should not generate gaps that permit a member organization to
operate differently than under the registration rules of BX, NASDAQ or
FINRA. The Exchange proposes to move the provisions of Rule 604(h) into
Rule 613 and Supplementary Material .04 of Rule 604 into Rule 613(e).
The Exchange believes that it is clearer to place the ``registered
representative'' requirement and category of registration all in one
rule, even though that differs from the FINRA and NASDAQ rules
slightly.
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    \15\ This provision is the same as BX Rule 1032.
    \16\ See e.g., BX Rules 1031 and 1032, NASDAQ rules 1031 and
1032, and NASD Rules 1031 AND 1031.
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    The Exchange also proposes to adopt a new limited category of
representative registration as Rule 613(f). The Exchange has been
working with other exchanges and FINRA to develop a registration
category and qualification examination for proprietary traders in lieu
of the Series 7, which is now available through WebCRD. Accordingly,
the Exchange proposes to recognize the new registration category,
Proprietary Trader, and related examination, the Series 56,\17\ and to
incorporate it into Rule 613(f), subject to filing the Series 56
content outline with the Commission.\18\ The Exchange intends to file
the Series 56 content outline with the Commission shortly.\19\ Proposed
Rule 613(f) would provide that members and associated persons engaged
solely in proprietary trading, market making or effecting transactions
on behalf of a broker-dealer account may register instead as a
Proprietary Trader and pass the Series 56 examination.\20\ The term
``persons engaged in effecting transactions on behalf of a broker-
dealer account'' is equivalent to persons engaged in proprietary
trading or market making, because it covers persons who do not deal
with the public. For example, this would include both Floor Brokers on
the Exchange's trading floor as well as persons performing brokerage
functions

off the trading floor (``upstairs'').\21\ The Exchange believes that
the Series 56 helps ensure that such persons are qualified, because it
addresses industry topics that establish the foundation for the
regulatory and procedural knowledge necessary for individuals required
to register as a Proprietary Trader.
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    \17\ This new examination, the Series 56, would also serve as a
prerequisite for a new principal registration category, which the
Exchange would recognize; the Series 24 would be the appropriate
examination for the new principal registration category, as
described below.
    \18\ See e.g., Securities Exchange Act Release No. 64699 (June
17, 2011) (SR-CBOE-2011-056).
    \19\ The Exchange is also proposing that the Series 56 serve as
a prerequisite to the Series 24, as described further below.
    \20\ See supra note 17.
    \21\ This provision is the same as the provision in Chicago
Board Options Exchange Incorporated (``CBOE'') rules which requires
that an individual Permit Holder or associated person who effects
transactions on behalf of a broker-dealer account register and pass
the Series 56 examination. See CBOE Rule 3.6A, Interpretation and
Policy .06.
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    The Exchange is proposing to delete Rule 604 in its entirety.\22\
With respect to paragraphs (a), (d) and (e), the Exchange believes that
the requirements of new Rule 613 cover every person subject to
registration as a representative and the Series 7 examination. The
Exchange believes that Rule 613 is broader, because it is not limited
to member organizations for which the Exchange is the designated
examining authority (``DEA'') nor is it limited to specific categories
of persons, such as Rule 604(e). In addition, the language of Rule 613
more closely aligns with the rules of FINRA and NASDAQ, which should
facilitate compliance by broker-dealers. Thus, although Rule 604 is
being deleted, the same persons will continue to be required to
successfully complete the Series 7 examination and be registered as a
``Registered Representative'' on Form U4 through WebCRD. This proposal
will extend the requirements of Rule 604(h) to all member
organizations, whereas today Rule 604(h) only applies to member
organizations registered to use PSX.\23\
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    \22\ The Exchange proposes to amend the following additional
rules to replace references to Rule 604 with the new applicable rule
number: Rule 1(cc), Rule 1090, Rule 3202, Equity Floor Procedure
Advice (``EFPA'') A-7 and Options Floor Procedure Advice (``OFPA'')
F-34. Rule 3202 will now refer to the applicability of Rules 611-616
to PSX users.
    \23\ See Rule 604(f).
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Principal Registration

