[Federal Register: February 25, 2010 (Volume 75, Number 37)]
[Notices]
[Page 8691-8693]
[DOCID:fr25fe10-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  3

February 17, 2010.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-749-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits an executed Wholesale
Market Participation Agreement.
    Filed Date: 02/05/2010.
    Accession Number: 20100216-0236.
    Comment Date: 5 p.m. Eastern Time on Friday, February 26, 2010.

    Docket Numbers: ER10-750-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc et al submits to the Commission
revisions

to the rules governing the Forward Capacity Market etc.
    Filed Date: 02/16/2010.
    Accession Number: 20100216-0235.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-751-000.
    Applicants: Xcel Energy Services Inc.
    Description: Northern States Power Company et al submits Original
Sheet 1 et al to FERC Electric Tariff, Original Volume 3--FERC Electric
Rate Schedule 280-NSP.
    Filed Date: 02/05/2010.
    Accession Number: 20100216-0234.
    Comment Date: 5 p.m. Eastern Time on Friday, February 26, 2010.

    Docket Numbers: ER10-752-000.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc et al submits transmittal letter
describing two minor changes to the ISO New England Financial Assurance
Policy etc.
    Filed Date: 02/16/2010.
    Accession Number: 20100216-0237.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-753-000.
    Applicants: California Independent System Operator Corporation.
    Description: The California Independent System Operator Corporation
submits filing to modify the credit policy and billing provisions of
the ISO tariff and to make related tariff changes.
    Filed Date: 02/05/2010.
    Accession Number: 20100216-0233.
    Comment Date: 5 p.m. Eastern Time on Friday, February 26, 2010.

    Docket Numbers: ER10-754-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool submits an executed service
agreement for Network Integration Transmission Service etc.
    Filed Date: 02/05/2010.
    Accession Number: 20100216-0246.
    Comment Date: 5 p.m. Eastern Time on Friday, February 26, 2010.

    Docket Numbers: ER10-755-000.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Company submits an Interconnection
Agreement with the Waverly Municipal Electric Utility, dated 2/1/2010.
    Filed Date: 02/16/2010.
    Accession Number: 20100216-0229.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-756-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits an executed Wholesale
Market Participation Agreement entered into among PJM, Recurrent Energy
Develo p.m.ent Holdings, LLC et al executed on 1/8/2010.
    Filed Date: 02/12/2010.
    Accession Number: 20100216-0230.
    Comment Date: 5 p.m. Eastern Time on Friday, March 5, 2010.

    Docket Numbers: ER10-757-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits Notice of Cancellation of Service
Agreement 228 under PacifiCorp's Seventh Revised Volume 11 Open Access
Transmission Tariff.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0211.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-758-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits revised sheets to its Open Access
Transmission Tariff reflecting updated Load Ratio Share figures to be
effective 7/31/10 and an updated Oregon District Access Monthly Demand
Charge.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0212.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-759-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits filing seeking Commission approval
to revise certain sections of its Open Access Transmission Tariff
related to PacifiCorp's Load Ration Share calculation.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0213.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-760-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits notice of
cancellation of the Point-to-Point Transmission Service Agreement
between SPP as Transmission Provider and Southwestern Public Service
Company et al as Transmission Customer.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0214.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-761-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits amendments to its
Open Access Transmission Tariff to include a new Attachment AR and
related provisions, which provide for a screening study process to
evaluate potential Long-Term Service etc.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0215.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-762-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits an executed Small
Generator Interconnection Agreement between SPP as Transmission
Provider et al.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0219.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-763-000.
    Applicants: Idaho Power Company.
    Description: Idaho Power Company submits Second Restated and
Amended Transmission Facilities Agreement between Idaho Power and
PacifiCorp.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0217.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-764-000.
    Applicants: Central Maine Power Company.
    Description: Central Maine Power Company submits Engineering and
Procurement Agreement.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0216.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Docket Numbers: ER10-765-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp request to
modify the ISO tariff in order to reduce barriers to the participation
of demand response in the ISO's market through the implementation of a
new demand response etc.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0218.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 9, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,

interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 email notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please email<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-3797 Filed 2-24-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 25, 2005 (Volume 70, Number 226)]
[Notices]
[Page 71116-71117]
[DOCID:fr25no05-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-97-000]

