[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3432-3433]
[FR Doc No: 2016-01094]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0749]

Implanted Blood Access Devices for Hemodialysis; Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Implanted Blood Access Devices
for Hemodialysis.'' This guidance was developed to support the
reclassification of the implanted blood access devices for hemodialysis
into class II (special controls) and to assist industry in preparing
premarket notification (510(k)) submissions for implanted blood access
devices for hemodialysis.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

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-

2013-D-0749 for ``Implanted Blood Access Devices for Hemodialysis.''
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 guidance document entitled
``Implanted Blood Access Devices for Hemodialysis'' 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: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides recommendations to assist manufacturers in
developing their premarket submissions of implanted blood access
devices for hemodialysis regulated under 21 CFR 876.5540(a)(1). The
draft of this guidance document was issued concurrently with the
proposed reclassification of implanted blood access devices under Sec.
876.5540(a)(1). FDA published a proposed order to reclassify this
device in the Federal Register of June 28, 2013 (78 FR 38867) and
announced the availability of the draft guidance elsewhere in the same
issue of the Federal Register (78 FR 38994). The comment period for the
draft guidance closed on August 27, 2013. FDA also held a meeting of
the Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee (the Panel), on June 27, 2013 (78 FR 25747, May 2,
2013), to discuss whether implanted blood access devices should be
reclassified or remain in class III. The draft guidance supported the
proposed reclassification.
    In response to the draft guidance, FDA received comments from one
commenter. The comments, in addition to the feedback from the Panel,
were considered and discussed in the final order reclassifying this
device type into class II (special controls) (79 FR 43241, July 25,
2014). This final guidance references the special controls for this
device type, and the recommendations in the draft guidance were
modified to be consistent with revisions to the special controls as
codified in the final order.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on implanted blood access devices for
hemodialysis. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the 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 ``Implanted Blood Access
Devices for Hemodialysis'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1781 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. 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 part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; the collections of information in 21 CFR part 801 and
809 have been approved under OMB control number 0910-0485; the
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; and the collections of information in 21
CFR part 50 and 56 have been approved under OMB control number 0910-
0130.

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01094 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P


Site Visit Report

	Danskammer Generating Station

	994 River Road

	Newburgh, NY 12250

April 16, 2008

Background and Objectives

The Environmental Protection Agency (EPA) is in the process of
developing 316(b) cooling water intake structure requirements that
reflect the best technology available (BTA) for minimizing adverse
environmental impact for all existing power plants and manufacturing
facilities. As part of this process, EPA staff is visiting electric
generators and manufacturers to better understand the cooling water
intake structure (CWIS) technologies in use at facilities, including the
site-specific characteristics of each facility and how these affect the
selection and performance of CWIS technologies.  EPA is also visiting
facilities to better understand cooling water use and specific issues or
technologies that can affect 316(b) compliance.  Danskammer Generating
Station (Danskammer) was selected for a site visit due to its use of
fine mesh traveling screens and its large intake flow.

Facility Description

Danskammer is located on the western bank of the Hudson River at
approximately river mile 62 on the same site as the Roseton Generating
Station; both facilities are owned by Dynegy.  Approximately 250
employees work at the two sites.

The facility’s NPDES permit (NY0006262) was renewed in 2006 and
included requirements for intake technologies and flow reductions.

Electricity Generation and Transmission

Danskammer has 4 generating units.  Units 1 and 2 are each 55 MW
oil-fired peaking units that were built in 1951 and 1954 and typically
only operate in the summer and winter.  Units 3 and 4 are coal-fired
baseload units (135 and 235 MW, respectively) that were built in 1959
and 1967.  The capacity utilization for Units 1 and 2 varies depending
on the severity of weather; Units 3 and 4 operate at higher utilization
levels.  In 2006, the facility-wide capacity utilization rate was 48%.

The facility schedules its outages around the peak entrainment seasons.
There are two short (1-2 week) outages per year, with one major outage
(4-6 weeks or more) every 4-5 years.

Cooling Water Intake Structure

Danskammer withdraws cooling water via a 450 foot long and 34 foot wide
intake canal.  The canal is relatively shallow -- as little as 8-10 feet
deep at low tide.  Intake bays for each unit are at the terminus of the
canal.

Units 1, 2 and 4 use standard 3/8” mesh traveling screens.  Unit 3 has
fine mesh traveling screens with a mesh size of 1/8” (3.2 mm) that
were installed in 1984.  When a unit is in operation, the traveling
screens are rotated continuously.  Units 1 and 2 share a common return
trough, and Units 3 and 4 share a second return trough.  Facility
representatives were unsure of the design intake velocity, but estimated
that it was approximately 0.5 feet per second; they also noted that the
intake velocity is dependent upon the number of circulating pumps in
operation.

The facility uses a once-through cooling water system with a design
intake flow of 457 million gallons per day.  As part of the 2006 permit
conditions, variable frequency drives (VFDs) were installed on Unit 4
(the largest unit) to enable reductions in intake flow when possible.
Additionally, the permit required the continued use of a sonic deterrent
at the mouth of the intake canal, which targets outmigrating
young-of-the-year herring.

No biocides or other biofouling measures are in use at the facility.

Impingement and Entrainment Information

Danskammer conducted a number of studies in the 1980s on various topics,
including intake technologies, behavioral technologies, flow reduction
alternatives, and entrainment survival.  Since 1993, the facility has
also participated in jointly funded studies with other utilities along
the Hudson River for comprehensive monitoring.  Impingement data has
also been collected at Danskammer and Roseton since 1972.  The past 2
years of impingement and entrainment monitoring have indicated that the
species of concern may be changing from previous assessments.

Monitoring has indicated a distinct diel pattern in the abundance of
organisms in the river; nighttime impingement rates are definitively
higher, while entrainment rates also show a modest increase.