    With respect to principal registration on the Exchange, Rule 604(g)
\24\ currently provides that certain member organizations must register
at least two principals with the Exchange,\25\ unless an exception
applies. The Exchange is proposing to adopt new Rule 611, Principal
Registration, and to move the provisions of existing Rule 604(g) over
into this new rule. Accordingly, the principal registration rules will
now apply beyond PSX users to all Phlx member organizations, with the
addition of two new registration categories to satisfy the principal
requirement: Registered Options Principal and Proprietary Trader
Principal.
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    \24\ This rule is similar to NASDAQ Rule 1021, BX Rule 1021 and
NASD Rule 1021.
    \25\ All persons who engage in specified supervisory functions
will be registered as principals. All principals are first required
to register as and qualify as Representatives.
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    Phlx rules will require that each principal must successfully
complete the General Securities Principal Examination (``Series 24'')
and submit a Form U4 via WebCRD reflecting registration as such, using
the category ``GP,'' unless a different category of principal
registration applies to such person. Specifically, new Rule 611 will
provide that all persons engaged or to be engaged in the investment
banking or securities business of a member organization who are to
function as principals shall be registered as such with the Exchange
through WebCRD in the category of registration appropriate to the
function to be performed as specified in Rule 612, Categories of
Principal Registration, which replaces existing Supplementary Material
.01-.03 of Rule 604. Before their registration can become effective,
they shall pass a qualification examination for principals appropriate
to the category of registration. Persons associated with a member
organization who are actively engaged in the management of the member
organization's investment banking or securities business, including
supervision, solicitation, conduct of business or the training of
persons associated with a member organization for any of these
functions are principals. Such persons shall include: sole proprietors,
officers, partners, managers of offices of supervisory
jurisdiction,\26\ and directors of corporations. This requirement will
now appear in Rule 611(b) and apply to all member organizations.
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    \26\ The Exchange defined the term ``office of supervisory
jurisdiction'' to mean any office of a member organization at which
any one or more of the following functions take place: order
execution and/or market making; structuring of public offerings or
private placements; maintaining custody of customers' funds and/or
securities; final acceptance (approval) of new accounts on behalf of
the member organization; review and endorsement of customer orders;
final approval of advertising or sales literature for use by persons
associated with the member organization, pursuant to Rule 605,
except for an office that solely conducts final approval of research
reports; or responsibility for supervising the activities of persons
associated with the member organization at one or more other branch
offices of the member organization. This definition is drawn from
NASD Rule 3010. The Exchange is adopting the reference to this term
in order to cover these managers in the new principal registration
requirement. The Exchange is not, at this time, adopting a
comprehensive program with regard to such offices, such as that
found in NASD Rule 3010. See proposed Rule 611(b).
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    Rule 604(g)(5) currently requires at least two registered
principals, which will now be contained in new Rule 611(e).\27\
Specifically, an Exchange member organization, except a sole
proprietorship, shall have at least two officers or partners who are
registered as principals with respect to each aspect of the member
organization's investment banking and securities business pursuant to
the applicable provisions of Rule 611; provided, however, that a
proprietary trading firm \28\ with 25 or fewer registered
representatives shall only be required to have one officer or partner
who is registered as a principal. This exception to the two principal
requirement is similar to that of several other exchanges and reflects
that such firms do not necessitate the same level of supervisory
structure as firms who have customers or larger firms. This exception
is not changing and will now be in Rule 611(e)(i), applicable to all
member organizations.\29\
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    \27\ All persons who engage in specified supervisory functions
must be registered as Principals.
    \28\ The term ``proprietary trading firm'' means a member
organization or applicant with the following characteristics: (A)
The applicant is not required by Section 15(b)(8) of the Act to
become a FINRA member but is a member of another registered
securities exchange not registered solely under Section 6(g) of the
Act; (B) all funds used or proposed to be used by the applicant for
trading are the applicant's own capital, traded through the
applicant's own accounts; (C) the applicant does not, and will not
have customers; and (D) all Principals and Representatives of the
applicant acting or to be acting in the capacity of a trader must be
owners of, employees of, or contractors to the applicant. See
proposed Rule 611(e)(i).
    \29\ Member organizations operating on the trading floor will be
subject to the minimum ``two principal'' requirement, except to the
extent that the ``proprietary trading firm'' exception permits
certain firms to have one principal.
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    Rule 611(e)(ii) will provide, like Rule 604(g) currently does, that
the Exchange may waive the two principal requirement in situations that
indicate conclusively that only one person should be required to
register as a principal. This provision is identical to that of several
other exchanges, and the Exchange believes that such waiver is
appropriate in certain situations, but should be carefully applied; for
example, the Exchange may determine to apply this provision to a very
small firm, with only a few employees in one location.
    To help determine how a person should register as a principal,
Supplementary Material .01-.03 to Rule 604 currently enumerates the
three categories of principal registration. These categories will now
be in new Rule 612. First, Rule 604.01, titled General Securities
Principal, provides that each member or person associated with a member
organization who is included within the definition of

