[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37603-37604]
[FR Doc No: 2016-13787]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1264]

Dissemination of Patient-Specific Information From Devices by
Device Manufacturers; Draft Guidance for Industry and Food and Drug
Administration Staff; 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the availability of the draft guidance entitled ``Dissemination of
Patient-Specific Information from Devices by Device Manufacturers.''
The FDA developed this draft guidance to facilitate the appropriate and
responsible dissemination of patient-specific information recorded,
stored, processed, retrieved, and/or derived from medical devices from
manufacturers to patients. This draft guidance provides recommendations
to industry, healthcare providers, and FDA staff about the mechanisms
and considerations for device manufacturers sharing such information
with patients. This draft guidance is not final nor is it in effect at
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-1264 for ``Dissemination of Patient-Specific Information
from Devices by Device Manufacturers.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Dissemination of Patient-Specific Information from Devices by Device
Manufacturers'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Sugato De, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5435, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Increasingly, patients seek to play an active role in their own
healthcare. FDA believes that manufacturers providing patients with
accurate, useable information about their healthcare (including the
medical products they use and patient-specific information these
products generate) will improve healthcare by empowering patients to
participate fully with their healthcare providers in making sound
medical decisions. For purposes of this guidance, patient-specific
information is defined as any information unique to an individual
patient or unique to that patient's treatment or diagnosis that may be
recorded, stored, processed, retrieved, and/or derived from a medical
device. This information may include, but is not limited to, recorded
patient data, device usage/output statistics, healthcare provider
inputs, incidence of alarms, and/or records of device malfunctions or
failures.
    FDA developed this draft guidance to convey FDA's policy regarding
the dissemination of patient-specific information recorded, stored,
processed, retrieved, and/or derived from a medical device and provided
by the manufacturer to the patient who is either treated or diagnosed
with that specific device. This draft guidance document also outlines
considerations for the form in which this information is communicated
to help to ensure clarity of content and appropriate context.
    Manufacturers may share patient-specific information (recorded,
stored, processed, retrieved, and/or derived from a medical device,
consistent with the intended use of that medical device) with patients
either on their own initiative or at the patient's request, without
obtaining additional premarket review before doing so. Any labeling, as
that term is defined in section 201(m) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), that is provided to the patient by the
manufacturer is subject to applicable requirements in the FD&C Act and
FDA regulations.

II. Significance of Guidance

    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 ``Dissemination
of Patient-Specific Information from Devices by Device Manufacturers.''
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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Dissemination of Patient-
Specific Information from Devices by Device Manufacturers'' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1500067 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 801 and 809,
regarding device labeling, are approved under OMB control number 0910-
0485.

    Dated: June 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13787 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Proposed Rules]
[Pages 28795-28797]
[FR Doc No: 2016-10921]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0768]
RIN 1625-AA09

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway
and Indian Creek, Miami, FL.

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes modifying the operating schedule that
governs the West 79th Street Bridge across the Atlantic Intracoastal
Waterway mile 1084.6, Miami, FL and the operating schedule that governs
the East 79th Street Bridge across Miami Beach Channel, Miami, FL. This
action will place the East and West 79th Street Bridges across Miami
Beach Channel and Atlantic Intracoastal Waterway, Miami, FL on a twice
an hour opening schedule between 7 a.m. and 7 p.m., Monday through
Friday, except Federal holidays. This action is intended to reduce
vehicular traffic caused by these bridges opening on demand.

DATES: Comments and related material must reach the Coast Guard on or
before July 11, 2016.

