FIFRA Scientific Advisory Panel Meeting, August 25-27, 2009

CHARGE QUESTIONS

Evaluation of the Expert System in the Context of the Organization for
Economic Cooperation and Development (OECD) Validation Principles

As discussed in the Preface and Introduction of the white paper, EPA’s
development of the Quantitative Structure Activity Relationship
(QSAR)-based expert system was guided by the OECD principles for (Q)SAR
validation.  The five principles include demonstration of:

a well defined endpoint,

mechanistic interpretation of the model,

defined domain of model applicability,

an unambiguous algorithm, and

appropriate measures of goodness of fit, robustness, and predictivity.

A prototype of the expert system was the subject of an OECD convened
peer-consultation in February 2009, at which time the system was
evaluated using the (Q)SAR validation principles.  Based on input from
this peer consultation, the Agency further refined the expert system,
particularly as it related to the OECD validation principles.  The
components to Charge Question 1 address specific issues concerning the
(Q)SAR validation principles and the subject expert system in the
context of its use to determine the order in which chemicals (i.e.,
food use inert ingredients and antimicrobial pesticides) will be subject
to Tier 1 screening under EPA’s Endocrine Disrupter Screening Program
(EDSP)  (i.e., for prioritization).

A.		Biological Endpoint

The biological endpoint that is predicted by the expert system is
relative binding affinity to the cytosolic rainbow trout estrogen
receptor (ER).  Based on preliminary studies it was anticipated that
food use inert ingredients and antimicrobial pesticides would have low
relative binding affinities.  In addition, an evaluation of the two
respective inventories indicated a wide range of structures and
associated physical-chemical properties (e.g., solubility, Kow, etc).
Consequently, assay methods used to measure binding affinity to
establish the training set were designed to detect low levels of binding
affinity (e.g., testing to solubility in binding assays and cytotoxicity
or solubility, as appropriate, in slice assays). Confirmatory binding
studies (Ki experiments) and transactivation assays were employed to
systematically verify that apparent low affinity binding levels
represented competitive displacement and translated to ER-mediated
transactivation.

Question A1. Please comment on the methods employed and their adequacy
for detecting and measuring ER binding affinity for the compounds in the
two chemical inventories of immediate interest.

Question A2. In the context chemical prioritization for Tier 1
screening, please comment on the decision to measure binding affinity up
to the maximum concentration based on the solution properties of the
chemical, rather than using ligand concentration ‘cut-off’ values of
-4 Log Molar to -3 Log Molar, which have typically been used to conclude
a compound does not bind to the ER.

Question A3. Please also comment on how any in vivo studies that are
available for compounds with low receptor binding affinity could be used
to provide a relative binding affinity ‘cut-off’ value either alone
or in combination with cut-off values based on the maximum solubility of
a ligand in the buffer solution.

B.	Mechanistic Interpretation

Numerous studies have established the alignment of estrogen and other
high affinity ligands within the ER binding domain and indicate that a
distance of 10.2 to 11A between the two H-bonding sites and stable
(non-flexible) ring structure is optimal for binding. These and other
studies lead to the assumption that acyclic compounds would not bind to
the ER, although a systematic analysis across a diversity of structures
was not available in the literature.  In the current study 25 acyclic
compounds across 10 classes present in the inventories were evaluated in
the training set and none were found to bind at a Relative Binding
Affinity (RBA) detection limit of 0.00001%.

Question B1. Please comment on the adequacy of this training set for
supporting the expert system’s rule that acyclic compounds do not bind
to the ER.

Based on studies by Katzenellenbogen et al. (2003 and references
therein) a working hypothesis in developing the training set was that
compounds in the inventories of interest could bind at one site; i.e.,
the A site or the B site, based on the presence of a hydrogen bond donor
or acceptor substituent.  The development of the training sets and the
resultant ER expert system use a chemical hierarchy based on different
binding mechanisms (i.e., A-B binding sites, A binding site only, B
binding site only).

Question B2. Please comment on strengths and limitations of this
mechanistic interpretation for selecting chemicals in the training sets
and for interpreting the observed binding data.

While ER binding can be an initial step in a toxicity pathway leading to
adverse reproductive outcomes (see Figure 1 in the white paper), the ER
binding data in the training set, and the associated expert system, were
not designed to predict in vivo responses.  Rather the expert system was
designed to predict relative ER binding affinity from a chemical’s
structure to support the prioritization of food use inert ingredients
and antimicrobial pesticides for in vitro and in vivo Tier 1 screening,
which is designed to ascertain if a compound has the potential to
interact with the estrogen system.

	Question B3. Please comment on the clarity of the white paper in
describing the differences in (Q)SAR development when the goal is to
predict in vitro ER receptor binding from chemical structure vs. when
the goal is to predict in vivo reproductive/developmental responses from
chemical structure.  Please indicate if additional discussion in the
white paper is needed to establish the relevance of ER binding affinity
(either measured or predicted) to interpret the potential for in vivo
outcomes.