Facility representatives also noted the total population of organisms
appears to be lower than 4-5 years ago and that the species composition
has also changed.  In general, Danskammer has a higher rate of
impingement and entrainment than Roseton.  The facility has not seen an
increase in vegetative debris over that period, but facility
representatives did note that the presence of zebra mussels upstream has
led to reduced turbidity, which may eventually result in increased
vegetative growth.

The facility has NPDES permit conditions that require mandatory outages
during key entrainment periods for river herring, alewife, and eels.
These conditions apply to individual units and include reductions in the
number of circulating pumps used while in operation.  The permit also
has tiered requirements, which increase the required reductions in
impingement and entrainment over time.

Cooling Tower Feasibility

As part of the facility’s NPDES permit renewal process, closed cycle
cooling was evaluated.  It was determined (with NYDEC concurrence) that
there was not sufficient space for cooling towers (with plume abatement)
on Danskammer’s property.  Facility representatives noted that a CSX
rail line bisects the property and steep slopes in other areas limit the
available space onsite.  NYDEC and Dynegy agreed that a patchwork of
cooling tower cells located in multiple locations was not a viable
solution, but noted that Roseton may have more flexibility for siting
cooling towers, as its property has a more open layout.

Additional Information

Facility representative stated that a barrier net installed at the mouth
of the intake canal was considered as one technology alternative.

Danskammer’s design is similar to that of the Lovett Generating
Station, located approximately 20 miles downstream.  Facility
representatives noted that the species composition at the two sites is
very different due to the salinity levels at each facility; Lovett
consequently has a longer peak entrainment season.

Roseton is a dual fired facility (oil or natural gas) but has recently
been downgraded from baseload generating status due to market factors;
its capacity utilization is less than 10%.  Roseton’s intake structure
employs standard mesh (3/8”) traveling screens.  The traveling screens
also withdraw from a much deeper area of the river (27 feet) than at
Danskammer.

Facility representatives stated that the fine mesh screens have not
required any significant maintenance or upkeep, noting that the
continuous screen rotation likely resolves most clogging issues.  They
added that the fine mesh screen may also provide some operational
advantages, as less debris is carried over into the condenser.  Newer
screen panels are constructed of a carbon composite material, also
reducing maintenance requirements.

Facility representatives stated that Danskammer did not have a formal
plan for complying with the now-suspended Phase II rule.  At the time,
the facility was already conducting studies as part of its permit
renewal process, but noted that flow reductions and scheduled outages
were the most attractive options for reducing entrainment.  Facility
representatives stated that they were likely to use the standard
calculation baseline configuration.

Attachments

Attachment A		List of Attendees

Attachment B		Aerial Photo

Attachment C	Roseton and Danskammer Point Generating Station impingement
monitoring report 2006 (excerpt)

Attachment D	Danskammer Impingement Monitoring Program: 2008 First
Quarter Summary Report

Attachment E		Sample environmental data for Danskammer Unit 3

Attachment F		Normandeau species cutoff list for 2008

Attachment G	Danskammer Point fine mesh screen evaluation: 1986 study
(excerpt)

Attachment H	Danskammer Point fine mesh screen evaluation: 1988 study
(excerpt)

Attachment I	Estimates of impingement mortality for selected fish
species at the Danskammer Point Generating Station 1975-1980

Attachment J		A biological evaluation of modified vertical traveling
screens

Attachment K		Engineering Diagrams

Attachment L		Site Visit Photos

Attachment A--List of Attendees

Paul Shriner, EPA

Jan Matuszko, EPA

Kelly Meadows, Tetra Tech

John Carnright, Dynegy

Eric Shaw, Dynegy

Attachment B--Danskammer Aerial Photo

Please see DCN 10-6505J accompanying this document.

Attachment C--Roseton and Danskammer Point Generating Station
Impingement Monitoring Report 2006 Annual Progress Report (excerpt)

Please see DCN 10-6505A accompanying this document.

Attachment D--Danskammer Impingement Monitoring Program: 2008 First
Quarter Summary Report

Please see DCN 10-6505B accompanying this document.

Attachment E--Sample environmental data for Danskammer Unit 3

Please see DCN 10-6505C accompanying this document.

Attachment F--Normandeau species cutoff list for 2008

Please see DCN 10-6505D accompanying this document.

Attachment G--Danskammer Point fine mesh screen evaluation: 1986 study

Please see DCN 10-6505E accompanying this document.

Attachment H--Danskammer Point fine mesh screen evaluation: 1988 study

Please see DCN 10-6505F accompanying this document.

Attachment I--Estimates of impingement mortality for selected fish
species at the Danskammer Point Generating Station 1975-1980

Please see DCN 10-6505G accompanying this document.

Attachment J--A biological evaluation of modified vertical traveling
screens

Please see DCN 10-6505H accompanying this document.

Attachment K--Engineering Diagrams

Please see DCN 10-6505I accompanying this document.

Attachment L--Site Visit Photos

Please see DCNs 10-6505K-N accompanying this document.

 Danskammer’s location is at the edge of the tidally influenced Hudson
River; the water is slightly brackish and there are small tidal
variations (approximately 3 feet).

 Danskammer and Roseton Generating Station operate independently, share
no infrastructure, and are separate legal entities (including a distinct
allocation of land on the site).  Roseton, along with Indian Point and
Bowline, were part of the 1981 Hudson River settlement, an agreement
with the state and environmental groups on fish protection issues in the
Hudson River.  (Danskammer is not part of the settlement agreement.)
Roseton’s permit (NY0008231) expired in 1992 and was administratively
extended; the permit is currently in the process of being renewed.

 Units 3 and 4 were originally designed as dual fuel units (coal and
oil) but were reconfigured in 1987 to use only coal.  Coal usually
arrives by boat from Venezuela, but rail is also a delivery option.  A
supply of approximately 30-40 days of fuel is stored onsite.  Over 85%
of the ash is sent offsite for beneficial uses.

 Side-by-side studies of impingement survival were conducted in the mid
1980s.  However, no comparative studies for entrainment have been
conducted.