ADDRESSES:  You may submit comments identified by docket number USCG-
2015-0768 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Michael Lieberum of the Coast Guard; telephone
305-415-6744, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section Symbol
U.S.C. United States Code
FDOT Florida Department of Transportation
AICW Atlantic Intracoastal Waterway

II. Background, Purpose and Legal Basis

    The East and West 79th Street Bridges currently open on signal,
pursuant to 33 CFR 117.5, which results in frequent openings that
restrict vehicle traffic during the day, especially during morning and
afternoon rush hour traffic. The Florida Department of Transportation
(FDOT), the bridge owner, and the City of North Bay Village requested a
change to the current operating schedule for both bridges to allow for
scheduled openings twice an hour during peak traffic times. Bridge logs
indicate these bridges open up to four times an hour or more during
peak travel times, which results in frequent vehicular traffic
disruptions.
    This proposed regulation would reduce vehicle traffic backups
without unreasonably restricting vessel traffic by scheduling two
openings per hour during peak traffic times, thereby balancing the
needs of both modes of transportation.
    Additionally, other bridges on this section of the Intracoastal
Waterway and Miami Channel open two times per hour. The proposed
scheduled openings will align the 79th Street bridge openings with
other bridges on the Intracoastal, namely, the Broad Causeway Bridge to
the North (33 CFR 117.261(mm)) and The Venetian Causeway Bridge to the
South (33 CFR 117.261(nn)), thereby allowing vessels to plan voyages
during opening times and vehicles to schedule commutes around these
openings.
    The East 79th Street Bridge across Miami Beach Channel, Miami, FL
has a vertical clearance of 25 feet at MHW in the closed to navigation
position and a horizontal clearance of 60 feet between fenders.
    The West 79th Street Bridge across the Atlantic Intracoastal
Waterway mile 1084.6, Miami, FL has a vertical clearance of 25 feet at
MHW in the closed to navigation position and a horizontal clearance of
90 feet between fenders.

III. Discussion of Proposed Rule

    The Coast Guard proposes to amend 33 CFR 117.261. The Coast Guard
will add paragraph (mm1) to this section. Under this proposed
regulation, the draw of the West 79th Street Bridges, at Miami, Florida
would open twice an hour, once on the hour and once on the half-hour,
Monday through Friday between the hours of 7 a.m. and 7 p.m. During
nights and weekends and on Federal holidays, the Bridge would open on
signal.
    The Coast Guard further proposes to add section 117.304 to title 33
of the CFR. This section will be entitled ``Miami Beach Channel'' and
would add the schedule for the East 79th Street Bridge that will be
identical to the proposed schedule for the West 79th Street Bridge
stated above.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders (E.O.s) related to rulemaking. Below we summarize
our analyses based on these statutes and E.O.s and we discuss First
Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting

flexibility. This NPRM has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, the NPRM has not
been reviewed by the Office of Management and Budget.
    This regulatory action determination is based on vessels being able
to plan voyages that require transiting the bridge during the scheduled
opening periods or, when capable of doing so, vessels may transit under
the bridge at any time. This rule will further meet the reasonable
needs of navigation while taking into consideration the reasonable
needs of vehicular traffic.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section IV.A
above this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. This proposed rule simply
promulgates the operating regulations or procedures for drawbridges.
Normally such actions are categorically excluded from further review,
under figure 2-1, paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this notice, and all public comments, are in
our online docket at http://www.regulations.gov and can be viewed by
following that Web site's instructions. Additionally, if you go to the
online docket and sign up for email alerts, you will be notified when
comments are posted or a final rule is published.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.261, add paragraph (mm1) to read as follows:

Sec.  117.261  Atlantic Intracoastal Waterway from St. Marys River to
Key Largo.

* * * * *
    (mm1) West 79th Street Bridge. The draw of the West 79th Street
Bridge, at Miami, Florida will open on signal, except that from 7 a.m.
to 7 p.m. Monday through Friday, except Federal holidays, the draw need
only open on the hour and half hour.
* * * * *
0
3. Add Sec.  117.304 to read as follows:

Sec.  117.304  Miami Beach Channel.

    The draw of the East 79th Street bridge, at Miami, Florida will
open on signal, except that from 7 a.m. to 7 p.m. Monday through
Friday, except Federal holidays, the draw need only open on the hour
and half hour.