C.	Model Domain

The domain of the current ER expert system includes rules to support
predictions of ER binding affinity for chemicals in the food use inert
ingredient and antimicrobial pesticide inventories.

Question C1. Please comment on the adequacy of the approach that was
used to select chemicals for the training sets in terms of these two
inventories.

D.	Algorithm

The ER expert system provides predictions for each chemical, with each
individual prediction traceable to chemical subgroups, binding mechanism
and endpoint databases.  In developing the expert system several
chemical subgroups were identified as chemicals that contain multiple
functional groups.

Question D1. Please make suggestions for improvements in presenting the
expert rules and their underlying rationale, especially with regard to
groups with multiple functional groups.

Question D2. Please also comment on the ability of the expert rules to
identify chemicals outside the model domain.

E.	Goodness of Fit, Robustness, and Predictivity

Consistent with suggestions by the EDSTAC (1998), and typical processes
for (Q)SAR development, the expert system rules were established through
an iterative process of defining subgroups, gathering empirical data to
refine subgroups rules, followed by collection of additional empirical
data to cover the structural domain and/or until a consistent pattern of
structural rules and activity emerged.  The expert rules permit each
chemical to be assigned to subgroups and an associated estimated binding
affinity value, accompanied by an explanation of the basis for the
estimate as well as of how the estimate compares to measured data for
other members of the same subgroup. The 2009 OECD expert consultation
report on the expert system recognized that standard statistical methods
such as those used to assess regression model QSARs are not necessarily
applicable to expert systems whereas transparency and usefulness as
described in the white paper are more appropriate parameters for
assessing the validity of an expert system. The peer consultation report
found the current approach, with individual predictions traceable to
chemical subgroups, binding mechanism and endpoint databases, to be
appropriate although the report noted that if additional information
could be made available it would facilitate future peer-review on this
issue.

Question E1. Please comment on the adequacy of information presented in
the white paper to evaluate the scientific rationale of how a chemical
is processed through the decision logic; i.e., how a chemical is
assigned to a subgroup with an associated binding affinity value; the
mechanistic rationale for estimates of binding affinity data, including
data for related chemicals; and how it is determined that a chemical is
outside of the domain of the expert system.

Question E2. While to date the Agency is not aware of statistical
approaches that would provide the means to assess goodness-of-fit or
predictivity of expert systems such as the one described here, is the
SAP aware of any statistical approaches or data presentations that could
be amenable for such evaluations?

F.	Transparency and Clarity of the Expert System

In its validation principles, OECD recognized the importance of a
transparent validation process for the development of (Q)SAR models in
order to further enhance their regulatory acceptance of (Q)SAR models.

Question F1. Please provide any additional comment on how well the white
paper’s summary of the expert system conforms to the OECD validation
principles and provide suggestions, as appropriate, to enhance the
clarity or transparency of the expert system’s development and
intended use with regard to the validation principles.

The white paper and associated presentations at the SAP meeting form the
basis of the documentation of the expert system.

Question F2. Please provide any suggestions for preparing the system
documentation that will enhance clarity and understanding for users.

Acyclic Compounds

Acyclic compounds comprise ~58% of the food use inert and antimicrobial
inventories.  As discussed in Question 1c, acyclic compounds were found
to not bind to the ER.  Generally, the absence of hydrogen bonding
groups, or inappropriate geometry can explain the failure of these
chemicals to bind to ER (e.g., see Katzenellenbogen et al., 2003).
Prior to the EPA research described in the SAP review, a diverse set of
acyclic structures had not been evaluated for ER binding affinity.

Question 2-1. Please comment on the extent to which the finding with
acyclic compounds in the FI and AM inventories may be broadly applicable
to other acyclic compounds. Suggestions on an approach to empirically
and efficiently assess a hypothesis that acyclic compounds will not bind
to the ER in other chemical inventories would be welcomed.

Question 2-2.  Please comment on the extent to which the finding with
acyclic compounds in the FI and AM inventories can be applied to other
nuclear steroid receptors in general. Suggestions on an approach to
empirically and efficiently assess a hypothesis that acyclic compounds
will not bind to the androgen receptor would be welcomed.

Prioritization for EDSP Tier 1 Screening

OECD member countries have long recognized the potential of (Q)SAR for
initial assessments for thousands of untested chemicals and to
establish priorities for follow up actions.  The OECD "Integrated
Approaches to Testing and Assessment" framework has encourage the use of
existing knowledge including (Q)SAR to effectively assess and manage
large chemical inventories
(http://www.oecd.org/dataoecd/45/52/40705314.pdf).  In its final
report, the EDSTAC (US EPA 1998a) recommended a tiered approach for
detecting chemicals with endocrine disrupting potential using a
resource-efficient manner that is similar to  OECD's Endocrine
Disruptor Testing and Assessment Framework
(http://www.oecd.org/document/58/0,3343,en_2649_34377_2348794_1_1_1_1,00
.html).  Like the OECD approach, the framework proposed by the EDSTAC
includes use of (Q)SARs and high through put screening assays.

