[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Pages 49328-49331]
[FR Doc No: 2014-19696]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1179]

Request for Nominations for Voting and/or Nonvoting Consumer
Representatives on Public Advisory Committees or Panels and Request for
Notification From Consumer Organizations Interested in Participating in
the Selection Process for Nominations for Voting and/or Nonvoting
Consumer Representatives on Public Advisory Committees or Panels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization. Nominations will be accepted for current vacancies and
for those that will or may occur through December 2014.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to the FDA (see ADDRESSES) by
September 19, 2014, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by September 19, 2014.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should submit their information
electronically to<EMAIL_ADDRESS>or by mail to Advisory
Committee Oversight and Management Staff, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, FAX<PHONE_NUMBER>.
    Consumer representative nominations should be submitted
electronically by logging into the FDA advisory Committee Membership
Nomination Portal at https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee
Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm.
5103, Silver Spring, MD 20993-0002, or by fax to<PHONE_NUMBER>.
Additional information about becoming a member on an FDA advisory
committee can also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.
    FOR FURTHER GENERAL INFORMATION CONTACT: Kimberly Hamilton,
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5117, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For questions relating to specific advisory
committees or panels, contact the following persons listed in table 1:

                  Table 1--Advisory Committee Contacts
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                  Contact person                       Committee/panel
------------------------------------------------------------------------
Jamie Waterhouse, Center for Devices and            Circulatory System
 Radiological Health, Office of Device Evaluation,   Devices Panel.
 Food and Drug Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 1611, Silver Spring, MD
 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Karen Strambler, Center for Food Safety and         Food Advisory
 Applied Nutrition, FDA College Park, CPK1, Rm.      Committee.
 1C016, College Park, MD 20740,<PHONE_NUMBER>, FAX:
<PHONE_NUMBER>, email<EMAIL_ADDRESS>Patricio Garcia, Center for Devices and             General and Plastic
 Radiological Health, Office of Device Evaluation,   Surgery Devices
 Food and Drug Administration, 10903 New Hampshire   Panel.
 Ave., Bldg. 66, Rm. 3631, Silver Spring, MD
 20903,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Sara J. Anderson, LCDR, U.S. Public Health          Hematology and
 Service, Center for Devices and Radiological        Pathology Devices
 Health, Office of Device Evaluation, Food and       Panel, Orthopaedic
 Drug Administration, 10903 New Hampshire Ave.,      and Rehabilitation
 Bldg. 66, Rm. 1643, Silver Spring, MD 20903, 301-   Devices Panel,
 796-7047, FAX:<PHONE_NUMBER>, email:                 National
<EMAIL_ADDRESS>                         Mammography and
                                                     Quality Assurance
                                                     Advisory Committee.
Pamela Scott, Center for Devices and Radiological   Medical Devices
 Health, Office of the Center Director, Food and     Dispute Resolution
 Drug Administration, 10903 New Hampshire Ave.,      Panel.
 Bldg. 66, Rm. 3611, Silver Spring, MD 20993, 301-
 796-5433, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Shanika Craig, Center for Devices and Radiological  Obstetrics and
 Health, Food and Drug Administration, 10903 New     Gynecology Devices
 Hampshire Ave., Bldg. 66, Rm. 1613, Silver          Panel.
 Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
 8122, email<EMAIL_ADDRESS>Walter Ellenberg, Office of the Commissioner,       Pediatrics Advisory
 Office of Pediatric Therapeutics, Food and Drug     Committee.
 Administration, Bldg. 32, Rm. 5154, 10903 New
 Hampshire Ave., Silver Spring, MD 20993-0002, 301-
 796-0885, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Kalyani Bhatt, Center for Drug Evaluation and       Psychopharmacologic
 Research, Food and Drug Administration, 10903 New   Drugs Advisory
 Hampshire Ave., Bldg. 31, Rm. 2438, Silver          Committee,
 Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-  Reproductive Health
 8533, email<EMAIL_ADDRESS>            Drugs Advisory
                                                     Committee.
------------------------------------------------------------------------