    Dated: May 4, 2016.
S.A. Buschman,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2016-10921 Filed 5-9-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: March 12, 2010 (Volume 75, Number 48)]
[Notices]
[Page 11972-11974]
[DOCID:fr12mr10-176]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61658; File No. SR-FINRA-2010-001]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Approving Proposed Rule Change Relating to
Publication of Certain Aggregate Daily Trading Volume Data

March 5, 2010.

I. Introduction

    On January 6, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change relating to the publication of aggregate daily
trading volume data for over-the-counter trades in NMS stocks that are
executed within a FINRA member's alternative trading system (``ATS'')
dark pool and reported to a FINRA Trade Reporting Facility
(``TRF'').\3\ The proposed rule change was published for comment in the
Federal Register on January 22, 2010.\4\ The Commission received one
comment on the proposal.\5\ This order approves the proposed rule
change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The FINRA TRFs are facilities used by members to report
over-the-counter transactions in NMS stocks to FINRA. There are two
TRFs in operation today: the FINRA/Nasdaq TRF and the FINRA/NYSE
TRF. Each TRF is operated in conjunction with the respective
exchange ``TRF Business Member.''
    \4\ See Securities Exchange Act Release No. 61361 (January 14,
2010), 75 FR 3768.
    \5\ See letter from Tom Jordan, Advisory Committee Chair,
Financial Information Forum, to Elizabeth M. Murphy, Secretary,
Commission, dated February 24, 2010 (``FIF Letter'').
---------------------------------------------------------------------------

II. Description of the Proposal

    FINRA has members that operate so-called ``dark pools'' of
liquidity. FINRA proposes to define such dark pools to include an ATS
that does not display quotations or subscribers' orders to any person
or entity, either internally within an ATS dark pool or externally
beyond an ATS dark pool (other than to employees of the ATS).\6\ Over-
the-counter transactions executed within an ATS dark pool are reported
by the ATS to a FINRA facility, e.g., a FINRA TRF. The FINRA facility
reports information regarding transactions executed within an ATS dark
pool to a central processor for consolidated market data in NMS stocks.
The central processor then distributes the information it receives from
the FINRA facility to the public in a consolidated stream pursuant to
joint-SRO plans. The information relating to the trading volume
reported to FINRA facilities by members operating ATS dark pools is not
currently separately identified to the public.
---------------------------------------------------------------------------

    \6\ See id. and proposed FINRA Rule 6160(c).
---------------------------------------------------------------------------

    The proposed rule change will allow for the publication of ATS dark
pool trading volume to the public. FINRA, through its TRF Limited
Liability Companies, will distribute transaction reporting data to the
TRF Business Members so that the TRF Business Members may publish,
after the close of trading, aggregate daily trading volume data for
trades executed within participating ATS dark pools. The TRF Business
Members will make the data widely available to the public at no cost.
Specifically, members will not be charged a fee for having their ATS
dark pool data included in the published aggregate daily trading volume
data. Additionally, no TRF Business Member will charge a fee to view
the aggregate daily trading volume data.
    The TRF Business Members will post the daily trading volume data
for trades executed within participating ATS dark pools on their
respective Web sites. The New York Stock Exchange LLC (``NYSE'') will
post daily trading volume data on its Web site based on transactions
reported to the FINRA/NYSE TRF, and the NASDAQ Stock Market LLC
(``Nasdaq'') will post daily trading volume data on its Web site based
on transactions reported to the FINRA/Nasdaq TRF. The TRF Business
Members will segregate the daily trading volume data for each
participating ATS dark pool.\7\
---------------------------------------------------------------------------

    \7\ Initially, the data may be presented as an overall volume
percentage; however, at a later date, it may be further broken down
by security. FINRA members that participate in the program must
acknowledge that their data may be published in one of these two
ways.

