[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81612-81614]
[FR Doc No: 2015-32895]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76768; File No. SR-NASDAQ-2015-155]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend NOM Rules at Chapter XV, Section 2

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

    The Exchange proposes to amend Chapter XV, entitled ``Options
Pricing,'' at Section 2, which governs pricing for Exchange members
using the NASDAQ Options Market (``NOM''), the Exchange's facility for
executing and routing standardized equity and index options.
    The Exchange purposes to lower the Non-NOM Market Maker \3\ Penny
Pilot Options \4\ Fee for Removing Liquidity

for options overlying iShares MSCI Emerging Markets (``EEM''), SPDR
Gold Shares (``GLD''), iShares Russell 2000 ETF (``IWM''), PowerShares
QQQ (``QQQ''), and SPDR S&P 500 (``SPY'') from $0.55 to $0.50 per
contract. While the changes proposed herein are effective upon filing,
the Exchange has designated the amendments [sic] become operative on
January 4, 2016.
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    \3\ A ``Non-NOM Market Maker'' is a registered market maker on
another options exchange that is not a NOM Market Maker. A Non-NOM
Market Maker must append the proper Non-NOM Market Maker designation
to orders routed to NOM.
    \4\ See Securities Exchange Act Release Nos. 57579 (March 28,
2008), 73 FR 18587 (April 4, 2008) (SR-NASDAQ-2008-026) (notice of
filing and immediate effectiveness establishing Penny Pilot); 60874
(October 23, 2009), 74 FR 56682 (November 2, 2009) (SR-NASDAQ-2009-
091) (notice of filing and immediate effectiveness expanding and
extending Penny Pilot); 60965 (November 9, 2009), 74 FR 59292
(November 17, 2009) (SR-NASDAQ-2009-097) (notice of filing and
immediate effectiveness adding seventy-five classes to Penny Pilot);
61455 (February 1, 2010), 75 FR 6239 (February 8, 2010) (SR-NASDAQ-
2010-013) (notice of filing and immediate effectiveness adding
seventy-five classes to Penny Pilot); 62029 (May 4, 2010), 75 FR
25895 (May 10, 2010) (SR-NASDAQ-2010-053) (notice of filing and
immediate effectiveness adding seventy-five classes to Penny Pilot);
65969 (December 15, 2011), 76 FR 79268 (December 21, 2011) (SR-
NASDAQ-2011-169) (notice of filing and immediate effectiveness [sic]
extension and replacement of Penny Pilot); 67325 (June 29, 2012), 77
FR 40127 (July 6, 2012) (SR-NASDAQ-2012-075) (notice of filing and
immediate effectiveness and extension and replacement of Penny Pilot
through December 31, 2012); 68519 (December 21, 2012), 78 FR 136
(January 2, 2013) (SR-NASDAQ-2012-143) (notice of filing and
immediate effectiveness and extension and replacement of Penny Pilot
through June 30, 2013); 69787 (June 18, 2013), 78 FR 37858 (June 24,
2013) (SR-NASDAQ-2013-082) (notice of filing and immediate
effectiveness and extension and replacement of Penny Pilot through
December 31, 2013); 71105 (December 17, 2013), 78 FR 77530 (December
23, 2013) (SR-NASDAQ-2013-154) (notice of filing and immediate
effectiveness and extension and replacement of Penny Pilot through
June 30, 2014); 79 FR 31151 [sic] (May 23, 2014), 79 FR 31151 (May
30, 2014) (SR-NASDAQ-2014-056) (notice of filing and immediate
effectiveness and extension and replacement of Penny Pilot through
December 31, 2014); 73686 (December 2, 2014) [sic], 79 FR 71477
(November 25, 2014) [sic] (SR-NASDAQ-2014-115) (notice of filing and
immediate effectiveness and extension and replacement of Penny Pilot
through June 30, 2015) and 75283 (June 24, 2015), 80 FR 37347 (June
30, 2015) (SR-NASDAQ-2015-063) (notice of filing and immediate
effectiveness and extension and replacement of Penny Pilot) See also
NOM Rules, Chapter VI, Section 5.
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    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to lower the Non-NOM Market Maker Penny Pilot
Options Fee for Removing Liquidity for options overlying EEM, GLD, IWM,
QQQ, and SPY from $0.55 to $0.50 per contract. The details of this
proposal are below.
Non-NOM Market Maker Penny Pilot Options Fee for Removing Liquidity
    The Exchange proposes, beginning January 4, 2016, to decrease the
Non-NOM Market Maker Fee for Removing Liquidity in Penny Pilot Options
from $0.55 to $0.50 per contract for options overlying EEM, GLD, IWM,
QQQ, and SPY. The Exchange notes that the Fees for Removing Liquidity
for other Participants in Penny Pilot Options will remain the same, at
$0.050 [sic] per contract. The Exchange believes that lowering this fee
may encourage additional order flow to be directed to NOM for options
overlying EEM, GLD, IWM, QQQ, and SPY.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Act,\5\ in general, and with Section 6(b)(4) and
6(b)(5) of the Act,\6\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees, and other charges among
members and issuers and other persons using any facility or system
which the Exchange operates or controls, and is not designed to permit
unfair discrimination between customers, issuers, brokers, or dealers.
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    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4) and (5).
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    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, for example, the Commission indicated that market forces should
generally determine the price of non-core market data because national
market system regulation ``has been remarkably successful in promoting
market competition in its broader forms that are most important to
investors and listed companies.'' \7\ Likewise, in NetCoalition v. NYSE
Arca, Inc.\8\ (``NetCoalition'') the D.C. Circuit upheld the
Commission's use of a market-based approach in evaluating the fairness
of market data fees against a challenge claiming that Congress mandated
a cost-based approach.\9\ As the court emphasized, the Commission
``intended in Regulation NMS that `market forces, rather than
regulatory requirements' play a role in determining the market data . .
. to be made available to investors and at what cost.'' \10\
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    \7\ Securities Exchange Act Release No. 51808 at 37499 (June 9,
2005) (``Regulation NMS Adopting Release'').
    \8\ NetCoalition v. NYSE Arca, Inc., 615 F.3d 525 (D.C. Cir.
2010).
    \9\ See NetCoalition, at 534.
    \10\ Id. at 537.
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    Further, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'. . . .'' \11\ Although the court and
the SEC were discussing the cash equities markets, the Exchange
believes that these views apply with equal force to the options
markets.
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    \11\ Id. at 539 (quoting ArcaBook Order, 73 FR at 74782-74783).
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Non-NOM Market Maker Penny Pilot Options Fee for Removing Liquidity
    The Exchange's proposal to decrease the Non-NOM Market Maker Fee
for Removing Liquidity in Penny Pilot Options from $0.55 to $0.50 per
contract for options overlying EEM, GLD, IWM, QQQ, and SPY is
reasonable because the Exchange seeks to assess all Participants the
same rate of $0.50 per contract to remove Penny Pilot Options on NOM.
Also, the Exchange believes that lowering this fee may encourage
additional order flow to be directed to NOM for options overlying EEM,
GLD, IWM, QQQ, and SPY.
    The Exchange's proposal to decrease the Non-NOM Market Maker Fee
for Removing Liquidity in Penny Pilot Options from $0.55 to $0.50 per
contract for options overlying EEM, GLD, IWM, QQQ, and SPY is equitable
and not unfairly discriminatory because all Participants will be
assessed a $0.50 per contract Fee for Removing Liquidity in Penny Pilot
Options for all options transacted on NOM.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own fees in response and because
market participants may readily adjust their order routing practices,
the Exchange believes that the degree to which fee changes in this
market may impose any burden on competition is extremely limited.
    In this instance, the proposed change to fees assessed to
Participants for execution of securities does not impose a burden on
competition because the Exchange's execution services are completely
voluntary and subject to extensive competition both from other
exchanges and from off-exchange venues.
Non-NOM Market Maker Penny Pilot Options Fee for Removing Liquidity
    The Exchange's proposal to decrease the Non-NOM Market Maker Fee
for Removing Liquidity in Penny Pilot Options from $0.55 to $0.50 per
contract for options overlying EEM, GLD, IWM, QQQ, and SPY does not
impose an undue burden on intra-market competition because the Exchange
will assess all Participants the same Fee for Removing Liquidity in
Penny Pilot Options.
    In sum, if the changes proposed herein are unattractive to market
participants, it is likely that the Exchange will lose market share as
a result. Accordingly, the Exchange does not believe that the proposed
change will impair the ability of Participants or competing order
execution venues to maintain their competitive standing in the
financial markets.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\12\
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    \12\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2015-155 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2015-155. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2015-155 and should
be submitted on or before January 20, 2016.
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    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Brent J. Fields,
Secretary.
[FR Doc. 2015-32895 Filed 12-29-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 24, 2010 (Volume 75, Number 226)]
[Notices]
[Page 71760-71762]
[DOCID:fr24no10-136]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63329; File No. SR-NYSEArca-2010-86]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of Proposed Rule Change Relating to the Listing and Trading of
Shares of the Peritus High Yield ETF

