[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52352-52357]
[FR Doc No: 2015-21296]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75751; File No. SR-MSRB-2015-08]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change Consisting of Amendments to MSRB Rule A-12, on Registration, and
MSRB Rule A-13, on Underwriting and Transaction Assessments for
Brokers, Dealers and Municipal Securities Dealers

August 24, 2015.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 10, 2015, the Municipal Securities Rulemaking Board (the
``MSRB'' or ``Board'') filed with the Securities and Exchange
Commission (the ``SEC'' or ``Commission'') the proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the MSRB. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB filed with the Commission a proposed rule change
consisting of amendments to MSRB Rule A-12, on registration, and MSRB
Rule A-13, on underwriting and transaction assessments for brokers,
dealers and municipal securities dealers (``proposed rule change'').
The MSRB designated the proposed rule change as ``establishing or
changing a due, fee or other charge'' under section 19(b)(3)(A)(ii) of
the Act \3\ and Rule 19b-4(f)(2) \4\ thereunder, which renders the
proposal effective upon filing with the Commission. The implementation
date of the proposed amendment to Rule A-12 is October 1, 2015 and the
implementation date for the proposed amendment to Rule A-13 is January
1, 2016.
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    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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    The text of the proposed rule change is available on the MSRB's Web
site at www.msrb.org/Rules-and-Interpretations/SEC-Filings/2015-Filings.aspx, at the MSRB's principal office, and at the Commission's
Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to adjust certain
existing MSRB fees applicable to dealers and municipal advisors that
engage in municipal securities and municipal advisory activities
(collectively ``regulated entities'') to continue to assess reasonable
fees necessary to

defray the costs and expenses of operating and administering the MSRB.
    The proposed rule change would amend Rule A-13 to decrease the
existing underwriting fee from $.03 per $1,000 of par value to $.0275
per $1,000 of par value. Additionally, the proposed rule change would
amend Rule A-12 to (i) increase the initial registration fee from $100
to $1,000 and (ii) increase the annual registration fee from $500 to
$1,000. Further, the proposed rule change would amend Rule A-13(c)(iii)
to clarify that securities issued pursuant to a commercial paper
program are not subject to the transaction fee.
Holistic Review of MSRB Fees
    The MSRB assesses regulated entities various fees designed to
defray the cost of its operations, including rulemaking, market
transparency and educational initiatives that fulfill its Congressional
mandate to, among other things, protect investors and municipal
entities by promoting the fairness and efficiency of the $3.7 trillion
municipal securities market. The MSRB provides investors, state and
local governments and other market participants with free access to
disclosure and transparency information in the municipal securities
market through its Electronic Municipal Market Access (EMMA[supreg])
\5\ Web site, the official repository for information on virtually all
municipal bonds. Additionally, the MSRB serves as an objective resource
on the municipal market, conducts extensive education and outreach to
market participants, and provides market leadership on key issues
impacting the municipal securities market.
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    \5\ EMMA is a registered trademark of the MSRB.
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    Section 15B(b)(2)(J) of the Act \6\ provides, in pertinent part,
that each dealer and municipal advisor shall pay to the Board such
reasonable fees and charges as may be necessary or appropriate to
defray the costs and expenses of operating and administering the Board
and that the MSRB shall have rules specifying the amount of such fees.
The current MSRB fees are:
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    \6\ 15 U.S.C. 78o-4(b)(2)(J).
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    1. Municipal advisor professional fee (Rule A-11) $300 annual fee
to be paid for each Form MA-I filed with the SEC by the municipal
advisor;
    2. Initial registration fee (Rule A-12) $100 one-time registration
fee to be paid by each dealer to register with the MSRB prior to
engaging in municipal securities activities and each municipal advisor
to register with the MSRB prior to engaging in municipal advisory
activities;
    3. Annual registration fee (Rule A-12) $500 annual fee to be paid
by each dealer and municipal advisor registered with the MSRB;
    4. Underwriting fee (Rule A-13) .003% ($.03 per $1,000) of the par
value to be paid by a dealer, except in limited circumstances, for all
municipal securities purchased from an issuer by or through such
dealer, whether acting as principal or agent, as part of a primary
offering;
    5. Transaction fee (Rule A-13) .001% ($.01 per $1,000) of the total
par value to be paid by a dealer, except in limited circumstances, for
inter-dealer sales and customer sales reported to the MSRB pursuant to
MSRB Rule G-14(b);
    6. Technology fee (Rule A-13) $1.00 paid by a dealer per
transaction for each inter-dealer sale and for each sale to customers
reported to the MSRB pursuant to MSRB Rule G-14(b); and
    7. Examination fee (Rule A-16) $150 test development fee assessed
per candidate for each MSRB examination.
    In addition, the MSRB charges data subscription and service fees
for subscribers, including dealers and municipal advisors, seeking
direct electronic delivery of municipal trade data and disclosure
documents associated with municipal bond issues.\7\
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    \7\ This information is available without direct electronic
delivery on the MSRB's EMMA Web site at no charge.
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    Over the course of the current fiscal year, the Board has
undertaken a holistic review of the fees assessed on regulated
entities. The last such review occurred in 2010 and culminated with
amendments to Rule A-13, specifically a transaction fee increase from
$.005 to $.01 per $1,000 of the total par value of inter-dealer and
customer sales reported to the MSRB and the establishment of a $1.00
technology fee per transaction for each inter-dealer and customer sale
reported to the MSRB.\8\ These two changes were necessitated by
increasing costs, including those associated with implementing the
mandates of the Dodd-Frank Wall Street Reform and Consumer Protection
Act (``Dodd-Frank'') \9\ and the need for additional revenue to replace
aging and outdated information technology software and hardware and
ensure the operational integrity of the MSRB's information systems. The
funds generated from the technology fee have been segregated for
accounting purposes and dedicated solely to funding capital expenses
for technology investments in capitalized hardware and software.
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    \8\ These fees became effective on January 1, 2011. See Exchange
Act Release No. 63621 (Dec. 29, 2010), 76 FR 604 (Jan. 5, 2011)
(File No. SR-MSRB-2010-10).
    \9\ Public Law 111-203, 124 Stat. 1376 (2010).
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    Since 2011, the MSRB has successfully reached and now exceeds the
operating reserve target of twelve months of operating expenses and has
accumulated the reserve target of three times the annual information
technology depreciation expenses. The annual technology fee revenues
exceed the annual information technology capital draws and have
provided the funding to establish the targeted technology renewal fund.
In fact, once the reserve target was met, excess revenues created a
surplus over the reserve target, resulting in the Board approving a
technology fee rebate of $3.6 million in July 2014.
    The Board recognized that, with the current revenue and information
technology capital spend rate for capitalized hardware and software,
the surplus in the segregated technology fund would continue to grow.
Meanwhile, the Board noted that operating reserves are projected to
fall to 12 months of operating expenses in fiscal year 2017 and
continue to decline thereafter because operating expenses continue to
modestly rise annually while the current primary revenue sources to
fund these operating expenses are projected to be effectively flat.
This decline in reserves could accelerate if bond and trade volumes
fall below projected levels causing funds from market activity fees to
decrease. The inverse relationship between the projected growing
surplus in the technology renewal fund and the potential erosion of
operating reserves in the next few years was the catalyst for the Board
to conduct a holistic fee review.
    The Board evaluated the assessment of MSRB fees on regulated
entities with the goal of better aligning revenue sources with
operating expenses and all capital needs. The Board strives to
diversify funding sources among regulated entities and other entities
that fund MSRB services in a manner that ensures long-term
sustainability, while continuing to strike an equitable balance among
regulated entities and a fair allocation of the expenses of the
regulatory activities, systems development and operational activities
undertaken by the MSRB. Proxies used by the Board for fairly allocating
to regulated entities the cost of MSRB regulation include, but are not
limited to: Being registered to engage in municipal securities or
municipal advisory activities; the level of dealer market activity as
determined by the number of transactions executed and total par value
of transactions executed;