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

    FINRA members may choose to participate in the proposed program to
publish dark pool transaction data. No member's ATS dark pool data will
be included in the aggregate daily trading volume unless the member
expressly requests that it be published. If a member decides to have
its ATS dark pool volume published, it must comply with FINRA Rule
6160. Under Rule 6160, FINRA currently permits members to obtain and
use multiple Market Participant Identifiers (``MPIDs'') for purposes of
reporting trades to a TRF on a pilot basis.\8\ The proposed rule change
will add paragraph (c) to Rule 6160 and will expand the scope of the
rule to allow FINRA members to request multiple MPIDs for the purpose
of reporting ATS dark pool transaction data, subject to certain
conditions.\9\
---------------------------------------------------------------------------

    \8\ Under Rule 6160, members must submit a written request to,
and obtain approval from, FINRA Operations for additional MPID(s).
As part of the approval process, members must provide bona fide
business and/or regulatory reasons for requesting an additional
MPID, such as to facilitate a member's back office operations.
    \9\ FINRA considers the issuance of, and trade reporting with,
multiple MPIDs to be a privilege and not a right. If FINRA
determines that the use of multiple MPIDs is detrimental to the
marketplace, or that a TRF participant is using one or more
additional MPIDs improperly or for other than the purpose(s)
identified by the participant, FINRA staff has full discretion to
limit or withdraw its grant of the additional MPID(s) to the
Participant for purposes of reporting trades to a TRF. See Rule
6160.
---------------------------------------------------------------------------

    If a member chooses to participate in the program to publish ATS
dark pool data (``participating member''), the member must obtain and
use a separate MPID designated exclusively for the reporting of
transactions executed within a single ATS dark pool.\10\ The member
will be required to use this separate MPID to report all transactions
executed within that ATS dark pool to a TRF (or TRFs).\11\ In addition,
the member will be prohibited from using such separate MPID to report
any transaction that is not executed within the ATS dark pool,
including, e.g., trades that are routed away by the ATS dark pool. Any
member that operates multiple ATS dark pools and decides to have each
ATS dark pool participate in the proposed program must obtain a
separate MPID for each ATS dark pool.\12\ FINRA members that choose to
have their ATS dark pool volume included in the published data also
will be required to have policies and procedures in place to ensure
that trades reported with a separate MPID obtained under proposed Rule
6160(c) are restricted to trades executed within that ATS dark pool.
---------------------------------------------------------------------------

    \10\ Today, under FINRA rules, a broker-dealer that operates an
ATS dark pool may report trades executed within the ATS using the
same MPID that it uses for transactions it executes in other areas
of its business (including, e.g., other ATSs it operates). As a
result, it would not be possible to determine from the trade
reporting data which trades were executed within the ATS dark pool
as opposed to other areas of the broker-dealer's business. An ATS
dark pool using such a ``multi-purpose'' MPID will be ineligible to
participate in the proposed program for publication of ATS dark pool
volume.
    \11\ For example, if ``Member A'' chooses to participate in the
program to publish data for its ATS dark pool, ``Dark Pool X,''
Member A will be assigned a single MPID to use exclusively to report
the trading information for Dark Pool X. Member A cannot be assigned
a second MPID to report the trading information for Dark Pool X.
    \12\ A member cannot use a single MPID to report transactions
executed within multiple ATS dark pools. For example, if ``Member
B'' participates in the program to publish data for its ATS dark
pools, ``Dark Pool Y'' and ``Dark Pool Z,'' Member B must obtain a
separate MPID for each dark pool. Member B cannot use the MPID that
is assigned to Dark Pool Y to report any transactions executed
within Dark Pool Z.
---------------------------------------------------------------------------

    If a FINRA member obtains a separate MPID for ATS dark pool
transaction reporting for purposes of the proposed program, then all
transactions reported under such MPID will be included in the published
ATS dark pool volume, irrespective of whether the member reports to a
single TRF or multiple TRFs.\13\ Because a member that opts in to the
proposed program may report transactions executed within its ATS dark
pool to more than one TRF, the data published on one TRF Business
Member's Web site may not reflect 100 percent of that member's volume
for that ATS dark pool. Persons who wish to view the ATS dark pool data
therefore may need to consult all TRF Business Members' Web sites to
see the total volume for any given ATS dark pool, and the TRF Business
Members will make prominent disclosure to this effect on their Web
sites.\14\
---------------------------------------------------------------------------