    FDA is requesting nominations for voting and/or nonvoting consumer
representatives for the vacancies listed in table 2:

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy and Approximate Date Needed
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      Committee/panel/areas of expertise needed       Current & upcoming vacancies     Approximate date needed
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Circulatory System Devices--Knowledgeable in the      Nonvoting...................  Immediately.
 safety and effectiveness of marked and
 investigational devices for use in the circulatory
 and vascular systems.
Food Advisory Committee--Knowledgeable in the fields  Voting......................  Immediately.
 of physical sciences, biological and life sciences,
 food science, risk assessment, nutrition, food
 technology, molecular biology, and other relevant
 scientific and technical disciplines.
General and Plastic Surgery Devices Panel of the      1-Nonvoting.................  9/1/2014.
 Medical Devices Advisory Committee--Knowledgeable
 in the fields of general, plastic, reconstructive,
 pediatric, thoracic, abdominal, pelvic and
 endoscopic surgery; biomaterials, lasers, wound
 healing, and quality of life issues.
Hematology and Pathology Devices Panel of the         1-Nonvoting.................  Immediately.
 Medical Devices Advisory Committee--Knowledgeable
 in the fields of hematology, hematopathology,
 coagulation and homeostasis, hematological
 oncology, and gynecological oncology.
Medical Devices Dispute Resolution Panel of the       1-Nonvoting.................  10/1/2014.
 Medical Devices Advisory Committee--Knowledgeable
 experts with broad, cross-cutting scientific,
 clinical, analytical, or mediation skills.
National Mammography Quality Assurance Advisory       1-Nonvoting.                  ............................
 Committee--Knowledgeable in clinical practice,
 research specialization, or professional work that
 has a significant focus on mammography.
Obstetrics and Gynecology Devices Panel of the        1-Nonvoting.................  Immediately.
 Medical Devices Advisory Committee--Knowledgeable
 in the fields of perinatology, embryology,
 reproductive endocrinology, pediatric gynecology,
 gynecological oncology, operative hysteroscopy,
 pelviscopy, electrosurgery, laser surgery, assisted
 reproductive technologies, contraception,
 postoperative adhesions, and cervical cancer and
 colposcopy; obstetrics/gynecology devices;
 gynecology in the older patient; midwifery; labor
 and delivery nursing.
Orthopaedic and Rehabilitation Devices Panel--        1-Nonvoting.................  Immediately.
 Knowledgeable in data concerning the safety and
 effectiveness of marketed and investigational
 orthopaedic and rehabilitation devices.
Pediatrics Advisory Committee--Knowledgeable in       1-Voting....................  Immediately.
 pediatric research, pediatric subspecialties,
 statistics, and/or biomedical ethics.
Psychopharmacologic Drugs Advisory Committee--        1-Voting....................  Immediately.
 Knowledgeable in the fields of psychopharmacology,
 psychiatry, epidemiology or statistics, and related
 specialties.
Bone, Reproductive, and Urologic Drugs Advisory       1-Voting....................  Immediately.
 Committee--Knowledgeable in the fields of
 obstetrics, gynecology, endocrinology, pediatrics,
 epidemiology, or statistics and related
 specialties.
----------------------------------------------------------------------------------------------------------------

I. Functions

A. Certain Panels of the Medical Devices Advisory Committee

    The committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) envisions for device advisory panels. With
the exception of the Medical Devices Dispute Resolution Panel, each
panel, according to its specialty area, advises the Commissioner of
Food and Drugs (the Commissioner) regarding recommended classification
or reclassification of devices into one of three regulatory categories,
advises on any possible risks to health associated with the use of
devices, advises on formulation of product development protocols,
reviews premarket approval applications for medical devices, reviews
guidelines and guidance documents, recommends exemption of certain
devices from the application of portions of the FD&C Act, advises on
the necessity to ban a device, and responds to requests from the Agency
to review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices. With the exception
of the Medical Devices Dispute Resolution Panel, each panel, according
to its specialty area, may also make appropriate recommendations to the
Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.

