[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Proposed Rules]
[Pages 45523-45527]
[FR Doc No: 2012-18800]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0927; FRL-9709-6]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Prevention of Significant Deterioration and Nonattainment New
Source Review; Fine Particulate Matter (PM2.5)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the Virginia State
Implementation Plan (SIP), submitted by the Virginia Department of
Environmental Quality (VADEQ) on August 25, 2011. These revisions
pertaining to Virginia's Prevention of Significant Deterioration (PSD)
and nonattainment New Source Review (NSR) programs incorporate
preconstruction permitting regulations for fine particulate matter
(PM2.5) into the Virginia SIP. A previous PSD program
approval of Virginia's Chapter 80, Article 8 regulations was provided
to the Commonwealth as a ``limited approval'' for reasons that will not
deny this action as being fully approved. In addition, EPA is proposing
to approve these revisions and portions of other related submissions
for the purpose of determining that Virginia has met its statutory
obligations with respect to the infrastructure requirements of the
Clean Air Act (CAA) which relate to Virginia's PSD permitting program
and are necessary to implement, maintain, and enforce the 1997 8-hour
ozone and PM2.5 National Ambient Air Quality Standards
(NAAQS), the 2006 PM2.5 NAAQS, and the 2008 lead NAAQS. EPA
is proposing to approve these revisions in accordance with the
requirements of the Clean Air Act (CAA).

DATES: Written comments must be received on or before August 31, 2012.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2011-0927 by one of the following methods:

    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2011-0927, Ms. Kathleen Cox, Associate
Director, Office of Permits and Air Toxics, Mailcode 3AP10, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2011-0927. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Mr. David Talley,<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Throughout this document, whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA. On August 25, 2011, VADEQ submitted a formal
revision to its State Implementation Plan (SIP) (the August 2011 SIP
submission). The SIP revision consists of amendments to major NSR
permitting regulations under the Virginia Administrative Code (VAC),
specifically Articles 8 and 9 of 9VAC5 Chapter 80. This SIP revision
generally pertains to two federal rulemaking actions regarding
PM2.5. The first is the ``Implementation of the New Source
Review (NSR) Program for Particulate Matter less than 2.5 Micrometers
(PM2.5)'' (NSR PM2.5 Rule), which was promulgated
on May 16, 2008 (73 FR 28321). The second is the ``Prevention of
Significant Deterioration (PSD) for Particulate Matter less than 2.5
Micrometers (PM2.5)--Increments, Significant Impact Levels
(SILs) and Significant Monitoring Concentration (SMC)'' (PSD
PM2.5 Rule), which was promulgated on October 20, 2010 (75
FR 64864).
    Whenever a new or revised NAAQS is promulgated, section 110(a) of
the CAA imposes obligations upon states to submit SIP revisions that
provide for the implementation, maintenance, and enforcement of the new
or revised NAAQS within three years following the promulgation of such
NAAQS--the so called infrastructure SIP revisions. Although states
typically have met many of the basic program elements required in
section 110(a)(2) through earlier SIP submissions in connection with
previous PM standards, states (including all the EPA Region III states)
were still required to submit SIP revisions that address section
110(a)(2) for the 1997 and 2006 PM2.5 NAAQS. In addition to
the August 2011 SIP submission, Virginia has previously submitted SIP
revisions addressing requirements set forth in CAA Section 110(a)(2)
for the 1997 and 2006 PM2.5 NAAQS, as well as the 1997 ozone
and 2008 lead NAAQS. Because these SIP submissions addressed Virginia's
compliance with CAA section 110(a)(2), these SIP submissions are
referred to as infrastructure SIP submissions. These previous
submittals, as well as a technical support document (TSD), are included
in the docket for today's action. The TSD contains a detailed
discussion of these submittals and their relationship to the
requirements of CAA section 110(a)(2).

A. Fine Particulate Matter and the NAAQS

    On July 18, 1997, EPA revised the NAAQS for particulate matter (PM)
to add new standards for fine particles, using PM2.5 as the
indicator. Previously, EPA used PM10 (inhalable particles
smaller than or equal to 10 micrometers in diameter) as the indicator
for the PM NAAQS. EPA established health-based (primary) annual and 24-
hour standards for PM2.5, setting an annual standard at a
level of 15 micrograms per cubic meter ([mu]g/m\3\) and a 24-hour
standard at a level of 65 [mu]g/m\3\ (62 FR 38652). At the time the
1997 primary standards were established, EPA also established welfare-
based (secondary) standards identical to the primary standards. The
secondary standards are designed to protect against major environmental
effects of PM2.5, such as visibility impairment, soiling,
and materials damage. On October 17, 2006, EPA revised the primary and
secondary NAAQS for PM2.5. In that rulemaking, EPA reduced
the 24-hour NAAQS for PM2.5 to 35 [mu]g/m\3\ and retained
the existing annual PM2.5 NAAQS of 15 [mu]g/m\3\ (71 FR
61236).

B. Implementation of NSR Requirements for PM2.5--the NSR PM2.5 Rule

    On May 16, 2008, EPA finalized a rule (the NSR PM2.5
Rule) to implement the 1997 p.m.2.5 NAAQS, including changes
to the NSR program (73 FR 28321). The 2008 NSR PM2.5 Rule
revised the NSR program requirements to establish the framework for
implementing preconstruction permit review for the PM2.5
NAAQS in both attainment and nonattainment areas. The 2008 NSR
PM2.5 Rule also established the following NSR requirements
to implement the PM2.5 NAAQS: (1) Require NSR permits to
address directly emitted PM2.5 and precursor pollutants; (2)
establish significant emission rates for direct PM2.5 and
precursor pollutants (including sulfur dioxide (SO2) and
oxides of nitrogen (NOX); (3) establish PM2.5
emission offsets; and (4) require states to account for gases that
condense to form particles (condensables) in PM2.5 emission
limits.

    Additionally, the 2008 final rule authorized states to adopt
provisions in their nonattainment NSR rules that would allow major
stationary sources and major modifications which will be located, or
take place in, areas designated nonattainment for PM2.5 to
offset emissions increases of direct PM2.5 emissions or
PM2.5 precursors with reductions of either direct
PM2.5 emissions or PM2.5 precursors in accordance
with offset ratios contained in the approved SIP for the applicable
nonattainment area. The inclusion, in whole or in part, of the
interpollutant offset provisions for PM2.5 is discretionary
on the part of the states. In the preamble to the 2008 final rule, EPA
included preferred or presumptive offset ratios, applicable to specific
PM2.5 precursors that states may adopt in conjunction with
the new interpollutant offset provisions for PM2.5, and for
which the state could rely on the EPA's technical work to demonstrate
the adequacy of the ratios for use in any PM2.5 non
attainment area. Alternatively, the preamble indicated that states may
adopt their own ratios, subject to the EPA's approval, that would have
to be substantiated by modeling or other technical demonstrations of
the net air quality benefit for ambient PM2.5
concentrations. The preferred ratios were subsequently the subject of a
petition for reconsideration, which the Administrator granted. EPA
continues to support the basic policy that sources may offset increases
in emissions of direct PM2.5 or of any PM2.5
precursor in a PM2.5 nonattainment area with actual
emissions reductions in direct PM2.5 or PM2.5
precursors in accordance with offset ratios as approved in the SIP for
the applicable nonattainment area. However, we no longer consider the
preferred ratios set forth in the preamble to the 2008 final rule for
PM2.5 NSR implementation to be presumptively approvable.
Instead, any ratio involving PM2.5 precursors adopted by the
state for use in the interpollutant offset program for PM2.5
nonattainment areas must be accompanied by a technical demonstration
that shows the net air quality benefits of such ratio for the
PM2.5 nonattainment area in which it will be applied.