Gas Transmission Northwest Corporation; Notice of Proposed
Changes in FERC Gas Tariff

November 18, 2005.
    Take notice that on November 16, 2005, Gas Transmission Northwest
Corporation (GTN) tendered for filing as

part of its FERC Gas Tariff, Third Revised Volume No. 1-A, the
following tariff sheets, to become effective December 19, 2005:

Fourth Revised Sheet No. 117
Third Revised Sheet No. 155

    GTN states that these tariff sheets are being submitted to add
tariff language that will allow GTN to mutually agree to provide
nomination and consolidated invoicing services to shippers requesting
such services.
    GTN further states that a copy of this filing has been served on
GTN's jurisdictional customers and interested state regulatory
agencies.
    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 in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not 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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6503 Filed 11-23-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4100-4104]
[FR Doc No: 2018-01536]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82569; File No. SR-Phlx-2018-10]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Section
VIII of the Exchange's Pricing Schedule

January 23, 2018.
    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 January 16, 2018, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Section VIII of the Exchange's
Pricing Schedule, Nasdaq PSX Fees, to modify the fee schedule for PSX
TotalView to reflect substantial enhancements to the product since the
current fees were set in 2010. Specifically, the Exchange proposes to:
(i) Introduce a monthly non-display usage fee of $50 per Professional
Subscriber for PSX TotalView based upon Direct Access; and (ii)
increase the monthly enterprise license fee for non-display usage of
PSX TotalView from $16,000 to $17,000 based upon Direct Access. The
proposal is described in further detail below.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to adjust the fee schedule for PSX TotalView
to reflect substantial enhancements to the product since the current
fees were set in 2010.\3\ Specifically, the Exchange proposes to: (i)
Introduce a monthly non-display usage \4\ fee of $50 per Professional
Subscriber \5\ for PSX TotalView based upon Direct Access; and (ii)
increase the monthly enterprise license fee for non-display usage of
PSX TotalView based upon Direct Access from $16,000 to $17,000.\6\
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    \3\ See Securities Exchange Act Release No. 62876 (September 9,
2010), 75 FR 56624 (September 16, 2010) (SR-Phlx-2010-120).
    \4\ ``Non-display usage'' refers to the usage of Exchange data
by a computer for calculations and routing decisions that does not
provide a means to display data on a screen. See Securities Exchange
Act Release No. 62876 (September 9, 2010), 75 FR 56624 (September
16, 2010) (SR\Phlx-2010-120).
    \5\ A ``Subscriber'' is a method of accessing data, defined as
``any access that a distributor of the data entitlement package(s)
provides to: (1) Access the information in the data entitlement
package(s); or (2) communicate with the distributor so as to cause
the distributor to access the information in the data entitlement
package(s).'' See Phlx Pricing Schedule, Section VIII, PSX TotalView
(d).
    \6\ The Exchange filed the proposed pricing changes on January
3, 2018 (SR-Phlx-2018-04). On January 16, 2018, the Exchange
withdrew that filing and submitted this filing.
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PSX TotalView
    PSX TotalView, like Nasdaq and BX TotalView, is a real-time market
data feed that provides access to every displayed quote and order at
every price level in Nasdaq-, NYSE-, NYSE American-, NYSE Arca-, CBOE-
and IEX-listed securities.\7\ PSX TotalView also provides anonymous
interest and administrative messages relating to trading halts and
symbol directory messages.\8\ The PSX TotalView entitlement today is
available for a