    \13\ In other words, once a member has chosen to participate in
the program, 100 percent of its ATS dark pool transactions must be
reported under a single MPID to one or more TRFs (the member can
choose to report to a single TRF or multiple TRFs) and 100 percent
of this volume will be published. Because FINRA's Alternative
Display Facility (``ADF'') does not offer a program to publish dark
pool transaction data, the member will be prohibited from reporting
to the ADF in this instance.
    \14\ The proposed Supplementary Material to Rule 6160 also will
clarify that the TRF Business Members will make such disclosure.
---------------------------------------------------------------------------

    Pursuant to the proposed Supplementary Material, a member operating
an ATS dark pool must certify in writing to FINRA that: (1) The member
is affirmatively opting in for purposes of having its ATS dark pool
transaction data included in the published data and acknowledges that
its data may be presented as an overall percentage volume only or may
be broken down by security; (2) the member meets the definition of ATS
dark pool in proposed Rule 6160(c); and (3) the member has obtained a
separate MPID that will be used exclusively for reporting its ATS dark
pool transactions as required by proposed Rule 6160(c). The member will
be required to identify to FINRA the MPID (or MPIDs, if the member
operates more than one ATS dark pool and opts to have each ATS dark
pool participate in the proposed program) that should be aggregated in
the published volume.
    The proposed requirements relating to the establishment and use of
separate MPIDs for purposes of ATS dark pool transaction reporting are
designed to ensure that the published volume is limited to the member's
ATS dark pool activity. In addition to these requirements, FINRA has
established certain other parameters to minimize the risk of double
counting and ensure the accuracy and reliability of the published data.
The data posted on each TRF Business Member's Web site will show the
trading volume reported to the respective TRF only and will not include
transactions reported to or counted by another venue, e.g., another
TRF. Only transactions that are reported for purposes of publication
will be included in the published data (i.e., ``non-tape'' regulatory
or clearing-only reports will not be included in the aggregate volume).
In addition, there will be no double counting of trade volume (i.e., a
1,000 share trade reported for publication purposes will not be counted
as 2,000 shares to reflect 1,000 shares on the buy side and 1,000
shares on the sell side).

III. Discussion and Commission's Findings

    After careful review of the proposed rule change, the Commission
finds that the proposed rule change is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities association.\15\ In particular, the Commission
finds that the proposed rule change is consistent with the provisions
of Section 15A(b)(6) of the Act,\16\ which requires, among other
things, that FINRA rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest; and are not designed to permit unfair

discrimination between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \15\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition and capital
formation. See 15 U.S.C. 78c(f).
    \16\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    The Commission believes that the proposed rule change will help
increase the information available about transactions executed in dark
pools, and therefore further the ability of investors to identify the
sources of liquidity in NMS stocks. The Commission notes that the
provisions of Rule 6160(c) are designed to ensure that once a member
determines to participate in the program with respect to one (or more)
of its ATS dark pools, all of that dark pool's transactions, and only
that dark pool's transactions, will be aggregated for publication.\17\
The published ATS dark pool information will separately identify each
dark pool and the TRF Business Members will make prominent disclosure
on their Web sites that a person may need to look at both Web sites to
obtain the total volume for a particular ATS dark pool.\18\ Further,
FINRA members will be required to have policies and procedures in place
to ensure that trades reported with a separate MPID obtained under
proposed Rule 6160(c) are restricted to trades executed within that ATS
dark pool. The Commission believes that these conditions are important
to assure that the public has accurate, reliable and complete
information regarding the activity of ATS dark pools that choose to
participate in this program.
---------------------------------------------------------------------------