Question 3-1. Based on the characteristics of the (Q)SAR-based expert
system presented in the white paper, please comment on the Agency’s
view that the expert system could be employed to support  "sorting and
prioritizing"  food use inert ingredients and antimicrobial pesticides
for EDSP Tier 1 screening

Cross Species Applicability

ERα, binding assays using full-length recombinant human   SEQ CHAPTER
\h \r 1 ERα and transactivation assays in human T47D cells are in
progress with food use inert ingredients and antimicrobial active
ingredients. Chemicals selected for human ER testing are based on
predictions from the current expert system and designed to cover each
chemical group and bracket the Log Kow ranges within the group.  To date
results show good species concordance with  chemical groups that have
members that bind trout ER also having chemicals that bind human   SEQ
CHAPTER \h \r 1 ER, although the trend is toward fewer members of a
chemical group binding to human ER than to rainbow trout ER (e.g., a
more restrictive Log Kow range for binding within a chemical group for
human ER). Therefore rainbow trout ER appears to bind more low affinity
chemicals within a group but bind the same type of chemicals as does
human ER.

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pesticides for EDSP Tier I screening.

 PAGE

 PAGE   6


1 Campbell County, Kentucky Campbell County is part of the Cincinnati Hamilton, OH KY IN Metropolitan Statistical Area ( MSA) and is located to the east of Kenton County, Kentucky, to the north of Pendleton County, Kentucky, and to the southeast of Cincinnati, Ohio.

EPA s June 29, 2004 proposal on appropriate designations for Kentucky included Campbell County as nonattainment based on the following criteria:

  EPA indicates that Campbell County has monitoring data very close to the PM2.5 standard, and that this indicates a potential to contribute to the PM2.5 violations in the area;

  EPA states that Campbell County has relatively high population, VMT and commuting patterns that are significant enough to contribute to PM2.5 violations in the MSA.

Monitoring Data and Trends The monitor located in Campbell County shows attainment with the PM2.5 standard and has the lowest design value of any monitor within the region. For the 2001 2003 timeframe the design value ( 13.9 µ g/ m 3) demonstrates attainment with the annual standard. The annual concentrations for the area also continue to show a downward trend as depicted in Figure 1, which utilized data from the year 2000 through April 2004.

Figure 1 Northern Kentucky Area PM 2.5 Trend 11 12 13 14 15 16 17 18 19 20 2000 2001 2002 2003 2004 Year A n n u a l A r i th m e t i c M e a n ( m ic r o g r a m s / c u b i c m e t e r )

Campbel, KY Kenton, KY Butler , OH Hamilton, OH 2 Figure 2 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 20.0 Hamilton, OH Butler, OH Kenton, KY Campbell, KY Decline in PM Values for NKY Area 2000 2001 2002 2003 2000 2003 shows decrease of 12% 2000 2003 shows decrease of 12% 2000 2003 shows decrease of 11% 2000 2003 shows decrease of 11%

As depicted in Figure 2 above, monitoring data for the Northern Kentucky area shows an 11 12% decrease from the year 2000 through 2003.

Kentucky believes Campbell County is attaining the PM2.5 standard and that the continuing downward trend in PM2.5 levels indicate no potential to impact the violations in the MSA.

Population, VMT, and Commuting Patterns EPA stated that Campbell County had relatively high population levels that had the potential to impact PM2.5 violations in the area. Campbell County makes up only 5% of the population in the entire MSA, see Figure 3 below. 3 Figure 3 Northern Kentucky Area 2002 Population for USEPA Proposed PM2.5 Nonattainment Counties Campbell, KY 5% Kenton, KY 8% Boone, KY 5% Dearborn, IN 2%

Clermont, OH 10% Butler, OH 18% Warren, OH 9% Hamilton, OH 43%

Therefore, it is Kentucky s position that the population in Campbell County should not be used as a determining factor for potential contributions to PM2.5 violations in Southwestern Ohio.

Based on EPA s June 29, 2004, discussion of VMT data in the region, an attempt was made to segregate county VMT data by state rather than reviewing the data for the region as a whole. This is an unfair comparison. Data presented by EPA shows the overwhelming contribution from VMT in the area to be occurring outside of Campbell County. Figure 4 below outlines total VMT per county for the MSA.

Figure 4 Cincinnati Hamilton MSA VMT per year in thousands 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 Hamilton, OH Clermont, OH Dearborn, IN Butler, OH Boone, KY Warren, OH Kenton, KY Campbell, KY Brown, OH Grant, KY Pendleton, KY Gallatin, KY Ohio, IN VMT 4 EPA s position on traffic and commuting patterns in the June 29 th letter noted that Campbell County has potentially significant numbers of commuters impacting Hamilton County.