monthly charge of $40 per Subscriber.\9\ A ``Subscriber'' is ``any
access that a distributor of the data entitlement package(s) provides
to: (1) Access the information in the data entitlement package(s); or
(2) communicate with the distributor so as to cause the distributor to
access the information in the data entitlement package(s).'' \10\ The
current monthly charge is based on the number of Subscribers, without
regard to whether a Subscriber is used for non-display or display
usage.
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    \7\ In contrast with Nasdaq and BX TotalView, all displayed
orders for PSX TotalView are displayed without attribution to the
entering market participant.
    \8\ Symbol directory messages include basic security data such
as the market tier and financial status indicator.
    \9\ The PSX fee of $40 applies to all securities; the BX
Exchange charges separate fees of $20 for Nasdaq-listed securities
and $20 for securities listed on NYSE and regional exchanges.
    \10\ See Note 5.
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    For firms that utilize PSX TotalView internally for non-display
purposes, the product may also be purchased through an enterprise
license fee of $16,000 per month for unlimited internal use of non-
display data. This enterprise license, which provides an alternative to
monthly per Subscriber fees, is designed to relieve firms with a large
number of internal Subscribers from the administrative burden of
identifying, tracking and reporting such Subscribers.
Proposed Changes
    PSX TotalView is one of a number of market information services
offered by the Exchange. Such services are inextricably connected to
trade execution: Market information services require trade orders to
provide useful information, and investors use market information to
make trading decisions. Over the seven years that have elapsed since
the current fee schedule for non-display usage and enterprise licenses
for PSX TotalView were introduced,\11\ the Exchange has invested in an
array of upgrades to both its trade execution and market information
services, which have increased the value of these services overall, and
PSX TotalView in particular.\12\
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    \11\ See Securities Exchange Act Release No. 62876 (September 9,
2010), 75 FR 56624 (September 16, 2010) (SR-Phlx-2010-120).
    \12\ Many of these upgrades are common to several Nasdaq-
affiliated exchanges, as improvements to the products and services
of one exchange are reproduced in other exchanges.
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    The Exchange proposes to adjust its fee schedule for PSX TotalView
to reflect the value of the many investments improving the product,
which include:
     Glimpse Snapshot Facility. In 2013, the Exchange
substantially updated the Glimpse snapshot facility, which allows firms
to obtain a snapshot of the Exchange's order book at any point during
the trading day. The service may be used to validate order book
displays or to recover from data gaps during the trading day.\13\
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    \13\ See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2013-33.
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     Enhanced Data Feed. In 2014, the Exchange enhanced the PSX
TotalView data feed by: (i) Converting to binary codes to make more
efficient use of bandwidth and to provide greater timestamp
granularity; (ii) adding a symbol directory message to identify a
security and its key characteristics; and (iii) adding the Market Wide
Circuit Breaker (``MWCB'') Decline Level message to inform recipients
of the setting for MWCB breach points for the trading day, and an MWCB
Status Level Message to inform data recipients when an MWCB has
breached an established level.\14\
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    \14\ See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2013-45 and http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2013-33.
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     Geographic Diversity. In 2015, all of the Nasdaq Exchanges
moved their Disaster Recovery (``DR'') center from Ashburn, Virginia,
to Chicago, Illinois. As a result, customers can both receive market
data and send orders through the Chicago facility, potentially reducing
overall networking costs. Adding such geographic diversity helps
protect the market in the event of a catastrophic event impacting the
entire East Coast.\15\
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    \15\ See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2015-17.
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     Chicago ``B'' Feeds. In 2017, all of the Nasdaq exchanges
added a multicast IP address for proprietary equity and options data
feeds in Chicago, allowing firms the choice of having additional
redundancy to ensure data continuity.\16\
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    \16\ See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2017-02.
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     Extended Transmission Hours. In 2014, the Exchange began
to transmit data between 3:00 and 4:00 a.m. Eastern, approximately
three hours earlier than previously,\17\ to provide customers with an
opportunity to test connectivity before pre-market sessions open at
8:00 a.m. Eastern.\18\
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    \17\ The extended schedule for data transmission did not extend
pre-market trading hours.
    \18\ See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2014-08.
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    While these many changes were in the process of implementation,
fees for PSX TotalView were falling in real terms as a result of price
inflation. Indeed, the proposed increase in the enterprise license fee
from $16,000 to $17,000 remains below the rate of inflation of that
period.\19\ Moreover, the proposed non-display fee increase from $40 to
$50 is largely offset by inflation, and only represents an
approximately 3.24 percent annual increase over the course of seven
years.
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    \19\ The Consumer Price Index indicates price increases of
approximately 13 percent between September 2010 and November 2017.
See https://www.bls.gov/data/inflation_calculator.htm.
---------------------------------------------------------------------------