November 17, 2010.

I. Introduction

    On September 23, 2010, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of the
Peritus High Yield ETF (``Fund''). The proposed rule change was
published for comment in the Federal Register on October 13, 2010.\3\
The Commission received no comments on the proposal. This order grants
approval of the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 63041 (October 5,
2010), 75 FR 62905 (``Notice'').
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II. Description of the Proposal

    The Exchange proposes to list and trade the Shares pursuant to NYSE
Arca Equities Rule 8.600, which governs the listing and trading of
Managed Fund Shares.\4\ The Shares will be offered by AdvisorShares
Trust (``Trust''), a statutory trust organized under the laws of the
State of Delaware and registered with the Commission as an open-end
management investment company.\5\ The investment advisor to the Fund is
AdvisorShares Investments, LLC (``Advisor''), and Peritus I Asset
Management, LLC is the Fund's sub-advisor (``Peritus'' or ``Sub-
Advisor'').\6\

The Exchange represents that the Shares will conform to the initial and
continued listing criteria under NYSE Arca Equities Rule 8.600 and
that, for initial and/or continued listing, the Fund will be in
compliance with Rule 10A-3 under the Exchange Act,\7\ as provided by
NYSE Arca Equities Rule 5.3. A minimum of 100,000 Shares will be
outstanding at the commencement of trading on the Exchange.
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    \4\ A Managed Fund Share is a security that, among other things,
represents an interest in an investment company registered under the
Investment Company Act of 1940 (``1940 Act'') organized as an open-
end investment company or similar entity that invests in a portfolio
of securities selected by its investment advisor consistent with its
investment objectives and policies. See NYSE Arca Equities Rule
8.600(c)(1).
    \5\ The Trust is registered under the 1940 Act. On May 11, 2010,
the Trust filed with the Commission Post-Effective Amendment No. 6
to Form N-1A relating to the Fund (File Nos. 333-157876 and 811-
22110) (``Registration Statement'').
    \6\ The Exchange represents that the Advisor and Sub-Advisor are
not affiliated with a broker-dealer. See Commentary .06 to NYSE Arca
Equities Rule 8.600 (requiring that, if the investment adviser is
affiliated with a broker-dealer, the investment adviser erect a
``fire wall'' between the investment adviser and the broker-dealer
with respect to access to information concerning the composition
and/or changes to the portfolio).
    \7\ 17 CFR 240.10A-3.
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    The Fund's investment objective is high current income with a
secondary goal of capital appreciation. The Fund, under normal
circumstances, will invest at least 80% of its net assets, plus any
borrowings for investment purposes, in high-yield debt securities,
which include senior and subordinated corporate debt obligations (such
as bonds, debentures, notes and commercial paper). The Fund does not
have any portfolio maturity limitation and may invest its assets from
time to time primarily in instruments with short-term, medium-term or
long-term maturities.
    In selecting securities for the Fund's portfolio, Peritus will
perform its own independent investment analysis of each issuer to
determine its creditworthiness. Peritus will focus on the secondary
market, predominantly investing in assets at a discount to par ($100),
allowing for a potential opportunity to generate capital gains in
addition to current yield. Peritus will place limited value on credit
ratings and instead will focus on true cash flow while looking to buy
credit at prices that it feels provide a margin of safety. Additional
factors will be considered when constructing the portfolio including,
but not limited to, excess cash on the balance sheet and/or a history
of producing real free cash flow, as well as a capital structure that
can be sustained on conservative forecasts. The Fund's portfolio will
typically consist of 40-60 holdings,\8\ which will be disclosed on its
Web site (http://www.advisorshares.com) daily after the close of
trading on the Exchange and prior to the opening of trading on the
Exchange the following day.
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    \8\ The Fund represents that the portfolio will include a
minimum of 13 non-affiliated issuers.
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    The Fund may seek investments in corporate debt securities
representative of one or more high-yield bond or credit derivative
indices, which may change from time to time. Selection will generally
be dependent on independent credit analysis or fundamental analysis
performed by the Sub-Advisor. The Fund may invest in all grades of
corporate securities, including those below investment grade.\9\ The
Fund will only invest in liquid securities and only purchase performing
securities and not distressed debt.\10\ To a lesser extent, the Fund
also may invest in unrated securities. The Fund may invest in the
securities of other investment companies to the extent that such an
investment would be consistent with the requirements of Section
12(d)(1) of the 1940 Act, or any rule, regulation or order of the
Commission.
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    \9\ The Fund has represented that it will invest only in U.S.-
registered bonds that are listed or traded in the United States.
However, certain of the Fund's debt holdings may be issued by
corporations domiciled outside the United States.
    \10\ Distressed debt is debt that is currently in default and is
not expected to pay the current coupon.
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    To respond to adverse market, economic, political or other
conditions, the Fund may invest 100% of its total assets, without
limitation, in high-quality short-term debt securities and money market
instruments. The Fund may be invested in these instruments for extended
periods, depending on the Sub-Advisor's assessment of market
conditions. These short-term debt securities and money market
instruments include shares of other mutual funds, commercial paper,
certificates of deposit, bankers' acceptances, and U.S. Government
securities.
    Additional details regarding the Shares and the Fund including,
among other things, the organization and structure of the Fund, the
investment objectives and methodologies, investment risks,
dissemination and availability of key information about the Fund, the
Shares, and the portfolio, creations and redemptions of Shares, trading
halts, trading rules, surveillance, and the Information Bulletin can be
found in the Notice and the Registration Statement, as applicable.\11\
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    \11\ See supra notes 3 and 5.
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III. Discussion and Commission's Findings