and the number of associated persons engaged in municipal advisory
activities on behalf of a registered municipal advisor. Recognizing
that in any given year there could be more or less activity by a
particular class of regulated entities, the Board, as it has
historically, sought to establish a fee structure that would result in
a balanced and reasonable contribution over the long run from all
regulated entities to defray the costs and expenses of operating and
administering the MSRB.
    The proposed changes resulting from the Board's holistic fee review
are summarized below.
Annual and Initial Fees Under MSRB Rule A-12
    The current annual registration fee of $500 pursuant to Rule A-12
is paid by each of the over 2,000 regulated entities registered with
the MSRB. While the annual fee amount has not been changed since
2009,\10\ the share of total expenses that the annual fees defray has
continued to decrease. For example, the total annual fees collected in
2009 defrayed nearly 5% of total expenses whereas the total annual fee
amounts currently defray only approximately 3.5% of total expenses
despite an increase in the number of regulated entities associated with
the registration of municipal advisors post Dodd-Frank. In addition,
approximately 35% of the entities registered with the MSRB as dealers
do not regularly engage in any municipal securities trade activity
subject to market activity fee assessments under Rule A-13. Therefore,
the annual fee is the primary way dealers who may only engage in
municipal fund securities business (i.e., 529 college savings plan
sales and Local Government Investment Pool sales) or have the
occasional municipal bond sale share in the costs and expenses of
operating and administering the MSRB. Thus, an increase in the annual
fee from $500 to $1,000 provides for all regulated entities to more
fairly contribute to defraying the costs and expenses of operating and
administering the MSRB.
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    \10\ See Exchange Act Release No. 60528 (Aug. 18, 2009), 74 FR
43205 (Aug. 26, 2009) (File No. SR-MSRB-2009-13).
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    Similarly, the Board concluded that an increase in the initial
registration fee under Rule A-12 from $100 to $1,000 was reasonable to
help defray a significant portion of the administrative and operational
costs associated with processing an initial registration. The fee for
initial registration has not been increased since its inception in 1975
and, as a result, is low for an initial registration fee.\11\ In an
effort to not overburden the municipal advisor community, the Board did
not consider an increase to the initial registration fee throughout the
post Dodd-Frank initial registration process.\12\
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    \11\ For example, the fee for initial registration as a broker-
dealer or investment adviser with the vast majority (47) of state
regulators is currently more than $100. Moreover, the fee for
initial registration with the Financial Industry Regulatory
Authority currently starts at $7,500.
    \12\ Post Dodd-Frank, 925 non-dealer municipal advisors
registered with the MSRB (exclusive of municipal advisors that are
also registered dealers), each of which paid $100 to register. There
are currently approximately 590 non-dealer municipal advisors
registered with the MSRB.
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    Together, the increase in the annual and initial fees would provide
approximately $1 million in annual revenue. The MSRB believes the
proposed increase in registration fees will equitably defray the
expenses of MSRB operations and allow the MSRB to lower underwriting
fees by an offsetting amount to achieve a more balanced distribution of
fees.
Market Activity Fees Under MSRB Rule A-13
    The market activity fees (i.e., underwriting, transaction and
technology fees) assessed under Rule A-13 represent 85% of the MSRB's
fiscal year 2014 total revenue. In 2014, of the over 2000 dealers and
municipal advisors registered with the MSRB, roughly 140 dealers were
assessed underwriting fees and 840 dealers were assessed transaction
and technology fees. The underwriting and transaction fees, which are
generally proportionate to a dealer's relative dollar volume of
activity within the industry, are based on the par value amount of
underwriting and customer and inter-dealer transactions during the
year. The technology fee is based on a dealer's participation in the
market as measured by the total number of inter-dealer and customer
sales reported to the MSRB, rather than par value, and coupled with the
transaction and underwriting fees, contribute to an equitable
distribution of the market activity assessments for dealers. However,
the assessment of these market activity fees is highly concentrated
among a small number of dealers; based on fiscal year 2014 fee revenue,
less than a dozen dealers paid 52% of all such fees. The Board
determined that, notwithstanding this concentration, these market
activity fees are reasonable in light of the level of participation in
the municipal securities market by these dealers.
Underwriting Fee
    With organizational reserves (operating reserves and the technology
renewal fund) currently above targeted levels and future year financial
pro formas indicating declines in aggregate reserve levels (while
remaining slightly above targeted levels), coupled with the increase in
registration fees, the Board determined to decrease the underwriting
fee from .003% ($.03) to .00275% ($.0275) per $1,000 of the par value.
Based on underwriting volume ranging from $300 billion to $400 billion
annually, the decrease in the underwriting fee will reduce MSRB revenue
by approximately $1 million annually.\13\ The Board decided to lower
the underwriting fee for several reasons. First, the fee is based on
the assessment factor (i.e., par value of underwriting) that is the
most volatile year over year. Second, as noted above, underwriting fees
are paid primarily by a small number of dealers, all of which also pay
significant transaction and technology fees, making some relief to such
firms equitable. Additionally, for each new underwriting, the sales of
the initial offering are subject to all three market activity fees such
that a decrease in the underwriting fee on initial bond sales is fair
and reasonable.
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    \13\ As noted above, this $1 million reduction in revenue will
be recouped through the increase in registration fees.
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Technology Fee
    The technology fee was implemented in January 2011 to fund
capitalized hardware and software for the MSRB market transparency
systems.\14\ At that time, the MSRB stated the assessment of the
technology fee would be reviewed periodically. The MSRB's market
transparency systems collect municipal market data, disclosures and
statistics and make this information available to investors and the
public, primarily through the EMMA Web site, at no cost. Almost five
years after the implementation of the technology fee, the ongoing
information technology support and operational costs of maintaining and
servicing EMMA, the Real-time Transaction Reporting System (``RTRS''),
the Short-term Obligation Rate Transparency (``SHORT'') system, as well
as other market transparency systems, exceeds capital needs for new
hardware and software. In fact, the annual operating costs of the
market transparency systems in fiscal year 2014 were approximately $14
million, which represents an almost doubling of the expenses for the
market transparency systems from $7.2 million in fiscal year