C. PSD PM2.5 Rule

    On October 20, 2010 (75 FR 64865), EPA promulgated the final
``Prevention of Significant Deterioration (PSD) for Particulate Matter
less than 2.5 Micrometers (PM2.5)--Increments, Significant
Impact Levels (SILs) and Significant Monitoring Concentration (SMC)''
(PSD PM2.5 Rule). That rulemaking finalized certain program
provisions under the regulations to prevent significant deterioration
of air quality due to emissions of PM2.5 (i.e., under the
PM2.5 PSD regulations). This final rule supplemented the
final implementation rule for PM2.5, known as the Clean Air
Fine Particle Implementation Rule (CAFPIR) that we promulgated on April
25, 2007 (72 FR 20586), and the PM2.5 NSR Implementation
Rule that we promulgated on May 16, 2008 (73 FR28321). Together, these
three rules established a regulatory framework for implementation of a
PM2.5 program in any area. This final rule established
increments, SILs, and an SMC for PM2.5 to facilitate ambient
air quality monitoring and modeling under the PSD regulations for areas
designated attainment or unclassifiable for PM2.5.

D. Infrastructure Requirements Relating to Virginia's PSD Permit
Program

    As stated earlier, Virginia's PSD and nonattainment programs are
currently operating under a limited SIP approval. However, EPA has
previously determined that this limited approval will not impair
Virginia's ability to enforce its PSD and nonattainment NSR provisions
in a manner consistent with federal requirements (See Section III,
below). With the addition of the PM2.5 requirements
described above, Virginia's nonattainment NSR and PSD programs contain
all of the emission limitations and control measures and other program
elements required by 40 CFR 51.165 and 40 CFR 51.166 related to the
PM2.5 NAAQS. Therefore, we are also proposing to approve the
August 25, 2011 SIP submittal and the relevant portions of Virginia's
infrastructure SIP submittals relating to the PSD permit program under
CAA sections 110(a)(2)(C), (D)(i)(II), and (J) for the 1997
p.m.2.5, 2006 p.m.2.5, and 2008 lead NAAQS. EPA
is also proposing to approve the relevant portion of Virginia's
infrastructure submittal relating to the PSD permit program pursuant to
CAA section 110(a)(2)(D)(i)(II) for the 1997 ozone NAAQS. Additionally,
Virginia has met its obligations with respect to the visibility
requirements of section 110(a)(2)(D)(i)(II) by virtue of its Regional
Haze SIP, which EPA took final action to approve on March 23, 2012 (77
FR 16397). Therefore, EPA is also proposing to approve the portions of
Virginia's infrastructure submittals related to the visibility
requirements of section 110(a)(2)(D)(i)(II) for the 1997 ozone, 1997
p.m.2.5, 2006 p.m.2.5, and 2008 lead NAAQS. As
already noted, the TSD for this action contains a detailed discussion
of the relevant submissions and EPA's rationale for making this
determination.

II. Summary of SIP Revision

    The SIP revision submitted by VADEQ consists of amendments to the
major NSR permitting regulations of Articles 8 and 9 of 9VAC5 Chapter
80. The revision fulfills the federal program requirements established
by the EPA rulemaking actions discussed above. The amendments establish
the major source threshold, significant emission rate and offset ratios
for PM2.5, and establish an allowance for interpollutant
trading for offsets and NSR applicability to PM2.5 precursor
pollutants, pursuant to the May 2008 NSR PM2.5 Rule. In
addition, the amendments add maximum allowable increases in ambient
pollutant concentrations (increments) pursuant to the October 2010 PSD
PM2.5 Rule. Several minor administrative revisions were made
as well.
    The amendments submitted by VADEQ for approval into the SIP were
adopted by the State Air Pollution Control Board on June 10, 2011, and
effective on August 17, 2011. They include revisions to the general
definitions under Chapter 10 of 9VAC5 (specifically 9VAC5-10-30), as
well as to Articles 8 (PSD) and 9 (nonattainment NSR) under Chapter 80
of 9VAC5. The following regulations under Article 8 are revised: 9VAC5-
80-1615 (Definitions), 9VAC5-80-1635 (Ambient Air Increments), and
9VAC5-80-1765 (Sources Affecting Federal Class I Areas--Additional
Requirements). Under Article 9, the regulations at 9VAC5-80-2010
(Definitions) and 9VAC5-80-2120 (Offsets) have been amended. Based upon
EPA's review of the revisions submitted by Virginia for approval into
the SIP, we find these revisions consistent with their federal
counterparts.
    The revisions submitted by the State of Virginia to address the new
PSD requirements for PM2.5 pursuant to the EPA's October 20,
2010 final rule include the regulatory text at 40 CFR 51.166(k)(2),
concerning the implementation of SILs for PM2.5. (See,
9VAC5-80-1715 (Source Impact Analysis)). We stated in the preamble to
the 2010 final rule that we do not consider the SILs to be a mandatory
SIP element, but regard them as discretionary on the part of permitting
authority for use in the PSD permitting process. Nevertheless, the
PM2.5 SILs are currently the subject of litigation before
the U.S. Court of Appeals (DC Circuit). In response to that litigation,
the EPA has requested that the Court remand and

vacate the regulatory text in the EPA's PSD regulations at paragraph
(k)(2) of section 51.166 so that the EPA can make necessary rulemaking
revisions to that text.
    In light of EPA's request for remand and vacatur and our
acknowledgement of the need to revise the regulatory text presently
contained at paragraph (k)(2) of sections 51.166 and 52.21, we do not
believe that it is appropriate at this time to approve that portion of
the State's SIP revision that contains the affected regulatory text in
the State's PSD regulations, specifically new paragraph A.2 of 9VAC5-
80-1715. Instead, we are taking no action at this time with regard to
that specific provision contained in the SIP revision.

III. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information that (1) generated or developed
before the commencement of a voluntary environmental assessment; (2)
prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege Law, Va. Code Sec.  10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. * * *'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.'' Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides
that ``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
PSD and nonattainment NSR programs consistent with the Federal
requirements. In any event, because EPA has also determined that a
state audit privilege and immunity law can affect only state
enforcement and cannot have any impact on Federal enforcement
authorities, EPA may at any time invoke its authority under the CAA,
including, for example, sections 113, 167, 205, 211 or 213, to enforce
the requirements or prohibitions of the state plan, independently of
any state enforcement effort. In addition, citizen enforcement under
section 304 of the CAA is likewise unaffected by this, or any, state
audit privilege or immunity law.