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\12\ In particular, the Commission finds that the proposed
rule change is consistent with the requirements of Section 6(b)(5) of
the Act,\13\ which requires, among other things, that the Exchange's
rules be designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in
facilitating transactions in securities, to remove impediments to, and
perfect the mechanism of, a free and open market and a national market
system, and, in general, to protect investors and the public interest.
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    \12\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
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    The Commission finds that the proposal to list and trade the Shares
on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the
Act,\14\ which sets forth Congress' finding that it is in the public
interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for and transactions in securities. Quotation and last-sale
information for the Shares will be disseminated through the facilities
of the Consolidated Tape Association. In addition, the Portfolio
Indicative Value (``PIV'') will be disseminated at least every 15
seconds during the Core Trading Session by one or more major market
data vendors. On each business day before commencement of trading in
Shares in the Core Trading Session on the Exchange, the Fund will
disclose on its Web site the Disclosed Portfolio, as defined in NYSE
Arca Equities Rule 8.600(c)(2), that will form the basis for the Fund's
calculation of net asset value (``NAV'') at the end of the business
day.\15\ In addition, information regarding market price and trading
volume of the Shares is and will be continually available on a real-
time basis throughout the day on brokers' computer screens and other
electronic services, and the previous day's closing price and trading
volume information will be published daily in the financial section of
newspapers. The Fund will also make available on its Web site daily
trading volume of the Shares, closing prices of the Shares, NAV, and
other related quantitative and trading information. A basket
composition file, which includes the security names and share
quantities required to be delivered in exchange for Fund shares,
together with estimates and actual cash components, will be publicly
disseminated daily prior to the opening of the New York Stock Exchange
(``NYSE'') via the National Securities

Clearing Corporation. The basket represents one Creation Unit of the
Fund. The NAV of the Fund will normally be determined as of the close
of the regular trading session on the NYSE (ordinarily 4 p.m. Eastern
Time) on each business day.
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    \14\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \15\ On a daily basis, the Advisor will disclose for each
portfolio security or other financial instrument of the Fund the
following information: Ticker symbol (if applicable), name of
security or financial instrument, number of shares or dollar value
of financial instruments held in the portfolio, and percentage
weighting of the security or financial instrument in the portfolio.
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    The Commission further believes that the proposal to list and trade
the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately and
to prevent trading when a reasonable degree of transparency cannot be
assured. The Commission notes that the Exchange will obtain a
representation from the issuer of the Shares that the NAV and the
Disclosed Portfolio will be made available to all market participants
at the same time.\16\\\ The Exchange may halt trading in the Shares if
the value of the Portfolio Indicative Value is no longer calculated or
available or the Disclosed Portfolio is not made available to all
market participants at the same time.\17\\\ In addition, NYSE Arca
Equities Rule 8.600(d)(2)(B)(ii) requires that the Reporting Authority
that provides the Disclosed Portfolio implement and maintain, or be
subject to, procedures designed to prevent the use and dissemination of
material non-public information regarding the actual components of the
portfolio. Lastly, the Commission notes that the Exchange will halt
trading in the Shares under the specific circumstances set forth in
NYSE Arca Equities Rule 8.600(d)(2)(D) and that, if there is an
additional Fund sub-advisor that is affiliated with a broker-dealer,
that sub-advisor must erect a fire wall between it and such broker-
dealer with respect to access to information concerning the composition
and/or changes to the investment portfolio of the Fund.\18\
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    \16\ See NYSE Arca Equities Rule 8.600(d)(1)(B) (also requiring
that the Exchange obtain a representation from the issuer that the
NAV per Share will be calculated daily).
    \17\ See NYSE Arca Equities Rule 8.600(d)(2)(C)(ii). With
respect to trading halts, the Exchange may consider other relevant
factors in exercising its discretion to halt or suspend trading in
the Shares. Trading on the Exchange in the Shares may be halted
because of market conditions or for reasons that, in the view of the
Exchange, make trading in the Shares inadvisable. These may include:
(1) The extent to which trading is not occurring in the securities
comprising the Disclosed Portfolio and/or the financial instruments
of the Fund; or (2) whether other unusual conditions or
circumstances detrimental to the maintenance of a fair and orderly
market are present.
    \18\ The Commission notes that the Exchange has represented that
neither the Fund's Advisor nor Sub-Advisor is affiliated with a
broker-dealer. See supra note 6.
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    The Exchange has represented that the Shares are deemed to be
equity securities, thus rendering trading in the Shares subject to the
Exchange's existing rules governing the trading of equity securities.
In support of this proposal, the Exchange has made representations,
including:
    (1) The Shares will conform to the initial and continued listing
criteria under NYSE Arca Equities Rule 8.600.
    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (3) The Exchange's surveillance procedures are adequate to properly
monitor Exchange trading of the Shares in all trading sessions and to
deter and detect violations of Exchange rules and applicable federal
securities laws.
    (4) Prior to the commencement of trading, the Exchange will inform
its ETP Holders in an Information Bulletin of the special
characteristics and risks associated with trading the Shares.
Specifically, the Information Bulletin will discuss the following: (a)
The procedures for purchases and redemptions of Shares in Creation Unit
aggregations (including noting that Shares are not individually
redeemable); (b) NYSE Arca Equities Rule 9.2(a), which imposes a duty
of due diligence on its ETP Holders to learn the essential facts
relating to every customer prior to trading the Shares; (c) the risks
involved in trading the Shares during the Opening and Late Trading
Sessions when an updated PIV will not be calculated or publicly
disseminated; (d) how information regarding the PIV is disseminated;
(e) the requirement that ETP Holders deliver a prospectus to investors
purchasing newly issued Shares prior to or concurrently with the
confirmation of a transaction; and (f) trading information.
    (5) A minimum of 100,000 Shares will be outstanding at the
commencement of trading on the Exchange.
    (6) For initial and continued listing, the Shares must comply with
Rule 10A-3 under the Act.\19\
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    \19\ 17 CFR 240.10A-3.
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    This approval order is based on the Exchange's representations.
    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act \20\ and the
rules and regulations thereunder applicable to a national securities
exchange.
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    \20\ 15 U.S.C. 78f(b)(5).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\21\ that the proposed rule change (SR-NYSEArca-2010-86), be, and
it hereby is, approved.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-29560 Filed 11-23-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7406-7407]
[FR Doc No: 2016-02776]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2015-0126]