    As a result of these substantial upgrades and the impact of overall
price inflation, the Exchange proposes two substantive changes to the
PSX TotalView fee schedule: (i) Introduce a monthly non-display usage
fee of $50 per Subscriber based upon Direct Access; and (ii) increase
the monthly enterprise license fee for non-display usage based upon
Direct Access from $16,000 to $17,000.\20\
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    \20\ In addition to these two substantive changes, the Exchange
proposes five sets of technical changes. First, the Exchange
proposes to add the phrase ``for display usage'' to Paragraph (a)(1)
to distinguish between display usage fees, which shall remain
unchanged, and non-display usage fees, which will increase. Second,
the Exchange proposes to change the reference to per Subscriber fees
in new paragraph (a)(3) from (a)(1) to (a)(2) because non-display
fees for Professionals that take the feed through Direct Access have
been moved from paragraph (a)(1) to (a)(2). Third, the Exchange
proposes to renumber former paragraph (a)(2) to (a)(3) to reflect
the introduction of new paragraph (a)(2). Fourth, the Exchange
proposes to delete the unnecessary word ``in'' from the phrase ``as
provided [in ]elsewhere in this rule . . . .'' from paragraph (a)(1)
as a grammatical correction. Fifth, the Exchange proposes to revise
paragraph (c) (``Free-Trial Offers) to reflect the new fees set
forth in paragraphs (a)(2) and (a)(3).
---------------------------------------------------------------------------

    The current fee structure allows firms to purchase PSX TotalView
for display or non-display usage by professionals for a monthly charge
of $40 per Subscriber. The Exchange proposes to separate this fee into
two distinct fees: One for display usage and non-display usage not
based upon Direct Access by professionals, and another for non-display
usage based upon Direct Access.\21\ The fee for display usage for
professionals will remain unchanged at $40 per month, as will the fee
for non-display usage without Direct Access, while the new non-display
usage fee based upon Direct Access will be set at $50 per month.\22\
With this change, the pricing structure for PSX TotalView will conform
to the pricing structure for Nasdaq TotalView (which has differential
fees for display and non-display usage),\23\ and the proposed pricing
structure for BX TotalView (proposed in a separate filing for the BX
Exchange), albeit at a lower rate than the

two other exchanges. The PSX TotalView pricing structure will also be
similar to the non-display fee structure for NYSE and other exchanges,
as differential pricing for display and non-display usage has become
the industry norm.\24\
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    \21\ Any Subscriber within a firm that obtains Exchange data
through a Subscriber with Direct Access from that same firm has
obtained such data ``based upon Direct Access.''
    \22\ ``Direct Access'' refers to the method for receiving
Exchange data. A firm may have Direct Access to receive Exchange
data through: (i) A telecommunications interface with the Exchange
for receiving Exchange data, (ii) an Exchange data feed within the
Exchange co-location facility, or (iii) via an extranet access
provider. See Phlx Pricing Schedule, Section VIII, Market Data
Distributor Fees (c).
    \23\ See Nasdaq Rule 7023(b)(2).
    \24\ See, e.g., NYSE PDP Market Data Pricing (November 3, 2017),
found at https://www.nyse.com/publicdocs/nyse/data/NYSE_Market_Data_Pricing.pdf.
---------------------------------------------------------------------------

    The second proposed substantive change will increase the monthly
enterprise license fee for internal non-display usage of PSX TotalView
based upon Direct Access from $16,000 to $17,000.
    PSX TotalView is optional in that the Exchange is not required to
offer it and broker-dealers are not required to purchase it. Firms can
discontinue use at any time and for any reason, including an assessment
of the fees charged.
    The proposed change does not change the cost of any other Exchange
product.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\25\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\26\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78f(b).
    \26\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and self-regulatory organization (``SRO'') revenues
and, also, recognized that current regulation of the market system
``has been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' \27\
---------------------------------------------------------------------------