Although EPA stated that commuting patterns may play a role in PM2.5 levels throughout the region. EPA states that a notable number of commuters from Kenton and Campbell Counties commute into Hamilton County. However, that statement is contradicted where they state further that  14,946 commuters traveling from Campbell County into Hamilton County is insignificant compared to total Hamilton County commuters in 2002. Based on total number of commuters within the entire region and total VMT data, Kentucky agrees with EPA that commuter data is insignificant and should not be a factor in determining nonattainment designations for Campbell County.

Additionally, when reviewing VMT data, it should be noted that in 2002 Campbell County contributed only 5.6% of the total VMT s in the counties recommended by EPA as having the potential to impact the violating monitors. This factor should also not be used in determining a nonattainment designation for Campbell County.

Therefore, Kentucky believes that Campbell County does not have population values, commuter or VMT potential to contribute to PM2.5 violations in the area.

Additional Regional/ National Controls The implementation of new federal rules to decrease the amount of sulfur in both gasoline and diesel fuel will significantly decrease the amount of SO2 in the entire area. Because of the Low Sulfur Diesel Rule, in 2007, new clean engines operating on 15 ppm sulfur diesel fuel will reduce NOx emissions by 50%, and reduce PM emissions by more than 90%. Due to the Tier 2 Vehicle and Gasoline Sulfur program, by 2006 average national gasoline sulfur levels will be 90% lower.

Upon implementation of the Clean Air Interstate Rule ( CAIR) SO2 emissions from power plants will be reduced nationwide by 3.6 million tons in 2010 ( approximately 40 percent below current levels) and by another 2 million tons per year when the rules are fully implemented ( approximately 70 percent below current levels). NOx emissions would be cut by 1.5 million tons nationwide in 2010 and 1.8 million tons annually in 2015 ( about 65 percent below today s levels).

The first phase of compliance under the CAIR rule to reduce both SO2 and NOx emissions would be required by 2010, allowing substantial emission reductions in the area, by the proposed attainment date for PM2.5 nonattainment areas. 5 Conclusions Based on the factors discussed above, Kentucky believes that Campbell County should be designated attainment for the PM2.5 standard.

  PM2.5 levels continue to decline throughout the entire region. From a review of all monitors in the region, an average 12% decline in PM2.5 levels has occurred from 2000 through 2003. The Campbell monitor in the region is currently showing attainment of the annual PM2.5 standard and has the lowest design value of any monitor within the region.

  Contributions from commuters and vehicle miles traveled in Campbell County have been shown to have no potential to impact PM2.5 levels within the region when compared to the levels from other counties and therefore should not be used to determine nonattainment status.

  Additional emission reductions on a national and regional level will provide substantial additional emission reductions in the region. The anticipated sulfur reductions due to the Low Sulfur Diesel Rule and the Tier 2 Vehicle and Gasoline Sulfur programs, and the Clean Air Interstate Rule ( CAIR) will further lower pollutant levels within this region.

Based on the above conclusions, Campbell County, Kentucky should be designated attainment for the PM2.5 standard. To have this county designated nonattainment would invoke additional, substantial, unnecessary requirements on local government planning agencies. Drastic emission reductions are scheduled to occur in the mobile sector throughout the next several years that will greatly impact pollutant levels in the area. Couple these changes with those anticipated by the CAIR provisions which will further reduce SOx and NOx emissions within the region, the air monitoring data demonstrating attainment of the PM2.5 Standard, and the downward trend in monitored values, the resulting conclusion should be that Campbell County, Kentucky, be designated attainment for the PM2.5 Standard.


[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70277-70279]
[FR Doc No: 2015-28809]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76385; File No. SR-FINRA-2015-045]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend FINRA Rule 7640A (Data Products Offered
by Nasdaq)

November 6, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 29, 2015, Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a National Association of Securities Dealers, Inc.
(``NASD'')) filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I, II
below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as constituting a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 under the Act,\3\ which
renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    FINRA is proposing to amend FINRA Rule 7640A (Data Products Offered
By Nasdaq) to identify the Nasdaq Last Sale Plus (``NLS Plus'') data
feed, which distributes FINRA/Nasdaq Trade Reporting Facility (``FINRA/
Nasdaq TRF'' or ``TRF'') data to third parties.
    Below is the text of the proposed rule change. Proposed new
language is in italics.
* * * * *

7000. Clearing, Transaction and Order Data Requirements, and Facility
Charges

* * * * *

7600. Data Products and Charges for Trade Reporting Facility Services

7600A. Data Products and Charges for FINRA/NASDAQ Trade Reporting
Facility Services

* * * * *

7640A. Data Products Offered by NASDAQ

    (a) through (b) No Change.
    (c) The following data products offered by Nasdaq pursuant to
Nasdaq rules use covered market data:
    (1) No Change.
    (2) Nasdaq Last Sale and Nasdaq Last Sale Plus Data Feeds under
Nasdaq Rule 7039; and
    (3) No Change.
* * * * *