 The facility typically documents any flow reductions using a measure of
organism density (organisms per unit flow) and reports this information
to NYDEC.  At this time, facility representatives are unsure of the flow
reduction due to the VFDs, as they have not calculated the frequency at
which the VFDs operate.

 Studies in Lake Ontario suggest that sonic deterrents can be effective
with herring.

 PAGE

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[Federal Register Volume 84, Number 130 (Monday, July 8, 2019)]
[Notices]
[Pages 32492-32497]
[FR Doc No: 2019-14402]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86257; File No. SR-FINRA-2019-017]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend
FINRA Rules 2210 (Communications With the Public) and 2241 (Research
Analysts and Research Reports)

July 1, 2019.
    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 June 20, 2019, Financial Industry Regulatory Authority, Inc.
(``FINRA'') 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 FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rules 2210 (Communications with
the Public) and 2241 (Research Analysts and Research Reports) to
conform to the requirements of the Fair Access to Investment Research
Act of 2017 (``FAIR Act'').\3\ The proposed rule change would eliminate
the ``quiet period'' restrictions in Rule 2241 on publishing a research
report or making a public appearance concerning a covered investment
fund and would create a filing exclusion under FINRA Rule 2210 for
covered investment fund research reports.
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    \3\ See Fair Access to Investment Research Act of 2017, Public
Law 115-66, 131 Stat. 1196 (2017).
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    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA 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, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
The FAIR Act
    The FAIR Act requires the SEC to propose and adopt rule amendments
that would extend the current safe harbor under Securities Act of 1933
(``Securities Act'') Rule 139 \4\ to a ``covered investment fund
research report'' upon terms and conditions that the SEC determines are
necessary or appropriate in the public interest, for the protection of
investors, and for the promotion of capital formation.\5\ In
implementing the safe harbor for covered investment fund research
reports, the SEC is required to: (1) Meet specified requirements
concerning the safe harbor's conditions, (2) prohibit any self-
regulatory organization (``SRO'') from maintaining or enforcing
specified rules regarding such reports, and (3) provide that a covered
investment fund research report is not subject to the sales material
filing requirements in section 24(b) of the Investment Company Act of
1940 (``Investment Company Act'').\6\ On November 30, 2018, the SEC
adopted its final rules and rule amendments to implement the mandates
of the FAIR Act.\7\ These requirements are discussed in more detail
below.
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    \4\ 17 CFR 230.139.
    \5\ See section 2(a) of the FAIR Act.
    \6\ See section 2(b) of the FAIR Act.
    \7\ See Securities Act Release No. 10580 (November 30, 2018), 83
FR 64180 (December 13, 2018) (the ``Release'').
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Definition of ``Covered Investment Fund Research Report''
    Under the FAIR Act, a ``research report'' generally has the meaning
given that term under section 2(a)(3) of the Securities Act.\8\ Under
section 2(a)(3), ``research report'' means ``a written, electronic or
oral communication that includes information, opinions, or
recommendations with respect to securities of an issuer or an analysis
of a security or an issuer, whether or not it provides information
reasonably sufficient upon which to base an investment decision.'' \9\
In contrast, under FINRA Rule 2241 (Research Analysts and Research
Reports), the term ``research report'' is defined as ``any written
(including electronic) communication that includes an analysis of
equity securities of individual companies or industries (other than an
open-end investment registered investment company that is not listed or
traded on an exchange) and that provides information reasonably
sufficient upon which to base an investment decision.'' \10\
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    \8\ However, the term does not include an oral communication.
See section 2(f)(6) of the FAIR Act.
    \9\ See section 2(a)(3) of the Securities Act, 15 U.S.C.
77b(a)(3).
    \10\ The definition includes a number of exclusions, such as for
communications that are limited to discussions of broad-based
indices, communications that are distributed to fewer than 15
persons, and statutory prospectuses that are filed as part of an
issuer's registration statement. See FINRA Rule 2241(a)(11).
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    Under the FAIR Act, the term ``covered investment fund research
report'' includes a research report published or distributed by a
broker-dealer about a ``covered investment fund,'' \11\ or any of the
covered investment fund's securities. However, a covered investment
fund research report excludes research published or distributed by the
covered investment fund itself, any affiliate of a covered investment
fund, or any broker-dealer that is an investment adviser (or an
affiliated person of an investment adviser) to the covered investment
fund.\12\
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    \11\ Section 2(f)(2) of the FAIR Act defines ``covered
investment fund'' as:
    (A) An investment company registered under, or that has filed an
election to be treated as a business development company under, the
Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.) and that
has filed a registration statement under the Securities Act of 1933
(15 U.S.C. 77a et seq.) for the public offering of a class of its
securities, which registration statement has been declared effective
by the Commission; and
    (B) a trust or other person--
    (i) issuing securities in an offering registered under the
Securities Act of 1933 (15 U.S.C. 77a et seq.) and which class of
securities is listed for trading on a national securities exchange;
    (ii) the assets of which consist primarily of commodities,
currencies, or derivative instruments that reference commodities or
currencies, or interests in the foregoing; and
    (iii) that provides in its registration statement under the
Securities Act of 1933 (15 U.S.C. 77a et seq.) that a class of its
securities are purchased or redeemed, subject to conditions or
limitations, for a ratable share of its assets.
    \12\ See section 2(f)(3) of the FAIR Act.
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Rule 139
    Securities Act Rule 139 provides that a broker's or dealer's
publication or distribution of a research report about an issuer or any
of its securities shall be deemed for purposes of sections 2(a)(10) and
5(c) of the Securities Act not to constitute an offer for sale or offer
to sell a security that is the subject of a registered offering,
provided that the issuer and its securities meet specified conditions
in the Rule. Rule 139 is sometimes described as a ``safe harbor'' for
such research reports, since they are