2008 prior to the launch of EMMA, and far exceeds the approximately $7
million generated annually from the technology fee.
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    \14\ See note 6 supra.
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    The Board evaluated reducing the technology fee because the target
to maintain three-times the annual information technology depreciation
expenses has been met. However, based on its analysis, the Board
recognized that without proposing a new fee on regulated entities, the
total revenue generated from all sources, excluding the technology fee,
would be inadequate to fund projected operational expenses of the
organization. When the technology fee was introduced in 2011, it was
believed that assessing a fee on a per trade basis established a more
balanced distribution of fees on dealers and their activities, which
the Board continues to support. The Board determined during the
holistic fee review that, if a new fee for regulated entities was
proposed, assessing the fee based on the number of trades would be the
appropriate measure. The Board considered the potential for additional
operational and compliance costs to both dealers and the MSRB in
implementing a new fee assessment and did not believe additional costs
were warranted when, instead of implementing a new fee based on the
number of trades, it would be reasonable to continue to assess the
technology fee at its current amount, provided that the revenue
collected would be available for funding all MSRB operations.
Understanding that technology related expenses currently account for
nearly 50% of the costs and expenses of operating and administering the
MSRB, the Board concluded that all fees collected from regulated
entities should be aggregated and available for the most appropriate
organizational uses.\15\ Therefore, to achieve adequate funding aligned
with expense levels, the Board determined to continue to assess a
technology fee ($1.00 per transaction for each inter-dealer municipal
securities sale and for each sale to customers), but that the revenue
from the technology fee will no longer be designated exclusively for
capitalized hardware and software expenses.
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    \15\ Based on the fiscal year 2014 audited financial statements
of the MSRB, total operational expenses were $29.5 million, of that,
48% was spent on market information transparency programs and
operations, 20% was spent on rulemaking and policy development, 7%
was spent on market leadership, outreach and education, 6% was spent
on Board governance and rulemaking oversight, and 19% was spent on
administration.
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Transaction Fee
    The transaction fee is assessed on the total par value of inter-
dealer and customer sales reported to the MSRB by dealers under Rule G-
14(b). Rule A-13(c)(iii) exempts from this fee sale transactions in
municipal securities that have a final stated maturity of nine months
or less or that, at the time of trade, may be tendered at the option of
the holder to an issuer of such securities or its designated agent for
redemption or purchase at par value or more at least as frequently as
every nine months until maturity, earlier redemption, or purchase by an
issuer or its designated agent. The Board continues to support such
exemptions recognizing that, given the traditionally low short-term
interest rates on such short-term instruments, charging fees on such
instruments may impair the market for these products. While the
transaction fee has never been applicable to commercial paper, which
usually has a final stated maturity of nine months or less, there are
occasions when the maturity date of commercial paper is extended past a
nine-month maturity date, which raises a question as to whether the
transaction fee would then apply. During its holistic fee review, the
Board confirmed that, even in cases of the extended maturity date,
commercial paper issues should remain exempt from the transaction fee.
Accordingly, the proposed rule change adds language to the exemption
provisions in MSRB Rule A-13(c)(iii) to clarify that the exemption from
the transaction fee assessment also applies to securities issued
pursuant to a commercial paper program.\16\
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    \16\ Furthermore, this revision clarifies that the transaction
fee exemption is not limited to ``commercial paper'' as specifically
defined in MSRB Rule G-32(d)(xiii).
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Fees Not Being Modified
    The municipal advisor professional fee under Rule A-11 currently
assesses $300 per professional for each Form MA-I filed with the
Commission as of January 31 of each year.\17\ In establishing that fee,
the MSRB had targeted fees generated from municipal advisors under Rule
A-11 to provide revenue of approximately $2 million annually, or
approximately 5% of total MSRB revenue; however, such fees are
currently expected to generate only approximately $1.17 million, or
approximately 3% of total revenue in fiscal year 2016. This decrease is
a result of the number of municipal advisor professionals for whom
Forms MA-I have been filed with the Commission being fewer than
originally estimated. The Board recognized the significant costs
associated with developing a new regulatory regime for municipal
advisors for the protection of investors, municipal entities and
obligated persons and acknowledged that to generate the targeted
revenue level, the professional fee for each person that engages in
municipal advisory activities on behalf of a municipal advisor may need
to be increased. However, the Board determined to not make any changes
to the professional fee at this time but to revisit the fee in the
future providing additional time for the municipal advisor regulations
and business models to more fully develop.
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    \17\ See Exchange Act Release No. 72019 (Apr. 25, 2014), 79 FR
24798 (May 1, 2014) (File No. SR-MSRB-2014-03).
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    The professional examination fees established under Rule A-16 were
increased from $60 to $150 effective April 1, 2015.\18\ The Board
believes that no further adjustment is currently warranted.
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    \18\ See Exchange Act Release No. 74561 (Mar. 23, 2015), 80 FR
16485 (Mar. 27, 2015) (File No. SR-MSRB-2015-01).
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    Data subscription service fees were studied and examined in fiscal
year 2014 and revised effective April 1, 2014.\19\ Fees for the
Comprehensive Transaction data service, the RTRS service and the SHORT
service were increased by 10% at that time. Since that increase, the
number of subscribers has increased by 4.4%, indicating the continuing
reasonableness of the prior fee increase. The Board believes that no
further adjustments are currently warranted.
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    \19\ See Exchange Act Release No. 71690 (Mar. 11, 2014), 78 FR
14769 (Mar. 17, 2014) (File No. SR-MSRB-2014-02).
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2. Statutory Basis
    The MSRB believes that the proposed rule change is consistent with
section 15B(b)(2)(J) of the Act \20\ which requires, in pertinent part,
that the MSRB's rules shall provide that each municipal securities
broker, municipal securities dealer, and municipal advisor shall pay to
the Board such reasonable fees and charges as may be necessary or
appropriate to defray the costs and expenses of operating and
administering the Board and that such rules shall specify the amount of
such fees and charges.
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    \20\ 15 U.S.C. 78o-4(b)(2)(J).
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    The MSRB believes that its rules provide for reasonable dues, fees
and other charges among registered entities. The MSRB believes that the
proposed fees are reasonable and necessary to fund MSRB services in a
manner that ensures long-term sustainability, seeking to achieve an
equitable balance