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated February 27, 2015, Union Pacific Railroad (UP) has petitioned the
Federal Railroad Administration (FRA) for a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR part 232, Brake System Safety Standards for Freight and Other
Non-Passenger Trains and Equipment; End-of-Train Devices. Specifically,
UP requests a waiver of compliance from the requirements of 49 CFR
232.205, Class I brake test-initial terminal inspection, to permit a
train to be split en route using the same initial terminal inspection.
FRA assigned the petition Docket Number FRA-2015-0126.
    In its petition, UP states that it is launching trains with
multiple locomotive consists within the train so that the train can be
split at an appropriate point en route, creating two separate trains
bound for different destinations. A combined train of this type
undergoes a Class 1 air brake test at departure pursuant to 49 CFR
232.205. At a location less than 1,000 miles from the departure point,
the combined train is cut at the distributed power units. No new
locomotive units are added to the resulting second train. The second
train is equipped with an end-of-train device or equivalent device,
linked to what is now the lead locomotive in the consist. No cars are
added to the second train. The cars on the second train were all part
of the original train and have not been off air for more than 4 hours.
These cars undergo a Class 3 air brake test pursuant to 49 CFR 232.211,
Class III brake tests-trainline continuity inspection, before
continuing to their destination.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200

New Jersey Avenue SE., W12-140, Washington, DC 20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by March 14, 2016 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its processes. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
See also http://www.regulations.gov/#!privacyNotice for the privacy
notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2016-02776 Filed 2-10-16; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register: April 24, 2006 (Volume 71, Number 78)]
[Notices]
[Page 21087-21088]
[DOCID:fr24ap06-111]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53670; File No. SR-Phlx-2006-21]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating To Delaying Implementation of Its Cancellation Fee

April 18, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 31, 2006, the Philadelphia Stock Exchange, Inc. (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Phlx. The Phlx
has filed the proposed rule change as one establishing or changing a
due, fee, or other charge imposed by the Phlx under Section
19(b)(3)(A)(ii) \3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders
the proposal effective upon filing with the Commission. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the effective date for the
cancellation fee it recently established \5\ from January 2, 2006 to
May 1, 2006. The Exchange also proposes to clarify that the
cancellation fee will not be assessed on any cancellation orders
received prior to the opening of trading.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 53226 (February 3,
2006), 71 FR 7602 (February 13, 2006) (SR-Phlx-2005-92).
---------------------------------------------------------------------------

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 Phlx 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 Phlx 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
    Previously, the Exchange adopted a cancellation fee of $1.10 per
cancellation order to be assessed on member organizations for each
cancelled AUTOM-delivered \6\ order in excess of the number of orders
executed on the Exchange by that member organization in a given
month.\7\ The cancellation fee was not to be assessed in a month in
which fewer than 500 AUTOM-delivered orders were cancelled. Simple
cancels and cancel-replacement orders were the types of orders that
were to be counted when calculating the number of AUTOM-delivered
orders.\8\ The objective of the fee was to discourage excessive use of
cancellations.\9\
---------------------------------------------------------------------------

    \6\ AUTOM is the Exchange's electronic order delivery, routing,
execution and reporting system, which provides for the automatic
entry and routing of equity option and index option orders to the
Exchange trading floor. See Exchange Rules 1014(b)(ii) and 1080.
    \7\ See supra note 5.
    \8\ A cancel-replacement order is a contingency order consisting
of two or more parts, which require the immediate cancellation of a
previously received order prior to the replacement of a new order
with new terms and conditions. If the previously placed order is
already filled partially or in its entirety, the replacement order
is automatically canceled or reduced by such number. See Exchange
Rule 1066(c)(7).
    \9\ The proposal did not cover orders delivered through the
Exchange's Floor Broker Management System.
---------------------------------------------------------------------------

    Prior to implementing the cancellation fee, the Exchange analyzed
data and then discussed with member organizations the potential effect
of the fee. However, it later came to the attention of the Exchange
that the data analyzed by the Exchange was incomplete. Therefore,
member organizations, based on the Exchange's analysis, did not believe
it was necessary to monitor the use of cancellation orders by any of
their respective customers. In actuality, the assessment of the
cancellation fee for some member organizations greatly exceeded the
estimated amount that was communicated to them.
    At this time, the Exchange has discussed with the affected member
organizations the amount of the cancellation fees that would have been
incurred based on revised and complete January and February 2006 data.
Therefore, the Exchange proposes to delay implementation of the
cancellation fee until May 1, 2006 to allow member organizations the
opportunity either to change behavior or

to determine how to most effectively deal with these charges. The
Exchange believes it is appropriate to delay implementation of the
cancellation fee due to the incomplete data that had been previously
communicated to the member organizations.\10\ In addition, the Exchange
seeks to clarify that pre-market cancellations are not included in the
calculation of the cancellation fee because this is not the type of
behavior that the Exchange is trying to discourage. No other changes
are being proposed in connection with the delayed assessment of the
cancellation fee.
---------------------------------------------------------------------------

    \10\ The Exchange indicated that no rebates need to be
processed. Although January and February cancellation charges were
billed on the February invoice, the Exchange separately discovered a
billing issue and credited the amount of cancellation charges billed
to member organizations while the billing issue was reviewed.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal to amend its schedule of
fees is consistent with Section 6(b) of the Act,\11\ in general, and
furthers the objectives of Section 6(b)(4) of the Act,\12\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among Exchange members.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \13\ and Rule
19b-4(f)(2) \14\ thereunder. Accordingly, the proposal will take effect
upon filing with the Commission. At any time within 60 days of the
filing of the proposed rule change, the Commission may summarily
abrogate 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.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \14\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Phlx-2006-21 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-Phlx-2006-21. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room. Copies of the
filing also will be available for inspection and copying at the
principal office of the Phlx. 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-Phlx-2006-21 and should be submitted on or before May
15, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
[FR Doc. E6-6072 Filed 4-21-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 187 (Tuesday, September 27, 2016)]
[Proposed Rules]
[Pages 66243-66244]
[FR Doc No: 2016-23253]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 390

[Docket No. FMCSA-2012-0103]
RIN 2126-AB90

Lease and Interchange of Vehicles; Motor Carriers of Passengers

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of meeting; request for comment.