not subject to many of the Securities Act's requirements for written
offers of securities. Prior to the SEC's adoption of rules required by
the FAIR Act, Rule 139's safe harbor was not available for a broker-
dealer's publication or distribution of research reports pertaining to
specific registered investment companies or business development
companies (``BDCs'').
    In implementing the safe harbor, the FAIR Act directs the SEC to
meet certain requirements concerning covered investment fund research
reports. For example, the SEC is limited in terms of imposing
conditions to the safe harbor related to a broker-dealer's initiation
of research, or related to a covered investment fund's registration
history or minimum net assets.
    In addition, the SEC must provide that covered investment fund
research reports will not be subject to the filing requirements of
section 24(b) of the Investment Company Act, or rules or regulations
thereunder, except to the extent that such reports are not subject to
content standards of any SRO rules related to research reports,
including those governing communications with the public.\13\ However,
the FAIR Act also specifies that nothing in the Act shall be construed
as in any way limiting the authority of any SRO to examine or supervise
a member's practices in connection with covered investment fund
research reports for compliance with federal law and SRO rules, or to
require the filing of communications the purpose of which is not to
provide research and analysis of covered investment funds.\14\
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    \13\ See section 2(b)(4) of the FAIR Act.
    \14\ See section 2(c)(2) of the FAIR Act.
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    The FAIR Act also requires the SEC to provide that SROs may not
prohibit the ability of a broker-dealer to publish or distribute a
covered investment fund research report solely because the broker-
dealer is participating in a registered offering or other distribution
of the fund, and that an SRO may not prohibit the ability of a broker-
dealer to participate in the registered offering or distribution of a
covered investment fund solely because the broker-dealer has published
or distributed research about the fund.\15\
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    \15\ See section 2(b)(3) of the FAIR Act.
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SEC Final Rules Under the FAIR Act
    On November 30, 2018, the SEC adopted its final rules and rule
amendments to implement the mandates of the FAIR Act.\16\ First, the
SEC adopted new Rule 139b under the Securities Act, which expanded the
Rule 139 safe harbor to include covered investment fund research
reports, subject to specified conditions. Rule 139b adopts the FAIR
Act's definitions of ``covered investment fund,'' ``covered investment
fund research report,'' and ``research report,'' subject to minor non-
substantive revisions.\17\
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    \16\ See Release, supra note 7.
    \17\ See 17 CFR 230.139b(c).
---------------------------------------------------------------------------

    Among other things, in order to qualify for the Rule 139b safe
harbor with respect to an issuer-specific research report, the covered
investment fund that is the subject of the report must have been
subject to relevant reporting requirements under the Investment Company
Act and the Exchange Act for at least 12 calendar months prior to the
reliance on the safe harbor, and these reports must have been filed in
a timely manner.\18\ In addition, the covered investment fund must
satisfy a minimum public market threshold at the date of reliance on
Rule 139b (the ``float'' requirement), which is currently $75
million.\19\ In addition, the safe harbor requires that a broker-
dealer's publication or distribution of research reports be ``in the
regular course of its business.'' \20\ Rule 139b also contains other
conditions for industry reports, and with regard to the presentation of
performance information of a registered open-end management investment
company or a trust account.\21\
---------------------------------------------------------------------------

    \18\ See 17 CFR 230.139b(a)(1)(i)(A).
    \19\ See 17 CFR 230.139b(a)(1)(i)(B). The required float value
does not include shares held by affiliates of the fund, and is based
on General Instruction I.B.1 to Form S-3.
    \20\ See 17 CFR 230.139b(a)(1)(ii).
    \21\ See 17 CFR 230.139b(a)(2) and (a)(3).
---------------------------------------------------------------------------

    In addition, Rule 139b provides that an SRO may not maintain or
enforce any rule that would prohibit the ability of a member to publish
or distribute a covered investment fund research report solely because
the member is participating in a registered offering or distribution of
securities of a covered investment fund, or to participate in a
registered offering or other distribution of such securities solely
because the member has published or distributed a covered investment
fund research report about the fund or its securities.\22\
---------------------------------------------------------------------------

    \22\ See 17 CFR 230.139b(b).
---------------------------------------------------------------------------

    The SEC also adopted new Rule 24b-4 under the Investment Company
Act, which specifies that a covered investment fund research report as
defined in Rule 139b that concerns a fund registered under the
Investment Company Act shall not be subject to section 24(b) of the Act
or any rules or regulations thereunder, unless the report is not
subject to SRO rules relating to research reports, including rules
governing communications with the public.\23\ Section 24(b) of the
Investment Company Act generally requires certain registered investment
companies and their underwriters to file sales material concerning
those funds with the SEC within 10 days of use.\24\
---------------------------------------------------------------------------

    \23\ See 17 CFR 270.24b-4.
    \24\ See 15 U.S.C. 80a-24(b). This filing requirement applies to
sales material concerning any registered open-end management
investment company, any registered unit investment trust (``UIT''),
or any registered face-amount certificate company (``FACC'').
---------------------------------------------------------------------------

Changes to FINRA Rules Required by the FAIR Act
    FINRA interprets the FAIR Act as requiring it to make two changes
to FINRA Rules. First, FINRA is proposing to amend Rule 2241 to
eliminate the quiet period restrictions on publishing a research report
or making a public appearance concerning a covered investment fund that
is the subject of such a report. Second, FINRA is proposing to amend
Rule 2210 to create a filing exclusion for covered investment fund
research reports that qualify for the Securities Act Rule 139b safe
harbor.
FINRA Equity Research Rules
    FINRA Rule 2241 governs the publication of research reports
concerning equity securities and the analysts that produce such
research. Under Rule 2241, members must establish, maintain and enforce
written policies and procedures reasonably designed to identify and
effectively manage conflicts of interest related to the preparation,
content and distribution of research reports and public appearances by
research analysts.\25\ Among other things, these policies and
procedures must define periods during which the member must not publish
or otherwise distribute research reports, and research analysts must
not make public appearances, related to the issuer (``quiet periods'').
---------------------------------------------------------------------------

    \25\ See FINRA Rule 2241(b)(1).
---------------------------------------------------------------------------

    These quiet periods restrict a member that has participated as an
underwriter or dealer in an initial public offering (``IPO'') from
publishing research or having its research analysts make public
appearances for a minimum of 10 days following the date of an IPO. They
also restrict a member that has acted as a manager or co-manager of a
secondary offering from publishing research or having its research
analysts make personal appearances for a minimum of three days
following the date of the offering.\26\
---------------------------------------------------------------------------

    \26\ See FINRA Rule 2241(b)(2)(I). This provision contains
specified exceptions to the quiet periods for research reports and
public appearances following an offering of securities of an
Emerging Growth Company, for reports or appearances that discuss
significant news or events concerning a subject company, and for
reports and appearances regarding subject companies with ``actively
traded securities'' as defined in SEC Regulation M.