    \27\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Likewise, in NetCoalition v. Securities and Exchange Commission
\28\ (``NetCoalition'') the D.C. Circuit upheld the Commission's use of
a market-based approach in evaluating the fairness of market data fees
against a challenge claiming that Congress mandated a cost-based
approach.\29\ As the court emphasized, the Commission ``intended in
Regulation NMS that `market forces, rather than regulatory
requirements' play a role in determining the market data . . . to be
made available to investors and at what cost.'' \30\
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    \28\ NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).
    \29\ See NetCoalition, at 534-535.
    \30\ Id. at 537.
---------------------------------------------------------------------------

    Further, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'' \31\
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    \31\ Id. at 539 (quoting Securities Exchange Act Release No.
59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008)
(SR-NYSEArca-2006-21)).
---------------------------------------------------------------------------

    The Exchange believes that the proposed fee changes are equitable
allocations of reasonable dues, fees and other charges in accordance
with Section 6(b)(4) of the Act, and not designed to permit unfair
discrimination between customers, issuers, brokers, or dealers in
accordance with Section 6(b)(5) of the Act. Both the monthly non-
display per Subscriber usage fee and the monthly enterprise license fee
for non-display usage are equitable allocations because, as has been
widely recognized, display and non-display functions provide different
value to the consumer because of differences in speed and efficiency
between the two modes of distribution, and it has become standard
industry practice to charge differing fees for these two different
modes of data consumption. Non-Display Usage provides greater value to
the customer because the computer systems utilizing Non-Display data
are able to analyze trading information thousands of times faster than
their human counterparts, hundreds of different securities can be
analyzed simultaneously, trading strategies can be executed much more
quickly, error rates are lower, and each hour of the trading day can be
used more efficiently. In addition, discounts based on high levels of
usage such as the enterprise license for non-display usage have
routinely been adopted by exchanges and approved as equitable
allocations of reasonable dues, fees and other charges.\32\ As such,
the proposed fees vary solely based on reasonable and well-established
industry norms regarding types of data usage, as discussed above.
---------------------------------------------------------------------------

    \32\ For example, the Commission has approved pricing discounts
for market data under Nasdaq Rule 7023.
---------------------------------------------------------------------------

    The Exchange also distinguishes between usage based on Direct
Access and other methods of connection: Non-display usage that is based
upon Direct Access will be charged $50 per month, while other non-
display usage will be charged $40 per month. This distinction is an
equitable allocation of reasonable dues, fees and other charges because
Direct Access provides the customer with source information in the
original raw format, which provides customers with the certainty that
they are receiving data without conflation or manipulation. This
distinction does not permit unfair discrimination between customers,
issuers, brokers, or dealers because the price differential is based on
the difference in value to the customer.
    In addition, the Exchange proposes to introduce clarifying language
stating that the enterprise license for non-display data will be
available only to firms with Direct Access. This is an equitable
allocation of reasonable dues, fees and other charges because firms
with sufficient activity to purchase an enterprise license have a
Direct Access connection. As such, the proposed language simply
clarifies how the enterprise license will be used with respect to
Direct Access, in a similar manner to the way that Direct Access is
addressed in paragraphs (a)(1) and (a)(2), without affecting the
service of any specific customer. This proposed change does not permit
unfair discrimination between customers, issuers, brokers, or dealers
for the same reason: The proposed language is simply a clarification
that will not lead to any actual difference in usage.
    The proposed changes do not permit unfair discrimination between
customers, issuers, brokers, or dealers because the Exchange makes all
services and products subject to these fees available on a non-
discriminatory basis to similarly-situated recipients. The proposed
fees are structured in a manner comparable to the corresponding fees of
Nasdaq already in effect, and compare favorably to fees charged by
Nasdaq and BX for the same product. The fees are uniform except with
respect to reasonable and well-established distinctions between display
and non-display data discussed above.