IV. Proposed Action

    Based upon EPA's review of the August 25, 2011 submittal, we find
the regulations consistent with their Federal counterparts. Only the
increment portion of the October 20, 2010 p.m.2.5 rule is a
required PSD program element. Therefore, EPA is proposing to approve
Virginia's SIP revision, with the exception of the portion of the
revision which relates to the SILs, upon which we are taking no action.
Additionally, in light of this SIP revision, EPA is proposing to
approve the portions of Virginia's prior infrastructure submittals
related to the PSD program which were not approved as part of our
October 11, 2011 action (See, 76 FR 62635) as follows: (1) We are
proposing to approve the portions of the December 13, 2007 submittal
which address the section 110(a)(2)(D)(i)(II) requirements related to
Virginia's PSD program for the 1997 ozone NAAQS; (2) We are proposing
to approve the portions of the July 10, 2008 and September 2, 2008
submittals which address the requirements of sections 110(a)(2)(C),
(D)(i)(II), and (J) which relate to Virginia's PSD program for the 1997
p.m.2.5 NAAQS; (3) We are proposing to approve the portions
of the April 1, 2011 submittal which address the requirements of
sections 110(a)(2)(C), (D)(i)(II), and (J) which relate to Virginia's
PSD program for the 2006 p.m.2.5 NAAQS; (4) We are proposing
to approve the portions of the March 9, 2012 submittal which address
the requirements of sections 110(a)(2)(C), (D)(i)(II), and (J) which
relate to Virginia's PSD program for the 2008 lead NAAQS; 5) We are
proposing to approve the portions of the November 13, 2007 submittal
which address the requirements of sections 110(a)(2)(D)(i) which relate
to Virginia's PSD program for the 1997 ozone and 1997
p.m.2.5 NAAQS; and 6) Because Virginia has met its
obligations with respect to the visibility requirements of section
110(a)(2)(D)(i)(II) by virtue of its Regional Haze SIP, which EPA took
final action to approve on March 23, 2012 (77 FR 16397), EPA is also
proposing to approve the portions of Virginia's previous infrastructure
submittals related to the visibility requirements of section
110(a)(2)(D)(i)(II) for the 1997 ozone, 1997 p.m.2.5, 2006
p.m.2.5, and 2008 lead NAAQS.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:

     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule pertaining to NSR requirements for
PM2.5 does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the state, and
EPA notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: July 23, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2012-18800 Filed 7-31-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 125 (Monday, June 30, 2014)]
[Notices]
[Pages 36854-36855]
[FR Doc No: 2014-15201]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72454; File No. SR-ISEGemini-2014-09]

Self-Regulatory Organizations; ISE Gemini, LLC; Order Instituting
Proceedings To Determine Whether To Approve or Disapprove Proposed Rule
Change Relating to Market Maker Risk Parameters

June 24, 2014.

I. Introduction

    On March 10, 2014, the ISE Gemini, LLC (``Exchange'' or ``ISE
Gemini'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend ISE Gemini Rule 804 to mitigate market
maker risk by adopting an Exchange-provided risk management
functionality. The proposed rule change was published for comment in
the Federal Register on March 26, 2014.\3\ The Commission received no
comments on the proposal. On May 7, 2014, pursuant to Section 19(b)(2)
of the Act,\4\ the Commission designated a longer period within which
to either approve the proposed rule change, disapprove the proposed
rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ This order institutes
proceedings under Section 19(b)(2)(B) of the Act \6\ to determine
whether to approve or disapprove the proposed rule change.\7\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 71758 (Mar. 20,
2014), 79 FR 16846 (``Notice'').
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 72118 (May 7, 2014),
79 FR 27355 (May 13, 2014). The Commission determined that it was
appropriate to designate a longer period within which to take action
on the proposed rule change so that it has sufficient time to
consider the proposed rule change. Accordingly, the Commission
designated June 24, 2014 as the date by which it should approve,
disapprove, or institute proceedings to determine whether to
disapprove the proposed rule change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ Relatedly, the Commission is also instituting proceedings
under Section 19(b)(2)(B) of the Act to determine whether to approve
or disapprove a proposed rule change filed by ISE Gemini's
affiliated exchange, International Securities Exchange, LLC
(``ISE''), that mirrors the rule change proposed by ISE Gemini. See
Securities Exchange Act Release No. 34-72455 (June 24, 2014).
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II. Description of the Proposal

    As described in the Notice, the Exchange proposes to amend ISE
Gemini Rule 804 to mitigate market maker risk by adopting an Exchange-
provided risk management functionality. Currently, pursuant to ISE
Gemini Rule 804, the Exchange automatically removes a market maker's
quotes in all series of an options class when certain parameter
settings are triggered. Specifically, there are four parameters that
can be set by market makers on a class-by-class basis and are available
for market maker quotes in single options series and in complex
instruments on the complex order book. Pursuant to the rules, market
makers establish a time frame during which the system calculates: (1)
The number of contracts executed by the market maker in an options
class; (2) the percentage of the total size of the market maker's
quotes in the class that has been executed; (3) the absolute value of
the net between contracts bought and contracts sold in an options
class; and (4) the absolute value of the net between (a) calls
purchased plus puts sold and (b) calls sold plus puts purchased. The
market maker establishes limits for each of these four parameters, and
when the limits are exceeded within the prescribed time frame, the
market maker's quotes in that class are removed or curtailed.\8\
Separately, the Exchange recently adopted another risk management
parameter that permits market maker quotes in all classes to be
automatically removed from the trading system if a specified number of
curtailment events are exceeded within the prescribed time period
across the ISE Gemini market.\9\ It is mandatory for market makers to
enter values into all of the quotation risk management parameters for
all options classes in which it enters quotes.
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    \8\ See Securities Exchange Act Release No. 70644 (October 9,
2013), 78 FR 62785 (October 22, 2013) (SR-Topaz-2013-06).
    \9\ See Securities Exchange Act Release No. 71447 (January 30,
2014), 79 FR 6956 (February 5, 2014) (SR-Topaz-2014-04).
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    In the Notice, the Exchange proposes to further enhance its risk
management offering by implementing an additional functionality that
would permit market maker quotes to be automatically removed from the
trading system if a specified number of curtailment events occur across
ISE Gemini and its affiliated exchange, ISE. According to the Exchange,
a single trading system governs the trading activity on both ISE Gemini
and ISE.\10\
---------------------------------------------------------------------------

    \10\ See Notice, supra note 3.
---------------------------------------------------------------------------

    As proposed, market makers who choose to use this functionality
would be able to set market wide parameters to govern its trading
activity across both ISE Gemini and ISE. Once the parameter is set, the
trading system would count the number of times a market maker's pre-set
curtailment event occurs on each exchange, as specified in ISE Gemini
Rule 804(g), and aggregate them. Once the specified number of
curtailment events across both markets has been reached, the trading
system would automatically remove all of the market maker's quotes in
all classes on both ISE Gemini and ISE. The Exchange believes this
functionality would reduce market maker risk in the event the market
maker suffers from a systems issue or the occurrence of an unusual or
unexpected market activity. As proposed, any quotes sent by the market
maker after the market-wide parameter across both markets has been
triggered would be rejected until the market maker notifies each
exchange--in a non-automated manner, such as email or telephone--that
it is ready to come out of its curtailment. Once notified by the market
maker, the market operations staff for each exchange would reactivate
the market maker's quotes and the market maker would again be active in
on both ISE Gemini and ISE.\11\
---------------------------------------------------------------------------