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

SUMMARY: FMCSA announces it will hold a roundtable discussion on
October 31, 2016, as a follow-up to its August 31, 2016, notice of
intent concerning the petitions for reconsideration of the final rule,
titled ``Lease and Interchange of Vehicles; Motor Carriers of
Passengers,'' which published May 27, 2015. The meeting will be open to
the public. Individuals with diverse experience, expertise, and
perspectives are encouraged to attend. If all comments have been
exhausted before the end of the session, the session may conclude
early.

DATES: The roundtable discussion will be held on Monday, October 31,
2016, from 9:30 a.m. to 4:30 p.m., Eastern Time (ET) at the U.S.
Department of Transportation, Media Center, 1200 New Jersey Avenue SE.,
Ground Floor, Washington, DC 20590. The entire proceedings will be
public.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System Docket ID (FMCSA-2012-0103) using any of the
following methods:
    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.
    Hand Delivery or Courier: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., ET, Monday through Friday, except Federal holidays.
    Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The online Federal document management system
is available 24 hours each day, 365 days each year. If you would like
acknowledgment that the Agency received your comments, please include a
self-addressed, stamped envelope or postcard or print the
acknowledgement page that appears after submitting comments online. The
docket FMCSA-2016-0102 will remain open indefinitely.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Loretta G. Bitner,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Chief, Commercial Passenger Carrier Safety
Division, Office of Enforcement and Compliance, Federal Motor Carrier
Safety Administration. FMCSA office hours are from 8 a.m. to 4:30 p.m.
ET, Monday through Friday, except Federal holidays.

    For information about the public meeting: Ms. Shannon L. Watson,
Senior Policy Advisor, Federal Motor Carrier Safety Administration,
1200 New Jersey Avenue SE., Washington, DC 20590, by telephone at 202-
366-2551, or by email at<EMAIL_ADDRESS>If you have questions
on viewing or submitting material to the docket, contact Docket
Services at<PHONE_NUMBER>. Business hours are from 8 a.m. to 4:30 p.m.
ET, Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background:

    On August 31, 2016, FMCSA published a notice of intent concerning
the lease and interchange of passenger-carrying commercial motor
vehicles (CMVs) (81 FR 59951). The purpose of the notice of intent was
to inform the public about the Agency's decision concerning the 37
petitions for reconsideration which have been filed in the public
docket referenced above. Upon review of these petitions, FMCSA
concluded that some have merit. FMCSA, therefore, extended the
compliance date of the final rule from January 1, 2017, to January 1,
2018 (82 FR 13998; March 16, 2016), to allow the Agency time to
complete any rulemaking action to amend the rule where necessary.

FMCSA Decision

    FMCSA plans to issue a rulemaking notice to address the four areas
of concern in the August 31, 2016, notice of intent:
    (1) Exclusion of ``chartering'' (i.e., subcontracting) from the
leasing requirements;
    (2) Amending the CMV requirements for the location of temporary
markings for leased/interchanged vehicles;
    (3) Changing the requirement that carriers notify customers within
24 hours when they subcontract service to other carriers; and
    (4) Expanding the 48-hour delay in preparing a lease to include
emergencies when passengers are not actually on board a bus.
    The Agency believes that less burdensome regulatory alternatives
that would not adversely impact safety could be adopted before the
January 1, 2018, compliance date.

Public Roundtable

    FMCSA will hold a public roundtable on Monday, October 31, 2016, to
discuss these four issue areas. The public will have an opportunity to
speak about these issues and provide the Agency with information on how
to address them. All public comments will be placed in the docket of
this rulemaking. The agenda for this meeting will be posted on the
FMCSA Web site www.fmcsa.dot.gov in the near future.

     Issued on: September 15, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-23253 Filed 9-26-16; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: October 6, 2005 (Volume 70, Number 193)]
[Notices]
[Page 58406]
[DOCID:fr06oc05-81]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Membership of Performance Review Board for Senior
Executives (PRB)

September 29, 2005.
    The Federal Energy Regulatory Commission hereby provides notice of
the membership of its Performance Review Board (PRB) for the
Commission's Senior Executive Service (SES) members. The function of
this board is to make recommendations relating to the performance of
senior executives in the Commission. This action is undertaken in
accordance with Title 5, U.S.C., Section 4314(c)(4). The Commission's
PRB will remove the following member: Cynthia A. Marlette and will add
the following member: John S. Moot.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5507 Filed 10-5-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Pages 20436-20441]
[FR Doc No: 2022-07451]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0907]

Medical Device User Fee Amendments; Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a virtual public meeting entitled ``Medical Device User Fee
Amendments.'' The purpose of the meeting is to discuss proposed
recommendations for the

reauthorization of the Medical Device User Fee Amendments (MDUFA) for
fiscal years (FYs) 2023 through 2027. MDUFA authorizes FDA to collect
fees and use them for the process for the review of device
applications. The current legislative authority for MDUFA expires
September 30, 2022. At that time, new legislation will be required for
FDA to continue collecting device user fees in future fiscal years.
Following discussions with the device industry and periodic
consultations with public stakeholders, the Federal Food, Drug, and
Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for
the reauthorized program in the Federal Register, provide for a period
of 30 days for the public to provide written comments on such
recommendations, and hold a meeting at which the public may present its
views on such recommendations. FDA will then consider such public views
and comments and revise such recommendations as necessary.

DATES: The public meeting will be held virtually on April 19, 2022,
from 12 p.m. to 4:30 p.m. Eastern Time. Submit electronic or written
comments to the public docket by April 21, 2022.