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

    While Rule 2241 excludes from its definition of ``research report''
communications related to mutual funds, the Rule applies to
communications that meet the definition of ``research report'' under
Rule 2241 concerning other covered investment funds, including closed-
end funds (``CEFs''), exchange-traded funds (``ETFs''), BDCs, UITs, and
commodity or currency funds, to the extent such research reports are
published by an underwriter or dealer in the IPO or manager or co-
manager of a secondary offering.\27\ Accordingly, such research reports
(as defined under Rule 2241) on covered investment funds (other than
mutual funds) are subject to Rule 2241's quiet periods.
---------------------------------------------------------------------------

    \27\ See FINRA Rule 2241(a)(11).
---------------------------------------------------------------------------

    As discussed above, the FAIR Act requires the SEC to prohibit any
SRO from maintaining or enforcing any rule that would prohibit the
ability of a member to:
     Publish or distribute a covered investment fund research
report solely because the member is also participating in a registered
offering or other distribution of the fund; or
     Participate in a registered offering or other distribution
of securities of a covered investment fund solely because the member
has published or distributed a covered investment fund research report
about the fund or its securities.\28\
---------------------------------------------------------------------------

    \28\ See section 2(b)(3) of the FAIR Act. The SEC implemented
this requirement in Securities Act Rule 139b(b).
---------------------------------------------------------------------------

    Accordingly, FINRA is proposing to amend Rule 2241 to add a new
exception from the Rule's quiet period requirements for the publication
or distribution of research reports and research analysts' public
appearances if the member has participated in the offering of the
subject company's securities.\29\ Under this new exception, the quiet
period requirements shall not apply to a research report or a public
appearance following any offering of the securities of a covered
investment fund that is the subject of a covered investment fund
research report.\30\ Although the FAIR Act does not address quiet
periods for public appearances by research analysts, FINRA also
proposes to eliminate quiet periods for public appearances concerning a
covered investment fund. Under Rule 2241, quiet periods for both
research reports and public appearances are the same, and FINRA
believes elimination of those quiet periods would advance the policy
objectives of the FAIR Act.\31\
---------------------------------------------------------------------------

    \29\ As discussed above, because the definition of ``research
report'' under Rule 2241 is narrower than the definition of
``research report'' under the FAIR Act, not all covered investment
fund research reports are subject to Rule 2241. Nevertheless, to the
extent that a covered investment fund research report is also a
research report subject to Rule 2241, the publication and
distribution of such reports will not be subject to the rule's quiet
periods.
    \30\ FINRA also proposes to define the terms ``covered
investment fund'' and ``covered investment fund research report'' as
having the same meanings as in Securities Act Rule 139b. See
proposed FINRA Rules 2241(a)(15) and (16) in Exhibit 5.
    \31\ FINRA rules do not prohibit a member from participating in
a registered offering or other distribution of securities of a
covered investment fund solely because the member has published
research about the fund. Accordingly, there is no need to amend any
FINRA rule to meet this requirement of section 2(b)(3) of the FAIR
Act or Securities Act Rule 139b(b).
---------------------------------------------------------------------------

Elimination of Filing Requirement
    As discussed above, section 24(b) of the Investment Company Act
requires registered open-end management investment companies,
registered UITs, registered FACCs, and their underwriters to file sales
material for the funds with the SEC within 10 days of first use.
Investment Company Act Rule 24b-3 provides that any sales material
shall be deemed filed with the SEC for purposes of section 24(b) upon
filing with a registered national securities association that has
adopted rules providing standards for the investment company
advertising practices of its members and has established and
implemented procedures to review that advertising.\32\
---------------------------------------------------------------------------

    \32\ FINRA is currently the only national securities association
registered under the Exchange Act that has adopted such rules and
procedures.
---------------------------------------------------------------------------

    Accordingly, virtually all principal underwriters of mutual funds,
ETFs, UITs and FACCs satisfy the section 24(b) requirement by filing
their sales material with FINRA. Rule 2210 requires members to file
within 10 business days of first use or publication retail
communications that promote or recommend a specific registered
investment company or family of registered investment companies
(including mutual funds, ETFs, variable insurance products, CEFs and
UITs), as well as retail communications that concern any other
registered security that is derived from or based on a single security,
a basket of securities, an index, a commodity, a debt issuance or a
foreign currency.\33\
---------------------------------------------------------------------------

    \33\ See FINRA Rules 2210(c)(3)(A) and (D). For a one-year
period beginning on the date reflected in FINRA's Central
Registration Depository (CRD[supreg]) system as the date that FINRA
membership became effective, a member also must file with FINRA at
least 10 business days prior to first use any broadly disseminated
retail communication, regardless of whether it concerns a registered
investment company. See FINRA Rule 2210(c)(1)(A). In addition, a
member must file at least 10 business days prior to first use any
retail communication concerning registered investment companies that
includes performance rankings or comparisons that are not generally
published, or that were created by the investment company, its
underwriter, or an affiliate. See FINRA Rule 2210(c)(2)(A).
---------------------------------------------------------------------------