    \11\ See Notice, supra note 3 for examples illustrating how the
Exchange's market wide risk management parameter would be applied
under the proposal.
---------------------------------------------------------------------------

    According to the Exchange, the proposed risk management
functionality would operate consistently with the firm quote
obligations of a broker-dealer pursuant to Rule 602 of Regulation NMS.
The Exchange anticipates that any marketable orders or executable
quotes received before the proposed functionality is triggered would
automatically execute at the price up to the market maker's size,
regardless of whether such execution would result in executions in
excess of the market maker's pre-set parameters. Further, the Exchange
states that the proposed cross-exchange market wide parameter will not
be mandatory and that market makers who prefer to use their own risk
management systems can set the Exchange parameters to not be triggered.

III. Proceedings To Determine Whether To Approve or Disapprove SR-
ISEGemini-2014-09 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \12\ to determine whether the proposed rule
change should be approved or disapproved. Institution of such
proceedings is appropriate at this time in view of the legal and policy
issues raised by the proposed rule change, as discussed below.
Institution of proceedings does not indicate that the Commission has

reached any conclusions with respect to any of the issues involved.
Rather, as described below, the Commission seeks and encourages
interested persons to provide additional comment on the proposed rule
change.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    As discussed above, the Exchange proposes to amend ISE Gemini Rule
804, which would expand the current risk management offerings by ISE
Gemini and provide for cross-exchange risk management functionality.
The Commission believes that the proposal, which seeks to allow removal
of a market maker's quotes in all classes on both ISE Gemini and ISE
once an aggregated pre-set number of curtailment events on both
exchanges is reached, raises important issues that warrant further
public comment and Commission consideration. Namely, the Commission
believes that proceedings are appropriate to consider, among other
matters, whether the proposal is unfairly discriminatory to any member
of the Exchange and the impact of the proposal on competition among
exchanges.
    Pursuant to Section 19(b)(2)(B) of the Act,\13\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(5)
of the Act, which requires, among other things, that the rules of a
national securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to perfect the mechanism of a free and open market
and a national market systems; and not be designed to permit unfair
discrimination between customers, issuers, brokers, or dealers.'' \14\
The Commission is also instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(8)
of the Act, which requires that rules of a national securities exchange
``do not impose any burden on competition not necessary or appropriate
in furtherance of the purposes of'' the Act.
---------------------------------------------------------------------------

    \13\ Id.
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
concerns identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Sections 6(b)(5) and 6(b)(8) or any other provision of
the Act, or the rules and regulations thereunder. Although there do not
appear to be any issues relevant to approval or disapproval which would
be facilitated by an oral presentation of views, data, and arguments,
the Commission will consider, pursuant to Rule 19b-4, any request for
an opportunity to make an oral presentation.\15\
---------------------------------------------------------------------------

    \15\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Act Amendments of 1975, Senate Comm. on
Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposal should be approved or
disapproved by July 21, 2014. Any person who wishes to file a rebuttal
to any other person's submission must file that rebuttal by August 4,
2014.
    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-ISEGemini-2014-09 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISEGemini-2014-09. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filings 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-ISEGemini-2014-09 and should
be submitted on or before July 21, 2014. Rebuttal comments should be
submitted by August 4, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-15201 Filed 6-27-14; 8:45 am]
BILLING CODE 8011-01-P


EPA ICR No. 2195.06	OMB Control No. 2070-0169

                                                ATTACHMENT C

Sections 408(b)(2)(A)(ii) and 408(e)(1)(C) of the Federal Food, Drug, and Cosmetic Act

 FFDCA Section 408(b)(2)(A)(ii)

    (b) AUTHORITY AND STANDARD FOR TOLERANCE. --
    * * * *
 STANDARD. --
 GENERAL RULE. --
    * * * *
    (ii) DETERMINATION OF SAFETY. -- As used in this section, the term "safe", with respect to a tolerance for a pesticide chemical residue, means that the Administrator has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.

FFDCA Section 408(e)(1)(C)

 ACTION ON ADMINISTRATOR'S OWN INITIATIVE. --
 GENERAL RULE. -- The Administrator may issue a regulation --
    * * * *
 (C) establishing general procedures and requirements to implement this section.


[Federal Register: September 14, 2006 (Volume 71, Number 178)]
[Notices]
[Page 54318-54321]
[DOCID:fr14se06-70]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54413; File No. SR-Amex-2006-72]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto To
Adopt New Rules To Implement on a Pilot Basis an Initial Version of
AEMI, Its Proposed New Hybrid Market Trading Platform for Equity
Products and Exchange Traded Funds

September 7, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 8, 2006, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. On
September 7, 2006, the Exchange filed Amendment No. 1 to the proposed
rule change.\3\ 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\ Amendment No. 1 replaces and supersedes the original filing
in its entirety.
---------------------------------------------------------------------------

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

    The Amex proposes to adopt new rules to implement an initial
version of AEMISM, its proposed new hybrid market trading
platform for equity products and Exchange Traded Funds (``ETFs'').
According to the Exchange, this initial version of AEMI (referred to
herein as ``AEMI-One'') is expected to become operative prior to the
final date set by the Commission for full operation of all automated
trading centers that intend to qualify their quotations for trade-
through protection under Rule 611 of Regulation NMS (``Trading Phase
Date'').\4\ The rule change is being proposed on a pilot basis from the
first day of operation of AEMI-One through the day prior to the Trading
Phase Date.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 53829 (May 18,
2006), 71 FR 30038 (May 24, 2006) (extending compliance dates for
Rules 610 and 611 of Regulation NMS).
---------------------------------------------------------------------------

    The text of the proposed rule change is available on Amex's Web
site (http://www.amex.com), at Amex's principal office, 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 Amex included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange has previously filed a Form 19b-4 with the Commission
(the ``AEMI Rule Filing''),\5\ in which the Exchange described the
implementation of a proposed new hybrid market structure for equity
products and ETFs \6\ that would provide for a single marketplace that
integrates automatic execution and floor-based auction trading. To
facilitate the hybrid market, the Exchange is undertaking a major
technology upgrade and will implement a new trading platform for equity
products and ETFs. This platform, designated as AEMI, is aimed at
providing easy and fast access to automated order execution, as well as
encompassing auction market capabilities for those situations in which
there are order imbalances that require additional liquidity, or price
improvement from the auction process is desired. The proposed operation
of AEMI is described in detail in the AEMI Rule Filing, which includes
in Amendment 5 thereto the text of the proposed new rules that would be
applicable (the ``AEMI Rules''). The Exchange believes that the
operation of AEMI under the AEMI Rules would comply in all respects
with the requirements of Regulation NMS, including the trade-through
provisions of Rule 611.
---------------------------------------------------------------------------