    The Act does not prohibit all distinctions among customers, but
rather discrimination that is unfair. As the Commission has recognized,
``[i]f competitive forces are operative, the self-interest of the
exchanges themselves will work powerfully to constrain unreasonable or
unfair behavior.'' \33\ Accordingly, ``the existence of significant
competition provides a substantial basis for finding that the terms of
an exchange's fee proposal are equitable, fair, reasonable, and not
unreasonably or unfairly discriminatory.'' \34\ The proposed fees, like
all market data fees, are constrained by the Exchange's need to compete
for order flow, and are subject to competition from other exchanges and
among broker-dealers for customers. If the Exchange is incorrect in its
assessment of price, it may lose market share as a result.
---------------------------------------------------------------------------

    \33\ See Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770 (December 9, 2008) (SR-NYSEArca-2006-21).
    \34\ Id.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own fees in response, and because
market participants may readily adjust their order routing practices,
the Exchange believes that the degree to which fee changes in this
market may impose any burden on competition is extremely limited.
    PSX TotalView is a type of depth-of-book product, which consists of
``outstanding limit orders to buy stock at prices lower than, or to
sell stocks at prices higher than, the best prices on each exchange.''
\35\ The question of whether the prices of depth-of-book products are
constrained by competitive forces was examined in 2016 by an
Administrative Law Judge in an application for review by the Securities
Industry and Financial Markets Association of actions taken by Self-
Regulatory Organizations.\36\ After a four-day hearing and presentation
of substantial evidence, the administrative law judge stated that
``competition plays a significant role in restraining exchange pricing
of depth-of-book products'' \37\ because ``depth-of-book products from
different exchanges function as substitutes for each other,'' \38\ and,
as such, ``the threat of substitution from depth-of-book customers
constrains their depth-of-book prices.'' \39\ As a result, ``[s]hifts
in order flow and threats of shifting order flow provide a significant
competitive force in the pricing of . . . depth-of-book data.'' \40\
The judge concluded that ``[u]nder the standards articulated by the
Commission and D.C. Circuit, the Exchanges have shown that they are
subject to significant competitive forces in setting fees for depth-of-
book data: The availability of alternatives to the Exchanges' depth-of-
book products, and the Exchanges' need to attract order flow from
market participants constrains prices.'' \41\
---------------------------------------------------------------------------

    \35\ See Securities Industry and Financial Markets Association,
Initial Decision Release No. 1015, 2016 SEC LEXIS 2278 at *4 (A.L.J.
June 1, 2016) (quoting NetCoalition v. SEC, 615 F3d 525, 529-30
(D.C. Cir. 2010)).
    \36\ Id.
    \37\ Id. at *92.
    \38\ Id.
    \39\ Id. at *93.
    \40\ Id. at *104.
    \41\ Id. at *86.
---------------------------------------------------------------------------