among regulated entities and a fair allocation of the expenses of the
regulatory activities, system development and operational activities
undertaken by the MSRB. The proposed rule change would maintain the
total amount of fees collected by the MSRB at approximately the same
levels while continuing to ensure that the MSRB maintains sufficient
reserves to meet its regulatory responsibilities.

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

    Section 15B(b)(2)(C) of the Act \21\ requires that MSRB rules not
be designed to impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act. In addition,
section 15B(b)(2)(L)(iv) of the Act \22\ provides that MSRB rules ``not
impose a regulatory burden on small municipal advisors that is not
necessary or appropriate in the public interest and for the protection
of investors, municipal entities, and obligated persons, provided that
there is robust protection of investors against fraud.''
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    \21\ 15 U.S.C. 78o-4(b)(2)(C).
    \22\ 15 U.S.C. 78o-4(b)(2)(L)(iv).
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    In considering these standards, the MSRB was guided by the Board's
Policy on the Use of Economic Analysis. The MSRB does not believe that
the proposed rule changes will impose additional burdens on competition
that are not necessary or appropriate in furtherance of the purposes of
the Act.
    The Board believes the increase in the initial fee under Rule A-12
from $100 to $1,000 is necessary and appropriate to ensure that new
registrants cover a significant portion of the MSRB administrative
costs of processing an initial registration. The MSRB recognizes the
possibility that these fees may represent an initial barrier to entry.
The Board is not aware of data or other information that would allow
for a quantification of the potential impact of this fee increase, but
based on experience expects the impact to be small and unlikely to
negatively impact the competitiveness of municipal securities or
municipal advisor markets in which the registrants participate.
Further, the Board notes that firms wishing to engage in municipal
securities activities and/or municipal advisory activities face other
costs associated with complying with applicable laws and regulations.
Based on the Board's experience, the one-time initial fee for
registration, even at its proposed new level of $1,000, represents a
relatively small share of the typically associated legal and regulatory
compliance costs. The MSRB anticipates that a potential market entrant
who is actually deterred by this fee may likely find it difficult to
fully comply with the other regulatory and legal requirements
associated with the market in which it wishes to offer services.
    The Board believes the increase in the annual fee under Rule A-12
from $500 to $1,000 is necessary and appropriate to ensure that MSRB
registrants that do not regularly engage in the market activities
assessed under Rule A-13, but nonetheless participate in the municipal
securities market more broadly, share in the costs and expenses of
operating and administering the MSRB. The MSRB recognizes that it is
possible that these fees may cause a small number of firms with limited
attachment to the municipal securities market to exit or further reduce
their activity. The Board is not aware of data or other information
that would allow for a quantification of this potential impact, but
based on experience expects the impact to be small and unlikely to
negatively impact the competitiveness of the municipal securities or
municipal advisor markets in which registrants participate. Further,
the Board notes that firms wishing to engage in municipal securities
activities and/or municipal advisory activities face other costs
associated with complying with applicable laws and regulations. Based
on the Board's experience, the annual fee, even at its proposed new
level of $1,000, represents a relatively small share of the typically
associated annual legal and regulatory compliance costs. The MSRB
anticipates that a registrant who is adversely impacted by a $500 per
year increase may likely find it difficult to fully comply with the
other regulatory and legal requirements associated with the market in
which it wishes to offer services.
    The Board is not making any changes to the municipal advisor
professional fee under Rule A-11 at this time. Therefore, the only fee
increase affecting small municipal advisors is that to the annual, per-
firm registration fee. The MSRB recognizes that any fee that is
assessed on a per firm basis, rather than activity basis, will likely
represent a greater share of a small firm's revenue than it will a
larger firm's revenue and that this could cause some small firms to
exit the market. However, the Board believes that in most cases, the
annual fee will represent a very small percentage of a firm's revenue.
As noted above, the Board also believes that a firm that is adversely
impacted by a $500 per year increase may find it difficult to fully
comply with the other regulatory and legal requirements associated with
the market in which it wishes to offer services. Further, as the SEC
concluded in its final rule on the permanent registration of municipal
advisors, the market would be likely to remain competitive despite the
potential exit of some municipal advisors (including small entity
municipal advisors), consolidation of municipal advisors, or lack of
new entrants into the market.

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

    Written comments were neither solicited nor received on the
proposed rule change.

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

    The forgoing rule change has become effective pursuant to section
19(b)(3)(A) of the Act \23\ and paragraph (f) of Rule 19b-4 \24\
thereunder. The amendments to Rule A-12 will have an implementation
date of October 1, 2015 and the amendments to Rule A-13 will have an
implementation date of January 1, 2016. At any time within 60 days of
the filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
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    \23\ 15 U.S.C. 78s(b)(3)(A).
    \24\ 17 CFR 240.19b-4(f).
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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-MSRB-2015-08 on the subject line.

Paper Comments

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

    All submissions should refer to File Number SR-MSRB-2015-08. This
file number should be included on the

subject line if email is used. To help the Commission process and
review your comments more efficiently, please use only one method. The
Commission will post all comments on the Commission's Internet Web site
(http://www.sec.gov/rules/sro.shtml). Copies of the submission, all
subsequent amendments, all written statements with respect to the
proposed rule change that are filed with the Commission, and all
written communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the MSRB. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-MSRB-2015-08 and should be submitted on or before
September 18, 2015.

    For the Commission, pursuant to delegated authority.\25\
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-21296 Filed 8-27-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17186-17188]
[FR Doc No: 2011-7182]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2011-0039]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation.

ACTION: Request for public comment on an extension of a currently
approved collection of information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes a collection of information for which NHTSA
intends to seek OMB approval.