    \5\ Securities Exchange Act Release No. 54145 (July 14, 2006),
71 FR 41654 (July 21, 2006) (File No. SR-Amex-2005-104).
    \6\ As used herein, the term ``equity products'' includes
equities and securities that trade like equities on the Exchange,
such as listed and UTP stocks, closed-end funds, and certain
structured products. The term ``ETFs'' includes Portfolio Depositary
Receipts, Index Fund Shares, Trust Issued Receipts, and Partnership
Units.
---------------------------------------------------------------------------

    The Exchange proposes to adopt, prior to the Trading Phase Date,
currently set for February 5, 2007, a slightly modified version of the
AEMI Rules (the ``AEMI-One Rules'') in connection with the
implementation of the AEMI-One version of AEMI as a limited pilot
program (the ``AEMI-One Pilot''). The Exchange recognizes that, during
the period between the start of its rollout of AEMI and the Trading
Phase Date, other SROs may also be in the process of deploying new or
modified systems intended to achieve full compliance with Rule 611 and
other provisions of Regulation NMS by the Trading Phase Date.
Consequently, the Exchange has designed the AEMI-One Pilot with the
objective in mind of protecting market quality and avoiding market
disruptions during this critical period of change, in addition to
assuring that investor protections are not compromised.
    The Exchange intends to deploy AEMI in a controlled manner during
the AEMI-One Pilot, commencing with two listed equities and two ETF UTP
securities. Following a successful ten-day period of trading, up to
four listed ETFs would be added for an additional five days of trading.
The Exchange would then accelerate the deployment of all equity
products and ETFs on a per-post basis and give notice to members and
publish on its Web site the timing for each group of securities being
migrated to the AEMI platform.
    Because the AEMI Rules are based on the assumption that all
provisions of Regulation NMS are fully operative, the proposed AEMI-One
Rules that appear in Exhibit 5 to the proposed rule change filed with
the Commission are slightly modified from their AEMI Rule counterparts
to reflect the different regulatory environments in effect before and
after the Trading Phase Date. The Exchange expects that the AEMI-One
Pilot would be in effect for only a few months up until the Trading
Phase Date, at which time the AEMI Rules would become effective and
supersede the AEMI-One Rules. The Exchange would then delete the AEMI-
One Rules from its rulebook via a filing with the Commission.
    The operation of AEMI-One would be, in most respects, consistent
with the operation of AEMI as described in the AEMI Rule Filing, except
for the specific provisions discussed below. To further highlight these
differences, the Exchange is providing as Exhibit 4 to the proposed
rule change filed with the Commission a marked version of the AEMI-One
Rules that illustrates the changes from the corresponding AEMI Rules.
    The key provisions of the AEMI-One Rules that differ from the AEMI
Rules are as follows:
     ``Protected quotations'' for trade-through purposes in
AEMI-One would consist of (1) All quotations, whether manual or
automated, at the national best bid or offer (``NBBO'') \7\ that are at
a better price than the next trade that would occur on AEMI; and (2)
quotations not at the NBBO, but priced better than the next trade that
would occur on AEMI, that are the best bid or offer of an automated
trading center that is not displaying a manual quote condition. In
contrast, a ``protected quotation'' under the AEMI Rules (proposed to
be effective on and after the Trading Phase Date) is defined to be
consistent with Rule 611 of Regulation NMS \8\ and must be an automated
quotation that is the best bid or offer of an automated trading center
whether or not at the NBBO.
---------------------------------------------------------------------------

    \7\ Because of the inclusion of manual quotes at the NBBO in the
definition of ``protected quotations,'' the term ``automated NBBO''
in the AEMI Rules would not be relevant during the AEMI-One Pilot.
    \8\ See 17 CFR 242.600(b)(58) (defining ``protected
quotation''); see also 17 CFR 242.600(b)(57) (defining ``protected
bid'' and ``protected offer'').
---------------------------------------------------------------------------

     An ``automated trading center'' under AEMI-One for order-
routing decision purposes would be based on a determination made by the
Exchange that would be publicly available. The Exchange would look
first at whether the away market is publishing quote

conditions that distinguish the away market's quotations as manual or
automated for all of the away market's securities. If the away market
were publishing such quote conditions, the away market would be
identified by AEMI-One as an automated trading center, and order
routing to that market for trade-through purposes would be determined
according to the quote condition (i.e., such orders would be routed to
quotations displayed by that market that are not at the NBBO, unless
those quotations were identified by that market as manual quotes). If
the away market were not publishing such quote conditions, the
determination of whether it were an automated trading center for
purposes of order routing decisions would be based on whether the
Exchange deems the away market to be executing all incoming orders
immediately and without human intervention. AEMI-One would contain a
``routing table,'' which also would be published on the Exchange's Web
site and updated on an inter-day basis to reflect any changes, listing
those markets that are not considered by the Amex to be automated
trading centers. In contrast, an automated trading center under the
AEMI Rules would be based upon the Regulation NMS definition of that
term \9\ and would not be determined independently by the Exchange.
---------------------------------------------------------------------------

    \9\ See 17 CFR 242.600(b)(4) (defining ``automated trading
center'').
---------------------------------------------------------------------------

     During the period of the AEMI-One Pilot, not all away
market centers that trade a particular security and whose quotes are
``protected quotes'' under the AEMI-One Rules may be capable of
receiving intermarket sweep orders (``ISOs''), as such orders are
defined in Regulation NMS.\10\ In such circumstances, AEMI would not
utilize ISOs and instead would generate ``away market obligations.'' An
``away market obligation'' is defined in the AEMI-One Rules as an
immediate or cancel limit order generated by AEMI in connection with
the execution of an order by AEMI and routed to one or more away market
centers to execute against all better-priced protected quotations
displayed by other market centers up to their displayed size. If an
away market that trades a particular security were capable of receiving
ISOs prior to the Trading Phase Date, then the Exchange could choose to
require AEMI to generate and utilize ISOs as the away market
obligations for that market. In contrast, the AEMI Rules effective on
and after the Trading Phase Date would provide for the use of ISOs
exclusively to comply with the trade-through provisions of Rule 611 for
better-priced protected quotations displayed at other market centers.
However, during the AEMI-One Pilot, AEMI would accept and trade all
ISOs received by the Exchange that involve securities traded on the
Exchange that have made the transfer from Amex's legacy systems to the
AEMI platform, similar to the way AEMI would operate following the
AEMI-One Pilot.
---------------------------------------------------------------------------

    \10\ See 17 CFR 242.600(b)(30) (defining ``intermarket sweep
order'').
---------------------------------------------------------------------------