principal, and each person designated as a Chief Compliance Officer on
Schedule A of Form BD shall be required to register with the Exchange
as a General Securities Principal and shall pass the Series 24
examination before such registration may become effective, unless such
person's activities are so limited as to qualify such person for one or
more of the limited categories of principal registration specified in
Rule 612.\30\ The Exchange proposes to move these provisions of Rule
604.01 to new Rule 612(a), also titled General Securities Principal.
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    \30\ However, pursuant to Rule 604.01(c), a person registered
solely as a General Securities Principal shall not be qualified to
function as a FINOP or a Limited Principal--General Securities Sales
Supervisor unless that person is also qualified and registered as
such.
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    The Exchange also proposes to recognize two new principal
registration categories. First, the Exchange proposes to adopt Rule
612(d) in order to permit Registered Options Principals to satisfy the
principal registration requirements of Rule 611. Specifically, each
member or person associated with a member organization who is included
within the definition of principal, and each person designated as a
Chief Compliance Officer on Schedule A of Form BD of a member
organization may register as a Registered Options Principal and
successfully complete the Series 4 examination, instead of registering
as a General Securities Principal and successfully completing the
Series 24 examination, if such person's activities are limited solely
to options. Specifically, Rule 612(d) will provide that such person's
supervisory responsibilities in the investment banking and securities
business must be limited to the options activities of a member
organization, that he or she must be registered pursuant to Exchange
Rules as a General Securities Representative, that he or she is
qualified to be so registered by passing the Series 4 examination, and
that he or she shall not be qualified to function in a principal
capacity with responsibility over any area of business activity other
than the supervision of persons involved exclusively in options
activity. The Exchange believes that the Registered Options Principal
category is appropriate for a principal whose activities are limited
solely to options.\31\ The Series 4 examination covers options-related
topics, which should help ensure that principals whose activities are
limited to options are properly qualified. Furthermore, Rule 1024
currently requires persons who supervise options sales practice
activities to register as a Registered Options Principal; thus, the
Exchange believes that some member organizations have already
registered certain associated persons in this category, such that these
persons could satisfy the new principal registration requirement for
applicable firms.
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    \31\ This is similar to BATS Exchange, Inc. (``BATS'') Rule
17.1(g).
---------------------------------------------------------------------------

    Second, the Exchange proposes to recognize the new Proprietary
Trader Principal category as a limited principal category in Rule
612(e). It would apply to persons whose supervisory responsibilities in
the investment banking and securities business are limited to the
activities of a member organization that involve proprietary trading,
market making and effecting transactions on behalf of broker-dealers.
It would require that he or she be registered pursuant to Exchange
Rules as a Proprietary Trader, be qualified to be so registered by
passing the Series 24 examination, and not function in a principal
capacity with responsibility over any area of business activity other
than proprietary trading, market making and effecting transactions on
behalf of broker-dealer accounts.
    The Exchange has been working with other exchanges and FINRA to
develop this registration category, which is limited to persons who
supervise persons engaged in proprietary trading, market making or
effecting transactions on behalf of broker-dealer accounts.\32\ This
category is in lieu of registration as a General Securities Principal,
for which the prerequisite qualification examination is the Series 7.
The appropriate qualification examination for the proposed new
registration category of Proprietary Trader Principal is the Series 24,
which is the same qualification required for registration as a General
Securities Principal; no new examination has been developed. However,
the prerequisite examination for the new Proprietary Trader Principal
category is the new Series 56, which is described above. Accordingly, a
person who has passed the Series 56 can register as a Proprietary
Trader Principal and take the Series 24 examination, under this
proposal, but cannot register as a General Securities Principal without
first qualifying as a General Securities Representative and passing the
Series 7. Thus, although the Series 24 will now be the appropriate
qualification examination for both categories (General Securities
Principal and Proprietary Trader Principal), different prerequisites
apply and different registration categories result.
---------------------------------------------------------------------------