B. Food Advisory Committee

    The Committee provides advice to the Commissioner of Food and Drugs
and other appropriate officials, on emerging food safety, food science,
nutrition, and other food-related health issues that the FDA considers
of primary importance for its food and cosmetics programs. The
Committee may be charged with reviewing and evaluating available data
and making recommendations on matters such as those relating to: (1)
Broad scientific and technical food or cosmetic related issues; (2) the
safety of new foods and food ingredients; (3) labeling of foods and
cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe
exposure limits for food contaminants. The Committee may also be asked
to provide advice and make recommendations on ways of communicating to
the public the potential risks associated with these issues and on
approaches that might be considered for addressing the issues.

C. National Mammography and Quality Assurance Advisory Committee

    The Committee reviews and evaluates: (1) Developing appropriate
quality standards and regulations for mammography facilities; (2)
developing appropriate standards and regulations for bodies accrediting
mammography facilities under this program; (3) developing regulations
with respect to sanctions; (4) developing procedures for monitoring
compliance with standards; (5) establishing a mechanism to investigate
consumer complaints; (6) reporting new developments concerning breast
imaging which should be considered in the oversight of mammography
facilities; (7) determining whether there exists a shortage of
mammography facilities in rural and health professional shortage areas
and determining the effects of personnel on access to the services of
such facilities in such areas; (8) determining whether there will exist
a sufficient number of medical physicists after October 1, 1999; and
(9) determining the costs and benefits of compliance with these
requirements.

D. Pediatric Advisory Committee

    The Committee advises and makes recommendations to the Commissioner
of Food and Drugs regarding: (1) Pediatric research; (2) identification
of research priorities related to pediatric therapeutics and the need
for additional treatments of specific pediatric diseases or conditions;
(3) the ethics, design, and analysis of clinical trials related to
pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric
labeling changes; (6) adverse event reports for drugs granted pediatric
exclusivity and any safety issues that may occur; (7) any other
pediatric issue or pediatric labeling dispute involving FDA regulated
products; (8) research involving children as subjects; and (9) any
other matter involving pediatrics for which FDA has regulatory
responsibility. The Committee also advises and makes recommendations to
the Secretary directly or to the Secretary through the Commissioner on
research involving children as subjects that is conducted or supported
by the Department of Health and Human Services.

E. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
practice of psychiatry and related fields.

F. Bone, Reproductive, and Urologic Drugs Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the practice of
obstetrics, gynecology, and related specialties.

G. The Medical Devices Dispute Resolution Panel

    The Panel provides advice to the Commissioner on complex or
contested scientific issues between the FDA and medical device
sponsors, applicants, or manufacturers relating to specific products,
marketing applications, regulatory decisions and actions by FDA, and
Agency guidance and policies. The Panel makes recommendations on issues
that are lacking resolution, are highly complex in nature, or result
from challenges to regular advisory panel proceedings or Agency
decisions or actions.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate ties to consumer and community-based organizations; (2) be
able to analyze technical data; (3) understand research design; (4)
discuss benefits and risks; and (5) evaluate the safety and efficacy of
products under review. The consumer representative should be able to
represent the consumer perspective on issues and actions before the
advisory committee, serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations, and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the

selection process and will forward to each such organization a ballot
listing at least two qualified nominees selected by the Agency based on
the nominations received, together with each nominee's current
curriculum vitae or r[eacute]sum[eacute]. Ballots are to be filled out
and returned to FDA within 30 days. The nominee receiving the highest
number of votes ordinarily will be selected to serve as the member
representing consumer interests for that particular advisory committee
or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations should include a cover letter and a current curriculum
vitae or r[eacute]sum[eacute] for each nominee, including a current
business and/or home address, telephone number, email address if
available, and a list of consumer or community-based organizations for
which the candidate can demonstrate active participation.
    Nominations should also specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation that the nominee is aware of the
nomination, unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters as financial
holdings, employment, and research grants and/or contracts to permit
evaluation of possible sources of conflicts of interest. Members will
be invited to serve for terms up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.