ADDRESSES: Registration to attend this virtual public meeting and other
information can be found at https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022.
    You may submit written comments on the recommendations as follows.
Please note that late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before April 21, 2022. The
https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of April 21, 2022.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-0907 for ``Medical Device User Fee Amendments; Public
Meeting.'' FDA published the commitment letter on March 22, 2022. The
commitment letter can be found in the docket and on this website at
https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v. The docket will close
on April 21, 2022. Received comments those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly available at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mimi Nguyen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5547, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of proposed recommendations for
the reauthorization of MDUFA, which authorizes FDA to collect user fees
and use them for the process for the review of device applications. We
are also announcing a virtual public meeting to discuss such
recommendations. The current authorization of the MDUFA program
continues until September 30, 2022. Without new legislation, FDA will
no longer be able to collect user fees for future fiscal years to
provide funds for the process for the review of device applications.
    Section 738A(b)(4) of the FD&C Act (21 U.S.C. 379j-1(b)(4))
requires that, after holding negotiations with regulated industry, we
take the following actions: (1) Present the recommendations to the
Committee on Energy and Commerce of the U.S. House of Representatives
and the Committee on Health, Education, Labor, and

Pensions of the U.S. Senate; (2) publish the recommendations in the
Federal Register; (3) provide a period of 30 days for the public to
submit written comments on the recommendations; (4) hold a meeting at
which the public may present its views on the recommendations; and (5)
after consideration of public views and comments, revise the
recommendations as necessary. This notice, the 30-day comment period,
and the public meeting will satisfy parts of these requirements. After
the public meeting, we will revise the recommendations as necessary. In
addition, the Agency will present the recommendations to the
Congressional committees.
    The purpose of the meeting is for the public to present its views
on the proposed recommendations for the reauthorized program (MDUFA V).
The meeting format will include presentations by FDA and different
stakeholder interest groups (such as industry, patient and consumer
advocates, healthcare professionals, and scientific and academic
experts). The Agency will also provide an opportunity for other
interested individuals to make presentations at the meeting.
    The following information is provided to help potential meeting
participants better understand the history and evolution of the medical
device user fee program and the current status of the proposed MDUFA V
recommendations.

II. What is MDUFA and what does it do?

    MDUFA is the law that authorizes FDA to collect fees from device
companies that register their establishments, submit applications to
market devices, and make other types of device submissions. In the
years preceding enactment of the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), FDA's medical
device program suffered a long-term, significant loss of resources that
undermined the program's capacity and performance. MDUFMA was enacted
``in order to provide FDA with the resources necessary to better review
medical devices, to enact needed regulatory reforms so that medical
device manufacturers can bring their safe and effective devices to the
American people at an earlier point in time, and to ensure that
reprocessed medical devices are as safe and effective as original
devices.'' H.R. Rep. 107-728 at p. 21 (October 7, 2002). MDUFMA was
authorized for 5 years and contained two important features that relate
to reauthorization:
     User fees for the review of medical device premarket
applications, reports, supplements, and premarket notification
submissions provided additional resources to make FDA reviews more
timely, predictable, and transparent to applicants. User fees and other
appropriations for the medical device program helped FDA expand
available expertise, modernize its information management systems,
provide new review options, and provide more guidance to prospective
submitters. The ultimate goal was for FDA to clear or approve safe and
effective medical devices more rapidly and predictably, benefiting
applicants, the healthcare community, and most importantly, patients.
     Negotiated performance goals for many types of premarket
reviews provided FDA with benchmarks for measuring review improvements.
These quantifiable goals became more demanding each year and included
FDA decision goals and cycle goals (cycle goals refer to FDA actions
prior to a final action on a submission). Under MDUFMA, FDA also agreed
to several other commitments that did not have specific timeframes or
direct measures of performance, such as expanding the use of meetings
with industry, maintenance of current performance in review areas where
specific performance goals had not been identified, and publication of
additional guidance documents.
    Medical device user fees and increased appropriations were viewed
by FDA, Congress, and industry stakeholders as essential to support
high-quality, timely medical device reviews, and other activities
critical to the device review program.
    MDUFMA provided for--and reauthorizations have maintained--fee
discounts and waivers for qualifying small businesses. Small businesses
make up a large proportion of the medical device industry, and these
discounts and waivers helped reduce the financial impact of user fees
on this sector of the device industry, which plays an important role in
fostering innovation.
    Since MDUFMA was first enacted in 2002, it has been reauthorized
three times through the Medical Device User Fee Amendments of 2007
(MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III),
and the Medical Device User Fee Amendments of 2017 (MDUFA IV). MDUFA IV
has been in effect since 2017 and will expire on September 30, 2022
(https://www.fda.gov/media/100848/download). The MDUFA IV agreement
enabled FDA to continue making progress on reducing review times and
bringing devices to patients more quickly, while also enabling FDA to
move forward in critical areas, including:
     Building a sustainable infrastructure for efficient,
consistent, transparent, and high-quality regulation of devices
throughout the total product lifecycle;
     Accessing and using real-world evidence in the regulatory
decision-making process;
     Advancing patient engagement and the regulatory science of
patient input;
     Advancing the smart oversight of digital health
technologies in ways that support innovation, balance innovation and
safety, and show promise as a potential blueprint for future regulatory
approaches to emerging technologies.
    In terms of review goals, FDA's performance was strong during the
initial years of MDUFA IV (FY 2018 and FY2019), continuing to meet and
exceed performance goals and working to reduce the time for patients to
have access to safe, new, innovative devices. During this time, FDA
achieved all of our submission review goals, met 21 of 24 performance
enhancement goals, and FDA and industry met three of four shared
outcome goals. Starting in FY 2020, the strain from the pandemic, as
well as a workload that exceeded assumptions underlying the MDUFA IV
agreement, resulted in failure to meet certain MDUFA IV goals.
    Preliminary performance data through September 30, 2021, including
completed and pending reviews, indicate that FDA has met (or has the
potential to meet) 13 of the 16 FY 2020 review goals and 9 of the 13 FY
2021 review goals for which FDA had a sufficient MDUFA cohort to
calculate performance. FDA also completed, on time, all eight
performance enhancement goals due in FY 2021. However, FDA's response
to the unprecedented COVID-19 public health emergency has impacted
FDA's MDUFA performance, resulting in three missed FY 2020 review goals
and four missed FY 2021 review goals. Information about FDA's
performance is available in the yearly and quarterly MDUFA performance
reports, which are online at: https://www.fda.gov/about-fda/user-fee-performance-reports/mdufa-performance-reports and https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/mdufa-reports.

III. Proposed MDUFA V Recommendations

    In preparing the proposed recommendations to Congress for MDUFA
reauthorization, FDA conducted discussions with the device

industry and consulted with stakeholders, as required by the FD&C Act.
The Agency began the MDUFA reauthorization process by publishing a
notice in the Federal Register requesting public input on the
reauthorization and announcing a public meeting that was held on
October 27, 2020. The meeting included presentations by FDA (which
complemented videos released ahead of the public meeting highlighting
FDA's efforts and accomplishments under the MDUFA IV agreement) and a
series of panels with representatives of different stakeholder groups,
including patient and consumer advocacy groups, regulated industry, and
healthcare professionals. The materials from the meeting, including a
transcript and webcast recording, can be found at https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-10272020.
    From February 2021 through March 2022, FDA conducted negotiations
with representatives of the device industry: The Advanced Medical
Technology Association; the Medical Device Manufacturers Association;
the Medical Imaging and Technology Alliance; and the American Clinical
Laboratory Association. During its negotiations with industry, FDA also
held monthly consultations with representatives of patient and consumer
advocacy groups and other public stakeholders. Meeting minutes are
posted on FDA's website at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
    The proposed recommendations for MDUFA V address many priorities
identified by industry and other stakeholders. While some of the
proposed recommendations are new, many either build on successful
enhancements or refine elements from the existing program. FDA posted
the full text of the proposed MDUFA V commitment letter at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v. Each significant new or
modified recommendation is briefly described below with reference to
the applicable section of the proposed commitment letter.