Amendment No. 1

    Amendment No. 1 replaced and superseded the original filing in its
entirety. Amendment No. 1 made a number of revisions to the text of the
proposed rule change. Among other things, Amendment No. 1 (1) Adds a
new proposed rule 126B--AEMI7-One that relates to the Exchange's order-
routing services for orders routed to other trading centers; (2)
requires that, during the period of the AEMI-One Pilot, a member of the
Exchange sending an intermarket sweep order to the AEMI platform must
simultaneously send an intermarket sweep order (or a comparable order)
for the full displayed size of the top of book of every other market
center displaying a better-priced quotation; \11\ and (3) adds
requirements that ``self-help'' be invoked by the Exchange pursuant to
objective industry-wide established interpretations and policies and be
based on repeated failures to respond within one second to orders
attempting to access another trading center's protected automated
quotations, where such failures are attributable to that trading center
and where the Exchange notifies the non-responding trading center of
its determination to invoke self help.\12\ The aforementioned proposed
Rule 126B--AEMI-One (Order Routing Services) provides, among other
things, for (1) Certain related agreements (e.g., on ``give-ups'' and
on the licensing of the routing technology); (2) the equitable
allocation of dues, fees, and other charges; (3) Exchange control of
the routing logic; and (4) the establishment and maintenance of
procedures and internal controls designed to protect confidential and
proprietary information. Finally, the amendment also makes a number of
relatively minor corrections to the proposed rule text, including
certain provisions related to Nasdaq securities that conform to recent
changes in the Exchange's current rules.
---------------------------------------------------------------------------

    \11\ See proposed Rule 131--AEMI-One, heading Intermarket sweep
order.
    \12\ See proposed Rule 126A--AEMI-One.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change, as amended, is
consistent with Section 6(b) of the Act,\13\ in general, and furthers
the objectives of Section 6(b)(5),\14\ 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.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange believes the proposed rule change would impose no
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 by the Exchange on
this proposal.

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 Exchange consents, the Commission will:
    (A) By order approve the proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, 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-2006-72 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2006-72. 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 Amex. 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-2006-72 and should be submitted on or before
October 5, 2006.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-15241 Filed 9-13-06; 8:45 am]

BILLING CODE 8010-01-P


"King, Heidi R."<EMAIL_ADDRESS> 02/20/2008 09:48 AM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Pat Dolwick/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Erika Sasser/RTP/USEPA/US@EPA

Subject

RE: From staff paper page - which county(ies)?

That's great; thanks

I feared the data was no longer available

I hate to bother folks with a wild goose chase, we are all so busy

Best regards,

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Wednesday, February 20, 2008 9:48 AM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: Re: From staff paper page - which county(ies)?

Heidi,

We can get that info for you.  Erika was just trying to answer what we

thought was your broader question, but obviously we were mistaken as to

what you wanted to know.  We'll trt to get the answer for you this

morning.

Lydia

----- Original Message -----

From: "King, Heidi R."<EMAIL_ADDRESS> Sent: 02/20/2008 09:42 AM EST

To: Lydia Wegman

Cc: Pat Dolwick; Tricia Crabtree; Erika Sasser

Subject: RE: From staff paper page - which county(ies)?

Hi Lydia,

Is it possible to get in touch with the lead on the Ozone NAAQS Staff

Paper Chapter 7 to help me find a label for a data point?

If the answer is not available to OMB then that would be the most

efficient answer - I hate to spend days on this

Thanks very much,

heidi

-----Original Message-----

From: King, Heidi R.

Sent: Tuesday, February 19, 2008 9:52 AM

To<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: RE: From staff paper page - which county(ies)?

Thank you very much, but my question must have been misunderstood.

I am simply looking for a label on a data point in a publicly available

document (I don't have any questions about how standards interface, what

data is a better reference point, etc)

Who would be able to answer my question about the data point in the

2004-2004 data?  I am just looking for a label on a data point --

Thank you, Erika et al,

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Saturday, February 16, 2008 12:48 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: RE: From staff paper page - which county(ies)?

Heidi--

The figure in the staff paper was based on 2002-2004 data, so it's

pretty out of date at this point.  We have done some looking at this

question of how primary and W126 would interface, but now that we have

2005 and 2006 data available, we've been focusing on the 2003-2005 and

2004-2006 periods, which are probably better reference points (although

by the time of designations, things would probably look different

still).   Based on data from these more recent periods, we have found no

counties that would violate a W126 of 21 but meet a primary 8-hour

standard of 0.075.   If you're interested in more specifics, let me

know.

Erika

             Pat

             Dolwick/RTP/USEP

             A/US                                                    To

                                      "King, Heidi R."

             02/15/2008 09:11<EMAIL_ADDRESS>

             PM                                                      cc

                                      Erika Sasser/RTP/USEPA/US@EPA

                                                                Subject

                                      RE: From staff paper page - which

                                      county(ies)?(Document link: Erika

                                      Sasser)

Heidi,

Sorry, I was out of the office today.  As of Thursday afternoon, I

believe Erika Sasser was working out the response.

Pat Dolwick

Physical Scientist

USEPA/OAQPS Mail Drop C439-03

Research Triangle Park, NC 27711

Phone:<PHONE_NUMBER>

E-mail<EMAIL_ADDRESS> -----"King, Heidi R."<EMAIL_ADDRESS>wrote: -----

 To: Pat Dolwick/RTP/USEPA/US@EPA

 From: "King, Heidi R."<EMAIL_ADDRESS>  Date: 02/15/2008 01:46PM

 Subject: RE: From staff paper page - which county(ies)?

 Hi Pat,

 Any follow up?

 Thx,

 h

 -----Original Message-----

 From<EMAIL_ADDRESS><EMAIL_ADDRESS>  Sent: Thursday, February 14, 2008 1:12 PM

 To: King, Heidi R.

 Cc<EMAIL_ADDRESS>  Subject: Re: From staff paper page - which county(ies)?

 Heidi,

 I do not have this information (more ambient data, than modeled), but

have forwarded your question on to the appropriate folks.  If you don't

have an answer shortly, please let me know & I'll see where we are at w/

it.

 Thanks,

 Pat Dolwick

 Physical Scientist

 USEPA/OAQPS Mail Drop C439-03

 Research Triangle Park, NC 27711

 Phone:<PHONE_NUMBER>

 E-mail<EMAIL_ADDRESS>              "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Pat Dolwick/RTP/USEPA/US@EPA

             02/14/2008 10:52                                        cc

             AM                       Lydia Wegman/RTP/USEPA/US@EPA

                                                                Subject

                                      From staff paper page - which

                                      county(ies)?

 Hi Pat,

 Thanks in advance for your help. I'm looking for the names of the

 county(ies) that appear to attain the 8-hour standard of 75ppb while

also exceeding W126 of 21 on figure 7-1 on page 7-18 of the Staff Paper

(cut and paste below).  Amy thought that Lydia had sent this to either

her or to Art earlier, but I / we cannot find it.

 I also tried to figure out which county from the attached map from the

proposal, but I'm afraid it was not as easy as "Where's Waldo".