    As discussed above, pursuant to section 2(b)(4) of the FAIR Act,
the SEC has adopted Investment Company Act Rule 24b-4, which provides
that a covered investment fund research report, as defined in
Securities Act Rule 139b(c)(3), of a covered investment fund registered
as an investment company under the Investment Company Act, shall not be
subject to section 24(b) of the Act. However, a covered investment fund
research report is still subject to the section 24(b) filing
requirement if the report is not subject to the content standards of
any SRO rules related to research reports, including those contained in
the SRO's communications rules regarding investment companies or
substantially similar standards.\34\
---------------------------------------------------------------------------

    \34\ See 17 CFR 270.24b-4.
---------------------------------------------------------------------------

    As discussed above, section 2(c)(2) of the FAIR Act provides that
nothing in the Act shall be construed as in any way limiting the
authority of any SRO to examine or supervise a member's practices in
connection with the member's publication or distribution of a covered
investment fund research report for compliance with applicable
provisions of the Federal securities laws or SRO rules related to
research reports, including those contained in rules governing
communications with the public, or to ``require the filing of
communications with the public the purpose of which is not to provide
research and analysis of covered investment funds.'' \35\ Accordingly,
FINRA interprets the FAIR Act as requiring FINRA to create a filing
exclusion in Rule 2210 for covered investment fund research reports,
but permits FINRA to require the filing of a covered investment fund
research report if the purpose of the report is not to provide research
and analysis of covered investment funds.
---------------------------------------------------------------------------

    \35\ See section 2(c)(2) of the FAIR Act.
---------------------------------------------------------------------------

    In the Release, the SEC made clear that, even if the exclusion of
covered investment fund research reports from the provisions of section
24(b) affects the applicability of FINRA Rule 2210's filing
requirements or exclusions, ``it would not affect FINRA's authority to
require the filing of a communication that is included in the FAIR Act

definition of `covered investment fund research report' but whose
purpose is not to provide research and analysis.'' \36\
---------------------------------------------------------------------------

    \36\ See Release, supra note 7, at 64196.
---------------------------------------------------------------------------

    The SEC also discussed in the Release industry comments
recommending that FINRA modify its rules in light of the FAIR Act. One
commenter recommended that FINRA harmonize its research rules with SEC
Rule 139b and that broker-dealers relying on Rule 139b be exempted from
FINRA's filing requirements with respect to covered investment fund
research reports. Another commenter suggested that the FAIR Act be
interpreted as limiting FINRA's authority to require the filing of
covered investment fund research reports only if a report provides
``information'' that a user would not be able to use for research and
analysis, since such information would be for promotional rather than
research purposes. In addition, one commenter argued that because the
definition of ``research report'' under the FAIR Act is broader than
FINRA's definition of ``research report'' in Rule 2241, this difference
may cause confusion and conflicting interpretive views on what
communications are deemed research for purposes of the safe harbor and
filing exclusion.\37\
---------------------------------------------------------------------------

    \37\ See supra note 36.
---------------------------------------------------------------------------

    FINRA believes that it would be inconsistent with the requirements
of Section 15D of the Exchange Act to modify the definition of
``research report'' under FINRA Rule 2241 to match the definition of
``research report'' under the FAIR Act and Rule 139b. Section 15D of
the Exchange Act, which was enacted as part of the Sarbanes-Oxley Act,
required FINRA to adopt rules reasonably designed to address research
analyst conflict of interests, and specifically defined ``research
report'' using language similar to that used in FINRA Rule 2241.\38\
FINRA further notes that SEC Regulation Analyst Certification (``Reg
AC'') also uses a substantially similar definition of ``research
report.'' FINRA Rule 2241 and Reg AC have different regulatory
objectives than the research report provisions of the FAIR Act, and
Congress could have--but chose not to--harmonize the statutory
definitions of ``research report'' in the FAIR Act.
---------------------------------------------------------------------------

    \38\ See Section 15D(d)(2) of the Exchange Act, 15 U.S.C. 78o-
6(d)(2).
---------------------------------------------------------------------------

    FINRA intends to create a rule that furthers the purposes of the
FAIR Act, protects investors, and is relatively straightforward for
broker-dealers to implement. These objectives can best be achieved if
the filing exclusion applies to any ``covered investment fund research
report'' as defined by Rule 139b that qualifies for the Rule 139b safe
harbor. The SEC has determined which research reports should be subject
to the safe harbor, and FINRA sees no policy reason to create a filing
exclusion for covered investment fund research reports that differs
from this standard.
    The FAIR Act authorizes FINRA to require members to file any
covered investment fund research report the purpose of which is not to
provide research and analysis of covered investment funds. FINRA could
simply amend Rule 2210 by adding a filing exclusion for covered
investment fund research reports, but qualifying the filing exclusion
as not applying to reports the purpose of which is not to provide
research and analysis of covered investment funds. While this approach
would adhere to the text of the FAIR Act, FINRA believes such an
approach would be difficult to apply in practice and would be
inconsistent with the purpose and spirit of the FAIR Act and Rule 139b.
    For example, if FINRA took this approach, members would have to
first determine whether a covered investment fund research report
qualifies for the Rule 139b safe harbor, and then determine if it is
for the purpose of providing research and analysis of covered
investment funds. This approach could create regulatory uncertainty for
members, and also require more compliance resources to process reports.
FINRA believes that the intent of the FAIR Act and Rule 139b is to
increase the volume and publication of research reports on covered
investment funds subject to appropriate conditions, and thus believes
that its filing exclusion should be consistent with this approach.
Moreover, FINRA believes that Rule 139b's requirements reflect the
Commission's careful consideration of balancing the need for more fund
research with investor protection.\39\ For these reasons, FINRA
proposes to exclude from filing all covered investment fund research
reports that qualify for the Rule 139b safe harbor. Of course, FINRA
may still review such reports through examinations, targeted sweeps, or
spot checks, and such reports will remain subject to the content
standards of FINRA rules governing communications with the public.\40\
---------------------------------------------------------------------------

    \39\ See generally Release, supra note 7, at 64183-64193.
    \40\ See section 2(c)(2) of the FAIR Act; see also Release,
supra note 7, at 64194 and fn. 185.
---------------------------------------------------------------------------