    \32\ In effect, supervisors who supervise persons engaged only
in activities covered by the proposed new Proprietary Trader
registration category can meet the principal registration
requirement by registering as a Proprietary Trader Principal.
---------------------------------------------------------------------------

    The new Proprietary Trader Principal category is expected to become
available to Phlx member organizations in WebCRD soon and the Exchange
will communicate the implementation date to the membership. The
Exchange believes that the new principal registration category is an
appropriate corollary to the new representative registration category
discussed above and reflects a substantial joint-exchange effort to
develop a registration framework specific to principals supervising
persons engaged in proprietary trading, market making and effecting
transactions on behalf of broker-dealer accounts. Furthermore, the
Exchange believes that the Series 24 is the appropriate examination for
Proprietary Trader Principals, because it tests knowledge and
understanding of supervision-related rules.
    Both the Registered Options Principal and the Proprietary Trader
Principal registrations count towards the minimum two principal
requirement in Rule 611. The Exchange believes that this is appropriate
because both of these principals are subject to a comprehensive
qualification examination that covers their area of supervision. Of
course, if the member organization is involved in activity other than
what a Proprietary Trader Principal and a Registered Options Principal
are permitted under these rules to supervise, an additional principal
would be required.
    Two other provisions of the current principal registration
framework are also becoming applicable to all member organizations, in
addition to the basic principal requirement. Rule 604.02, titled
Limited Principal--Financial and Operations, currently requires that
each member organization of the Exchange that is subject to Rule 604(g)
and that is operating pursuant to the provisions of SEC Rule 15c3-
1(a)(1)(ii), (a)(2)(i) or (a)(8), designate as Limited Principal--
Financial and Operations (``FINOP'') those persons associated with it,
at least one of whom shall be its chief financial officer, who perform
the following duties: final approval and responsibility for the
accuracy of financial reports submitted to any duly established
securities industry regulatory body; final preparation of such reports;
supervision of individuals who assist in the preparation of such
reports; supervision of and responsibility for individuals who are
involved in the actual maintenance of the member organization's books
and records from which such reports are derived; supervision and/or
performance of the

member organization's responsibilities under all financial
responsibility rules promulgated pursuant to the provisions of the Act;
overall supervision of and responsibility for the individuals who are
involved in the administration and maintenance of the member
organization's back office operations; or any other matter involving
the financial and operational management of the member organization.
Each FINOP must register with the Exchange and pass the Series 27
examination. The Exchange proposes to move this provision to Rule
612(b) and extend it beyond PSX users, including trading floor members.
This provision is intended to ensure that persons handling the
financial affairs of a firm are properly registered and qualified. This
requirement also harmonizes the Exchange's rules with those of other
exchanges \33\ and recognizes the importance and complexity of the
rules governing financial responsibility for broker-dealers.\34\
Although the FINOP is a type of principal registration, because its
scope is limited to financial matters, the FINOP does not count toward
the two principal requirement of Rule 611.
---------------------------------------------------------------------------

    \33\ See e.g., CBOE Rule 3.6A(b).
    \34\ See e.g., Phlx Rule 703.
---------------------------------------------------------------------------

    Rule 604.03, Limited Principal--General Securities Sales
Supervisor, is also being extended to all member organizations as new
Rule 612(c). It currently provides that each person associated with a
member organization who is included in the definition of principal in
Rule 604(g) (changing to Rule 611) may register with the Exchange as a
Limited Principal--General Securities Sales Supervisor, or ``SU,'' if
applicable. This provision is being moved, unchanged, in its entirety
to new Rule 612(c). Like the FINOP, the General Securities Sales
Supervisor does not count toward satisfying the two principal
requirement of Rule 611.
    In total, although various other supervisory rules currently
operate, such as Phlx Rule 748,\35\ extending these principal
registration requirements beyond Exchange member organizations doing
business on PSX should strengthen the framework of supervisory rules.
The Exchange believes that the broader application of the principal
registration requirement is an important change. The Exchange also
believes that offering categories of limited principal registration
should help ensure that principals are properly qualified for their
specific functions, such as supervising persons involved in options and
proprietary trading.
---------------------------------------------------------------------------

    \35\ Currently, Rule 748, Supervision, establishes the
supervisory requirement for member organizations, including that all
locations and activities of a member organization be supervised by a
qualified supervisor.
---------------------------------------------------------------------------