    \17\ Rule 6160(c) requires FINRA members that choose to
participate in the program with respect to an ATS dark pool to
provide all of the transaction data for that ATS dark pool to one or
more of the FINRA TRFs for purposes of publication by the TRF
Business Members. Thus, members may not selectively report some
transactions executed within a participating ATS dark pool and keep
other transactions executed in the ATS ``dark.'' Further, Rule
6160(c) requires FINRA members that choose to participate in the
program to use a single MPID to report transaction information for
each participating ATS dark pool. A member cannot be assigned a
second MPID to report the trading information for the same dark pool
and cannot use a single MPID to report transactions executed within
multiple dark pools.
    \18\ The TRF Business Members will segregate the information
they receive for each ATS dark pool on their Web site and must
prominently disclose that the Web site may not reflect 100 percent
of that dark pool's volume, and that interested parties will need to
consult all TRF Business Members' Web sites to see the total volume
for any given ATS dark pool.
---------------------------------------------------------------------------

    The Commission received one comment letter in connection with the
proposed rule change.\19\ This commenter expressed concern that, while
the publishing of ATS dark pool transactions is voluntary under the
proposed rule change, the requirement of a separate MPID designed
exclusively for reporting a member's ATS dark pool transactions could
limit ATS participation and delay implementation because of both
administrative processes and technology modifications required to
implement this reporting in the manner defined in the rule filing.\20\
While the commenter believes that publishing ATS dark pool volume would
be beneficial to the market and the public, it believes that FINRA
should consider other methods to achieve this goal.\21\ The commenter
suggested some alternatives to identifying ATS dark pool volume other
than obtaining a separate MPID.\22\ The Commission appreciates this
commenter's view on the proposed rule change. However, the Commission
believes that FINRA's proposal to allow members to request multiple
MPIDs for the purpose of reporting ATS dark pool transaction data is a
reasonable method by FINRA to assure the accuracy of the information
being made public. In addition, the Commission notes that a FINRA
member's participation in the program to publish ATS dark pool
information is voluntary and that if a member does not wish to obtain a
separate MPID to display its ATS dark pool data, it does not have to
participate.
---------------------------------------------------------------------------

    \19\ See FIF Letter, supra note 5.
    \20\ See FIF Letter, supra note 5, at 1.
    \21\ Id.
    \22\ See FIF Letter, supra note 5, at 2.
---------------------------------------------------------------------------

    In addition, the Commission finds that the proposed rule change is
consistent with Section 15A(b)(6) of the Act,\23\ which requires, among
other things, that FINRA rules are not designed to permit unfair
discrimination between customers, issuers, brokers or dealers, and Rule
603(a) of Regulation NMS under the Act,\24\ which requires, among other
things, that any national securities exchange, national securities
association, broker or dealer that distributes information with respect
to quotations for or transactions in an NMS stock to a securities
information processor, broker, dealer, or other persons shall do so on
terms that are not unreasonably discriminatory. In approving the
proposed rule change, the Commission notes that FINRA, through its TRF
Limited Liability Companies, will distribute the transaction reporting
data for ATS dark pools that choose to participate in this program to
the TRF Business Members so that the TRF Business Members may publish,
after the close of trading, aggregate daily trading volume data for
trades executed within the participating ATS dark pools, separated by
dark pool, on their respective Web sites. The Commission also notes
that FINRA members will not be charged a fee for having their ATS dark
pool data included in the published aggregate daily trading volume data
and that no TRF Business Member will charge a fee to anyone to view the
aggregate daily trading volume data posted on its Web site. The
Commission believes that these conditions are necessary and appropriate
to ensure that investors, market participants and other persons will
have access to the ATS dark pool data on terms that are not
unreasonably or unfairly discriminatory.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78o-3(b)(6).
    \24\ 17 CFR 242.603(a).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\25\ that the proposed rule change (SR-FINRA-2010-001) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
---------------------------------------------------------------------------

    \26\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-5300 Filed 3-11-10; 8:45 am]
BILLING CODE 8011-01-P