A. Shared Outcome Goals

    FDA and representatives of the device industry believe that the
process improvements outlined in the proposed commitment letter, when
implemented by all parties as intended, should reduce the average Total
Time to Decision for premarket approval applications (PMAs), and
premarket notification (510(k)) submissions, provided that the total
funding of the device review program adheres to the assumptions
underlying the MDUFA V agreement. Reducing average Total Time to
Decision, as defined in the commitment letter, is an important aspect
of the user fee program, so that safe and effective devices reach
patients and healthcare professionals more quickly. FDA proposes, for
PMA and 510(k) submissions, with the performance improvement
adjustments described below, that the Total Time to Decision will reach
270 calendar days for original PMA and panel-track supplement
submissions and 108 calendar days for 510(k)s by FY 2027.
    Additional details regarding the shared outcome goals can be found
in Sections I and III of the proposed commitment letter.

B. Pre-Submissions

    MDUFA V provides additional resources for FDA to address the
increasing volume of Pre-Submissions requests and to improve the Pre-
submission performance goal. FDA proposes to ramp up to a performance
goal of providing written feedback on at least 90 percent of Pre-
Submissions within 70 days or 5 calendar days prior to the scheduled
meeting, whichever comes sooner, by FY 2025. With the performance
improvement adjustments described below, FDA may continue to improve
this performance goal in FY 2026-2027. FDA will also update guidance to
include additional information to assist applicants and review staff in
identifying the circumstances in which an applicant's question is most
appropriate for informal communication instead of a Pre-Submission.
Additional details regarding Pre-Submissions can be found in Sections
II.A and III.C of the proposed commitment letter.

C. De Novo Requests

    FDA will have an opportunity, with the performance improvement
adjustments described below, to ramp up to a De Novo decision goal of
90 percent of De Novo request submissions within 150 days in FY 2027.
Additional details regarding De Novo requests can be found in Sections
II.E and III.B of the proposed commitment letter.

D. Opportunity for Performance Improvements

    FDA proposes adding a new performance improvement adjustment for
MDUFA V that would allow FDA to collect fees in addition to annual
total revenue in FY 2025, FY 2026, and/or FY 2027, if certain review
performance and/or shared outcome goals are met for FY 2023, 2024, and/
or 2025. If applicable, these fee increases will apply solely to
establishment registration fees and support improvements to the 510(k)
and PMA Shared Outcome Total Time to Decision goals, the Pre-Submission
Written Feedback goal, and the De Novo decision goal. The following
examples describe adjustments if goals are met for FY 2023:
     If FDA's 510(k) decision goal, the FDA/Industry 510(k)
Shared Outcome Total Time to Decision goal, FDA's PMA decision goal,
and the FDA/Industry PMA Shared Outcome Total Time to Decision goal are
met for FY 2023, and fee revenue above the annual total revenue amount
is provided in FYs 2026 and 2027, then the 510(k) Shared Outcome Total
Time to Decision goal and the PMA Shared Outcome Total Time to Decision
goal will be adjusted. Specifically, the 510(k) Shared Outcome Total
Time to Decision goal will be improved to 108 days for FYs 2026 and
2027, and the PMA Shared Outcome Total Time to Decision goal will be
improved to 275 days for FYs 2026 and 2027.
     If the Pre-Submission Written Feedback goal is met for FY
2023, and fee revenue above the annual total revenue amount is provided
to support performance improvements in FYs 2025, 2026, and 2027, the
maximum number of Pre-Submissions subject to the goal will improve to
4,700 Pre-Submissions in FYs 2025, 2026, and 2027.
     If the De Novo decision goal is met for FY 2023, and fee
revenue above the annual total revenue amount is provided in FYs 2026
and 2027 to support performance improvements, the goal will improve to
80 percent of De Novo requests receiving a MDUFA decision within 150
FDA days for FYs 2026 and 2027.
    Additional details regarding the opportunity for performance
improvements can be found in Section III of the proposed commitment
letter. Under the new performance improvement adjustment, FDA may
receive additional funding up to the following maximum amounts (which
would be adjusted for inflation):

 $15,396,600 for FY 2025
 $44,135,700 for FY 2026
 $56,244,000 for FY 2027

E. Deficiency Letters

    To support improved communication in FDA letters requesting
additional

information, FDA will clarify what constitutes a statement of the basis
for the deficiency in updated guidance, train staff and managers on the
updated guidance, and establish a performance goal for providing a
statement of the basis for the deficiency that ramps up to 95 percent
by FY 2027.

F. Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot

    FDA will launch a voluntary pilot program to provide more frequent
and timely interactions for industry and other stakeholders earlier in
the device development process with a focus on Breakthrough (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program) and Safer Technologies Program devices
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices). Through the TAP
Pilot, FDA will provide strategic engagement for innovative devices of
public health importance by facilitating improved strategic decision
making during product development, including earlier identification,
assessment, and mitigation of product-development risk. The TAP Pilot
will also support engagement to better align expectations regarding
evidence generation, improve submission quality, and improve the
efficiency of the premarket review process. Additional details
regarding the TAP Pilot can be found in Section V.J of the proposed
commitment letter.

G. Patient Science and Engagement

    FDA proposes to continue building the Patient Science and
Engagement program, which engages patients and supports incorporating
their perspectives in the regulatory process. In particular, FDA
proposes to expand the program through the following activities:
Facilitate patient engagement through patient-friendly educational
content; explore ways to advance health equity; continue to expand
patient science review expertise and capacity; improve the regulatory
predictability and impact of patient science, including shared
examples; hold a public meeting on patient-generated health data for
collecting clinical outcome assessment (COA) data and for remote
clinical trials; and issue draft guidance on incorporating COA into
premarket studies and update patient preference information guidance.
Additional details regarding patient science and engagement can be
found in Section V.E of the proposed commitment letter.

H. Enhanced Use of Consensus Standards

    During MDUFA IV, FDA initiated the voluntary Accreditation Scheme
for Conformity Assessment (ASCA) pilot to enhance product reviewers'
and device manufacturers' confidence in medical device testing when
manufacturers rely on testing completed by ASCA-accredited testing
laboratories. FDA proposes to use lessons learned from implementation
of the ASCA pilot in MDUFA IV to transition to a sustainable and
expanded program in MDUFA V. Additional details regarding the enhanced
use of consensus standards can be found in Section V.C of the proposed
commitment letter.