    Accordingly, FINRA proposes to create a new filing exclusion under
Rule 2210 for ``any covered investment fund research report that is
deemed for purposes of sections 2(a)(10) and 5(c) of the Securities Act
not to constitute an offer for sale or offer to sell a security under
Securities Act Rule 139b.'' \41\ FINRA also proposes to define
``covered investment fund research report'' as having the same meaning
given that term in paragraph (c)(3) of Securities Act 139b.\42\
---------------------------------------------------------------------------

    \41\ See proposed FINRA Rule 2210(c)(7)(P) in Exhibit 5.
    \42\ See proposed FINRA Rule 2210(a)(7) in Exhibit 5.
---------------------------------------------------------------------------

Affiliated Research Reports
    The FAIR Act and Securities Act Rule 139b define ``covered
investment fund research report'' to exclude a research report to the
extent that the report is published or distributed by the covered
investment fund, any affiliate of the covered investment fund, or any
broker or dealer that is an investment adviser (or an affiliated person
of an investment adviser) for the covered investment fund.\43\ Thus,
research reports published or distributed by a covered investment fund,
its affiliate, or any broker-dealer that is an investment adviser (or
an affiliate of the investment adviser) for the covered investment fund
will still have to be filed under Investment Company Act section 24(b)
and FINRA Rule 2210.\44\
---------------------------------------------------------------------------

    \43\ See section 2(f)(3) of the FAIR Act and Securities Act Rule
139b(c)(3).
    \44\ If a research report concerns both a covered investment
fund that is an affiliate of the member that is publishing or
distributing the research report, as well as a third-party fund that
is not affiliated with the member publishing or distributing the
report, the research report would not qualify as a covered
investment fund research report. See Release, supra note 7, at 64191
(``[w]e believe extending the rule 139b safe harbor to affiliated
funds in industry research reports (whether industry representation
or comprehensive list reports) would not be consistent with the
intent and plain language of section 2(f)(3) of the FAIR Act'').
---------------------------------------------------------------------------

    In some cases an investment adviser or another affiliate of a
registered investment company will enter into an agreement with an
unaffiliated broker-dealer to act as the principal underwriter for the
fund (``third-party distributor''). Third-party distributors provide a
variety of services pursuant to their distribution agreements with
investment companies. Typically, these funds' investment advisers or
the funds themselves prepare the retail communications concerning the
funds, and then submit the communications to the third-party
distributor for compliance review and filing with FINRA. These
communications typically are published on the website for the fund or
its investment adviser, or

the investment adviser or another fund affiliate requests that it be
published or distributed through other media.
    As the SEC noted in the Release, one factor to consider in
evaluating whether a research report has been published or distributed
by a person covered by the affiliate exclusion from the definition of
covered investment fund research report is the extent of such person's
involvement in the preparation of the research report.\45\ These
determinations would be based on the extent to which a person covered
by the affiliate exclusion, or any person acting on its behalf, has
been involved in preparing the information or explicitly or implicitly
endorsed or approved the information. The Commission refers to such
affiliate involvement or endorsement as ``the entanglement or adoption
theory, respectively.'' \46\
---------------------------------------------------------------------------

    \45\ See Release, supra note 7, at 64182.
    \46\ See supra note 45.
---------------------------------------------------------------------------

    Thus, FINRA will not consider research reports on covered
investment funds to be excluded from filing under the proposed changes
to Rule 2210 if personnel of the covered investment fund, any affiliate
of the fund, or any broker-dealer that is the investment adviser or an
affiliated person of the investment adviser were entangled with the
preparation of the report, or had adopted its contents after it had
been prepared.\47\ For example, if a third-party distributor publishes
or distributes research concerning a fund that was written by personnel
of the fund's investment adviser, the report still would be subject to
filing under Rule 2210.
---------------------------------------------------------------------------

    \47\ See Release, supra note 7, at 64181-64183 (discussion of
affiliate exclusion).
---------------------------------------------------------------------------

    If the Commission approves the proposed rule change, FINRA will
announce the approval of the proposed rule change in a Regulatory
Notice to be published no later than 60 days following Commission
approval. The effective date will be the date of Commission approval of
the proposed rule change.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\48\ 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. FINRA believes that the FAIR Act mandates the proposed
changes to the FINRA Rule 2241 quiet periods around publication of
covered investment fund research reports. FINRA believes the additional
proposed change to eliminate quiet periods around public appearances
involving an offering of covered investment fund securities furthers
the policies underlying the statutory mandate by improving information
flow to investors regarding such funds. FINRA believes that the
proposed filing exclusion under FINRA Rule 2210 for covered investment
fund research reports that qualify for the SEC Rule 139b safe harbor is
consistent with the FAIR Act's intent to increase the volume and
publication of research reports on covered investment funds subject to
appropriate conditions. FINRA also believes that the proposed rule
change will improve efficiency and reduce regulatory burden without
diminishing investor protection. As discussed above, FINRA retains
other methods to review covered investment fund research reports.
---------------------------------------------------------------------------