    Dated: August 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19696 Filed 8-19-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95213-95216]
[FR Doc No: 2016-31109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79617; File No. SR-NASDAQ-2016-168]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Exchange Data Fees at Rule 7052

December 20, 2016.
    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 December 12, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' 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.
---------------------------------------------------------------------------

    \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 the Exchange's data fees at Rule
7052 to replace the current $500 per month fee for both internal and
external distribution of short sale data with two separate fees: (1) A
$750 monthly fee for the distribution of short sale data to internal
users, and (2) a $1,250 monthly fee for the distribution of short sale
data to external users, as described further below.

    While these amendments are effective upon filing, the Exchange has
designated the proposed amendments to be operative on January 1, 2017.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.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 purpose of the proposed rule change is to replace the current
$500 per month fee for both internal and external distribution of short
sale data with two separate fees: (1) A $750 monthly fee for the
distribution of short sale data to internal users, and (2) a $1,250
monthly fee for the distribution of short sale data to external users.
Daily and Monthly Short Sale Files
    Nasdaq distributes two types of short sale data: (1) Daily Short
Sale Volume files, and (2) Monthly Short Sale Transaction files.
    The Daily Short Sale Volume files reflect the aggregate number of
shares executed on the Nasdaq market during regular trading hours on a
daily basis. At the security level, these files show the volume for
executed short sales and the total trading volume for the Nasdaq
market. The files include data for Nasdaq, NYSE and regional exchange-
listed securities.
    The Monthly Short Sale Transaction files provide a trade-by-trade
record of all short sales executed on the Nasdaq execution system and
reported to a consolidated tape in Nasdaq, NYSE and regional exchange-
listed securities. The records include the transaction time, price and
number of shares for every short sale transaction. The files are
provided on a monthly basis, separated into daily files. Historical
files are available from August 2005.
    The current fee for internal and external distribution of the Daily
Short Sale Volume and Monthly Short Sale Transaction files is $500 per
month.
Proposed Changes
    The Exchange proposes to replace the current $500 per month fee for
both internal and external distribution of short sale data with two
separate fees: (1) a $750 monthly fee for the distribution of short
sale data to internal users, and (2) a $1,250 monthly fee for the
distribution of short sale data to external users.
    The purpose of the proposed rule change is to create a pricing
system that better reflects the value of the product to our customers.
External Distributors, unlike Internal Distributors, are typically
compensated for the distribution of short sale data through
subscription fees or other mechanisms. Some External Distributors
incorporate short sale data into their own proprietary products, which
they sell to downstream users. These distributors may not charge
separately for the Nasdaq short sale data, but nevertheless gain value
from the data by incorporating it into their product. The price
increase for External Distributors reflects the additional value these
distributors gain from the product.
    In addition, the value of the short sale data has increased over
time for all distributors that have purchased short sale data over a
long period of time. Short sale data is frequently used to develop
trading models, conduct analyses and assess long-term risks. As time
passes, long-term distributors are able to accrue a larger database,
rendering the data more valuable. The proposed price increases reflect
the growing value of the data over time.
    Purchases of the Daily Short Sale Volume and Monthly Short Sale
Transaction files are entirely optional. These reports are not
necessary to execute trades, but rather are typically used to develop
trading models, conduct analyses and assess long-term risks. This type
of activity is entirely at the discretion of the subscriber.
    The proposed changes do not impact or raise the cost of any other
Nasdaq product. Short sale reports from the Nasdaq BX and PSX Exchanges
will continue to be provided free of charge, as they have been since
2010.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\3\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\4\ 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.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4) and (5).
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    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 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.'' \5\
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    \5\ 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 \6\
(``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.\7\ 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.'' \8\
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    \6\ NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).
    \7\ See NetCoalition, at 534-535.
    \8\ 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'. . . .'' \9\
---------------------------------------------------------------------------