DATES: Comments must be received on or before May 27, 2011.

ADDRESSES: You may submit comments using any of the following methods.
All comments must have the applicable DOT docket number (e.g., NHTSA-
2011-0039) noted conspicuously on them.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays. Telephone: 1-800-647-
5527.
     Fax:<PHONE_NUMBER>

    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Alex Ansley, Recall Management
Division (NVS-215), Room W46-412, NHTSA, 1200 New Jersey Ave.,
Washington, DC 20590. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation, see 5 CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use

of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology, e.g. permitting electronic submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following collection of information:
    Title: Defect and Noncompliance Reporting and Notification.
    Type of Request: Extension of a currently approved information
collection.
    OMB Control Number: 2127-0004.
    Affected Public: Businesses or individuals.
    Abstract: This notice requests comment on NHTSA's proposed
extension to approved collection of information OMB No. 2127-0004. This
collection covers the information collection requirements found within
various statutory sections in the Motor Vehicle Safety Act of 1966
(Act), 49 U.S.C. 30101, et seq., that address and require manufacturer
notifications to NHTSA of safety-related defects and failures to comply
with Federal Motor Vehicle Safety Standards (FMVSS) in motor vehicles
and motor vehicle equipment, as well as the provision of particular
information related to the ensuing owner and dealers notifications and
free remedy campaigns that follow those notifications. The sections of
the Act imposing these requirements include 49 U.S.C. 30118, 30119,
30120, and 30166. Many of these requirements are implemented through,
and addressed with more specificity in, 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports (part 573) and 49 CFR part
577, Defect and Noncompliance Notification.
    Pursuant to the Act, motor vehicle and motor vehicle equipment
manufacturers are obligated to notify, and then provide various
information and documents, to NHTSA in the event a safety defect or
noncompliance with Federal Motor Vehicle Safety Standards (FMVSS) is
identified in products they manufactured. See 49 U.S.C. 30118(b) and 49
CFR 573.6 (requiring manufacturers to notify NHTSA, and provide certain
information, when they learn of a safety defect or noncompliance).
Manufacturers are further required to notify owners, purchasers,
dealers and distributors about the safety defect or noncompliance. See
49 U.S.C. 30118(b), 30120(a), and 49 CFR 577.7, 577.13. They are
required to provide to NHTSA copies of communications pertaining to
recall campaigns that they issue to owners, purchasers, dealers, and
distributors. See 49 U.S.C. 30166(f) and 49 CFR 573.6(c)(10).
    Manufacturers are also required to file with NHTSA a plan
explaining how they intend to reimburse owners and purchasers who paid
to have their products remedied before being notified of the safety
defect or noncompliance, and explain that plan in the notifications
they issue to owners and purchasers about the safety defect or
noncompliance. See 49 U.S.C. 30120(d) and 49 CFR 573.13. They are
further required to keep lists of the respective owners, purchasers,
dealers, distributors, lessors, and lessees of the products determined
to be defective or noncompliant and involved in a recall campaign, and
are required to provide NHTSA with a minimum of six quarterly reports
reporting on the progress of their recall campaigns. See 49 CFR 573.8
and 573.7, respectively.
    The Act and Part 573 also contain numerous information collection
requirements specific to tire recall and remedy campaigns. These
requirements relate to the proper disposal of recalled tires, including
a requirement that the manufacturer conducting the tire recall submit a
plan and provide specific instructions to certain persons (such as
dealers and distributors) addressing that disposal, and a requirement
that those persons report back to the manufacturer certain deviations
from the plan. See 49 U.S.C. 30120(d) and 49 CFR 573.6(c)(9). They also
require the reporting to NHTSA of intentional and knowing sales or
leases of defective or noncompliant tires.
    49 U.S.C. 30166(n), and its implementing regulation found at 49 CFR
573.10, mandates that anyone who knowingly and willfully sells or
leases for use on a motor vehicle a defective tire or a tire that is
not compliant with FMVSS, and with actual knowledge that the tire
manufacturer has notified its dealers of the defect or noncompliance as
required under the Act, is required to report that sale or lease to
NHTSA no more than five working days after the person to whom the tire
was sold or leased takes possession of it.
    Estimated Burden: This collection has an approved burden of 21,370
hours per year.\1\ Our review of recall information since we last
requested approval of this collection does not demonstrate that this
figure requires adjustment. A summary explanation of how this total
annual figure was calculated follows.
---------------------------------------------------------------------------

    \1\ See Federal Register notices of March 28, 2008 (73 FR 16740)
and June 5, 2008 (73 FR 32073) for the analysis and discussion
associated with this burden hour estimate.
---------------------------------------------------------------------------

    There continue to be an average of 650 noncompliance or safety
defect notifications to NHTSA filed each year by approximately 175
distinct manufacturers, with an estimated 750 quarterly reports filed
per quarter (or 3,000 reports per year). Although the average number of
recalls filed per year and the average number of manufacturers filing
fluctuates each year, we have not seen, nor expect to see, consistent
dramatic changes in these averages.
    We continue to estimate that it takes a manufacturer an average of
4 hours to complete each notification report to NHTSA, that it takes
another 4 hours to complete each quarterly report, and that maintenance
of the required owner, purchaser, dealer and distributors lists
requires 8 hours. Accordingly, the subtotal estimate of annual burden
hours related to the reporting to NHTSA of a safety defect or
noncompliance, completion of quarterly reports on the progress of
recall campaigns, and maintenance of owner and purchaser lists is
16,000 hours annually ((650 notices x 4 hours/report) + (3,000
quarterly reports x 4 hours/report) + (175 manufacturers x 8 hours)).
    In addition, we continue to estimate an additional 2 hours will be
needed to add to a manufacturer's information report details relating
to the manufacturer's intended schedule for notifying its dealers and
distributors, and tailoring its notifications to dealers and
distributors in accordance with the requirements of 49 CFR 577.13. This
would total to an estimated 1,300 hours annually (650 notices x 2
hours/report).
    In the event a manufacturer supplied the defect or noncompliant
product to independent dealers through independent distributors, that
manufacturer is required to include in its notifications to those
distributors an instruction that the distributors are to then provide
copies of the manufacturer's notification of the defect or
noncompliance to all known distributors or retail outlets further down
the distribution chain within five working days. See 49 CFR
577.8(c)(2)(iv). As a practical matter, this requirement would only
apply to equipment manufacturers since vehicle manufacturers generally
sell and lease vehicles through a dealer network, and not through
independent distributors. We continue to believe previous estimates of
roughly 90 equipment recalls per year are sound. Although the
distributors are not technically under any regulatory requirement to
follow that instruction, we expect that they will, and have estimated
the burden associated with these notifications (identifying retail
outlets, making copies of the manufacturer's notice, and