    \48\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. FINRA has undertaken an
economic impact assessment, as set forth below, to analyze the
regulatory need for the proposed rulemaking, its potential economic
impacts, including anticipated costs and benefits, and the alternatives
FINRA considered in assessing how to best meet its regulatory
objectives.
Economic Impact Assessment
    FINRA interprets the FAIR Act as requiring it to make two changes
to its rules regarding quiet periods for covered investment funds and
communications filings of covered investment fund research reports. The
Economic Impact Assessment considers only the impacts of the specific
aspects of the proposed rule changes over which FINRA has used its
discretion. The economic implications for the other aspects of the
proposed rule change that are mandated by the FAIR Act can be deemed
assessed as part of the Act.
    In this proposal, FINRA used its discretion in two areas. First,
FINRA has chosen to include research analysts' public appearances as
part of the proposed exception to Rule 2241's quiet period
requirements. Second, FINRA has chosen to create a new filing exclusion
under 2210 for all covered investment fund research reports that
qualify for the Rule 139b safe harbor rather than just the reports that
are for research and analysis purposes.
Regulatory Need
    Consistent with requirements in the FAIR Act, FINRA is proposing to
amend Rule 2241 to eliminate the Rule's quiet periods for the
publication of research reports concerning covered investment funds
where the member is also participating in a registered offering or
other distribution of the fund. Although not specifically addressed by
the FAIR Act, quiet periods for public appearances by research analysts
that are responsible for covered investment fund research reports will
also be eliminated. FINRA believes that including public appearances in
the proposed amendments is consistent with how FINRA has traditionally
viewed them vis-[agrave]-vis research reports and is in accordance with
the spirit of the FAIR Act.
    FINRA is also proposing to amend Rule 2210 to create a new filing
exclusion for any covered investment fund research report that
qualifies for the Rule 139b safe harbor. The FAIR Act authorizes FINRA
to continue to require members to file any covered investment fund
research reports whose purpose is for something other than research and
analysis of covered investment funds. FINRA has chosen to exclude from
Rule 2210 filing requirements all covered investment fund research
reports that qualify for the safe harbor under Rule 139b regardless of
their purpose.
Economic Baseline and Impact
Quiet Period
    Currently under Rule 2241, members must establish policies and
procedures that prohibit research analysts that produce ``research
reports'' as defined under that rule from making public appearances
during specified quiet periods following the offering of an equity
security. As Rule 2241 does not apply to research reports concerning
mutual funds, this proposed change will only affect public appearances
by analysts responsible for reports concerning other types of equity
securities, including covered investment funds such as BDCs, commodity
or currency funds.
    The proposed rule change will create a new exception from the
Rule's quiet period requirements for the publication or distribution of
research reports and research analysts' public appearances. Elimination
of the quiet period for research analysts' public appearances will
allow analysts to provide the same information contemporaneously
through both research reports and public

appearances. However, the elimination of the quiet period could
increase the risk that research analysts make misleading statements in
public appearances at an earlier date. This risk is mitigated by the
other aspects of Rule 2241, including identifying and managing
conflicts of interest, with which members are still required to comply.
Communications Filings
    Currently Rule 2210 requires members to file within 10 business
days of first use or publication certain retail communications
including covered investment fund research reports that would qualify
under the Rule 139b safe harbor. FINRA is proposing to create a new
filing exclusion under Rule 2210 for all covered investment fund
research reports that qualify for the safe harbor under Rule 139b
regardless of their purpose.
    Between 2016 and 2018, approximately 381 covered investment fund
research reports were filed by members unaffiliated with the covered
investment fund. Over 90 percent of these reports were filed by three
member firms. FINRA does not know how many of the filings were for
purposes other than research and analysis. Members that currently file
these types of reports will benefit through savings on the
administrative costs associated with tracking filing deadlines for the
communications and with the time and effort to put together the filings
as well as fees associated with filing the reports. Alternatively, the
exclusion of these reports from filing requirements could increase
risks to investors. Lower costs could increase the number of non-
research related reports on unaffiliated covered investment funds
published by members. Further, members may risk including more biased
or misleading statements in the reports given the lack of immediate
FINRA oversight.
    This risk to investors is mitigated by two factors. First, only
reports published or distributed by a member unaffiliated with the
covered investment fund qualify for the exclusion. Members unaffiliated
with the covered investment fund have a lower incentive to provide
misleading information than those affiliated with the fund. Second,
FINRA continues to have the ability to review these communications as
part of the examination process or through a sweep or spot checks.
Alternatives Considered
    FINRA considered excluding from the Rule's filing requirements only
those covered investment fund research reports whose purpose is to
provide research and analysis of the covered investment funds. If FINRA
carved out of the proposed exclusion non-research related reports,
members would be required to first evaluate whether the report was
covered under the safe harbor and then determine whether its purpose
was for research and analysis or something else. This additional
evaluation criterion could lead to higher compliance costs and greater
regulatory uncertainty, especially for those members that publish or
distribute a high number of covered investment fund research reports.
While this requirement could reduce risks to investors, FINRA believes
that the reduced risk is not commensurate with the increased costs to
members in complying with the rule and would be inconsistent with the
purpose and spirit of the FAIR Act and Rule 139b.

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

    Comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2019-017 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2019-017. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of FINRA. All comments received will be
posted without change. Persons submitting comments are cautioned that
we do not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
FINRA-2019-017 and should be submitted on or before July 29, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\49\
---------------------------------------------------------------------------

    \49\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-14402 Filed 7-5-19; 8:45 am]
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[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Page 2777]
[FR Doc No: 2018-00929]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9037-2]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements
Filed 01/08/2018 Through 01/12/2018
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federalagencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

EIS No. 20180001, Draft, USFS, ID, Little Boulder Project, Comment
Period Ends: 03/09/2018, Contact: Stephanie Israel<PHONE_NUMBER>.
EIS No. 20180002, Final, FHWA, MO, I-70 Second Tier Combined Final
Environmental Impact Statement and Record of Decision, Pursuant to 23
U.S.C. 139(N), The 30-day wait/review period does not apply to this
FEIS, Contact: Kevin W. Ward<PHONE_NUMBER>.
EIS No. 20180003, Draft, USFS, NV, Mt. Rose Ski Tahoe--Atoma Area
Project, Comment Period Ends: 04/19/2018, Contact: Marnie Bonesteel
775-352-1240.
EIS No. 20180004, Final, BR, NM, Pojoaque Basin Regional Water System
EIS, Review Period Ends: 02/20/2018, Contact: Sarah Branum 505-462-
3591.
EIS No. 20180005, Draft, USFS, CO, Steamboat Ski Area Improvements,
Comment Period Ends: 03/05/2018, Contact: Erica Dickerman<PHONE_NUMBER>.

    Dated: January 16, 2018.
Kelly Knight,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2018-00929 Filed 1-18-18; 8:45 am]
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