    \9\ 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 proposal to replace the current fee
of $500 per month for the internal and

external distribution of short sale data with a monthly fee of $750 per
month for the distribution of short sale data to internal users, and a
monthly fee of $1,250 for the distribution of short sale data to
external users, is fair and equitable in accordance with Section
6(b)(4) of the Act, and not unreasonably discriminatory in accordance
with Section 6(b)(5) of the Act. As described above, it is reasonable
for external distributors to bear a higher proportion of the cost
because they receive greater value from the product, and it is
reasonable for Nasdaq to increase a fee for a product that has become
more valuable over time. Moreover, short sale data fees, like all
proprietary data fees, are constrained by the Exchange's need to
compete for order flow, and are subject to competition from other
products, such as the short sale data products produced by NYSE and
BATS.
    The Exchange believes that the proposed change is an equitable
allocation and is not unfairly discriminatory because the Exchange will
apply the same fee to all similarly-situated distributors.

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.
    The proposed fees replace the current fee of $500 per month for the
internal and external distribution of short sale data with a monthly
fee of $750 per month for distribution to internal users, and a monthly
fee of $1,250 for distribution to external users. 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.
    Specifically, market forces constrain fees for Daily Short Sale
Volume files and Monthly Short Sale Transaction files in three
respects. First, all fees related to short sale data are constrained by
competition among exchanges and other entities attracting order flow.
Firms make decisions regarding short sale data and other proprietary
data based on the total cost of interacting with the Exchange, and
order flow would be harmed by the supracompetitive pricing of any
proprietary data product. Second, prices for short sale data are
constrained by the sale of short sale data by other exchanges. Third,
competition among Distributors will constrain the cost of short sale
data.
Competition for Order Flow
    Fees related to short sale data are constrained by competition
among exchanges and other entities seeking to attract order flow. Order
flow is the ``life blood'' of the exchanges. Broker-dealers currently
have numerous alternative venues for their order flow, including self-
regulatory organization (``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 Amex, NYSE Arca,
BATS, 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 Nasdaq 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.
Substitute Products
    The price of short sale data from Nasdaq is constrained by the
availability of short sale data from other exchanges, such as NYSE and
BATS. Short sale data is used to support various analytical tools, and
Distributors would not pay an excessive price for such data when
similar information is available from other sources.
Competition Among Distributors
    Distributors provide another form of price discipline for
proprietary data products. Distributors are in competition for users,
and can simply refuse to purchase any proprietary data product that
fails to provide sufficient value for the price. If the price of short
sale data were set above competitive levels, Distributors purchasing
such data would be at a disadvantage relative to their competitors, and
would therefore either purchase a substitute or

forego the product altogether. This competition for customers provides
another check on the price for short sale data.
    In summary, market forces constrain the price of short sale data
through competition for order flow, competition from substitute
products, and in the competition among distributors for customers. For
these reasons, the Exchange has provided a substantial basis
demonstrating that the fee is equitable, fair, reasonable, and not
unreasonably discriminatory, and therefore consistent with and in
furtherance of the purposes of the Exchange Act.

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

    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.\10\
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    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    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_ADDRESS>Please include
File Number SR-NASDAQ-2016-168 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-NASDAQ-2016-168. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2016-168 and should
be submitted on or before January 17, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-31109 Filed 12-23-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Page 11502]
[FR Doc No: 2015-04432]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, March
5, 2015 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session, and determined that no
earlier notice thereof was possible.
    The subject matter of the Closed Meeting will be: Institution and
settlement of injunctive actions; Institution and settlement of
administrative proceedings; Consideration of amicus participation; and
Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: February 26, 2015.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-04432 Filed 2-27-15; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Notices]
[Pages 61208-61209]
[FR Doc No: 2015-25753]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2014-0734; FRL 9933-60-OEI]

Agency Information Collection Activities; Information Collection
Request Submitted to OMB for Review and Approval; Comment Request;
Health and Safety Data Reporting, Submission of Lists and Copies of
Health and Safety Studies