    The proposed changes will: (i) Introduce a monthly non-display
usage fee of $50 per Professional Subscriber based upon Direct Access;
and (ii) increase the monthly enterprise license fee for non-display
usage based upon Direct Access from $16,000 to $17,000. These proposed
price changes will not impose any burden on competition because market
data fees are but one aspect of the overall competition among exchanges
to solicit order flow; if the overall price of interacting with the
Exchange rises above competitive levels because of market data fees,
market forces would cause the Exchange to lose market share.
    Market forces constrain fees for PSX TotalView, as well as other
market data fees, in the competition among exchanges and other entities
to attract order flow and in the competition among Distributors for
customers. Order flow is the ``life blood'' of the exchanges. Broker-
dealers currently have numerous alternative venues for their order
flow, including SRO markets, as well as internalizing broker-dealers
(``BDs'') and various forms of alternative trading systems (``ATSs''),
including dark pools and electronic communication networks (``ECNs'').
Each SRO market competes to produce transaction reports via trade
executions, and two FINRA-regulated Trade Reporting Facilities
(``TRFs'') compete to attract internalized transaction reports. The
existence of fierce competition for order flow implies a high degree of
price sensitivity on the part of BDs, which may readily reduce costs by
directing orders toward the lowest-cost trading venues.
    The level of competition and contestability in the market for order
flow is demonstrated by the numerous examples of entrants that swiftly
grew into some of the largest electronic trading platforms and
proprietary data producers: Archipelago, Bloomberg Tradebook, Island,
RediBook, Attain, TracECN, BATS Trading and BATS/Direct Edge. A
proliferation of dark pools and other ATSs operate profitably with
fragmentary shares of consolidated market volume. For a variety of
reasons, competition from new entrants, especially for order execution,
has increased dramatically over the last decade.
    Each SRO, TRF, ATS, and BD that competes for order flow is
permitted to produce proprietary data products. Many currently do or
have announced plans to do so, including NYSE, NYSE American, NYSE
Arca, CBOE, and IEX. This is because Regulation NMS deregulated the
market for proprietary data. While BDs had previously published their
proprietary data individually, Regulation NMS encourages market data
vendors and BDs to produce proprietary products cooperatively in a
manner never before possible. Order routers and market data vendors can
facilitate production of proprietary data products for single or
multiple BDs. The potential sources of proprietary products are
virtually limitless.
    The markets for order flow and proprietary data are inextricably
linked: A trading platform cannot generate market information unless it
receives trade orders. As a result, the competition for order flow
constrains the prices that platforms can charge for proprietary data
products. Firms make decisions on how much and what types of data to
consume based on the total cost of interacting with PSX and other
exchanges. Data fees are but one factor in a total platform analysis.
If the cost of the product exceeds its expected value, the broker-
dealer will choose not to buy it. A supracompetitive increase in the
fees charged for either

transactions or proprietary data has the potential to impair revenues
from both products. In this manner, the competition for order flow will
constrain prices for proprietary data products.
    Competition among Distributors provides another form of price
discipline for proprietary data products. If the price of PSX TotalView
were set above competitive levels, Distributors purchasing PSX
TotalView would be at a disadvantage relative to their competitors, and
would therefore either curtail their purchase or forego the product
altogether.
    Market forces constrain the price of depth-of-book data such as PSX
TotalView through the competition for order flow and in the competition
among vendors for customers. If the changes proposed herein are
unattractive to market participants, it is likely that the Exchange
will lose market share as a result. Accordingly, the Exchange does not
believe that the proposed changes will impair the ability of members or
competing order execution venues to maintain their competitive standing
in the financial markets.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\42\
---------------------------------------------------------------------------

    \42\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) 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 protected]. Please include
File Number SR-Phlx-2018-10 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-Phlx-2018-10. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2018-10 and should be submitted on
or before February 20, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\43\
Eduardo A. Aleman,
Assistant Secretary.
---------------------------------------------------------------------------

    \43\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2018-01536 Filed 1-26-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Notices]
[Page 44508-44509]
[DOCID:fr08au07-58]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0038 FRL-8142-8]

System Research and Applications Corporation; Transfer of Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by the submitter, will be transferred to System Research and
Applications Corporation, in accordance with 40 CFR 2.307(h)(3) and
2.308(i)(2). System Research and Applications Corporation, has been
awarded a contract to perform work for OPP, and access to this
information will enable System Research and Applications Corporation,
to fulfill the obligations of the contract.

DATES: System Research and Applications Corporation will be given
access to this information on or before August 13, 2007.

FOR FURTHER INFORMATION CONTACT: Felicia Croom, Information Technology
and Resources Management Division (7502P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action applies to the public in general. As such, 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2007-0038 Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (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 telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Contractor Requirements

    Under Contract No. EP-W-05-024 Task Order 39, System
Research and Applications Corporation, will perform configuration
management support to the Enterprise Policy and Planning Oversight
Staff. System Research and Applications Corporation will designate a
configuration management contractor to assist in creating policy,
administer and support the database, and assist in facilitating the
configuration