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

    In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    FINRA Rule 7640A describes FINRA's practices relating to the
distribution of market data for over-the-counter (``OTC'') transactions
in NMS stocks generated through the operation of the FINRA/Nasdaq TRF
by Nasdaq, Inc. (``NASDAQ''), the Business Member under the Limited
Liability Company agreement governing the FINRA/Nasdaq TRF (the ``LLC
Agreement''),\4\ and its affiliate, The NASDAQ Stock Market LLC
(``Nasdaq''). Rule 7640A was adopted pursuant to SR-FINRA-2014-002,
which describes in greater detail the TRF framework and FINRA's
oversight of TRF operations and use of FINRA/Nasdaq TRF data in Nasdaq
market data products.\5\ As described in that filing, although the
FINRA/Nasdaq TRF is a facility of FINRA and TRF data is OTC data for
which FINRA is responsible under the Act, NASDAQ, as the Business
Member, has the contractual right to develop market data products using
TRF data. As such, use of FINRA/Nasdaq TRF data is conducted through
Nasdaq, is subject to a separate proposed rule change filed with the
Commission by Nasdaq in its capacity as a self-regulatory organization
(``SRO'') and must satisfy the appropriate statutory standards.
---------------------------------------------------------------------------

    \4\ As approved by its board of directors and the Commission
[sic], effective September 8, 2015, NASDAQ changed its legal name
from The NASDAQ OMX Group, Inc. to Nasdaq, Inc. See Nasdaq, Inc.
Form 8-K Current Report (filed September 8, 2015) (available at
www.sec.gov/Archives/edgar/data/1120193/000119312515314459/d48431d8k.htm).
     FINRA and NASDAQ are in the process of amending the LLC
Agreement to reflect the name change. FINRA will file a separate
proposed rule change to update the FINRA manual, including Rule
7640A, accordingly.
    \5\ See Securities Exchange Act Release No. 71350 (January 17,
2014), 79 FR 4218 (January 24, 2014) (Notice of Filing and Immediate
Effectiveness; File No. SR-FINRA-2014-002).
---------------------------------------------------------------------------

    Paragraph (a) of Rule 7640A codifies the contractual arrangement
between FINRA and NASDAQ and provides for the overall structure
relating to the FINRA/Nasdaq TRF and the permissible use of FINRA/
Nasdaq TRF data. Paragraph (b) provides that fees for market data
products that use FINRA/Nasdaq TRF data are charged by Nasdaq under
Nasdaq rules. Nasdaq must adopt such fees pursuant to a proposed rule
change submitted to the Commission under Section 19(b) of the Act, and
must demonstrate that the fees are consistent with the requirements of
the Act, including that they are reasonable, equitably allocated and
not unfairly discriminatory. Paragraph (c) identifies Nasdaq rules
relating to products that use FINRA/Nasdaq TRF data, including Nasdaq
Rule 7039 relating to the Nasdaq Last Sale (``NLS'') data feeds.\6\
---------------------------------------------------------------------------

    \6\ Pursuant to Nasdaq Rule 7039, the NLS data feeds combine
both Nasdaq Market Center and FINRA/Nasdaq TRF last sale data and
provide real-time execution price, volume and time information for
each reported sale.
---------------------------------------------------------------------------

    On June 22, 2015, the Commission approved proposed rule change SR-
NASDAQ-2015-055, pursuant to which Nasdaq proposed to amend Nasdaq Rule
7039 to fully reflect the NLS Plus data feed and to rename the rule
``Nasdaq Last Sale and Nasdaq Last Sale Plus Data Feeds.'' \7\ As
described in Nasdaq's filing, NLS Plus has been offered since 2010 via
NASDAQ OMX Information LLC, a subsidiary of NASDAQ. As further
described in Nasdaq's filing, in offering NLS Plus, NASDAQ OMX
Information LLC is acting as a redistributor of the last sale products
already offered by NASDAQ's three equity exchanges (Nasdaq, NASDAQ OMX
BX and NASDAQ OMX PSX), as well as volume information provided by the
securities information processors (``SIPs''). As such, NLS Plus
includes transactions from all of NASDAQ's equity markets, as well as
the FINRA/Nasdaq TRF data that is included in the current NLS product,
as contemplated under Rule 7640A. In other words,

NASDAQ OMX Information LLC redistributes last sale data that has been
the subject of a proposed rule change filed with the Commission at
prices that have also been the subject of a proposed rule change filed
with the Commission.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 75257 (June 22,
2015), 80 FR 36862 (June 26, 2015) (Order Approving File No. SR-
NASDAQ-2015-055).
---------------------------------------------------------------------------