mailing) to be 5 hours per recall campaign. Assuming an average of 3
distributors per equipment item, (which is a liberal estimate given
that many equipment manufacturers do not use independent distributors)
the total number of burden hours associated with this third party
notification burden is approximately 1,350 hours per year (90 recalls x
3 distributors x 5 hours).
    As for the burden linked with a manufacturer's preparation of and
notification concerning its reimbursement for pre-notification
remedies, consistent with previous estimates (see 69 FR 11477 (March
10, 2004)), we continue to estimate that preparing a plan for
reimbursement takes approximately 8 hours annually, and that an
additional 2 hours per year is spent tailoring the plan to particular
defect and noncompliance notifications to NHTSA and adding tailored
language about the plan to a particular safety recall's owner
notification letters. In sum, these required activities add an
additional 2,700 annual burden hours ((175 manufacturers x 8 hours) +
(650 recalls x 2 hours)).
    In summary, the total burden associated with the defect and
noncompliant information collection and reporting requirements we
continue to estimate at 21,350 hours per year.
    As explained earlier, the Act and part 573 also contain numerous
information collection requirements specific to tire recall and remedy
campaigns, as well as a statutory and regulatory reporting requirement
that anyone that knowingly and intentionally sells or leases a
defective or noncompliant tire notify NHTSA of that activity.
    Manufacturers are required to include specific information relative
to tire disposal in the notifications they provide NHTSA concerning
identification of a safety defect or noncompliance with FMVSS in their
tires, as well as in the notifications which they issue to their
dealers or other tire outlets participating in the recall campaign. See
49 CFR 573.6(c)(9). We continue to estimate that there will be about 10
tire recall campaigns per year, and that inclusion of this additional
information will require an additional two hours of effort beyond the
subtotal above associated with non-tire recall campaigns. This
additional effort consists of one hour for the NHTSA notification and
one hour for the dealer notification for a total of 20 burden hours (10
tire recalls a year x 2 hours per recall).
    Manufacturer owned or controlled dealers are required to notify the
manufacturer and provide certain information should they deviate from
the manufacturer's disposal plan. Consistent with previous analysis, we
continue to ascribe zero burden hours to this requirement since to date
no such reports have been provided and our original expectation that
dealers would comply with manufacturers' plans has proven true.
    Accordingly, we estimate 20 burden hours a year will be spent
complying with the tire recall campaign requirements found in 49 CFR
573.6(c)(9).
    And, as we have yet to receive a single report of a defective or
noncompliant tire being intentionally sold or leased in the fourteen
years since this rule was proposed, our previous estimate of zero
burden hours remains unchanged with this notice.
    In summary, our previous estimate of 21,370 total burden hours
associated with this approved information collection stands.

Estimated Number of Respondents

    NHTSA receives reports of defect or noncompliance from roughly 175
manufacturers per year. Again, this figure fluctuates from year to
year, but we do not have a basis at this juncture to suspect this
annual figure will change significantly. Accordingly, we estimate that
there will continue to be approximately 175 manufacturers per year
filing defect or noncompliance reports and completing the other
information collection responsibilities associated with those filings.
    We discussed above that we have yet to receive a single report
filed pursuant to 49 CFR 573.10. This information collection
requirement, to reiterate, requires anyone who sells or leases a
defective or noncompliant tire, with knowledge of that tire's
defectiveness or noncompliance, to report that sale or lease to NHTSA.
Given the lack of filing history over many years, we estimate that
there will continue to be zero reports filed and therefore zero
respondents as to this requirement.
    In summary, we estimate that there will be a total of 175
respondents per year associated with OMB No. 2127-0004.

    Issued on: March 22, 2011.
Frank Borris,
Director, Office of Defects Investigation.
[FR Doc. 2011-7182 Filed 3-25-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Rules and Regulations]
[Pages 16776-16778]
[FR Doc No: 2018-08011]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0068]
RIN 1625-AA09

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway
and Biscayne Bay, Miami, FL

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is modifying the operating schedule that
governs the Venetian Causeway Bridge (West) across the Atlantic
Intracoastal Waterway mile 1088.6, and the operating schedule that
governs the Venetian Causeway Bridge (East) across Biscayne Bay, Miami
Beach, FL. This action will extend the daily twice an hour opening
schedule of the Venetian Causeway Bridges (East and West) to include
weekends and Federal holidays. This action is intended to reduce
vehicular traffic caused by the on-demand weekend and Federal holiday
bridge openings.

DATES: This rule is effective May 17, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov. Type USCG-
2017-0068 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Ruth Sadowitz, Coast Guard Sector Miami, FL, Waterways
Management Division, telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
NPRM Notice of proposed rulemaking (Advance, Supplemental)
Sec.  Section
U.S.C. United States Code
AICW Atlantic Intracoastal Waterway
FDOT Florida Department of Transportation
FL Florida
MHW Mean High Water

II. Background Information and Regulatory History

    On September 5, 2017, we published a notice of proposed rulemaking
(NPRM) entitled Drawbridge Operation Regulation; Atlantic Intracoastal
Waterway and Biscayne Bay, Miami, FL in the Federal Register (82 FR
41901). We received 2 comments on this rule.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
499.
    The Venetian Causeway Bridge (West), across the Atlantic
Intracoastal Waterway, mile 1088.6, is a double leaf bascule bridge and
has a vertical clearance of 12 feet at Mean High Water (MHW) in the
closed to navigation position and a horizontal clearance of 90 feet
between fenders. The Venetian Causeway Bridge (East), across Biscayne
Bay, at Miami Beach, FL is a double leaf bascule bridge with a vertical
clearance of 5 feet at MHW in the closed to navigation position and a
horizontal clearance of 57 feet between fenders. Presently, in
accordance with 33 CFR 117.261(nn) and 33 CFR 117.269, the bridges
shall open on signal, except that from 7 a.m. to 7 p.m., Monday through
Friday, except Federal holidays, the bridges need only open on the hour
and half hour.
    Miami-Dade County, the bridge owner, and the Cities of Miami and
Miami Beach requested the daily twice an hour operating schedule for
both bridges be changed to include weekends and Federal holidays. This
should provide relief to the increase vehicle traffic congestion on the
weekends while meeting the reasonable needs of navigation.