management workflow process for ITRMD/EPPOS.
    The OPP has determined that access by System Research and
Applications Corporation, to information on all pesticide chemicals is
necessary for the performance of this contract.
    Some of this information may be entitled to confidential treatment.
The information has been submitted to EPA under sections 3, 4, 6, and 7
of FIFRA and under sections 408 and 409 of FFDCA.
    In accordance with the requirements of 40 CFR 2.307(h)(2), the
contract with System Research and Applications Corporation, prohibits
use of the information for any purpose not specified in the contract;
prohibits disclosure of the information to a third party without prior
written approval from the Agency; and requires that each official and
employee of the contractor sign an agreement to protect the information
from unauthorized release and to handle it in accordance with the FIFRA
Information Security Manual. In addition, System Research and
Applications Corporation, are required to submit for EPA approval a
security plan under which any CBI will be secured and protected against
unauthorized release or compromise. No information will be provided to
System Research and Applications Corporation, until the requirements in
this document have been fully satisfied. Records of information
provided to System Research and Applications Corporation, will be
maintained by EPA Project Officers for this contract. All information
supplied to System Research and Applications Corporation, by EPA for
use in connection with this contract will be returned to EPA when
System Research and Applications Corporation, have completed their
work.

List of Subjects

    Environmental protection, Business and industry, Government
contracts, Government property, Security measures.

    Dated: July 25, 2007.
Oscar Morales,
Acting Director, Office of Pesticide Programs.
[FR Doc. E7-15053 Filed 8-7-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Page 2907]
[FR Doc No: 2023-00845]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ23-4-000]

City of Banning, California; Notice of Filing

    Take notice that on December 23, 2022, City of Banning, California
submits tariff filing: City of Banning 2023 Transmission Revenue
Balancing Account Adjustment/Existing Transmission Contracts Update, to
be effective January 1, 2023.
    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. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5 p.m. Eastern Time on January 23, 2023.

    Dated: January 11, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-00845 Filed 1-17-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Pages 74737-74738]
[FR Doc No: 2020-25744]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1848]

Clinical Drug Interaction Studies With Combined Oral
Contraceptives; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Clinical
Drug Interaction Studies With Combined Oral Contraceptives.'' This
guidance assists sponsors of investigational new drug applications and
new drug applications in evaluating the need for and design drug-drug
interaction (DDI) studies involving combined oral contraceptives (COCs)
during drug development as well as determining how to communicate the
results and recommendations from the DDI studies. Specifically, this
guidance focuses on the conduct of clinical studies to evaluate the DDI
potential of an investigational drug on a COC, including the need for
and design of the clinical studies and the interpretation of the study
results.

DATES: Submit either electronic or written comments on the draft
guidance by February 22, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1848 for ``Clinical Drug Interaction Studies With Combined
Oral Contraceptives.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-

0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lauren Milligan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3159, Silver Spring, MD 20903-0002, 301-
796-5008, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Drug Interaction Studies With Combined Oral
Contraceptives.'' COCs can effectively prevent pregnancy; however, the
use of concomitant medications could result in DDIs that affect the
safety and/or efficacy of COCs. For example, the induction of drug
metabolizing enzymes could cause lower levels of progestin and/or
estrogen and compromise the efficacy of COCs, while inhibition of
metabolizing enzymes could cause higher levels of these hormones and
increase the risk of safety events such as venous thromboembolism.
    This draft guidance discusses when DDI studies with COCs should be
conducted. It also provides recommendations on the design and conduct
of such studies, including but not limited to the study population, the
choice of COC, study design, pharmacokinetic sampling schedule, and
pharmacodynamic assessments. This guidance discusses the interpretation
of results from clinical DDI studies with COCs and whether it is
possible to extrapolate the results of such studies to other COCs.
Based on the study results, specific recommendations for labeling are
provided. Decision trees regarding whether a DDI study with a COC is
recommended based on the metabolizing enzyme inhibition or induction
potential of the investigational drug are also included.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Clinical
Drug Interaction Studies With Combined Oral Contraceptives.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for submissions of investigational new drug
applications, new drug applications, and biologic license applications
in 21 CFR parts 312, 314, and 601 have been approved under OMB control
numbers 0910-0014; 0910-0001; and 0910-0338, respectively. In addition,
the submission of prescription drug labeling under 21 CFR 201.56 and
201.57 has been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: November 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25744 Filed 11-20-20; 8:45 am]
BILLING CODE 4164-01-P