    Because the NLS Plus product provides a subset of the same last
sale data that is disseminated by the SIPs, the feed is structured so
that data is not provided to the NLS Plus product sooner than it is
provided to the SIPs. NASDAQ currently monitors for potential latency
by comparing the time of the dissemination of FINRA/Nasdaq TRF data to
the SIPs and to the NLS data feeds, including NLS Plus. In that regard,
NASDAQ has made specific commitments and undertakings with respect to
its products that use FINRA/Nasdaq TRF data, including that, consistent
with the Commission's interpretation of Rule 603(a) under SEC
Regulation NMS, it will not transmit any FINRA/Nasdaq TRF transactions
data to a vendor or user any sooner than the FINRA/Nasdaq TRF transmits
the data to the SIPs.\8\ Thus, FINRA believes that the NLS Plus product
satisfies the requirement that FINRA/Nasdaq TRF transaction data not be
disseminated to a vendor or user any sooner than such data is
transmitted to the SIPs.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 71350 (January 17,
2014), 79 FR 4218 (January 24, 2014) (Notice of Filing and Immediate
Effectiveness; File No. SR-FINRA-2014-002).
---------------------------------------------------------------------------

    Accordingly, FINRA is proposing to amend Rule 7640A(c)(2) to
identify the NLS Plus product in the cross-reference to Nasdaq Rule
7039. FINRA believes that the proposed rule change will ensure that
Rule 7640A accurately reflects the Nasdaq products that use FINRA/
Nasdaq TRF data.
    On July 24, 2015, Nasdaq filed proposed rule change SR-NASDAQ-2015-
088 to amend Nasdaq Rule 7039 with language indicating fees for NLS
Plus.\9\ Specifically, firms that receive the NLS Plus feed pay annual
administration fees for applicable NASDAQ equity exchanges ($1,000 for
Nasdaq, $1,000 for BX and $1,000 for PSX), are liable for NLS or Nasdaq
Basic fees under Nasdaq Rules and, pursuant to SR-NASDAQ-2015-088, pay
a data consolidation fee of $350 per month. As stated in Nasdaq's
filing, the NLS Plus fee is a codification of the existing NLS Plus
fee, with the addition of a monthly data consolidation fee, and as
such, meets the requirements of the Act.
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 75600 (August 4,
2015), 80 FR 47968 (August 10, 2015) (Notice of Filing and Immediate
Effectiveness; File No. SR-NASDAQ-2015-088).
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness. FINRA is proposing that the proposed rule change will be
operative immediately upon filing.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\10\ which requires, among
other things, that FINRA rules be 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. FINRA believes the proposed rule change will provide
greater clarity to members and the public regarding Nasdaq market data
products that use FINRA/Nasdaq TRF data by specifically identifying NLS
Plus under Rule 7640A. In addition, consistent with SR-NASDAQ-2015-055,
NLS Plus is an additional means by which investors may access
information about securities transactions, thereby providing investors
with additional options for accessing information that may help inform
their trading decisions. In approving the NLS Plus product, the
Commission specifically determined that it is consistent with the
Act.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78o-3(b)(6).
    \11\ See Securities Exchange Act Release No. 75257 (June 22,
2015), 80 FR 36862 (June 26, 2015) (Order Approving File No. SR-
NASDAQ-2015-055).
---------------------------------------------------------------------------

    FINRA also believes that the proposed rule change is consistent
with the provisions of Section 15A(b)(5) of the Act,\12\ which
requires, among other things, that FINRA rules provide for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system that
FINRA operates or controls. As noted above, the fees for the NLS Plus
product are not charged by FINRA under FINRA rules, but rather are
charged by Nasdaq under Nasdaq rules. Such fees have been adopted
pursuant to a proposed rule change submitted to the Commission pursuant
to Section 19(b) of the Act.\13\ In its rulemaking, Nasdaq was required
to demonstrate that the fees are consistent with the requirements of
the Act, including that they are reasonable, equitably allocated and
not unfairly discriminatory. In its filing, Nasdaq stated that the fees
for the NLS Plus product are simply a codification of the existing fee
structure, with the addition of the consolidation fee. Nasdaq further
stated that the fees apply equally to all firms that choose to
subscribe to the NLS Plus product, and no firm is required to use NLS
Plus.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78o-3(b)(5).
    \13\ See Securities Exchange Act Release No. 75600 (August 4,
2015), 80 FR 47968 (August 10, 2015) (Notice of Filing and Immediate
Effectiveness; File No. SR-NASDAQ-2015-088).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. As described above, use of
FINRA/Nasdaq TRF data is conducted through Nasdaq, is subject to a
separate proposed rule change filed with the Commission by Nasdaq in
its capacity as an SRO and must satisfy the appropriate statutory
standards. As such, Nasdaq has the obligation of assessing the
potential impacts of the NLS Plus product in its own rulemaking. As
described more fully in SR-NASDAQ-2015-055, Nasdaq's ability to offer
and price NLS Plus is constrained by: (1) Competition between exchanges
and other trading platforms that compete with each other in a variety
of dimensions; (2) the existence of inexpensive real-time consolidated
data and market-specific data and free delayed consolidated data; and
(3) the inherent contestability of the market for proprietary last sale
data.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \14\ and Rule 19b-
4(f)(6) thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act normally does not become operative for 30 days after the date of
its filing. However, Rule 19b-4(f)(6)(iii) permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. FINRA has asked the
Commission to waive the 30-day operative delay so that the proposal may
become operative upon filing. The Commission believes that waiver of
the

30-day operative delay is appropriate because the proposed rule change
merely adds a reference to Nasdaq Last Sale Plus Data Feeds to Rule
7640A to reflect recently approved changes to NASDAQ's rules. Based on
the foregoing, the Commission believes that the waiver of the operative
delay is consistent with the protection of investors and the public
interest.\16\ The Commission hereby grants the waiver and designates
the proposal operative upon filing.
---------------------------------------------------------------------------

    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2015-045 on the subject line.