Other Rules

    The Exchange proposes to renumber Rule 604(i), Persons Exempt from
Registration, as new Rule 614. No changes are proposed thereto. These
registration exemptions will now apply to all member organizations and
are intended to make clear that registration of certain, specific
persons is not necessary, because of their functions. This provision is
based on exemptions contained in, for example, NASDAQ Rule 1060 and BX
Rule 1060.
    Rule 604(i)(2) provides that member organizations, and persons
associated with a member organization, may pay nonregistered foreign
persons transaction-related compensation based upon the business of
customers they direct to member organizations under certain conditions
detailed in the rule. This provision is intended to cover the payment
of fees to finders,\36\ and is being moved to Rule 614(b), without
change.
---------------------------------------------------------------------------

    \36\ This provision is identical to NASDAQ Rule 1060(b) and BX
Rule 1060(b).
---------------------------------------------------------------------------

    The Exchange proposes to renumber Rule 604(j) as Rule 615, Waiver
of Requirements. Currently, Rule 604(j) provides that the Exchange may,
in exceptional cases and where good cause is shown, waive the
applicable Qualification Examination and accept other standards as
evidence of an applicant's qualifications for registration. Advanced
age or physical infirmity will not individually of themselves
constitute sufficient grounds to waive a Qualification Examination.
Experience in fields ancillary to the investment banking or securities
business may constitute sufficient grounds to waive a Qualification
Examination. The rule is not changing and is based on corresponding
rules of FINRA, NASDAQ and BX.
    The Exchange proposes to adopt Rule 616, Electronic Filing
Requirements for Uniform Forms. Rule 616(a), WebCRD Filing, will
provide that forms required to be filed under the Rule 600 Series shall
be filed electronically through WebCRD.\37\ Currently, some of the
rules in the 600 series state this and others do not, such that
adopting a separate, new rule should be clearer. Similarly, new Rule
616(b), Form U4 and U5 Filing Requirements, will require that initial
filings and amendments of Forms U4 and U5 be submitted electronically.
Furthermore, as part of the member organization's recordkeeping
requirements, it shall retain such records for a period of not less
than three years, the first two years in an easily accessible place, in
accordance with Exchange Act Rule 17a-4, and make such records
available promptly upon regulatory request. In addition, every
application for registration filed with the Exchange shall be kept
current at all times by supplementary amendments via electronic filing
or such other process as the Exchange may prescribe. Such amendments
shall be filed not later than 30 days after the applicant learns of the
facts or circumstances giving rise to the need for the amendment. These
requirements also currently may appear in various rules but not each
applicable rule, such that adopting a separate, new rule should be
clearer.\38\
---------------------------------------------------------------------------

    \37\ This is similar to International Securities Exchange, LLC
(``ISE'') Rules 313.01 and .02.
    \38\ This rule is similar to NASDAQ Rule 1031(d)(3).
---------------------------------------------------------------------------

    The Exchange also proposes to amend OFPA F-34 and EFPA A-7, both
titled Failure to Timely Submit Amendments to Form U4, Form U5 and Form
BD; these are the corollary minor rule plan provisions for Rule 623,
which are being amended only to add new rule numbers 611-613 and 616
and to delete reference to Rule 604.
    The Exchange proposes to amend Rule 620, Trading Floor
Registration, to specifically state the registration categories
governed by the rule, to require all trading floor associated persons
of member organizations to register via Form U4, to delete unnecessary
language and to strengthen a time requirement. Specifically, the
Exchange proposes to add to Rule 620(a), which requires the
registration of Floor Brokers, Specialists and Registered Options
Traders on an Exchange trading floor via Form U4, that the appropriate
registration category on such form is ``Member Exchange (``ME'')''
under ``PHLX.'' This is intended to specify registration categories in
the Exchange's rules whenever possible, for clarity. The Exchange notes
that this provision covers members operating on the trading floor and
that such members are required to successfully complete the Exchange's
Trading Floor Qualification Examination. The Exchange also proposes to
delete a reference in Rule 620(a) to updating Form U4 within a certain
time period, because this requirement will now appear in new Rule 616,
as explained above.
    Currently, Rule 620(b) covers all trading floor personnel, such as
clerks, interns, and other associated persons of member organizations,
not required to register under Rule 620(a) and requires