IV. Discussion of Comments, Changes and the Final Rule

    Of the 2 comments received, one was a political statement that had
no bearing on the proposed regulation; the second comment was in favor
of the operating schedule change. The submitter in favor of the change
did suggest that there may be a negative impact to small entities on
land economically if the bridge is open for an extended period of time
allowing vessels that have been waiting to pass and vice versa for
commercial vessels that missed the opening and have to wait until the
next scheduled opening. While the Coast Guard does acknowledge that
there may be additional vessels waiting for openings due to this
change, it should not have a substantial negative impact on land and
maritime traffic as it mirrors the current operating schedule Monday
through Friday.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive Orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive Orders, and we
discuss First Amendment rights of protesters.

A. Regulatory Planning and Review

    Executive Orders 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. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, it has not been reviewed by the Office of
Management and Budget (OMB) and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the continued
ability for vessels to transit the bridge during the twice-an-hour
opening schedule. Vessels in distress, Public vessels of the United
States and tugs with tows must be passed at any time.

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 received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will 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 V.A
above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this 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,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule calls 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 rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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.

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 rule will not result in
such an expenditure,

we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

    We have analyzed this 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
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 rule simply promulgates the operating regulations or
procedures for drawbridges. This action is categorically excluded from
further review, under figure 2-1, paragraph (32)(e), of the
Instruction.
    A Record of Environmental Consideration and a Memorandum for the
Record are not required for this 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.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
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. Amend Sec.  117.261 by revising paragraph (nn) to read as follows:

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

* * * * *
    (nn) The Venetian Causeway Bridge (West), mile 1088.6, at Miami.
The draw shall open on signal, except that from 7 a.m. to 7 p.m. daily,
including Federal holidays, the draw need only open on the hour and
half hour.
* * * * *

0
3. Revise Sec.  117.269 to read as follows:

Sec.  117.269   Biscayne Bay.

    The Venetian Causeway Bridge (East), across Miami Beach Channel.
The draw shall open on signal, except that from 7 a.m. to 7 p.m. daily,
including Federal holidays, the draw need only open on the hour and
half hour.

    Dated: February 8, 2018.
Peter J. Brown,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2018-08011 Filed 4-16-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Proposed Rules]
[Pages 65328-65330]
[FR Doc No: 2023-20407]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1883; Project Identifier MCAI-2023-00804-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus SAS Model A350-941 airplanes. This proposed AD was
prompted by a report of cracks found on the trunnion arms of the
inboard flap assemblies. This proposed AD would require, repetitive
inspections for cracking of the trunnion arms of the inboard flap
assembly, and applicable corrective actions, as specified in a European
Union Aviation Safety Agency (EASA) AD, which is proposed for
incorporation by reference (IBR). This proposed AD would also prohibit
the installation of affected parts. The FAA is proposing this AD to
address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by November 6,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1883; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For material that is proposed for IBR in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]; website easa.europa.eu. You may
find this material on the EASA website ad.easa.europa.eu. It is also
available at regulations.gov under Docket No. FAA-2023-1883.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th Street,
Des Moines, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dat Le, Aviation Safety Engineer, FAA,
1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-
7300; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-1883; Project Identifier
MCAI-2023-00804-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dat
Le, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone:<PHONE_NUMBER>; email: [email protected]. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2023-0132, dated July 3, 2023 (EASA
AD 2023-0132) (also referred to as the MCAI), to correct an unsafe
condition for certain Airbus SAS Model A350-941 airplanes. The MCAI
states that cracks were found on the trunnion arms of the inboard flap
assemblies that were made of forging aluminum 7037. This condition, if
not detected and corrected, could affect the structural integrity of
the trunnion arms.
    The FAA is proposing this AD to address the unsafe condition on
these products. You may examine the MCAI in the AD docket at
regulations.gov under Docket No. FAA-2023-1883.

Related Service Information Under 1 CFR Part 51

    EASA AD 2023-0132 specifies procedures for repetitive ultrasonic
inspections for cracking of the trunnion arms of the inboard flap
assemblies, and corrective actions, as applicable. Corrective actions
include obtaining and following repair instructions if any

cracking is found. EASA AD 2023-0132 also prohibits the installation of
affected parts. This material is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2023-0132 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2023-0132 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2023-0132 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2023-0132 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2023-
0132. Service information required by EASA AD 2023-0132 for compliance
will be available at regulations.gov under Docket No. FAA-2023-1883
after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 4 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
            Labor cost                Parts cost       Cost per product            Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 17 work-hours x $85 per hour             $10  Up to $1,455.........  Up to $5,820.
 = $1,445.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the on-condition repairs specified in this proposed AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Airbus SAS: Docket No. FAA-2023-1883; Project Identifier MCAI-2023-
00804-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by November 6, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS Model A350-941 airplanes,
certificated in any category, as identified in European Union
Aviation Safety Agency (EASA) AD 2023-0132, dated July 3, 2023 (EASA
AD 2023-0132).

(d) Subject

    Air Transport Association (ATA) of America Code: 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report of cracks found on the trunnion
arms of the inboard flap assemblies. The FAA is issuing this AD to
address potential cracks of the trunnion arms. The unsafe condition,
if not addressed, could adversely affect the structural integrity of
the trunnion arms.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2023-0132.

(h) Exceptions to EASA AD 2023-0132

    (1) Where EASA AD 2023-0132 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (2) of EASA AD 2023-0132 specifies if ``any
crack is detected, before next flight, contact Airbus for approved
instructions and, within the compliance time(s) specified in those
instructions, accomplish those instructions accordingly,'' this AD
requires replacing those word with ``if any cracking is detected,
the cracking must be repaired before further flight using a method
approved by the Manager, International Validation Branch, FAA; or
EASA; or Airbus SAS's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.''
    (3) This AD does not adopt the ``Remarks'' section of EASA AD
2023-0132.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (j) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (i)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(j) Additional Information

    For more information about this AD, contact Dat Le, Aviation
Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone:<PHONE_NUMBER>; email: [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2023-0132,
dated July 3, 2023.
    (ii) [Reserved]
    (3) For EASA AD 2023-0132, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th
Street, Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 15, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-20407 Filed 9-21-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)]
[Notices]
[Pages 32661-32662]
[FR Doc No: 2018-14978]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR18-63-000.
    Applicants: Black Hills Gas Distribution LLC.
    Description: Tariff filing per 284.123(b),(e)/: Black Hills Gas
Distribution LLC SOC Filing to be effective 6/1/2018.
    Filed Date: 7/2/18.
    Accession Number:<PHONE_NUMBER>32.
    Comments/Protests Due: 5 p.m. ET 7/23/18.