I. International Harmonization

    FDA will enhance international harmonization activities by
expanding engagement in international harmonization and convergence
efforts to promote alignment with international best practices and
internationally developed policies. Additional details regarding
international harmonization can be found in Section V.I of the proposed
commitment letter.

J. Third Party Premarket Review Program

    FDA proposes to maintain the Accredited Persons (Third Party
Review) program in MDUFA V. Additional details regarding the Third
Party Review program can be found in Section V.D of the proposed
commitment letter.

K. Real World Evidence (RWE)

    FDA proposes to continue to advance the development of Real-World
Data (RWD) and RWE methods and policies to advance regulatory
acceptance for premarket submissions. Additional details regarding RWE
can be found in Section V.F of the proposed commitment letter.

L. Digital Health

    FDA proposes to continue building its digital health expertise,
working to streamline and align FDA review processes with software
lifecycles for digital health products, engaging in international
harmonization efforts related to software review, and conducting other
activities related to digital health. Additional details regarding
digital health can be found in Section V.G of the proposed commitment
letter.

M. Information Technology (IT)

    FDA proposes to continue to enhance IT infrastructure to support
the process for the review of device applications, including improving
a submission progress tracking system and developing electronic
submission templates for more submission types. Additional details
regarding IT can be found in Section IV.C of the proposed commitment
letter.

N. Financial Transparency and Hiring

    FDA proposes to take several new steps to provide additional
transparency and accountability measures with respect to MDUFA V
finances and hiring. The Agency proposes to publish a MDUFA 5-year
financial plan that will be updated annually. In addition, new
statutory language for an operating reserve adjustment is proposed to
reflect FDA and industry-agreed measures for managing the amount of
operating reserves in the MDUFA carryover balance. Under this new
provision, FDA would decrease registration fees if the amount of
operating reserves exceeds the designated amount. The designated amount
for a fiscal year is equal to 13 weeks of operating reserves plus the 1
month of operating reserves required by statute. Further, the amount of
carryover user fees intended to support the Third Party Review program
and TAP Pilot during MDUFA V would be excluded for the period of FY
2023 through FY 2026 when calculating the amount of operating reserves
to determine if registration fees will be decreased. User fee funds in
the carryover balance that are considered unappropriated or unearned
are not included in the operating reserves.
    To help ensure that FDA accomplishes hiring in accordance with the
assumptions underlying the MDUFA V agreement, FDA proposes to set
annual hiring goals for MDUFA V positions. Proposed statutory language
would provide for the reduction of establishment registration fees for
FYs 2025, 2026, and 2027, if the Agency does not meet those goals for
FYs 2023, 2024, and 2025, respectively, by a certain threshold. The
amount of the hiring adjustment fee decrease would be the product of
the number of hires by which the hiring goal was missed and one-quarter
of the inflation-adjusted cost per full time equivalent. Additional
details regarding financial transparency and hiring can be found in
Section IV.B of the proposed commitment letter.

O. Independent Assessments

    FDA and industry propose to participate in a targeted assessment of
the management of the process for the review of device applications.
FDA also proposes to retain an independent contractor with expertise in
assessing public sector workforce data analysis

and reporting to conduct an assessment of current methodologies and
data/metrics available to represent the MDUFA workforce. Additional
details regarding the independent assessments can be found in Section
VI of the proposed commitment letter.

P. Performance Reports

    FDA proposes to continue to report quarterly and annually on
performance against commitments. Additionally, FDA proposes to report
quarterly on progress toward hiring goals and funding intended for RWE
activities. FDA will report annually on the primary cost drivers for
changes to personnel compensation and benefits costs. Additional
details regarding performance reporting can be found in Section VII of
the proposed commitment letter.

Q. User Fee Revenue and Fee Allocations

    As part of MDUFA V, FDA and industry propose updating the base fee
amounts for PMAs and annual establishment registrations, as well as the
annual total revenue amounts, to reflect negotiated fee levels. The
statutory total revenue amounts, base fee amounts, and amounts for
potential performance improvement adjustments are proposed in FY 2021
dollars, such that annual inflation adjustments will be used to inflate
FY 2021 dollars to the appropriate amounts for each fiscal year in
MDUFA V. FDA and industry also propose to change the fee for a PMA
Panel-Track supplement from 75 percent to 80 percent of the fee for an
original PMA and to change the fee for a 510(k) submission from 3.4
percent to 4.5 percent of the fee for a PMA. Finally, a minor change is
proposed to the statutory provisions regarding fee waivers and
reductions for small businesses to clarify that an applicant seeking a
waiver or reduction is not required to submit a certification from the
national taxing authority of the foreign country in which the
applicant, or its affiliate, is located, if the country has no national
taxing authority.
    FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022.

IV. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022. Please provide complete contact information
for each attendee, including name, title, affiliation, email, and
telephone number. Registrants will receive confirmation after they have
been accepted.
    Registration is free. Persons interested in attending by webcast
the MDUFA virtual public meeting must register online by 4 p.m. Eastern
Time, April 18, 2022. Early registration is recommended.
    If you need special accommodations because of a disability, please
contact Susan Monahan at<PHONE_NUMBER> or [email protected] no
later than April 11, 2022.
    Requests for Oral Presentations: This meeting includes a public
comment session and topic-focused sessions. During online registration
you may indicate if you wish to present during the public comment
session or a specific session, and which topic(s) you wish to address.
All requests to make oral presentations virtually by webcast must be
received by April 11, 2022, at 4 p.m. Eastern Time. FDA will do its
best to accommodate requests to make public comments. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations and request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin
and will notify speakers by April 12, 2022. If selected for
presentation, any presentation materials must be emailed to Mimi Nguyen
(see FOR FURTHER INFORMATION CONTACT) no later than April 13, 2022, at
4 p.m.. Eastern Time. No commercial or promotional material will be
permitted to be presented or distributed at the meeting.
    FDA is holding this meeting to provide information on the proposed
recommendations for the reauthorization of MDUFA for FYs 2023 through
2027. To permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the meeting topics. The docket was opened on March 22, 2022.
The proposed commitment letter was posted in the docket and on this
website at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v. The
docket will close on April 21, 2022, 30 days after the proposed
commitment letter was posted.
    Streaming Webcast of the Public Meeting: The webcast link will be
available on the registration web page after April 11, 2022.
Organizations are requested to register all participants.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at in the docket at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available
approximately 45 days after the public workshop on the internet at:
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022.

    Dated: April 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07451 Filed 4-6-22; 8:45 am]
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