them to register with the Exchange on a form supplied by the Exchange.
The Exchange proposes to significantly strengthen this requirement by
requiring these individuals to be registered on Form U4 on WebCRD, not
just with the Exchange. Accordingly, these associated persons will be
subject to the comprehensive disclosure obligations of Form U4, which
the Exchange believes is an important enhancement. For example, once a
Form U4 submission is required, the background information of these
individuals will be available electronically within WebCRD for access
by the appropriate regulators. The specific registration category will
be ``Floor Employee (``FE'')'' under ``PHLX,'' which will be stated
expressly in the rule. The Exchange does not intend to require a
qualification examination for non-member trading floor personnel at
this time. The Exchange does not believe that the Series 7, Series 56
or the Exchange's own Trading Floor Qualification Examination are
appropriate for the limited functions of a trading floor clerk, because
these persons are not members trading on the floor and they are
supervised by members. These persons do not execute transactions on the
Exchange, but rather enter orders and report trades, for example, and
related clerical functions.\39\ Specifically, the types of questions
covered by the Exchange's Trading Floor Qualification Examination
include announcing trades, trade allocation and floor broker
responsibilities, all of which are rules that apply to trading floor
members, but not clerks or off-floor persons.
---------------------------------------------------------------------------

    \39\ See Rule 1090.
---------------------------------------------------------------------------

    The Exchange also proposes to amend Rule 620(b) to provide that
following the termination of, or the initiation of a change in the
status of any such personnel of a member organization who has been
issued an Exchange access card and a trading floor badge, the
appropriate Exchange form must be completed, approved and dated by a
member organization principal, officer, or member of the member
organization with authority to do so, and submitted to the appropriate
Exchange department no later than 9:30 a.m. the next business day by
the member organization employer. The Exchange proposes to strengthen
this requirement by adding that such submission should occur, rather
than no later than 9:30 a.m. the next business day, as soon as possible
but no later than 9:30 a.m. the next business day.
    Lastly, the Exchange proposes to amend Rule 623, Fingerprinting, to
adopt a new paragraph (b), which is similar to NASDAQ Rule 1140(d).
Upon filing an electronic Form U4 pursuant to Rule 616 on behalf of a
person applying for registration, a member shall promptly submit
fingerprint information for that person. The Exchange may make a
registration effective pending receipt of the fingerprint information.
The fingerprinting requirement is not new, but rather is being codified
into the appropriate rule.\40\
---------------------------------------------------------------------------

    \40\ OFPA F-25 and EFPA A-4 are the corollary minor rule plan
provisions for Rule 623; these are not changing.
---------------------------------------------------------------------------

Conclusion

    The Exchange believes that these proposed new rules should form a
solid framework for the registration and qualification of all member
organizations and their personnel. As a result of the new registration
requirements, additional persons will become subject to the Exchange's
continuing education requirement in Rule 640. The Exchange will
announce to the membership when these new requirements will be
implemented and available for member organizations to access.
    The Exchange proposes to require that member organizations comply
with the new registration and qualification requirements within 90 days
of the Exchange's issuance of an alert to its membership, announcing
Commission approval; respecting any registration category and related
examination that has a prerequisite, the Exchange proposes to require
its member organizations to comply therewith 90 days after successful
completion of the prerequisite exam.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \41\ in general, and furthers the objectives of: (1)
Section 6(c)(3)(B) of the Act,\42\ pursuant to which a national
securities exchange prescribes standards of training, experience and
competence for members and their associated persons; and (2) Section
6(b)(5) of the Act,\43\ in that it is designed, among other things, 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, by
extending its registration and qualification requirements beyond PSX
users. Overall, as discussed in more detail above, the Exchange
believes that these new requirements bolster the integrity of the
Exchange by helping to ensure that all associated persons engaged in a
securities business are, and will continue to be, properly trained and
qualified to perform their functions, will be supervised, and can be
identified by regulators.
---------------------------------------------------------------------------

    \41\ 15 U.S.C. 78f(b).
    \42\ 15 U.S.C. 78(c)(3)(B).
    \43\ 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 will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2012-23 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-Phlx-2012-23. 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-Phlx-2012-23 and should be submitted on or before March
28, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\44\
---------------------------------------------------------------------------

    \44\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-5555 Filed 3-6-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Page 24561]
[FR Doc No: 2011-10498]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2000-7257; Notice No. 66]

Railroad Safety Advisory Committee; Notice of Meeting

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Announcement of Railroad Safety Advisory Committee (RSAC)
Meeting.