    Docket Number: PR18-38-001.
    Applicants: Transfer Fuel, LP.
    Description: Tariff filing per 284.123(b),(e)/: Amended Rate
Election & SOC of Energy Transfer Fuel, LP Effective March 16, 2018 to
be effective 3/16/2018.
    Filed Date: 6/27/18.
    Accession Number:<PHONE_NUMBER>96.
    Comments/Protests Due: 5 p.m. ET 7/18/18.

    Docket Number: CP16-357-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Amendment to Application of Columbia Gas Transmission,
LLC.
    Filed Date: 7/3/18.
    Accession Number:<PHONE_NUMBER>79.
    Comments Due: 5 p.m. ET 7/16/18.

    Docket Numbers: RP10-837-000.
    Applicants: Dominion Transmission, Inc.
    Description: Report Filing: DETI--Operational Gas Sales Report--
2018.
    Filed Date: 6/29/18.
    Accession Number: 20180629-5237.
    Comments Due: 5 p.m. ET 7/11/18.

    Docket Numbers: RP10-900-000.
    Applicants: Dominion Transmission, Inc.
    Description: Report Filing: DETI--Informational Fuel Report--2018.
    Filed Date: 6/29/18.
    Accession Number: 20180629-5236.
    Comments Due: 5 p.m. ET 7/11/18.

    Docket Numbers: RP18-960-000.
    Applicants: Dominion Energy Questar Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Statement of Negotiated Rates
Version 14.0.0 to be effective 8/6/2018.
    Filed Date: 7/6/18.
    Accession Number: 20180706-5030.
    Comments Due: 5 p.m. ET 7/18/18.

    Docket Numbers: RP18-961-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: TCO Spotlight Negotiated Rate
Agmt to be effective 7/6/2018.
    Filed Date: 7/6/18.
    Accession Number: 20180706-5043.
    Comments Due: 5 p.m. ET 7/18/18.

    Docket Numbers: RP18-962-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: Revision of Cash-Out Rates to
be effective 7/1/2018.
    Filed Date: 7/6/18.
    Accession Number: 20180706-5055.
    Comments Due: 5 p.m. ET 7/18/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and

385.214) on or before 5:00 p.m. Eastern time on the specified date(s).
Protests may be considered, but intervention is necessary to become a
party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

     Dated: July 9, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-14978 Filed 7-12-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48869-48870]
[FR Doc No: 2015-19990]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2711]

Neurodiagnostics and Non-Invasive Brain Stimulation Medical
Devices; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
following two-day public workshop entitled, ``Neurodiagnostics and Non-
Invasive Brain Stimulation Medical Devices Workshop''. The focus of the
first day of the workshop will be cognitive assessment medical devices,
which are intended to provide healthcare professionals with an
evaluation of cognitive function through non-invasive measurements. The
focus of the second day of the workshop will be non-invasive brain
stimulation medical devices, which are medical devices that are
intended to improve, affect, or otherwise modify the cognitive function
of a normal individual (i.e., without a treatment objective) by means
of non-invasive electrical or electromagnetic stimulation to the head.
The purpose of this workshop is to obtain public input and feedback on
scientific, clinical, and regulatory considerations associated with
medical devices for assessing and influencing cognitive function. Ideas
generated during this workshop may facilitate further development of
guidance regarding the content of premarket submissions for
neurodiagnostics and non-invasive brain stimulation medical devices and
help to speed development and approval of future submissions.
    Dates and Times: The public workshop will be held on November 19
and 20, 2015, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    Contact Persons: Hilda Scharen, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm 3625, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Jay Gupta, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993<EMAIL_ADDRESS>301-796-2795.
    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by November 6, 2015, at 4 p.m. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan<EMAIL_ADDRESS>or<PHONE_NUMBER> no
later than November 5, 2015.
    To register for the public workshop, please visit FDA's Medical
Devices Workshops and Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this
meeting/public workshop from the posted events list. Please provide
complete contact information for each attendee, including name, title,
affiliation, email, and telephone number. Those without Internet access
should contact Susan Monahan to register (see Contact for special
accommodations). Registrants will receive confirmation after they have
been accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be available via Webcast. Persons interested in viewing the
Webcast must register online by 4 p.m., November 6, 2015. Early
registration is recommended because Webcast connections are limited.
Organizations are requested to register all participants, but to view
using one connection per location. Webcast participants will be sent
technical system requirements after registration and will be sent
connection access information after November 10, 2015. If you have
never attended a Connect Pro event before, test your connection at
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Comments: In order to permit the widest possible opportunity to
obtain public comment, FDA is soliciting either electronic or written
comments on all aspects of the public workshop topics. The deadline for
submitting comments related to this public workshop is December 5,
2015.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when providing comments to
the topics as outlined in section II of this document, please identify
the question you are addressing. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The address of
the Division of Freedom of Information is available on the Agency's Web
site at http://www.fda.gov. A link to the transcripts will also be
available approximately 45 days after the public workshop on the
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the
posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    Cognitive assessment medical devices are intended to provide
healthcare professionals with an evaluation of cognitive function
through non-invasive measurements. Non-invasive brain stimulation
medical devices are intended to improve, affect, or otherwise modify
the cognitive function of a normal individual (i.e., has no cognitive
impairment) by means of non-invasive electrical or electromagnetic
stimulation to the head. These medical devices both present important
safety and effectiveness questions as well as study design and data
analysis challenges.

II. Topics for Discussion at the Public Workshop

    The workshop seeks to involve industry and academia in addressing
scientific, clinical, and regulatory considerations associated with
medical devices for assessing and influencing cognitive function. By
bringing together relevant stakeholders, which include scientists,
patient advocates, clinicians, researchers, industry representatives,
and regulators, to this workshop, we hope to facilitate the improvement
of this rapidly evolving product area.
    This workshop is aimed to address scientific, clinical, and
regulatory considerations associated with medical devices for assessing
and influencing cognitive function; including, but not limited to, the
following topic areas:
     Considerations for clinical study trial designs, patient
populations, and patient selection methods;
     considerations for clinical study endpoints, e.g.,
clinically relevant outcome measures and related statistical analyses;
     identification of risks and risk mitigation strategies;
and
     evaluation of prior studies, current clinical research,
and available scientific and clinical evidence.

    Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19990 Filed 8-13-15; 8:45 am]
 BILLING CODE 4164-01-P