 I appreciate your help;

 heidi

 (See attached file: Ozone NAAQS Proposal Maps W126.pdf)(Embedded image

moved to file: pic27248.jpg)


[Federal Register: September 22, 2010 (Volume 75, Number 183)]
[Notices]
[Page 57787-57789]
[DOCID:fr22se10-74]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0332; FRL-8846-2]

Methyl Parathion; Notice of Receipt of Request to Voluntarily
Cancel Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of a request by the registrant to voluntarily cancel
their section 24(c) Special Local Needs (SLN) registrations of certain
products containing the pesticide methyl parathion. The request would
delete methyl parathion use in or on sweet potatoes, walnuts, and yams.
The request would terminate the last methyl parathion products
registered for use in the United States. EPA intends to grant this
request at the close of the comment period for this announcement unless
the Agency receives substantive comments within the comment period that
would merit its further review of the request, or unless the registrant
withdraws its request. If this request is granted, any sale,
distribution, or use of products listed in this notice will be
permitted after the registration has been canceled only if the sale,
distribution, or use is consistent with the terms as described in the
final order.

DATES: Comments must be received on or before October 22, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID)

number EPA-HQ-OPP-2009-0332, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility's telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0332. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available in the electronic docket, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The hours of operation of this Docket Facility are from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility's telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kelly Ballard, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry, pesticide
users, and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests To Cancel and/or Amend
Registrations To Delete Uses

    This notice announces receipt by EPA of a request from the
registrant, United Phosphorus, Inc., to cancel certain methyl parathion
product registrations. Methyl parathion is a restricted use
organophosphate insecticide and acaricide. In a letter dated August 6,
2010, United Phosphorus, Inc., requested EPA to cancel certain
pesticide product registrations identified in Table 1 of Unit III.
Specifically, the registrant requested voluntary cancellation of all
section 24(c) SLN registrations for methyl parathion. This cancellation
request is directly related to the Memorandum of Agreement (MOA) signed
on March 29, 2010, between Cheminova A/S, Cheminova, Inc., United
Phosphorus, Inc., and the Agency. In this MOA, the registrants agreed
to voluntarily cancel all methyl parathion product registrations
including the parent product for these SLNs. The Agency previously
issued a cancellation order for the parent products containing methyl
parathion on July 27, 2010 (75 FR 43981). This action on the
registrant's request will terminate the last methyl parathion products
registered in the United States.

III. What action is the agency taking?

    This notice announces receipt by EPA of a request from a registrant
to cancel certain methyl parathion product registrations. The affected
products and the registrant making the request are identified in Tables
1 and 2 of this unit.
    Unless a request is withdrawn by the registrant or if the Agency
determines that there are substantive comments that warrant further
review of this request, EPA intends to issue an order canceling the
affected registrations.

             Table 1--Methyl Parathion Product Registrations With Pending Requests for Cancellation
----------------------------------------------------------------------------------------------------------------
           Registration No.                     Product name                            Company
----------------------------------------------------------------------------------------------------------------
AL-000001............................  Penncap-M Microencapsulated    United Phosphorus, Inc.
                                        Insecticide.
AR-000006............................  Penncap-M Microencapsulated    United Phosphorus, Inc.
                                        Insecticide.
CA-000001............................  Penncap-M Microencapsulated    United Phosphorus, Inc.
                                        Insecticide.
LA-090005............................  Penncap-M Microencapsulated    United Phosphorus, Inc.
                                        Insecticide.
MS-000009............................  Penncap-M Microencapsulated    United Phosphorus, Inc.
                                        Insecticide.
TX-990012............................  Penncap-M Microencapsulated    United Phosphorus, Inc.
                                        Insecticide.
----------------------------------------------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record for
the registrant of the products listed in Table 1 of this unit.

Table 2--Registrants Requesting Voluntary Cancellation and/or Amendments
------------------------------------------------------------------------
            EPA company No.                  Company name and address
------------------------------------------------------------------------
70506..................................  United Phosphorus, Inc. 630
                                          Freedom Business Center, Suite
                                          402 King of Prussia, PA 19406.
------------------------------------------------------------------------

IV. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register.
    Section 6(f)(1)(B) of FIFRA requires that before acting on a
request for voluntary cancellation, EPA must provide a 30-day public
comment period on the request for voluntary cancellation or use
termination. In addition, FIFRA section 6(f)(1)(C) requires that EPA
provide a 180-day comment period on a request for voluntary
cancellation or termination of any minor agricultural use before
granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The EPA Administrator determines that continued use of the
pesticide would pose an unreasonable adverse effect on the environment.
    The methyl parathion registrant has requested that EPA waive the
180-day comment period. Accordingly, EPA will provide a 30-day comment
period on the proposed requests.

V. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product
cancellation or use deletion should submit the withdrawal in writing to
the person listed under FOR FURTHER INFORMATION CONTACT.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
action. If the request for voluntary cancellation is granted, the
Agency intends to publish the cancellation order in the Federal
Register.
    As specified in the MOA, registrants are prohibited from selling
and distributing end-use products as of December 31, 2012. Persons
other than the registrants are permitted to sell or distribute end-use
products prior to August 31, 2013. All sales and distributions of end-
use products shall be prohibited as of August 31, 2013, except for
exports consistent with section 17 of FIFRA or for proper disposal.
Additionally, all use of existing stocks of the end-use products shall
be prohibited as of December 31, 2013.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 15, 2010.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2010-23722 Filed 9-21-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 68 (Thursday, April 9, 2015)]
[Notices]
[Page 19111]
[FR Doc No: 2015-08122]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Aircraft
Registration Renewal

AGENCY: Federal Aviation Administration (FAA), DOT

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on December 22, 2014. The information collected on an
Aircraft Registration Renewal Application, AC Form 8050-1B, is used by
the FAA to verify and update aircraft registration information
collected for an aircraft when it was first registered.

DATES: Written comments should be submitted by May 11, 2015.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0729
    Title: Aircraft Registration Renewal.
    Form Numbers: AC Form 8050-1B
    Type of Review: Revision of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on December 22, 2014 (79 FR 76437). The information
collected on an Aircraft Registration Renewal Application (AC Form
8050-1B) is used by the FAA to verify and update the aircraft
registration information collected for an aircraft when it was first
registered. The updated registration database will then be used by the
FAA to monitor and control U.S. airspace and to distribute safety
notices and airworthiness directives to aircraft owners.
    Respondents: Approximately 95,653 aircraft owners.
    Frequency: Information is collected triennially.
    Estimated Average Burden per Response: 30 minutes to complete the
form manually, 10 minutes to complete the form electronically.
    Estimated Total Annual Burden: 23,912 hours.

    Issued in Washington, DC on April 2, 2015.
Ronda Thompson,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2015-08122 Filed 4-8-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44625-44626]
[FR Doc No: 2017-20375]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4952]

Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance, and Good Clinical Practice; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
educational conference co-sponsored with the Society of Clinical
Research Associates (SOCRA). The public workshop on FDA's clinical
trial requirements is designed to aid the clinical research
professional's understanding of the mission and authority of FDA and to
facilitate interaction with FDA representatives. The program will focus
on the relationships among FDA and clinical trial staff, investigators,
and institutional review boards (IRBs). Individual FDA representatives
will discuss the informed consent process and informed consent
documents; regulations relating to drugs, devices, and biologics; and
inspections of clinical investigators, IRBs, and research sponsors.

DATES: The public workshop will be held on November 15 and 16, 2017,
from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at the Wyndham Lake Buena
Vista Resort, 1850 Hotel Plaza Blvd., Lake Buena Vista, FL 32830, 407-
828-4444.