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

SUMMARY: FRA announces the forty-fourth meeting of the RSAC, a Federal
advisory committee that develops railroad safety regulations through a
consensus process. The RSAC meeting topics will include opening remarks
from the FRA Administrator, and status reports will be provided by the
Passenger Hours of Service, Training Standards, Track Safety Standards,
Dark Territory, Passenger Safety, and Medical Standards Working Groups.
This agenda is subject to change, including the possible addition of
further proposed tasks under the Rail Safety Improvement Act of 2008.

DATES: The meeting of the RSAC is scheduled to commence at 9:30 a.m. on
Friday, May 20, 2011, and will adjourn by 4:30 p.m.

ADDRESSES: The RSAC meeting will be held at the Crowne Plaza Washington
National Airport, 1480 Crystal Drive, Arlington, VA 22202. The meeting
is open to the public on a first-come, first-served basis, and is
accessible to individuals with disabilities. Sign and oral
interpretation can be made available if requested 10 calendar days
before the meeting.

FOR FURTHER INFORMATION CONTACT: Larry Woolverton, RSAC Administrative
Officer/Coordinator, FRA, 1200 New Jersey Avenue, SE., Mailstop 25,
Washington, DC 20590,<PHONE_NUMBER>; or Robert Lauby, Deputy Associate
Administrator for Regulatory and Legislative Operations, FRA, 1200 New
Jersey Avenue, SE., Mailstop 25, Washington, DC 20590,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of a
meeting of the RSAC. The RSAC was established to provide advice and
recommendations to FRA on railroad safety matters. The RSAC is composed
of 54 voting representatives from 31 member organizations, representing
various rail industry perspectives. In addition, there are non-voting
advisory representatives from the agencies with railroad safety
regulatory responsibility in Canada and Mexico, the National
Transportation Safety Board, and the Federal Transit Administration.
The diversity of the Committee ensures the requisite range of views and
expertise necessary to discharge its responsibilities. See the RSAC Web
site for details on prior RSAC activities and pending tasks at: http://rsac.fra.dot.gov/. Please refer to the notice published in the Federal
Register on March 11, 1996 (61 FR 9740) for additional information
about the RSAC.

    Issued in Washington, DC, on April 26, 2011.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2011-10498 Filed 4-29-11; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Pages 56851-56853]
[FR Doc No: 2012-22658]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369 (formerly Docket 2007D-0168)]

Draft and Revised Draft Guidances for Industry Describing
Product-Specific Bioequivalence Recommendations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
June 11, 2010, FDA announced the availability of a guidance

for industry entitled ``Bioequivalence Recommendations for Specific
Products,'' which explained the process that would be used to make
product-specific BE recommendations available to the public on FDA's
Web site. The BE recommendations identified in this notice were
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
these draft and revised draft guidances before it begins work on the
final versions of the guidances, submit either electronic or written
comments on the draft and revised draft product-specific BE
recommendations listed in this notice by November 13, 2012.

ADDRESSES: Submit written requests for single copies of the individual
BE guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance recommendations.
    Submit electronic comments on the draft product-specific BE
recommendations 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.

FOR FURTHER INFORMATION CONTACT: K. Geoffrey Wu, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as
a means to develop and disseminate product-specific BE recommendations
and provide a meaningful opportunity for the public to consider and
comment on those recommendations. Under that process, draft
recommendations are posted on FDA's Web site and announced periodically
in the Federal Register. The public is encouraged to submit comments on
those recommendations within 60 days of their announcement in the
Federal Register. FDA considers any comments received and either
publishes final recommendations or publishes revised draft
recommendations for comment. Recommendations were last announced in the
Federal Register of June 14, 2012 (77 FR 35688). This notice announces
draft product-specific recommendations, either new or revised, that are
being posted on FDA's Web site concurrently with publication of this
notice.