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has submitted the following information collection request
(ICR) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (PRA): ``Health
and Safety Data Reporting, Submission of Lists and Copies of Health and
Safety Studies'' and identified by EPA ICR No. 0575.15 and OMB Control
No. 2070-0004. The ICR, which is available in the docket along with
other related materials, provides a detailed explanation of the
collection activities and the burden estimate that is only briefly
summarized in this document. EPA did not receive any comments in
response to the previously provided public review opportunity issued in
the Federal Register on March 30, 2015 (80 FR 16672). With this
submission, EPA is providing an additional 30 days for public review.

DATES: Comments must be received on or before November 9, 2015.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0734, to both EPA and OMB as follows:
     To EPA online using http://www.regulations.gov (our
preferred method) or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460.
     To OMB via email to<EMAIL_ADDRESS>Address
comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the
docket without change, including any personal information provided,
unless the comment includes profanity, threats, information claimed to
be Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute. Do not submit electronically any
information you consider to be CBI or other information whose
disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Colby Lintner, Environmental
Assistance Division (7408M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Docket: Supporting documents, including the ICR that explains in
detail the information collection activities and the related burden and
cost estimates that are summarized in this document, are available in
the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The telephone number for the Docket Center is (202)
566-1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    ICR status: This ICR is currently scheduled to expire on November
30, 2015. Under OMB regulations, the Agency may continue to conduct or
sponsor the collection of information while this submission is pending
at OMB.
    Under PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information, unless it displays a currently valid OMB control number.
The OMB control numbers are displayed either by publication in the
Federal Register or by other appropriate means, such as on the related
collection instrument or form, if applicable. The display of OMB
control numbers for certain EPA regulations is consolidated in 40 CFR
part 9.
    Abstract: Section 8(d) of the Toxic Substances Control Act (TSCA)
and 40 CFR part 716 require manufacturers and processors of chemicals
to submit lists and copies of health and safety studies relating to the
health and/or environmental effects of certain chemical substances and
mixtures. In order to comply with the reporting requirements of TSCA
section 8(d), respondents must search their records to identify any
health and safety studies in their possession, copy and process
relevant studies, list studies that are currently in progress, and
submit this information to EPA.
    EPA uses this information to construct a complete picture of the
known effects of the chemicals in question, leading to determinations
by EPA of whether additional testing of the chemicals is required. The
information enables EPA to base its testing decisions on the most
complete information available and to avoid demands for testing that
may be duplicative. EPA will use information obtained via this
collection to support its investigation of the risks posed by chemicals
and, in particular, to support its decisions on whether to require
industry to test chemicals under section 4 of TSCA. This information
collection request addresses the reporting requirements found in TSCA
section 8(d).
    Respondents/Affected Entities: Persons who manufacture, process, or
distribute in commerce chemical substances or mixtures, or who propose
to do so.
    Respondent's obligation to respond: Mandatory. (see 40 CFR part
716).
    Estimated total number of potential respondents: 119.
    Frequency of response: On occasion.
    Estimated total burden: 1,605 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Estimated total costs: $116,551 (per year), includes no annualized
capital investment or maintenance and operational costs.
    Changes in the estimates: There is a net decrease of 6,778 hours in
the total estimated respondent burden compared with that identified in
the ICR currently approved by OMB. This decrease reflects in particular
EPA's withdrawal of a cadmium reporting rule, the burden for which is
included in the currently approved ICR. In addition there was a smaller
burden increase resulting from the one-time requirement for respondents
to register with EPA's CDX reporting system and to establish electronic
signature agreements, plus correcting the estimated number of robust
summaries submitted each year. This change is both a program change (in
the case of the burden decrease due to the withdrawal of the cadmium
rule) and an adjustment (for all other burden changes).

    Authority: 44 U.S.C. 3501 et seq.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-25753 Filed 10-8-15; 8:45 am]
BILLING CODE 6560-50-P