FOR FURTHER INFORMATION CONTACT: Kim Prenter, Food and Drug
Administration, 15100 NW. 67th Ave., Suite 400, Miami Lakes, FL 33014,
305-816-1474, Fax:<PHONE_NUMBER>; or Society of Clinical Research
Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA
18914,<PHONE_NUMBER>, Fax<PHONE_NUMBER>, email<EMAIL_ADDRESS>Web
site: https://www.socra.org.

SUPPLEMENTARY INFORMATION:

I. Background

    The public workshop helps fulfill the Department of Health and
Human Services' and FDA's important mission to protect the public
health. The public workshop will provide those engaged in FDA-regulated
(human) clinical trials with information on a number of topics
concerning FDA requirements related to clinical investigations,
informed consent, and inspections of clinical investigators and IRBs.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The public workshop helps to achieve objectives set
forth in section 406 of the Food and Drug Administration Modernization
Act of 1997 (21 U.S.C. 393), which includes working closely with
stakeholders and maximizing the availability and clarity of information
to stakeholders and the public. The workshop also is consistent with
the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121), as outreach activities by Government agencies to small
businesses.

II. Topics for Discussion

    Topics for discussion include the following: (1) What FDA Expects
in a Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--
Science, Regulation, Error and Safety; (3) Part 11 Compliance--
Electronic Signatures; (4) Informed Consent Regulations; (5) IRB
Regulations and FDA Inspections; (6) Keeping Informed and Working
Together; (7) FDA Conduct of Clinical Investigator Inspections; (8)
Meetings with FDA: Why, When, and How; (9) Investigator Initiated
Research; (10) Medical Device Aspects of Clinical Research; (11)
Working with FDA's Center for Biologics Evaluation and Research; and
(12) The Inspection Is Over--What Happens Next? Possible FDA Compliance
Actions.

III. Participating in the Public Workshop

    Registration: Attendees are responsible for their own
accommodations. Please mention SOCRA to receive the hotel room rate of
$129 plus applicable taxes (available until October 16, 2017, or until
the SOCRA room block is filled). For additional registration and
meeting information, visit https://www.socra.org/ or https://www.socra.org/conferences-and-education/live-conferences/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference/register/.
    Registrations fees are as follows: $575 for SOCRA members, $650 for
non-members (includes membership), $450 for Federal Government members,
$525 for Federal Government non-members, and fee waived for FDA
Employees.
    The registration fee covers expenses including refreshments, lunch,
materials, and speaker expenses. Registration for the conference is
open through November 14, 2017.
    If you need special accommodations due to a disability, please
contact Kim Prenter (see FOR FURTHER INFORMATION CONTACT) at least 10
days in advance.
    Other Issues for Consideration: Extended periods of question and
answer and discussion have been included in the program schedule. This
program offers 13.3 hours of Continuing Medical Education (CME) and
Continuing Nursing Education (CNE) credit. CME for Physicians: The
Society of Clinical Research Associates is accredited by the
Accreditation Council for Continuing Medical Education to provide
continuing medical education for physicians. CNE for Nurses: The
Society of Clinical Research Associates is accredited as a provider of
continuing nursing education by the American Nurses Credentialing
Center's Commission on Accreditation. ANCC/PSNA Provider Reference
Number: 205-3-A-09.

    Dated: September 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20375 Filed 9-22-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11972-11973]
[FR Doc No: 2019-06130]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9991-22-OA]

Meetings of the Local Government Advisory Committee and the Small
Communities Advisory Subcommittee

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Local Government Advisory Committee (LGAC) will meet in
Washington, DC, on Thursday, May 2, 2019, 9:30 a.m.-5:35 p.m. (EDT),
and Friday, May 3, 2019, 10:00 a.m.-12:30 p.m. (EDT). The focus of the
Committee meeting will be on issues pertaining to water and water
infrastructure issues; Waters of the U.S., emerging contaminants;
superfund and brownfields; risk communication and other issues in EPA's
Strategic Plan. The Small Communities Advisory Subcommittee (SCAS) will
meet in Washington, DC, on Friday, May 3, 2019, 8:00 a.m.-9:00 a.m.
(EDT). The Subcommittee will discuss water infrastructure, community
revitalization, agricultural issues, and other issues and
recommendations to the Administrator regarding environmental issues
affecting small communities.
    These are open meetings, and all interested persons are invited to
participate. The SCAS will hear comments from the public between 8:40
a.m. and 8:45 a.m. on Friday, May 3, 2019. The LGAC will hear comments
from the public between and 10:20 a.m. and 10:30 a.m. on Friday, May 3,
2019. Individuals or organizations wishing to address the Subcommittee
or the

Committee will be allowed a maximum of five minutes to present their
point of view. Also, written comments should be submitted
electronically to [email protected] for the LGAC and to
[email protected] for the SCAS. Please contact the Designated
Federal Officers (DFO) at the numbers listed below to schedule a time
on the agenda. Time will be allotted on a first-come first-serve basis,
and the total period for comments may be extended if the number of
requests for appearances requires it.

ADDRESSES: The Local Government Advisory Committee meetings will be
held at the U.S. Environmental Protection Agency, Conference Room 1153,
William Jefferson Clinton EPA East Building, 1201 Constitution Avenue
NW, Washington, DC 20460. The Small Communities Advisory Subcommittee
meetings will be held at the U.S. Environmental Protection Agency,
Conference Room 1153, William Jefferson Clinton EPA East Building, 1201
Constitution Avenue NW, Washington, DC 20460. Meeting summaries will be
available after the meeting online at www.epa.gov/ocir/scas_lgac/lgac_index.htm and can be obtained by written request to the DFO. In
the event of cancellation for unforeseen circumstances, please contact
the the designated federal officer(s) for reschedule information.

FOR FURTHER INFORMATION CONTACT: Local Government Advisory Committee
(LGAC) contact Frances Eargle, Designated Federal Officer, at (202)
564-3115 or email at [email protected]. and Small Communities
Advisory Subcommittee (SCAS), contact Cristina Mercurio, Designated
Federal Officer, at<PHONE_NUMBER> or email at
[email protected].
    Information on Services for Those With Disabilities: For
information on access or services for individuals with disabilities,
please contact Frances Eargle at<PHONE_NUMBER> or email at
[email protected] . To request accommodation of a disability,
please request it 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

    Dated: March 11, 2019.
Jack Bowles,
Director, State and Local Relations, Office of Congressional and
Intergovernmental Relations.
[FR Doc. 2019-06130 Filed 3-28-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 24, 2007 (Volume 72, Number 100)]
[Notices]
[Page 29147]
[DOCID:fr24my07-58]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TS07-5-000]

Neptune Regional Transmission System; Notice of Request for
Exemption

May 17, 2007.
    Take notice that on May 10, 2007, Neptune Regional Transmission
System filed a request for exemption from standards of conduct,
pursuant to Part 358 of the Commission's regulations and Order No.
2004.
    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 and 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 Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 11, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-9992 Filed 5-23-07; 8:45 am]

BILLING CODE 6717-01-P