II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing new draft product-specific BE recommendations for
drug products containing the following active ingredients:

A

Amoxicillin
Amoxicillin; clavulanate potassium
Amphetamine aspartate; amphetamine sulfate; dextroamphetamine
saccharate; dextroamphetamine sulfate

B

Budesonide
Bupropion hydrochloride (multiple reference listed drugs (RLDs))

C

Calcitonin salmon
Carbidopa; levodopa
Carglumic acid
Ciclesonide
Ciprofloxacin; dexamethasone
Cyclophosphamide

D

Dalteparin sodium

E

Estramustine phosphate sodium

F

Fentanyl citrate

K

Ketoconazole

L

Linagliptin

M

Mesalamine (multiple RLDs and dosage forms)
Methylphenidate hydrochloride (multiple RLDs)

N

Nifedipine

O

Omega-3-acid ethyl esters
Omeprazole

P

Paclitaxel
Pazopanib hydrochloride
Progesterone

R

Rilpivirine hydrochloride
Roflumilast

S

Saxagliptin hydrochloride

T

Telaprevir
Tenofovir disoproxil fumarate
Thioguanine
Thalidomide
Tretinoin (multiple RLDs and dosage forms)

III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing revised draft product-specific BE recommendations
for drug products containing the following active ingredients:

A

Azacitidine
Azelaic acid

C

Capecitabine

E

Estrogen, esterified
Etravirine

H

Hydrochlorothiazide; losartan potassium

L

Lopinavir; ritonavir

P

Phytonadione (multiple RLDs and dosage forms)
Propranolol hydrochloride

S

Sapropterin dihydrochloride
Sumatriptan

T

Tadalafil
Theophylline (multiple RLDs)
Tolterodine tartrate
Topiramate
Trazodone hydrochloride
    For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, please go to
http://www.regulations.gov and enter docket number FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). These
guidances represent the Agency's current thinking on product-specific
design of BE studies to support ANDAs. They do not create or confer any
rights for or on any person and do not operate to bind FDA or the
public. An

alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments on any of the
specific BE recommendations posted on FDA's Web site. 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. The
guidances, notices, and received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22658 Filed 9-13-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Page 71133]
[FR Doc No: 2010-29292]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0571]

Guidance for Industry: The Safety of Imported Traditional Pottery
Intended for Use With Food and the Use of the Term ``Lead Free'' in the
Labeling of Pottery; and Proper Identification of Ornamental and
Decorative Ceramicware; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry: The Safety
of Imported Traditional Pottery Intended for Use With Food and the Use
of the Term `Lead Free' in the Labeling of Pottery; and Proper
Identification of Ornamental and Decorative Ceramicware.'' FDA is
issuing the guidance in response to recent findings of lead
contamination of imported traditional pottery labeled as ``Lead Free.''
The guidance identifies several key practices that manufacturers of
pottery may implement to help ensure that lead contamination of non-
lead glazed (NLG) pottery will not occur and also reminds manufacturers
of existing requirements for properly labeling certain ornamental and
decorative ceramicware as not for use for food-handling purposes.

DATES: Submit either electronic or written comments on the guidance at
any time.

ADDRESSES: 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. Submit written requests for single
copies of the guidance to the Office of Food Safety, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``The
Safety of Imported Traditional Pottery Intended for Use With Food and
the Use of the Term `Lead Free' in the Labeling of Pottery; and Proper
Identification of Ornamental and Decorative Ceramicware.'' FDA is
issuing the guidance in response to recent findings of lead
contamination of imported traditional pottery labeled as ``Lead Free.''
This contamination is occurring even with the use of newer production
practices that do not utilize intentionally added lead (e.g., the use
of non-lead glazes). The guidance identifies several key practices that
manufacturers of pottery may implement to help ensure that lead
contamination of NLG pottery will not occur and also reminds
manufacturers of existing requirements for properly labeling certain
ornamental and decorative ceramicware items as not for use for food-
handling purposes.
    FDA is issuing this guidance as level 1 guidance. Consistent with
FDA's good guidance practices regulation (21 CFR 10.115), the Agency
will accept comments, but is implementing the guidance document
immediately, in accordance with 21 CFR 10.115(g)(2), because the Agency
has determined that prior public participation is not feasible or
appropriate in light of the need to respond expeditiously to numerous
recent reports of lead contamination of imported traditional pottery.
The guidance represents the Agency's current thinking on food safety
considerations relevant to lead contamination of NLG traditional
pottery, and labeling considerations for food use and non food use
pottery that may contain lead. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternate approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
guidance. 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. Electronic Access

    Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29292 Filed 11-19-10; 8:45 am]
BILLING CODE 4160-01-P