Paper Comments:

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

All submissions should refer to File Number SR-FINRA-2015-045. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. 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-FINRA-2015-045 and should be
submitted on or before December 4, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-28809 Filed 11-12-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Proposed Rules]
[Page 33749-33751]
[DOCID:fr13jn08-29]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. FDA-2008-N-0310]

Medical Devices; Medical Device Reporting; Baseline Reports;
Companion to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its medical device reporting regulations to remove a requirement for
baseline reports that the agency deems no longer necessary. Currently,
manufacturers provide baseline reports to FDA that include the FDA
product code and the premarket approval or premarket notification
number. Because most of the information in these baseline reports is
also submitted to FDA in individual adverse event reports, FDA is
proposing to remove the requirement for baseline reports. The removal
of this requirement would eliminate unnecessary duplication and reduce
the manufacturer's reporting burden. This proposed rule is a companion
document to the direct final rule published elsewhere in this issue of
the Federal Register.

DATES: Submit written or electronic comments by August 27, 2008.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0310, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see section IX of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Howard A. Press, Center for Devices
and Radiological Health (HFZ-530), Food and Drug Administration, 1350
Piccard Dr, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Why Is This Companion Proposed Rule Being Issued?

    This proposed rule is a companion to the direct final rule
regarding baseline reporting requirements for medical devices that is
published in the final rules section of this issue of the Federal
Register. The direct final rule and this companion proposed rule are
substantively identical. This companion proposed rule provides the
procedural framework to finalize the rule in the event that the direct
final rule receives any significant adverse comment and is withdrawn.
We are publishing the direct final rule because we believe the rule is
noncontroversial, and we do not anticipate receiving any significant
adverse comments. If no significant adverse comment is received in
response to the direct final rule, no further action will be taken
related to this proposed rule. Instead, we will publish a confirmation
document within 30 days after the comment period ends confirming when
the direct final rule will go into effect.
    If we receive any significant adverse comment regarding the direct
final rule, we will withdraw the direct final rule within 30 days after
the comment period ends and proceed to respond to all of the comments
under this companion proposed rule using usual notice-and-comment
rulemaking procedures under the Administrative Procedure Act (APA) (5
U.S.C. 552a et seq). The comment period for this companion proposed
rule runs concurrently with the direct final rule's comment period. Any
comments received under this companion proposed rule will also be
considered as comments regarding the direct final rule and vice versa.
We will not provide additional opportunity for comment.
    A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. In determining whether an adverse comment is
significant and warrants withdrawing a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the APA (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered adverse under this procedure. For example, a comment
recommending an additional change to the rule will not be considered a
significant adverse comment, unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to part of a rule and that part can
be severed from the remainder of the rule, we may adopt as final those
parts of the rule that are not the subject of a significant adverse
comment.
    In the Federal Register of November 21, 1997 (62 FR 62466), you can
find additional information about FDA's direct final rulemaking
procedures in the guidance document entitled ``Guidance for FDA and
Industry: Direct Final Rule Procedures.'' This guidance document may be
accessed at http://www.fda.gov/opacom/morechoices/industry/
guidance.htm.

II. What Is the Background of the Proposed Rule?

    In the Federal Register of December 11, 1995 (60 FR 63578), FDA
published a final rule revising part 803 (21 CFR part 803) and
requiring medical device manufacturers to submit certain reports
relating to adverse events, including a requirement under Sec.  803.55
to submit baseline reports on FDA Form 3417 or an electronic
equivalent. Section 803.55 requires manufacturers to submit baseline
reports when the manufacturer submits the first adverse event report
under Sec.  803.50 for a device model. In addition, Sec.  803.55
requires annual updates of each baseline report.
    The baseline report includes address information for the reporting
and manufacturing site for the device, device identifiers, the basis
for marketing for the device (e.g., the 510(k) number or PMA number),
the FDA product code, the shelf life of the device (if applicable) and
the expected life of the device, the number of devices distributed each
year, and the method used to calculate that number. In the Federal
Register of July 31, 1996 (61 FR 39868), FDA stayed the requirement for
manufacturers to submit information on the number of devices
distributed each year and the method used to calculate that number,
because of questions raised about the feasibility of obtaining such
information and the usefulness of such information once submitted to
FDA.
    With the requirement for these two data elements stayed, the data
submitted in baseline reports largely overlapped with the data
submitted in individual adverse event reports. That is, FDA had access
to much of the information included in baseline reports through the
individual adverse event reports submitted on the MedWatch mandatory
reporting form (FDA Form 3500A). Two notable exceptions were the basis
for marketing and the FDA product code, data elements that were
included in the baseline reports but were not included in the FDA Form
3500A and its instructions.
    The basis for marketing and the FDA product code were, however,
subsequently incorporated into the FDA Form 3500A and its instructions.
In the Federal Register of December 27, 2004 (69 FR 77256), FDA
announced proposed modifications to FDA Form 3500A, which included
adding an entry for the basis for marketing (PMA or 510(k) number). In
the Federal Register of December 7, 2005 (70 FR 72843), FDA announced
that the Office of Management and Budget (OMB) approved these
modifications under the Paperwork Reduction Act of 1995. FDA also
modified the instructions for FDA Form 3500A to state that
manufacturers use the FDA product code when completing the entry for
``Common Device Name'' on FDA Form 3500A.
    With the addition of these two data elements (basis for marketing
and FDA product code) to FDA Form 3500A and its instructions, the
information submitted in FDA Form 3500A largely replicates the
information submitted in baseline reports. As a result, the agency
deems the baseline reporting requirement in Sec.  803.55 no longer
necessary. The agency believes that removing Sec.  803.55 would reduce
the reporting burden for manufacturers without impairing the agency's
receipt of device adverse event information.

III. What Does This Companion Proposed Rule Do?

    FDA proposes to remove Sec.  803.55, which requires manufacturers
to submit a baseline report when they submit the first report under
Sec.  803.50 involving a device model and provide annual updates
thereafter. In addition, FDA proposes to make conforming amendments to
Sec. Sec.  803.1(a), 803.10(c), and 803.58(b) to remove references to
baseline reports and to Sec.  803.55. Finally, FDA proposes to remove
the terms ``device family'' and ``shelf life'' from the definitions in
Sec.  803.3 because these terms are used only in the context of
baseline reports.

IV. What is the Legal Authority for This Proposed Rule?

    FDA is issuing this proposed rule under the device and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 331, 351, 352, 360i, 371, and 374).

V. What is the Environmental Impact of This Proposed Rule?

    The agency has determined under 21 CFR 25.30(h) and (i) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VI. What is the Economic Impact of This Proposed Rule?

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule, if finalized, would not be a significant regulatory
action as defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The rule would amend the existing medical device
reporting regulation to remove Sec.  803.55, which requires that
manufacturers submit baseline reports, and make conforming amendments
to Sec. Sec.  803.1(a), 803.3, 803.10(c), and 803.58(b) to remove
references to baseline reports and to Sec.  803.55 and to remove the
terms ``device family'' and ``shelf life.'' The rule would not impose
any new requirements but instead would remove a reporting requirement
for manufacturers that FDA deems no longer necessary. The agency
certifies that the proposed rule will not have a significant economic
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

VII. How Does the Paperwork Reduction Act of 1995 Apply to This
Proposed Rule?

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by OMB under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VIII. What are the Federalism Impacts of This Proposed Rule?

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency has concluded
that the proposed rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

IX. How Do You Submit Comments on This Proposed Rule?

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic comments or
submissions will be accepted by FDA only through FDMS at http://
www.regulations.gov.

List of Subjects in 21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend 21 CFR part 803 as follows:

PART 803--MEDICAL DEVICE REPORTING

    1. The authority citation for 21 CFR Part 803 continues to read as
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

Sec.  803.1  [Amended]

    2. Section 803.1 is amended in paragraph (a), in the fourth
sentence, by removing the phrase ``and baseline reports''.

Sec.  803.3  [Amended]

    3. Section 803.3 is amended by removing the definitions for
``Device family'' and ``Shelf life''.

Sec.  803.10  [Amended]

    4. Section 803.10 is amended by removing paragraph (c)(3) and
redesignating paragraph (c)(4) as paragraph (c)(3).

Sec.  803.55  [Removed]

    5. Section 803.55 is removed.

Sec.  803.58  [Amended]

    6. Section 803.58 is amended in paragraph (b)(1) by removing
``803.55,''.

    Dated: June 5, 2008.
Jeffrey Shuren,
 Associate Commissioner for Policy and Planning.
[FR Doc. E8-13349 Filed 6-12-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: September 24, 2008 (Volume 73, Number 186)]
[Notices]
[Page 55069-55070]
[DOCID:fr24se08-79]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER08-100-003; ER07-265-003; ER07-1215-004]

Sempra Energy Trading LLC; Sempra Energy Solutions LLC; The Royal
Bank of Scotland plc; Notice of Filing

September 17, 2008.
    Take notice that on September 11, 2008, Sempra Energy Trading LLC,
Sempra Energy Solutions LLC, and The Royal Bank of Scotland plc
(together Applicants) filed a response to Commission staff regarding
its July 30, 2008 filing, affirming that none of the Applicants or any
of their affiliates has erected or will erect barriers to entry into
the relevant market.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    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 October 2, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-22268 Filed 9-23-08; 8:45 am]

BILLING CODE 6717-01-P